600. Evaluation of IRB Membership and Selection of Reviewers

Updated July 14, 2021

Experience and expertise of IRB members, and diversity of IRB membership are necessary to ensure the IRB is sufficiently qualified to promote respect for its advice and counsel in safeguarding the rights and welfare of research participants.

Evaluation of IRB Roster

The Research Integrity Director and IRB Chair review the roster annually to identify needs and opportunities and confirm compliance with regulatory and policy requirements. When warranted, Research Integrity staff may notify the Director or Chair of representation needs suggested by current trends in research submissions.

When evaluating IRB membership, the Research Integrity Director and Chair assess for the required diversity and consider the following:

• type of research reviewed by the University IRB;
• race and cultural backgrounds;
• sensitivity towards community attitudes; and
• knowledge about institutional commitments and policies, applicable laws, and standards of professional conduct and practice.

After assessing the needs of the IRB, the Research Integrity Director or IRB Chair may ask for recommendations for volunteers from:

• department chairs, deans or other responsible officials,
• institutional leadership,
• Faculty Senate, and
• investigators involved in research studies currently or previously approved by the IRB.

Selection of Meeting Attendees and Primary and Expedited Reviewers

Research Integrity staff use the information in the Office for Human Research Protections (OHRP) IRB roster to assess member qualifications with consideration for action items for upcoming IRB meetings and for selecting IRB-member reviewers for non-exempt research. When specific expertise is required, Research Integrity staff may supplement the information in the IRB roster with IRB members' curricula vitae (CVs). (See the online Human Research Protection Program (HRPP) Policy Manual for more information about reviewer assignment.)

When indicated, Research Integrity staff invite individuals with competence in special areas to assist in the review of issues requiring expertise beyond or in addition to that available through the IRB members. These individuals are considered consultants, and do not vote (see using consultants in the online HRPP Policy Manual).

When non-exempt research involving vulnerable populations or populations requires specific expertise, Research Integrity staff ensure at least one person who is knowledgeable about or experienced in working with the populations takes part in the review either as reviewer or consultant. When such projects/packages require Full Committee Review, at least one person with the requisite knowledge/experience must be present at the meeting or the review will be deferred until such expertise can be obtained through membership or consultation.

Research Integrity Staff ensure IRB minutes demonstrate that each IRB meeting was convened with members appropriately representing regulatory or legal requirements and the general perspective of participants; and the name and reason when IRB members leave the meeting due to a conflict of interests.

IRB Member and Chair Agreements, Terms, and Evaluations

Each IRB member signs an IRB Member Annual Agreement form when first becoming an IRB member and then annually at the beginning of each calendar year. The form describes requirements for member attendance, confidentiality, and conflict of interests.

Annually, each member (including the IRB Chair/Co-Chair) completes a self-evaluation of:

• her/his/their understanding of regulations and policies,
• review and preparation of materials prior to meetings,
• participation in meeting discussions,
• interactions with investigators and IRB staff, and
• human research education during the previous year.

The IRB Chair or Co-Chair review member self-assessments to:

• evaluate member performance,
• determine areas of focus for IRB member training, and
• inform decisions related to future needs for IRB leadership and membership.

IRB members serving for three consecutive years may be given special consideration related to their continued interest in serving on the IRB.

Each IRB member is given a copy of her/his/their completed evaluation.

IRB Chair/Co-Chair self-evaluations are reviewed by the Research Integrity Director. Feedback is given to the Chair/Co-Chair by the Director and shared with the Vice President for Research and Innovation.

Annually, via a designation of authority memo, the IRB Chair identifies members who are qualified to complete expedited reviews or chair meetings in the absence of the IRB Chair.