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388-04-030  <<  388-04-040 >>   388-04-050

PDFWAC 388-04-040


(1) The department shall maintain a human research review board which shall have primary responsibility for the ethical and technical review of the use of human subjects in research and related projects conducted within the department's jurisdiction. Unfavorable review dispositions by this review board, including disapproval of proposed research, research restrictions, or special approval conditions, cannot, by federal regulation (45 C.F.R. 46.112) be removed except by the review board. Favorable review decisions by the board shall be subject to review and concurrence by appropriate departmental officials.
(2) To assure continued protection of human subjects in on-going research at the activity site, departmental service units involved in a significant number of research and related activities shall establish their own research oversight committees. These local committees shall function as extensions of the human research review board. They shall be responsible for providing ethical and procedural oversight in accordance with the review board's directions.
(3) Review of proposals requiring professional competencies beyond those represented on the human research review board shall require prior and written review consultation with at least four research experts who are competent to judge the scientific merit, benefits, and risks of the proposed research.
[WSR 99-15-021, recodified as § 388-04-040, filed 7/12/99, effective 7/12/99. Statutory Authority: RCW 43.20A.550. WSR 81-17-022 (Order 1687), § 388-10-040, filed 8/12/81.]
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