IRB Composition and Procedural Guidelines

1. The IRB must have at least five voting members with varying backgrounds to complete an adequate review of research activities commonly conducted by UW-Eau Claire. The IRB must be sufficiently qualified through the experience and expertise of its members and the diversity of their backgrounds, including consideration of their racial and cultural heritage and their sensitivity to issues such 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 must 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 must therefore include persons knowledgeable in these areas. No IRB, however, may consist entirely of members of one profession.
   
   If the IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, the IRB must consider the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects. Department of Education regulations require, in addition, that when an IRB reviews research for one of its programs that purposefully requires inclusion of handicapped children or mentally disabled persons as research subjects, the IRB must include at least one person primarily concerned with the welfare of these subjects [34 CFR 350.3(d)2); 34 CFR 356.3(c)(2)].
   
   The IRB must include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in non-scientific areas. It must also 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. In addition, the Director of Health Services serves as an ex officio voting member. The Assistant Vice Chancellor for Research and the Coordinator of Research Services serve as ex officio, non-voting members of the IRB.
   
   NOTE: In reviewing proposals involving children, pregnant women, or mentally disabled persons, the IRB membership shall be expanded, if necessary, to include an appropriate representative who is knowledgeable about and experienced in working with these special subjects. When prisoners are the subject of research, 45 CFR 46.304 requires that at least one member of the Board be a prisoner representative. 
   
   
2. Voting members shall serve three-year staggered terms and shall be eligible for reappointment.
3. The Vice Chancellor for Academic Affairs, in consultation with the IRB Chair and the University Senate Executive Committee, shall appoint the voting members of the IRB.
4. The IRB Chair shall appoint a Secretary of the IRB. 
5. No IRB member shall participate in the review of any research project in which said member has a conflict of interest, except to provide information upon the request of the IRB.    
6. The IRB shall meet as necessary on a monthly basis during the academic year and continue through the summer session to conduct the business of the IRB. 
7. Detailed minutes of all IRB meetings shall be recorded and maintained. The Secretary of the IRB shall distribute said minutes through appropriate channels. 
8. The IRB shall comply with the provisions of the Wisconsin Open Meetings Law including the option of going into closed session, as appropriate, to protect the patent and/or publication rights of the investigator(s).

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