IRB Manual
  COMPOSITION AND APPOINTMENT OF THE IRB
      2.1 IRB Membership
   


Each IRB must consist of at least five (5) members. 

Term:   These members shall be appointed, in writing, by the Director of the institution for a maximum one year term. At the discretion of the Director, appointments may be renewed.

OMH Facilities:  Appointment as a member is contingent upon the member signing an IRB Member Confidentiality Agreement (see section 2.3 of this manual). If the member is a non-affiliated member, the member should enroll as a volunteer.  

Composition:    The following criteria should be used when determining the composition of the IRB and the selection of individual members:
 
(1)   
The members should have diverse backgrounds and represent a variety of professions, which will promote complete and adequate review of research and will contribute the professional competence necessary to review the types of research considered by the Board.
 
(2)   
The IRB shall be sufficiently qualified through experience, expertise and racial and cultural backgrounds to be sensitive to community attitudes and to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. 

 
(3)   
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 include persons knowledgeable in these areas.
 
(4)   
Every non-discriminatory effort must be made to ensure that the IRB does not consist 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.
 
(5)   
The IRB must include at least one member whose primary concerns are in a non-scientific area. (A quorum requires at least one non-scientific member to be present. Therefore, it may be advisable to appoint more than one non-scientific member or to appoint an alternate for the non-scientific member.)

 
(6)   
 The IRB must include at least one member whose primary concerns are in scientific areas.
 
(7)   
 If biomedical research is to be reviewed, the IRB must include at least two M.D.'s.
 
(8)   
If  behavioral research is to be reviewed, the IRB must include at least two Ph.D. level behavioralists.  Behavioralists include, but are not limited to, psychologists, sociologists, social workers and psychiatrists.
 
(9)   
The IRB must include at least one member who is not otherwise affiliated with the institution and is not a part of the immediate family of a person affiliated with the institution.  An investigator who conducts or plans to conduct research at the institution does not qualify as an unaffiliated member.
 
(10)   
DMH IRBs regularly review research which involves vulnerable categories of subjects, (e.g., children, pregnant women or handicapped or mentally disabled persons). IRBs must include as members of one or more individuals who are knowledgeable about and experienced in working with these subjects.  (If a research project involves a category of vulnerable subjects that the IRB does not normally review, a consultant may be used to fulfill this requirement.)  Recipients, family members and/or advocates should  be included as members.
 
(11)   
 Special membership requirements apply to IRBs which review research involving prisoners. See Section 7.5 for details. 

 
(12)   
When research involves subject matter and/or subject populations which the IRB determines are outside its areas of expertise, an outside consultant or consultants with the necessary expertise shall be used.  (Researchers should be consulted before their applications are referred to a reviewer who is not employed by DMH/RFMH.)
 
(13)   
OMH facilities only: The Quality Management Director or his/her authorized representative (a competent quality assurance staff person with previous research monitoring experience and interest) must be appointed to the IRB.
 
(14)   
When choosing members of the IRB the Director must consider the racial/ethnic composition of the subject populations that are regularly engaged in research at the facility and make clear efforts to include persons from these racial/ethnic groups in the membership of the IRB.
   

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.

     
   

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