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1 KC IRB Crosswalk: Completing the IRB Application (implemented 08.29.2019) Back to Top

Guidance for Research Involving Human Subjects

KC IRB Crosswalk: Table of Contents This crosswalk is meant as a tool for investigators, HSO staff, and IRB members and provides information about the KC IRB application process, specifically the questionnaire functionality. This information is meant as a tool only and should be considered guidance. Please contact the HSO if you are unsure how to answer a specific question.

• Using the Crosswalk • Important Topics for Full Board & Expedited Studies

Use the links in the table below to view the questionnaires and review Tips & Tricks for answering specific questions.

Full Board/Expedited Questionnaires Initial Submission & Review

Full Board/Expedited Questionnaires Post-Approval

Exempt Questionnaires Questionnaires for Additional Types of Research

• Conflicts of Interest • A – Level of Review Assessment • B – Lay Summary & Research Design • C – Sites & Collaborations • D – Recruitment Methods • E – Risks Benefits, Protections • F – Data Safety Monitoring • G1 – Children • G2 – Individuals Lacking Consent Capacity • G3 – Pregnant Women/Fetuses/Neonates • G4 - Prisoners • G5 – Transnational Research • H – Informed Consent Process • J – Child Assent & Parental Consent Process • K – HIPAA • L – VA Research • M – ClinicalTrials.gov

• Amendment • Renewal:

o Open to Enrollment – Enrollment continues; Closed to Enrollment – Research interventions continue or Clinical Follow-up Only Path

o Open to Enrollment - No subjects consented to date Path

o Data Analysis Only Path • Reportable Event (FYI) • Study Closure/Closeout Report

• Conflicts of Interest • Exempt Research

• Reliance Request • Humanitarian Use Device • Research Not Subject to Human Subjects

Regulations


Using the Crosswalk The crosswalk consists of two parts: Important Topics – provides a summary of the information you should have available when completing your application for a full Board or Expedited study. Description of each topic includes:

o Information necessary for…: a short explanation of why the information is necessary for the IRB o Old HSO Forms: a reference to the HSO form where the information was previously requested o New Location: reference to the KC IRB tab or questionnaire where the information is now requested o References: a list of additional educational resources about the topic

Questionnaires – viewable copy of the individual questionnaires available in KC IRB including hierarchy and logic and information about each question therein.

The numbering system provided in the viewable questionnaires is included only for ease of understanding and readability, and to demonstrate the hierarchy of the questions. The numbers do NOT correspond to KC IRB.

The Question ID corresponds directly to the question ID in KC IRB and can be used to identify the specific question during discussion, pre-review, and IRB review.

The Appropriate Answer Types column provides information about the type of answer that KC IRB expects. Questions generally fall into one of the following categories:

• Free Text • Y/N – indicates a Yes/No question • Multiple Choice – The crosswalk includes the available options and

how many answers can be chosen. • Dropdown/List– The crosswalk includes the available options.

The Tips & Tricks column provides suggestions from staff and IRB members regarding appropriate answers and regulatory expectations.


Important Topics for Full Board & Expedited Studies The following is a list of items that you should be ready to describe in your IRB application. Description of each topic includes:

• Information necessary for…: a short explanation of why the information is necessary for the IRB • Old HSO Forms: a reference to the HSO form where the information was previously requested • New Location: reference to the KC IRB tab or questionnaire where the information is now requested • References: a list of additional educational resources about the topic

Topic Information necessary for…. Retired HSO Forms New Location References

Please note that additional SOPs and guidance documents are also available on the HSO website

Level of Review Identification of regulatory requirements • Protocol tab > Required Fields for Saving Document • KC IRB Questionnaire A – Level of Review Assessment

HSO guidance: • Expedited Research

Title Study identification Protocol tab > Required Fields for Saving Document

Principal Investigator Study identification Protocol tab > Required Fields for Saving Document

Funding Identification of additional requirements specific to funding sources

• Protocol tab > Funding Sources panel • KC IRB Questionnaire B – Lay Summary & Research

Design

Study Description (objectives, hypothesis)

• Study meets the definition of research • IRB reviewer understanding of the study

SSS, Section I KC IRB Questionnaire B – Lay Summary & Research Design

Number of Subjects • Risks to subjects are minimized (45 CFR 46, Criteria for Approval #1)

SSS, Section V Protocol tab

Performance Sites • Selection of subjects is equitable (45 CFR 46, Criteria for Approval #3)

• VA regulations for human subjects research

• SSS, Section IV • Request Form – Transnational

Research

• Protocol tab > Organizations Panel • KC IRB Questionnaire C – Sites & Collaborations • KC IRB Questionnaire G5– Transnational Research • KC IRB Questionnaire L – VA Research

HSO Guidance: • Research in International

Settings

Special Populations • Selection of subjects is equitable (45 CFR 46, Criteria for Approval #3)

• Additional safeguards have been included to protect the rights and welfare of any subjects likely to be vulnerable to coercion or undue influence (45 CFR 46).

• 45 CFR 46, Subpart B – Additional Protections for Pregnant Women, Human Fetuses, and Neonates Involved in Research

• SSS, Section V • Request Form for the Inclusion

of Children in Research • Request Form for the Inclusion

of Cognitively Impaired Individuals in Research

• Request Form for the Inclusion of Pregnant Women, Human

• Protocol tab > Participant Types panel • KC IRB Questionnaire G1 – Children • KC IRB Questionnaire G2 – Individuals Lacking Consent

Capacity • KC IRB Questionnaire G3 – Pregnant Women, Neonates,

Fetuses • KC IRB Questionnaire G4 – Prisoners

IU HRPP Policies: • Adult Individuals Lacking

Consent Capacity in Research • Children in Research • Pregnant Women, Fetuses,

Neonates in Research • Prisoners in Research HSO Guidance:

https://research.iu.edu/compliance/human-subjects/guidance/index.html

https://research.iu.edu/compliance/human-subjects/guidance/expedited.html

https://research.iu.edu/compliance/human-subjects/guidance/transnational.html


https://research.iu.edu/policies/human-subjects-irb.html


• 45 CFR 46, Subpart C – Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects

• 45 CFR 46, Subpart D – Additional Protections for Children Involved as Subjects in Research

Fetuses, and Neonates in Research

• Request Form for the Inclusion of Prisoners in Research

• Research with Adult Individuals Lacking Consent Capacity

• Conducting Research with Children

• Research Enrolling Prisoners as Subjects

• Recruiting Students as Research Subjects

• Research in International Settings

Inclusion/Exclusion • Risks to subjects are minimized (45 CFR 46, Criteria for Approval #1)

• Risk to subjects are reasonable in relation to anticipated benefits (45 CFR 46, Criteria for Approval #2)

• Selection of subjects is equitable (45 CFR 46, Criteria for Approval #3)

SSS, Section V KC IRB Questionnaire B – Lay Summary & Research Design

Study Procedures • Risks to subjects are minimized (45 CFR 46, Criteria for Approval #1)

SSS, Section VII KC IRB Questionnaire B – Lay Summary & Research Design

Risks & Benefit Information • Risks to subjects are minimized (45 CFR 46, Criteria for Approval #1)


SSS, Section VIII KC IRB Questionnaire E – Risks, Benefits, Protections

Protection Procedures • Risks to subjects are minimized (45 CFR 46, Criteria for Approval #1)


SSS, Section IX KC IRB Questionnaire E – Risks, Benefits, Protections IU HRPP Policies: • Research Data Management

Data Safety Monitoring Plan • The research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects (45 CFR 46, Criteria for Approval #6)

SSS, Section X KC IRB Questionnaire F – Data Safety Monitoring HSO Guidance: • Data Safety Monitoring

Payment for Participation • Additional safeguards have been included to protect the rights and welfare of any subjects likely to be vulnerable to coercion or undue influence (45 CFR 46).

SSS, Section XI KC IRB Questionnaire B – Lay Summary & Research Design IU HRPP Policies: • Recruitment of Human

Subjects HSO Guidance: • Identifying Potential

Subjects, Contacting, and Screening

https://research.iu.edu/compliance/human-subjects/guidance/subject-types/individuals-lacking-consent-capacity.html



https://research.iu.edu/compliance/human-subjects/guidance/subject-types/children.html

https://research.iu.edu/compliance/human-subjects/guidance/subject-types/children.html

https://research.iu.edu/compliance/human-subjects/guidance/subject-types/prisoners.html

https://research.iu.edu/compliance/human-subjects/guidance/subject-types/prisoners.html

https://research.iu.edu/compliance/human-subjects/guidance/subject-types/students.html

https://research.iu.edu/compliance/human-subjects/guidance/subject-types/students.html






https://research.iu.edu/compliance/human-subjects/guidance/data-safety.html




https://research.iu.edu/compliance/human-subjects/guidance/recruitment.html




Recruitment procedures • Selection of subjects is equitable (45 CFR 46, Criteria for Approval #3)

• There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data (45 CFR 46, Criteria for Approval #7)

• SSS, Section VI • HIPAA & Recruitment Checklist

• KC IRB Questionnaire D – Recruitment Methods • KC IRB Questionnaire L – VA Research

IU HRPP Policies: • Recruitment of Human

Subjects HSO Guidance: • Identifying Potential

Subjects, Contacting, and Screening

• Competitive Study Enrollments

Consent procedures • An IRB shall require that information given to subjects as part of informed consent is in accordance with §46.116. (45 CFR 46)

• An IRB shall require documentation of informed consent or may waive documentation in accordance with §46.117. (45 CFR 46)

• Informed consent will be sought from each prospective subject or the subject's legally authorized representative (45 CFR 46, Criteria for Approval #4)

• Informed consent will be appropriately documented (45 CFR 46, Criteria for Approval #5)

• SSS, Section XII • Request Form for Inclusion of

Children in Research

• KC IRB Questionnaire H – Informed Consent Process • KC IRB Questionnaire J – Child Assent & Parental Consent

Process

IU HRPP Policies: • Informed Consent

HSO Guidance: • Obtaining Valid Informed

Consent Informed consent template

HIPAA • There are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data (45 CFR 46, Criteria for Approval #7)

• SSS, Section II • HIPAA & Recruitment Checklist

• KC IRB Questionnaire K – HIPAA • KC IRB Questionnaire L – VA Research

IU HRPP Policies: • Use of Protected Health

Information (PHI) in Research HSO Guidance: • HIPAA

Authorization Template

Test Articles • SSS, Section III • Protocol tab > Additional Information panel - IND/IDE # • KC IRB Questionnaire B – Lay Summary & Research

Design • Drug & Biological Products Form • Medical Device Form

IU HRPP Policies: • Emergency Use of

Investigational Test Articles HSO Guidance: • Seeking FDA Opinion On

Drug Exemptions

Post-Approval Submissions

Changes to previously approved research

An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy. (45 CFR 46)

Amendment Form KC IRB Questionnaire – Amendment







https://research.iu.edu/compliance/human-subjects/guidance/competing-studies.html


http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.116

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.117




https://research.iu.edu/compliance/human-subjects/guidance/informed-consent.html


https://research.iu.edu/forms/human-subjects-irb.html


https://research.iu.edu/compliance/human-subjects/guidance/hipaa.html






https://research.iu.edu/compliance/human-subjects/guidance/fda-drug-exemption.html

https://research.iu.edu/compliance/human-subjects/guidance/fda-drug-exemption.html


Ongoing review of research An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year… (45 CFR 46)

Renewal Form • KC IRB Questionnaire – Protocol Status & Summary • KC IRB Questionnaire – Changes and Amendments

KC IRB Questionnaire – IRB & Conflicts of Interest Displays if the Protocol Type is Exempt, Expedited, Full Board, or Deferral. Topics addressed: Institutional and financial Conflicts of Interest Minimum number of questions: 3 Maximum number of questions: 7

Question Question ID Appropriate Answer Types Tips/Tricks 1. Are any of the investigators listed in the personnel tab aware of an

institutional conflict of interest which could affect or be affected by this research?

134 Y/N

1.1. [If Y] Explain the institutional conflict of interest. 24900 Free text 2. Do any of the investigators listed in the Personnel tab (or their immediate

family members) have a significant financial interest which could affect this research?

24901 Y/N Link goes to: https://policies.iu.edu/policies/aca-74-financial-conflicts-interest-research/index.html

2.1. [If Y] List the investigator(s) who have a significant financial interest which could affect this research.

24902 Free text

2.2. [If Y] Describe the nature of the significant financial interest. 24903 Free text 2.3. [If Y] Have all significant financial interests listed above been

disclosed to the IU Conflicts of Interest Office? 24907

Multiple Choice – choose one.

• Yes – The disclosure has been approved by the appropriate IU Conflicts of Interest Office OR a copy of the management plan is on file.

• No – Please contact the appropriate IU Conflicts of Interest Office immediately. Research may not be approved until all disclosures have been reviewed and managed, if necessary.

3. Does the Principal Investigator affirm all investigators listed as personnel on this protocol have agreed to participate in this project, are aware of their status and role, and have been adequately trained to participate in the project?

24905 Y/N

https://policies.iu.edu/policies/aca-74-financial-conflicts-interest-research/index.html

https://policies.iu.edu/policies/aca-74-financial-conflicts-interest-research/index.html

https://research.iu.edu/compliance/conflict-interest/index.html


KC IRB Questionnaire A – Level of Review Assessment Displays if the Protocol Type is Full Board or Expedited. Topics addressed: Level of review Minimum number of questions: 1 Maximum number of questions: 9

Question Question ID Appropriate Answer Types Tips/Tricks 1. Does any research activity in this study present more than minimal risk to

human subjects? Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Risks may be psychological, physical, and/or privacy-related.

720 Multiple Choice – choose one. • Yes. The research may require review by the

Full IRB. • No. The research may qualify for Expedited

review if all research procedures fall into one of the categories below.

Determining whether a research activity presents more than minimal risk involves comparing the possible harms or discomforts experienced in normal daily life or during routine physical or psychological examinations or tests with the possible harms or discomforts that will be faced by subjects as a consequence of research participation.

1.1. [If No] Check any category(ies) applicable to this research. 721 Multiple Choice – choose all that apply. • Category 1 - Clinical studies of drugs and

medical devices • Category 2 - Collection of blood samples by

finger stick, heel stick, ear stick, or venipuncture

• Category 3 - Prospective collection of biological specimens for research purposes by noninvasive means

• Category 4 - Collection of data through noninvasive procedures routinely employed in clinical practice

• Category 5 - Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes

• Category 6 - Collection of data from voice, video, digital or image recordings made for research purposes

• Category 7 - Research on individual or group characteristics or behavior, or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies

• None of the Above – Research is minimal risk but all procedures do not fit into the above categories.

Category 1: Use of the drug or device must be dictated by the protocol. Category 3: Examples include: hair clippings, nail clippings, deciduous teeth at the time of exfoliation or during routine care, permanent teeth extracted for routine care, excreta and external secretions, uncannulated saliva, placenta removed at delivery, amniotic fluid obtained at the time of rupture or during labor, supra- and subgingival dental plaque and calculus collected in a way that is no more invasive than routine care, mucosal and skin cells collected by buccal scraping or swab, skin swab or mouth washings, sputum collected after saline mist nebulization. Category 4: Does not include procedures that involve x-rays or microwaves.

1.1.1. [If Category 1] Choose the appropriate description of the research. If none apply, please uncheck Category 1 above.

722 Multiple Choice – choose one.


• Research on drugs which does not require an investigational new drug (IND) application.

• Research on medical devices which does not require an investigational device exemption (IDE) application.

• Research on medical devices which are cleared/approved for marketing and are being used in accordance with the cleared/approved labeling.

1.1.2. [If Category 2] Choose the appropriate description of the research. If none apply, please uncheck Category 2 above.

723 Multiple Choice – choose all that apply. • Collection of blood samples from healthy,

non-pregnant adults who weigh at least 110 pounds (49.9 kg). Amount drawn will not exceed 550 ml in an 8-week period and collection will not occur more frequently than 2 times per week.

• Collection of blood samples from adults and children, with consideration to the age, weight, and health of the subjects, along with the collection procedure, the amount of blood to be collected and the frequency of collection. Amount drawn will not exceed the lesser of 50 ml or 3 ml per kg in an 8-week period and collection will not occur more frequently than 2 times per week.

1.1.3. [If Category 5] Will the researchers be using a data collection form?

724 Multiple Choice – choose one. • Yes. It is/will be attached to the Notes &

Attachments tab. • No

If you answer yes to this question, you must upload the data collection form to the Notes & Attachments tab, with an Attachment Type of Data Collection Form, in order to take the Submit for Review action.

1.1.3.1. [If No] List all data points that will be recorded or collected.

725 Free text Be sure to list the specific data points you plan to collect. Listing categories such as “demographics” is not sufficient.

1.2. [If No] Would identification of subjects and/or their responses reasonably place them at risk for any of the following (check any that apply):

23340 Multiple Choice – choose all that apply. • None • Criminal or Civil liability • Damage to the subjects' financial standing • Damage to the subjects' reputation • Damage to the subjects' ability to be

employed • Damage to the subjects' ability to be insured • Possibility of negative stigma

1.2.1. [If any except None] Explain how the protection procedures described in the Risks, Benefits, and Protections questionnaire below ensure that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

23341 Free text


KC IRB Questionnaire B – Lay Summary & Research Design Displays if the Protocol Type is Full Board or Expedited. Topics addressed: Funding, study description, inclusion/exclusion, study procedures, payment for participation Minimum number of questions: 12 Maximum number of questions: 23

Question Question ID Appropriate Answer Types Tips/Tricks 1. Describe the purpose of this study in lay terms, including research

question(s) and hypothesis. 22122 Free text This provides our nonscientist reviewers with a lay summary of your research, so please

make sure any medical terms have a lay definition and spell out any abbreviations. 2. List and describe all research interactions and/or interventions, including

the frequency and duration of procedures, and length of participation for individual subjects. Research interactions and/or interventions are those which would not occur outside of the research study, and include planned communication or interpersonal contact with subjects; any data collection methods such as surveys, interviews, instruments, and biomedical procedures; and manipulations of subjects’ environment.

22123 Free text, up to 20,000 characters. If some procedures will be performed as standard of care and others solely as a part of the research, be sure to note which procedures are standard of care and which are research.

3. Will any non-English study documents be uploaded to the Notes & Attachments tab?

23358 Y/N Be sure to upload non-English study documents to the Notes & Attachments tab.

3.1. [If Y] The PI affirms that translated versions are complete and accurate translations which do not contain information not presented within the context of the English version(s).

23359 Y/N

4. Is this research funded by, or has a funding application been submitted to, a federal agency? This includes funding from CTSI and federal pass-through funding.

24919 Y/N Answer “Yes” if you are receiving federal funds, or if you are receiving internal funding which are subject to federal oversight and reporting.

4.1. [If Y] Provide the name of the funding agency: 25019 Search via IU Sponsor Table 5. List inclusion criteria - eligibility criteria for subjects. 23234 Free text, up to 20,000 characters. Please include an age range for subjects, if relevant. If the research has multiple subject

groups, describe the requirements for each separately. 6. List exclusion criteria (any criteria which would exclude otherwise

acceptable subjects). 23235 Free text, up to 20,000 characters. If you do not plan to include children, please be sure to state that subjects under the age

of 18 will be excluded. If the research has multiple subject groups, describe the requirements for each separately.

7. Will subjects be paid for their participation in the study? Payment includes reimbursement of expenses (other than compensation for injury).

23346 Y/N

7.1. [If Y] Describe the payment arrangement, including amount and timing of disbursement.

23347 Free text

7.2. [If Y] Justify the proposed payment arrangement described above, specifically why payment does not provide undue influence for subject participation.

23348 Free text

7.3. [If Y] Will partial payment be provided if the subject withdraws prior to completion of the study?

23349 Y/N Answer Yes if any payment will be provided, even if payment is not considered partial.

7.3.1. [If N] Explain why failure to offer partial payment will not unduly influence subjects to complete the study.

23350 Free text

7.3.2. [If Y] Explain the plan for providing partial payment. 23351 Free text


8. Does this research involve (choose all that apply): • the STUDY of any of the following products (regardless of FDA

approval status). “The study of” means at least one objective of the study is related to obtaining data about the product

• USE of any of the following products which have not been cleared or approved by the FDA for use in the US

• USE of any of the following products for open label extension, treatment, or compassionate use

23352 Multiple Choice – choose all that apply. • NONE • DRUG

A substance manufactured via chemical process and intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease OR (other than food) intended to affect the structure or any function of the body of man.

• BIOLOGICAL PRODUCT A substance manufactured via biological process and otherwise meets the above definition of a drug; includes a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins.

• DIETARY SUPPLEMENT A product taken by mouth that is intended to supplement the diet and that contains one or more dietary ingredients.

• MEDICAL DEVICE An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, OR intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

• FOOD Articles used for food or drink (or for components of such articles) and intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.

• COSMETIC

Diagnostic assays are considered medical devices.


Articles (except soap) intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance (and any component of any such articles) AND intended for use to affect the structure or function of the body or to prevent, treat, mitigate, cure, or diagnose a disease.

8.1. [If DRUG or BIOLOGICAL PRODUCT] Is the study being conducted under an IND (investigational new drug application)?

30135 Y/N

8.1.1. [If Y] List all drugs or biological products being used. 30136 Free text 8.1.2. [If Y] IND number. Ensure documentation of the IND number

(e.g. letter from FDA including protocol title and IND number, or protocol including IND number) has been uploaded to the Notes & Attachments tab.

30137 Free text

8.1.3. [If Y] Does the local investigator hold the IND? 30138 Multiple Choice – choose one. • No. • Yes. The investigator must attend a meeting

to discuss the additional responsibilities as a sponsor-investigator. Staff will reach out to the study team to schedule the meeting

8.1.4. [If Y] Will Investigational Drug Services (IDS, e.g. IU Health or Eskenazi) be used for drug handling and control at ALL drugs at ALL locations?

30139 Y/N

8.1.4.1. [If N] For any locations not using IDS, describe how you will ensure appropriate labeling, storage, and control of investigational test articles, including ensuring test articles are used and distributed only in accordance with the IRB-approved human subjects application and approval, and maintain adequate records. See the IU HRPP Policy on Research Personnel Responsibilities.

30140 Free text

8.1.5. [If N] Has an IND exemption been obtained from the FDA? 30141 Free text 8.1.5.1. [If No] Is some aspect of the drug’s administration or use

is dictated by the protocol (e.g. randomization to determine the drug(s) administered; protocol dictates the route, dose, timing, etc.)?

23353 Y/N

8.1.5.1.1. [If N] Will data generated be submitted to the FDA?

23354 Y/N

8.1.5.1.2. [If Y] List all drugs or biological products being studied. Complete and upload a Drug or Biological Product Form for each drug listed. This study is considered FDA-regulated.

23355 Free text Upload the Drug and Biological Products Form to the Notes & Attachments tab, with an Attachment Type of Drug and Biological Products Form. Your study is considered FDA-regulated. Forms: https://research.iu.edu/forms/human-subjects-irb.html


8.2. [If DIETARY SUPPLEMENT] Is this study intended to evaluate a dietary supplement’s ability to diagnose, cure, mitigate, treat, or prevent a disease?

30143 Multiple Choice – choose one. • Yes • No. The research is designed to study the

relationship between the dietary supplement’s effect on normal structure or function in humans or characterize the mechanism by which a dietary supplement acts to maintain such structure or function.

8.2.1. List all dietary supplements being studied. 30144 Free text 8.2.2. [If N] Explain why the supplement is not being used to

diagnose, cure, mitigate, treat, or prevent a disease. 30145 Free text

8.2.3. [If Y] Does the disease being targeted result from an essential nutrient deficiency (e.g. scurvy, pellagra)?

30146 Y/N

8.2.3.1. [If N] Is some aspect of the dietary supplement’s administration or use dictated by the protocol (e.g. randomization to determine the dietary supplement(s) administered; protocol dictates the route, dose, timing, etc.)?

30147 Multiple Choice – choose one. • No • Yes. Use of the dietary supplement is

regulated by the FDA as a drug. You must contact the FDA to determine whether an IND is needed.

8.2.3.1.1. [If Yes] Indicate the result of the IND discussion with the FDA.

30148 Multiple Choice – choose one. • IND has been granted. IND number: • FDA confirmed that an IND is not needed and

documentation has been uploaded to the Notes & Attachments tab..

8.2.3.1.1.1. [If IND number] Does the local investigator hold the IND?

30138 Multiple Choice – choose one. • No. • Yes. The investigator must attend a meeting


8.2.3.1.1.2. [If IND number] Describe how you will ensure appropriate labeling, storage, and control of the food, including ensuring it is used and distributed only in accordance with the IRB-approved human subjects application and approval, and maintain adequate records. See the IU HRPP Policy on Research Personnel Responsibilities.

30149 Free text

8.3. [If MEDICAL DEVICE] Is the study being conducted under an IDE (investigational device exemption)?

30150 Y/N

8.3.1. [If Y] IDE number. Ensure documentation of the IDE number (e.g. letter from FDA including protocol title and IDE number, or protocol including IDE number) has been uploaded to the Notes & Attachments tab.

30151 Free text

8.3.2. [If Y] Does the local investigator hold the IDE? 30152 Multiple Choice – choose one.


• No. • Yes. The investigator must attend a meeting


8.3.3. [If N] Has the FDA confirmed and provided documentation that use of the device is exempt from IDE requirements or considered nonsignificant risk? Documentation of 510K clearance is not documentation of device exemption.

30154 Multiple Choice – choose one. • Yes. Upload documentation to the Notes &

Attachments tab. • No.

8.3.3.1. [If No] Is some aspect of the device’s administration or use dictated by the protocol (e.g. randomization to determine the device(s) administered; protocol dictates the route, dose, timing, etc.)?

30294 Y/N

8.3.3.1.1. [If N] Will data generated be submitted to the FDA?

