A person may satisfy more than one membership requirement. For example, a non- affiliated Ph.D. psychologist provides one non-affiliated member and one Ph.D. level behavioralist.
A copy of the letter of appointment and a brief curriculum vitae for each member, which includes the member’s full name, highest degree earned, scientific specialty and the nature of their affiliation with the institution (if any), must be forwarded to the RFMH which will then inform the Office for Human Research Protections. Changes in IRB membership must be promptly reported (before the new member takes part in protocol review). Copies of Member Confidentiality Agreements and documentation of enrollment of outside members as volunteers should be retained by the IRB and must be available for review by DMH/RHMH on request.
Alternates: Alternates for specific members or types of members (M.D's, Ph.D. level behavioralists, non-affiliated members, non-scientific members), may be appointed. The alternate IRB members must be formally appointed by the Director and the appointment reported to RFMH. The IRB roster must specify the primary member(s) for whom each alternate member may substitute. The alternate member must have the appropriate qualifications and experience to substitute for a primary member. For example, physicians should be alternate members for physicians, non-affiliated members should be alternates for non-affiliated members, etc. Alternates must receive the same training as primary members. When alternates do substitute for the primary member, the alternate must receive, and have sufficient time to review, the same material that the primary member received or would have received. The IRB minutes must document when an alternate member replaces a primary member. Alternates are encouraged to attend all IRB meetings but may only vote when the primary member is not present or is not participating in the vote for a particular study, e.g., due to potential conflict of interest
In the past, questions have been raised about the eligibility of the Director of an Institution to become a member or chairperson of the IRB. Due to a possible appearance of conflict of interest and/or undue influence, this is not appropriate. Both the independence and the credibility of an IRB would be severely compromised by such an appointment. Similarly, some other senior staff, depending on their role relative to the IRB and its members or to the conduct of research at the facility, may not be approved for IRB membership.
There are no special requirements for the selection of a chairperson. (It is acceptable to appoint an outside member or a person without an M.D. or Ph.D.). A Vice-Chair or Co-Chair should be appointed by the Director to provide coverage when the chairperson is absent.
Removal of IRB Members: An IRB may recommend to the Director that a person be removed as a member for cause, by specifying the reasons in writing, and providing a copy to the member. The Director shall give the person 15 days to respond in writing to the IRB’s recommendation and reasons. Within a further 15 days the Director shall make a determination based on a review of the written materials in light of the responsibilities of the IRB described in this Manual. That determination may, within 15 days, be appealed to the Commissioner's Designee or the OPWDD Director of District Operations who shall issue a final decision within 15 days.