Institutional Review Board
Assurance of Compliance
Institutions that engage in research funded by the Department of Health and Human Services (DHHS) must file
an assurance of compliance with the agency's regulations governing the protection of human subjects. The assurance
is a written agreement, which includes the following:
- A statement of ethical principles and institutional policies governing research involving human subjects
- IRB, institution, and investigator compliance with 45 CFR Part 46
- Certification of IRB approval and institutional endorsement
- A list of IRB members and their qualifications
Institutions of higher education normally use one of two mechanisms for providing assurance of compliance. These
- Single Project Assurance (SPA) An SPA acknowledges an intent to comply with DHHS human subjects regulations
in the conduct of a specific research project or activity. At the time of submission of the grant proposal,
the College indicates, usually on the face page of the proposal, a willingness to comply with DHHS regulations.
Once the decision is made to fund the proposal, the appropriate funding agency contacts the OPRR, which in turn
contacts the College. The College submits additional documentation and the SPA. The OPRR reviews the assurance
and, if approved, assigns an assurance number to the project or activity. The SPA is generally used by institutions
whose level of DHHS-supported research involving human subjects is low. NSU routinely uses the SPA.
- Multiple Project Assurance (MPA) Institutions of higher education that engage in a significant number
of DHHS-sponsored research projects or activities involving human subjects are invited to file a MPA. The OPRR
receives the assurance, negotiates the final agreement, and assigns an assurance number to the institution. Wofford
College currently does not have a MPA.
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