23354 Y/N

8.3.3.1.2. [If Y] List all devices being studied. Complete and upload a Medical Device Form for each device listed. This study is considered FDA-regulated.

23357 Free text Upload the Medical Device Form to the Notes & Attachments tab, with an Attachment Type of Medical Device Form. Your study is considered FDA-regulated. Forms: https://research.iu.edu/forms/human-subjects-irb.html

8.4. [If FOOD] Explain why use of the food in this study does not require an Investigational New Drug Application (IND) to the FDA. Consult with HSO staff, and see FDA Guidance for Clinical Investigators, Sponsors, and IRBs: Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an IND.

30156 Free text FDA guidance: https://www.fda.gov/downloads/drugs/guidances/ucm229175.pdf

8.5. [If COSMETIC] Explain why use of the cosmetic in this study does not require an Investigational New Drug Application (IND) to the FDA. Consult with HSO staff, and see FDA Guidance for Clinical Investigators, Sponsors, and IRBs: Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted Without an IND.

30157 Free text FDA guidance: https://www.fda.gov/downloads/drugs/guidances/ucm229175.pdf

8.6. [If NOT NONE] Is this an Investigator Initiated Trial (IIT)? 30402 Y/N 9. This research involves (check all that apply): 23454 Multiple Choice – choose all that apply.

• Prospective cancer-related research utilizing IU Simon Cancer Center patients or resources). Documentation of approval from the Scientific Review Committee (SRC) must be uploaded to the Notes & Attachments tab.

• Radiation/radioactivity in addition to what is used for standard clinical treatment. Radiation safety approval must be obtained. Submission to the Radiation Safety Office must be made prior to submission to the IRB.

https://www.fda.gov/downloads/drugs/guidances/ucm229175.pdf

https://www.fda.gov/downloads/drugs/guidances/ucm229175.pdf


• Recombinant or synthetic nucleic acid molecules. IBC protocol number:

• Human gene transfer research. Research which involves the deliberate transfer of recombinant or synthetic nucleic acid molecules, into human research participants.

• None of the Above 10. Is this research considered a prospective clinical study?

Prospective research collects data looking forward using either one-time or periodic observations collected predominantly following subject enrollment. This could occur during a single visit or throughout a series of visits.

A clinical study uses human subjects to evaluate a biomedical or health-related outcome. This includes, but is not limited to: prevention and treatment of a disease/diagnosis; prevention and treatment of genetic and environmental factors related to disease and health; studies surrounding cost of care; studies regarding patient satisfaction; observations surrounding a disease/diagnosis and patient health; specimen or tissues collection; and registries.

25049 Multiple Choice – choose one. • Yes – This study may require entry in OnCore.

For more information, click here or email [email protected].

• No

For more information, visit https://ocr.iu.edu/investigators-study-coordinators/oncore/%20training-support/#documents.

11. Is this community-engaged research? 30000 Y/N For the purposes of IRB at IU, community-engaged research is defined as research that “includes the meaningful involvement of community partners in the research process, including but not limited to topic development, need identification, research design, conduct of research, and/or sharing of results.”

11.1. [If Y] How are/were the community partner(s) involved in the research? Choose all that apply.

30001 Multiple Choice – choose all that apply. • Topic development, need identification, and/or

development of research questions • Research design and/or selection of

appropriate measures and data collection methods

• Contribution to consensus about findings, conclusions, and/or recommendations for implementing findings

• Dissemination of findings and actions taken based upon results

• Only provided access to study subjects or project sites, and not involved with study design, subject recruitment, data collection, data analysis, or dissemination of results

This information is shared with and used by several units at IU to support, inform, and advocate for faculty who choose to conduct community-engaged research and the community members and organizations they engage. For more information about how units use this information, see the IUPUI Office of Community Engagement’s website: https://engage.iupui.edu/research/share-community-engaged-research.html.

mailto:[email protected]

https://ocr.iu.edu/investigators-study-coordinators/oncore/%20training-support/#documents


https://engage.iupui.edu/research/share-community-engaged-research.html


KC IRB Questionnaire C – Sites & Collaborations Displays if the Protocol Type is Full Board or Expedited. Topics addressed: Performance sites Minimum number of questions: 3 Maximum number of questions: 15

Question Question ID Appropriate Answer Types Tips/Tricks 1. Are there additional locations of research, not already listed on the

Protocol tab? 700 Y/N Answer Yes if there are locations that were not found in the Organizations folder of the

Protocol tab. This list should include locations where research will be conducted, and/or data will be analyzed and stored.

1.1. [If Y] Provide the name of the site, including city and state. 701 Free text 1.2. [If Y] Is any research taking place outside the United States? 702 Y/N If you answer yes to this question, you must have selected Transnational as a participant

type on the Protocol tab. 1.2.1. [If Y] List each country: 703 Free text. Each text box allows up to 100

characters, and up to 10 boxes may be used.

2. Are you requesting that IU serve as the IRB of record for any researchers who are not IU affiliates? IU Affiliates include Goodman Campbell Brain & Spine, Eskenazi Health, Indiana State Department of Health, IU Health, Purdue Pharmacy Practice, Regenstrief Institute, Rehabilitation Hospital of Indiana, Roudebush VAMC, and Sigma Theta Tau International.

704 Y/N

2.1. [If Y] Please choose the option which best describes the role of the non-affiliated investigators in the research.

25332

Multiple Choice – choose one. • Non-affiliated investigators are conducting all

of the procedures specified in the protocol. • Non-affiliated investigators are conducting only

some of the procedures specified in the protocol.

2.1.1. [If all of the procedures] Please list the external site(s) and the Site-Specific PI for each.

25333 Free text

2.1.2. [If some of the procedures] Please choose the research activities being conducted by the non-affiliated investigators.

25334 Multiple Choice – choose all that apply. • Identification of subjects • Enrollment of subjects, including obtaining

informed consent and/or authorization • Biomedical research interventions or

interactions • Social/behavioral/educational interventions or

interactions (e.g. surveys, questionnaires, etc.) • Collection or analysis of identifiable data or

identifiable biospecimens • Analysis of deidentified data or deidentified

biospecimens ONLY. (Please note that non-affiliated investigators who are only involved in


analysis of deidentified data or deidentified biospecimens are not engaged in research and should not be added to IRB protocol information. Also, please do not update Questionnaire C with their information. Contact HSO for more information.)

• Other:[small text field]

2.1.3. [If some of the procedures] Please list the non-affiliated investigator(s) and the name(s) of the institution(s) with which they are affiliated (e.g. name of academic institution, academic medical center, corporation or other entity).

25335 Free text

2.1.3.1. Please choose the best description of the non-affiliated investigator’s role at their own institution.

25336 Multiple Choice – choose all that apply. • Faculty or staff • Student • None - investigator is participating in this

research as a volunteer on their own time. • Other: [small text field]

2.1.3.1.1. [If Student] Is the student receiving course or other credit (e.g. work study) toward their degree requirements for their participation in this research?

25337 Multiple Choice – choose one. • Yes • No. Please have the student and PI complete a

Non-Affiliated Investigator Agreement and upload to the Notes & Attachments tab.

2.2. [If Y] Please describe the plan for management and communication of IRB-related information to sites and/or non-affiliated investigators, including ensuring that non-affiliated investigators are familiar with and will follow IU HRPP policies and procedures, that required reporting and requests for amendments by non-affiliated investigators are submitted to the IU IRB, and that IRB decisions and approved documents are communicated. Alternatively, attach a document describing this plan.

25338 Free text

3. Is this a multi-center study or multi-site clinical trial? 710 Y/N 3.1. [If Y] State the number of subjects to be enrolled in the study

nationally. 711 Number

3.2. [If Y] Is the Lead investigator at IU? 712 Y/N 3.2.1.1. [If Y] Describe the plan for the management and

communication of multi-site information that may be relevant to the protection of participants.

714 Free text


KC IRB Questionnaire D – Recruitment Methods Displays if the Protocol Type is Full Board or Expedited. Topics addressed: Recruitment procedures Minimum number of questions: 7 Maximum number of questions: 15

Question Question ID Appropriate Answer Types Tips/Tricks 1. Describe how potential subjects will be initially identified. 23236 Free text

1.1. Check any of the following sources of information which will be used to identify potential subjects.

30002 Multiple Choice – choose all that apply. • Subject self-referral in response to

recruitment materials • Medical records or clinic schedules • Physician/provider referral • Student data • Other:

Sources may include databases, medical records, ads, flyers, self-referral, physician referral, clinics of investigators, etc.

2. Describe how potential subjects will be initially contacted. 30003 Free text

2.1. Check any of the following recruitment materials which will be used to contact potential subjects.

23237 Multiple Choice – choose all that apply. • Direct mail/email • Flyers/Brochures • Published Advertisements • Verbal Scripts • Website • Social Media • Other: [describe] • None

If you plan to utilize any of these recruitment materials, please ensure they are uploaded to the Notes & Attachments tab, with an Attachment Type of “Recruitment Materials.” Please Note: Approved studies will be made available to the public through All IN for Health studies listing (www.allin4health.info). All IN for Health is a program made possible by the Indiana Clinical and Translational Science Institute (CTSI), a research partnership of Indiana University, Purdue University & the University of Notre Dame. This listing is used to promote research throughout the state and allow the public the opportunity to volunteer for studies. For additional information or volunteer matching services, please contact [email protected]

3. Select any of the following circumstances which apply to this research. 25426 Multiple Choice – Choose all that apply. • A member of the study team is an instructor

and his or her own students will participate as subjects in the research

• A member of the study team is an employer or supervisor of individuals who will participate as subjects in the research

• A member of the study team is a health care professional and his or her patients will participate as subjects in the research


• None of the above.

3.1. [If own students] Describe the plan to ensure that the subjects’ instructor will not know whether students participated in the research until after course grades are final.

25386 Free text

3.2. [If employer or supervisor] Confirm subjects will be informed that their decision to participate will not affect their employment.

25428 Free text

3.3. [If health care professional] Confirm subjects will be informed that their decision to participate will not affect their relationship with their health care provider.

26690 Free text

4. Would participation in this study preclude subjects from participating in other research studies?

23245 Y/N

4.1. [If Y] Is the investigator currently aware of competing studies? Refer to the IU IRB Guidance Document – Enrolling Into Competing Studies for definitions.

23246 Y/N Common examples of competing studies (1) If two or more studies have substantially the same inclusion/exclusion criteria; (2) if the subject population for the two potentially competing studies is very limited (i.e. if recruitment is successful, a large number of the eligible individuals will be enrolled into one of the two studies). Guidance: https://research.iu.edu/compliance/human-subjects/guidance/competing-studies.html

4.1.1. [If Y] Please describe the plan to assure that potential subjects will be informed of all studies for which they qualify and will be supported in making an informed and voluntary choice regarding study participation.

23247 Free text For more information on appropriate plans, see the IU IRB Guidance on Enrolling into Competing Studies.

4.1.2. [If Y] If such an approach will potentially introduce bias into recruitment, please address such difficulties.

23248 Free text

4.1.3. [If Y] If the approach suggests that multiple competing studies could exist concurrently, please justify the existence of an adequate subject population to meet the recruitment goals of each study.

23249 Free text




KC IRB Questionnaire E – Risks, Benefits, Protections Displays if the Protocol Type is Full Board or Expedited. Topics addressed: Risks & benefit information, protection procedures Minimum number of questions: 6 Maximum number of questions: 7

Question Question ID Appropriate Answer Types Tips/Tricks 1. List and describe (in lay terms) the potential risks to which subjects may be

exposed as a result of their participation in the research. Risks may be physical, psychological, social, legal, etc. Please note that all research exposes to subjects to some risk, even if the only risk is a potential loss of confidentiality.

23296 Free text, up to 20,000 characters. All risks should be listed, even if risks are minimal (e.g., loss of confidentiality, risks of blood draw, possible discomfort with research questions).

2. Describe procedures for protecting against, or minimizing, the potential risks listed above. Include any procedures that are already being performed on subjects for diagnostic, treatment, or standard purposes.

23297 Free text, up to 20,000 characters.

3. Explain how research data will be protected so that only approved persons have access to subjects’ identifiable data (i.e. confidentiality of data).

23299 Free text Data protection methods may include electronic encryption, storing hard copies of any data in a locked office cabinet, etc.

4. Explain how subjects’ physical privacy will be protected, both during recruitment/screening and during participation in the research.

23300 Free text Question refers to physical privacy, as opposed to confidentiality.

5. Is there a potential for subjects to benefit directly from participation in the study?

23301 Y/N Benefit is defined as a valued or desired outcome, or an advantage, which subjects may experience as a result of their participation in the study. Payment for participation is not considered a benefit and should not be listed here.

5.1. [If Y] Describe the potential benefits to be gained by the individual SUBJECT. Please note that payment for participation is not considered a benefit.

23302 Free text

6. State the potential benefits or information which may accrue to SCIENCE or SOCIETY in general as a result of this work.

23303 Free text


KC IRB Questionnaire F – Data Safety Monitoring Displays if the Protocol Type is Full Board or Expedited. Topics addressed: Data safety monitoring Minimum number of questions: 1 Maximum number of questions: 4

Question Question ID Appropriate Answer Types Tips/Tricks 1. [For MINIMAL RISK] Describe the provisions for monitoring the data to

ensure the safety of subjects. 23304 Free text Question displays if the Level of Review Assessment questionnaire indicates that the study

does NOT present more than minimal risk to human subjects. For minimal risk studies, provisions for monitoring data may be as simple as the study team reviewing the data on an ongoing or interim basis to ensure that the study is proceeding as planned and no additional risks have been identified.

2. [For GREATER THAN MINIMAL RISK] Explain who will be responsible for the data and safety monitoring, including their role in the study, if any, and whether the individual or committee is independent from the sponsor and/or PI.

23305 Free text Question displays if the Level of Review Assessment questionnaire indicates that the study does present more than minimal risk to human subjects. The level of monitoring the IRB will expect depends on the specific study’s procedures and risks. Not all studies require a Data Safety Monitoring Board; however, you should indicate here if a Board has been created, or if data monitoring will be performed by the PI or study team. Be sure to answer all parts of the question.

2.1. Choose all of the following which will be monitored as part of the DSMP.

23306 Multiple Choice – choose all that apply. • Data quality • Subject recruitment • Accrual • Retention • Outcome and adverse event data • Assessment of scientific reports or

therapeutic development • Results of related studies that may impact

subject safety • Procedures designed to protect the privacy of

subjects • Other: [describe]

For greater than minimal risk studies, it is likely that the IRB will expect that all of the listed options are being monitored as part of the Data Safety Monitoring Plan; however, additional items may be added in the Other text box.

2.2. Describe how often individuals or committee responsible for the DSMP will monitor the study.

23307 Free text Use this question to help the IRB understand the timing of data safety monitoring.

2.3. Describe any planned statistical analyses and any pre-planned stopping rules, actions to be taken upon specific events, and/or endpoints.

23308 Free text Some protocols include planned recruitment stops or statistical analyses to allow for data safety monitoring to occur at certain points during the study. If your study includes such a plan, or if specific stopping rules have already been denoted, describe them here. If not, simply N/A or “nothing planned at this time” is sufficient.


KC IRB Questionnaire G1 – Children Displays if the Protocol Type is Full Board or Expedited, and Children has been chosen as a Participant Type on the Protocol tab. Topics addressed: Special populations Minimum number of questions: 2 Maximum number of questions: 9

Question Question ID Appropriate Answer Types Tips/Tricks 1. Select all categories below that apply. Note that studies with multiple

groups of children (e.g., randomized studies, studies with a combination of healthy and other subjects) may require the selection of more than one category.

22116 Multiple Choice – choose all that apply. • 45 CFR 46.404: Research not involving greater

than minimal risk to children. • 45 CFR 46.405: Research involving greater

than minimal risk but presenting the prospect of direct benefit to the individual child.

• 45 CFR 46.406: Research involving greater than minimal risk and no prospect of direct benefit to the individual child, but likely to yield generalizable knowledge about the child’s disorder or condition.

• 45 CFR 46.407: Research not otherwise approvable under one of the above categories, which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. The Secretary of Health and Human Services must approve, after consultation with a panel of experts following publication and public comment.

Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Risks may be psychological, physical, and/or privacy-related. Level of risk assessment must be made based on an assessment of risk and anticipated benefit presented by each individual procedure, not by the study as a whole. For example, greater than minimal risk studies involve a placebo or control group are likely Category 3 since at least one subject population has no possibility of receiving direct benefit from their participation in the study. For 45 CFR 46.404:

• The study is likely expedited. Do not choose this category if you indicated in the Level of Review Assessment questionnaire that the study is greater than minimal risk, unless only the procedures involving children are minimal risk.

• FDA-regulated studies and studies involving randomized use of drugs, biologics, or devices are not minimal risk and should not be considered Category 1.

For 45 CFR 46.407: please contact HSO staff for further information. Studies with this category require approval from the Secretary of Health & Human Services.

1.1. [If 45 CFR 46.405] Explain why the risk is justified by the anticipated benefit to the child.

22118 Free text Carefully weigh the risks versus the benefits of participation in the study.

1.2. [If 45 CFR 46.405] Explain why the risk/benefit ratio is at least as favorable to the subjects as that presented by available alternative approaches.

22119 Free text

1.3. [If 45 CFR 46.406] Explain why the risk represents a minor increase over minimal risk.

22120 Free text Detail the additional risks of the study and explain why they represent only a minor increase over minimal risk. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Risks may be psychological, physical, and/or privacy-related.

1.4. [If 45 CFR 46.406] Explain why the intervention or procedure presents experiences to subjects that are reasonably equivalent with those presented by their actual or expected medical, dental, psychological, social, or educational situations.

22121 Free text Describe subjects’ potential experience in the study and how it compares to the expected standard of care if they did not participate.


1.5. [If 45 CFR 46.406] Explain why the intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or condition, which is of vital importance for the understanding or improvement of the subjects’ disorder or condition.

22127 Free text

1.6. [If 45 CFR 46.407] Explain why the proposed research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children.

22128 Free text

2. Will you be enrolling foster children or children who are considered wards (i.e. who have been placed in the legal custody of the State or other agency, institution per local, state, or federal law)?

23199 Y/N If you are enrolling foster children or wards of the state, and the study is related to abuse or possible disclosure of sexual activity in children under 14 years, please contact the Indiana Department of Child Services, as an application for child abuse research may be required.

2.1. [If Y] Explain why foster children and/or wards are being enrolled. 23133 Free text 2.2. [If Y] Choose all that apply. 23200 Multiple Choice – choose all that apply.

• Foster children • Wards

2.2.1. [If Foster children] Explain the process for identifying the correct person to provide consent for participation of foster children.

23201 Free text Please contact HSO staff for additional guidance. In general, the child’s Department of Child Services case worker or social worker should be contacted first since they are often in the best position to identify the child’s legal guardian. Consent may need to be obtained from one or more of the following:

• Biological parent(s), especially in situations where placement in foster care is considered temporary;

• Foster parents, in cases where the parental relationship has been terminated or where the foster parents are given authority to consent to medical treatment under the medical passport program (see Indiana Code § 31-28-3-3);

• Case worker or social worker; or • Judicially appointed guardian.

Investigators should be prepared to obtain consent from multiple parties and should be aware that, in limited situations, a court order may be required. If the child’s familial status changes (e.g., the child is adopted, placed in a different foster home, placed with his/her biological family), the investigator may need to seek re-consent from the new parent/guardian if that person did not provide consent at initial enrollment.

2.2.2. [If Wards] Choose the appropriate description of the research. 23202 Multiple Choice – choose one. • Research is related to the children’s status as

wards of the state • Research is conducted in schools, camps,

hospitals, institutions, or similar settings in which the majority of the children involved are not wards of the state.

• Neither. Enrollment of wards is not appropriate.

Question displays if research applies to 45 CFR 46.406 or 45 CFR 46.407.

2.2.2.1. [If Research is] Explain the process for appointing an advocate for each child to act in the best interests of the child throughout the research process.

23203 Free text The advocate must an individual who has the background and experience to act in, and agrees to act in, the best interest of the child throughout the research process. The advocate may be anyone appointed by the IRB (e.g., an IRB member, case worker, social

http://www.in.gov/legislative/ic/code/title31/ar28/ch3.html


worker, or counselor) but should be completely independent of the research, the investigators, and the guardian organization. Please contact HSO with specific questions about the appointment procedure.


KC IRB Questionnaire G2 – Individuals Lacking Consent Capacity Displays if the Protocol Type is Full Board or Expedited, and Individuals Lacking Consent Capacity has been chosen as a Participant Type on the Protocol tab. Topics addressed: Special populations Minimum number of questions: 4 Maximum number of questions: 6

Question Question ID Appropriate Answer Types Tips/Tricks 1. Explain how/why subjects may lack consent capacity. 23132 Free text There are several potential reasons why subjects may not be capable of making consent

decisions for themselves, including cognitive disease such as dementia or Alzheimer’s, injury such as traumatic brain injury or coma, or anesthesia.

2. Explain whether the patient’s physician or another health care provider will be consulted before any individual is invited to participate in the research.

23134 Free text

3. Explain whether the research is likely to interfere with ongoing therapy or regimens.

23135 Free text

4. Will inpatient psychiatric subjects be involved in the research? 23136 Y/N 4.1. [If Y] Provide justification for the enrollment of inpatient psychiatric

subjects, including why an alternative subject population is not appropriate for this research, or why participation in the research offers the potential for significant benefit to inpatient psychiatric subjects.

23137 Free text

4.2. [If Y] Please describe additional safeguards which will be implemented to protect inpatient psychiatric subjects from potential coercion or undue influence.

25051 Free text

5. One of the following conditions must be met for inclusion of subjects lacking consent capacity:

24908 Multiple Choice – choose one. • The research presents no more than

minimal risk to subjects • The research presents greater

probability of direct benefit to subjects than harm to subjects

• The research presents greater than minimal risk with no prospect of direct benefit but is likely to yield generalizable knowledge about the subjects’ disorder/condition that is of vital importance for the understanding or amelioration of the disorder/condition

6. Justify the inclusion of subjects with limited decision making capacity. 24909 Multiple Choice – choose one. • The research cannot happen solely with

those who have consent capacity and the focus is the disorder which led to the lack of capacity.

• The research is not directly related to capacity but the investigator makes a compelling argument for inclusion of these subjects.


6.1. [If The research is not directly related] Explain the need for inclusion of such subjects.

24911 Text


KC IRB Questionnaire G3 – Pregnant Women/Fetuses/Neonates Displays if the Protocol Type is Full Board or Expedited, and Pregnant Women/Fetuses/Neonates has been chosen as a Participant Type on the Protocol tab. Topics addressed: Special populations Minimum number of questions: 5 Maximum number of questions: 12

Question Question ID Appropriate Answer Types Tips/Tricks 1. Choose all that apply to the research participants. 23220 Multiple Choice – choose all that apply.

• Pregnant Women or Fetuses • Nonviable Neonates • Neonates of Uncertain Viability

1.1. [If Pregnant Women or Fetuses] Choose the appropriate option.

23221 Multiple Choice – choose one. • This research holds out the prospect of a

direct benefit both to the pregnant woman and to the fetus.

• This research holds out the prospect of a direct benefit only to the pregnant woman.

• This research holds out the prospect of a direct benefit only to the fetus.

• This research does not hold out the prospect of a direct benefit for the woman or the fetus

If there is potential benefit to the pregnant woman and fetus, or pregnant woman only, consent for participation should be obtained from the mother. If there is potential benefit to the fetus only, consent for participation should be obtained from both mother and father. If direct benefit is expected to the pregnant woman or the fetus, consent from the pregnant woman only is acceptable.

1.1.1. [If research holds out the prospect of a direct benefit] Explain why any risk to the fetus is caused solely by interventions or procedures which hold out direct prospect of benefit to the pregnant woman or fetus.

23222 Free text

1.1.2. [If research holds out the prospect of a direct benefit only to the fetus]Explain how consent will be obtained from the pregnant woman and the father.

23225 Free text The father's consent need not be obtained if he is unable to consent due to unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest.

1.1.3. [If does not hold out the prospect of a direct benefit] Explain why the risk to the fetus is not more than minimal.

23223 Free text

1.1.4. [If does not hold out the prospect of a direct benefit] Explain why the knowledge to be gained by the research cannot be obtained any other way.

23224 Free text

1.1.5. Describe any relevant pre-clinical and clinical studies which may help assess potential risks to pregnant women and fetuses.

23226 Free text

1.1.6. Explain why the risk presented by the research is the least possible for achieving the objectives.

23227 Free text

1.1.7. Confirm the following statements: 23228 Multiple Choice – choose all that apply. • No inducements, monetary or otherwise, will

be offered to terminate a pregnancy • Individuals engaged in the research will have

no part in any decisions as to the timing,

Federal regulations require all these statement be true. If any options are not checked, IRB approval cannot be granted.


method, or procedures used to terminate a pregnancy

• Individuals engaged in the research will have no part in determining the viability of a neonate.

1.1.8. Explain how subjects will be fully informed of the potential impact of the research on the fetus or neonate.

23229 Free text

1.2. [If Neonates] Describe any relevant pre-clinical and clinical studies which may help assess potential risks to neonates.

23230 Free text

1.3. [If Nonviable Neonates] Explain why the knowledge to be gained by the research cannot be obtained any other way.

23744 Free text

1.4. [If Nonviable Neonates] Confirm all of the following statements:

23233 Multiple Choice – choose all that apply. • Vital functions of the neonate will not be

artificially maintained. • The research will not terminate the heartbeat

or respiration of the neonate. • Individuals engaged in the research will have

no part in determining the viability of a neonate.

• There will be no added risk to the neonate resulting from the research.

• The purpose of the research is the development of important biomedical knowledge, which cannot be obtained by other means.

