As prescribed in 370-304(b) , the Contracting Officer shall insert the following clause:
Restriction on Use of Human Subjects (January 2006)
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) designated under the Contractor's Federal-wide assurance of compliance. This restriction applies to all collaborating sites, whether domestic or foreign, and subcontractors. The Contractor must ensure compliance by collaborators and subcontractors.
(End of clause)
