Administrative Code

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

12VAC5-20-50. Review process for department.

A. Prior to the initiation of a human research project by any component of the department, a description of the proposed human research project shall be submitted to a research review committee established by the department for review and approval. The description shall include a statement of the purpose of the proposed project and justification thereof, the criteria for inclusion as 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. The 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.

C. The chair of the committee shall report as soon as possible to the commissioner any violation of the research protocol that led the committee to either suspend or terminate the research.

D. The commissioner may inspect the records of the committee.

E. The commissioner shall report at least annually to the Governor and General Assembly on the human research projects conducted by any component of the department as annually reported to the commissioner by the committee.

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, Virginia Register Volume 32, Issue 8, eff. January 14, 2016.

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