79C3C34C52B45572883A05D425EB0F82
DoDI 3216.02
https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodi/321602p.pdf
http://leaux.net/URLS/ConvertAPI Text Files/A7824D0E38F50EB19F8C4BFB42817769.en.txt
Examining the file media/Synopses/A7824D0E38F50EB19F8C4BFB42817769.html:
This file was generated: 2020-12-01 05:11:06
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
Searching for indicator prisoners:
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p.000004: Activities for Which an Institution is not Required to Have a Federal Assurance 13
p.000004: DoD-CONDUCTED RESEARCH INVOLVING HUMAN SUBJECTS 13
p.000004: DoD Institutional Approval and Oversight 13
p.000004: DoD Component Review and Oversight 15
p.000004: RESEARCH INVOLVING HUMAN SUBJECTS CONDUCTED BY A NON-DoD INSTITUTION
p.000004: 16
p.000004: Clause in Contracts and Agreements 16
p.000004: Non-DoD Institutional Responsibilities 17
p.000004: DoD Component Review, Approval, and Oversight 17
p.000004: EDUCATION AND TRAINING 18
p.000004: SELECTION OF HUMAN SUBJECTS AND EVALUATING RISK 19
p.000004: Selection of Human Subjects
p.000004: 19
p.000004: Evaluating Risk
p.000004: 19
p.000004: ADDITIONAL PROTECTIONS FOR HUMAN SUBJECTS 19
p.000004: Pregnant Women, Fetuses, and Neonates as Subjects 20
p.000004: Prisoners as Subjects
p.000004: 20
p.000004: Treatment of Detainees
p.000004: 22
p.000004: Children as Subjects
p.000004: 22
p.000004: DoD Personnel as Subjects
p.000004: 23
p.000004: RESEARCH MONITOR
p.000004: 24
p.000004: UNIQUE DoD LIMITATIONS ON WAIVER OF INFORMED CONSENT 25
p.000004: PROTECTING HUMAN SUBJECTS FROM MEDICAL EXPENSES IF INJURED 26
p.000004: DoD-Supported Research Involving Human Subjects 26
p.000004: DoD-Conducted Research Involving Human Subjects 26
p.000004: DoD-Collaborative Research Involving Human Subjects 26
p.000004: COMPENSATION TO HUMAN SUBJECTS FOR PARTICIPATION IN RESEARCH 27
p.000004: DoD-Conducted Research Involving Human Subjects 27
p.000004: Non-DoD-Conducted Research Involving Human Subjects 28
p.000004: SERVICE MEMBERS AND THEIR STATUS AS ADULTS 29
p.000004: Change 1, 10/15/2018 4
p.000005: CONTENTS
p.000005:
p.000005: DoDI 3216.02, November 8, 2011
p.000005: CLASSIFIED RESEARCH INVOLVING HUMAN SUBJECTS 29
p.000005: ADDITIONAL PROTECTIONS FOR CONFIDENTIALITY 30
p.000005: Confidential Information Protection and Statistical Efficiency Act (CIPSEA) for
p.000005: Non-Statistical Agencies
p.000005: 30
p.000005: CIPSEA for Statistical Agencies
p.000005: 30
p.000005: Certificates for Confidentiality
...
p.000010: women as subjects may be exempt from the requirements of part 219 of Reference (c) and subpart B of Reference (i) if
p.000010: the research meets the exemption criteria at section 219.101(b) of Reference (c). If the pregnant woman is a prisoner,
p.000010: then paragraph 7.b. of this section also applies. If the pregnant woman is a minor, paragraph 7.d. of this section
p.000010: also applies. For purposes of applying paragraph 7.a., the phrase “biomedical knowledge” in subpart B of Reference (i)
p.000010: shall be replaced with “generalizable knowledge” throughout the subpart.
p.000010:
p.000010: (2) The applicability of subpart B of Reference (i) is limited to research involving:
p.000010:
p.000010: (a) Pregnant women as human subjects involved in research that is more than minimal risk and includes interventions or
p.000010: invasive procedures to the woman or the fetus; or
p.000010:
p.000010: (b) Fetus or neonate (see Glossary) as human subjects.
