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Appendix C
DoD Instruction 3216.02
Protection of Human Subjects and
Adherence to Ethical Standards
in DoD-Supported Research
DoD Instruction 3216.02 "establish[es] policy and assign[s] responsi-
bilities for the protection of human subjects in DoD-supported programs to
implement . . . `the Common Rule.'" The text below reproduced the version
of the document dated November 8, 2011, the most current available when
this report was completed.
Chapter 3 of the report discusses this and other military rules address-
ing human subjects research and privacy.
145
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Department of Defense
INSTRUCTION
NUMBER 3216.02
November 8, 2011
USD(AT&L)
SUBJECT: Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported
Research
References: See Enclosure 1
1. PURPOSE. This Instruction reissues DoD Directive (DoDD) 3216.02 (Reference (a)) as a DoD
Instruction in accordance with the authority in DoDD 5134.01 (Reference (b)) to establish policy
and assign responsibilities for the protection of human subjects in DoD-supported programs to
implement part 219 of title 32, Code of Federal Regulations (CFR) (also known and hereinafter
referred to as "the Common Rule" (Reference (c)).
2. APPLICABILITY
a. This Instruction applies to:
(1) OSD, the Military Departments, the Office of the Chairman of the Joint Chiefs
of Staff and the Joint Staff, the Combatant Commands, the Office of the
Inspector General of the Department of Defense, the Defense Agencies, the
DoD Field Activities, and all other organizational entities within the
Department of Defense (hereinafter referred to collectively as the "DoD
Components").
(2) All DoD-conducted or -supported research involving human subjects as
defined in the Glossary. All such activities must include both systematic
investigation designed to develop or contribute to generalizable knowledge
AND involve a living individual about whom an investigator conducting
research obtains data through intervention or interaction with the individual or
about whom identifiable private information is obtained. All activities meeting
both of these conditions will hereinafter be referred to as "research involving
human subjects" in this Instruction.
(3) Activities such as research, development, testing, and evaluation (RDT&E) that
meet the definition of research involving human subjects (as defined in the
Glossary), as well as clinical investigations or medical activities regulated by
the Food and Drug Administration (FDA) in parts 50, 56, 312, 600, and 812 of
title 21, CFR (Reference (d)). DoDI 3216.02, November 8, 2011
b. Applicability is not dependent upon the budget activities funding the research, the
mission of the DoD organization conducting or supporting the research, the security
classification of the research, the location of the research in the United States or a foreign
country, or whether the research is conducted or supported under a program that is not
considered research for other purposes.
3. DEFINITIONS. See Glossary.
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APPENDIX C 147
4. POLICY. It is DoD policy that:
a. All research involving human subjects that is conducted or supported by the Department
of Defense shall comply with part 219 of Reference (c), which incorporates the ethical
principles of respect for persons, beneficence, and justice, as codified in page 23192 of
the Federal Register (also known as "The Belmont Report" (Reference (e)).
b. Certain categories of human subjects in research are recognized as vulnerable
populations, groups, or individuals and are afforded additional protections as specified in
section 7 of Enclosure 3 of this Instruction.
c. Research involving human subjects for testing of chemical or biological warfare agents is
generally prohibited by section 1520a of title 50, United States Code (U.S.C.) (Reference
(f)), subject to possible exceptions for research for prophylactic, protective, or other
peaceful purposes.
d. DoD-appropriated funds shall not be used to support research involving a human being as
an experimental subject, as defined in this Instruction, without the prior informed consent
of the experimental subject or in accordance with section 980 of title 10, U.S.C.
(Reference (g)) and this Instruction (see section 9 of Enclosure 3 of this Instruction for
details). The definitions of research involving a human being as an experimental subject
and research involving human subjects are different; see the Glossary for an explanation.
e. Research involving human subjects covered under this Instruction shall also comply with
applicable Federal and State laws and regulations. When the research is conducted
outside of the United States, it must also comply with applicable requirements of the
foreign country and its national laws and requirements. In the event of an unresolved
conflict between this Instruction, including its references, and other applicable laws and
requirements such that compliance with both is impossible, the requirements most
protective of the human subjects shall be followed. When there is an unresolved conflict,
DoD Components shall consult with legal counsel and seek guidance from the Assistant
Secretary of Defense for Research and Engineering (ASD(R&E)).
5. RESPONSIBILITIES. See Enclosure 2.
6. PROCEDURES. See Enclosure 3.
7. RELEASABILITY. UNLIMITED. This Instruction is approved for public release and is available
on the Internet from the DoD Issuances Website at http://www.dtic.mil/whs/directives.
8. EFFECTIVE DATE. This Instruction is effective upon its publication to the DoD Issuances
Website.
