[Code of Federal Regulations]

[Title 48, Volume 4]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 48CFR370.301]



[Page 88-89]

 

            TITLE 48--FEDERAL ACQUISITION REGULATIONS SYSTEM

 

                  CHAPTER 3--HEALTH AND HUMAN SERVICES

 

PART 370_SPECIAL PROGRAMS AFFECTING ACQUISITION--Table of Contents

 

           Subpart 370.3_Acquisitions Involving Human Subjects

 

Sec. 370.301  Policy.



    It is the policy of the Department of Health and Human Services 

(DHHS) that no contract involving human subjects shall be awarded until 

acceptable assurance has been given that the activity will be subject to 

initial and continuing review by an appropriate Institutional Review 

Board (IRB) as described in DHHS regulations at 45 CFR 46.103. An 

applicable Multiple Project Assurance (MPA) or Single Project Assurance 

(SPA), approved by the Office for Protection from Research Risks (OPRR), 

National Institutes of Health (NIH), shall be required of each 

contractor, subcontractor, or cooperating institution having 

responsibility for human subjects involved in performance of the 

contract. The OPRR, NIH, is responsible for negotiating assurances 

covering all DHHS-supported or DHHS-conducted activities involving human 

subjects. Contracting officers shall be guided by OPRR regarding 

nonaward or termination of a contract due to inadequate assurance or 

breach



[[Page 89]]



of assurance for protection of human subjects.