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Oklahoma Administrative Code (Last Updated: March 11, 2021) |
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TITLE 450. Department of Mental Health and Substance Abuse Services |
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Chapter 1. Administration |
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Subchapter 11. Research |
SECTION 450:1-11-8. IRB Membership
Latest version.
- (a) The ODMHSAS IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted at facilities or programs operated or funded by ODMHSAS. 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 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 agency commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If the IRB reviews research that involves a vulnerable category of subjects, such as 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) The Commissioner or designee shall appoint IRB members and the IRB chairperson.(c) Every nondiscriminatory effort shall be made to ensure that the ODMHSAS IRB does not consist entirely of men or entirely of women, including the agency'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.(d) The ODMHSAS 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.(e) The ODMHSAS IRB shall include at least one member who is not otherwise affiliated with the ODMHSAS and who is not part of the immediate family of a person who is affiliated with ODMHSAS.(f) ODMHSAS IRB Members will not 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.(g) The IRB may 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.