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FORM – Initial Review Application: Retrospective Medical Record Chart Review for JBVAMC ONLYVersion: 1.0Date: 8/28/2014

Office for the Protection of Research Subjects (OPRS)

Institutional Review BoardFWA# 00000083

203 AOB (MC 672)1737 West Polk Street

Chicago, IL 60612-7227Phone: 312 996-1711 Fax: 312 413-2929

http://research.uic.edu/compliance/irb

To Be Completed By the Investigator For OPRS Use OnlyDate Application Completed: UIC Protocol #:

Application Document Version #: IRB #4

I. Research Title:

II. PersonnelA. Principal Investigator (PI)

Name (Last, First)

Degree(s)

University Status/Title

Department

College

Mailing Address

M/C

Phone Number

Fax Number

E-mail Address

B. Faculty Sponsor – required when PI is a student, fellow or residentName (Last, First)

Degree(s)

University Status/Title

Department

College

Mailing Address

M/C

Phone Number

Fax Number

E-mail Address

C. LIST ALL ADDITIONAL KEY RESEARCH PERSONNEL ON APPENDIX P and SUBMIT WITH THIS APPLICATION PACKET.

III. Performance SitesA. Performance Site Identification:

1. Will JBVAMC be a performance site? No – STOP. You cannot use this form. Refer to the OPRS Website for additional forms. Yes

of 14 OVCR Document #0962

http://research.uic.edu/compliance/irb

http://research.uic.edu/compliance/human-subjects-irb/forms


IR Application: Retrospective Medical Record Chart Review for JBVAMC Version: 1.0

IV. Research Funding

A. Is this research funded? No. Go to Section V. Yes or pending. Complete the rest of this Section (below).

B. Check all of the appropriate boxes for funding sources (including pending sources) for this research.

EXTRAMURAL: Federal Agency Name: Foundation Name: State Agency Name: Industry Sponsor Name:

The UIC OVCR assesses an administrative fee for the IRB review of all pharmaceutical industry sponsored human subjects research. Please refer to the Protocol Processing Fee for Industry Sponsored IRB Submissions to the UIC IRB for an explanation of this policy and fee schedule. The account number to be charged must be provided below before IRB review commences.

Account Number to be charged: Department of Defense – Complete and submit Appendix Q Sub-contract from non-UIC agency or institution: Name: Other - Name:

INTRAMURAL: Campus Research Board (CRB) Departmental Other - Name:

C. Funding Identification: For each funding source, provide the following information. Use Appendix Z if this study is supported by more than one funding source. Note: Any subsequent change in funder or funding status requires the submission of Appendix Z via an IRB amendment.

PLEASE ATTACH A COPY OF THE GRANT or CONTRACT TO THIS APPLICATION FOR FEDERALLY FUNDED RESEARCH WHERE UIC IS THE AWARDEE INSTITUTION OR LEAD SITE.

1. Proposal Approval Form (PAF) Number: 2. a. Name of the PI on the grant or contract received directly from the sponsor: b. Is the PI of this grant or contract affiliated with UIC? No Yes

If NO,Identify the agency or institution with which the above PI is affiliated: Explain the relationship between that agency or institution and UIC:

3. Funding Agency Grant Account Number: Grant, contract or sub-contract pending. Not Applicable, Non-federally funded research

4. Grant, contract or sub-contract title: 5. Is this grant a Master, Training, or Development grant (grants used to train fellows or

support the development of other research protocols)? No Yes




http://research.uic.edu/node/731


V. Conflict of Interest (COI) All investigators must disclose all real, apparent, or potential Significant Financial Interest (SFI) to the IRB. For more information, see the Investigator Conflict of Interest Disclosure Policy for Human Subjects.

A. Disclosure 1. At present or in the 12 months prior to this disclosure, did or does any investigator or

investigator’s family members have a significant financial interest (SFI) with the research sponsor or any subcontract recipient; or have a SFI reasonably related to a product (e.g., drug, device, method, treatment, etc.) that is the subject of the research; or have any other relationships (e.g. fiduciary, even if uncompensated) that may present a potential conflict of interest with this research?

