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Institutional Review Board

“The Institutional Review Board (IRB) also known as an Independent Ethics Committee (IEC), Ethical Review Board (ERB), or Research Ethics Board (REB), is a kind of committee that applies research ethics by evaluating the methods used for research to ensure that they are ethical.

These boards are formally designated for the acceptance (or rejection), monitoring and review of human biomedical and behavioral studies.

What is Institutional Review Board?

The Institutional Review Board ( IRB) is an administrative body set up to protect the rights and health of human research subjects recruited to participate in research activities carried out under the auspices of the institution it is associated with.

They also perform some form of risk-benefit analysis in an attempt to decide whether research should be carried out or not.

The goal of the IRB is to ensure that adequate measures are taken to protect the rights and welfare of the participating human beings as subjects in a research study.

Most developing countries, along with developed countries, have established national, regional, or local IRBs to safeguard ethical conduct of research on national and international norms, laws, or codes.

The IRB is concerned with safeguarding human subjects’ health, freedoms and privacy.

The IRB has the authority to approve, oppose, track and mandate changes in all research activities falling under its jurisdiction as defined by both the federal regulations and institutional policies.

IRB Committee Membership

Composition of IRB

  1. Each IRB Committee will be composed of at least five members with varying experience and expertise to provide a thorough and comprehensive review of the institution’s common research activities.
  2. IRB membership must be sufficiently eligible through its members ‘experience and skills and the diversity of its members, including consideration of race, gender, and cultural backgrounds and responsiveness to issues such as community attitudes, to promote respect for its advice and advice in safeguarding human research subjects’ rights and welfare.
  3. Each IRB committee includes persons able to establish the acceptability of the proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice.
  4. Each IRB committee includes members of more than one profession.
  5. Each IRB committee includes at least one member representing the viewpoint of the participants in the research.
  6. Each IRB committee includes at least one member whose primary concern is in scientific areas, and at least one member whose primary concern is in non-scientific areas.
  7. Each IRB committee includes at least one member who is not otherwise affiliated with the University of Pittsburgh, UPMC, CHP, UPMC Cancer Centers, or Magee, and who is not part of the immediate family of a person with such affiliation (i.e., “unaffiliated member”).
  8. Regardless of the level of risk associated with the protocol, research organized by the national Institute for Disability, Independent Living and Recovery Research that specifically includes the inclusion of children with disabilities or people with mental disabilities must be examined by at least one individual who is primarily concerned with the welfare of these research subjects.

This representative must have the necessary scientific or academic expertise to serve in that role. If this is a full board review a committee member may act as a primary or secondary reviewer in this capacity.

In the absence of a suitable reviewer, the IRB may appoint a consultant to act in this position. This will be recorded in Full Board RRC generated minutes.

If the study meets an expedited review category, an suitable consultant will review the protocol. This will be documented on the Documentation Form generated by the EERRC.

Appointment of IRB Members

Institutional Official (IO) shall make appointments of voting members of the IRB Committee. Recommendations for board members may be provided by either the IRB Chair or Associate Director to the IO on the basis of the IRB Committee’s specific needs.

  • The IRB Chair or his nominee requests recommendations from the Division Chiefs and Department Chairs for faculty volunteers as needed based on factors including, but not limited to, the size, skills and experience needed of the committee; knowledge of the interest of the individual; recommendations of institutional leadership; and/or investigators involved in research studies currently or previously approved by the IRB.
  • The IRB Chair or his designee reviews the membership rosters and recommends appointment by the Institutional Official of potential non-scientific and/or non-affiliated members to the IRB based on the considerations including, but not limited to: required committee composition, expertise and experience, knowledge of the individual’s interest, recommendations of current or past non-scientific and/or non-affiliated members, and individuals recruited from disease-related organizations or groups.
  • The IRB Chair and Associate Director must review the CV and demographic sheet for each new member on the IRB rosters for educational background, work history, and current vocation to assess the status of the member (i.e., scientific versus non-scientific, associated versus non-affiliated)

Term of Service

Committee members are primarily appointed to a term of three years. Committee members may be requested to accept reappointment to the IRB for an additional term of three years at the caution of the Chair.

A determination regarding an additional reappointment period will be made at the end of the six-year term. If a member declines full membership, he / she may be asked to become a member alternate.

An updated CV and demographic sheet will be requested from the reappointed members.

Compensation of IRB Members

Representatives of the associated IRB Committee will not receive any direct monetary compensation for membership in the body. Unaffiliated members of the IRB Committee will be reimbursed for internet access at an rate not to exceed $50 a month. Refund payments are to be made on a quarterly basis.

Indemnification

University Policy 07-06-06 sets forth the conditions under which indemnification and legal defense may be available to faculty and staff.

University Policy 07-06-07 sets forth the conditions under which indemnification and legal defense may be available to volunteers at the University. Indemnification may be afforded to the IRB members as set forth in these policies.