• Both parents have provided informed consent for participation of the neonate. NOTE: If one parent cannot consent due to unavailability, incompetence, or temporary incapacity, please explain in the informed consent questionnaire.

1.5. [If Neonates of Uncertain Viability] Select the most appropriate description.

23231 Multiple Choice – choose one. • The research holds out the prospect of

enhancing the probability of the neonate’s survival to viability.

• The purpose of the research is the development of important biomedical knowledge which cannot be obtained by other means and there will be no added risk to the neonate resulting from the research.

1.5.1. Explain why the above choice is the most appropriate. 23232 Free text 1.5.2. Confirm that individuals engaged in the research will

have no part in determining the viability of the neonate. 23743 Y/N


KC IRB Questionnaire G4 – Prisoners Displays if the Protocol Type is Full Board or Expedited, and Prisoners has been chosen as a Participant Type on the Protocol tab. Topics addressed: Special populations Minimum number of questions: 8 Maximum number of questions: 12

Question Question ID Appropriate Answer Types Tips/Tricks 1. Identify the appropriate research category. When conducting

prisoner research, Minimal Risk is: the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examinations of healthy persons.

23169 Multiple Choice – choose all that apply. • A study of the possible causes, effects, and

processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects.

• A study of prisons as institutional structures or of prisoners as incarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects.

• Research on conditions particularly affecting prisoners as a class. For example, vaccine trials and other research on hepatitis which is much more prevalent in prisons than elsewhere, or research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults. The study may proceed only after the Secretary (through OHRP) has consulted with appropriate experts including experts in penology, medicine, and ethics and published notice, in the Federal Register, of his intent to approve such.

• Research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject. In cases in which those studies require the assignment of prisoners in a manner consistent with protocols approved by the IRB to control groups which may not benefit from the research, the study may proceed only after the Secretary (through OHRP) has consulted with appropriate experts including experts in penology, medicine, and ethics and published notice, in the Federal Register, of his intent to approve such research.

Question will display only if study was identified as federally funded in the Lay Summary & Research Design questionnaire.


2. Explain how any possible advantages to the prisoner through his or her participation in the research do not provide undue influence when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison. The possibility for undue influence exists when the advantages are of such a magnitude that the subject’s ability to weigh the risks of the research against the value of participation is impaired, given the limited choice environment of the subject.

23170 Free text Consider that incentives that may seem trivial to the general population could be significant to prisoners.

3. Explain how the risks involved in the research are equivalent to those which would be accepted by non-prisoner participants.

23172 Free text

4. Explain how procedures for the selection of subjects within the prison are fair to all prisoners and not subject to arbitrary intervention by prison authorities or prisoners.

23173 Free text

5. Will prisoners serve as control subjects? 23208 Y/N 5.1. [If Y] Will control subjects be selected randomly from the group

of available prisoners who meet the characteristics needed for the research?

23209 Y/N

5.1.1. [If N] Explain how control subjects will be selected, and provide justification why random selection is not appropriate for this research.

23210 Free text

6. Provide assurance that parole boards will not take into account a prisoner’s participation in the research when making decisions regarding parole.

23175 Free text Parole boards should not be provided with information about prisoners’ participation in research.

7. Explain how each prisoner subject will be clearly informed in advance that participation in the research will have no effect on his or her parole.

23174 Free text

8. Is follow-up examination or care of subjects after the end of their participation in research necessary or appropriate?

23176 Y/N

8.1. [If Y] Explain the procedures for ensuring examination or care is conducted, including how subjects will be informed?

23217 Free text

9. Will the research be conducted within a federal prison or a state department of corrections facility?

23177 Multiple Choice – choose one. • No • Yes. Additional requirements apply. Please

contact the HSO for more information.

9.1. [If Y] Choose the appropriate location. 23219 Multiple Choice – choose all that apply. • Indiana Department of Corrections facility:

[name the facility] • Federal Bureau of Prisons facility: [name the

facility] • Other: [describe]


KC IRB Questionnaire G5 – Transnational Research Displays if the Protocol Type is Full Board or Expedited, and Transnational has been chosen as a Participant Type on the Protocol tab. Topics addressed: Performance sites Minimum number of questions: 8 Maximum number of questions: 13

Question Question ID Appropriate Answer Types Tips/Tricks 1. Provide a brief overview of the laws and regulations regarding

human research protections applicable to any of the non-US sites. 23361 Free text U.S. Department of Health & Human Services offers a compilation of International Human

Research Standards; you may find this a useful starting point.

2. Is there an IRB, ethics committee, or other community body which reviews human subjects research for the non-US site(s)?

23362 Y/N If you are collaborating with local researchers, check with them regarding any such obligations. If you are not, you may need to check with local government offices. See the Transnational Research Guidance for further information.

2.1. [If Y] Provide the committee or group name. Please note that documentation of approval from the committee must be obtained and attached to the Notes & Attachments.

23363 Free text

2.2. [If Y] Explain how the PI or study team will communicate with this committee during the conduct of the study.

23364 Free text

3. Describe any current social, cultural, economic, and political considerations for the non-US site(s) which may impact the research, including consent and/or assent considerations.

23365 Free text This applies not only to the countries in which you will conduct research, but also to the specific region(s) and population(s) with which you wish to work. Marginalized populations in otherwise stable countries may require additional or different considerations, for example.

4. Describe the PI or study team’s experiences with and knowledge of the non-US site(s).

23366 Free text

5. Describe the communications which have occurred between the PI or study team and researchers, community leaders, and/or stakeholders at the non-US site(s).

23367 Free text If not applicable, simply indicate N/A.

6. List the main language(s) spoken by the study population. 23368 Free text 7. Are the PI and/or study team members who will be on site fluent in

the language(s)? 23369 Y/N

7.1. [If N] How will the researchers communicate with the study participants?

23370

Multiple Choice – choose all that apply. • Interpreter • Other: [describe]

8. Are there any specific risks to subjects which exist as a result of the population’s locality?

23372 Y/N Consider risks to your subject population that may be unique to their situation. For example, a researcher working with black African political organizers in South Africa in the 1970s would have needed additional safeguards compared to a researcher conducting similar research today.

8.1. [If Y] List the potential risks. 23373 Free text 8.2. [If Y] Explain how the risks will be minimized. 23374 Free text

http://www.hhs.gov/ohrp/international/

http://www.hhs.gov/ohrp/international/

http://researchcompliance.iu.edu/hso/hs_transnational.html


KC IRB Questionnaire H – Informed Consent Process Displays if the Protocol Type is Full Board or Expedited. Topics addressed: Consent procedures Minimum number of questions: 1 Maximum number of questions: 31

Question Question ID Appropriate Answer Types Tips/Tricks 1. Will all or some subjects consent to participate in the research? 901 Multiple Choice – choose one.

• The only participants are Children. The process will be described in the Child Assent & Parental Consent Process Questionnaire.

• All subjects (or their legally authorized representative) will consent to participate in the research.

• Some subjects (or their legally authorized representative) will consent to participate in the research, and some subjects will not.

• No subjects will consent to participate in the research.

If you wish to request a waiver of documentation of consent, do not select “No subjects will consent to participate in the research.” Select another option, and you will have an opportunity to request a waiver of documentation later in the questionnaire.

1.1. [If Some subjects] Explain which subjects will consent to the research, and which subjects will not.

902 Free text

1.2. [If All subjects or Some subjects] For those subjects who will consent to participate, explain how subjects (or subjects’ legally authorized representative) will be presented with the information needed to decide to participate, including all elements of informed consent.

909 Free text The following elements of informed consent must be presented to subjects: • Statement that the study involves research • Explanation of the purposes of the research • Expected duration of subject participation • Description of procedures to be followed • Identification of any procedures that are experimental • Description of any foreseeable risks or discomforts to subjects • Description of benefits (to subjects or others) that may reasonably be expected

from the research • Disclosure of appropriate alternative procedures or courses of treatment • Statement describing the extent to which confidentiality of records identifying

subjects will be maintained • Contact information for questions about the research, research-related injury,

or subjects’ rights • Statement that participation is voluntary • If applicable, an explanation that some information is being withheld until the

research is complete. 1.2.1. Describe the plan for assessing potential subjects’

capacity to consent to determine whether they are capable of consenting on their own behalf, including: which subjects will be assessed, timing of assessment, mechanism for assessment, any assessment tools to be used, and plans for reassessing subjects who may lose their capacity to consent during the course of the study.

910 Free text Question displays only if Individuals Lacking Consent Capacity has been chosen as a Participant Type on the Protocol tab. Describe any assessments that will be used and include a copy on the Notes and Attachments tab. If assessments will be performed during the study to ensure that subjects retain capacity, state how frequently they will be performed.


1.2.2. Explain how you will identify persons authorized to give legally valid consent on behalf of individuals who cannot consent for themselves, and how they will be adequately informed of their roles and obligations for protecting the subject.

911 Free text Question displays only if Individuals Lacking Consent Capacity has been chosen as a Participant Type on the Protocol tab.

1.2.3. Explain how you will obtain and document assent to participate from individuals who cannot consent for themselves. If assent will not be obtained, please justify.

912 Free text Question displays only if Individuals Lacking Consent Capacity has been chosen as a Participant Type on the Protocol tab. Submit any assent documents on the Notes and Attachments tab. If an assessment will be used to determine whether subjects can assent, submit the assessment and explain how it will be used.

1.2.4. Describe any informed consent tools which will be used to present information to potential subjects (i.e. consent documents, videos, brochure, drug/device information, etc) and how they will be used.

903 Free text

1.2.5. Describe the timing of the informed consent process, including how you will ensure potential subjects have sufficient opportunity to discuss and consider participation before agreeing to participate in the research.

925 Free text Describe any waiting period between the consent conversation and the subject’s decision, (even if no time will be given due to urgency of enrolling in the study to receive treatment).

1.2.6. Will you include all required elements of consent in your consent process?

30127 Y/N

1.2.6.1. [If N] Choose the elements which will be omitted from your consent proces.

916 Multiple Choice – choose all that apply. • Statement that the study involves research • Explanation of the purposes of the research • Expected duration of subject participation • Description of procedures to be followed • Identification of any procedures that are

experimental • Description of any foreseeable risks or

discomforts to subjects • Description of benefits (to subjects or others)

that may reasonably be expected from the research

• Disclosure of appropriate alternative procedures or courses of treatment

• Statement describing the extent to which confidentiality of records identifying subjects will be maintained

• Contact information for questions about the research, research-related injury, or subjects’ rights

• Statement that the study data or biospecimens may/may not be de-identified and used for future research

• Statement that participation is voluntary.



1.2.6.2. [If any except All elements will be included] The IRB must approve a modification to the consent process. Explain how the research involves no more than minimal risk to the subject.

917 Free text

1.2.6.2.1. Explain how the modification will not adversely affect the rights and welfare of subjects.

918 Free text Describe whether the subject population, in general, would consider their rights violated if they knew of the waiver, or whether the waiver has the potential to cause adverse consequences for their welfare or general well-being. Explain whether subjects will be informed that some information is being withheld until the research is complete.

1.2.6.2.2. Explain how the research could not be practicably carried out if all elements of informed consent were required.

919 Free text Describe any special circumstances, such as study design, that would make it impossible to include all elements. For example, if deception regarding the purpose of the study is necessary in order to receive valid results, explain.

1.2.6.2.3. Explain why the research could not be practicably carried out without identifiers.

30004 Free text

1.2.6.2.4. Explain how subjects will be informed of pertinent results at the conclusion of the study, if appropriate. If subjects will not be informed, enter N/A.

920 Free text If the purpose or other information about the study will not be disclosed to subjects prior to the study, describe any debriefing that will occur after subjects complete procedures.

1.2.7. Indicate in what language(s) the consent conversation will be conducted.

921 Multiple Choice – choose all that apply. • English • Spanish • Other

1.2.7.1. [If Spanish or Other] Describe how you will ensure the consent conversation is conducted in a language which is understandable to the subject (e.g. use of interpreter, etc).

922 Free text For example, if an interpreter will be used, explain how you will identify the interpreter and how you will ensure that the interpreter is qualified.

1.2.7.2. [If Other] Specify additional languages which you reasonably expect to use during the consent conversation.

923 Free text

1.2.7.3. [If Spanish or Other] If non-English consent documents will be used, the PI affirms that translated versions are complete and accurate translations which do not contain information not presented within the context of the English version(s).

924 Y/N/NA

1.2.8. Explain how you will ensure potential subjects understand the information you have presented to them before they agree to participate in the study.

926 Free text Examples might include asking subjects if they have questions at the end of the consent conversation, asking subjects to summarize complicated sections of the consent document, having subjects complete a short post-test after the consent conversation, etc.

1.2.9. Briefly describe any training provided to investigators who are obtaining informed consent.

929 Free text

1.2.10. Does the research include any minimal risk procedures to which subjects will not consent?

931 Y/N


1.2.10.1. [If Y] A waiver of consent for those procedures is required. Explain how the procedures involve no more than minimal risk to the subject.

932 Free text

1.2.10.1.1. Explain how the waiver will not adversely affect the rights and welfare of subjects.

933 Free text Describe whether the subject population, in general, would consider that their rights were violated if they knew of the waiver, or that the waiver has the potential to cause adverse consequences for their welfare or general well-being.

1.2.10.1.2. Explain how the research could not be practicably carried out if informed consent were required.

905 Free text The IRB will consider factors such as the scale of the research, the procedures being used to collect data or samples, whether investigators will interact with subjects, and if using samples, whether the sample would exist outside of clinical care.


30004 Free text


914 Free text Describe any debriefing or communications with subjects that will occur after subjects complete procedures.

1.2.11. For those subjects who will consent to participate, choose whether the consent process will be documented by a written signature from subjects. Please note that you may request a waiver of the signature requirement if this study is minimal risk OR if the only record linking the subject and the research would be the consent document and the principal risk of the study is potential harm resulting from a breach of confidentiality.

23678 Multiple Choice – choose one. • All consented subjects will provide a written

signature as documentation of consent. • Some subjects will provide a written signature

as documentation of consent, and some subjects will not.

• No subjects will provide a written signature as documentation of consent.

1.2.11.1. [If All or Some subjects will provide a written signature] Will subjects participate in any study activity prior to physically signing a consent document? For example, some studies require subjects to fast, to refrain from drinking or smoking, or to keep a food or exercise journal prior to their first study visit.

30129 Y/N

1.2.11.1.1. [If Y] List the activities in which subjects will participate prior to signing the consent document. Each activity must present no more than minimal risk of harm to subjects AND involve no activities for which written consent is normally required outside of the research. Please note that subjects should provide verbal consent to these activities.

30130 Free text

1.2.11.2. [If All consented subjects] Explain the process for obtaining a written signature from subjects.

940 Free text


1.2.11.3. [If Some subjects] Explain which subjects will provide a written signature as documentation of consent, and which subjects will not.

939 Free text

1.2.11.3.1. Explain the process for obtaining a written signature from subjects.

940 Free text

1.2.11.3.2. Since some subjects will not provide a written signature as documentation of consent, a waiver of documentation of consent is required. Choose the option which most appropriately applies to your study.

934 Multiple Choice – choose one. • The research presents no more than minimal

risk of harm to subjects AND involves no procedures for which written consent is normally required outside of the research

• The only record linking the subject and the research would be the consent document and the principal risk of the study is potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research and the subject’s wishes will govern.

• The subjects or legally authorized representatives are members of a distinct cultural group or community. Signing forms is not the norm for this group, the research presents no more than minimal risk of harm to subjects, and there is an appropriate alternative mechanism for documenting that informed consent was obtained.

1.2.11.4. [If No subjects] Since no subjects will provide a written signature as documentation of consent, a waiver of documentation of consent is required. Choose the option which most appropriately applies to your study.




• The subjects or legally authorized representatives are members of a distinct cultural group or community. Signing forms is not the norm for this group, the research presents no more than minimal risk of harm to subjects, and there is an appropriate


alternative mechanism for documenting that informed consent was obtained.

1.3. [If No subjects will consent] Explain how the research involves no more than minimal risk to the subjects.

904 Free text

1.3.1. Explain how the waiver will not adversely affect the rights and welfare of subjects.


1.3.2. Explain how the research could not be practicably carried out if informed consent were required.


1.3.3. Explain why the research could not be practicably carried out without identifiers.

30004 Free text

1.3.4. Explain how subjects will be informed of pertinent results at the conclusion of the study, if appropriate. If subjects will not be informed, enter N/A.


1.4. [If Some subjects will consent] Since some subjects will not consent to participation in the research, a waiver of consent is required.

23764 Multiple Choice – choose one. • Research is minimal risk and obtaining consent is

not practicable. • This research qualifies for an exception to

informed consent requirements for emergency research. Please complete and upload the Request for Waiver of Informed Consent for Planned Emergency Research.

1.4.1. [If Research is minimal risk] Explain how the research involves no more than minimal risk to the subjects.

904 Free text

1.4.2. [If Research is minimal risk] Explain how the waiver will not adversely affect the rights and welfare of subjects.


1.4.3. [If Research is minimal risk] Explain how the research could not be practicably carried out if informed consent were required.


1.4.4. [If Research is minimal risk] Explain why the research could not be practicably carried out without identifiers.

30004 Free text

1.4.5. [If Research is minimal risk] Explain how subjects will be informed of pertinent results at the conclusion of the study, if appropriate. If subjects will not be informed, enter N/A.



KC IRB Questionnaire J – Child Assent & Parental Consent Process Displays if the Protocol Type is Full Board or Expedited, and Children has been chosen as a Participant Type on the Protocol tab. Topics addressed: Consent procedures Minimum number of questions: 9 Maximum number of questions: 36

Question Question ID Appropriate Answer Types Tips/Tricks 1. Can children provide legal consent for themselves to participate in

this study? 23808 Multiple Choice – choose one.

• All children can provide legal consent for themselves.

• Some children can provide legal consent for themselves and some cannot.

• No children can provide legal consent for themselves

1.1. [If All or Some children can provide legal consent] Explain why children can provide legal consent for themselves to participate in this study.

949 Free text

1.1.1. For those subjects who will consent to participate, explain how subjects (or subjects’ legally authorized representative) will be presented with the information needed to decide to participate, including all elements of informed consent.

23809 Free text

1.1.2. Describe any informed consent tools which will be used to present information to potential subjects (i.e. consent documents, videos, brochure, drug/device information, etc) and how they will be used.

23810 Free text

1.1.3. Describe the timing of the informed consent process, including how you will ensure potential subjects have sufficient opportunity to discuss and consider participation before agreeing to participate in the research.


1.1.4. Will you include all required elements of consent in your consent process?

30127 Y/N https://research.iu.edu/compliance/human-subjects/guidance/informed-consent.html

1.1.4.1. [If N] Choose the elements which will be omitted from your consent process.



discomforts to subjects



• Description of benefits (to subjects or others) that may reasonably be expected from the research





• Statement that participation is voluntary 1.1.4.2. [If N] The IRB must approve a modification to the

consent process. Explain how the research involves no more than minimal risk to the subject.

23815 Free text

1.1.4.2.1. Explain how the modification will not adversely affect the rights and welfare of subjects.

23816 Free text Describe whether the subject population, in general, would consider their rights violated if they knew of the waiver, or whether the waiver has the potential to cause adverse consequences for their welfare or general well-being. Explain whether subjects will be informed that some information is being withheld until the research is complete.

1.1.4.2.2. Explain how the research could not be practicably carried out if all elements of informed consent were required.



30004 Free text


23818 Free text If the purpose or other information about the study will not be disclosed to subjects prior to the study, describe any debriefing that will occur after subjects complete procedures.

1.1.5. Indicate in what language(s) the consent conversation will be conducted.

23819 Multiple Choice – choose all that apply. • English • Spanish • Other

1.1.5.1. [If Spanish or Other] Describe how you will ensure the consent conversation is conducted in a language which is understandable to the subject (e.g. use of interpreter, etc).


1.1.5.2. [If Other] Specify additional languages which you reasonably expect to use during the consent conversation.

23821 Free text


1.1.5.3. [If Spanish or Other] If non-English consent documents will be used, the PI affirms that translated versions are complete and accurate translations which do not contain information not presented within the context of the English version(s).

23822 Y/N/NA

1.1.6. Explain how you will ensure potential subjects understand the information you have presented to them before they agree to participate in the study.

23823 Free text Examples might include asking subjects if they have questions at the end of the consent conversation, asking subjects to summarize complicated sections of the consent document, having subjects complete a short post-test after the consent conversation, etc.

1.1.7. Briefly describe any training provided to investigators who are obtaining informed consent.

23826 Free text

1.1.8. Does the research include any minimal risk procedures to which subjects will not consent?

23829 Y/N

1.1.8.1. [If Y] A waiver of consent for those procedures is required. Explain how the procedures involve no more than minimal risk to the subject.

23830 Free text






30004 Free text This question only displays if Performing Organization ≠ VA.



1.1.9. For those subjects who will consent to participate, choose whether the consent process will be documented by a written signature from subjects.

23678 Multiple Choice – choose one. • All consented subjects will provide a written

signature as documentation of consent.; • Some subjects will provide a written signature

as documentation of consent, and some subjects will not.

• No subjects will provide a written signature as documentation of consent.

1.1.9.1. [If All or Some subjects will provide written signature] Will subjects participate in any study activity prior to physically signing a consent document? For example, some studies require subjects to fast, to refrain from drinking or smoking, or to keep a food or exercise journal prior to their first study visit.

30129 Y/N

1.1.9.1.1. [If Y] List the activities in which subjects will participate prior to signing the consent

30130 Free text


document. Each activity must present no more than minimal risk of harm to subjects AND involve no activities for which written consent is normally required outside of the research. Please note that subjects should provide verbal consent to these activities.

1.1.9.2. [If All consented subjects] Explain the process for obtaining a written signature from subjects.

940 Free text

1.1.9.3. [If Some subjects] Explain which subjects will provide a written signature as documentation of consent, and which subjects will not.

939 Free text

1.1.9.3.1. Explain the process for obtaining a written signature from subjects.

940 Free text

1.1.9.3.2. Since some subjects will not provide a written signature as documentation of consent, a waiver of documentation of consent is required. Choose the option which most appropriately applies to your study.





1.1.9.4. [If No subjects] Since no subjects will provide a written signature as documentation of consent, a waiver of documentation of consent is required. Choose the option which most appropriately applies to your study.






1.2. [If Some children or No children] Will consent be obtained from subjects’ parents/guardians? Select both options if consent will be obtained from some parents but not all.

936 Multiple Choice – choose all that apply. • Yes • No. I am requesting a waiver of parental

consent.

If the Lay Summary & Research Design questionnaire has indicated that your study is FDA-regulated, your study is not eligible for a waiver of parental consent.

1.2.1. [If Y AND Category 3 or 4 risk to children] Confirm that consent will be obtained from both parents unless one parent is deceased, unknown, incompetent, or not reasonably available, or unless only one parent has legal responsibility for the care and custody of the child.

938 Y/N

1.2.2. [If Y] Explain how parents/guardians will be presented with the information needed to decide to participate, including all elements of informed consent.

23779 Free text The following elements of informed consent must be presented to subjects:

• Statement that the study involves research • Explanation of the purposes of the research • Expected duration of subject participation • Description of procedures to be followed • Identification of any procedures that are experimental • Description of any foreseeable risks or discomforts to subjects • Description of benefits (to subjects or others) that may reasonably be expected from

the research • Disclosure of appropriate alternative procedures or courses of treatment • Statement describing the extent to which confidentiality of records identifying

subjects will be maintained • Contact information for questions about the research, research-related injury, or

subjects’ rights • Statement that participation is voluntary • If applicable, an explanation that some information is being withheld until the

research is complete. 1.2.2.1. Describe any informed consent tools which will be

used to present information (i.e. consent documents, videos, brochure, drug/device information, etc) and how they will be used.

23780 Free text

1.2.2.2. Describe the timing of the informed consent process, including how you will ensure parents/guardians have sufficient opportunity to discuss and consider their children’s participation before agreeing to allow their children to participate in the research.



1.2.2.3. Will you include all required elements of consent in your consent process.

30127 Y/N https://research.iu.edu/compliance/human-subjects/guidance/informed-consent.html

1.2.2.3.1. [If N] Choose the elements which will be omitted from your consent process.



discomforts to subjects • Description of benefits (to subjects or others)

that may reasonably be expected from the research





• Statement that participation is voluntary

1.2.2.3.2. [If any except All elements will be included] The IRB must approve a modification to the consent process. Explain how the research involves no more than minimal risk to the subject.

23785 Free text If the Lay Summary & Research Design questionnaire has indicated that your study is FDA-regulated, your study is not eligible for a modification of the consent process.

1.2.2.3.2.1. Explain how the modification will not adversely affect the rights and welfare of subjects.

23786 Free text Describe whether the subject population, in general, would consider that their rights were violated if they knew of the waiver, or that the waiver has the potential to cause adverse consequences for their welfare or general well-being. Explain whether subjects will be informed that some information is being withheld until the research is complete.

1.2.2.3.2.2. Explain how the research could not be practicably carried out if all elements of informed consent were required.


1.2.2.3.2.3. Explain why the research could not be practicably carried out without identifiers.

30004 Free text



1.2.2.3.2.4. Explain how subjects will be informed of pertinent results at the conclusion of the study, if appropriate. If subjects will not be informed, enter N/A.

23788 Free text Describe any debriefing or communications with parents that will occur after subjects complete procedures.

1.2.2.4. Indicate in what language(s) the consent conversation will be conducted.

23789

Multiple Choice – choose all that apply. • English • Spanish • Other

1.2.2.4.1. [If Spanish or Other]Describe how you will ensure the consent conversation is conducted in a language which is understandable to the parents/guardians (e.g. use of interpreter, etc).


1.2.2.4.2. [If contains text value Other] Specify additional languages which you reasonably expect to use during the consent conversation.

