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UNIVERSITY OF MISSOURI CAMPUS

INSTITUTIONAL REVIEW BOARD

IRB Basics

Presenter: Janelle Greening, M.B.A., C.I.P. Compliance OfficerRevised: July 2011

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CAMPUS IRB WEBSITES Campus IRB Website:

www.research.missouri.edu/cirb

Online Electronic System:http://irb.missouri.edu/eirb MU faculty, staff and students can login without

creating an account.

Location: 485 McReynolds Hall

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IRB CERTIFICATION

www.citiprogram.org Create an Account Associate with UMC Campus SBR – User Group Basic Course: Select “Human Subject

Research Course” Refresher Course

Training is active for two years.

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JOIN OUR LISTSERV Up-to-date IRB information Changes to policies and procedures Training opportunities Send an e-mail to

listserv@po.missouri.edu and putting “SUBSCRIBE CIRB” in the body of the email

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STAFF MEMBERS: YOUR RESOURCE

Michele Kennett, Director Janelle Greening, Compliance Officer Compliance Specialists:

Erin BryantMelissa FreemanChristie GehaDenise Harrington

Campus IRB Phone Number: 882-9585

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TOPICS TO COVER IRB Functions Ethical

Principles Federal

Definitions 3 Levels of

Review Special

Categories of Research

Vulnerable Subjects

Recruitment Process

Informed Consent Investigator

Reporting Requirements

IRB Forms Criteria for

Approval

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TODAY’S OBJECTIVES

1. Basic understanding of the federal regulations governing human subject research

2. Basic understanding the federal definition of “human subject” and “research”

3. Understanding the importance of informed consent and respect for persons

4. Knowing your reporting responsibilities

5. Maintaining appropriate oversight of your research

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PURPOSE

1.Safeguard human subject research participants in accordance with the DHHS federal regulations 45 CFR 46

2.Comply with the ethical principles outlined in the Belmont Report, released in 1979

3.Comply with MU Institutional Policy Chapter 410: Research Involving Humans

4.Comply with the Federalwide Assurance Agreement

5.Comply with State or Local laws which provide additional protections for human subjects

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IRB FUNCTIONS AND OPERATIONS

Protect the rights and welfare of human subjects

Review, approve, require modifications, or disapprove all research activities involving human subjects

Approve changes in previously approved research (adding/removing components)

Provide continuing review of all humans subject research activities

Any other steps necessary to protect the human subject participants

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ETHICAL PRINCIPLES

Belmont Report: 1) A statement of the basic ethical

principles to be used to resolve ethical problems that surround the conduct of research with human subjects

2) Identifies three basic principles for conducting research with human subjects

3) Provides a foundation for the federal regulations

4) MU must comply with the Belmont Report as outlined in our Federalwide Assurance Agreement

5) Focus on what is right or wrong

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CAMPUS IRB MEMBERSHIP

At least 5 members Diverse membership

1 non-affiliated member1 scientific member1 non-scientific member

Adequate expertise Consultants, if necessary

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RESPECT FOR PERSONS Recognition of personal dignity and

autonomy of individualsCreate a meaningful consent processProvide subjects with all necessary

information to make a decision to participate

Allow subjects to withdraw without penalty or adverse consequences

Demands that subjects enter into the research voluntarily and with adequate information

Persons with diminished autonomy are entitled to protection

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BENEFICENCE Minimize risks of harm and maximize

the potential benefits Ensure the benefits justify the risks of

harm Risks may include:

PhysicalPsychologicalLegalSocialEconomic

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JUSTICE Fair procedures and outcomes in the selection of

research subjects Selection of research subjects needs to be

scrutinized in order to determine whether some classes are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied.

Participants should not be selected for research solely because: they are available; vulnerable; or they cannot say no

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ACCOUNTABILITY Institution Investigator IRB

We are all accountable for a successful local human subject protection program

Each is expected to play a role

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FEDERALWIDE ASSURANCE

A contractual agreement between MU and OHRP which guarantees this institution’s commitment that all human subject research complies with the regulations protecting human subject participants.

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FEDERAL DEFINITIONS

1) Research2) Human Subject3) Minimal Risk

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RESEARCH A systematic investigation, including research development,

testing and evaluation, designed to develop or contribute to generalizable knowledge

Internal MU Definitions: Systematic Investigation: A "systematic investigation" is an

activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question.

Generalizable Knowledge: Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program (e.g., publications or presentations.) However, research results do not have to be published or presented to qualify the experiment or data gathering as research. The intent to contribute to "generalizable (scholarly) knowledge" makes an experiment or data collection research, regardless of publication.

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HUMAN SUBJECT A living individual about whom an

investigator obtains:Data through intervention or interactions

with the individual; OR Identifiable private information

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HUMAN SUBJECT CONTINUED

Intervention: Includes both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes

Interaction: Includes communication or interpersonal contact between investigator and subject

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PRIVATE INFORMATION Includes information about behavior that

occurs in a context in which: An individual can reasonably expect:

That no observation or recording is taking place, AND The information will not be made public.

