[Code of Federal Regulations]
[Title 48, Volume 5]
[Revised as of October 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 48CFR752.7012]

[Page 80-81]
 
            TITLE 48--FEDERAL ACQUISITION REGULATIONS SYSTEM
 
             CHAPTER 7--AGENCY FOR INTERNATIONAL DEVELOPMENT
 
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

[[Page 81]]

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 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]