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The Federal Policy (Common Rule) for the protection of human subjects at Section 103(a) requires that each institution “engaged” in Federally supported human subject research file an “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.

 

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, awardee 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 awardee institution bears ultimate responsibility for protecting human subjects under the award. The awardee is also responsible for ensuring that all collaborating institutions engaged in the research hold an OHRP approved Assurance prior to their initiation of the research.(Link)