Private information must be individually identifiable (i.e. the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

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MINIMAL RISK The probability and magnitude of harm

or discomfort anticipated in the research are not greater in and of themselves than those encountered in daily life or during the performance of routine physical or psychological examinations or tests.

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3 LEVELS OF IRB REVIEW

1. Exempt2. Expedited3. Full Board

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EXEMPT Determination must come from the IRB Projects involving minimal risk Must fall under 1 of the 6 categories in the

federal regulations 45 CFR 46 Cannot involve prisoners or children

Investigators must complete the Exempt Application for initial review Modifications: Exempt Amendment Form Continuing Review: Annual Exempt

Certification Form Complete Applications: ~1 business day turnaround

time

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EXEMPT CATEGORIES1. Research conducted in established or commonly

accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

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EXEMPT CATEGORIES CONT…

3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

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EXEMPT CATEGORIES CONT…

5. Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

6. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

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EXPEDITED Projects involving minimal risk Minor changes to approved research Must fall under 1 of the 7 categories of

initial review or 1 of the 2 categories of continuing review

Investigators must complete the Expedited/Full Board Application for initial review Modifications: Amendment Form Continuing Review: Continuing Review

Status Report Complete Applications: ~5-10 business day

turnaround time

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FULL BOARD Projects not meeting the criteria for

Exempt or Expedited review Projects involving greater than minimal

risk

Investigators must complete the Expedited/Full Board Application for initial review Modifications: Amendment Form Continuing Review: Continuing Review Status

Report Deadline: 1st of every month or the following business

day

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CONTINUING REVIEW 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.

PURPOSE: Ensure the research remains justified and the rights and welfare of the participants continue to be fully protected.

Failure to provide the annual report could lead to study suspension, a loss of funding and/or publication possibilities, or reporting of noncompliance to sponsors or funding agencies.

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SPECIAL CATEGORIES OF RESEARCH TO DISCUSS

Internet Research International Research Ethnographic Research Survey Research Qualitative Research Collaborative Research Deception Studies

Any others you would like to discuss?

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RESEARCH THAT MAY NOT BE SUBJECT TO IRB REVIEW Research using de-identified secondary

datasets Quality improvement/program evaluation

only studies Classroom research only submitted for a

grade – not disseminated outside the classroom

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VULNERABLE POPULATIONS Vulnerable as defined by the federal

regulationsPregnant Women: 45 CFR 46.201Prisoners: 45 CFR 46.301Children: 45 CFR 46.401Wards: 45 CFR 46.409

Possible other vulnerable subjectsStudentsLow-IncomeEmployeesElderly

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PRISONERS Constraints could affect their ability to

make a truly voluntary and uncoerced decision whether or not to participate

Prisoner representative will review the study

Must fall under one of the categories for research involving prisoners

Parole boards will not take into account a prisoner’s participation in research

Additional duties of IRBs where prisoners are involved

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CHILDREN Research must fall under one of the

four categories for research involving children

Cannot be Exempt Child assent and parental permission

must be obtained unless waived Describe for the IRB how child assent

will be documented if not written

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WARDS Greater than minimal risk studies

where there is no direct benefit:Research is related to their status as

wards; orConducted in schools, camps, hospitals,

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

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OTHER VULNERABLE POPULATIONS Students: Extra/Course Credit,

Instructor initiated studies (Undue Influence)

Non-English Speaking: Comprehension Low-Income: Monetary incentives Elderly: Comprehension, Capability to

consent Employees: Employability risks

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SUBJECT RECRUITMENT

The four Cs of Recruitment from an IRB perspective

1. Consent (ongoing)2. Coercion3. Confidentiality and Privacy4. Completeness (accuracy as well as

truthfulness versus deception)

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ADVERTISEMENTS The advertisement is limited to the

information the prospective subjects need to determine their eligibility and interest, such as: The name and address of the investigator or

research facility The condition under study or the purpose of the

research In summary form, the criteria that will be used to

determine eligibility for the study A brief list of participation benefits, if any The time or other commitment required of the

subjects The location of the research and the person or

office to contact for further information

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COMPENSATION Describe the amount, method, and timing of

disbursement Compensation is not contingent upon

completing the entire study Any amount of compensation as a bonus for

completion is reasonable and not so large as to unduly induce subjects to stay in the study when they would otherwise have withdrawn

Course/Extra Credit:  The alternative assignment is comparable in time and effort

Accounting Services Approval is required when the investigator proposes to use internal or external funding, and offering cash or non-cash items to their subjects

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INFORMED CONSENT

Informed consent is a process that enables persons to voluntarily decide whether or not to participate as a research subject

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RESPECT FOR PERSONS Consent is a fundamental mechanism to

ensure the basic ethical principle of respect for persons is met through a provisional process of thoughtful consent for a voluntary act.

Consent is a procedure designed to educate the subject population in terms that they can understand.

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ISSUES TO CONSIDER Who is obtaining consent and do they have

proper training and oversight? Is it coercive? Is it voluntary? Does the subject have time to consider

participation? Does the subject understand the alternatives? Do they have the legal and mental capacity to

consent or is a Legally Authorized Representative required to consent on their behalf?

