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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 45 - Public Welfare |
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Subtitle A - Department of Health and Human Services |
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SubChapter A - General Administration |
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Part 46 - Protection of Human Subjects |
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Subpart A - Basic HHS Policy for Protection of Human Research Subjects |
§ 46.107 - IRB membership.
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§ 46.107 IRB membership.
(a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members (professional competence), and the diversity of the 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 subjects. In addition to possessing the professional competence necessary to review specific research activities, the The IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments (including policies and resources) and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable category of subjects that is vulnerable to coercion or undue influence, such as children, prisoners, pregnant womenindividuals with impaired decision-making capacity, or handicapped economically or mentally disabled educationally disadvantaged persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these categories of subjects.
(c)(b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession.
Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.
d(
c) Each IRB shall 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.
e(
d) No IRB may 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.
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whiche) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues
that require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.