Wash. Admin. Code § 388-04-040 - Implementation
(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.
Notes
99-15-021, recodified as § 388-04-040, filed 7/12/99, effective 7/12/99. Statutory Authority: RCW 43.20A.550. 81-17-022 (Order 1687), § 388-10-040, filed 8/12/81.
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