What is a Federal Wide Assurance?
Under the Department of Health and Human Services (DHHS) human subjects protection regulations at 45 CFR 46.103, every institution engaged in human subjects research supported or conducted by DHHS must obtain an assurance of compliance approved by the Office for Human Research Protections (OHRP). Under the Federal Policy (Common Rule) at Section 102(f) 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. In addition, institutions are automatically considered to be “engaged” in human subject research whenever they receive a direct HHS award to support such research, even where all activities involving human subjects are carried out by a subcontractor or collaborator. In such cases, the institution bears ultimate responsibility for protecting h