Enclosures
1. References
2. Responsibilities
3. Procedures
Glossary
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ENCLOSURE 1
REFERENCES
(a) DoD Directive 3216.02, "Protection of Human Subjects and Adherence to Ethical Standards in
DoD-Supported Research," March 25, 2002 (hereby cancelled)
(b) DoD Directive 5134.01, "Under Secretary of Defense for Acquisition, Technology and Logistics
(USD(AT&L))," December 9, 2005
(c) Parts 22 (Appendix B), 37 (Appendix D), 108 and 2191 of title 32, Code of Federal Regulations
(d) Parts 50, 56, 312, 600, and 812 of title 21, Code of Federal Regulations
(e) Page 23192 of Volume 44, Federal Register, April 18, 1979 (also known as "The Belmont
Report")2
(f) Section 1520a of title 50, United States Code
(g) Sections 139(a)(2)(A), 980, 1074f , and 1102 of title 10, United States Code
(h) Part 46, subparts A-D of title 45, Code of Federal Regulations
(i) Memorandum of Understanding between the Food and Drug Administration and the Department
of Defense, "Concerning Investigational Use of Drugs, Antibiotics, Biologics, and Medical
Devices by the Department of Defense," May 21, 1987
(j) Sections 241(d) and 289g289g-2 of title 42, United States Code
(k) Public Law 107-347, "Confidential Information Protection and Statistical Efficiency Act of 2002
(CIPSEA)," December 17, 2002
(l) Pages 33362-33377 of Volume 72, Federal Register, June 15, 2007
(m) Sections 2105, 3109, 3371-3376,3 and 5536 of title 5, United States Code
(n) Sections 2.101 and 252.235-7004 of title 48, Code of Federal Regulations
(o) Section 252 of Public Law 103-160, "National Defense Authorization Act for Fiscal Year 1994,"
November 30, 1993
(p) DoD Directive 2310.01E, "The Department of Defense Detainee Program," September 5, 2006
(q) Section 30 of title 24, United States Code
(r) Executive Order 13526, "Classified National Security Information," December 29, 2009
(s) DoD 6025.18-R, "DoD Health Information Privacy," January 24, 2003
(t) Executive Order 12333, "United States Intelligence Activities," as amended, August 18, 2010
(u) DoD 5400.11-R, "Department of Defense Privacy Program," May 14, 2007
(v) DoDI 6000.08, "Funding and Administration of Clinical Investigation Programs," December 3,
2007
(w) DoD Instruction 5025.01, "DoD Directives Program," October 28, 2007
1
Also known as "the Common Rule"
2
Available on the Internet at http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm. The Belmont Report's
2-volume appendix is available from the Government Printing Office as DHEW Publication Nos. (OS) 78-0013 and
(OS) 78-0014
3
Also known as "The Intergovernmental Personnel Act of 1970, as amended"
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APPENDIX C 149
(x) DoD Instruction 6200.02, "Application of Food and Drug Administration (FDA) Rules to
Department of Defense Force Health Protection Program," February 27, 2008
(y) DoD Instruction 6025.13, "Medical Quality Assurance (MQA) and Clinical Quality Management
in the Military Health System (MHS)," February 17, 2011
(z) DoD Directive 5240.01, "DoD Intelligence Activities," August 27, 2007 DoDI 3216.02,
November 8, 2011
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ENCLOSURE 2
RESPONSIBILITIES
1. ASD(R&E). The ASD(R&E), under the authority, direction, and control of the Under Secretary
of Defense for Acquisition, Technology, and Logistics, shall:
a. Be the single DoD point of contact for all matters related to DoD compliance with this
Instruction and shall act as the principal DoD liaison with organizations outside the
Department of Defense on matters pertaining to research involving human subjects.
b. Provide guidance and procedures necessary to implement this Instruction. The
ASD(R&E) will consult with the Assistant Secretary of Defense for Health Affairs
(ASD(HA)) for matters affecting medical research involving human subjects.
c. Exercise the authorities of the Head of the Department identified in part 219 of Reference
(c), the Secretary as identified in subparts B-D of part 46 of title 45, CFR (Reference (h))
for research described in section 7 of Enclosure 3 of this Instruction, and the Secretary of
Defense identified in section 980 of Reference (g).
d. Grant exceptions to any procedures or requirements in this Instruction based upon an
appropriate justification from the Head of an OSD or DoD Component and consistent
with law.
e. Establish a process to oversee the DoD Components' implementation of their respective
Component human research protection program (HRPP) management plan and
compliance with this Instruction.
f. Establish a framework for educational training requirements for DoD personnel in key
HRPP roles commensurate with their duties and responsibilities.
g. Work with the DoD Components supporting international research involving human
subjects to resolve conflicts between this Instruction, including its references, and other
applicable foreign laws and requirements.
h. Maintain a list of foreign country and international standards that are at least equivalent
to those in part 219 of Reference (c).
i. Designate DoD representatives to Federal committees, such as the Human Subject
Research Subcommittee of the National Science and Technology Council's Committee
on Science or other committees established by the White House.
j. Designate a DoD representative to the Secretary's Advisory Committee on Human
Research Protection established by the Secretary of Health and Human Services (HHS)
and successor entities established by the Secretary of HHS.
k. Establish the DoD Coordinating Committee for Human Research Protection Programs
(CCHRPP) to act as the central advisory committee to the ASD(R&E) on all matters
regarding the ethical involvement of human subjects in research. Membership shall be
appointed as described in section 18 of Enclosure 3 of this Instruction.
2. ASD(HA). The ASD(HA), under the authority, direction, and control of the Under Secretary of
Defense for Personnel and Readiness (USD(P&R)), shall:
a. Advise the ASD(R&E) on matters related to the participation of human subjects in
research, especially regarding medical safety, bioethics, and standards of professional
health care and conduct.
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APPENDIX C 151
b. Represent the Department of Defense on matters relating to implementation of FDA
regulatory requirements in Reference (d) and the Memorandum of Understanding
between the FDA and the Department of Defense (Reference (i)).
3. HEADS OF THE OSD AND DoD COMPONENTS. The Heads of the OSD and DoD
Components that conduct or support research involving human subjects covered by this
Instruction shall:
a. Develop, issue, and monitor a Component HRPP management plan (see section 1 of
Enclosure 3 of this Instruction for details).
b. Establish and oversee DoD Component policies and procedures that ensure compliance
with this Instruction and any other supplementing or implementing issuances (see section
1 of Enclosure 3 for details).
c. Exercise the authority as outlined in this Instruction.
d. Oversee each institutional official's (IO) (see Glossary) implementation of their
organization's HRPP.
e. Provide members to intra- and interagency committees and to the CCHRPP when
requested by the ASD(R&E) consistent with section 18 of Enclosure 3.
f. Provide in a timely manner to the ASD(R&E) the following:
(1) A copy of all reports provided to the appropriate Congressional Committees in
accordance with Reference (f) for any research involving human subjects for
testing of chemical or biological warfare agents. DoD Components shall also
send a copy to the Assistant Secretary of Defense for Nuclear, Chemical, and
Biological Defense Programs.
