HHSAR 370.301, Acquisitions Involving Human Subjects

Performance of HHS mission requires the support of contractors involving human subjects. Before awarding a contract to any contractor which will need to use human subjects, the CO is required to verify that the contractor holds a valid Federal Wide Assurance (FWA) approved by the Office for Human Research Protections (OHRP). The provisions are implemented via contract clauses found at HHSAR 352.270-4a (Protection of Human Subjects), the clause at 352.270-4b (Protection of Human Subjects), the provision at 352.270-10 (Notice to Offerors-Protection of Human Subjects, Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required), and the clause at 352.270-11 (Protection of Human Subjects-Research Involving Human Subjects Committee (RIHSC) Approval of Research Protocols Required).

The latest form for HHSAR 370.301, Acquisitions Involving Human Subjects expires 2021-12-31 and can be found here.