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] responsibilities 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 addressing human subjects research and privacy.



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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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146 FUTURE USES OF THE DOD JPC BIOREPOSITORY 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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148 FUTURE USES OF THE DOD JPC BIOREPOSITORY 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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150 FUTURE USES OF THE DOD JPC BIOREPOSITORY 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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152 FUTURE USES OF THE DOD JPC BIOREPOSITORY 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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154 FUTURE USES OF THE DOD JPC BIOREPOSITORY 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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168 FUTURE USES OF THE DOD JPC BIOREPOSITORY 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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170 FUTURE USES OF THE DOD JPC BIOREPOSITORY 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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APPENDIX C 171 (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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172 FUTURE USES OF THE DOD JPC BIOREPOSITORY 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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APPENDIX C 173 (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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174 FUTURE USES OF THE DOD JPC BIOREPOSITORY 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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APPENDIX C 175 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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176 FUTURE USES OF THE DOD JPC BIOREPOSITORY 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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APPENDIX C 177 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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178 FUTURE USES OF THE DOD JPC BIOREPOSITORY 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.