(2) Copies of any waivers from requirements that have been granted in accordance
with this Instruction.
(3) Copies of any approved fetal research covered under sections 289g289g-2 of
title 42, U.S.C. (Reference (j)).
(4) Copies of any research involving human subjects conducted consistent with
section 512 of Public Law 107-347 (Reference (k)). DoD Components shall
also send a copy to the Office of Management and Budget (OMB), as required
by Reference (k) and pages 33362-33377 of Volume 72, Federal Register
(Reference (l)).
(5) Any allegation of serious or continuing noncompliance related to research
involving human subjects that has been substantiated by inquiry or
investigation and any subsequent actions taken based on the findings consistent
with section 16 of Enclosure 3. The DoD Component may send an initial
notification of potential serious or continuing noncompliance to ASD(R&E)
based on the gravity or magnitude of the initial allegation.
(6) Any notifications to a DoD Component by another Federal agency or by an
appropriate State agency or foreign government that an institution of the
Component is under investigation for cause or for noncompliance with the
applicable laws and regulations, including the Common Rule.
(7) Any substantiated unanticipated problems involving risks to human subjects or
others (UPIRTSO).
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g. Maintain all records identified in this Instruction or required by a reference in this
Instruction as described in section 15 of Enclosure 3.
4. IOs OF DoD INSTITUTIONS. Each IO, under the authority, direction, and control of the Heads
of the OSD and DoD Components shall:
a. Establish and maintain an HRPP to ensure the institution's compliance with this
Instruction.
b. Provide the resources needed to ensure compliance with this Instruction.
c. Establish and maintain a DoD assurance and other appropriate Federal assurances, if the
institution is engaged in non-exempt research involving human subjects (see Glossary).
d. Evaluate and improve the institution's HRPP.
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APPENDIX C 153
ENCLOSURE 3
PROCEDURES
1. DoD COMPONENT HRPP MANAGEMENT PLAN
a. The DoD Component HRPP management plan shall include, by reference, DoD
Component policies to implement the procedures set forth in this enclosure and
identify the responsible DoD Component office(s) for actions identified in this
Instruction. DoD Component policies may be more restrictive than the requirements
in this Instruction, but they may not be less restrictive. They may also impose
additional requirements needed to implement this Instruction.
b. The plan shall identify a single, senior official having the authority and responsibility
for implementing the DoD Component HRPP management plan. This authority shall
not be delegated lower than the general or flag officer (GO/FO), Senior Executive
Service (SES), or equivalent level. All authorities delegated by the Head of the OSD
or DoD Component must be identified in the management plan.
c. The plan shall reference DoD Component policies and procedures that:
(1) Direct each institution within the DoD Component conducting or
supporting research involving human subjects to establish an HRPP that is
compliant with this Instruction and the DoD Component's HRPP
management plan.
(2) Describe DoD Component oversight of each institution's HRPP.
(3) Describe DoD Component administrative review of DoD-conducted and -
supported research involving human subjects (see sections 3 and 4 of this
enclosure for details).
(4) Delineate institutional responsibilities when performing research involving
human subjects in collaboration with another DoD Component. These
responsibilities shall include establishing written agreements for tasks such
as minimizing the number of institutional review boards (IRBs) and DoD
Components that review and approve the research (see sections 3 and 4 of
this enclosure for details). DoD Component policies and procedures shall
include a requirement to justify the duplication of reviews of protocols (for
example, IRB and Component Headquarters reviews).
(5) Outline education and training for implementation, management, and
oversight of this Instruction (see paragraph 1.f. of Enclosure 2 and section
5 of this enclosure for details).
(6) Address the management of allegations and findings of noncompliance
concerning DoD-conducted and -supported research involving human
subjects (see section 16 of this enclosure for details).
(7) Identify and manage conflicts of interest, not limited to financial, for DoD
personnel involved in the HRPP.
(8) Require a process to evaluate and improve the DoD Component's
implementation of its HRPP management plan down to the level of the
institutional HRPP.
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d. A DoD Component may rely on another DoD Component for implementation of
elements of the management plan except for designation of the single, senior official
responsible for the management plan identified in paragraph 1.b. of this enclosure.
Any such reliance must be reflected in the DoD Component's HRPP management
plan.
2. REQUIREMENTS FOR A FEDERAL ASSURANCE
a. Activities for Which an Institution is Required to Have a Federal Assurance. Any
institution engaged in non-exempt research involving human subjects that is
conducted or supported by the Department of Defense shall have a Federal assurance
consistent with section 219.103 of Reference (c) and acceptable to the funding
agency.
(1) A DoD institution engaged in non-exempt research involving human
subjects shall have a DoD assurance of compliance. Additionally, a DoD
institution shall have an HHS assurance when engaged in non-exempt
research involving human subjects funded by HHS (unless HHS will
accept a DoD assurance). When conducting HHS-funded research
involving human subjects, the DoD institution must follow this Instruction
and any additional HHS requirements.
(2) In complying with the requirements of section 219.103 of Reference (c), a
non-DoD institution that is engaged in DoD-supported non-exempt
research involving human subjects:
(a) Need not have a DoD assurance if it has an existing Federal
assurance appropriate for the research being conducted. If the
institution does not have a Federal assurance, the institution must
provide either a DoD assurance to the DoD Component supporting
the research or a Federal wide assurance to HHS, Office for Human
Research Protections. Alternatively, if the institution does not have a
Federal assurance, the researcher may use an Individual Investigator
Agreement to associate with an institution having a Federal
assurance and thus fulfill the requirement of conducting non-exempt
research involving human subjects under an approved Federal
assurance. In summary, all researchers conducting non-exempt
research involving human subjects must be covered either directly
under their institution's Federal assurance or indirectly using an
Individual Investigator Agreement.
