The Common Rule (45 CFR part 46) published in 1991 is used by 15 Federal departments and agencies to provide protections for human subjects involved in research activities. The Common Rule also provides guidelines for the administration of the IRB and the composition of the board. Like many Federal regulations, some elements of 45 CFR part 46 are definitive while others are open to interpretation. This is true for the membership and qualifications of the board.
- 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, 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 shall 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 shall 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 shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.
(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.
(c) 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) 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) 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.
(f) 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 may not vote with the IRB
The Common Rule does stipulate the board must have no fewer than 5 members and 1 must be a non-scientist. The Common Rule does not specify the education or training required for board members, only that they are “qualified” to conduct the reviews. Many IRBs require the same human subjects training for reviewers and researchers. Solutions IRB also requires initial and ongoing training of all reviewers.
The board of Solutions IRB consists of a diverse group of individuals. Many of the members of our board hold doctoral degrees and are experienced educators and researchers. Our membership includes the following:
Certified IRB Professional (CIP)
Family Medicine Physician
Director of Research Information Systems
Licensed Behavior Therapist
No convened board meeting can be held without the non-scientist. The non-scientist fulfills a very important role. These members often are drawn from the community in which an IRB resides. They may be members of local clergy, interested volunteers, teachers, retirees, nurses or ethicists. They also may represent ethnic, socio-economic or patient groups that add a needed voice to IRB decisions.
The guidelines provided by the Common Rule for IRB membership are followed by all IRBs. The specific membership of each will differ based on the types of studies reviewed, study populations, and settings. All IRBs strive to provide a thorough review to evaluate the risk/benefits and ethics of the proposed study for the protection of human subjects. For additional information on our IRB, please visit www.solutionsirb.com.
- 46.107 IRB membership: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.107