23791 Free text

1.2.2.4.3. [If Spanish or Other] If non-English consent documents will be used, the PI affirms that translated versions are complete and accurate translations which do not contain information not presented within the context of the English version(s).

23792 Y/N/NA

1.2.2.5. Explain how you will ensure parents/guardians understand the information you have presented to them before they agree to allow their children to participate in the research.

23793 Free text Examples might include asking parents if they have questions at the end of the consent conversation, asking parents to summarize complicated sections of the consent document, having parents complete a short post-test after the consent conversation, etc.

1.2.2.6. Briefly describe any training provided to investigators who are obtaining informed consent.

23798 Free text

1.2.2.7. Does the research include any minimal risk procedures to which parents/guardians will not consent for their children to participate?

23800 Y/N

1.2.2.7.1. [If Y] A waiver of consent for those procedures is required. Explain how the procedures involve no more than minimal risk to the subject.

23801 Free text

1.2.2.7.1.1. Explain how the waiver will not adversely affect the rights and welfare of subjects.


1.2.2.7.1.2. Explain how the research could not be practicably carried out if informed consent were required.



1.2.2.7.1.3. Explain why the research could not be practicably carried out without identifiers.

30004 Free text

1.2.2.7.1.4. Explain how subjects will be informed of pertinent results at the conclusion of the study, if appropriate. If subjects will not be informed, enter N/A.


1.2.3. [If Yes] For those parents/guardians who will consent to allow their children to participate, choose whether the consent process will be documented by a written signature from.

30330 Multiple Choice – choose one. • All consented parents/guardians will provide a

written signature as documentation of consent.;

• Some parents/guardians will provide a written signature as documentation of consent, and some subjects will not.

• No parents/guardians will provide a written signature as documentation of consent.

1.2.3.1. [If All or Some parents/guardians will provide written signature] Will subjects participate in any study activity prior to parents/guardians physically signing a consent document? For example, some studies require subjects to fast prior to their first study visit.

30331 Y/N

1.2.3.1.1. [If Y] List the activities in which subjects will participate prior to parents/guardians signing the consent document. Each activity must present no more than minimal risk of harm to subjects AND involve no activities for which written consent is normally required outside of the research. Please note that parents/guardians should provide verbal consent to these activities.

30332 Free text

1.2.3.2. [If All consented subjects] Explain the process for obtaining a written signature from parents/guardians.

30333 Free text

1.2.3.3. [If Some subjects] Explain which parents/guardians will provide written signature as documentation of consent, and which will not.

30334 Free text

1.2.3.3.1. Explain the process for obtaining a written signature from parents/guardians.

30333 Free text

1.2.3.3.2. Since some parents/guardians will not provide a written signature as documentation of consent, a waiver of documentation of parental/guardian consent is required. Choose the option




which most appropriately applies to your study.


• The subjects/parents/guardians or legally authorized representatives are members of a distinct cultural group or community. Signing forms is not the norm for this group, the research presents no more than minimal risk of harm to subjects, and there is an appropriate alternative mechanism for documenting that informed consent from parents/guardians was obtained.

1.2.3.4. [If No subjects] Since no parents/guardians will provide a written signature as documentation of consent, a waiver of documentation of parental/guardian consent is required. Choose the option which most appropriately applies to your study.



• The only record linking the subject and the research would be the consent document and the principal risk of the study is potential harm resulting from a breach of confidentiality. Each subject/parent/guardian will be asked whether they want documentation linking the subject with the research and their wishes will govern.

• The subjects/parents/guardians or legally authorized representatives are members of a distinct cultural group or community. Signing forms is not the norm for this group, the research presents no more than minimal risk of harm to subjects, and there is an appropriate alternative mechanism for documenting that informed consent from parents/guardians was obtained.

1.2.4. [If No. I am requesting a waiver] Choose the option which most appropriately applies to your study.

942 Multiple Choice – choose one. • Parental/guardian consent cannot be

practicably obtained. • Parental/guardian consent is not a reasonable

requirement to protect participants.

If the Lay Summary & Research Design questionnaire has indicated that your study is FDA-regulated, your study is not eligible for a waiver of parental consent.

1.2.4.1. [If consent cannot practicably be obtained] Explain how the research involves no more than minimal risk to the subject, and is not FDA Regulated.

943 Free text





945 Free text The IRB will consider factors such as the scale of the research, the procedures being used to collect data or samples, whether investigators will interact with parents/subjects, and if using samples, whether the sample would exist outside of clinical care.


30004 Free text


946 Free text Describe any debriefing or communications with parents/subjects that will occur after subjects complete procedures.

1.2.4.2. [If not a reasonable requirement to protect participants] Explain why parental/guardian consent is not a reasonable requirement to protect participants in this study.

947 Free text For example, parental/guardian consent may not be a reasonable requirement if the study involves neglected or abused children.

1.2.4.2.1. Describe how you will implement an appropriate mechanism for protecting the children who will participate since parent/guardian consent will not be obtained. An appropriate mechanism includes consideration of the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research participants, and their age, maturity, status, and condition.

948 Free text

1.3. [If Some children OR No children] In order to describe the process for obtaining assent from children, check all that apply.

950 Multiple Choice – choose all that apply. • Some/all children are not capable of providing

assent. • Some/all children will not provide assent even

though they are otherwise capable. A waiver of assent will be requested.

• Some/all children will provide assent.

1.3.1. [If not capable] Explain why children are not capable of providing assent. Consider age, maturity, and psychological state, and situations where capability is so limited that they cannot reasonably be consulted.

951 Free text Generally, children ages 7-17 are considered capable of providing assent; however, younger children may also be capable considering the specific circumstances of the study, and vice versa.

1.3.2. [If will not provide assent] Choose the option which most appropriately applies to your study.

952 Multiple Choice – choose one. • Assent cannot be practicably obtained. • The intervention(s) or procedure(s) holds out

the prospect of direct benefit that is important to the health or well-being of the child and is available only in the context of the research.

If the Lay Summary & Research Design questionnaire has indicated that your study is FDA-regulated, your study is not eligible for a waiver of assent.


1.3.2.1. [If Assent cannot practicably be obtained] Explain how the research involves no more than minimal risk to the subject.

953 Free text



1.3.2.1.2. Explain how the research could not be practicably carried out if child asssent were required.



30004 Free text



1.3.2.2. [If The intervention holds out the prospect of direct benefit] Explain why the intervention(s) or procedure(s) holds out the prospect of direct benefit that is important to the health or well-being of the child and is available only in the context of the research.

957 Free text

1.3.3. [If will provide assent] Describe the timing of the assent process, including how you will ensure potential subjects have sufficient opportunity to discuss and consider participation before agreeing to participate in the research.


1.3.3.1. Describe any assent tools which will be used to present information to potential subjects (i.e. assent document, study information sheet, videos, brochure, drug/device information, etc) and how they will be used.

959 Free text

1.3.3.2. Will children indicate their assent with a signature on an assent or consent document?

996 Multiple Choice – choose all that apply. • Assent form • Consent Statement • Subjects will not provide a signature

If children will indicate their assent with a signature, it is generally expected that children ages 7-13 will sign an age-appropriate assent form. Children ages 14 and up can often provide signature on the parental consent form, which should be written at an 8th-grade reading level.


KC IRB Questionnaire K – HIPAA Displays if the Protocol Type is Full Board or Expedited. Topics addressed: HIPAA Minimum number of questions: 1 Maximum number of questions: 38

Question Question ID Appropriate Answer Types Tips/Tricks 1. Are you part of a covered entity (health care provider that transmits

health information electronically) or are you receiving information from a covered entity as part of your research? For more information on covered entities, and a list of IU-affiliated covered entities, see IU Guidance on HIPAA.

23253 Y/N

1.1. [If Y] Will protected health information be utilized, accessed, collected, or generated as part of the study? Protected health information is information, including demographic data, that relates to an individual’s past present or future physical or mental health condition, the provision of health care to the individual, or the past, present, and future payment for the provision of health care to the individual.

23254 Y/N

1.1.1. [If Y] Select the electronic systems to be used for the collection and/or storage of protected health information (ePHI). Choose all that apply. Consult the HRPP Guidance on HIPAA.

30347 Multiple Choice – choose all that apply. • OnCore • REDCap • IU Box Health Data Account • Other • No ePHI will be collected or stored at IU - you

may also select this option if IU researchers will enter ePHI in only sponsor-provided record systems.

Question only displays if Protocol includes at least one IU organization.

1.1.1.1. [If Other] For Other systems, provide additional information regarding status of certification.

30349 Multiple Choice – choose one. • All electronic systems used to collect or store

ePHI have previously been approved or certified

• The study team will complete the required IU system certification checklist and process for certifying the collection and/or storage locations and systems with their IT professional and data steward prior to the collection of any ePHI. See Checklist for System Providers

1.1.2. [If Y] Will you be accessing or collecting protected health information for RECRUITMENT purposes? You should answer Yes if you are using medical records to identify subjects who may be eligible for your study, or to determine whether patients are eligible (i.e. screening).

23257 Y/N Answer Yes if the study is a chart review, and access to Protected Health Information (PHI) is needed to select records or data points for inclusion in the research.

https://compliance.iu.edu/compliance-areas/hipaa/index.html



https://datamanagement.iu.edu/tools/checklist-for-system-providers.php

https://datamgmt.iu.edu/tools/checklist-for-system-providers.php



1.1.2.1. [If Y] Choose all that apply to the recruitment plans.

23258 Multiple Choice – choose all that apply. • Review of medical records by the study team • Subject self-report of health information for

eligibility • Health information provided by clinicians not

part of the study team

1.1.2.1.1. [If Review of medical records by the study team] Will review of medical records for recruitment purposes be conducted by an investigator who is NOT a part of the potential subject’s care team? The care team includes the potential subject’s care provider, and any authorized delegates of the care provider who are a part of the covered entity’s workforce.

23259

Y/N

1.1.2.1.1.1. [If Y] Explain who will conduct review of medical records.

23260 Free text

1.1.2.1.1.2. [If Y] HIPAA authorization or a waiver of authorization is required. Choose all that apply.

23262 Multiple Choice – choose all that apply. • I will obtain written, signed authorization

from subjects prior to the review of records. • I will obtain authorization from subjects prior

to the review of records but subjects will not physically sign a document.

• I will not obtain authorization prior to the review of records.

1.1.2.1.1.2.1. [If subjects will not physically sign or I will not obtain authorization] A waiver or alteration of the requirement for a written signature must be approved by the IRB. See HIPAA Waiver questions below.

23263 Free text

1.1.2.1.1.2.2. [If subjects will not physically sign a document] Explain which subjects will sign a written authorization form and which subjects will not.

23692 Free text This process is similar to the “waiving documentation of informed consent,” where you will review the HIPAA Authorization with the subject but, since it may not be feasible (such as lack of personal contact with the subject), the signature requirement may be waived. In other words, this process harmonizes the waiver of documentation of consent process and the waiver of authorization process.

1.1.2.1.1.2.2.1. Please explain how the elements of authorization will be presented to potential subjects, including a

23324 Free text The verbal Authorization process (when/where) should be described in detail here.


description of any tools used.

1.1.2.1.2. [If Subject self-report of health information for eligibility] Will you need to gather additional details about the potential subject’s health (in addition to contact information and basic eligibility information) in order to determine his/her eligibility for the study?

23270 Y/N

1.1.2.1.2.1. [If Y] Choose all that apply. 23640 Multiple Choice – choose all that apply. • I will obtain written, signed authorization

from subjects prior to collection of the additional information.

• I will obtain authorization from subjects prior to the collection of the additional information but subjects will not physically sign a document.

• I will not obtain authorization prior to collection of the additional information.

Choose the options that apply specifically to the screening procedures involving the collection of Protected Health Information (PHI).

1.1.2.1.2.1.1. [If subjects will not physically sign or I will not obtain authorization] A waiver or alteration of the requirement for a written signature must be approved by the IRB. See HIPAA Waiver questions below.

23765 Free text

1.1.2.1.3. [If Health information provided by clinicians not part of the study team] Will the clinician direct the potential subject to contact the study team?

23271 Y/N

1.1.2.1.3.1. [If N] Will the clinician obtain written, signed authorization from the potential subject in order to release the subject’s information to the study team?

23272 Y/N

1.1.2.1.3.1.1. [If N] A waiver of authorization for recruitment is required. See HIPAA Waiver questions below.

24855 Free text

1.1.3. [If Y] HIPAA applies to your study, and requires that you obtain authorization for PARTICIPATION in research, or that you request a waiver. Check all that apply.

23277 Multiple Choice – choose all that apply. • I will obtain written, signed authorization

from subjects prior to their participation.

If you indicate that you will obtain written, signed authorized from subjects, you must upload a HIPAA Authorization Form to the Notes & Attachments tab, with an Attachment Type of HIPAA Authorization Form (non-VA) or VA – HIPAA Authorization Form.


• I will obtain authorization from subjects prior to their participation but subjects will not physically sign a document.

• I will not obtain authorization prior to their participation.

1.1.3.1. [If Subjects will not physically sign OR I will not obtain authorization] Provide a brief description of the PHI to be used or disclosed. See HIPAA Waiver questions below.

23650 Free text Displays if the VA has not been included as an organization on the Protocol tab.

1.1.3.2. [If VA study AND Subjects will not physically sign OR I will not obtain authorization] Choose the appropriate description of the PHI.

23293 Multiple Choice – choose one. • Partial Record Review • Full Record Review, Including but not limited

to information provided by the subject directly to the research team, hospital records and reports, admission histories, physicals, x-rays films and reports, operative reports, laboratory reports, treatment and test results, immunizations, allergy reports, prescriptions, consultations, clinic notes, and any other medical or dental records needed by the research team.

Displays if the VA has been included as an organization on the Protocol tab.

1.1.3.2.1. [If Partial Record Review] List all data elements to be used or disclosed (do not refer to an attachment).

23386 Free text

1.1.3.2.2. Choose all applicable Title 38 USC 7332-protected information to be utilized for research purposes?

23294 Multiple Choice – choose all that apply. • Mental health records • Psychotherapy notes • HIV/AIDS • Sexually transmitted diseases • Alcohol/substance abuse • Sickle-Cell Anemia • None of the above

1.1.3.2.2.1. [If any except None of the above] Confirm all of the following:

23295 Multiple Choice – choose all that apply. • The VA Privacy Officer has been contacted to

assure all necessary requirements are met. • The information will not be redisclosed except

back to the VA. • The information will not identify any

individual patient in any report of the research or otherwise disclose patient identifiers.

• No subjects will be identified, directly or indirectly, in any report.


1.1.3.3. [If I will obtain written, signed authorization from subjects] Will you be collecting information from subjects’ medical records?

23278 Multiple Choice – choose one. • Yes, I have uploaded an Authorization

template to the Notes & Attachments tab. • No, I have uploaded the healthy subjects

Authorization template to the Notes & Attachments tab.

1.1.3.4. [If subjects will not physically sign a document] Explain which subjects will sign a written authorization form and which subjects will not.

23693 Free text This process is similar to the “waiving documentation of informed consent” where you will review the HIPAA Authorization with the subject but, since it may not be feasible (such as lack of personal contact with the subject), the signature requirement may be waived. In other words, this just harmonizes the waiver of documentation of consent process and the waiver of authorization process.

1.1.3.4.1. Explain how the elements of authorization will be presented to potential subjects, including a description of any tools used.

23694 Free text

HIPAA Waiver Questions

1. List all data elements to be used or disclosed (do not refer to an attachment).

23263, 23765, 24855, 23639, 23650, 24957

Free text When offering a description of PHI, please include a listing of the data elements to be used or disclosed, in lieu of referencing an attachment.

2. Explain how this research involves no more than minimal risk of loss of confidentiality to the subject.

23264, 23766, 24856, 23641, 23651, 24958

Free text The response should be specific to loss of confidentiality, not whether the study procedures as a whole are minimal risk.

3. Describe the plan for protecting identifiers from improper use and disclosure.

23265, 23767, 24857, 23642, 23652, 24959

Free text

4. Describe the plan to destroy identifiers at the earliest opportunity appropriate for the research, considering the purpose of the research and local data retention requirements.

23266, 23768, 24858, 23643, 23653, 24960

Free text

5. Confirm that the study team will assure identifiable PHI will not be re-used or disclosed to individuals outside the study team, except as required by law.

23267, 23769, 24859, 23644, 23654, 24961

Free text It is sufficient to quote the statement: “identifiable health information will not be reused or disclosed to individuals outside the study team, except as required by law.”

6. Explain how the research could not be practicably conducted without waiver of authorization or alteration of authorization requirements.

23268, 23770, 24860, 23645, 23655, 24962

Free text If subjects will be identified prior to participation, or if the study team will have physical access to subjects prior to collection of PHI, authorization will typically be required and a waiver will not be approved.

7. Explain how the research could not be practicably conducted without access to and use of identifiable PHI.

23269, 23771, 24861, 23646, 23656, 24963

Free text Please be as detailed as possible. However, in certain circumstances, it is sufficient to state the identifiable PHI is needed to answer the research question.


KC IRB Questionnaire L – VA Research Displays if the Protocol Type is Full Board or Expedited, and the VA has been included as an organization on the Protocol tab Topics addressed: Performance sites, recruitment procedures, HIPAA Minimum number of questions: 5 Maximum number of questions: 19

Question Question ID Appropriate Answer Types Tips/Tricks 1. Will VA time or resources be used to support the conduct of this

study in non-veterans? 23376 Y/N

1.1. [If Y] Choose the appropriate description for the inclusion of non-veterans.

22145 Multiple Choice – choose all that apply. • Subjects are VA health care providers or

employees • Family members of veterans • Active duty military personnel • Other

1.1.1. [If Other] Explain and provide justification for the use of VA time or resources for non-veterans:

23378 Free text

2. Explain how this research is relevant to the VA mission and the veteran population it serves.

30381 Free text

3. Will this study involve both VA and non-VA investigators? 22148 Y/N 3.1. [If Y] Describe specifically which research procedures, including

recruitment and all interactions, interventions, data collection, etc., will be conducted by VA investigators on VA time.

22149 Free text

4. Will any research data be stored outside the VA? 22151 Y/N 4.1. [If Y] Describe where data will be stored. 22152 Free text

5. Responses above indicate that a waiver of HIPAA authorization for recruitment purposes is required for this study. Choose the appropriate description of the PHI to be used for recruitment purposes.

23385 Multiple Choice – choose one. • Partial Record Review • Full Record Review ;Including but not limited

to information provided by the subject directly to the research team, hospital records and reports, admission histories, physicals, x-ray films and reports, operative reports, laboratory reports, treatment and test results, immunizations, allergy reports, prescriptions, consultations, clinic notes, and any other medical or dental records needed by the research team.

This question will display if you answered Yes to ID 23257 in Questionnaire K – HIPAA, indicating that access to PHI is needed to recruit or identify subjects’ records for inclusion in the research.

5.1. [If Partial Record Review] List all data elements to be used or disclosed (do not refer to an attachment).

23386 Free text


KC IRB Questionnaire M – ClinicalTrials.gov Displays if the Protocol Type is Expedited, Full Board, or Deferral.. Topics addressed: Whether registration on clinicaltrials.gov website is needed Minimum number of questions: 1 Maximum number of questions: 2

Question Question ID Appropriate Answer Types Tips/Tricks 1. This research project meets the following definitions (check all that apply).

If you are unsure or need additional help, please email [email protected] for more information.

24840 Multiple Choice – check all that apply. • Food and Drug Administration Amendments

Act (FDAAA) Applicable Clinical Trial Registration, Maintenance and Results Reporting Controlled, clinical investigation (drugs and/or biologics), other than Phase I, FDA regulated OR controlled, prospective clinical study of health outcomes (devices including IDE exempt or nonsignificant risk), FDA regulated OR pediatric postmarket surveillance of a device.

• National Institutes of Health (NIH) Funded and/or Supported Clinical Trial

• Registration, Maintenance and Results Reporting for NIH Funded Initiated January 18, 2017 or Later One or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

• International Committee of Medical Journal Editors (ICMJE) Clinical Trial Registration for ICMJE Journal Publication Prospectively assigned people or a group of people to an intervention, with or without concurrent comparison or control groups, to study the cause-and-effect relationship between a health-related intervention and a health outcome.

• Centers for Medicare and Medicaid Services (CMS) Clinical Trial Registration for Research Billing Claim Requires the billing of qualified claims for research related items and services.

• None of the above

Please reference the IU ClinicalTrials.gov Compliance policy for more information on requirements. For additional information or assistance, please contact [email protected].

1.1. [If Clinical Trial] Does this research project have a record posted publicly on ClinicalTrials.gov?

25048 Multiple Choice – choose one. • Yes. National Clinical Trial (NCT) number:


http://policies.iu.edu/policies/categories/research/IU-Research-Policies/clinicaltrials.gov.shtml



• No


KC IRB Questionnaire – Amendment Displays if the Protocol Type is Full Board or Expedited, and Submission Type is Amendment. Topics addressed: Changes to previously-approved research Minimum number of questions: 3 Maximum number of questions: 31

Question Question ID Appropriate Answer Types Tips/Tricks

1. Select the appropriate status of the study. 351 Multiple Choice – choose all that apply. • Open to Enrollment – No subjects consented to

date • Open to Enrollment – Enrollment continues • Closed to Enrollment – Research interventions

continue • Closed to Enrollment - Clinical Follow-up Only

Remaining research activities are limited to accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care

• Data Analysis Only Remaining research activities are limited to analysis of identifiable information or biospecimens

2. Does this amendment include revisions to study personnel? 25055 Y/N 2.1. [If Y] Please indicate the role(s) of study personnel being

revised. 25056 Multiple Choice – choose all that apply.

• Principal Investigator, Site Specific PI, Key Personnel, or Student, Fellow, Resident PI

• Non-Key Personnel

2.2. [If Y] Please indicate if study personnel are being added or removed.

25057 Multiple Choice – choose one. • Add • Remove

2.2.1. [If Remove AND Qu ID 25056 = Principal Investigator, Site Specific PI, Key Personnel, or Student, Fellow, Resident PI

] List the personnel removed.

24849 Free text

2.2.2. [If Add AND Qu ID 25056 = Principal Investigator, Site Specific PI, Key Personnel, or Student, Fellow, Resident PI

] List the personnel added.

159 Free text

2.2.3. [If Add] Are any of the study personnel being added non-affiliated?

25058 Multiple Choice – choose one. • No • Yes. Please update Questionnaire C to indicate

that the IU IRB is being asked to provide IRB approval for non-affiliated investigators

3. Does this amendment include any of the following? 25059 Multiple Choice – choose all that apply.


• Changes to the KC IRB Protocol information or study documents other than personnel

• An updated Investigator Brochure or package insert that does not result in any changes to study documents or KC IRB information.

• No – the only changes being made are personnel changes

4. [If Changes to the KC IRB Protocol information or study documents other than personnel OR non-affiliated investigators are being added] Does this amendment involve adding a study sponsor or new funding source?

165 Y/N

4.1. [If Y] Provide the name of the new sponsor or funding source. 168 Free text 4.2. List the number of active subjects: 157 Number Displays only if response to ID 351 = Enrollment continues or Research interventions

continue 4.2.1. [If Not 0] Summarize the status of active subjects. 25154 Free text

4.3. List and describe the changes proposed with this amendment. 169 Free text Try to be as detailed as possible. Keep in mind the reviewer is looking at the submission with fresh eyes, so consider the information you would need to approve the amendment if you weren’t working closely with the study on a regular basis.

4.4. State the rationale or justification for the proposed changes. 177 Free text Be as detailed as possible. If you aren’t able to provide justification for the amendment it may be hard for the reviewer to justify full approval.

4.5. Do the proposed changes update risk to subjects? 191 Y/N 4.5.1. [If Y] Explain the updated risks. 205 Free text Being detailed here helps, especially if a summary of changes has not been provided.

Page numbers where the changes can be found in the protocol or Investigator’s Brochure also help speed up the reviewing process.

4.6. Do the proposed changes alter the risk to benefit assessment? 155 4.6.1. [If Y] Explain how the proposed changes alter the risk to

benefit assessment. 143 Free text Think critically about the types of risk that are being added and consider whether the risks

outweigh the benefits. 4.7. Does this amendment require changes to the informed

consent/assent process and/or the Informed Consent Statement(s), Assent Document(s), or Study Information Sheet(s)?

196 Y/N Think carefully about which documents need to be included in your submission. For example, if the amendment includes updates to the Informed Consent Statement, you may need to update in the Questionnaire as well. If your research involves children, be sure to consider whether the Assent needs to be revised.

4.7.1. [If Y] Select the appropriate option: 163 Multiple Choice – choose one. • New document(s) are in addition to the

current study documents • New document(s) replace current documents • Changes are being made to the informed

consent process only and document(s) will not change

4.8. Will previously enrolled subjects (whether active or not) be informed of the change(s) described in this amendment?

158 Multiple Choice – choose one. • All previously enrolled subjects will be

informed of the change(s). • Some previously enrolled subjects will be

informed and some will not. • No previously enrolled subjects will be

informed of the change(s).

If the reviewer feels the changes are significant, especially if the amendment involves a change in risk, he/she will most likely expect to see a plan for informing subjects of the changes that have been made. This question will NOT appear if response to 351 = No subjects consented to date.


4.8.1. [If Some previously enrolled subjects will be informed and some will not] Explain which subjects will be informed and which will not.

25060 Free text

4.8.2. [If All previously enrolled subjects will be informed of the change(s)] Select how subjects will be informed of the change(s).

25061 Multiple Choice – choose all that apply. • Subjects will be re-consented. • Subjects will be informed in writing (e.g.,

letter) but will not sign a revised Informed Consent Statement.

• Subjects will be verbally informed. • Other

Be sure to consider all the possible options for notification and make a proposal based on the changes. Options may include full re-consent, a letter informing subjects of the change, or verbal notification.

