VCU IRB is seeking feedback about non-medical research interventions
The VCU Office of Research Subjects Protection is seeking to engage with faculty, staff, and students across VCU about a new category of exempt research related to benign behavioral interventions.
- Revisions to the Department of Health and Human Services federal regulations (45 CFR 46) for the protection of human subjects in research went into effect on January 21, 2019.
- One of the revisions to the regulations was the addition of a new category of research that can qualify for exemption from the federal regulations.
- Exempt Category 3 – Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection. (45 CFR 46.104(d)(3))
- The regulatory text describes qualities of a “benign behavioral intervention.” However, it does not provide operational definitions of the terms that are used (e.g. terms like “brief” or “harmless”). Federal regulators have not released guidance yet about Exempt Category 3.
We are administering an anonymous 15 minute survey as a quality improvement initiative to help develop institutional definitions and policies about what types of non-medical research interventions will qualify for exemption under this category.
If you are interested in providing your perspectives and opinions, click here to begin the survey.
Feedback from non-researchers and students is welcome!