Subject: IRB Committee Membership

Policy:

It is the policy of Mayo Clinic's Office for Human Research Protection – Institutional Review Board (IRB) – that each IRB will have membership as defined by Federal regulations.

1. Each IRB will have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB will be sufficiently qualified through the experience and expertise of its members, and the diversity of the 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 subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB will be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB will therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration will be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.
2. Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB will consist entirely of members of one profession.
3. Each IRB will include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas (non-scientific member).
4. Each IRB will include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution (non-affiliated member).
5. No IRB will have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.
6. An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals will not vote with the IRB (Ex Officio and Administrative Members). ^[1], ^[2]

^[1] 45 CFR 46.107

^[2] 21 CFR 56.107