OPRR Guidance on 45 CFR 46.101(b)(5)
Exemption for Research and Demonstration Projects on
Public Benefit and Service Programs
The Office for Protection from Research Risks (OPRR) has determined that the following criteria (see 48 FR 9266-9270, March 4, 1983) must be satisfied to invoke the exemption for research and demonstration projects examining "public benefit or service programs" as specified under Department of Health and Human Services (HHS) regulations at 45 CFR 46.101(b)(5):
- The program under study must deliver a public benefit (e.g., financial or medical benefits as provided under the Social Security Act) or service (e.g., social, supportive, or nutrition services as provided under the Older Americans Act).
- The research or demonstration project must be conducted pursuant to specific federal statutory authority.
- There must be no statutory requirement that the project be reviewed by an Institutional Review Board (IRB).
- The project must not involve significant physical invasions or intrusions upon the privacy of participants.
Institutions should consult with the HHS funding agency regarding the above conditions before invoking this exemption. In addition, it is extremely important that staff in all HHS agencies understand and respect the following principles, which are critical to the successful implementation of human subject protections under HHS regulations:
- Institutions conducting (nonexempt) HHS-supported human subjects research must provide OPRR with an acceptable Assurance of Compliance with the human subjects regulations [45 CFR 46.103(a)]. Under the terms of such Assurances, it is typically the responsibility of the Institutional Review Board (IRB) or other designated institutional official(s), not the investigator, to determine whether research activities qualify for exemption. Institutions holding OPRR-approved Assurances generally require that all research involving human intervention/interaction or identifiable private information [45 CFR 46.102(f)(2)] be subjected to independent verification of exempt status.
- Institutions may elect under their Assurance not to claim the exemptions provided in the regulations, choosing instead to require IRB review of all research involving human intervention/interaction or identifiable private information.
- While HHS requires neither an Assurance nor a Certification of IRB Review [45 CFR 46.103(f)] for exempt research, institutional requirements regarding review of such research are, nevertheless, binding on investigators. It would be inappropriate for staff of any HHS agency to discourage potential awardees from submitting their activities for institutionally required IRB review.