No Yes (If yes, see Section B below.)

2. Does an institutional conflict of interest exist with this study?

No Yes (If yes, see Section B below.)

B. Management If YES is checked for any of these questions, attach a Significant Financial Interest – Disclosure and Management Plan (SFI-DMP). The SFI-DMP form and guidance on how to write the SFI-DMP are available on the COI website at http://research.uic.edu/compliance/coi. Final IRB approval of the research cannot be provided until a management plan is in place.

For additional assistance contact the COI Office at (312) 996-3642/ (312) 996-4070 or email [email protected].

VI. IRB Disapproval of the ResearchA. To your knowledge, has this protocol been reviewed and subsequently disapproved by any

IRB? No Yes - Please provide the details of the disapproval including the reviewing IRB name, the

date of review, the issues resulting in disapproval, and how these issues have been resolved.

VII. Classified ResearchA. Has this research been declared to be classified and/or does it involve any classified data or

subjects? No Yes - STOP. Please contact the Director of the Office for the Protection of

Research Subjects. UIC IRBs generally do not review classified research involving human subjects.


http://research.uic.edu/directory?display=unit&unit=34&first=&last=&search=1

http://research.uic.edu/directory?display=unit&unit=34&first=&last=&search=1

mailto:[email protected]

http://research.uic.edu/compliance/coi




VIII. Additional Reviews RequiredReviews beyond that of the IRB may be required for this study. Please indicate which of the reviews below apply to this study. If you have already received review approval documents, please attach.

Review Review Required?

If YES, check that necessary documents are attached

UIC Cancer Center Review - protocols eligible for expedited review may be submitted simultaneously to the Cancer Center and IRB.

Yes

No

Cancer Center approval is pending

Cancer Center approval is attachedApproval date:

IX. Risk Level to SubjectsA. The level of risk to subjects in this research study is as follows:

Not greater than minimal risk, keeping data linked to identifiers – Expedited Category 5: “Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).”

Therefore, the following are met: the data collected will be from health information records that exist at JBVAMC or some

other entity at the time of IRB submission, and no on-going or prospective collection of data will occur, and/or identifiers will be recorded in the research record.

A Waiver of Informed Consent must be requested in section XIV and a parallel Waiver of Authorization must be requested in section XV.

No – STOP. You cannot use this form. Refer to the OPRS Website for additional forms. Yes

X. Protocol ComponentsA. Indicate the section of the research protocol that discusses the research hypothesis being

explored, the aims of the research, and the significance of the research.

B. Provide the location (name of building, address if off-campus and room number) where the following research activities will occur:1. Review of medical records for eligibility

2. Review of medical records for data collection (if multiple locations, match each location with the procedure(s) being performed there)

3. Data analysis



http://www.chicago.medicine.uic.edu/cancercenter


C. Research Records1. Indicate the type(s) of data being collected and/or recorded (check all that apply):

Data containing no health information Study-generated health information Lab, pathology and/or radiology results University of Illinois Hospital & Health Sciences System medical records Physician/clinic/hospital medical records from sources outside of UI Health System Psychotherapy Notes (Please note that waivers cannot be granted for these notes.) Billing records Data previously collected for research purposes Clinical Research Data Warehouse data set

Other. Describe:

2. Indicate the identifiable elements that will be collected and/or included in the research records.Check all that apply:

Names Social Security Numbers* Device identifiers/Serial numbers Phone numbers Medical record numbers Web URLs Street address Health plan numbers IP address numbers City or state Account numbers Biometric identifiers Zip Code Fax numbers Vehicle ID numbers E-mail address License/Certificate numbers Facial Photos/Images Financial account information (including student ID) All elements of dates (except year) for dates directly related to an individual; and all ages

over 89 and all elements of dates (including year) indicative of such age Date of Birth Any other unique identifier - Specify: None of the identifiers listed above

Biometric Identifiers are observable biological characteristics which could be used to identify an individual, e.g., fingerprints, iris/retina patterns, and facial patterns.