Responsibilities of IRB Members

General Responsibilities of all IRB Members include:

  • Reviewing research study proposals and then evaluating them from the perspective of the regulatory criteria for approval addressed under 45 CFR 46.111, 21 CFR 56.111 (if applicable); and any other relevant ethical, scientific or compliance considerations;

  • Reviewing and evaluating informed consent documents from the perspective of addressing the necessary and additional elements of informed consent described under 45 CFR 46.116, 21 CFR 50.20 (if applicable) and any other related ethical or regulatory considerations;

  • Attending at least 70 percent of IRB meetings in person, unless challenging circumstances prevent such attendance from occasional occasions, reporting promptly at the time specified to convene the meeting; and remaining at the meeting until the full agenda has been addressed:

  • Participating in IRB meetings on problems associated in the planned study studies and relevant informed consent documents, and making suggestions for risk management and enhancement of informed consent process and otherwise enhancement of the security of human subjects;

  • Voting for full approval, approval subject to modification(s), reconsideration, or disapproval of the human subject research as outlined in Chapter;

  • Evaluating the risk level (i.e., minimal or greater than minimal) of the proposed research. In performing this evaluation, IRB members will use the following absolute definition for “minimal risk” at 45 CFR 46.102(i) unless the research is directed at prisoner-subjects:
  • “Low risk means that the probability and severity of harm or discomfort expected in the study is not greater in and of itself than those typically experienced in everyday life ( i.e., in the general population) or during regular physical or psychological exams or tests.”

  • Deciding, for the research studies of greater than minimal risk, if IRB continuing review of the research is justified on a more frequent basis than the requisite annual review. In making this determination, IRB members will follow the procedure outlined in Chapter;

  • Deciding, where the informed consent process and/or other aspects of the research study should be audited by the ORP Education and Compliance Office of the University of Pittsburgh for research studies involving greater than minimal risk, difficulty or conflict of interest concerns;

  • Deciding, for the research studies involving an unapproved device, if the device and its proposed use represent a non-significant or significant risk to research subjects;

  • Deciding, for research studies subject to IRB continuation approval, if verification from sources other than the investigator is needed that there have been no material changes since the previous IRB review using the criteria outlined in Chapter 12;

  • Recommending improvements to the IRB policies and procedures so as to improve IRB review process and/or human subject protections;

  • Informing the IRB Chair or an IRB Vice Chair of human subject research noncompliance problems or ethical issues of which they become aware;

  • Conforming their behavior in compliance with the legal and ethical principles approved by the IRB at all times; including, but not limited to, upholding the confidentiality / non-disclosure of human subject work submitted for review and approval by the IRB, and engaging in good faith discussions by the IRB without indication of discrimination or conflict of interest.

The IRB must have at least five members with varying histories to provide a complete and accurate analysis of human research and its administrative , legal, scientific, and social implications.

The board will also have at least one non-institutionally associated member and one non-scientist Independent review of clinical research by IRB is required for US studies funded by the Department of Health and Human Services (DHHS) and other US federal agencies, as well as for research testing interventions—such as drugs, biologics, and devices—that are under the jurisdiction of the US Food and Drug Administration (FDA) (Table)

Regulation   Requirements
Membership (45CFR.46 107; 21CFR.56.107)At least 5 members of varying backgrounds, both sexes, and > 1 profession  

At least 1 scientific member, 1 nonscientific member, and 1 unaffiliated member  

Members sufficiently qualified through diverse experience and expertise to safeguard subjects’ rights and welfare and to evaluate research acceptability related to laws, regulations, institutional commitments, and professional standards

At least 1 member knowledgeable about any regularly researched vulnerable groups

Members report and recusal for conflicts of interest Ad hoc experts as needed
Functions/operations (45CFR.46 108; 21CFR.56.108)Follow written procedures for initial and continuing review and for any changes and amendments  

Written procedures for reporting unanticipated problems, risks, and noncompliance Quorum of majority at convened meetings. Approval requires majority vote
Review (45CFR.46 109; 21CFR.56.109)  Authority to approve, require modifications of, or disapprove research

Require informed consent and documentation (or approve a waiver1)

Notify investigators in writing

At least annual continuing review
Criteria for approval (45CFR.46 111; 21CFR.56.111)IRB should determine that risks are minimized; risks are reasonable in relation to anticipated benefits, if any, and the importance of the expected knowledge; subject selection is equitable and attention to vulnerable populations; informed consent will be sought and documented; adequate provisions for monitoring; adequate provisions to protect confidentiality; additional safeguards for subjects vulnerable to coercion or undue influence
Authority (45CFR.46. 113; 21CFR.56.113)Institutional officials cannot approve research that is disapproved by the IRB (45CFR.46 only)
The IRB can suspend or terminate research for serious harm or noncompliance
Records (45CFR.46. 115, 21CFR.56.115)Records of research proposals, meetings, actions, correspondence, members, and so forth

CFR = Code of Federal Regulations

Where Does an IRB Get Its Authority?