p.000010:
p.000010: (3) Research involving human subjects using fetal tissue shall comply with sections 289g–289g-2 of Reference (k).
p.000010:
p.000010: b. Prisoners as Subjects
p.000010:
p.000010: (1) Research Intending to Include Prisoners as Subjects
p.000010:
p.000010: (a) Research involving human subjects that includes prisoners must meet the additional relevant protections of subpart
p.000010: C of Reference (i), unless modified by this Instruction. If the prisoner is a pregnant woman, then paragraph 7.a. of
p.000010: this section also applies. If the prisoner is a minor, then paragraph 7.d. of this section also applies.
p.000010:
p.000010: (b) Research intending to include prisoners as subjects cannot be reviewed by the IRB through an expedited review
p.000010: procedure.
p.000010:
p.000010: (c) The IRB reviewing research intending to include prisoners as subjects shall be composed of at least one prisoner
p.000010: representative (see Glossary). The prisoner representative may be a prisoner, an employee of the prison, or an
p.000010: individual not affiliated with the prison. The prisoner representative shall have knowledge of the culture(s) of the
p.000010: prisoners and knowledge of the prison operations. At least one prisoner representative must be present for a quorum.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000000: Change 1, 10/15/2018 20
p.000001: ENCLOSURE 3
p.000001:
p.000001: DoDI 3216.02, November 8, 2011
p.000001:
p.000001: (d) Research involving prisoners at prisons or other types of institutions may be subject to additional review by
p.000001: institution authorities (e.g., Bureau of Prisons).
p.000001:
p.000001: (2) Categories of Allowable Research Involving a Prisoner. In addition to the four categories of permissible research
p.000001: involving human subjects identified in subpart C of Reference (i), two additional categories are allowable.
p.000001:
p.000001: (a) Epidemiological research that meets the following criteria can also be approved in accordance with the
p.000001: requirements of subpart C of Reference (i) and the requirements of this Instruction:
p.000001:
p.000001: 1. The research describes the prevalence or incidence of a disease by identifying all cases or studies potential risk
p.000001: factor associations for a disease.
p.000001:
p.000001: 2. The research presents no more than minimal risk.
p.000001:
p.000001: 3. The research presents no more than an inconvenience to the human subject.
p.000001:
p.000001: 4. Prisoners are not a particular focus of the research.
p.000001:
p.000001: (b) Research involving human subjects that would meet the criteria described at section 219.101(b) of Reference (c)
p.000001: can be conducted, but must be approved by a convened IRB and meet the requirements of subpart C of Reference (i), this
p.000001: Instruction, and other applicable requirements.
p.000001:
p.000001: (3) When a Subject Becomes a Prisoner
p.000001:
p.000001: (a) When a previously enrolled human subject becomes a prisoner and the relevant research protocol was not reviewed
p.000001: and approved by the IRB in accordance with the requirements of subparagraphs 7.b.(1) and (2) of this section, the
p.000001: principal investigator shall promptly notify the IRB.
p.000001:
p.000001: (b) If the principal investigator asserts to the IRB that it is in the best interest of the prisoner-subject to
p.000001: continue to participate in the research while a prisoner, the IRB Chair may determine that the prisoner-subject may
p.000001: continue to participate until the convened IRB can review this request to approve a change in the research protocol and
p.000001: until the IO and DoD Component office review the IRB’s approval to change the research protocol. Otherwise, the IRB
p.000001: Chair shall require that all research interactions and interventions with the prisoner-subject (including obtaining
p.000001: identifiable private information) cease until the convened IRB can review this request to approve a change in the
p.000001: research protocol.
