Office for
Human Research Protections |
Federalwide
Assurance (FWA) |
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) |