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Virginia Administrative Code
Title 22. Social Services
Agency 40. Department of Social Services
Chapter 890. Human Subject Research Regulations
4/15/2025

22VAC40-890-80. Expedited review of human research participants.

A. The committee is authorized to conduct an expedited review of a human research project that involves no more than minimal risk to the participants if the research review committee affiliated with another state department, local department, licensed facility, or institution has reviewed and approved the project.

B. In accordance with 45 CFR 46.110, as determined by the U.S. Secretary of Health and Human Services (HHS) and published as a notice in the Federal Register, certain categories of research may be reviewed by the Institutional Review Board (IRB) through an expedited review procedure. The Secretary of HHS will evaluate the list at least every eight years and amend the list, as appropriate. A copy of the list is available from the Office for Human Research Protections, HHS, or any successor office.

C. The IRB may use the expedited review procedure to review the following:

1. Some or all of the research appearing on the list described in subsection B of this section, unless the reviewer determines that the study involves more than minimal risk; or

2. Minor changes in previously approved research during the period for which approval is authorized.

D. Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB, except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the nonexpedited procedure set forth in 22VAC40-890-70.

E. The committee shall adopt a method for keeping all members advised of research proposals that have been approved under the procedure.

F. The expedited review procedure may not be used where identification of a subject or a subject's responses would reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

Statutory Authority

§§ 63.2-217 and 63.2-218 of the Code of Virginia.

Historical Notes

Derived from VR615-80-01 § 8, eff. August 11, 1993; amended, Virginia Register Volume 41, Issue 10, eff. February 13, 2025.

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