12 Va. Admin. Code § 5-20-60 - Review process for institutions or agencies funded or licensed by the department
A. Prior to
the initiation of a human research project by any institution or agency funded
or licensed by the department, a description of the proposed human research
project shall be submitted to a research review committee for review and
approval. The description shall include a statement of the purpose of the
proposed project and justification thereof, the criteria for inclusion of a
subject in the research project, a description of what will be done to the
subjects, and a copy of the informed consent statement.
B. When more than one such institution or
agency is involved in a research project, the cooperating entities may enter
into joint review.
C. Such
institutions or agencies having a committee shall report by March 31 of each
year to the commissioner on activities of the committee during the previous
calendar year. Such reports shall include:
1.
A description of each human research project reviewed and whether it was
approved or disapproved;
2. Any
significant deviations from proposals as approved;
3. A list of committee members, their
qualifications for service on the committee, and their institutional
affiliation; and
4. A copy of the
minutes of any committee meetings conducted.
D. The chair of the committee shall report as
soon as possible to the head of such institution or agency and to the
commissioner any violation of the research protocol which led the committee to
suspend or terminate the research.
E. The commissioner may inspect the records
of the committee.
F. The
commissioner shall report at least annually to the Governor and General
Assembly on the human research projects conducted by such institutions or
agencies as annually reported to the commissioner by the relevant research
review committees.
Notes
Statutory Authority: §§ 32.1-12 and 32.1-12.1 of the Code of Virginia.
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