Administrative Code

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Virginia Administrative Code
Title 12. Health
Agency 35. Department of Behavioral Health And Developmental Services
Chapter 180. Regulations to Ensure the Protection of Subjects in Human Research

12VAC35-180-90. Expedited review procedures for certain kinds of human research involving no more than minimal risk.

A. A research review committee may conduct an expedited review of a human research project that involves no more than minimal risk to the individuals who are the subjects of the human research if (i) another institution's or agency's human research review committee has reviewed and approved the project, or (ii) the review involves only minor changes in previously approved human research and the changes occur during the approved project period. Under an expedited review procedure, the review may be carried out by the committee chair and two or more experienced reviewers designated by the chair from among members of the committee. In reviewing the human research, the reviewers may exercise all of the authority of the committee except that the reviewers may not disapprove the human research. A human research project may be disapproved only after review in accordance with the nonexpedited review elements set forth in 12VAC35-180-70.

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

Statutory Authority

§§ 37.2-203 and 37.2-402 of the Code of Virginia.

Historical Notes

Derived from VR470-06-01:1 § 9, eff. May 15, 1993; amended, Virginia Register Volume 20, Issue 9, eff. February 11, 2004; Volume 26, Issue 2, eff. November 12, 2009; Volume 36, Issue 11, eff. March 15, 2020.

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