*NOTE: If social security numbers will be collected, explain below why they are necessary and how they will be used:

D. Eligibility Criteria - Indicate the section of the research protocol that discusses the:

1. Inclusion Criteria:

2. Exclusion Criteria:

3. The process of assessing the subjects’ medical records and determination of eligibility for the research:

4. The process of documenting initial eligibility:

E. Equitable Selection of SubjectsFederal regulations require that the selection of research subjects be equitable in order for the IRB to approve the research. If a particular population will be excluded (for example: pregnant women or



non-English speaking subjects), you must JUSTIFY the exclusion of this population. NOTE: This question does not refer to research protocol exclusion criteria, unless entire populations are excluded (for example: if the research is targeting African Americans, Hispanics, or children).

No subjects will be excluded based upon sex, race/ethnic group, or religion. The following population of subjects will be excluded from the research:

Indicate the section of the research protocol that provides the justification for exclusion:

XI. Research Subject Population A. Subject Population

1. Requested total number of subjects/charts at JBVAMC & UIC : Note: The total number stated here will be the total number of approved subjects/charts and will appear in the approval letter. If you are only extracting and/or analyzing case data, and not recruiting subjects, this number will represent the number of cases or charts you are analyzing. This is a specific number and you must not exceed this number. To increase the approved sample size, an amendment must be submitted and IRB-approved prior to recruiting and consenting, or accessing the case data for, more than the approved number of subjects.

B. Age Range (check all that apply): Newborn to 17 years of age* - Complete Appendix B 18 - 64 Years 65+ Years

C. Indicate which populations below are the PRIMARY FOCUS of this research. Remember to take into account the location where the research will be conducted. Also note that additional information and/or safeguards will be required, as indicated below, when a subject population has been designated as vulnerable (with an asterisk *).

Check all that apply Adults: Healthy Subjects or Control Subjects Adults: Patient Subjects Minors *– Appendix B must be completed. Pregnant Women, Neonates, Fetuses/Fetal Tissue* – Appendix U must be completed Prisoners* – Appendix C must be included - Please note that certain types of research

with prisoners approvable under the federal regulations may not be allowed under Illinois state law including, but not limited to, biomedical research.

UIC Employees* Decisionally Impaired* - Appendix V must be completed Economically and/or Educationally Disadvantaged* Vulnerable to Coercion or Undue Influence* JBVAMC Other: specify

Please note the groups listed directly above marked with an asterisk (*), as well as subjects under the age of 18, are considered “vulnerable” and require special consideration by the federal regulatory agencies and/or by the UIC IRB.

D. The appropriate Appendices (as indicated above) must be attached to this application. When an appendix is not available for a vulnerable populations checked above, provide a rationale for their inclusion and what additional safeguards, if any, are in place to protect their rights and welfare:








XII. Reasonably Anticipated Risks and Benefits of the Research A. Indicate the section of the research protocol that identifies and discusses the reasonably

anticipated risks or discomforts that may result from participation in this research. As this research involves review of medical records, the potential for loss of privacy or confidentiality of health information should be listed as a risk within the research protocol.

B. Indicate the section of the research protocol that discusses how the knowledge gained from the study could produce a benefit to society or to others who share the same disorder or condition.

XIII. Research Procedures to Minimize RiskA. Indicate the section of the research protocol that describes the precautions taken to protect

the subjects’ privacy and confidentiality during research.

B. Data Security Measures. This section asks you to describe provisions you will make to maintain

the confidentiality of the research data.

1. Indicate the type of subject identifiers (identifiable elements) that will be linked to the research data (directly or indirectly via a code):

No subject identifiers will be maintained with the data (i.e., data are anonymous/permanently de-identified; no one, including the study team, can identify a subject from the data. None of the identifiers listed in X.C.3. is included).

Limited Data Set (Protected Health Information subject to the Privacy Rule that includes elements limited to city, state, ZIP Code, elements of date, and other numbers, characteristics, or codes not considered as direct identifiers). Requires a Data Use Agreement if investigator is outside the covered entity and data is being shared outside the entity.