p.000001:
p.000001: (c) The convened IRB, upon receipt of notification that a previously enrolled human subject has become a prisoner,
p.000001: shall promptly re-review the research protocol to ensure that the rights and wellbeing of the human subject, now a
p.000001: prisoner, are not in jeopardy. The IRB should consult with a subject matter expert having the expertise of a prisoner
p.000001: representative if the IRB reviewing the research protocol does not have a prisoner representative. If the
p.000001: prisoner-subject
p.000001:
p.000001:
p.000001:
p.000001: Change 1, 10/15/2018 21
p.000002: ENCLOSURE 3
p.000002:
p.000002: DoDI 3216.02, November 8, 2011
p.000002:
p.000002: can continue to consent to participate and is capable of meeting the research protocol requirements, the terms of the
p.000002: prisoner-subject’s confinement does not inhibit the ethical conduct of the research, and there are no other significant
p.000002: issues preventing the research involving human subjects from continuing as approved, the convened IRB may approve a
p.000002: change in the study to allow this prisoner-subject to continue to participate in the research. This approval is
p.000002: limited to the individual prisoner-subject and does not allow recruitment of prisoners as subjects.
p.000002:
p.000002: (d) This type of request for change in the research protocol cannot be reviewed and approved by the IRB using
p.000002: expedited review procedures. The research involving human subjects does not have to meet one of the six allowable
p.000002: categories of research as described in subparagraph 7.b.(2) of this enclosure.
p.000002:
p.000002: (e) If the research involving human subjects is conducted by a non-DoD institution, the non-DoD institution shall
p.000002: promptly report all decisions in this matter to the HRPO. If the research is conducted by a DoD institution, the IRB
p.000002: shall promptly report all decisions in this matter to the IO and to the DoD Component office conducting the reviews
p.000002: identified in paragraph 3.b. of this enclosure. For all DoD-conducted or -supported research involving human subjects,
p.000002: the applicable DoD Component office conducting the reviews identified in paragraphs
p.000002: 3.b. or 4.c. of this enclosure must concur with the IRB before the human subject can continue to participate while a
p.000002: prisoner. This approved change to a research protocol does not require ASD(R&E) approval.
p.000002:
p.000002: c. Treatment of Detainees
p.000002:
p.000002: (1) Research involving a detainee, as defined in DoD Directive 2310.01E (Reference (q)), as a human subject is
p.000002: prohibited.
p.000002:
p.000002: (2) The prohibition in paragraph c.(1) of this section does not apply to activities covered by investigational new
p.000002: drug or investigational device provisions of Reference (d) when for the purpose of diagnosis or treatment of a medical
p.000002: condition in a patient. Such treatment (e.g., an investigational new drug) may be offered to detainees with the
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Political / vulnerable
Searching for indicator vulnerable:
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p.000002:
p.000002: (3) Activities such as research, development, testing, and evaluation (RDT&E) that meet the definition of research
p.000002: involving human subjects (as defined in the Glossary), as well as clinical investigations or medical activities
p.000002: regulated by the Food and Drug Administration (FDA) in parts 50, 56, 312, 600, and 812 of title 21, CFR (Reference
p.000002: (d)).
p.000002:
p.000002: DoDI 3216.02, November 8, 2011
p.000002:
p.000002:
p.000002:
p.000002: b. Applicability is not dependent upon the budget activities funding the research, the mission of the DoD organization
p.000002: conducting or supporting the research, the security classification of the research, the location of the research in the
p.000002: United States or a foreign country, or whether the research is conducted or supported under a program that is not
p.000002: considered research for other purposes.
p.000002:
p.000002:
p.000002: 3. DEFINITIONS. See Glossary.
p.000002:
p.000002:
p.000002: 4. POLICY. It is DoD policy that:
p.000002:
p.000002: a. All research involving human subjects that is conducted or supported by the Department of Defense shall comply with
p.000002: part 219 of Reference (c), which incorporates the ethical principles of respect for persons, beneficence, and justice,
p.000002: as codified in page 23192 of the Federal Register (also known as “The Belmont Report” (Reference (e)).
p.000002:
p.000002: b. Certain categories of human subjects in research are recognized as vulnerable populations, groups, or individuals
p.000002: and are afforded additional protections as specified in section 7 of Enclosure 3 of this Instruction.
p.000002:
p.000002: c. Research involving human subjects for testing of chemical or biological warfare agents is generally prohibited by
p.000002: section 1520a of title 50, United States Code (U.S.C.) (Reference (f)), subject to possible exceptions for research for
p.000002: prophylactic, protective, or other peaceful purposes.
