[Federal Register: July 29, 2009 (Volume 74, Number 144)]
[Rules and Regulations]
[Page 37648-37649]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29jy09-29]
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DEPARTMENT OF DEFENSE
Defense Acquisition Regulations System
48 CFR Parts 207, 235, and 252
RIN 0750-AF96
Defense Federal Acquisition Regulation Supplement; Protection of
Human Subjects in Research Projects (DFARS Case 2007-D008)
AGENCY: Defense Acquisition Regulations System, Department of Defense
(DoD).
ACTION: Final rule.
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SUMMARY: DoD has issued a final rule amending the Defense Federal
Acquisition Regulation Supplement (DFARS) to address requirements for
the protection of human subjects involved in research projects. The
rule contains a clause for use in contracts that include or may include
research involving human subjects.
DATES: Effective Date: July 29, 2009.
FOR FURTHER INFORMATION CONTACT: Mr. Mark Gomersall, Defense
Acquisition Regulations System, OUSD (AT&L) DPAP (DARS), IMD 3D139,
3062 Defense Pentagon, Washington, DC 20301-3062. Telephone 703-602-
0302; facsimile 703-602-7887. Please cite DFARS Case 2007-D008.
SUPPLEMENTARY INFORMATION:
A. Background
This final rule adds DFARS policy addressing statutory and
regulatory requirements for the ethical treatment of human subjects
involved in research projects. The rule contains a clause for use in
contracts involving human subjects in research, to inform contractors
of their responsibilities for compliance with 32 CFR Part 219; DoD
Directive 3216.02; applicable DoD component policies; 10 U.S.C. 980;
and, when applicable, Food and Drug Administration policies and
regulations.
DoD published a proposed rule at 73 FR 63666 on October 27, 2008.
DoD received no comments on the proposed rule. Therefore, DoD has
adopted the proposed rule as a final rule without change.
This rule was subject to Office of Management and Budget review
under Executive Order 12866, dated September 30, 1993.
B. Regulatory Flexibility Act
DoD certifies that this final rule will not have a significant
economic impact on a substantial number of small entities within the
meaning of the Regulatory Flexibility Act, 5 U.S.C. 601, et seq.,
because the rule is a reinforcement of existing requirements and
obligations that apply with regard to the protection of human subjects
involved in research projects.
C. Paperwork Reduction Act
The Paperwork Reduction Act does not apply, because the rule does
not contain any new information collection requirements that require
the approval of the Office of Management and Budget under 44 U.S.C.
3501, et seq.
List of Subjects in 48 CFR Parts 207, 235, and 252
Government procurement.
Michele P. Peterson,
Editor, Defense Acquisition Regulations System.
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Therefore, 48 CFR parts 207, 235, and 252 are amended as follows:
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1. The authority citation for 48 CFR parts 207, 235, and 252 continues
to read as follows:
Authority: 41 U.S.C. 421 and 48 CFR Chapter 1.
PART 207--ACQUISITION PLANNING
0
2. Section 207.172 is added to read as follows:
207.172 Human research.
Any DoD component sponsoring research involving human subjects--
(a) Is responsible for oversight of compliance with 32 CFR Part
219, Protection of Human Subjects; and
(b) Must have a Human Research Protection Official, as defined in
the clause at 252.235-7004, Protection of Human Subjects, and
identified in the DoD component's Human Research Protection Management
Plan. This official is responsible for the oversight and execution of
the requirements of the clause at 252.235-7004 and shall be identified
in acquisition planning.
PART 235--RESEARCH AND DEVELOPMENT CONTRACTING
0
3. Section 235.072 is amended by adding paragraph (e) to read as
follows:
235.072 Additional contract clauses.
* * * * *
(e) Use the clause at 252.235-7004, Protection of Human Subjects,
in solicitations and contracts that include or may include research
involving human subjects in accordance with 32 CFR Part 219, DoD
Directive 3216.02, and 10 U.S.C. 980, including research that meets
exemption criteria under 32 CFR 219.101(b). The clause--
(1) Applies to solicitations and contracts awarded by any DoD
component, regardless of mission or funding Program Element Code; and
(2) Does not apply to use of cadaver materials alone, which are not
directly regulated by 32 CFR Part 219 or DoD Directive 3216.02, and
which are governed by other DoD policies and applicable State and local
laws.
PART 252--SOLICITATION PROVISIONS AND CONTRACT CLAUSES
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4. Section 252.235-7004 is added to read as follows:
252.235-7004 Protection of Human Subjects.