(b) Shall comply with the terms of its Federal assurance, applicable
sections of this Instruction, and relevant policies of the supporting
DoD Component.
(3) All institutions providing a DoD assurance to a designated DoD
Component office shall include the items identified in section 219.103(b)
of Reference (c).
(a) All institutions shall identify at least one IRB on their DoD
assurance. DoD institutions shall identify all IRBs that are internal to
the institution on their DoD assurance.
(b) When any institution relies upon another institution's IRB, there
must be a written agreement defining the responsibilities and
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APPENDIX C 155
authorities of each organization in complying with the terms of each
institution's Federal assurance and this Instruction (e.g., an
Institutional Agreement for IRB Review). The existence of a DoD
Institutional Agreement for IRB Review or a similar agreement will
satisfy the Federal assurance requirements at sections 219.103(b)(2)-
(5) of Reference (c).
b. Activities for Which an Institution is not Required to Have a Federal Assurance
(1) An institution is not required to have a Federal assurance if its personnel
only conduct research that does not involve human subjects or the research
involving human subjects meets at least one of the exemption criteria in
section 219.101(b) of Reference (c).
(2) An institution that is only providing resources to support research
involving human subjects (see Glossary definition of DoD-supported
research involving human subjects) is not required to have a Federal
assurance unless its involvement also meets the definition of being engaged
in non-exempt research involving human subjects. When a DoD institution
passes resources to another institution that will not be engaged in research,
but will only transfer the resources to a third institution that will engage in
research involving human subjects, the pass through institution is not
required to have a Federal assurance. The institution engaged in non-
exempt research involving human subjects must have a Federal assurance.
(3) An institution is not required to have a Federal assurance if it is
collaborating in a research protocol that is non-exempt research involving
human subjects and the institution's role in the collaborative research is
limited to any of the following:
(a) Specific tasks that do not involve research involving human subjects;
or
(b) Specific tasks that do not include the collection or handling of
identifiable data or specimens. Research in which the human
subjects' data or specimens are coded and the institution is prevented
from having access to the code are considered non-identifiable for
the purpose of this subparagraph.
(4) A DoD institution that does not meet the criteria for requiring a Federal
assurance but conducts only exempt research involving human subjects or
supports research involving human subjects must have an HRPP approved
by its DoD Component that includes relevant policies and procedures to
ensure compliance with this Instruction.
3. DoD-CONDUCTED RESEARCH INVOLVING HUMAN SUBJECTS
a. DoD Institutional Approval and Oversight
(1) DoD institutions conducting intramural research as defined in the Glossary
involving human subjects shall have procedures to ensure appropriate
regulatory determinations for activities that constitute research, activities
that constitute research involving human subjects, or activities that are
research involving human subjects but that meet the exemption criteria in
section 219.101(b) of Reference (c). Such procedures shall include the
designation, oversight, and appropriate training of DoD personnel.
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in non-exempt research involving human subjects and that are a direct
result of research activities performed by DoD personnel. This does not
apply to expenses resulting from the injury due to actions performed by the
non-DoD institution(s).
(2) When DoD personnel are conducting the research involving human
subjects at the collaborating institution and the Department of Defense
does not have the primary involvement, the DoD Components are not
required to have procedures to protect human subjects from medical
expenses. For this purpose the determination of primary involvement shall
be based on consideration of the type and portion of the DoD involvement
in the collaborative research (e.g., research staff, human subjects, facilities,
equipment, IRB, and all other assets).
(3) When the collaboration is such that it is difficult to separate DoD
involvement from that of the non-DoD institution, the Head of the OSD or
DoD Component may waive this requirement to have procedures to protect
human subjects from medical expenses. This waiver authority may be
delegated, as described in the Component's HRPP management plan, but
not at or below the position of the institution's DoD IO.
11. COMPENSATION TO HUMAN SUBJECTS FOR PARTICIPATION IN RESEARCH
a. DoD-Conducted Research Involving Human Subjects
(1) When the Human Subjects Are On-Duty Federal Personnel
(a) Federal personnel (civil servants or Service members) participating
as human subjects in DoD-conducted research while on duty (i.e.,
not on leave and participating during their duty hours) may be
compensated up to $50 for each blood draw if the research meets the
purpose of section 30 of title 24, U.S.C. (Reference (q)). Payment for
blood draws may come directly from a Federal or non-Federal
source. By permitting compensation for blood draws, Reference (q)
provides an exception to section 5536 of Reference (m), which
prohibits Federal personnel from being paid by any source other than
their regular Federal salaries while they are on duty.
(b) Federal personnel participating as human subjects in DoD-conducted
research while on duty may only be compensated for blood draws as
described in this paragraph and may not be otherwise compensated
for general research participation.
(2) When the Human Subjects Are Off-Duty Federal Personnel
(a) Federal personnel (civil servants or Service members) participating
as human subjects in DoD-conducted research while off duty may be
compensated up to $50 for each blood draw if the research meets the
purpose of Reference (q). Payment for blood draws may come from
a Federal or non-Federal source.
(b) Additionally Federal personnel while off duty may be compensated
for research participation other than blood draws in the same way as
human subjects who are not Federal personnel (i.e., compensated for
participation in a reasonable amount as approved by the IRB
according to local prevailing rates and the nature of the research).
