Section 1580.30  Institutional Review Board Composition  

a)         An IRB shall be qualified through the experience, expertise, and diversity of its members, considering race, gender, cultural backgrounds and sensitivity to issues such as community attitudes. The IRB shall review proposed research in light of existing Authority commitments; applicable laws, regulations and guidelines; and standards of professional conduct and practice. The IRB shall include persons with expertise in these areas.

b)         IRB members shall be appointed by the executive director of the Authority. An IRB must consist of at least five members with varying backgrounds. The Authority must adhere to the following IRB membership rules:

1)         Every nondiscriminatory effort must be made to ensure that an IRB does not consist entirely of men or entirely of women.

2)         An IRB must not consist entirely of members of one profession.

3)         An IRB must include at least one member whose primary concerns are in scientific areas.

4)         An IRB must include at least one member whose primary concerns are in nonscientific areas.

5)         An IRB must include at least one member who is not otherwise affiliated with, or part of the immediate family of a person who is affiliated with, the Authority.

6)         An IRB member must not participate in the initial or continuing review of any project in which the member has a conflict of interest, except to provide information requested by the IRB.

7)         An IRB may, in its discretion, invite individuals with special expertise to assist in the review of issues requiring that expertise. These individuals may not vote with the IRB.

8)         An IRB must reflect all applicable laws and regulations regarding IRB membership.