4.8.2.1. [If Subjects will be re-consented] Describe the re-consent process, including whether it will be conducted in person or via mail/phone.

25062 Free text

4.8.2.2. [If Other] Please explain. 25082 Free text 4.8.2.3. Describe the timing of notification or re-consent. 25063 Free text

4.8.3. [If Some previously enrolled subjects will be informed and some will not] Select how subjects will be informed of the change(s).

25061

Multiple Choice – choose all that apply. • Subjects will be re-consented. • Subjects will be informed in writing (e.g.,




4.8.4. [If Subjects will be re-consented] Describe the re-consent process, including whether it will be conducted in person or via mail/phone.

25062

Free text

4.8.5. [If Matches text Other] Please explain. 25082 Free text 4.8.6. Describe the timing of notification or re-consent. 25063

Free text

4.9. [If No previously enrolled subjects will be informed of the change(s)] Explain why subjects will not be informed:

200 Free text

4.10. [If N] Will any non-English study documents be uploaded to the Notes & Attachments tab?

23358 Y/N

4.10.1. [If Y] The PI affirms that translated versions are complete and accurate translations which do not contain information not presented within the context of the English version(s).

23359 Y/N


KC IRB Questionnaire – Renewal (Open to Enrollment – Enrollment continues; Closed to Enrollment – Research interventions continue or Clinical Follow-up Only Path) Displays if the Protocol Type is Full Board, Expedited, or HUD and Submission Type is Renewal with Amendment or Renewal without Amendment, and response selected to Question ID 351 is Open to Enrollment – Enrollment continues; Closed to Enrollment – Research interventions continue; or Closed to Enrollment – Clinical Follow-up Only. Topics addressed: Ongoing review of research Minimum number of questions: 12 Maximum number of questions: 68

Question Question ID Appropriate Answer Types Tips/Tricks Protocol Status & Summary 1. Projected date of study completion: 350 Free text 2. Select the appropriate status of the study. 351 Multiple Choice – choose one.

• Open to Enrollment – No subjects consented to date

• Open to Enrollment – Enrollment continues

• Closed to Enrollment – Research interventions continue

• Closed to Enrollment - Clinical Follow-up Only Remaining research activities are limited to accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care


This section of the Crosswalk shows the path for Protocols in the following statuses: • Open to Enrollment – Enrollment continues • Closed to Enrollment – Research interventions continue • Closed to Enrollment – Clinical Follow-up Only

For the Open to Enrollment – No subjects consented to date and Data Analysis Only paths, please see below.

2.1. Is the study temporarily suspended by the investigator sponsor due to risk, or safety, or compliance issues?

359 Y/N

2.1.1. [If Y] Explain the circumstances of the suspension, including when and how the suspension is expected to be lifted.

360 Free text Provide as many details about the suspension as possible, including who initiated the suspension (investigator or sponsor), why the study was suspended, and the circumstances that led to the study suspension.

2.2. Since the last IRB review, how many subjects have been consented?

365 Number When you get to this section, it is helpful to have the previous year’s renewal form handy. This should be the total number of subjects consented since the number reported at the last IRB renewal. This number should include any subjects who signed an informed consent document and were found ineligible for the study or withdrew from the study prior to completion.

2.2.1. [If 0 AND question 351 = Open to Enrollment – Enrollment continues] Justify study continuation, since no subjects have been consented since the last IRB review.

366 Free text If the study is having trouble meeting accrual goals, the reviewer will expect to see justification for the continuation of the study. Carefully consider the feasibility of recruiting from this study population and meeting your accrual goals. Clearly explain why the study has not been able to accrue subjects and provide a plan for increasing enrollment.

2.2.2. [If not 0] Since the last IRB review, how many subjects failed screening?

367 Number Provide the total number of subjects who signed an informed consent document and were then found to be ineligible for the study (during or after the screening process). If


the IRB approved a waiver of consent for the study, the failed screening number should reflect the number of records, specimens, etc., that were found to be ineligible.

2.2.3. Since the last IRB review, how many subjects have withdrawn from the study?

368 Number Provide the total number of subjects who signed an informed consent document (unless the IRB approved a waiver of consent) and subsequently discontinued participation prior to their completion of the study. This discontinuation can be initiated by the PI, sponsor, or subject and may occur at any point during the study, but prior to study completion. Withdrawn also includes deaths if death is not an endpoint of the study, in which case the death should be reported as a completion.

2.2.3.1. [If not 0 and Protocol has NO previous renewal] State the reasons for subject withdrawal since the last review.

30036 Text Provide the total number of subjects who signed an informed consent document (unless the IRB approved a waiver of consent) and subsequently discontinued participation prior to their completion of the study. This discontinuation can be initiated by the PI, sponsor, or subject and may occur at any point during the study, but prior to study completion. Withdrawn also includes deaths if death is not an endpoint of the study, in which case the death should be reported as a completion.

2.2.4. [If Protocol has previous renewal] Since the beginning of the study, how many subjects have been consented?

370 Number The previous renewal form will come in handy here. Review the previously-reported “total number consented since the beginning of the study” and add it to the “total number of subjects consented since last year’s renewal” listed in question ID 365. This number should include any subjects who signed an informed consent document and were found ineligible for the study or withdrew from the study prior to completion.

2.2.4.1. [If not 0] Since the beginning of the study, how many subjects failed screening?

371 Number Provide the total number of subjects who signed an informed consent document and were then found to be ineligible for the study (during or after the screening process). If the IRB approved a waiver of consent for the study, the failed screening number should reflect the number of records, specimens, etc., that were found to be ineligible.

2.2.4.2. [If not 0] Since the beginning of the study, how many subjects have withdrawn from the study?


2.2.4.2.1. [If not 0] State the reasons for subject withdrawal since the last review. Summarize the reasons for withdrawal in previous years.

369 Free text Be detailed. If a number of subjects have withdrawn and no explanation is provided, the reviewer will request additional information.

2.2.5. State the total number of ACTIVE subjects currently in the study.

373 Number Provide the total number of subjects who signed an informed consent document (unless the IRB approved a waiver of consent) and are: (1) awaiting treatment or study intervention/interaction; (2) actively receiving treatment or intervention/interaction; (3) being followed by the study team. Active should be equal to the number consented minus the number(s) who: failed screening, withdrew, or completed the study.

2.2.6. State the total number of subjects who have completed the study to date.

374 Number Provide the total number of subjects who signed an informed consent document (unless the IRB approved a waiver of consent) and have completed the planned protocol. This does not include any subject who is considered withdrawn from the study or has been lost to follow-up. Completed includes deaths if death is an endpoint of the study.

2.2.7. If necessary provide further explanation regarding the number of subjects. (Enter N/A if none)

24863 Free text


2.2.8. Were any subjects consented using the short form written consent document?

377 Y/N

2.2.8.1. [If Y] Describe the circumstances of each subject consented, and indicate the language in which the consent process was conducted.

378 Free text

2.2.8.2. [If Y] Is there a reasonable possibility that additional subjects who speak this language could be enrolled?

379 Y/N

2.2.8.2.1. [If Y] Have you submitted a translated version of the IRB-approved consent document for review and approval?

380 Y/N

2.2.8.2.1.1. [If N] Explain why translated versions have not been provided.

381 Free text

2.2.9. State the total number of VA subjects consented, or VA records or specimens reviewed or collected.

382 Free text Displays if the VA has been included as an organization on the Protocol tab. If the study is being conducted nationally, list both the number enrolled nationally as well as locally at Roudebush VAMC.

2.2.9.1. Select all of the additional categories in which the VA subjects, records, or specimens fall, and indicate the number of subjects in the box provided.

383 Multiple Choice – choose all that apply. • Children: • Individuals Lacking Consent Capacity: • Economically/Educationally Disadvantaged: • Pregnant Women and Fetuses: • Prisoners: • Students of the Investigators: • None of the above

2.2.10. Since the last IRB review, did events occur that required prompt reporting to the IU IRB?

400 Y/N For information regarding prompt reporting requirements, see the HSO guidance on Reportable Events.

2.2.10.1. [If Y] Were these events reported previously to the IU IRB (and VA, if applicable)?

401 Y/N

2.2.10.1.1. [If N] Explain why the events were not reported previously and confirm a Reportable Events submission has now been completed.

402 Free text The more details you can provide the better. If no detail is provided, the reviewer will request additional information.

2.2.10.1.2. [If Y] Provide a summary of the event(s) or indicate that a summary has been uploaded to the Notes & Attachments tab.

403 Free text

2.2.11. Since the last IRB review, did any minor deviations or minor noncompliance occur at an IU IRB-approved performance site that did NOT require prompt reporting to the IRB?

404 Y/N Please explain any complaint made by a subject as part of the research (could include complaints such as “the investigator was late to my appointment” or “the clinic was dirty”). This clarification, which was provided by the Office for Human Research Protections (OHRP), is because these and other complaints could be indications of larger problems.

2.2.11.1. [If Y] Provide a summary of the event(s) or indicate that a summary has been uploaded to the Notes & Attachments tab.

405 Free text Details are very important here. If the same deviation is seen multiple times, please provide a plan to prevent the deviation from recurring in the future.

http://researchcompliance.iu.edu/hso/hs_rep.html



2.2.12. Since the last IRB review, did any adverse events occur at a greater frequency and/or severity than was previously expected based on the current protocol, informed consent document, and/or investigator’s brochure?

25374 Y/N

2.2.12.1. [If Y] Provide a summary of the events, including why frequency and/or severity are considered greater than currently expected.

25375 Free text

2.2.13. Is there a Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC) for this study?

407 Y/N

2.2.13.1. [If Y] Confirm the most recent report has been uploaded to the Notes & Attachments tab.

25052 Y/N If the study involves a Data Safety Monitoring Board, the Board will expect to see a report at the time of each renewal.

2.2.13.1.1. [If N] Explain why a report or findings are not available.

25053 Free text If a report is not available or the DSMB has not met since the last renewal, explain why. Failure to do so will likely result in additional requests from the reviewer.

2.2.13.2. [If N] Summarize the data safety monitoring findings since the last IRB review, explain why findings are not available, or indicate that a summary or report has been uploaded to the Notes & Attachments tab.

25054 Free text

2.2.14. Describe the progress of the research, including any preliminary observations and information about study results or trends.

408 Free text

2.2.15. Have subjects experienced any direct benefit(s) from their participation in the study?

409 Y/N Question displays only if subjects have been enrolled in the study, based on response to Question ID 352.

2.2.15.1. [If Y] Describe the direct benefit(s) to subjects. 410 Free text Examples include pain reduction or disease remission. Payment for participation in the study should not be considered benefit and should not be listed here.

2.2.15.2. [If N] Explain why subjects have not experienced benefit(s).

24864 Free text

2.2.16. Have any of the following occurred since the last IRB review? Choose all that apply.

411 Multiple Choice – choose all that apply. • Literature publication which demonstrates a

significant impact on the conduct of the study, or the well-being of subjects

• Audit from federal agencies which identified unanticipated problems involving risks to subjects or others or noncompliance

• Events which affected the validity of the data • Increase in risk to subjects or others • Change in the risk to benefit assessment • None of the above

2.2.16.1. [If any except None of the Above] Provide an explanation of any options checked above.

412 Free text Please attach any supporting documentation on the Notes & Attachments tab.

Changes & Amendments 1. Review the information in the Protocol and Personnel tabs, and all

attachments on the Notes & Attachments tab and confirm that no changes are needed. Choose all that apply.

211 Multiple Choice – choose all that apply. • No changes are needed.


• Changes are needed to the Protocol, Personnel, or Notes & Attachment tabs to reflect previously approved information.

• This renewal includes changes to Personnel. • This renewal includes an amendment.

1.1. [If changes to Personnel] Please indicate the role(s) of study personnel being revised.

25056 Multiple Choice – choose all that apply. • Principal Investigator, Site Specific PI, Key

Personnel, or Student, Fellow, Resident PI • Non-Key Personnel

1.2. [If changes to Personnel] Please indicate if study personnel are being added or removed.


1.2.1. [If Remove AND Qu ID 25056 = Principal Investigator, Site Specific PI, Key Personnel, or Student, Fellow, Resident PI] List the personnel removed.

24849 Free text

1.2.2. [If Add AND Qu ID 25056 = Principal Investigator, Site Specific PI, Key Personnel, or Student, Fellow, Resident PI] List the personnel added.

159 Free text




1.3. [If this renewal includes an amendment] Does this amendment involve adding a study sponsor or new funding source?.

165 Y/N

1.3.1. [If Y] Provide the name of the new sponsor or funding source.

168 Free text

1.4. [If This renewal includes an amendment.] List and describe the changes proposed with this amendment.

169 Free text Try to be as detailed as possible. Keep in mind the reviewer is looking at the submission with fresh eyes, so consider the information you would need to approve the amendment if you weren’t working closely with the study on a regular basis.

1.4.1. State the rationale or justification for the proposed changes.

177 Free text Be as detailed as possible. If you aren’t able to provide justification for the amendment it may be hard for the reviewer to justify full approval.

1.4.2. Do the proposed changes update risk to subjects? 191 Y/N 1.4.2.1. [If Y] Explain the updated risks. 205 Free text Being detailed here helps, especially if a summary of changes has not been provided.


1.4.3. Do the proposed changes alter the risk to benefit assessment?

155 Y/N

1.4.3.1. [If Y] Explain how the proposed changes alter the risk to benefit assessment.

143 Free text Think critically about the types of risk that are being added and consider whether the risks outweigh the benefits.

1.4.4. Does this amendment require changes to the informed consent/assent process and/or the Informed Consent Statement(s), Assent Document(s), or Study Information Sheet(s)?



1.4.4.1. [If Y] Select the appropriate option: 163 Multiple Choice – choose all that apply. • New document(s) are in addition to the

current study documents. • New document(s) replace current documents. • Changes are being made to the informed

consent process only and document(s) will not change.

1.4.5. Will previously enrolled subjects (whether active or not) be informed of the change(s) described in this amendment?





If the reviewer feels the changes are significant, especially if the amendment involves a change in risk, he/she will most likely expect to see a plan for informing subjects of the changes that have been made.

1.4.5.1. [If Some previously enrolled subjects will be informed and some will not] Explain which subjects will be informed and which will not.

25060 Free text

1.4.5.2. [If All previously enrolled subjects will be informed] Select how subjects will be informed of the change(s).





1.4.5.2.1. [If Subjects will be re-consented] Describe the re-consent process, including whether it will be conducted in person or via mail/phone.

25062 Free text

1.4.5.2.2. [If Other] Please explain. 25082 Free text 1.4.5.2.3. Describe the timing of notification or re-

consent. 25063 Free text

1.4.5.3. [If Some previously enrolled subjects will be informed and some will not] Select how subjects will be informed of the change(s).






25062 Free tet

1.4.5.3.2. [If Other] Please explain. 25082 Free text


1.4.5.3.3. Describe the timing of notification or re-consent.

25063 Free text

1.4.5.4. [If No previously enrolled subjects will be informed of the change(s)] Explain why subjects will not be informed:

200 Free text Details are important here.

1.4.6. Will any non-English study documents be uploaded to the Notes & Attachments tab?

23358 Y/N

1.4.6.1. [If Y] The PI affirms that translated versions are complete and accurate translations which do not contain information not presented within the context of the English version(s).

23359 Y/N


KC IRB Questionnaire – Renewal (Open to Enrollment – No subjects consented to date Path) Displays if the Protocol Type is Full Board, Expedited, or HUD, and Submission Type is Renewal with Amendment or Renewal without Amendment, and response selected to Question ID 351 is Open to Enrollment – No subjects consented to date. Topics addressed: Ongoing review of research Minimum number of questions: 14 Maximum number of questions: 66



• Open to Enrollment – Enrollment continues • Closed to Enrollment – Research

interventions continue • Closed to Enrollment - Clinical Follow-up

Only Remaining research activities are limited to

accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care


This section of the Crosswalk shows the path for Open to Enrollment – No subjects consented to date. For the Open to Enrollment – Enrollment continues, Closed to Enrollment – Research interventions continue or Clinical Follow-up Only, and Data Analysis Only paths, please see above and below.

2.1. Justify study continuation since no subjects have been consented to date..

353 Free text

2.2. Is the study temporarily suspended by the investigator sponsor due to risk, safety, or compliance issues?

359 Y/N

2.2.1. [If Y] Explain the circumstances of the suspension, including when and how the suspension is expected to be lifted.

360 Free text Provide as many details about the suspension as possible, including who initiated the suspension (investigator or sponsor), why the study was suspended, and the circumstances that led to the study suspension.

2.3. Since the last IRB review, did any events occur that required prompt reporting to the IU IRB?

400 Y/N

2.3.1. [If Y] Were these events reported previously to the IU IRB (and VA, if applicable)?

401 Y/N

2.3.1.1. [If N] Explain why the events were not reported previously, and confirm a Reportable Events submission has now been completed.

402 Free text


403 Free text

2.3.2. Since the last IRB review, did any events occur, involving an IU IRB-approved performance site, that did NOT

404 Y/N


require prompt reporting to the IRB (e.g. minor protocol deviations, minor noncompliance)?



2.3.3. Since the last IRB review, did any adverse events occur at a greater frequency and/or severity than was previously expected based on the current protocol, informed consent document, and/or investigator’s brochure?

25374 Y/N

2.3.3.1. [If Y] Provide a summary of the events, including why frequency and/or severity are considered greater than currently expected.

25375 Free text

2.3.4. [If Y] Is there a Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC) for this study?

407 Y/N

2.3.4.1. [If Y] Confirm the most recent report has been uploaded to the Notes & Attachments tab.


2.3.4.1.1. [If N] Explain why a report or findings are not available.


2.3.4.2. [If N] Summarize the data safety monitoring findings since the last IRB review, explain why findings are not available, or indicate that a summary has been uploaded to the Notes & Attachments tab.

25054 Free text

2.3.5. Describe the progress of the research, including any preliminary observations and information about study results or trends.

408 Free text

2.3.6. Have any of the following occurred since the last IRB review? Choose all that apply.




• Events which affected the validity of the data • Increase in risk to subjects or others • Protocol deviations, problems, or complaints • Change in the risk to benefit assessment • None of the above

2.3.6.1. [If any except None of the Above] Provide an explanation of any options checked above.



attachments on the Notes & Attachments tab and confirm that no changes are needed. Choose all that apply.

211 Multiple Choice – choose all that apply. • No changes are needed.


• Changes are needed to the Protocol, Personnel, or Notes & Attachment tabs to reflect previously approved information.

• This renewal includes changes to Personnel. • This renewal includes an amendment.

1.1. [If changes to Personnel] Please indicate the role(s) of study personnel being revised.

25056 Multiple Choice – choose all that apply. • Principal Investigator, Site Specific PI, Key

Personnel, or Student, Fellow, Resident PI • Non-Key Personnel

1.2. [If changes to Personnel] Please indicate if study personnel are being added or removed.


1.2.1. [If Remove AND Qu ID 25056 = Principal Investigator, Site Specific PI, Key Personnel, or Student, Fellow, Resident PI] List the personnel removed.

24849 Free text

1.2.2. [If Add AND Qu ID 25056 = Principal Investigator, Site Specific PI, Key Personnel, or Student, Fellow, Resident PI] List the personnel added.

159 Free text




1.3. [If this renewal includes an amendment] Does this amendment involve adding a study sponsor or new funding source?.

165 Y/N

1.3.1. [If Y] Provide the name of the new sponsor or funding source.

168 Free text

1.4. [If This renewal includes an amendment.] List and describe the changes proposed with this amendment.

169 Free text Try to be as detailed as possible. Keep in mind the reviewer is looking at the submission with fresh eyes, so consider the information you would need to approve the amendment if you weren’t working closely with the study on a regular basis.

1.4.1. State the rationale or justification for the proposed changes.

177 Free text Be as detailed as possible. If you aren’t able to provide justification for the amendment it may be hard for the reviewer to justify full approval.

1.4.2. Do the proposed changes update risk to subjects? 191 Y/N 1.4.2.1. [If Y] Explain the updated risks. 205 Free text Being detailed here helps, especially if a summary of changes has not been provided.


1.4.3. Do the proposed changes alter the risk to benefit assessment?

155 Y/N

1.4.3.1. [If Y] Explain how the proposed changes alter the risk to benefit assessment.

143 Free text Think critically about the types of risk that are being added and consider whether the risks outweigh the benefits.

1.4.4. Does this amendment require changes to the informed consent/assent process and/or the Informed Consent Statement(s), Assent Document(s), or Study Information Sheet(s)?



1.4.4.1. [If Y] Select the appropriate option: 163 Multiple Choice – choose all that apply. • New document(s) are in addition to the

current study documents. • New document(s) replace current documents. • Changes are being made to the informed

consent process only and document(s) will not change.

1.4.5. Will previously enrolled subjects (whether active or not) be informed of the change(s) described in this amendment?





If the reviewer feels the changes are significant, especially if the amendment involves a change in risk, he/she will most likely expect to see a plan for informing subjects of the changes that have been made.

1.4.5.1. [If Some previously enrolled subjects will be informed and some will not] Explain which subjects will be informed and which will not.

25060 Free text

1.4.5.2. [If All previously enrolled subjects will be informed] Select how subjects will be informed of the change(s).






25062 Free text

1.4.5.2.2. [If Other] Please explain. 25082 Free text 1.4.5.2.3. Describe the timing of notification or re-

consent. 25063 Free text

1.4.5.3. [If Some previously enrolled subjects will be informed and some will not] Select how subjects will be informed of the change(s).






25062 Free tet

1.4.5.3.2. [If Other] Please explain. 25082 Free text


1.4.5.3.3. Describe the timing of notification or re-consent.

25063 Free text

1.4.5.4. [If No previously enrolled subjects will be informed of the change(s)] Explain why subjects will not be informed:

200 Free text Details are important here.

1.4.6. Will any non-English study documents be uploaded to the Notes & Attachments tab?

23358 Y/N

1.4.6.1. [If Y] The PI affirms that translated versions are complete and accurate translations which do not contain information not presented within the context of the English version(s).

23359 Y/N


KC IRB Questionnaire – Renewal (Data Analysis Only Path) Displays if the Protocol Type is Full Board, Expedited, or HUD, and Submission Type is Renewal with Amendment or Renewal without Amendment, and response selected to Question ID 351 is Data Analysis Only. Topics addressed: Ongoing review of research Minimum number of questions: 7 Maximum number of questions: 10



• Open to Enrollment – Enrollment continues • Closed to Enrollment – Research

interventions continue • Closed to Enrollment - Clinical Follow-up

Only Remaining research activities are limited to

accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care


This section of the Crosswalk shows the path for Data Analysis Only studies. For the Open to Enrollment and Closed to Enrollment paths, please see above.

2.1. Do the researchers still need access to the personally identifiable information or subjects OR access to codes or keys that would allow for the potential of identifying individuals in the future?

355 Multiple Choice – choose one. • Yes • No – The study may be eligible for closure –

Please contact the Human Subjects Office.

2.1.1. [If Yes AND Protocol has previous renewal] At last renewal, was the study in Data Analysis Only OR Closed to Enrollment with no active subjects?

357 Y/N If response is No, follow Closed to Enrollment path above beginning with question ID 359.

2.1.1.1. [If Y] Since the last renewal, have there been any changes to the IRB-approved documents or KC IRB protocol, other than personnel changes?

358 Y/N If response is Yes, follow Closed to Enrollment path above beginning with question ID 359.

2.1.1.1.1. Since the last IRB review, how many subjects have been consented?


2.1.1.1.1.1. [If not 0] Since the last IRB review, how many subjects failed screening?



2.1.1.1.1.2. Since the last IRB review, how many subjects have withdrawn from the study?


2.1.1.1.1.3. [If Protocol has previous renewal] Since the beginning of the study, how many subjects have been consented?


2.1.1.1.1.3.1. [If not 0] Since the beginning of the study, how many subjects failed screening?


2.1.1.1.1.3.2. [If not 0] Since the beginning of the study, how many subjects have withdrawn from the study?


2.1.1.1.1.3.2.1. [If not 0] State the reasons for subject withdrawal since the last review. Summarize the reasons for withdrawal in previous years.


2.1.1.1.1.4. State the total number of subjects who have completed the study to date.


2.1.1.1.1.5. If necessary provide further explanation regarding the number of subjects. (Enter N/A if none)

24863 Free text

2.1.1.1.1.6. Since the last IRB review, were any subjects consented using the short form written consent document?

377 Y/N

2.1.1.1.1.6.1. [If Y] Describe the circumstances of each subject consented, and indicate the language in which the consent process was conducted.

378 Free text


2.1.1.1.1.6.2. [If Y] Is there a reasonable possibility that additional subjects who speak this language could be enrolled?

379 Y/N

2.1.1.1.1.6.2.1. [If Y] Have you submitted a translated version of the IRB-approved consent document for review and approval?

380 Y/N

2.1.1.1.1.6.2.2. [If N] Explain why translated versions have not been provided.

381 Free text

2.1.1.1.1.7. State the total number of VA subjects consented, or VA records or specimens reviewed or collected.


2.1.1.1.1.7.1. Select all of the additional categories in which the VA subjects, records, or specimens fall, and indicate the number of subjects in the box provided.


2.1.1.1.1.8. Since the last IRB review, did events occur that required prompt reporting to the IU IRB?


2.1.1.1.1.8.1. [If Y] Were these events reported previously to the IU IRB (and VA, if applicable)?

401 Y/N

2.1.1.1.1.8.1.1. [If N] Explain why the events were not reported previously and confirm a Reportable Events submission has now been completed.


2.1.1.1.1.8.1.2. [If Y] Provide a summary of the event(s) or indicate that a summary has

403 Free text




been uploaded to the Notes & Attachments tab.

