Code of Federal Regulations Title 48. Federal Acquisition Regulations System 48.352.270-6 Restriction on Use of Human Subjects

As prescribed in HHSAR 370–304(b), the Contracting Officer shall insert the following clause:

Pursuant to 45 CFR part 46, Protection of Human Research Subjects, the Contractor shall not expend funds under this award for research involving human subjects or engage in any human subjects research activity prior to the Contracting Officer's receipt of a certification that the research has been reviewed and approved by the Institutional Review Board (IRB) registered with OHRP. This restriction applies to all collaborating sites, whether domestic or foreign, and subcontractors. The Contractor must ensure compliance by collaborators and subcontractors.

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