p.000002:
p.000002: d. DoD-appropriated funds shall not be used to support research involving a human being as an experimental subject, as
p.000002: defined in this Instruction, without the prior informed consent of the experimental subject or in accordance with
p.000002: section 980 of title 10, U.S.C. (Reference (g)) and this Instruction (see section 9 of Enclosure 3 of this Instruction
p.000002: for details). The definitions of research involving a human being as an experimental subject and research involving
p.000002: human subjects are different; see the Glossary for an explanation.
p.000002:
p.000002: e. Research involving human subjects covered under this Instruction shall also comply with applicable Federal and
p.000002: State laws and regulations. When the research is conducted outside of the United States, it must also comply with
p.000002: applicable requirements of the foreign country and its national laws and requirements. In the event of an unresolved
p.000002: conflict between this Instruction, including its references, and other applicable laws and requirements such that
p.000002: compliance with both is impossible, the requirements most protective of the human subjects shall be followed. When
...
p.000004: or individuals appointed as experts or consultants in accordance with section 3109 of Reference (n).
p.000004:
p.000004: (b) For DoD IRBs, the requirement to have a non-affiliated IRB member (section 219.107(d) of Reference (c)) can be
p.000004: fulfilled by a person who meets the criteria in subparagraph
p.000004:
p.000004:
p.000004:
p.000004: Change 1, 10/15/2018 14
p.000005: ENCLOSURE 3
p.000005:
p.000005: DoDI 3216.02, November 8, 2011
p.000005:
p.000005: 3.a.(7)(a) of this section and is from an organization that is not part of the institution as defined on the
p.000005: institution’s Federal assurance. DoD IRBs shall designate at least one alternate for the non-affiliated member.
p.000005: Although the presence of a non-affiliated member is not a requirement to have a quorum, the designation of one or more
p.000005: alternates will increase the likelihood that a
p.000005: non-affiliated member is present at the meetings.
p.000005:
p.000005: (c) The IRB shall also have a scientist and a non-scientist to meet the requirements in section 219.107(c) of
p.000005: Reference (c). A member whose primary concerns are in a non-scientific area (i.e., the non-scientist) must be present
p.000005: to have a quorum at convened meetings. The
p.000005: non-affiliated position and the non-scientist position may be filled by the same person, or the non-affiliated position
p.000005: and the scientist position may be filled by the same person.
p.000005:
p.000005: (d) The DoD institution shall consider including one or more community members on the IRB who are familiar with the
p.000005: perspectives of the human subjects (i.e., the community being recruited) commonly recruited and vulnerable subjects
p.000005: recruited by the institution. Community members may or may not be affiliated with the institution or have a scientific
p.000005: background. The appointment of the community members must comply with subparagraph 3.a.(7)(a) of this section.
p.000005:
p.000005: (e) DoD IRBs may consult with subject matter experts (e.g., in science, in statistics, in ethics, for the subject
p.000005: population) who are not Federal employees or board members, but these consultants may not vote.
p.000005:
p.000005: (8) DoD institutions engaged in non-exempt research involving human subjects and collaborating with a non-DoD
p.000005: institution may rely on a collaborating non-DoD institution’s IRB if these minimum conditions are met:
p.000005:
p.000005: (a) The DoD Component determines the collaborating non-DoD institution has an appropriate Federal assurance.
p.000005:
p.000005: (b) The involvement of DoD personnel in the conduct of the research involving human subjects is secondary to that of
p.000005: the non-DoD institution.
p.000005:
p.000005: (c) The DoD institution, the non-DoD institution, and the non-DoD institution’s IRB have a written agreement defining
p.000005: the responsibilities and authorities of each organization in complying with the terms of the Federal assurances and
p.000005: this Instruction (i.e., have an Institutional Agreement for IRB Review or similar agreement). The DoD Component shall
p.000005: approve the terms of the agreement prior to the DoD institution’s engagement in the research involving human subjects.
