Assurance of Protection of Human Subjects

The Federal Policy (Common Rule) for the protection of human subjects requires that each institution "engaged" in Federally-supported human subject research file an "Assurance" of protection for human subjects with the Office for Human Research Protections (OHRP), the federal agency which regulates these assurances. This Assurance formalizes the institution's commitment to protect human subjects. The requirement to file an Assurance includes both "awardee" and collaborating "performance site" institutions.

Registration is also required for Institutional Review Boards designated under an OHRP Federalwide Assurance of Protection for Human Subjects.

Completing a Federalwide Assurance (FWA) and registering an Institutional Review Board (IRB) is a two-step process.

• First, the IRB or Independent Ethics Committee (IEC) designated under the Assurance must be registered with OHRP.  To register an IRB: https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/irb-registration/index.html
   
• Second, the FWA application must be completed.  To complete the FWA application: https://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/fwas/index.html

Detailed information on the regulations, policy and guidance for registering an IRB and filing an assurance are available on OHRP’s website at http://www.hhs.gov/ohrp.

Upon approval, an assurance number will be assigned by OHRP, providing assurance coverage for a five-year period. Whenever there is a change in information regarding your institution's FWA, an update to the FWA must be submitted to OHRP. Any renewal or update that is submitted to, and accepted by, OHRP begins a new five-year effective period.