2.1.1.1.1.9. Since the last IRB review, did any minor deviations or minor noncompliance occur at an IU IRB-approved performance site that did NOT require prompt reporting to the IRB?


2.1.1.1.1.9.1. [If Y] Provide a summary of the event(s) or indicate that a summary has been uploaded to the Notes & Attachments tab.


2.1.1.1.1.10. Since the last IRB review, did any adverse events occur at a greater frequency and/or severity than was previously expected based on the current protocol, informed consent document, and/or investigator’s brochure?

25374 Y/N

2.1.1.1.1.10.1. [If Y] Provide a summary of the events, including why frequency and/or severity are considered greater than currently expected.

25375 Free text

2.1.1.1.1.11. Is there a Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC) for this study?

407 Y/N

2.1.1.1.1.11.1. [If Y] Confirm the most recent report has been uploaded to the Notes & Attachments tab.


2.1.1.1.1.11.1.1. [If N] Explain why a report or findings are not available.


2.1.1.1.1.11.2. [If N] Summarize the data safety monitoring findings since the last IRB review, explain why findings are not available, or indicate that a summary or report has been uploaded to the Notes & Attachments tab.

25054 Free text


2.1.1.1.1.12. Describe the progress of the research, including any preliminary observations and information about study results or trends.

408 Free text

2.1.1.1.1.13. Have subjects experienced any direct benefit(s) from their participation in the study?


2.1.1.1.1.13.1. [If Y] Describe the direct benefit(s) to subjects.

410 Free text Examples include pain reduction or disease remission. Payment for participation in the study should not be considered benefit and should not be listed here.

2.1.1.1.1.13.2. [If N] Explain why subjects have not experienced benefit(s).

24864 Free text

2.1.1.1.1.14. Have any of the following occurred since the last IRB review? Choose all that apply.





2.1.1.1.1.14.1. [If any except None of the Above] Provide an explanation of any options checked above.


2.1.1.2. [If N (to 357)] Since the last IRB review, how many subjects have been consented?


2.1.1.2.1. [If not 0] Since the last IRB review, how many subjects failed screening?


2.1.1.2.2. Since the last IRB review, how many subjects have withdrawn from the study?



2.1.1.2.3. [If Protocol has previous renewal] Since the beginning of the study, how many subjects have been consented?


2.1.1.2.3.1. [If not 0] Since the beginning of the study, how many subjects failed screening?


2.1.1.2.3.2. [If not 0] Since the beginning of the study, how many subjects have withdrawn from the study?


2.1.1.2.3.2.1. [If not 0] State the reasons for subject withdrawal since the last review. Summarize the reasons for withdrawal in previous years.


2.1.1.2.4. State the total number of subjects who have completed the study to date.


2.1.1.2.5. If necessary provide further explanation regarding the number of subjects. (Enter N/A if none)

24863 Free text

2.1.1.2.6. Since the last IRB review, were any subjects consented using the short form written consent document?

377 Y/N

2.1.1.2.6.1. [If Y] Describe the circumstances of each subject consented, and indicate the language in which the consent process was conducted.

378 Free text

2.1.1.2.6.2. [If Y] Is there a reasonable possibility that additional subjects who speak this language could be enrolled?

379 Y/N

2.1.1.2.6.2.1. [If Y] Have you submitted a translated version of the IRB-approved consent document for review and approval?

380 Y/N

2.1.1.2.6.2.1.1. [If N] Explain why translated versions

381 Free text


have not been provided.

2.1.1.2.7. State the total number of VA subjects consented, or VA records or specimens reviewed or collected.


2.1.1.2.7.1. Select all of the additional categories in which the VA subjects, records, or specimens fall, and indicate the number of subjects in the box provided.


2.1.1.2.8. Since the last IRB review, did events occur that required prompt reporting to the IU IRB?


2.1.1.2.8.1. [If Y] Were these events reported previously to the IU IRB (and VA, if applicable)?

401 Y/N

2.1.1.2.8.1.1. [If N] Explain why the events were not reported previously and confirm a Reportable Events submission has now been completed.


2.1.1.2.8.1.2. [If Y] Provide a summary of the event(s) or indicate that a summary has been uploaded to the Notes & Attachments tab.

403 Free text

2.1.1.2.9. Since the last IRB review, did any minor deviations or minor noncompliance occur at an IU IRB-approved performance site that did NOT require prompt reporting to the IRB?


2.1.1.2.9.1. [If Y] Provide a summary of the event(s) or indicate that a summary has been uploaded to the Notes & Attachments tab.


2.1.1.2.10. Since the last IRB review, did any adverse events occur at a greater frequency and/or severity than was previously expected based on the current protocol,

25374 Y/N



informed consent document, and/or investigator’s brochure?

2.1.1.2.10.1. [If Y] Provide a summary of the events, including why frequency and/or severity are considered greater than currently expected.

25375 Free text

2.1.1.2.11. Is there a Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC) for this study?

407 Y/N

2.1.1.2.11.1. [If Y] Confirm the most recent report has been uploaded to the Notes & Attachments tab.


2.1.1.2.11.1.1. [If N] Explain why a report or findings are not available.


2.1.1.2.11.2. [If N] Summarize the data safety monitoring findings since the last IRB review, explain why findings are not available, or indicate that a summary or report has been uploaded to the Notes & Attachments tab.

25054 Free text

2.1.1.2.12. Describe the progress of the research, including any preliminary observations and information about study results or trends.

408 Free text

2.1.1.2.13. Have subjects experienced any direct benefit(s) from their participation in the study?


2.1.1.2.13.1. [If Y] Describe the direct benefit(s) to subjects.


2.1.1.2.13.2. [If N] Explain why subjects have not experienced benefit(s).

24864 Free text

2.1.1.2.14. Have any of the following occurred since the last IRB review? Choose all that apply.






2.1.1.2.14.1. [If any except None of the Above] Provide an explanation of any options checked above.


2.1.2. [If Yes (to 355) AND Protocol has NO previous renewal] Since the last IRB review, how many subjects have been consented?


2.1.2.1. [If not 0] Since the last IRB review, how many subjects failed screening?


2.1.2.2. Since the last IRB review, how many subjects have withdrawn from the study?


2.1.2.3. [If Protocol has previous renewal] Since the beginning of the study, how many subjects have been consented?


2.1.2.3.1. [If not 0] Since the beginning of the study, how many subjects failed screening?


2.1.2.3.2. [If not 0] Since the beginning of the study, how many subjects have withdrawn from the study?


2.1.2.3.2.1. [If not 0] State the reasons for subject withdrawal since the last review. Summarize the reasons for withdrawal in previous years.


2.1.2.4. State the total number of subjects who have completed the study to date.


2.1.2.5. If necessary provide further explanation regarding the number of subjects. (Enter N/A if none)

24863 Free text


2.1.2.6. Since the last IRB review, were any subjects consented using the short form written consent document?

377 Y/N

2.1.2.6.1. [If Y] Describe the circumstances of each subject consented, and indicate the language in which the consent process was conducted.

378 Free text

2.1.2.6.2. [If Y] Is there a reasonable possibility that additional subjects who speak this language could be enrolled?

379 Y/N

2.1.2.6.2.1. [If Y] Have you submitted a translated version of the IRB-approved consent document for review and approval?

380 Y/N

2.1.2.6.2.2. [If N] Explain why translated versions have not been provided.

381 Free text

2.1.2.7. State the total number of VA subjects consented, or VA records or specimens reviewed or collected.


2.1.2.7.1. Select all of the additional categories in which the VA subjects, records, or specimens fall, and indicate the number of subjects in the box provided.


2.1.2.8. Since the last IRB review, did events occur that required prompt reporting to the IU IRB?


2.1.2.8.1. [If Y] Were these events reported previously to the IU IRB (and VA, if applicable)?

401 Y/N

2.1.2.8.1.1. [If N] Explain why the events were not reported previously and confirm a Reportable Events submission has now been completed.


2.1.2.8.1.2. [If Y] Provide a summary of the event(s) or indicate that a summary has been uploaded to the Notes & Attachments tab.

403 Free text

2.1.2.9. Since the last IRB review, did any minor deviations or minor noncompliance occur at an

404 Y/N Please explain any complaint made by a subject as part of the research (could include complaints such as “the investigator was late to my appointment” or “the clinic was



IU IRB-approved performance site that did NOT require prompt reporting to the IRB?

dirty”). This clarification, which was provided by the Office for Human Research Protections (OHRP), is because these and other complaints could be indications of larger problems.

2.1.2.9.1. [If Y] Provide a summary of the event(s) or indicate that a summary has been uploaded to the Notes & Attachments tab.


2.1.2.10. Since the last IRB review, did any adverse events occur at a greater frequency and/or severity than was previously expected based on the current protocol, informed consent document, and/or investigator’s brochure?

25374 Y/N

2.1.2.10.1. [If Y] Provide a summary of the events, including why frequency and/or severity are considered greater than currently expected.

25375 Free text

2.1.2.11. Is there a Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC) for this study?

407 Y/N

2.1.2.11.1. [If Y] Confirm the most recent report has been uploaded to the Notes & Attachments tab.


2.1.2.11.1.1. [If N] Explain why a report or findings are not available.


2.1.2.11.2. [If N] Summarize the data safety monitoring findings since the last IRB review, explain why findings are not available, or indicate that a summary or report has been uploaded to the Notes & Attachments tab.

25054 Free text

2.1.2.12. Describe the progress of the research, including any preliminary observations and information about study results or trends.

408 Free text

2.1.2.13. Have subjects experienced any direct benefit(s) from their participation in the study?


2.1.2.13.1. [If Y] Describe the direct benefit(s) to subjects.


2.1.2.13.2. [If N] Explain why subjects have not experienced benefit(s).

24864 Free text

2.1.2.14. Have any of the following occurred since the last IRB review? Choose all that apply.






2.1.2.14.1. [If any except None of the Above] Provide an explanation of any options checked above.



attachments on the Notes & Attachments tab and confirm that no changes are needed.

24854 Multiple Choice – choose all that apply. • No changes are needed • This renewal includes changes to Personnel. • An updated Investigator Brochure or package

insert is being submitted with this Renewal, but no other study documents are being changed as a result of the IB update.

1.1. [If This renewal includes changes to Personnel] List the personnel additions. (Enter N/A if none)

24852 Free text

1.2. List the personnel removed. (Enter N/A if none) 24853 Free text


KC IRB Questionnaire – Reportable Events Displays for all Protocol Types when Submission Type is FYI Minimum number of questions: 6 Maximum number of questions: 132

Question Question ID Appropriate Answer Types Tips/Tricks 1. Event occurred on: 25151 Date (MM/DD/YYYY) 2. Event discovered by Study Team on: 25152 Date (MM/DD/YYYY) 3. Site(s) where event occurred: 25153 Free text 4. Select the appropriate status of the study. 351 Multiple Choice – choose one.


• Open to Enrollment – Enrollment continues • Closed to Enrollment – Research interventions

continue • Closed to Enrollment – Clinical Follow-up Only

Remaining research activities are limited to accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care


4.1. [If NOT No subjects consented to date] Since the beginning of the study, how many subjects have been consented?

370 Number List the number of subjects who consented to participate in the study, even if subjects were later determined to be ineligible or failed screening The previous renewal form will come in handy here. Review the previously-reported “total number consented since the beginning of the study” and add it to the “total number of subjects consented since last year’s renewal”, listed in question ID 365.” This number should include any subjects who signed an informed consent document and were found ineligible for the study or withdrew from the study prior to completion.

4.2. [If Enrollment continues, intervention continues, or clinical follow-up] State the total number of ACTIVE subjects currently in the study.

373 Number

4.2.1. Summarize the status of active subjects. 25154 Free text 5. Type of event(s) are you reporting. See HSO Guidance on Reportable

Events for additional information.

25155 Multiple Choice – choose all that apply. • Conduct of human subjects research without

IRB approval • Local or external Adverse Event requiring

prompt reporting • Unanticipated Adverse Device Effect • Major protocol deviation/protocol

noncompliance requiring prompt reporting • Consent and/or authorization issue • Subject complaint

http://researchcompliance.iu.edu/hso/hs_reportableevents.html

http://researchcompliance.iu.edu/hso/hs_reportableevents.html


• Study suspension or hold • Incident that may compromise information

security, subject privacy, and/or confidentiality • Audit Report • Follow-up information regarding previously

reported FYI • Other

5.1. [If Conduct of human subjects research without IRB approval] Choose the option(s) that best fit the event you are reporting.

25156 Multiple Choice – choose all that apply. • Conduct of research without submitting study

for IRB review • Conduct of research prior to receiving IRB

notification of final approval • Initiation of substantive changes without prior

IRB approval, including changes necessary to eliminate apparent immediate hazards to the subject

• Inclusion of vulnerable population without specific IRB approval

• Conduct of research when IRB approval has expired or been closed, suspended or terminated

• Subject interactions or review of identifiable research data by individual(s) who have not completed appropriate investigator requirements

5.1.1. [If Conduct of research without submitting study for IRB review, Conduct of research prior to receiving IRB notification of final approval, or Conduct of research when IRB approval has expired or been closed, suspended or terminated] What study procedures were conducted prior to IRB review or approval or during expiration?

25157 Free text

5.1.1.1. Have you submitted a Renewal or New Study to request approval to conduct the research?

25158 Y/N If you have already received final approval of your Renewal or New Study, please answer Yes.

5.1.1.1.1. [If N] Please explain. 25082 Free text 5.1.1.2. Are you requesting to use research data collected

during the period you did not have valid IRB approval?

25159 Multiple Choice – choose all that apply. • Yes • No • Not applicable – event does not relate to data

collection

5.1.1.2.1. [If Yes] Provide justification for the use of the data collected.

25160 Free text

5.1.1.2.2. [If No] Confirm that data will be stored securely in accordance with applicable data

25131 Free text


management policies and not used for any other purpose.

5.1.1.3. Will subjects be notified of the conduct of study procedures without IRB approval?

25161 Multiple Choice – choose all that apply. • Yes • No • Not applicable – study did not/would not

require Informed Consent

5.1.1.3.1. [If Yes] Explain how subjects will be notified (including timing and form of notification).

25162 Free text

5.1.1.3.2. [If No] Provide justification. 25111 Free text 5.1.2. [If Initiation of substantive changes without prior IRB

approval, including changes necessary to eliminate apparent immediate hazards to the subject] What changes were implemented without prior IRB approval?

25163 Free text

5.1.2.1. Were these changes implemented to eliminate apparent immediate hazard to subjects?

25164 Y/N

5.1.2.1.1. [If Y] Please explain. 25082 Free text 5.1.2.1.2. [If N] Describe the circumstances that led

to implementation of changes without IRB approval.

25165 Free text

5.1.2.1.2.1. Are you requesting to use research data collected during the period you did not have valid IRB approval?

25159 Multiple Choice – choose one. • Yes • No • Not applicable – event does not relate to data

collection

5.1.2.1.2.1.1. [If Yes] Provide justification for the use of the data collected.

25160 Free text

5.1.2.1.2.1.2. [If No] Confirm that data will be stored securely in accordance with applicable data management policies and not used for any other purpose.

25131 Free text

5.1.2.2. Have you submitted an Amendment seeking IRB approval for the change(s)?

25167 Y/N If the study procedures have been completed or the revised documents or procedures are no longer in effect, an Amendment should not be submitted and this should be answered No.

5.1.2.2.1. [If N] Please Explain. 25082 Free text 5.1.2.3. Have all affected subjects been notified? 25141 Multiple Choice – choose one.

• Yes • No • Not applicable. No subjects were affected.

5.1.2.3.1. [If Yes] Explain how and when subjects were notified and what information was provided to subjects.

25142 Free text


5.1.2.3.2. [If No] Explain how and when subjects will be notified and what information will be provided to subjects.

25143 Free text

5.1.2.3.3. [If Not applicable] Please explain. 25082 Free text 5.1.3. [If Inclusion of vulnerable population without specific IRB

approval] Which vulnerable population was included in the study without IRB approval (check all that apply)?

25169 Multiple Choice – choose all that apply. • Children • Prisoners • Individuals who lack consent capacity • Pregnant women/fetuses/neonates

5.1.3.1. Describe the circumstances that led to inclusion of the vulnerable population.

25170 Free text

5.1.3.2. Are you requesting to use research data collected from the subject(s)?

25171 Multiple Choice – choose one. • Yes • No • Not applicable. No data was collected from

the subject(s).

5.1.3.2.1. [If Yes] Provide justification for the use of the data collected.

25160 Free text

5.1.3.2.2. [If No] Confirm that data will be stored securely in accordance with applicable data management policies and not used for any other purpose.

25131 True/False

5.1.3.3. Have you submitted an Amendment seeking inclusion of this population?

25172 Y/N If the study procedures have been completed with the subject(s), an Amendment should not be submitted and this should be answered No.

5.1.3.3.1. [If N] Confirm that no additional subjects from this population will be included in the study.

25173 • No additional subjects will be included from this population.

5.1.3.4. Have all affected subjects been notified? 25141 Multiple Choice – choose one. • Yes • No • Not applicable. No subjects were affected.

5.1.3.4.1. [If Yes] Explain how and when subjects were notified and what information was provided to subjects.

25142 Free text

5.1.3.4.2. [If No] Explain how and when subjects will be notified and what information will be provided to subjects.

25143 Free text

5.1.3.4.3. [If Not applicable] Please explain. 25082 Free text 5.1.4. [If Subject interactions or review of identifiable research

data by individual(s) who have not completed appropriate investigator requirements] Provide name(s) of study personnel who interacted with subjects or reviewed identifiable subject data without having completed appropriate investigator requirements.

25174 Free text


5.1.4.1. List study procedures that were conducted by these individuals.

25175 Free text

5.1.4.2. Explain why the lack of training and/or COI disclosure did not adversely affect the rights of subjects.

25176 Free text

5.1.4.3. Choose all that apply. 25177 Multiple Choice – choose all that apply. • Personnel will complete/have completed all

investigator requirements and if not already listed on Personnel tab, an Amendment will be submitted adding this individual as study personnel

• The individuals who have not completed requirements will not engage in study procedures going forward.

5.1.4.3.1. [If Personnel will complete/have completed all investigator requirements and if not already listed on Personnel tab, an Amendment will be submitted adding this individual as study personnel] List individuals who will engage in study procedures going forward.

25178 Free text

5.1.4.3.2. [If The individuals who have not completed requirements will not engage in study procedures going forward] List individuals who will NOT engage in study procedures going forward.

25292

Free text

5.1.5. Explain the preventive measures that have been and/or will be taken to prevent recurrence of this event in the future, including whether any study documents will be updated.

25148 Free text

5.2. [If Local or external Adverse Event requiring prompt reporting] Please confirm that the event meets ALL of the following required prompt reporting criteria by checking the boxes below.

25179 Multiple Choice – choose all that apply. • Unexpected • Related or possibly related • Suggests that the research places subject(s) or

others at a greater risk of harm than was previously known.

Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document and (b) the characteristics of the subject population being studied' Related or possibly related to participation in the research: there is a reasonable possibility (more likely than not) that the incident, experience, or outcome may have been caused by the procedures involved in the research Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized. Please note that such events routinely warrant consideration of substantive changes in the research protocol or informed consent process/document or other corrective actions in order to protect the safety, welfare, or rights of subjects or others


5.3. [Local or external Adverse Event requiring prompt reporting] Please confirm that the event is a local research death, local serious adverse event, or serious problem which meets both of the following required prompt reporting criteria by checking the boxes below.

25180 Multiple Choice – choose all that apply. • Unanticipated • Related to the research

Only displays when Roudebush VAMC is listed as an organization

5.4. [Local or external Adverse Event requiring prompt reporting] Describe the event, including whether the adverse event has resolved, and the subject’s current status.

25182 Free text

5.4.1. Did the event occur with a local or external subject? 25183 Multiple Choice – choose one. • Local • External, i.e., subject was not enrolled at any

site covered by the IU IRB approval

5.4.1.1. [If Local] Will the subject remain enrolled in the study?

25184 Multiple Choice – choose one. • Yes, study procedures will continue with the

subject • Yes, but no additional interventions will be

done with the subject but the subject will remain on follow up

• No, subject has been/will be withdrawn and no further data will be collected from the subject

5.4.2. Will the risk information in the study documents be updated as a result of this event?

25185 Multiple Choice – choose one. • Yes • No • Pending. Sponsor review ongoing.

5.4.2.1. [If Yes] Has an Amendment been submitted revising study documents?

25186 Y/N

5.4.2.1.1. [If N] Explain the plan for updating study documents.

25307 Free text

5.4.2.1.2. Will enrollment be held until the IRB has approved revised study documents?

25187 Y/N

5.4.2.1.2.1. [If N] Please provide justification. 25111 Free text 5.4.2.2. [If No] Please provide justification for not revising

any study documents. 25188 Free text

5.4.3. Have previously enrolled subjects been notified of this event.

25099 Multiple Choice – choose one. • All previously enrolled subjects have been

notified. • Some previously enrolled subjects have been

notified. • No subjects have been notified.

5.4.3.1. [If All previously enrolled subjects have been notified] Explain the method of notification, timing of notification, and the information that was shared with the subjects.

25100 Free text


5.4.3.2. [If Some previously enrolled subjects have been notified] Explain which subjects have been notified, the method of notification, timing of notification, and the information that was shared with the subjects. Please also clarify why (and which) subjects were not notified.

25101 Free text

5.4.3.3. [If No subjects have been notified] Please explain. 25082 Free text 5.4.4. Who else has been notified regarding this event? 25103 Multiple Choice – choose all that apply.

• Study sponsor • FDA • Other • Not applicable

5.4.4.1. [If Other] Explain who has been notified of the event other than the groups noted above.

25104 Free text


25148 Free text

5.5. [If Unanticipated Adverse Device Effect] Describe the event, including whether the adverse event has resolved, and the subject’s current status.

25182

Free text

5.5.1. Did the event occur with a local or external subject? 25183 Multiple Choice – choose one. • Local • External, i.e., subject was not enrolled at any

site covered by the IU IRB approval

5.5.1.1. [If Local] Will the subject remain enrolled in the study?

25184 Multiple Choice – choose one. • Yes, study procedures will continue with the

subject • Yes, but no additional interventions will be

done with the subject but the subject will remain on follow up

• No, subject has been/will be withdrawn and no further data will be collected from the subject

5.5.2. Will the risk information in the study documents be updated as a result of this event?

25185 Multiple Choice – choose one. • Yes • No • Pending. Sponsor review ongoing.

5.5.2.1. [If Yes] Has an Amendment been submitted revising study documents?

25186 Y/N

5.5.2.1.1. Will enrollment be held until the IRB has approved revised study documents?

25187 Y/N

5.5.2.1.2. [If N] Explain the plan for updating study documents.

25307 Free text


5.5.2.2. [If No] Please provide justification for not revising any study documents.

25188 Free text

5.5.3. Have previously enrolled subjects been notified of this event?

25099 Multiple Choice – choose one. • All previously enrolled subjects have been

notified. • Some previously enrolled subjects have been

notified. • No subjects have been notified.

5.5.3.1. [If All previously enrolled subjects have been notified] Explain the method of notification, timing of notification, and the information that was shared with the subjects.

25100 Free text

5.5.3.2. [If Some previously enrolled subjects have been notified] Explain which subjects have been notified, the method of notification, timing of notification, and the information that was shared with the subjects.

25101 Free text

5.5.3.3. [If No subjects have been notified] Please explain. 25082 Free text 5.5.4. Who else has been notified regarding this event? 25103 Multiple Choice – choose all that apply.

• Study sponsor • FDA • Other • Not applicable

5.5.4.1. [If Other] Explain who has been notified of the event other than the groups noted above.

25104 Free text


25148 Free text

5.6. [If Major protocol deviation/protocol noncompliance requiring prompt reporting] Describe the deviation, including when and how the deviation was discovered, what should have occurred per protocol, and what did occur.

25116 Free text

5.6.1. Select the criteria that are met related to the protocol deviation.

25117 Multiple Choice – choose all that apply. • May impact subject safety • May affect the integrity of study data

5.6.1.1. [If May impact subject safety] Explain how the deviation may have impacted subject safety, and if applicable, the current status of the subject(s) affected.

25118 Free text

5.6.1.1.1. Have all affected subjects been notified? 25141 Multiple Choice – choose one. • Yes • No • Not applicable. No subjects were affected.


5.6.1.1.1.1. [If Matches text Yes] Explain how and when subjects were notified and what information was provided to subjects.

25142 Free text

5.6.1.1.1.2. [If Matches text No] Explain how and when subjects will be notified and what information will be provided to subjects.

25143 Free text

5.6.1.1.1.3. [If Not applicable] Please explain. 25082 Free text 5.6.1.2. [If May affect the integrity of study data] Explain

how the deviation may affect the integrity of the study data, including whether the affected subject(s) data will be included in data analysis.

25122 Free text

5.6.1.2.1. Have all affected subjects been notified? 25141

Multiple Choice – choose one. • Yes • No • Not applicable. No subjects were affected.

5.6.1.2.1.1. [If Yes] Explain how and when subjects were notified and what information was provided to subjects.

25142

Free text

5.6.1.2.1.2. [If No] Explain how and when subjects will be notified and what information will be provided to subjects.

25143

Free text

5.6.1.2.1.3. [If Not applicable] Please explain. 25082

Free text

5.6.2. Describe any corrective measures taken to resolve the event/circumstances that led to the deviation.

25123 Free text

5.6.3. Who else has been notified regarding this event? 25103 Multiple Choice – choose all that apply. • Study sponsor • FDA • Other • Not applicable

5.6.3.1. [If begins with text Other] Explain who has been notified of the event other than the groups noted above.

25104 Free text


25148 Free text

5.7. [If Consent and/or authorization issue] Select the type of consent/authorization issue you are reporting.

