U.S. Department of Health & Human Services
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How do I determine the various categories of members for the IRB roster?
The following are some general guidelines to assist you in composing the IRB membership roster.
Scientist/Nonscientist - Members whose training, background, and occupation would incline them to view scientific activities from the standpoint of someone within a behavioral or biomedical research discipline should be considered a scientist, while members whose training, background, and occupation would incline them to view research activities from a standpoint outside of any biomedical or behavioral scientific discipline should be considered a nonscientist. In addition, the IRB must have members with sufficient knowledge of the specific scientific discipline(s) relevant to the research that it reviews.
Affiliation - An employee or agent of the organization registering the IRB (or a member of that person’s immediate family) is considered affiliated. Affiliated members include, but are not limited to, individuals who are: part-time employees; current students; members of any governing panel or board of the institution; paid or unpaid consultants; healthcare providers holding credentials to practice at the institution; and volunteers working at the institution on business unrelated to the IRB. An individual that has no affiliation with the organization registering the IRB, other than as an IRB member, is considered unaffiliated with the entity operating the IRB. Unaffiliated members may include people whose only association with the institution is that of a patient, subject, or former student at that institution. Paying unaffiliated members for their services would not make the member “otherwise affiliated” as stated in the regulations, or cause the member to have a conflicting interest.
Alternate Members – The HHS regulations at 45 CFR part 46 do not address the designation of alternate IRB members. However, for many years, the OHRP has permitted organizations submitting IRB registrations to OHRP to identify alternate members for primary members. When reviewing rosters that include alternate members OHRP assumes that, in general, with respect to the capacity in which the primary IRB member was intended to serve, each alternate IRB member has experience, expertise, background, professional competence, and knowledge comparable to that of the primary IRB member whom the alternate would replace. The minutes of an IRB meeting should document the attendance of all primary and alternate IRB members who attended any part of the IRB meeting. If both a primary IRB member and his or her alternate(s) attend the same IRB meeting, OHRP assumes that the primary member is acting as the official voting member of the IRB for review of research protocols, unless the minutes clearly indicate otherwise. A designated alternate IRB member for a primary IRB member may substitute for the primary IRB member for an entire meeting or at any time during a meeting. Substitution during a meeting commonly occurs when the primary member is (a) absent from the room for part of the meeting, or (b) recused from review of certain research protocols because the primary IRB member has a conflicting interest with respect to a specific research protocol. Whenever this occurs, the minutes of the IRB meeting should indicate clearly that the alternate IRB member has replaced the designated primary IRB member. OHRP recommends that the reason for the substitution of the alternate IRB member also should be documented in the minutes.
Last Reviewed: 12/02/2010
Related Questions:
- Does a FWA have to be updated if an institution later relies on an IRB not included in the original FWA submission?
- Does registration mean that an IRB is in full compliance with the HHS regulations, 45 CFR part 46, or is otherwise meeting a particular standard of competence or expertise?
- When must an IRB registration be renewed or updated?
- What are the requirements for providing information on the number of protocols being reviewed by the IRB?
- What are the requirements for providing information on the number of full time equivalent positions?