As prescribed in 235.072(e), use the following clause:
[[Page 37649]]
PROTECTION OF HUMAN SUBJECTS (JUL 2009)
(a) Definitions. As used in this clause--
(1) Assurance of compliance means a written assurance that an
institution will comply with requirements of 32 CFR Part 219, as
well as the terms of the assurance, which the Human Research
Protection Official determines to be appropriate for the research
supported by the Department of Defense (DoD) component (32 CFR
219.103).
(2) Human Research Protection Official (HRPO) means the
individual designated by the head of the applicable DoD component
and identified in the component's Human Research Protection
Management Plan as the official who is responsible for the oversight
and execution of the requirements of this clause, although some DoD
components may use a different title for this position.
(3) Human subject means a living individual about whom an
investigator (whether professional or student) conducting research
obtains data through intervention or interaction with the
individual, or identifiable private information (32 CFR 219.102(f)).
For example, this could include the use of human organs, tissue, and
body fluids from individually identifiable living human subjects as
well as graphic, written, or recorded information derived from
individually identifiable living human subjects.
(4) Institution means any public or private entity or agency (32
CFR 219.102(b)).
(5) Institutional Review Board (IRB) means a board established
for the purposes expressed in 32 CFR Part 219 (32 CFR 219.102(g)).
(6) IRB approval means the determination of the IRB that the
research has been reviewed and may be conducted at an institution
within the constraints set forth by the IRB and by other
institutional and Federal requirements (32 CFR 219.102(h)).
(7) Research means a systematic investigation, including
research, development, testing, and evaluation, designed to develop
or contribute to generalizable knowledge. Activities that meet this
definition constitute research for purposes of 32 CFR Part 219,
whether or not they are conducted or supported under a program that
is considered research for other purposes. For example, some
demonstration and service programs may include research activities
(32 CFR 219.102(d)).
(b) The Contractor shall oversee the execution of the research
to ensure compliance with this clause. The Contractor shall comply
fully with 32 CFR Part 219 and DoD Directive 3216.02, applicable DoD
component policies, 10 U.S.C. 980, and, when applicable, Food and
Drug Administration policies and regulations.
(c) The Contractor shall not commence performance of research
involving human subjects that is covered under 32 CFR Part 219 or
that meets exemption criteria under 32 CFR 219.101(b), or expend
funding on such effort, until and unless the conditions of either
the following paragraph (c)(1) or (c)(2) have been met:
(1) The Contractor furnishes to the HRPO, with a copy to the
Contracting Officer, an assurance of compliance and IRB approval and
receives notification from the Contracting Officer that the HRPO has
approved the assurance as appropriate for the research under the
Statement of Work and also that the HRPO has reviewed the protocol
and accepted the IRB approval for compliance with the DoD component
policies. The Contractor may furnish evidence of an existing
assurance of compliance for acceptance by the HRPO, if an
appropriate assurance has been approved in connection with previous
research. The Contractor shall notify the Contracting Officer
immediately of any suspensions or terminations of the assurance.
(2) The Contractor furnishes to the HRPO, with a copy to the
Contracting Officer, a determination that the human research
proposed meets exemption criteria in 32 CFR 219.101(b) and receives
written notification from the Contracting Officer that the exemption
is determined acceptable. The determination shall include citation
of the exemption category under 32 CFR 219.101(b) and a rationale
statement. In the event of a disagreement regarding the Contractor's
furnished exemption determination, the HRPO retains final judgment
on what research activities or classes of research are covered or
are exempt under the contract.
(d) DoD staff, consultants, and advisory groups may
independently review and inspect the Contractor's research and
research procedures involving human subjects and, based on such
findings, DoD may prohibit research that presents unacceptable
hazards or otherwise fails to comply with DoD procedures.
(e) Failure of the Contractor to comply with the requirements of
this clause will result in the issuance of a stop-work order under
Federal Acquisition Regulation clause 52.242-15 to immediately
suspend, in whole or in part, work and further payment under this
contract, or will result in other issuance of suspension of work and
further payment for as long as determined necessary at the
discretion of the Contracting Officer.
(f) The Contractor shall include the substance of this clause,
including this paragraph (f), in all subcontracts that may include
research involving human subjects in accordance with 32 CFR Part
219, DoD Directive 3216.02, and 10 U.S.C. 980, including research
that meets exemption criteria under 32 CFR 219.101(b). This clause
does not apply to subcontracts that involve only the use of cadaver
materials.
(End of clause)
[FR Doc. E9-17949 Filed 7-28-09; 8:45 am]
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