p.000005:
p.000005: (d) The DoD Component must conduct an appropriate administrative review of the research involving human subjects to
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p.000009: DoD-conducted or -supported clinical research involving human subjects shall comply with section 252 of Public Law
p.000009: 103-160 (Reference (p)). The Head of the OSD or DoD Component may exercise the waiver authority under this law. This
p.000009: waiver authority may be delegated, as described in the Component’s HRPP management plan, but not to an individual at
p.000009: the level of the institutional HRPP.
p.000009:
p.000009: b. Evaluating Risk. The phrase “ordinarily encountered in daily life or during the performance of routine physical or
p.000009: physiological examinations or tests” in the definition of minimal risk (section 219.102(j)) of Reference (c)) shall not
p.000009: be interpreted to include the inherent risks certain categories of human subjects face in their everyday life. For
p.000009: example, the risks imposed in research involving human subjects focused on a special population should not be evaluated
p.000009: against the inherent risks encountered in their work environment (e.g., emergency responder, pilot, soldier in a combat
p.000009: zone) or having a medical condition (e.g., frequent medical tests or constant pain).
p.000009:
p.000009:
p.000009: 7. ADDITIONAL PROTECTIONS FOR HUMAN SUBJECTS. In addition to the requirements of part 219 of Reference (c),
p.000009: additional safeguards described in this section shall be provided for human subjects in all DoD-conducted research
p.000009: involving human subjects who may be considered vulnerable due to their association with groups or populations
p.000009: specifically defined by Federal regulations in subparts B-D of Reference (i) and this Instruction. Similarly, as
p.000009: provided in Reference (o) or Parts 22 (Appendix B) and 37 (Appendix D) of Reference (c), such additional safeguards
p.000009: shall also be provided in comparable DoD-supported research involving human subjects. For purposes of this
p.000009: Instruction, actions authorizing or requiring any action by an official of HHS about any requirements of subparts B-D
p.000009: of Reference (i) shall be under the authority of the ASD(R&E). Investigators, IRBs, IOs, and DoD Component personnel
p.000009: reviewing research protocols shall consider the need for appropriate similar safeguards for other vulnerable
p.000009: populations, such as: research involving human subjects and investigators in supervisor- subordinate relationships,
p.000009: human subjects with decisional or mental impairments, human
p.000009:
p.000009:
p.000009:
p.000009: Change 1, 10/15/2018 19
p.000010: ENCLOSURE 3
p.000010:
p.000010: DoDI 3216.02, November 8, 2011
p.000010:
p.000010: subjects with a physical disability, or any other kind of human subjects in circumstances that may warrant provision of
p.000010: additional protections. As appropriate, qualified individuals (e.g., research monitors, ombudsmen, advocates) may be
p.000010: appointed to perform oversight functions or assist the human subjects.
p.000010:
p.000010: a. Pregnant Women, Fetuses, and Neonates as Subjects
p.000010:
p.000010: (1) Non-exempt research involving pregnant women, fetuses, or neonates as human subjects must meet the additional
p.000010: relevant protections of subpart B of Reference (i), unless modified by this Instruction. Research involving pregnant
p.000010: women as subjects may be exempt from the requirements of part 219 of Reference (c) and subpart B of Reference (i) if
...
p.000001: Instruction. For allegations that involve more than one DoD Component or a non-DoD institution, the involved
p.000001: institutions should jointly determine and assign executive responsibility for responding to the allegation(s). For
p.000001: allegations involving a non-DoD institution, the DoD Component supporting the research involving human subjects shall
p.000001: ensure the allegation is properly investigated and reported to the DoD Component. All findings of serious or
p.000001: continuing noncompliance with this Instruction that have been substantiated by inquiry or investigation shall be
p.000001: reported to the ASD(R&E) in a timely manner.
