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Virginia Administrative Code
Title 12. Health
Agency 5. Department of Health
Chapter 20. Regulations for the Conduct of Human Research
7/12/2020

12VAC5-20-60. 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.

Statutory Authority

§§ 32.1-12 and 32.1-12.1 of the Code of Virginia.

Historical Notes

Derived from VR355-01-400 § 1, eff. July 1, 1993; amended, Volume 32, Issue 08, eff. January 14, 2016.

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