Defense Federal Acquisition Regulation Supplement; Protection of Human Subjects in Research Projects (DFARS Case 2007-D008), 63666-63667 [E8-25562]

Agencies

• Defense Acquisition Regulations System
• DEPARTMENT OF DEFENSE

[Federal Register Volume 73, Number 208 (Monday, October 27, 2008)]
[Proposed Rules]
[Pages 63666-63667]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-25562]


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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: Proposed rule with request for comments.

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SUMMARY: DoD is proposing to amend the Defense Federal Acquisition 
Regulation Supplement (DFARS) to address requirements for the 
protection of human subjects involved in research projects. The 
proposed rule contains a clause for use in contracts that include or 
may include research involving human subjects.

DATES: Comments on the proposed rule should be submitted in writing to 
the address shown below on or before December 26, 2008, to be 
considered in the formation of the final rule.

ADDRESSES: You may submit comments, identified by DFARS Case 2007-D008, 
using any of the following methods:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments.
     E-mail: dfars@osd.mil. Include DFARS Case 2007-D008 in the 
subject line of the message.
     Fax: 703-602-7887.
     Mail: Defense Acquisition Regulations System, Attn: Mr. 
Mark Gomersall, OUSD (AT&L) DPAP (DARS), IMD 3D139, 3062 Defense 
Pentagon, Washington, DC 20301-3062.
     Hand Delivery/Courier: Defense Acquisition Regulations 
System, Crystal Square 4, Suite 200A, 241 18th Street, Arlington, VA 
22202-3402.
    Comments received generally will be posted without change to http:/
/www.regulations.gov, including any personal information provided.

FOR FURTHER INFORMATION CONTACT: Mr. Mark Gomersall, 703-602-0302.

SUPPLEMENTARY INFORMATION: 

A. Background

    This proposed rule addresses statutory and regulatory requirements 
for the ethical treatment of human subjects involved in research 
projects. The proposed 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.
    This proposed rule was subject to Office of Management and Budget 
review under Executive Order 12866, dated September 30, 1993.

B. Regulatory Flexibility Act

    DoD does not expect this proposed rule to 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 proposed rule is a reinforcement of existing requirements 
and obligations that apply with regard to the protection of human 
subjects involved in research projects. Therefore, DoD has not 
performed an initial regulatory flexibility analysis. DoD invites 
comments from small businesses and other interested parties. DoD also 
will consider comments from small entities concerning the affected 
DFARS subparts in accordance with 5 U.S.C. 610. Such comments should be 
submitted separately and should cite DFARS Case 2007-D008.

C. Paperwork Reduction Act

    The Paperwork Reduction Act does not apply, because the proposed 
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.
    Therefore, 48 CFR Parts 207, 235, and 252 are proposed to be 
amended as follows:
    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

    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

[[Page 63667]]

    (b) Must have a Human Research Protection Official, as defined in 
the clause at 252.235-70XX, 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 252.235-70XX and shall be identified 
in acquisition planning.

PART 235--RESEARCH AND DEVELOPMENT CONTRACTING

    3. Section 235.072 is amended by adding paragraph (e) to read as 
follows:


235.072  Additional contract clauses.

* * * * *
    (e) Use the clause at 252.235-70XX, 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

    4. Section 252.235-70XX is added to read as follows:


252.235-70XX  Protection of Human Subjects.

    As prescribed in 235.072(e), use the following clause:

PROTECTION OF HUMAN SUBJECTS (XXX 2008)

    (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. E8-25562 Filed 10-24-08; 8:45 am]
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