Federalwide Assurance

The Federal Policy for the Protection of Human Subjects requires that each institution “engaged” in Federally-supported human subject research file in “Assurance” of protection for human subjects. The Assurance formalizes the institution’s commitment to protect human subjects. The requirement to file an Assurance includes both “awardee” and collaborating “performance site” institutions. Per Federal Policy, awardees and their collaborating institutions become “engaged” in human subject research whenever their employees or agents (i) intervene or interact with living individuals for research purposes; or (ii) obtain, release, or access individually identifiable private information for research purposes.