p.000001:
p.000001:
p.000001: 17. APPLICABILITY TO OTHER REQUIREMENTS. Compliance with this Instruction does not imply that all other applicable
p.000001: requirements have been met for DoD-conducted and
p.000001: -supported research involving human subjects. No DoD agency within the Intelligence
p.000001:
p.000001:
p.000001:
p.000001: Change 1, 10/15/2018 31
p.000002: ENCLOSURE 3
p.000002:
p.000002: DoDI 3216.02, November 8, 2011
p.000002:
p.000002: Community shall sponsor, contract for, or conduct non-exempt research involving human subjects except in accordance
p.000002: with paragraph 2.10 of Executive Order 12333 (Reference (u)). Additionally, research involving human subjects using
p.000002: surveys, materials under the purview of the FDA, or individually identifiable health information may be subject to
p.000002: additional Federal or DoD requirements, such as those identified in Reference (t), DoD 5400.11-R (Reference (v)), and
p.000002: DoDI 6000.08 (Reference (w)). States may have differing definitions and protections for vulnerable populations.
p.000002: Research involving human subjects conducted in foreign countries may be subject to additional national and local
p.000002: requirements.
p.000002:
p.000002:
p.000002: 18. CCHRPP MEMBERSHIP. The CCHRPP shall be composed of senior officials at the GO/FO, SES, or equivalent level. The
p.000002: Heads of the OSD and DoD Components with a DoD Component HRPP management plan shall each identify one member to
p.000002: represent their Component to the ASD(R&E). The Chair shall be designated by the ASD(R&E). The CCHRPP shall be
p.000002: supported by an Executive Secretariat (O-6 or equivalent level) composed of representatives from the DoD Components’
p.000002: human research protection oversight offices.
p.000002:
p.000002:
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p.000002:
p.000002:
p.000002:
p.000002: Change 1, 10/15/2018 32
p.000003: ENCLOSURE 3
p.000003:
p.000003: DoDI 3216.02, November 8, 2011
p.000003:
p.000003: GLOSSARY
p.000003:
p.000003: PART I. ABBREVIATIONS AND ACRONYMS
p.000003:
p.000003:
p.000003: ASD(HA) Assistant Secretary of Defense for Health Affairs ASD(R&E) Assistant Secretary of Defense for Research
p.000003: and Engineering
p.000003:
p.000003: CCHRPP Coordinating Committee for Human Research Protection Programs CFR Code of Federal
p.000003: Regulations
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Health / Drug Usage
Searching for indicator drug:
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p.000002: of human subjects in DoD-supported programs to implement part 219 of title 32, Code of Federal Regulations (CFR) (also
p.000002: known and hereinafter referred to as “the Common Rule” (Reference (c)).
p.000002:
p.000002:
p.000002: 2. APPLICABILITY
p.000002:
p.000002: a. This Instruction applies to:
p.000002:
p.000002: (1) OSD, the Military Departments, the Office of the Chairman of the Joint Chiefs of Staff and the Joint Staff, the
p.000002: Combatant Commands, the Office of the Inspector General of the Department of Defense, the Defense Agencies, the DoD
p.000002: Field Activities, and all other organizational entities within the Department of Defense (hereinafter referred to
p.000002: collectively as the “DoD Components”).
p.000002:
p.000002: (2) All DoD-conducted or -supported research involving human subjects as defined in the Glossary. All such activities
p.000002: must include both systematic investigation designed to develop or contribute to generalizable knowledge AND involve a
p.000002: living individual about whom an investigator conducting research obtains data through intervention or interaction with
p.000002: the individual or about whom identifiable private information is obtained. All activities meeting both of these
p.000002: conditions will hereinafter be referred to as “research involving human subjects” in this Instruction.
p.000002:
p.000002: (3) Activities such as research, development, testing, and evaluation (RDT&E) that meet the definition of research
p.000002: involving human subjects (as defined in the Glossary), as well as clinical investigations or medical activities
p.000002: regulated by the Food and Drug Administration (FDA) in parts 50, 56, 312, 600, and 812 of title 21, CFR (Reference
p.000002: (d)).
p.000002:
p.000002: DoDI 3216.02, November 8, 2011
p.000002:
p.000002:
p.000002:
p.000002: b. Applicability is not dependent upon the budget activities funding the research, the mission of the DoD organization
p.000002: conducting or supporting the research, the security classification of the research, the location of the research in the
p.000002: United States or a foreign country, or whether the research is conducted or supported under a program that is not
p.000002: considered research for other purposes.
p.000002:
p.000002:
p.000002: 3. DEFINITIONS. See Glossary.