Limited Data Set as described above without zip code and birth date (health information in this form negates the need for notification under the HITECH Act if a breach occurs). Requires a Data Use Agreement if investigator is outside the covered entity and data is being shared outside the entity.

UIC and/or outside agencies may require the use of a data transfer agreement that outlines the procedures necessary to protect identifiable or coded data that will be transferred or shared between agencies.

Indirectly with a code linked to the identity of the subject.* Indicate the section of the research protocol that describes the coding method, specifies who will have access to the code/master key, and how the code/master key will be


Coded data: data that has been stripped of direct identifiers, but a code was assigned so that the information could be linked back to an individual.

De-identified data: data has been stripped of all identifiers, so that the information could not be traced back to an individual.


protected against unauthorized access. The code/master key should be stored separately from study data.:

Directly, personal or private identifiers (identifiable elements) are maintained with the data.* Justify the inclusion of direct subject identifiers:

2. Will any identifiable data, or coded data where a master list to the codes exists, be stored for future use beyond the aims of this research or entered into an existing databank as a result of the research?

No

Yes - Complete and submit Appendix D2 with this application packet.

Note: A separate data/tissue repository/bank research protocol must be submitted for IRB review and approval if identifiable and/or coded data will be retained after the research has been completed.

3. Storage and Security Measures for Research Dataa. In what format will information be maintained (Please mark all that apply)?

Paper Electronic

Indicate how data will be stored and secured. Please mark all that apply.b. Electronic data. Please mark all that apply.

Not applicable De-identified data only (i.e., no personal identifiers, including 18 HIPAA identifiers, are

included with or linked to the data) Password access Coded, with a master list secured and kept separately

REDCap [define host CCTS/IHRP Other (define): ] Encryption software will be used. Specify encryption software: Secure network server will be used to store data. Specify secure server: Stand alone desktop/laptop computer will be used to store data Not connected to server/internet An organization outside of the UIC covered entity will store the code key. The

organization will have a business associate agreement with UIC. Other (specify):

c. Hardcopy data. Please mark all that apply.

Not applicable De-identified data only (i.e., no personal identifiers, including 18 HIPAA identifiers,

are included with or linked to the data) Coded data, a master list secured and kept separately. Locked file cabinet Locked office/lab Locked suite Other (specify):




d. Indicate below whether data will be hosted at any time, even temporarily, on electronic portable devices (e.g., laptops, PDAs, smart phones, mp3 players, external hard drives). Note: only the “minimum data necessary” should be stored on portable devices.

Personal or private identifiable data WILL NOT be stored on portable devices.

Personal or private identifiable data WILL be stored on portable devices. Note: PHI and sensitive identifiable data stored in this manner must be encrypted.1. Rationale for keeping personal or private identifiable data on electronic

portable devices:

e. Indicate the physical location of all storage devices containing data (specify):

4. Sharing of Research Dataa. Other than JBVAMC and/or UIC investigators and research staff noted on the protocol

application, indicate who will have access to the data during the course of the research study. (Check all that apply)

Not Applicable – Skip to item 5 Statistician. Specify: Colleagues (s) / Collaborators. Specify: Data Coordinating Center. Specify: Consultants. Specify: Data Repository(ies): Specify: Sponsor / Funding Agency. Specify: Other. Specify:

b. How the data will be shared or disclosed? Without any identifiers. With identifiers* With a linked code*

Identify who will have access to the code key or master list: Limited Data Set (requires a Data Use Agreement if investigator is outside the

covered entity and data is being shared outside the entity) Limited data set as described above without zip code and birth date (requires a Data

Use Agreement if investigator is outside the covered entity and data is being shared outside the entity)

c. Describe how data will be transferred (e.g. courier, mail) or transmitted electronically to prevent unauthorized access (check all that apply)

Overnight courier US Postal Service Transmitted over a secure network. Specify network: . Transmitted over a public network. PHI and sensitive identifiable data must be

encrypted. Specify encryption: Via e-mail. PHI and sensitive identifiable data must be encrypted.

