600. IRB Membership and Evaluation
Updated July 1, 2019
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 human subjects.
- at least five members with varying backgrounds of research commonly conducted by the Organization;
- at least one member whose primary concerns are in scientific areas (although the majority of IRB faculty members are scientists);
- at least one member whose primary concerns are in nonscientific areas;
- at least one member who is not otherwise affiliated with the Organization and who is not part of the immediate family of a person who is affiliated with the Organization;
- both females and males;
- members representing more than one profession; and
- at least one member who represents the perspective of research participants.
Research Integrity obtains and maintains a copy of each IRB member's resume or Curriculum Vitae when the member is appointed or reappointed. IRB member CVs and current and previous IRB membership rosters are available to University administrators and University Affiliates (including the VASNHCS) upon request.
NOTE: The nonaffiliated members (i.e., community representatives) of the University IRB also represent the perspective of research participants. Individuals who agree to participate as community representatives are held to the same attendance standard as affiliated members (i.e., members must attend at least 75% of scheduled meetings per year (9/12 meetings)). Meeting attendance for community representatives is documented through financial records.
The RI Director or designee completes the OHRP/FDA IRB registration forms in accordance with OHRP and FDA registration requirements and updates the registration in a timely manner when the IRB membership changes. The IRB registration form contains IRB Chairperson and IRB Roster sections.
IRB roster section contains the information necessary to assess the qualifications and required diversity of IRB membership including:
- Earned degrees;
- Scientific/nonscientific status;
- Scientific/nonscientific specialty (i.e., descriptions of each IRB member's chief anticipated contribution);
- Affiliation status (whether the IRB member or her/his immediate family member is or is not affiliated with the University through employment or other relationship); and
- Alternate Member status (see below for details).
Alternative Member Status
IRB members designated as Alternative Members are members who may replace a specified Primary Member or class of primary members when the latter cannot attend a convened meeting. Alternative members' qualifications are comparable to those of the specified primary members. Members may be designated as an alternative for more than one Primary Member. Terms of appointment, length of service, training, and duties for alternative members are identical to those for primary members. When attending a meeting as an alternative for a primary member, alternative members are given the same access to project/package materials and have all the authority of primary members. If a Primary Member and her/his designated Alternative attend the same convened meeting, only one of them votes and is counted toward quorum.
Evaluation of IRB Roster
Research Integrity (RI) Director and IRB Chair review the roster annually to identify needs and opportunities, and confirm compliance with. When warranted, RI staff may notify the Director or Chair of representation needs suggested by current trends in research submissions.
When evaluating IRB membership, the RI Director and Chair assess for the required diversity and also 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 RI 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
RI staff use the information in the 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, RI staff may supplement the information in the IRB roster with IRB members' curricula vitae (CVs). (See the online HRPP policy manual for more information about reviewer assignment.)
When indicated, RI 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, RI 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.
RI 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) completes a self-evaluation of
- her/his 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 Vice 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 completed evaluation.
IRB Chair self-evaluations are reviewed by the RI Director. Feedback is given to the 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.