12 Va. Admin. Code § 5-20-40 - Policy
A. No human
research shall be conducted without informing the subject or his legally
authorized representative of the procedures, risks, and discomforts of the
research. The consent of the subject or his legally authorized representative
to participate in the research shall be subscribed to in writing by the subject
or his legally authorized representative and supported by the signature of a
witness not involved in the conduct of the research, except as provided for in
12VAC5-20-100. Special
arrangements shall be made for those who need assistance in understanding the
consequences of participating in the research.
B. Each human research activity shall be
reviewed and approved by a committee as set forth in
12VAC5-20-70 composed of
representatives of varied backgrounds who shall assure the competent, complete,
and professional review of human research activities.
C. Every person engaged in the conduct of
human research or proposing to conduct human research shall associate himself
with an institution or agency having a research review committee, and the human
research which he conducts or proposes to conduct shall be subject to review
and approval by such committee in the manner set forth in this
chapter.
D. Nontherapeutic research
using patients or residents within an institution as defined herein is
forbidden unless it is determined by the research review committee that such
nontherapeutic research shall not present greater than minimal risk.
E. The person, institution, or agency
conducting the human research shall notify all subjects of human research of
the risks caused by the research that are discovered after the research has
concluded. If consent has been obtained by the signature of the legally
authorized representative, the legally authorized representative shall also be
notified.
F. No official or
employee of the institution or agency conducting or authorizing the human
research shall be qualified to act as a legally authorized representative for a
subject of the particular human research.
Notes
Statutory Authority: §§ 32.1-12 and 32.1-12.1 of the Code of Virginia.
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