Re: Sponsored Programs Representation on the IRB Reynolds, Craig A. 06 Sep 2006 15:15 EST
Does anyone know if similar concerns have been expressed by USDA or PHS regarding animal care and use committees? Craig -----Original Message----- From: Research Administration List [mailto:xxxxxx@HRINET.ORG] On Behalf Of Lawrence Waxler Sent: Wednesday, September 06, 2006 4:09 PM To: xxxxxx@HRINET.ORG Subject: Re: [RESADM-L] Sponsored Programs Representation on the IRB George, We recently had a friendly OHRP site review. I, the Director of the Office of Sponsored Programs, had been a non-voting ex-officio member of the IRB, a position that I was comfortable with. Last year, the Board decided to make me a voting member * I dissented. OHRP indicated that because of my position I had both a conflict of interest in that I approved proposals that were submitted to sponsors and could vote to push a proposal through the IRB. Additionally, they indicated that I was in a position to influence the Board. They also concluded, as a result of their review, that the Board operated very independently and ethically and they saw no evidence that I exerted any undue influence. Nevertheless, they "recommended" that I be removed as a voting member. They suggested two categories of attendees at the meetings: members who vote and guests. As a result of this, I resigned from the IRB, with some disappointment as I enjoyed the meetings and discussions. I also recommended that I not be replaced by anyone from my staff as a member to avoid the appearance of a conflict. I, or a member of my staff can still attend as a guest. For the Reference to the Federal Code see the Code of Federal Regulations, Title 45, Part 46, §46.107 IRB Membership. As follows: (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 a! s 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 Larry Waxler, Director Office of Sponsored Programs University of Southern Maine P.O. Box 9300 Portland, ME 04104-9300 Telephone: 207-780-4413 Telefax: 207-780-4927 >>> George Turnbull <xxxxxx@UMRESEARCH.UMD.EDU> 9/6/2006 3:39 PM >>> Does your institution have a representative from the Sponsored Program Office as a regular member of the Institutional Board; and if so, are they a voting or non-voting member? If your institution excludes members of the Sponsored Programs Office from participation (or presence) in the IRB, can you provide the explanation for that policy (i.e., regulatory, statutory, or institutional policy)? Thank you. George Turnbull Compliance Administrator University of Maryland Office of Research, Administration, and Advancement Lee Building, Room 3103 College Park, MD 20742 301-405-6278 Fax 301-314-9569 ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ====================================================================== ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ====================================================================== ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ======================================================================