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

12VAC5-20-90. Expedited review of human research projects.

A. The committee is authorized to conduct an expedited review of a human research project that involves no more than minimal risk to the subjects and involves only research procedures listed in one or more categories established by the Secretary of Health and Human Services and published in the Federal Register pursuant to 45 CFR 46.110.

B. The committee also is authorized to conduct an expedited review of a human research project that involves no more than minimal risk to the subjects if:

1. Another institution's or agency's human research review committee has reviewed and approved the project; or

2. The review involves only minor changes in previously approved research and the changes occur during the approved project period.

C. An expedited review may be carried out by the chair of the committee or by one or more experienced reviewers designated by the chair from among the committee members. In reviewing the research project, the reviewers may exercise all of the authorities of the committee except that the reviewers may not disapprove the research project. A research project may be disapproved only after review by the full committee in accordance to the procedures set forth in 12VAC5-20-80.

D. Each committee that uses an expedited review procedure shall adopt a method for keeping all members advised of research projects that have been approved under the procedure.

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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