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BASIC ELEMENTS OF CONSENT

(1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;

(2) A description of any reasonably foreseeable risks or discomforts to the subject;

(3) A description of any benefits to the subject or to others which may reasonably be expected from the research;

(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

(5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

(6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;

(7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and

(8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

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ADDITIONAL ELEMENTS OF CONSENT (1) A statement that the particular treatment or procedure

may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;

(2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;

(3) Any additional costs to the subject that may result from participation in the research;

(4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;

(5) A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and

(6) The approximate number of subjects involved in the study.

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TYPES OF CONSENT Written Consent Short Form Waiver of Documentation (no signature) Waiver of Consent

A copy of the consent document must be provided to the subject unless waived by the IRB

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SHORT FORM For the occasional and unanticipated non-English-

speaking subject, an alternative "short form" method is allowed

Used because no consent form in the subject's language was prepared

Routine use of the "short form" for obtaining informed consent is strongly discouraged

The short form consent process cannot be used for vulnerable subject populations

There will be a witness to the oral presentation Contact the IRB for additional requirements

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CRITERIA FOR WAIVERS Waiver or Alteration of

Consent

No more than minimal risk to subjects

Would not adversely affect the rights and welfare of subjects

Could not practicably be carried out without the waiver or alteration; and

When appropriate, debriefing session is available

Waiver of Documentation

 That the only record linking the subject and the research would be the consent document and the principal risk would be 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; or

 That 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 context.

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COMPREHENSION/READABILITY

Does the subject understand the information provided?

It is your responsibility to enhance each subject’s comprehension of the information

Avoid complex terms and sentences No exculpatory language (waiving legal

rights) The investigator must consider:

The nature of the subject population The type of information conveyed The circumstances under which the consent

process will take place The primary language of the participant

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TEMPLATE LANGUAGE Contact our office for template

language:Certificates of confidentialityUse of electrodesStudies involving alcohol consumption IRB contact information Injury statement (greater than minimal risk

studies)Etc.

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NON-ENGLISH SPEAKING Translated documents shall be prepared after

IRB review and approval of the English version

Minimal Risk Studies: The qualifications of the individual performing the translation will be assessed by the IRB. A letter from the translator describing their qualifications must be provided with the translation documents.

Greater than Minimal Risk Studies: A certified translation is one that has been formally verified by a licensed translator or translation company for use in official purposes.

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PARENTAL AND YOUTH ASSENT

The parental consent process must contain all elements of consent unless a waiver is approved by the IRB

Consent may need to be obtained from one or two parents (greater than minimal risk studies with no direct benefit)

The IRB shall determine that adequate provisions are made for soliciting the assent of children. Are the children capable of providing assent? Is a waiver appropriate? Take into consideration age, maturity, and

psychological state

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CONSENT APPROVALS The Campus IRB will save a revised

copy of your consent document(s) to the document storage of eIRB. We will place a footer in the document with the approval date and IRB number.

You must use this copy when obtaining consent.

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INVESTIGATOR REPORTING RESPONSIBILITIES

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REPORTING REQUIREMENTS

Changes Deviations Unanticipated Problems Conflicts of Interest Subject Complaints Known or suspected noncompliance Funding Source / Personnel changes Suspension or closure of approved projects

Any issue that arises that could impact the adequate protection of human subjects involved in research

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CAMPUS IRB FORMS

Located at: http://irb.missouri.edu/eirb

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CAMPUS IRB FORMS Exempt Application Expedited/Full Board Application Exempt Amendment Amendment Form (Expedited/Full

Board) Annual Exempt Certification Form Continuing Review Status Report Event Form Site Additions Form Project Personnel Change Form Completion/Withdrawal Report

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SUPPORTIVE DOCUMENTATION Exempt Research:

Permission LettersAccounting ServicesCover LetterFunding ProposalInstruments

Interview Questions Survey Questions Focus Group Questions

Information provided to subjects about the research

Expedited & Full Board Research:Permission LettersRecruitment

MaterialsConsent DocumentsAccounting ServicesInstrumentsFunding ProposalsAny other documents

to support the research application

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DOCUMENT STORAGE: NEW FEATURE

The IRB now marks approved documents.

You must use the documents we mark approved in document storage.

Go to the upper right hand corner and select approved documents from the drop-down list.

Use the IRB approved consent documents stamped with our approval footer

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DATA STORAGE The research plan makes adequate

provision for monitoring the data collected to ensure the safety of the subjects

There also must be adequate provisions to protect the privacy of subjects and to maintain the confidentiality of the data.

All research records must be retained for at least seven years after completion of the research InspectionCopying

Records must be retained at MU

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CRITERIA FOR IRB APPROVAL OF

RESEARCH1. Risks to subjects are minimized2. Risks to subjects are reasonable in relation

to anticipated benefits3. Selection of subjects is equitable4. Informed consent will be sought from each

prospective subjects5. Informed consent will be appropriately

documented6. When appropriate, the research plan makes

adequate provisions for monitoring the data collected to ensure the safety of the subject

7. When appropriate, the research plan makes adequate provisions to protect the privacy of subjects and to maintain confidentiality

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CONCLUSIONEvery effort must be made to protect human subjects from harm.