ÍƼöÐÓ°ÉÔ­´´

Updated May 31, 2024

Composition of IRB

The University IRB is comprised of at least five members, with varying backgrounds and expertise to provide complete and thorough review of research activities commonly conducted by University and Affiliate researchers.”

The membership of the University IRB is sufficiently qualified through the experience and expertise of its members and the diversity of its members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human research subjects.

The University IRB includes persons able to ascertain the acceptability of the proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice.

The University IRB includes members of more than one profession.

The University IRB members are not all males or all females.

The University IRB includes at least one member who represents the perspective of research participants.

The University IRB includes at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in non-scientific areas.

The University IRB includes at least one member who is not otherwise affiliated with the University and who is not part of the immediate family of a person who is affiliated with the University.

Individuals who are responsible for business development are prohibited from serving as members on the University IRB.

Research Integrity & Security 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.

Alternates

Research Integrity & Security maintains a roster of trained alternates who may vote in place of an absent voting member. In addition, all active members listed on the roster may be utilized as alternates for other active members as long as all applicable regulatory requirements and IRB policies are met. The alternate member will have similar expertise as the regular committee member for whom they are serving as a replacement for (clinical scientific to other clinical scientific; social, behavioral, and education research (SBER) scientific to other SBER scientific; and non-scientific to non-scientific). The alternate member will assume all of the responsibilities of the committee member for whom they are serving as a replacement for.

Alternate members may attend IRB meetings without serving as a replacement for a regular committee member; however, in this capacity, the alternate member may not participate in any of the final approval decisions of the committee.

IRB minutes will document if a member present at the meeting is an alternate as well as the IRB member for whom the alternate is substituting.

Appointment of IRB Members

Appointments of voting IRB Committee members, including alternates, are made by the Institutional Official (IO). Recommendations for board members can be made to the IO by either the IRB Chair or Research Integrity & Security Director based on the specific needs of the IRB Committee.

The IRB Chair or his designee requests recommendations for volunteers as needed based on considerations including, but not limited to, required committee composition, expertise, and experience; knowledge of the individual’s interest; 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 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 Research Integrity & Security Director will review each new member’s CV and demographic sheet for educational background, work history, as well as her/his/their current vocation to determine the member’s status (i.e., scientific versus non-scientific, affiliated vs. non-affiliated) on the IRB rosters.

IRB Roster

The IRB membership roster will include the following information and will be used to determine relevant expertise in making protocol assignments at convened meetings:

Names of members;

Earned degrees;

Representative capacities;

Affiliation status (whether the IRB member or an immediate family member of the IRB member is affiliated with the organization);

Scientific/nonscientific status;

Indications of experience sufficient to describe each IRB member’s chief anticipated contributions;

Employment or other relationship between each IRB member and the organization;

Alternate members, including the primary members or class of primary members for whom each alternate can substitute.