Specify encryption: Secure File Transfer Protocol (sFTP). Specify: Other. Specify:

Note: Telefaxing of identifiable data is not generally allowed.

Please note: The UIC OPRS/IRB and Auditors from UIC or the State of Illinois always have the right to inspect research records for research conducted at UIC.



5. Describe the plans for destruction/removal of identifiers. (Identifiers should be removed at the earliest opportunity.)

Please note: The destruction of VA data (including VA identifiers) is prohibited as per the record retention schedule.

End of study years after study completion Other (specify)

Consider the following when answering item 5: If VA research, destruction of identifiers is prohibited. Investigator must adhere to sponsor requirements or procedures outlined in the grant,

if applicable.

C. Indicate the location within the research protocol that describes the Data and Safety Monitoring plan/measures. Please note that this is required for JBVAMC research.

XIV. Request for Waiver of ConsentA. Indicate the types of waiver of informed consent under 38 CFR 16.116(d) and/or 45 CFR 46.116

(d) to be used in the research. Waiver of informed consent is not being requested. Waiver of Informed Consent Waiver of Parental Permission* - Requires Appendix B Waiver of Assent* - Requires Appendix B

In order to apply for a waiver of consent, you must provide protocol specific justification for the four following criteria. Refer to the UIC OPRS Guidance for Investigators – Informed Consent for example responses. B. Criteria for the Waiver of Informed Consent

1. Please provide a written explanation as to why you believe the proposed research will present no more than minimal risk to the subjects who participate:

2. Please explain whether or not a waiver of informed consent would adversely affect the rights and welfare of subjects:

3. Please explain whether or not it would be possible to conduct this research without a waiver of informed consent:

4. Please explain your plans, when appropriate, for providing any pertinent information to the subjects at a later date (e.g., after their participation in the study):

XV. HIPAA Compliance/Waiver of Authorization of 14 OVCR Document #0962





A. Indicate the types of waiver of authorization under 45 CFR 164.512(i)(1)(i) to be used in the research.

Waiver of authorization is not being requested. Waiver of Authorization

B. Describe the identifiable health information that will be accessed under this waiver.

C. Criteria for Waiver of Authorization

1. Explain how the use and disclosure of the information presents no more than minimal risk to the privacy of the individual.

2. Describe the plan to protect the identifiers from improper use and disclosure (i.e., where will

the identifiers will be stored and who will have access).

3. Describe the plan to destroy the identifiers at the earliest opportunity consistent with the

conduct of the research. If such a plan is not in place, please provide a health or research justification for retaining identifiers or explain whether such retention is required by law.

4. Explain why the research would be so difficult as to be nearly impossible to conduct without the

waiver of authorization.

5. Explain why the research could not be conducted without access to and use of the PHI.

6. The PHI being requested is the minimum information necessary to accomplish the objectives of

the proposed research.

Yes

No – Explain: 7. I certify that the information obtained as part of this research (including PHI) will not be reused

or disclosed to any other person or entity other than those identified on this form, except as required by law. Reuse of this information for other purposes or disclosure of the information to other individuals or entities will not occur without first seeking approval by the UIC IRB.

Yes

No – Explain:

8. Confirm that the documentation of waiver approval will be maintained for 6 years following study completion to conform to the HIPAA regulation’s accounting requirements related to a waiver of authorization [Privacy Rule, 45 CFR Part 164].

Yes

No – Explain:



XVI. CONTACT INFORMATIONA. Who should be the primary person contacted (for example, Research Coordinator) by OPRS if

further information about this protocol is needed? This person may be someone other than the PI or other individuals listed as key research personnel (i.e., Administrative Coordinator).

Name (Last, First)

Title

E-mail Address

Date

Phone Number

Fax Number

B. Do you wish to grant this individual RiSCWeb access to this research protocol? Yes. No.

C. Have you used any services provided by the UIC Center for Clinical and Translational Science (CCTS) on this protocol?

Yes. No.

D. Would you like to give the CCTS coordinators access to this protocol in RiSCWeb for tracking and facilitation purposes?