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APPENDIX C 169
However, payment to off-duty Federal personnel for research
participation other than blood draws must not be directly from a
Federal source (payment from a Federal contractor or other non-
Federal source is permissible).
(3) When the Human Subjects Are Not Federal Personnel
(a) Non-Federal personnel participating as human subjects in DoD-
conducted research may be compensated up to $50 for each blood
draw if the research meets the purpose of Reference (q). Payment for
blood draws may come directly from a Federal or non-Federal
source.
(b) Additionally non-Federal personnel may be compensated for
research participation other than blood draws in a reasonable amount
as approved by the IRB according to local prevailing rates and the
nature of the research. Payment for general research participation
may come directly from a Federal or non-Federal source.
b. Non DoD-Conducted Research Involving Human Subjects
(1) When the Human Subjects Are On-Duty Federal Personnel
(a) Federal personnel (civil servants or Service members) participating
as human subjects in research conducted by a non-DoD institution
(whether or not the research is Federally funded) may be
compensated up to $50 for each blood draw if the research meets the
purpose of Reference (q). By permitting compensation for blood
draws, Reference (q) provides an exception to section 5536 of
Reference (m), which prohibits Federal personnel from being paid by
any source other than their regular Federal salaries while they are on
duty.
(b) Federal personnel participating as human subjects in non-DoD-
conducted research while on duty may only be compensated for
blood draws as described in this paragraph and may not be otherwise
compensated for general research participation, even if the research
is not Federally funded or conducted.
(2) When the Human Subjects Are Off-Duty Federal Personnel
(a) Federal personnel (civil servants or Service members) participating
as human subjects in Federally-funded human subject research
conducted by a non-DoD institution may be compensated up to $50
for each blood draw if the research meets the purpose of Reference
(q). However, if the research is not Federally funded, the human
subjects may be compensated for blood draws in a reasonable
amount as approved by the IRB according to local prevailing rates
and the nature of the blood draw unless it is prohibited by this
Instruction or another policy (i.e., the $50 limitation per blood draw
does not apply).
(b) Additionally Federal personnel while off duty may be compensated
for research participation other than blood draws in the same way as
human subjects who are not Federal personnel (i.e., compensated for
participation in a reasonable amount as approved by the IRB
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according to local prevailing rates and the nature of the research).
However, payment to off-duty Federal personnel for general research
participation must not be directly from a Federal source (payment
from a Federal contractor or other non-Federal source is
permissible).
(3) When the Human Subjects Are Not Federal Personnel
(a) Non-Federal personnel participating as human subjects in DoD-
funded research may be compensated up to $50 for each blood draw
if the research meets the purpose of Reference (q).
(b) Additionally non-Federal personnel may be compensated for
participation in DoD-supported research for other than blood draws
in a reasonable amount as approved by the IRB according to local
prevailing rates and the nature of the research. Payment for general
research participation may come directly from a Federal or non-
Federal source.
12. SERVICE MEMBERS AND THEIR STATUS AS ADULTS. For purposes of legal capacity
to participate in DoD-conducted or -supported research involving human subjects, all active
duty Service members and all Reserve Component members in a Federal duty status are
considered for purposes of this Instruction to be adults. The participation of such members is
not subject to requirements of paragraph 7.d. of this enclosure or subpart D of Reference (h)
regarding research involving children or minors. When Service members are under 18 years
of age, students at Service Academies, or trainees, the IRB shall carefully consider the
recruitment process and the necessity to include such members as human subjects.
13. CLASSIFIED RESEARCH INVOLVING HUMAN SUBJECTS. For all DoD-conducted
non-exempt research involving human subjects that involves classified information as defined
in Executive Order 13526 (Reference (r)), and, to the extent provided pursuant to Parts 22,
37, and 219 of Reference (c) and Reference (n), comparable DoD-supported research, the
additional requirements in this section apply. The involvement of classified information may
be limited to information needed for IRB approval and oversight of the research; information
needed to inform the human subjects during the consent process; and information provided by
the human subjects during the course of the research. If this activity is part of a classified
program, this section does not apply if the information required to be contained in the
research protocol or needed by either the IRB or the human subjects is not classified.
a. Secretary of Defense approval is required for all classified non-exempt research
involving human subjects. Submission for approval shall be from the Head of the
OSD or DoD Component conducting or supporting the non-exempt research
involving human subjects. The request shall be coordinated with the ASD(R&E) and
General Counsel of the Department of Defense after the IRB has approved the
research.
b. Waivers of informed consent are prohibited.
c. Informed consent procedures shall include:
(1) Identification of the Department of Defense as the supporting institution of
the research, unless the research involves no more than minimal risk. The
Secretary of Defense may grant an exception to this requirement on the
grounds that providing this information could compromise intelligence
sources or methods.
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(2) A statement that the research involving human subjects is classified and an
explanation of the impact of the classification.
d. IRB approval process shall meet the following requirements:
(1) IRB review shall be conducted using a full board review. Use of an
expedited review procedure is prohibited.
(2) At least one non-affiliated member shall be a non-Federal employee (other
than as an individual appointed as an expert or consultant in accordance
with section 3109 of Reference (m) for purposes of service on the IRB).
(3) Any IRB member who disagrees with a majority decision approving a
project may appeal the decision to the Secretary of Defense. The appeal
shall be included in the DoD Component's submission to the Secretary of
Defense.
(4) The IRB shall determine whether potential human subjects need access to
classified information to make a valid, informed consent decision.
e. Disclosure or use of classified information must comply with the requirements of
Reference (r) for access to and protection of classified information.
