Wash. Admin. Code § 388-04-070 - Human research review guidelines
(1) The department shall develop and publish
a comprehensive set of procedural guidelines for the protection of human
research subjects within its jurisdiction. These guidelines shall be at least
as restrictive as the minimum requirements set forth in Title 45, Part 46 of
the Code of Federal Regulations, but may be more restrictive if necessary to
satisfy the protective purposes of the department's human subjects protection
policy.
(2) The published
guidelines shall speak at least to the following topics:
(a) Applicability;
(b) Responsibility for policy and rule
implementation;
(c) Basic
definitions;
(d) Proposal format
and content;
(e) Review and
certification requirements;
(f)
Activities exempt from review requirements;
(g) Approval and disapproval authority;
appeals;
(h) Qualification
requirements for investigators;
(i)
Review board composition and functions;
(j) Review of ongoing research
projects;
(k) Informed consent
requirements;
(l) Disclosure of
personal records for research purposes;
(m) Publication conditions;
(n) Provisions for adapting guidelines to the
changing requirements of state and federal laws and regulations.
Notes
99-15-021, recodified as § 388-04-070, filed 7/12/99, effective 7/12/99. Statutory Authority: RCW 43.20A.550. 81-17-022 (Order 1687), § 388-10-070, filed 8/12/81.
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