25124 Multiple Choice – choose all that apply. • Failure to obtain consent and/or authorization • Failure to obtain the subject’s signature on the

informed consent and/or authorization


• Enrolling subjects using a consent which does not include all known risks, or continuation of subject participation without notification of newly identified risks

• Other major deficiencies in informed consent or HIPAA authorization process or documentation

• Minor deficiencies in informed consent or HIPAA authorization process or documentation affecting ten (10) or more subjects

5.7.1. Describe the issue, including any information subjects should have received but did not.

25125 Free text

5.7.2. How many subjects were affected? 25126 Number 5.7.3. Will affected subjects be re-consented/reauthorized

using the IRB approved Informed Consent or Authorization?

25127 Multiple Choice – choose one. • All affected subjects will be re-consented or

reauthorized. • Some affected subjects will be re-

consented/reauthorized and some will not. • No subjects will be re-consented/reauthorized.

5.7.3.1. [If All or some affected subjects will be re-consented or reauthorized] Explain the process and timing for re-consent/reauthorization, including which subjects will be re-consented/reauthorized and which will not, if applicable.

25128 Free text

5.7.3.2. [If No subjects will be re-consented/reauthorized] Explain why subjects will not be re-consented/reauthorized (e.g., the issue or error would not affect subject willingness to participate).

25129 Free text

5.7.3.3. [If Some subjects will not be re-consented/reauthorized of No subjects will be re-consented/reauthorized] Do you intend to include any data collected from affected subjects for analysis?

25130 Multiple Choice – choose one. • Yes • No • Not applicable. No data was collected from

affected subjects.

5.7.3.3.1. [If Yes] Please provide justification. 25111 Free text 5.7.3.3.2. [If No] Confirm that data will be stored

securely in accordance with applicable data management policies and not used for any other purpose.

25131 True/False


25148 Free text

5.8. [Subject complaint] Describe the complaint. 25132 Free text


5.8.1. How did you or will you address the complaint? 25133 Free text 5.8.2. Explain the preventive measures that have been and/or

will be taken to prevent recurrence of this event in the future, including whether any study documents will be updated.

25148 Free text

5.9. [If Study suspension or hold] Describe the event/circumstances that led to the suspension of the study, including who imposed the suspension, what activities were suspended, and why.

25134 Free text

5.9.1. Were any subjects impacted by the suspension? 25135 Y/N 5.9.1.1. [If Y] Please explain. 25082 Free text 5.9.1.2. [If Y] Have affected subjects been notified? 25136

5.9.2. Describe any corrective measures taken to resolve the event/circumstances that led to the suspension.

25137 Free text

5.9.3. Has the suspension been lifted? 25138 Y/N 5.9.3.1. [If N] What is required for the suspension to be

lifted? 25139 Free text


25148 Free text

5.10. [If Incident that may compromise information security, subject privacy, and/or confidentiality] Describe the incident, including what information was released and to whom.

25140 Free text

5.10.1. Have all affected subjects been notified? 25141 Multiple Choice – choose one. • Yes • No • Not applicable. No subjects were affected.

5.10.1.1. [If Yes] Explain how and when subjects were notified and what information was provided to subjects.

25142 Free text

5.10.1.2. [If No] Explain how and when subjects will be notified and what information will be provided to subjects.

25143 Free text

5.10.1.3. [If Not applicable] Please explain. 25082 1000 characters 5.10.2. If the incident involved release of protected health

information (PHI) to individuals not authorized to receive the PHI, have you notified the appropriate HIPAA privacy officer?

25144 Multiple Choice – choose one. • Yes • Not applicable. The incident did not involve

release of PHI.


25148 Free text

5.11. [If Follow-up information regarding previously reported FYI] Provide the FYI item number (e.g., F001) assigned when the event was initially reported to the IRB.

25145 Free text


5.12. [If Follow-up information regarding previously reported FYI] Describe additional information related to the event.

25146 Free text

5.13. [If Other] Describe the issue you are reporting, including why this issue is being reported promptly to the IRB and how the issue is being corrected.

25147 Free text


25148 Free text

6. Did the event affect VA subjects? 25149 Y/N 6.1. [If Y] Please explain.

25150 Free text Report should be submitted concurrently to Research Services, Veterans Administration,

[email protected].



KC IRB Questionnaire – Study Closure/Closeout Report Displays if the Protocol Action = Request to Close. Minimum number of questions: 10 Maximum number of questions: 47

Question Question ID Appropriate Answer Types Tips/Tricks 1. Select the appropriate status of the study. 25320 Multiple Choice – choose one.

• Study will not be initiated. • Study closed prior to completion. • Study completed.

No further interaction/intervention with subjects, including follow-up, or access to subjects’ personally identifiable information for the purpose of research data collection AND all data collection and analysis of identifiable data (including specimens) involving the research site(s), under the IU IRB approval, is complete.

1.1. [If Study will not be initiated] Explain why the study will not be initiated or completed.

25321 Free text

1.2. [If Study closed prior to completion] Explain why the study will not be initiated or completed.

25318 Free text

1.3. [If Study closed prior to completion OR Study completed] Since the beginning of the study, how many subjects have been consented?

370 Number List the number of subjects who consented to participate in the study, even if subjects were later determined to be ineligible or failed screening The previous renewal form will come in handy here. Review the previously-reported “total number consented since the beginning of the study” and add it to the “total number of subjects consented since last year’s renewal” listed in question ID 365. This number should include any subjects who signed an informed consent document and were found ineligible for the study or withdrew from the study prior to completion.

1.3.1. [If not equal to number 0] Since the beginning of the study, how many subjects failed screening?


1.3.2. [If not equal to number 0] Since the beginning of the study, how many subjects have withdrawn from the study?


1.3.2.1. [If not equal to number 0] State the reasons for subject withdrawal since the last review. Summarize the reasons for withdrawal in previous years.


1.4. [If Study closed prior to completion OR Study completed] State the total number of VA subjects consented, or VA records or specimens review or collected.



1.4.1. Select all of the categories in which the VA subjects,

records, or specimens fall, and indicate the number of subjects in the box provided.

383 Multiple Choice – choose all that apply. • Children • Individuals Lacking Consent Capacity • Economically/Educationally

Disadvantaged • Pregnant Women and Fetuses • Prisoners • Students of the Investigator • None of the Above

1.5. [If Study closed prior to completion OR Study completed] Since the last IRB review, did any events occur that required prompt reporting to the IU IRB?


1.5.1. [If Y] Were these events reported previously to the IU IRB (and VA, if applicable)?

401 Y/N

1.5.2. [If N] Explain why the events were not reported previously, and confirm a Reportable Events submission has now been completed.


1.5.3. [If Y] Provide a summary of the event(s) or indicate that a summary has been uploaded in the attachment section above.

25322

Free text

1.6. [If Study closed prior to completion OR Study completed] Since the last IRB review, did any minor deviations or minor noncompliance occur at an IU IRB-approved performance site that did not require prompt reporting to the IRB?


1.6.1. [If Y] Provide a summary of the event(s) or indicate that a summary has been uploaded in the attachment section above.

25323 Free text

1.7. [If Study closed prior to completion OR Study completed] Since the last IRB review, did any adverse events occur at a greater frequency and/or severity than was previously expected based on the current protocol, informed consent document, and/or investigator’s brochure?

25375 Y/N

1.7.1. [If Y] Provide a summary of the events, including why frequency and severity are considered greater than currently expected.

25375 Free text

1.8. [If Y]Is there a Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC) for this study?

407 Free text

1.8.1. [If Y] Confirm the most recent report has been uploaded in the attachments section above.

25324 Y/N

1.8.1.1. [If N] Explain why a report or findings are not available.


1.8.2. [If N] Summarize the data safety monitoring findings since the last IRB review, explain why findings are not

25325 Free text


available, or indicate that a summary or report has been uploaded in the attachments section above.

1.9. [If Study closed prior to completion OR Study completed] Describe any observations and information about study results or trends.

25326 Free text

1.10. [If Study closed prior to completion OR Study completed] Have subjects experienced any direct benefit(s) from their participation in the study?

409 Y/N

1.10.1. [If Y] Describe the direct benefit(s) to subjects. 410 Free text Examples include pain reduction or disease remission. Payment for participation in the study should not be considered benefit and should not be listed here.

1.11. [If N] Explain why subjects have not experienced direct benefit(s).

24864 Free text

1.12. [If Study closed prior to completion OR Study completed] Have any of the following occurred since the last IRB review? Choose all that apply.

25327 Multiple Choice – choose all that apply. • Literature publication which

demonstrates a significant impact on the conduct of the study, or the well-being of subjects


• Events which affected the validity of the data

• Increase in risk to subjects or others • Investigator brochure update • Change in the risk to benefit assessment • None of the above

1.12.1. [If not None of the Above] Provide an explanation of any options selected above.

25328 Free text


KC IRB Questionnaire – Exempt Research Displays if the Protocol Type is Exempt. Minimum number of questions: 9 Maximum number of questions: 55

Question Question ID Appropriate Answer Types Tips/Tricks 1. Describe the purpose of this study in lay terms. 625 Free text 2. List and describe all research interactions and/or interventions,

including the frequency and duration of procedures, and length of participation for individual subjects.

25377

Free text If some procedures will be performed as standard of care and others solely as a part of the research, be sure to note which procedures are standard of care and which are research.

3. List criteria used to determine that a subject, record, or specimen is eligible to be included in this study.

25378

Free text

4. Select the categories that apply to this study:

25380

Multiple Choice – choose all that apply. • Research Studying Educational Practices Includes research conducted in commonly

accepted educational settings, involving normal educational practices, including research on regular and special education instructional strategies, or effectiveness of or comparison among instructional techniques, curricula, or classroom management.

• Research Involving Data Collection WITH Subject Interaction

Includes educational tests (cognitive, diagnostic, aptitude, achievement), surveys, interviews, or benign behavioral interventions.

• Research Involving Data Collection WITHOUT Subject Interaction

Includes observation of public behavior, secondary use of identifiable private information, and/or retrospective or prospective chart review.

• Research Studying Federal Government-Funded Programs

• Taste and Food Quality Evaluation and Consumer Acceptance Studies

Includes evaluation of taste, food quality, and consumer acceptance, if wholesome foods without additives are consumed, or if food ingredients or chemicals are used that have


been determined to be safe by appropriate government agencies.

4.1. [If Research Studying Educational Practices] Explain how the research is not likely to adversely affect students’ opportunity to learn required educational content, or the assessment of educators who provide instruction.

25381

Free text

4.1.1. This research includes (choose all that apply): 25382

Multiple Choice – choose all that apply. • Analysis of educational and/or student records • Analysis of NON-educational or student record

information created for non-research purposes • Research procedures which are not otherwise

part of an existing course or curriculum

For additional information about FERPA and Research with Student Records, go to: http://researchcompliance.iu.edu/hso/hs_ferpa.html..

4.1.1.1. [If begins with text Analysis of educational and/or student records]: (1) the research is designed to study the effectiveness of an instructional technique, curricula or classroom management method in an IU course; (2) the student education records are limited to IU records; (3) all researchers who will have access to the identifiable records are IU personnel conducting this research to fulfill their professional responsibilities at IU.

25383

Y/N

4.1.1.1.1. [If N] You will need a FERPA Release to access FERPA protected information. Describe how written permission from subjects will be obtained. The following information must be shared with subjects: (a) What records may be disclosed (e.g., grades, course work); (b) To whom the records may be disclosed; (c) The purpose of the disclosure; (d) The time period or event to which the permission pertains; and (e) The signature of the student and date.

26725 Free text

4.1.1.2. [If Research procedures which are not otherwise] Describe the plan to ensure that the course instructor(s) will not know whether their students participated in the research until after course grades are final.

25386

Free text

4.1.1.3. [If begins with text Research procedures which are not otherwise] Describe how subjects will be recruited, including how they will be identified and contacted, and any written materials that will be used, such as advertisements. All materials that

24944 Free text

http://researchcompliance.iu.edu/hso/hs_ferpa.html


will be shared with subjects must be uploaded to the Notes & Attachments tab.

4.1.1.4. [If begins with text Analysis of NON-educational] Describe the source of the information.

25422 Free text

4.1.1.5. [If begins with text Research procedures which are not otherwise] Describe how you will obtain permission from subjects to participate, which includes the following information: (i) they are being asked to participate in research, (ii) what they will be asked to do, (iii) their participation is voluntary, (iv) the risks and benefits of participation, and (v) who to contact with any questions about the research.

25424

Multiple Choice – choose all that apply. • A separate Study Information Sheet will be

given to each potential subject to review. A copy will be uploaded to the Notes & Attachments tab.

• Study personnel will verbally discuss the research with potential subjects

• This information will be included at the beginning of written materials, such as a survey, that will be completed by subjects

• Other

Policy: Informing subjects about the nature of research which they may agree to participate in can be done via several methods. The most common method is to make use of a Study Information Sheet to present potential subjects with written information about the nature of the study and what their participation would entail. This could take the form of a separate document presented to subjects or be information proceeding something else, such as a survey. Depending on the nature of the study, researchers may find that presenting subjects with a written document is not practical or may not be the most effective method of communication. Researchers may choose to create a script to be used by study personnel to explain study details orally, make use of a video, or develop some other method of informing potential subjects.

4.1.1.5.1. [If Other] Explain other methods for informing subjects.

25425 Free text

4.2. [If Research Involving Data Collection WITH Subject Interaction] Choose the research procedures to be conducted.

25389

Multiple Choice – choose all that apply. • Educational tests, surveys, interviews, focus

groups • Benign behavioral interventions which are brief

in duration, harmless, painless, and not physically invasive

4.2.1. Will all subjects be age 18 or older, or will you communicate that individuals under age 18 should not participate?

25398

Multiple Choice – choose one. • Yes • No. Please note that this research is not

eligible for exemption. Return to the Protocol tab, change Protocol Type to Expedited, and return to this tab to complete the questionnaires.

4.2.2. Choose the best description of your research. 25395

Multiple Choice – choose one. • All research data collected will be recorded in a

way that human subjects can NOT be identified, directly or through identifiers linked to the subject.

• Research data will be recorded in a way that human subjects CAN be identified, directly or through identifiers linked to the subject.,

4.2.2.1. [If Research data will be recorded in a way that human subjects CAN be identified] Choose the best option regarding the possible risk of disclosure of the identifiable information outside of the research. Risk relates to criminal or civil liability, or damage to subjects’ financial standing,

26791 Multiple Choice – choose one. • Disclosure would NOT place subjects at risk. • Disclosure COULD place subjects at risk.


employability, educational advancement, or reputation.

4.2.2.2. [If Research data will be recorded in a way that human subjects CAN be identified] Explain how research data will be protected so that only approved persons have access to subjects’ identifiable data (i.e. confidentiality of data).

25396

Free text

4.2.2.3. Explain how subjects’ physical privacy will be protected, both during recruitment/screening and during participation in the research.

25397 Free text

4.2.3. [If Benign behavioral intervention] Explain why procedures are not likely to have a significant adverse lasting impact on subjects.

25391

Free text

4.2.4. [If Benign behavioral intervention] Explain why subjects are not likely to find procedures offensive or embarrassing.

25392

Free text

4.2.5. [If Benign behavioral intervention] Will research subjects be unaware of or misled regarding the nature or purposes of the research?

25393

Y/N

4.2.5.1. [If Y] To be eligible for Exemption, subjects must prospectively agree to participate knowing they will be unaware of or misled regarding the nature or purpose of the research. Describe the circumstances and setting in which you will obtain their prospective permission to be deceived.

25394

Free text

4.2.6. Describe how subjects will be recruited, including how they will be identified and contacted, and any written materials that will be used, such as advertisements. All materials that will be shared with subjects must be uploaded to the Notes & Attachments tab.

24944 Free text

4.2.7. Select any source of information listed below that will be used for the research, either to identify potential subjects or gather research data.

24953 Multiple Choice – choose all that apply. • Medical records or information from a health

care provider • Student records • Subject-provided health information • None of the above.

4.2.7.1. [If Student records] Describe the student records, how you will access them, and what will be recorded for the research.

24998 Free text

4.2.7.2. [If Student records] Confirm: (1) the research is designed to study the effectiveness of an instructional technique, curricula or classroom management method in an IU course; (2) the student education records are limited to IU records; (3) all researchers who will have access to

25383

Y/N


the identifiable records are IU personnel conducting this research to fulfill their professional responsibilities at IU.


26725 Free text

4.2.7.3. [If Medical records] HIPAA applies to your study. How will the study team obtain access to the medical records or health information?

24954 Multiple Choice – choose all that apply. • A member of the study team is the subjects’

care provider • A member of the study team works in the same

department or practice plan as the subjects’ care provider

• Other

4.2.7.3.1. [If Other] Explain how the study team will obtain the medical records or health information.

24955 Free text

4.2.7.3.2. [If Other]You must obtain authorization to access PHI or request a waiver. Choose all that apply.

24956

Multiple Choice – choose all that apply. • I will obtain written, signed authorization from

subjects prior to accessing or receiving PHI. • I will obtain authorization from subjects prior

to accessing PHI but subjects will not physically sign a document.

• I will not obtain authorization prior to accessing or receiving PHI.

4.2.7.3.2.1. [If subjects will not physically sign a document or will not obtain authorization prior to accessing or receiving PHI] See HIPAA Waiver questions.

24957-24963 Free text

4.2.7.3.3. HIPAA authorization or a waiver of authorization may be required for participation. Will health information be recorded in the research record?

24964 Multiple Choice – choose one. • Yes • No. The medical records or health information

will only be used to identify potential subjects or to determine eligibility.

4.2.7.3.3.1. [If Yes] Authorization or a waiver of authorization for participation is required. Choose all that apply.

24965 Multiple Choice – choose all that apply. • I will obtain written, signed authorization from

subjects.

Does not display if response to question 24956 is ‘I will obtain written, signed authorization from subjects prior to accessing or receiving PHI.’


• I will obtain authorization from subjects but subjects will not physically sign a document.

• I will not obtain authorization. 4.2.7.3.3.1.1. [If subjects will not physically

sign a document or will not obtain authorization prior to accessing or receiving PHI] See HIPAA Waiver questions.

24957-24963 Free text

4.2.7.4. [If question 24953 has response Subject-provided health information and not Medical Records or information from a health care provider] Is any member of the study team conducting the research on behalf of a covered entity or an IU covered component (HIPAA Affected Area)? See list of IU HIPAA Affected Areas for additional information.

24968 Y/N

4.2.7.4.1. [If Y] HIPAA applies to your study and may require that you obtain authorization or request a waiver prior to collection of subject health information. Choose all that apply.

24969 Multiple Choice – Choose all that apply. • I will obtain authorization prior to obtaining

any health information. • I will receive limited subject health

information to determine basic eligibility prior to obtaining authorization.

• I will receive detailed subject health information to determine eligibility prior to obtaining authorization.

4.2.7.4.1.1. [If you will receive detailed subject health information] You must obtain authorization or request a waiver of authorization for recruitment. Choose all that apply.

24970 Multiple Choice – Choose all that apply. • I will obtain written, signed authorization

from subjects prior to collection of detailed health information.

• I will obtain authorization from subjects prior to collection of detailed health information but subjects will not physically sign a document.

• I will not obtain authorization prior to collection of detailed health information.

4.2.7.4.1.1.1. [If subjects will not physically sign a document or will not obtain authorization] See HIPAA Waiver questions.

24957-24963 Free text

4.2.7.4.1.2. [If you will receive limited or detailed subject health information] HIPAA authorization or a waiver of authorization may be required for participation. Will health

24971 Multiple Choice – Choose one. • Yes • No. Health information will only be used to

identify potential subjects or to determine eligibility.

http://www.iu.edu/%7Evpgc/docs/Compliance/List%20for%20Designation%20Statement%2001%2028%202015.pdf


information be recorded in the research record?

4.2.7.4.1.2.1. [If Yes] Subjects must provide authorization for participation, or you must request a waiver of authorization. Choose all that apply.

24973 Multiple Choice – Choose all that apply. • I will obtain written, signed authorization

from subjects prior to their participation. • I will obtain authorization from subjects prior

to their participation but subjects will not physically sign a document.

• I will not obtain authorization for participation.

4.2.7.4.1.2.1.1. [If subjects will not physically sign a document or will not obtain authorization] See HIPAA Waiver questions.

24957-24963 Free text

4.2.7.5. Describe how you will obtain permission from subjects to participate, which includes the following information: (i) they are being asked to participate in research, (ii) what they will be asked to do, (iii) their participation is voluntary, (iv) the risks and benefits of participation, and (v) who to contact with any questions about the research.

25424

Multiple Choice – Choose all that apply. • A separate Study Information Sheet will be




• Other

Policy: Informing subjects about the nature of research which they may agree to participate in can be done via several methods. The most common method is to make use of a Study Information Sheet to present potential subjects with written information about the nature of the study and what their participation would entail. This could take the form of a separate document presented to subjects or be information proceeding something else, such as a survey. Depending on the nature of the study, researchers may find that presenting subjects with a written document is not practical or may not be the most effective method of communication. Researchers may choose to create a script to be used by study personnel to explain study details orally, make use of a video, or develop some other method of informing potential subjects.


25425

Free text

4.2.7.6. Select any of the following circumstances which apply to this research.

25426

Multiple Choice – Choose all that apply. • A member of the study team is an instructor

and his or her own students will participate as subjects in the research

• A member of the study team is an employer or supervisor of individuals who will participate as subjects in the research

• A member of the study team is a health care professional and his or her patients will participate as subjects in the research

• None of the above.

4.2.7.6.1. [If contains text value own students] Describe the plan to ensure that the course instructor(s) will not know whether their

25386

Free text More Information: Please review the guidance on use of a researcher’s own students as subjects. http://researchcompliance.iu.edu/hso/hs_studentsubjects.html

http://researchcompliance.iu.edu/hso/hs_studentsubjects.html


students participated in the research until after course grades are final.

4.2.7.6.2. [If Contains text value employer] Confirm subjects will be informed that their decision to participate will not affect their employment.

25428

Y/N Policy: You must confirm this statement by selecting Yes in order to submit.

4.2.7.6.3. [If Contains text value health care professional] Confirm subjects will be informed that their decision to participate will not affect their relationship with their health care provider.

26690

Y/N Policy: You must confirm this statement by selecting Yes in order to submit.

4.3. [If Research Studying Educational Practices OR Research Involving Data Collection WITH Subject Interaction] Will subjects be paid for participation in the study?

25429

Y/N

4.3.1. [If Y] Describe the payment arrangement, including amount and timing of disbursement.

25430

Free text

4.3.2. Will the research be conducted at any non-IU affiliated site?

25431

Y/N

4.3.2.1. [If Y] Provide the name of the site, including city and state.

701 Free text

4.3.2.2. [If Y] Is permission necessary to conduct research at the non-IU site?

25432

Multiple Choice – Choose all that apply. • Yes. A letter, email, or other correspondence

indicating agreement to conduct research at the external facility is attached on the Notes & Attachments tab.

• Yes. I will obtain permission from appropriate contacts before the research begins.

• No.

4.3.2.2.1. [If No] Explain why permission is not required.

25388

Free text

4.3.2.3. [If Y] Is any research taking place outside the United States?

25433

Y/N

4.3.2.3.1. [If Y] List each country: 25434

Free text

4.3.2.3.2. [If Y] Describe the researchers' familiarity with local customs, culture, and languages spoken.

25435

Free text

4.3.2.3.3. [If Y] Describe any local ethical review requirements.

25436

Free text

4.4. [If Research Involving Data Collection WITHOUT Subject Interaction] Choose the best description of your data collection methods.

25415

Multiple Choice – Choose one. • Research involves observation of public

behavior • Identifiable private information or

biospecimens being accessed are publicly available


• Identifiable information will be accessed, but will be recorded in a way that subjects can NOT be identified, directly or through identifiers linked to the subject, AND subjects will not be contacted, AND the investigator will not re-identify subjects.

• Research involves ONLY collection and analysis of data from medical records (select for chart reviews).

4.4.1. [If Observation of public behavior] Choose the best description of your research.

25395

Multiple Choice – Choose one. • All research data collected will be recorded in a

way that human subjects can NOT be identified, directly or through identifiers linked to the subject.

• Research data will be recorded in a way that human subjects CAN be identified, directly or through identifiers linked to the subject.

4.4.1.1. [If Begins with text Research data will be recorded] Choose the best option regarding the possible risk of disclosure of the identifiable information outside of the research. Risk relates to criminal or civil liability, or damage to subjects’ financial standing, employability, educational advancement, or reputation.

26791 Multiple Choice – Choose one. • Disclosure would NOT place subjects at risk. • Disclosure COULD place subjects at risk.

4.4.1.2. [If Research data will be recorded in a way that human subjects CAN be identified] Explain how research data will be protected so that only approved persons have access to subjects’ identifiable data (i.e. confidentiality of data).

25396 Free text

4.4.2. [If Observation of public behavior] Describe the setting in which subjects will be observed.

25416

Free text

4.4.3. [If Identifiable private information or biospecimens] Describe the source of the information or biospecimens.

25417

Free text

4.4.4. [If Identifiable private information or Identifiable information will be accessed] Will the researchers be using a data collection form?

633 Multiple Choice – Choose one. • Yes – it is attached to the Notes & Attachments

tab • No

4.4.4.1. [If N] List the specific data points to be recorded (e.g., age, sex, date of injury, GPA, Pell Grant eligibility, or date of admission). General descriptors, such as demographics, are not sufficient.

25418

Free text

4.4.5. [If Begins with text Identifiable information will be accessed] Select any source of information accessed in the research.

25419

Multiple Choice – Choose all that apply. • Medical records or information provided by a

health care provider


• Student records • Other

4.4.5.1. [If Other] Describe the source of the information. 25422

Free text

4.4.5.2. [If Student records] Describe the student records, how you will access them, and what will be recorded for the research.