14. ADDITIONAL PROTECTIONS FOR CONFIDENTIALITY. This section outlines certain
authorities that the DoD Components may consider using, subject to applicable requirements,
for particular sensitive research activities when additional protections for confidentiality
would improve participation and results.
a. Confidential Information Protection and Statistical Efficiency Act (CIPSEA) for
Non-Statistical Agencies. Any DoD Component may use the authority pursuant to
sections 501-513 of Reference (k) to assure that data or information acquired by the
DoD Component under a pledge of confidentiality for exclusively statistical purposes
shall be used exclusively for statistical purposes and may not be disclosed in
identifiable form for any other purpose, except with the informed consent of the
respondent. Use of this authority is subject to the requirements of sections 512 and
523-525 of Reference (k) and of Reference (l), including that the research involving
human subjects is conducted by a DoD Component or other Federal agency and not
by a contractor, grantee, or other non-Federal entity, and that use of the authority is
reported annually to OMB by the DoD Component.
b. CIPSEA for Statistical Agencies. Any DoD Component or unit thereof designated a
statistical agency by the OMB pursuant to section 522 of Reference (k) and
Reference (l) may designate agents (e.g., contractor, grantee, or other non-Federal
entity under a qualifying agreement) that may assure that data or information
acquired for the Component under a pledge of confidentiality for exclusively
statistical purposes shall be used exclusively for statistical purposes, and may not be
disclosed in identifiable form for any other purpose, except with the informed
consent of the respondent. Use of this authority is subject to the requirements of
sections 512 and 523-525 of Reference (k) and of Reference (l).
c. Certificate of Confidentiality. A DoD Component or a contractor, grantee, or other
non-Federal entity conducting DoD-supported research involving human subjects
may request from the National Institutes of Health (NIH) of the Department of HHS
a Certificate of Confidentiality pursuant to section 241(d) of Reference (j). Such a
Certificate of Confidentiality authorizes persons engaged in biomedical, behavioral,
clinical, or other research related to mission areas of the NIH to protect the privacy of
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human subjects of sensitive research against compulsory disclosure in any Federal,
State, or local judicial, administrative, or legislative proceeding to identify human
subjects. Issuance of any Certificate of Confidentiality is at NIH's discretion and is
subject to the requirement of section 241(d) of Reference (j) and any other NIH
guidelines.
15. RECORD KEEPING
a. Part 219 of Reference (c) requires all institutions engaged in DoD-conducted or -
supported research involving human subjects to retain records for at least 3 years
after the completion of the research. Research involving human subjects may be
covered by other Federal regulations that impose longer record keeping requirements.
The DoD Components may rely on the non-DoD institutions to keep the required
records that were generated by the institution, or the DoD Components may make
arrangements to transfer the records.
b. The DoD Components shall also retain records regarding the oversight of DoD
Component-supported research involving human subjects for at least 3 years after the
completion of the research, HRPP education or training program, or other action
relevant to the HRPP. Additionally, the DoD Components shall keep all records
regarding DoD Component waivers, exemptions, and extensions, and all DoD
Component requests for exceptions, waivers, exemptions, and extensions submitted
to the ASD(R&E) for action for at least 3 years after the completion of the research.
c. The DoD Components may be required to retain records for longer than specified in
paragraphs 15.a. and 15.b. of this section. For example, some Health Insurance
Portability and Accountability Act documentation is required to be retained for 6
years (in accordance with DoD 6025.18-R (Reference (s))). For complete
recordkeeping guidance and instruction, the DoD Components shall consult their
respective records disposition schedules.
d. Records maintained by non-DoD institutions that document compliance or
noncompliance with this Instruction shall be made accessible for inspection and
copying by authorized representatives of the Department of Defense at reasonable
times and in a reasonable manner as determined by the supporting DoD Component.
16. NONCOMPLIANCE WITH THIS INSTRUCTION. The DoD Components shall respond to
allegations of noncompliance with this Instruction. For allegations that involve more than one
DoD Component or a non-DoD institution, the involved institutions should jointly determine
and assign executive responsibility for responding to the allegation(s). For allegations
involving a non-DoD institution, the DoD Component supporting the research involving
human subjects shall ensure the allegation is properly investigated and reported to the DoD
Component. All findings of serious or continuing noncompliance with this Instruction that
have been substantiated by inquiry or investigation shall be reported to the ASD(R&E) in a
timely manner.
17. APPLICABILITY TO OTHER REQUIREMENTS. Compliance with this Instruction does
not imply that all other applicable requirements have been met for DoD-conducted and -
supported research involving human subjects. No DoD agency within the Intelligence
Community shall sponsor, contract for, or conduct non-exempt research involving human
subjects except in accordance with paragraph 2.10 of Executive Order 12333 (Reference (t)).
Additionally, research involving human subjects using surveys, materials under the purview
of the FDA, or individually identifiable health information may be subject to additional
Federal or DoD requirements, such as those identified in Reference (s), DoD 5400.11-R
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(Reference (u)), and DoDI 6000.08 (Reference (v)). States may have differing definitions and
protections for vulnerable populations. Research involving human subjects conducted in
foreign countries may be subject to additional national and local requirements.
18. CCHRPP MEMBERSHIP. The CCHRPP shall be composed of senior officials at the GO/FO,
SES, or equivalent level. The Heads of the OSD and DoD Components with a DoD
Component HRPP management plan shall each identify one member to represent their
Component to the ASD(R&E). The Chair shall be designated by the ASD(R&E). The
CCHRPP shall be supported by an Executive Secretariat (O-6 or equivalent level) composed
of representatives from the DoD Components' human research protection oversight offices.