Yes. No.



XVII. ASSURANCES INVESTIGATOR ASSURANCEI certify that the information provided in this application is complete and correct. I understand that as Principal Investigator, I am ultimately responsible for the protection of the rights and welfare of human subjects and the ethical performance of the research. I agree to comply with all applicable JBVAMC and/or UIC policies and procedures, and applicable federal, state and local laws. I also agree to the following:

The research will only be performed by qualified personnel as specified in the approved research application and/or protocol;

No changes will be made to the research protocol (except when necessary to eliminate apparent immediate hazards to the subject), or the consent process without prior approval by the UIC IRB;

Unanticipated problems involving risks to subjects or others (including adverse events), other reportable events, and subject complaints will be reported to the UIC IRB in a timely manner;

All research staff that are involved in the research will comply with the HIPAA regulations. Further, I assure that all research staff will have completed the JBVAMC and/or UIC HIPAA research training requirement prior to research participation. I agree that any breach or suspected breach of confidentiality (data security) meeting the definition of an unanticipated problem will be promptly reported to the IRB. I also agree that any breach or suspected breach involving UIC PHI in the custody of the principal investigator, co-investigator(s), research staff, students, or business associate will be immediately reported to the HIPAA Privacy Officer: (312) 355-5650 [email protected]. I assure that the information obtained as part of this research (including protected health information) will not be reused or disclosed to any other person or entity other than those identified on this form, except as required by law. If at any time I want to reuse this information for other purposes or disclose the information to other individuals or entities I will seek approval by the UIC IRB.

I certify that I have completed the required educational program on ethical principles and regulatory requirements in Human Subject Protections. I further certify that the proposed research is not currently underway and will not begin until IRB approval has been obtained.

Principal Investigator Signature _____________________________________DATE____________________

Name printed: _________________________________________________

FACULTY SPONSOR* ASSURANCE*The faculty sponsor must be a member of the JBVAMC and/or UIC faculty. The faculty member is considered the responsible party for legal and ethical performance of the project.By my signature as sponsor on this research application, I certify that the student, fellow, or resident is knowledgeable about the regulations and policies governing research with human subjects and has sufficient training and experience to conduct this particular study in accord with the approved protocol.In addition,

I agree to meet with the investigator on a regular basis to monitor study progress, Should problems arise during the course of the study, I agree to be available, personally, to supervise the

investigator in solving them, I will ensure that the Principal Investigator promptly reports unanticipated problems involving risks to subjects or

others (including adverse events), other reportable events, and subject complaints to the UIC IRB in a timely manner,

If I will be unavailable, as when on sabbatical leave or vacation, I will arrange for an alternate faculty sponsor to assume responsibility during my absence and I will advise the UIC IRB by letter of such arrangements, and

I insure that the investigator has completed the required educational program on ethical principles and regulatory requirements and will complete all required continuing education.

I further certify that the proposed research is not currently underway and will not begin until approval has been obtained from all the appropriate committees.

I will ensure that the Principal Investigator submits a Final Report upon completion of the research. In the event that the Principal Investigator is unable to do so, I accept the ultimate responsibility for submission of the Final Report closing the research study.

Faculty Sponsor Signature_______________________________________Date______________

Name printed: _________________________________________________


mailto:[email protected]


DEPARTMENT HEAD* SIGNATURE*If the Department Head is the Principal Investigator or any of the Co-Investigators, the Department Head’s superior (for example: Dean), must sign in place of the Department Head.As department head (or signatory official), I acknowledge that this research is in keeping with the standards set by our department and I insure that the Principal Investigator has met all departmental requirements for review and approval of this research. By my signature as department head (or signatory official) on this research application, I certify that the Principal Investigator has the training and expertise to conduct research at JBVAMC and/or UIC, that the research meets the standards of the specific discipline, as well as the standards and guidelines of any relevant professional organizations, societies, or licensing bodies, and sufficient resources available to carry out the research.

Department Head Signature_______________________________________________________Date___________

Name printed:________________________________________________________________


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