[Code of Federal Regulations]

[Title 48, Volume 5]

[Revised as of October 1, 2006]

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

[CITE: 48CFR752.7012]



[Page 73-74]

 

            TITLE 48--FEDERAL ACQUISITION REGULATIONS SYSTEM

 

             CHAPTER 7--AGENCY FOR INTERNATIONAL DEVELOPMENT

 

PART 752_SOLICITATION PROVISIONS AND CONTRACT CLAUSES--Table of Contents

 

             Subpart 752.70_Texts of USAID Contract Clauses

 

Sec. 752.7012  Protection of the individual as a research subject.



    This clause is for use in any USAID contract which involves research 

using human subjects.



      Protection of the Individual as a Research Subject (AUG 1995)



    (a) Safeguarding the rights and welfare of human subjects in 

research conducted under a USAID contract is the responsibility of the 

contractor. USAID has adopted the Common Federal Policy for the 

Protection of Human Subjects. USAID's Policy is found in Part 225 of 

Title 22 of the Code of Federal Regulations (the ``Policy''). Additional 

interpretation, procedures, and implementation guidance of the Policy 

are found in USAID General Notice entitled ``Procedures for the 

Protection of Human Subjects in Research Supported by USAID'', issued 

April 19, 1995, as from time to time amended (a copy of which is 

attached to this contract). USAID's Cognizant Human Subjects Officer 

(CHSO) and USAID/W has oversight, guidance, and interpretation 

responsibility for the Policy.

    (b) Contractors must comply with the Policy when humans are the 

subject of research, as defined in 22 CFR 225.102(d), performed as part 

of the contract, and contractors must provide ``assurance'', as required 

by 22 CFR 225.103, that they follow and abide by the procedures in the 

Policy. See also Section 5 of the April 19, 1995, USAID General Notice 

which sets forth activities to which the Policy is applicable. The 

existence of a bona fide, applicable assurance approved by the 

Department of Health and Human Services (HHS) such as the ``multiple 

project assurance'' (MPA) will satisfy this requirement. Alternatively, 

contractors can provide an acceptable written assurance to USAID as 

described in 22 CFR 225.103. Such assurances must be determined by the 

CHSO to be acceptable prior to any applicable research being initiated 

or conducted under the contract. In some limited instances outside the 

U.S., alternative systems for the protection of human subjects may be 

used provided they are deemed ``at least equivalent'' to those outlined 

in Part 225 (see 22 CFR 225.101(h)). Criteria and procedures for making 

this determination are described in the General Notice cited in the 

preceding paragraph.

    (c) Since the welfare of the research subject is a matter of concern 

to USAID as well



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as to the contractor, USAID staff, consultants and advisory groups may 

independently review and inspect research, and research processes and 

procedures involving human subjects, and based on such findings, the 

CHSO may prohibit research which presents unacceptable hazards or 

otherwise fails to comply with USAID procedures. Informed consent 

documents must include the stipulation that the subject's records may be 

subject to such review.



[61 FR 39095, July 26, 1996]