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GLOSSARY
PART I. ABBREVIATIONS AND ACRONYMS
ASD(HA) Assistant Secretary of Defense for Health Affairs
ASD(R&E) Assistant Secretary of Defense for Research and Engineering
CCHRPP Coordinating Committee for Human Research Protection Programs
CFR Code of Federal Regulations
CIPSEA Confidential Information Protection and Statistical Efficiency Act of 2002
DFARS Defense Federal Acquisition Regulation Supplement
DoDD Department of Defense Directive
FDA Food and Drug Administration
GO/FO general or flag officer
HHS Health and Human Services
HRPO human research protection official
HRPP Human Research Protection Program
IO institutional official
IRB institutional review board
NCOs noncommissioned officers
NIH National Institutes of Health
OMB Office of Management and Budget
OT&E operational test and evaluation
RDT&E research, development, test and evaluation
SES Senior Executive Service
UPIRTSO unanticipated problems involving risks to subjects or others
U.S.C. United States Code
USD(P&R) Under Secretary of Defense for Personnel and Readiness
PART II. DEFINITIONS
Unless otherwise noted, these terms and their definitions are for the purpose of this Instruction.
administrative review. A review of a research protocol and supporting documents (e.g., safety review,
scientific review, IRB minutes) related to DoD-supported research involving human subjects which
ensures the institution engaged in the research involving human subjects has met the requirements of all
applicable regulations and policies. This review is NOT an IRB review.
classified research involving human subjects. Research involving human subjects where the protocol or
other information required by the IRB for review and oversight or required or provided by the research
subjects includes classified information, as defined in Reference (q).
clinical investigations. Any research or experiments that involve a test article, one or more human
subjects, and are performed under the requirements of Reference (d). Clinical investigations are a
subcategory of research involving human subjects.
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continuing noncompliance. A pattern of noncompliance (see definition of noncompliance) that suggests
the likelihood that, without intervention, instances of noncompliance will recur. A repeated unwillingness
to comply with this Instruction or a persistent lack of knowledge of how to comply with this Instruction.
Common Rule. The regulation adopted by multiple Federal departments and agencies for the protection of
human subjects in research. The Department of Defense's implementation of the Common Rule is part
219 of Reference (c); the Department of HHS's implementation of the Common Rule is subpart A of
Reference (h).
detainee. Defined in Reference (p).
DoD-conducted research involving human subjects. Research involving human subjects that is performed
by DoD personnel. Intramural research is one type of DoD-conducted research involving human subjects.
See "engaged in research involving human subjects."
DoD personnel. DoD civilian employees and members of the military services.
DoD civilian employee. An individual meeting the definition of "employee" consistent with section
2105 of Reference (m). It includes employees of DoD Non-Appropriated Fund Instrumentalities;
DoD civilian employees filling full-time, part-time, intermittent, or on-call positions; and individuals
serving under personal services contracts consistent with section 2.101 of Reference (n). It excludes
employees of contractors (other than personal services contractors) and foreign nationals of host
countries.
Service members. Individuals appointed, enlisted, or inducted for military service under the authority
of the Department of Defense. The Military Services are the Army, the Navy, the Air Force, the
Marine Corps, the Coast Guard, and the Reserve Components, which includes the Army and the Air
National Guards of the United States. Members of the Reserve Components are included when in a
duty status.
DoD-supported research involving human subjects. Research involving human subjects for which the
Department of Defense is providing at least some of the resources (see "research involving human
subjects"). Resources may include but are not limited to funding, facilities, equipment, personnel
(investigators or other personnel performing tasks identified in the research protocol), access to or
information about DoD personnel for recruitment, or identifiable data or specimens from living
individuals. It includes both DoD-conducted research involving human subjects (intramural research) and
research conducted by a non-DoD institution.
engaged in research involving human subjects. An institution is engaged in research involving human
subjects when its personnel are conducting activities covered by section 219.101(a) of Reference (c) and
this Instruction. An institution that is funding, providing equipment, providing access to or information
about potential human subjects (but not recruiting human subjects), providing data or specimens (either
identifiable or not), or overseeing the research from a regulatory or compliance standpoint is not engaged
in the research involving human subjects (but is supporting the research (see "DoD-supported research
involving human subjects")).
exempt research involving human subjects. Research involving human subjects where the only
involvement of the human subjects in the research will be in one or more of the categories identified in
section 219.101(b) of Reference (c).
experimental subject. See "research involving a human being as an experimental subject."
Federal assurance. A written document in which an institution (not an IRB) commits to a Federal
department or agency their compliance with the requirements set forth in the Common Rule. Institutions
engaged in non-exempt research involving human subjects conducted or supported by the Department of
Defense or other Federal departments and agencies that have adopted the Common Rule must have a
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Federal assurance approved or accepted by the Federal agency supporting the research. The elements of a
Federal assurance are outlined in section 219.103(b) of Reference (c).
fetus. The product of conception from implantation until delivery as defined in subpart B of Reference
(h).
HRPO. An individual who is delegated the responsibilities as defined in paragraph (a)(2) of section
252.235-7004 of Reference (n). There may be more than one HRPO in a DoD Component. Some DoD
Components may use a different title for the person(s) with the defined responsibilities.
HRPP. An institution's system of interdependent elements that implement policies and practices to
protect human subjects involved in research. An HRPP may or may not include a Federal assurance. If the
HRPP includes a Federal assurance, it may contain policies and procedures for an IRB belonging to the
institution or for a relationship with an IRB external to the institution.
human subject. A living individual about whom an investigator conducting research obtains data through
intervention or interaction with the individual or obtains identifiable private information as defined in
section 219.102(f) of Reference (c). (FDA regulations include a different definition of human subject.
With respect to research subject to FDA regulations, the FDA definition in section 50.3(g) of Reference
(d) also applies.)
identifiable private information. Defined in section 219.102(f) of Reference (c).
intervention and interaction. An intervention includes both physical procedures by which data are
gathered and manipulations of the subject or the subject's environment that are performed for research
purposes. Interaction includes communication or interpersonal contact between investigator and subject.