24998 Free text

4.4.5.3. [If Student records] Confirm: (1) the research is designed to study the effectiveness of an instructional technique, curricula or classroom management method in an IU course; (2) the student education records are limited to IU records; (3) all researchers who will have access to the identifiable records are IU personnel conducting this research to fulfill their professional responsibilities at IU.

25383

Y/N


26725 Free text

4.4.5.4. [If Medical records] Describe the medical records or information and how you will access them.

26869 Free text

4.4.5.5. [If Medical records] A waiver of HIPAA authorization is required for collection and use of the data. List all data elements to be used or disclosed (do not refer to an attachment).

25420

Free text

4.4.5.5.1. Explain how this research involves no more than minimal risk of loss of confidentiality to the subject.

24958 Free text

4.4.5.5.2. Describe the plan for protecting identifiers from improper use and disclosure.

24959 Free text

4.4.5.5.3. Describe the plan to destroy identifiers at the earliest opportunity appropriate for the research, considering the purpose of the research and local data retention requirements.

24960 Free text

4.4.5.5.4. Confirm that the study team will assure identifiable PHI will not be re-used or

24961 Free text


disclosed to individuals outside the study team, except as required by law.

4.4.5.5.5. Explain how the research could not practicably be conducted without waiver of authorization or alteration of authorization requirements.

24962 Free text

4.4.5.5.6. Explain how the research could not be practicably conducted without access to and use of identifiable PHI.

24963 Free text

4.4.6. [If Begins with text Research involves ONLY collection] A waiver of HIPAA authorization is required for collection and use of the data. List all data elements to be used or disclosed (do not refer to an attachment).

25420

Free text

4.4.6.1. Explain how this research involves no more than minimal risk of loss of confidentiality to the subject.

24958 Free text

4.4.6.2. Describe the plan for protecting identifiers from improper use and disclosure.

24959 Free text

4.4.6.3. Describe the plan to destroy identifiers at the earliest opportunity appropriate for the research, considering the purpose of the research and local data retention requirements.

24960 Free text

4.4.6.4. Confirm that the study team will assure identifiable PHI will not be re-used or disclosed to individuals outside the study team, except as required by law.

24961 Free text

4.4.6.5. Explain how the research could not practicably be conducted without waiver of authorization or alteration of authorization requirements.

24962 Free text

4.4.6.6. Explain how the research could not be practicably conducted without access to and use of identifiable PHI.

24963 Free text

4.5. [If Research Studying Federal Government-Funded Programs] Choose the appropriate description of the research.

25427 Multiple Choice – Choose one. • Research conducted or supported by a Federal

department or agency designed to study, evaluate, improve, or otherwise examine public benefit or service programs

• Research conducted by, or on behalf of, a federal agency using government-generated or government-collected information obtained for non-research activities.

4.5.1. [If Contains text value designed to study, evaluate, improve] Has the department or agency conducting or

26737 Multiple Choice – Choose one. • Yes. Provide a link to the list:


supporting the research included this protocol on a publicly accessible list of the research and demonstration projects it conducts or supports ?

• No. I confirm that the research or demonstration project WILL be published on this list prior to commencing any research activities involving human subjects.

4.5.2. [If Contains text value government-collected information] Describe the source of the information.

25422 Free text

4.5.3. [If Contains text value government-collected information] Confirm that all of the following are true:<br>1) Identifiable private information will be maintained on technology which is subject to and compliant with 208(b) of the E-Government Act of 2002, 44 USC 3501 note<br> 2) Identifiable private information will be maintained in systems of records subject to the Privacy Act of 1974, 5 USC 522a<br> 3) If applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 USC 3501 et seq.

26739 Y/N

4.6. [If Taste and food quality evaluation and consumer acceptance research] Does the food that will be consumed contain any additives?

24933 Y/N

4.6.1. [If Y] Are the level of the additives (i.e. food ingredients, chemical additives, or environmental contaminants) at or below the levels approved by the FDA, EPA, or USDA?

25421

Multiple Choice – Choose one. • Yes. I have attached supporting

documentation on the Notes & Attachments tab.

• No. The research is not eligible for exemption. Return to the Protocol tab, change Protocol Type to Full Board, and return to this tab to complete the questionnaires.

4.6.2. Describe how subjects will be recruited, including how they will be identified and contacted, and any written materials that will be used, such as advertisements. All materials that will be shared with subjects must be uploaded to the Notes & Attachments tab.

24944 Free text

4.6.2.1. Describe how subjects will be given the following minimum information: (i) they are being asked to participate in research, (ii) what they will be asked to do, (iii) their participation is voluntary, (iv) the risks and benefits of participation, and (v) who to contact with any questions about the research.

24945 Multiple Choice – Choose all that apply. • A separate Study Information Sheet will be




• Other


24946 Free text


4.6.2.2. Will subjects be paid for participation in the study? 644 Y/N 4.6.2.2.1. [If Y] Describe the payment arrangement,

including amount and timing of disbursement.

23347 Free text

4.6.2.3. Will the research be conducted at any non-IU affiliated site??

25431

Y/N

4.6.2.3.1. [If Y] Provide the name of the site, including city and state.

701 Free text

4.6.2.3.2. [If Y] Is permission necessary to conduct research at the non-IU site?

25432 Multiple Choice – Choose all that apply. • Yes. A letter, email, or other correspondence

indicating agreement to conduct research at the external facility is attached on the Notes & Attachments tab.

• Yes. I will obtain permission from appropriate contacts before the research begins.

• No.

4.6.2.3.2.1. [If No] Explain why permission is not required.

25388 Free text

4.6.2.3.3. [If Y] Is any research taking place outside the United States?

608 Y/N

4.6.2.3.3.1. [If Y] List each country: 703 Free text 4.6.2.3.3.2. [If Y] Describe the researchers'

familiarity with local customs, culture, and languages spoken.

609 Free text

4.6.2.3.3.3. [If Y] Describe any local ethical review requirements.

610 Free text

5. Provide the anticipated end date of the research. 627 [Date Selector] or enter MM/DD/YYYY


KC IRB Questionnaire – Reliance Request Displays if the Protocol Type is Reliance Request. Minimum number of questions: 9 Maximum number of questions: 18

Question Question ID Appropriate Answer Types Tips/Tricks 1. This research is: 22166 Multiple Choice – choose one.

• Minimal risk • Greater than minimal risk • Greater than minimal risk, but IU

investigators are performing only minimal risk procedures

Choose the appropriate option based on the role of the IU investigators in the study. For example, if the study procedures include collection of survey data followed by a biopsy (which is considered more than minimal risk) but only collection of survey data will be conducted at IU, choose the third option, “greater than minimal risk, but IU investigators will only perform minimal risk procedures.” If you are unsure, check with the HSO or with the IRB who is providing review and approval for the study. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Risks may be psychological, physical, and/or privacy-related.

2. Please choose the option which best describes the role of the IU-affiliated investigators in the research.

25342 Multiple Choice – choose one. • IU-affiliated investigators are conducting all of

the procedures specified in the protocol. • IU-affiliated investigators are conducting only

some of the procedures specified in the protocol.

• IU is the direct grant recipient of a federally-funded research project, but IU-affiliated investigators are not conducting any research activities that are considered human subjects research.

2.1. [If “all of the procedures”] For HIPAA compliance purposes, choose all that apply.

25028 Multiple Choice – choose all that apply. • The reviewing IRB has granted a waiver of

HIPAA authorization for this study. Documentation of approval of the waiver must be uploaded to the Notes & Attachments tab.

• I will obtain authorization from subjects enrolled at this site. The HIPAA authorization to be used must be uploaded to the Notes & Attachments tab.

• This study is not subject to HIPAA.

Note: If you choose the 2nd option, i.e., I will obtain authorization from subjects enrolled at this site, you must upload the authorization form to the Notes & Attachments tab using one of the following Protocol Attachment Types:

• HIPAA Authorization Form (Non-VA) • VA – HIPAA Authorization Form • HIPAA Authorization Form – Healthy Subjects

Otherwise, you will be unable to submit your Protocol to the IRB.

2.1.1. [If contains text value authorization] Select the electronic systems to be used for the collection and/or storage of protected health information (ePHI). Choose all that apply. Consult the HRPP Guidance on HIPAA.

30347 Multiple Choice – choose all that apply. • OnCore • REDCap • IU Box Health Data Account • Other

Question only displays if Protocol includes at least one IU organization.



No ePHI will be collected or stored at IU - you may also select this option if IU researchers will enter ePHI in only sponsor-provided record systems.

2.1.1.1. [If Other] For Other systems, provide additional information regarding status of certification.

30349 Multiple Choice – choose one. • All electronic systems used to collect or store

ePHI have previously been approved or certified

• The study team will complete the required IU system certification checklist and process for certifying the collection and/or storage locations and systems with their IT professional and data steward prior to the collection of any ePHI. See Checklist for System Providers

2.2. [If “some of the procedures”] Please choose the research activities which will be conducted by the IU-affiliated investigators.

25343 Multiple Choice – choose all that apply. • Identification of subjects • Enrollment of subjects, including obtaining

informed consent and/or authorization • Biomedical research interventions or

interactions • Social/behavioral/educational interventions or

interactions (e.g. surveys, questionnaires, etc.) • Collection or analysis of identifiable data or

identifiable biospecimens • Analysis of deidentified data or deidentified

biospecimens ONLY. (Please note that investigators who are only involved in analysis of deidentified data or deidentified biospecimens are not engaged in research and do not need to obtain IRB approval or IRB reliance for their participation. Please do not submit a reliance request for those applicable individuals. Contact HSO for more information.)

• Other: [text field]

2.2.1. [If Identification of subjects] Please explain how subjects will be identified and how they will be directed to the study team.

25345 Free text

2.2.2. [If Enrollment of Subjects] For HIPAA compliance purposes, choose all that apply.

25028 Multiple Choice – choose all that apply. • The reviewing IRB has granted a waiver of

HIPAA authorization for this study. Documentation of approval of the waiver must be uploaded to the Notes & Attachments tab.

• I will obtain authorization from subjects enrolled at this site. The HIPAA authorization

Note: If you choose the 2nd option, i.e., I will obtain authorization from subjects enrolled at this site, you must upload the authorization form to the Notes & Attachments tab using one of the following Protocol Attachment Types:

• HIPAA Authorization Form (Non-VA) • VA – HIPAA Authorization Form • HIPAA Authorization Form – Healthy Subjects

Otherwise, you will be unable to submit your Protocol to the IRB.

https://datamanagement.iu.edu/tools/checklist-for-system-providers.php




to be used must be uploaded to the Notes & Attachments tab.

• This study is not subject to HIPAA. 2.2.3. [If contains text value interventions or interactions]

Please list the specific procedures to be conducted by the IU-affiliated investigators.

25346 Free text

3. Indicate why reliance on an external IRB is appropriate for this study. 25347 Multiple Choice – choose all that apply. • Sponsor or funding agency request or

requirement • Single IRB review required under NIH Policy on

the Use of a Single Institutional Review Board (effective January 25, 2018)

• Study is part of an existing network, consortium, or agency which encourages single IRB review

• Efficiency considerations, especially for collaborative research

• Request of IU institutional official, Office of Research Compliance staff, IRB, etc.

• Conflict of interest concerns • None of the above/Other: [explain]

3.1. [If Study is part of an existing] Name of the network, consortium, or agency.

25348 Free text

3.2. [If Conflict of interest concerns] Describe the potential conflict of interest and why it necessitates reliance on an external IRB.

25349 Free text

4. Choose the IRB which will review the research. 25350 Multiple Choice – choose one. • Advarra • Boston Children’s Hospital • Chesapeake IRB • Children’s Hospital of Philadelphia • Cincinnati Children’s Hospital • Community Health Network • Franciscan Health • Jaeb Center for Health Research • National Marrow Donor Program (NMDP) IRB • Nationwide Children’s Hospital • NCI CIRB • The Ohio State University • Oregon Health & Science University • Purdue University • Quorum IRB • Schulman IRB • Sterling IRB • St. Louis University


• St. Vincent/Ascension Health • TrialNet OneIRB (University of Miami) • University of Indianapolis • University of Kentucky • University of Michigan/IRBMed • University of Notre Dame • University of Wisconsin-Madison • Vanderbilt University • Washington University in St. Louis • WIRB/Copernicus Group • Other: [text box]

5. This research involves (check all that apply): 23454 Multiple Choice – choose all that apply. • Prospective cancer-related research utilizing

IU Simon Cancer Center patients or resources. Documentation of approval from the Scientific Review Committee (SRC) must be uploaded to the Notes & Attachments tab.

• Radiation/radioactivity in addition to what is used for standard clinical treatment. Radiation safety approval must be obtained. Submission to the Radiation Safety Office must be made prior to submission to the IRB.

• Recombinant or synthetic nucleic acid molecules. IBC protocol number:

• Human gene transfer research (i.e. research which involves the deliberate transfer of recombinant or synthetic nucleic acid molecules, or DNA or RNA derived from recombinant or synthetic nucleic acid molecules, or into human research participants.)

• None of the Above

6. Is this a multi-center study or multi-site clinical trial? 710 Y/N 6.1. [If Y] State the number of subjects to be enrolled in the study at

all sites. 711 Number

6.2. [If Y] Is the Lead Investigator at IU? 712 Y/N 7. Is the research considered a prospective clinical study?

Prospective research collects data looking forward using either one-time or periodic observations collected predominantly following

25049

Multiple Choice – choose one. • Yes - This study may require entry in

OnCore. For more information, click here or email [email protected].

• No

Click here goes to: https://ocr.iu.edu/investigators-study-coordinators/oncore/%20training-support/#documents.





subject enrollment. This could occur during a single visit or throughout a series of visits.

A clinical study uses human subjects to evaluate a biomedical or health-related outcome. This includes, but is not limited to: prevention and treatment of a disease/diagnosis; prevention and treatment of genetic and environmental factors related to disease and health; studies surrounding cost of care; studies regarding patient satisfaction; observations surrounding a disease/diagnosis and patient health; specimen or tissues collection; and registries.

8. Is this community-engaged research? 30000 Y/N For the purposes of IRB at IU, community-engaged research is defined as research that “includes the meaningful involvement of community partners in the research process, including but not limited to topic development, need identification, research design, conduct of research, and/or sharing of results.”

8.1. [If Y] How are/were the community partner(s) involved in the research? Choose all that apply.

30001 Multiple Choice – choose all that apply. • Topic development, need identification, and/or

development of research questions • Research design and/or selection of

appropriate measures and data collection methods

• Contribution to consensus about findings, conclusions, and/or recommendations for implementing findings

• Dissemination of findings and actions taken based upon results

• Only provided access to study subjects or project sites; not involved with study design, subject recruitment, data collection, data analysis, or dissemination of results

This information is shared with and used by several units at IU to support, inform, and advocate for faculty who choose to conduct community-engaged research and the community members and organizations they engage. For more information about how units use this information, see the IUPUI Office of Community Engagement’s website: https://engage.iupui.edu/research/share-community-engaged-research.html.

https://engage.iupui.edu/research/share-community-engaged-research.html


KC IRB Questionnaire – Humanitarian Use Device Displays if the Protocol Type is Humanitarian Use Device (HUD). Minimum number of questions: 8 Maximum number of questions: 9

1. Will safety or effectiveness data be collected for purposes of supporting a premarket (PMA) application for the HDE-approved indication?

23396 Multiple Choice – choose one. • No. • Yes. The proposed use of the HUD is

considered a clinical investigation. Change the protocol type to Full Board before proceeding.

If safety and effectiveness data will be collected, the use of the HUD is considered a clinical investigation and you must submit a full application for review and approval by the IRB. On the Protocol tab, change the Protocol Type to Full Board or Expedited as appropriate, and then complete the required questionnaires on the Questionnaire tab.

1.1. [If N] Name of device: 23397 Free text 1.1.1. Name of device manufacturer: 23398 Free text 1.1.2. Describe (in lay terms) the objective(s) of the proposed

use of the HUD. 23399 Free text

1.1.3. List specific eligibility requirements for use of the HUD. 23400 Free text 1.1.4. Provide a brief summary of FDA-approved product

labeling/indications for use of the HUD. 23401 Free text

1.1.5. Will the HUD be used locally for any indications which are NOT listed in the FDA-approved label?

23402 Y/N

1.1.5.1. [If Y] List the additional indications and provide justification for use of the device in this way.

23403 Free text You may request (and the IRB may grant) approval to use the HUD for off-label uses; however, you must provide a list of the additional indications and a justification for doing so.

1.1.6. Provide a summary of how physicians will use the device, including a description of any screening procedures, the HUD procedure, and any patient follow-up visits, tests, or procedures.

23404 Free text


KC IRB Questionnaire – Research Not Subject to Human Subjects Regulations Displays if the Protocol Type is Not Human Subject Research. Minimum number of questions: 2 Maximum number of questions: 5

1. Provide a brief summary of the project in lay terms. 25358 Free text 2. Choose the category of activities which will be conducted by the IU-

affiliated investigators. 25359 Multiple Choice – choose all that apply.

• Access to or collection of identifiable information or biospecimens protected by HIPAA, but IU-affiliated investigators are not engaged in human subjects research Click here for additional information about engagement in research.

• Receipt and/or analysis of coded private information or biospecimens

• Receipt and/or analysis of a limited data set • Receipt and/or analysis of fully deidentified

data • Receipt and/or analysis of decedent PHI • Quality improvement/quality assurance project

not intended to contribute to generalizable knowledgeality improvement/quality assurance project not intended to contribute to generalizable knowledge

• Student project not intended to contribute to generalizable knowledge

• Case report • Other

Click here goes to: https://research.iu.edu/training/guides/human-subjects/research-personnel.html

2.1. [If identifiable information] List all data points which will be accessed or collected by the IU-affiliated individuals. This includes data that will be viewed, but not shared with other personnel.

30482 Free text

2.1.1. Explain how this research involves no more than minimal risk of loss of confidentiality to the subject.

23264 Free text

2.1.2. Describe the plan for protecting identifiers from improper use and disclosure.

23265 Free text

2.1.3. Describe the plan to destroy identifiers at the earliest opportunity appropriate for the research, considering the purpose of the research and local data retention requirements.

23266 Free text

2.1.4. Confirm that the study team will assure identifiable PHI will not be re-used or disclosed to individuals outside the study team, except as required by law.

23267 Free text


2.1.5. Explain how the research could not be practicably conducted without waiver of authorization or alteration of authorization requirements.

23268 Free text

2.1.6. Explain how the research could not be practicably conducted without access to and use of identifiable PHI.

23269 Free text

2.1.7. Choose the source of the information/biospecimens. 30470 Multiple Choice – choose all that apply. • Medical record • Biospecimens collected for clinical purposes • Biospecimens or information originally

collected for another research project • Other

2.1.7.1. [If Medical record or collected for clinical purposes] Identify the source of the medical record information.

30477 Multiple Choice – choose all that apply. • IU Health • Regenstrief Institute/INPC (Indiana Network for

Patient Care) • Eskenazi Hospital • Roudebush VA Hospital • Rehabilitation Hospital of Indiana University • Other: [Text box]

2.1.7.1.1. [If IU Health or Regenstrief] Confirm that you will abide by the Terms of Access.

30483 Multiple Choice – only one option. • Yes

For information about the Terms of Use, please see HIPAA Guidance

HIPAA Guidance goes to: https://research.iu.edu/compliance/human-subjects/guidance/hipaa.html

2.1.7.2. [If another research project] Which IRB provided approval for the collection of the information or specimens?

30478 Multiple Choice – choose all that apply. • IU IRB • Other

2.1.7.2.1. [If IU IRB] Provide the IU IRB protocol number(s).

30479 Free text

2.1.7.2.2. [If Other] Confirm you have uploaded a copy of the IRB approval documentation and the consent form used for collection of the data or specimens.

30480 Multiple Choice – only one option. • Yes.

2.1.7.3. [If Other] Explain the source of the information/biospecimens.

30465 Free text

2.1.8. Explain the purpose of the sharing outside of IU and/or its affiliates.

30466 Free text

2.1.8.1. List the principal investigator(s) and institution(s) with whom you will share information/ biospecimens.

30467 Free text

2.1.8.2. What information will be shared (choose all that apply)?

30468 Multiple Choice – choose all that apply. • Identifiable data

See 2.1 in the Use of PHI in Research policy • Limited data set

See 2.4 in the Use of PHI in Research policy

All links go to: https://research.iu.edu/policies/human-subjects-irb/use-of-phi-in-research.html

https://research.iu.edu/policies/human-subjects-irb/use-of-phi-in-research.html

https://research.iu.edu/policies/human-subjects-irb/use-of-phi-in-research.html


• Deidentified data See 2.3 in the Use of PHI in Research policy

• Biospecimens • Images

2.1.8.2.1. [If identifiable or limited] Provide a list of all data points to be shared or indicate that a list has been uploaded to the Notes & Attachments tab.

30469 Free text

2.1.8.2.2. [If deidentified] Confirm that you will remove the following 18 identifiers prior to sharing any data:

• names, including initials • any geographic subdivision smaller than a state,

including street address, city, county, precinct, zip codes (if the geographic unit of combining all the same three initial digits contains more than 20,000 people)

• all elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death

• ages over 89 (unless aggregated in a single category of age 90 or older)

• telephone number • fax numbers • email addresses • social security numbers • medical record numbers • health plan beneficiary numbers • account numbers • certificate/license numbers • vehicle identifiers and serial numbers, including

license plate numbers • device identifiers and serial numbers • web universal resource locators (URLs) • internet protocol (IP) address numbers • biometric identifiers, including finger and voice

prints • full face photographic images and any comparable

images

30471 Multiple Choice – only one option. • Yes.

2.1.8.3. Do you expect the recipient of the information to provide results back to you?

30472 Y/N


2.1.8.4. Indicate additional expectations that should be placed on the recipient of the information, such as return of or destruction of information or specimens, notification of publication, etc., or indicate that there are no additional expectations.

30473 Free text

2.1.8.5. Is the sharing of information/biospecimens being done pursuant to or because of an existing sponsored project, data consortium agreement, or other external collaboration?

30474 Multiple Choice – choose one. • Yes • No. HSO will determine whether an agreement

is required for the data sharing. • Not sure

2.2. [If limited data set] Will the IU-affiliated investigators have access to any of the following identifiers? • Names, including initials • Postal code information other than city, state, or zip code • Telephone or fax numbers • Electronic email addresses • Social security numbers, medical record numbers, or

health plan beneficiary numbers, account numbers • Certificate/license numbers • vehicle identifiers and serial numbers, including license

plate numbers • device identifiers and serial numbers • web universal resource locators (URLs) • internet protocol (IP) address numbers • biometric identifiers, including finger and voice prints • full face photographic images and any comparable

images.

25360 Multiple Choice – choose one. • No. Please note that a data use agreement

must be established between the entities providing the data and the investigator.

• Yes. Your data is not a limited data set. Please review the other options and/or contact the Human Subjects Office for assistance.

2.3. [If deidentified data] Will the IU-affiliated investigators have access to any information (i.e. any unique identifying number, character, or code) which would allow them to readily identify subjects? Identifiers include the following: • Names, including initials • any geographic subdivision smaller than a state, including

street address, city, county, precinct, zip codes (if the geographic unit of combining all the same three initial digits contains more than 20,000 people)

• all elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death

• ages over 89 (unless aggregated in a single category of age 90 or older)

• telephone number • fax numbers • email addresses

25361 Multiple Choice – choose one. • No. • Yes. Your project includes identifiers. Please

review the other options and/or contact the Human Subjects Office for assistance.


• social security numbers • medical record numbers • health plan beneficiary numbers • account numbers • certificate/license numbers • vehicle identifiers and serial numbers, including license

plate numbers • device identifiers and serial numbers • web universal resource locators (URLs) • internet protocol (IP) address numbers • biometric identifiers, including finger and voice prints • full face photographic images and any comparable

images 2.4. [If decedent PHI] Confirm all of the following statements are

true in order for research on decedent PHI to be allowable. • The use is solely for research on the identifiable health

information of decedents. • The PHI sought is necessary for the purposes of the

research. • Upon request, I can provide documentation of the death

of the individual(s) about whom information is being sought.

25362 Multiple Choice – choose one. • Yes • No. Your project involves more than just

decedent PHI. Please review the other options and/or contact the Human Subjects Office for assistance.

2.5. [If coded private information] Were the coded data or biospecimens collected specifically for this research project through an interaction or intervention with human subjects?

25363 Y/N

2.5.1. [If Y] Confirm that the private information or biospecimens were collected at another institution under an appropriate IRB approval.

25364 Multiple Choice – choose one. • Yes • No. Please contact the Human Subjects Office

for assistance.

2.6. [If coded private information] Confirm how you will ensure that that the IU-affiliated investigators will not be able to ascertain the identity of subjects.

25365 Multiple Choice – choose one. • The key to the code will be destroyed before the

IU-affiliated investigators access private information or biospecimens.

• The IU-affiliated investigators and the holder of the code will enter into an agreement prohibiting the release of the code/key to the IU-affiliated investigators.

• Other

2.6.1. [If Other] Explain. 25366 Free text Explain how you will ensure that the IU-affiliated investigators will not be able to ascertain the identity of the subjects.

2.7. [If quality improvement] Choose how data will be collected. 25367 Free text 2.7.1. Choose at least one option that justifies why the project

is not intended to contribute to generalizable knowledge. 30475 Multiple Choice – choose all that apply.

• Data collected/results of analysis will not be disseminated outside the institution


• The project is limited to evaluating implementation of an accepted practice

• Other 2.7.1.1. [If Other] Explain why the project is not intended

to contribute to generalizable knowledge. 30476 Free text

2.8. [If Other] Describe the activities which will be conducted by the IU-affiliated investigators and why the project does not meet the definition of human subjects research.

25370 Free text

guidance for research involving human subjects kc irb ......1 kc irb crosswalk: completing the irb...

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