Assurance

Assurance needs to be provided to the U.S. Department of Health and Human Services' Office for Human Research Protections (HRP), under 45 CFR Part 46, that the research will be conducted according to human subjects research governmental regulations.

Assurance is provided by completing one of the following (APRNet will assist applicants in obtaining the appropriate assurance).

Unaffiliated Investigator Agreement

This form is for an applicant who works alone or with fewer than five colleagues. (.pdf)

Federal-Wide Assurance (FWA)

The form that is for applicants who work with more than four colleagues can be downloaded from this page.

Inter-IRB Agreement

For applications that work at sites with their own federally-approved IRBs.

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