In 1974, the Department of Health Education and Welfare instituted the regulations that formed the IRB for the protection of human subjects. IRBs are managed at state level by the Office for the Protection of Human Studies, an agency of the Department of Health and Human Services(OHRP).

OHRP supports IRBs in their work and receives allegations of inappropriate research practices and investigates them.

The institution served by the IRB offers administrative support for its operations including the appointment of an person to supervise research and IRB functions within the institution.

The organization also files a “Assurance” with the federal government, explaining the protocols and instructions to be followed by the IRB.

What is an “assurance” or a “multiple project assurance?”

An “assurance,” is a contract signed in compliance with HHS regulations between an entity and Department of Health and Human Services (HHS).

Of work involving human subjects performed by HHS or funded in full or in part by HHS, the HHS regulations include the performance site institution’s written guarantee that the institution will comply with the HHS regulations on the security of human subjects[45 CFR part 46].

The assurance mechanism is described in 45 CFR 46.103. Once an institution’s assurance has been approved by the HHS, a number is assigned to the assurance.

Assurance can be for a single grant or contract (“single project assurance”); multiple grants (“multiple project assurances”-commonly known as “general assurances”); or for other forms of projects, such as oncology group studies and AIDS research group studies (“cooperative project assurances”).

The Office for Human Research Protection (OHRP) is responsible for implementing the HHS regulations.

Is an “assurance” required by FDA?

At present, FDA regulations do not require an assurance. FDA regulations [21 CFR parts 50 and 56] apply to the research involving products regulated by FDA – federal funds and/or support do not need to be involved for the FDA regulations to apply.

When research studies connecting products regulated by FDA are funded/supported by HHS, the research institution must comply with both the HHS and FDA regulations. [A table of significant differences between 45 CFR Part 46, Subpart A and 21 CFR Parts 50 and 56 is available on the FDA website.]

What Kind of Research Projects Do IRBs Review?

IRBs are responsible for reviewing all federally funded research projects involving human subjects with a few exceptions ( e.g., evaluations of documents or surveys in which subjects cannot be identified individually or where exposure of the responses of respondents does not put them at risk of criminal or civil liability and does not affect participants financially, professionally or socially).

On the other hand, based on the procedures set forth in the Institutional Assurance, the IRB may review all the research projects, regardless of the source of funding.

How Does an IRB Make Its Decisions?

Before an investigator can receive federal funds in order to conduct a research project, the protocol (research procedures) is reviewed by the IRB.

The researcher provides the IRB with all the necessary materials for conducting its review, including a full description of the proposed project, materials that will be used by the subjects (surveys, question, tests, etc.),), a description of how the subjects will be recruited and consent to participate in the project (including a consent form), and how confidentiality of the subjects will be maintained.

The IRB analyses all of these materials to determine if there is sufficient protection for the research participants. Consideration by the IRB is largely focused on assessing the research’s costs and benefits.

Risks may be physical , social, psychological or economic. Benefits include both those for the individual person in the study and for the whole of society.

The IRB also considers the population being studied — Does it require additional protections? Would this population assess the risks and the benefits differently?

What Does An IRB Do After Reviewing the Project?

After evaluating the materials that the researcher offers to the IRB, they have to decide if the research ‘s benefits have been maximized and the risks minimized, and make a final decision as to whether the benefits justify the risks to the subject.

If the IRB considers this to be the case, then the protocol can be accepted. Alternatively, the IRB may demand that the researcher make specific methodological changes and approve the protocol based on those changes, or recommend revision and re-submission of the protocol.

The IRB can ultimately decide to disapprove of the proposal. Institutional officials may reject IRB-approved research protocols but may not grant approval for research projects that have been disapproved by the IRB.

In addition to evaluating new research procedures, IRBs are also monitoring existing programs or those that have process changes. Continuing projects are reviewed yearly (or more often if the IRB feels it is necessary).

How Does an IRB Protect Special Populations?

The Code of Federal Regulations requires IRBs to give special consideration to several classes of subjects: children, prisoners, pregnant women, mentally disabled people and economically or educationally disadvantaged people.

There are a number of ways the IRB carries out this charge. In certain cases, work with such subjects will only be accepted by the IRB when it requires minimal risk or when the benefits relate directly to the subject.

Furthermore, if the IRB regularly examines procedures that include one of the special groups, they might have a community member whose main concerns are in one of those groups.

Who has Access to IRB Records?

The institution and the IRB maintain records of IRB practices including copies of the checked work procedures, minutes of meetings, and correspondence. All documents must be made accessible by OHRP for analysis.”

References:
https://www.apa.org/advocacy/research/defending-research/review-boards
https://research.oregonstate.edu/irb/frequently-asked-questions/what-institutional-review-board-irb
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/institutional-review-boards-frequently-asked-questions#IRBOr
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4631034/



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