See section 219.102(f) of Reference (c) for more information. Examples include, but are not limited to, a
physical procedure, a drug, a manipulation of the human subject or subject's environment, the
withholding of an intervention that would have been undertaken if not for the research purpose, or
communication such as a survey or interview.
intramural research. Research (see "research involving human subjects") that is conducted by an entity
that is part of the Department of Defense.
institution. An organization or entity defined in a Federal assurance or HRPP.
IO. The senior person authorized to establish and responsible to maintain the HRPP for the institution.
Responsible for a Federal assurance and the IRBs internal to the institution, if these elements are part of
the HRPP.
neonate. Newborns as defined in subpart B of Reference (h).
non-affiliated IRB member. Defined in section 219.107(d) of Reference (c). This member is not
connected with the institution(s), as defined in the institution's Federal assurance that is creating or
relying on the IRB, or a member of the immediate family of a person who is associated with the
institution creating or relying on the IRB.
noncompliance. Failure of a person, group, or institution to act in accordance with this Instruction, its
references, or applicable requirements.
non-DoD institution. An entity that is not part of the Department of Defense.
non-exempt research involving human subjects. An activity that meets the definitions of research and
human subject but does not meet the criteria where the only involvement of the human subjects in the
research are in one or more of the categories identified in section 219.101(b) of Reference (c).
ombudsman. A person who acts as an impartial and objective advocate for human subjects participating in
research.
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OSD Component. Defined in DoD Instruction 5025.01 (Reference (w)).
OT&E. Defined in section 139(a)(2)(A) of Reference (g).
prisoner. Defined in subpart C of Reference (h). Includes military personnel in either civilian or military
custody or detainment.
prisoner representative. An individual member on the IRB who shall have working knowledge of the
human subject population to be recruited, a reasonable familiarity with the operations of the prison or
confinement facility, and any other legally imposed restrictive conditions involved in the research, and
appropriate background and expertise to serve in this capacity.
private information. Defined in section 219.102(f) of Reference (c).
research. Any activity that is a systematic investigation, including RDT&E, designed to develop or
contribute to generalizable knowledge as defined in section 219.102(d) of Reference (c).
research involving human subjects. Activities that include both a systematic investigation designed to
develop or contribute to generalizable knowledge AND involve a living individual about whom an
investigator conducting research obtains data through intervention or interaction with the individual or
identifiable private information. Activities covered by section 219.101(a) of Reference (c) (including
exempt research involving human subjects) and this Instruction.
The following activities conducted or supported by the Department of Defense are NOT research
involving human subjects:
Activities carried out solely for purposes of diagnosis, treatment, or prevention of injury and disease
in Service members and other mission essential personnel under force health protection programs of
the Department of Defense, including health surveillance pursuant to section 1074f of Reference (g)
and the use of medical products consistent with DoD Instruction 6200.02 (Reference (x)).
Authorized health and medical activities as part of the reasonable practice of medicine or other health
professions undertaken for the sole purpose of patient treatment.
Activities performed for the sole purpose of medical quality assurance consistent with section 1102 of
Reference (g) and DoDD 6025.13 (Reference (y)).
Activities performed solely for an OT&E project where the activities and project meet the definition
of OT&E as defined in section 139(a)(2)(A) of Reference (g).
Activities performed solely for assessing compliance of individuals and organizations with
requirements applicable to military, civilian, or contractor personnel or to organizational units,
including such activities as occupational drug testing, occupational health and safety reviews,
network monitoring, and monitoring for compliance with requirements for protection of classified
information.
Activities, including program evaluation, customer satisfaction surveys, user surveys, outcome
reviews, and other methods, designed solely to assess the performance of DoD programs where the
results of the evaluation are only for the use of Government officials responsible for the operation or
oversight of the program being evaluated and are not intended for generalized use beyond such
program.
Survey, interview, or surveillance activities and related analyses performed solely for authorized
foreign intelligence collection purposes, as authorized by DoDD 5240.01 (Reference (z)).
research involving a human being as an experimental subject. An activity, for research purposes, where
there is an intervention or interaction with a living individual for the primary purpose of obtaining data
regarding the effect of the intervention or interaction. Research involving a human being as an
experimental subject is a subset of research involving human subjects. This definition relates only to the
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application of section 980 of Reference (g); it does not affect the application of part 219 of Reference (c).
This definition does not include activities that are not considered research involving human subjects,
activities that meet the exemption criteria at section 219.101(b) of Reference (c), and research involving
the collection or study of existing data, documents, records, or specimens from living individuals.
research monitor. Individuals with expertise consonant with the nature of risk(s) identified within the
research protocol, whose role is to protect the safety and well-being of human subjects.
secretarial designee program. Defined in section 108.3 of Reference (c).
serious noncompliance. Failure of a person, group, or institution to act in accordance with this Instruction
and its references such that the failure could adversely affect the rights, safety, or welfare of a human
subject; place a human subject at increased risk of harm; cause harm to a human subject; affect a human
subject's willingness to participate in research; or damage or compromise the scientific integrity of
research data.
UPIRTSO. Any incident, experience, or outcome that meets ALL three of the following conditions:
Is unexpected (in terms of nature, severity, or frequency) given the procedures described in the
research protocol documents (e.g., the IRB-approved research protocol and informed consent
document) and the characteristics of the human subject population being studied.
Is related or possibly related to participation in the research (in this Instruction, possibly related
means there is a reasonable possibility that the incident, experience, or outcome may have been
caused by the procedures involved in the research).
Suggests that the research places human subjects or others at a greater risk of harm (including
physical, psychological, economic, or social harm) than was previously known or recognized, even if
no harm has actually occurred.