p.000002:
p.000002:
p.000002: 4. POLICY. It is DoD policy that:
p.000002:
p.000002: a. All research involving human subjects that is conducted or supported by the Department of Defense shall comply with
p.000002: part 219 of Reference (c), which incorporates the ethical principles of respect for persons, beneficence, and justice,
p.000002: as codified in page 23192 of the Federal Register (also known as “The Belmont Report” (Reference (e)).
p.000002:
p.000002: b. Certain categories of human subjects in research are recognized as vulnerable populations, groups, or individuals
p.000002: and are afforded additional protections as specified in section 7 of Enclosure 3 of this Instruction.
p.000002:
p.000002: c. Research involving human subjects for testing of chemical or biological warfare agents is generally prohibited by
p.000002: section 1520a of title 50, United States Code (U.S.C.) (Reference (f)), subject to possible exceptions for research for
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p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Change 1, 10/15/2018 5
p.000006: CONTENTS
p.000006:
p.000006: DoDI 3216.02, November 8, 2011
p.000006:
p.000006: ENCLOSURE 1
p.000006:
p.000006: REFERENCES
p.000006:
p.000006:
p.000006: (a) DoD Directive 3216.02, “Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported
p.000006: Research,” March 25, 2002 (hereby cancelled)
p.000006: (b) DoD Directive 5134.01, “Under Secretary of Defense for Acquisition, Technology and Logistics (USD(AT&L)),”
p.000006: December 9, 2005
p.000006: (c) Parts 22 (Appendix B), 37 (Appendix D), 108 and 2191 of title 32, Code of Federal Regulations
p.000006: (d) Parts 50, 56, 312, 600, and 812 of title 21, Code of Federal Regulations
p.000006: (e) Page 23192 of Volume 44, Federal Register, April 18, 1979 (also known as “The Belmont Report”) 2
p.000006: (f) Section 1520a of title 50, United States Code
p.000006: (g) Sections 139(a)(2)(A), 980, 1074f , and 1102 of title 10, United States Code
p.000006: (h) Deputy Secretary of Defense Memorandum, “Establishment of the Office of the Under Secretary of Defense for
p.000006: Research and Engineering and the Office of the Under Secretary of Defense for Acquisition and Sustainment,” July 13,
p.000006: 2018
p.000006: (i) Part 46, subparts A-D of title 45, Code of Federal Regulations
p.000006: (j) Memorandum of Understanding between the Food and Drug Administration and the Department of Defense, “Concerning
p.000006: Investigational Use of Drugs, Antibiotics, Biologics, and Medical Devices by the Department of Defense,” May 21, 1987
p.000006: (k) Sections 241(d) and 289g–289g-2 of title 42, United States Code
p.000006: (l) Public Law 107-347, “Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA),”
p.000006: December 17, 2002
p.000006: (m) Pages 33362-33377 of Volume 72, Federal Register, June 15, 2007
p.000006: (n) Sections 2105, 3109, 3371-3376,3 and 5536 of title 5, United States Code
p.000006: (o) Sections 2.101 and 252.235-7004 of title 48, Code of Federal Regulations
p.000006: (p) Section 252 of Public Law 103-160, “National Defense Authorization Act for Fiscal Year 1994,” November 30, 1993
p.000006: (q) DoD Directive 2310.01E, “The Department of Defense Detainee Program,” September 5, 2006
p.000006: (r) Section 30 of title 24, United States Code
p.000006: (s) Executive Order 13526, “Classified National Security Information,” December 29, 2009
p.000006: (t) DoD 6025.18-R, “DoD Health Information Privacy,” January 24, 2003
p.000006: (u) Executive Order 12333, “United States Intelligence Activities,” as amended, August 18, 2010
p.000006: (v) DoD 5400.11-R, “Department of Defense Privacy Program,” May 14, 2007
p.000006: (w) DoDI 6000.08, “Funding and Administration of Clinical Investigation Programs,” December 3, 2007
p.000006:
p.000006:
p.000006: 1Also known as “the Common Rule”
p.000006: 2 Available on the Internet at http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm. The Belmont Report’s
p.000006: 2-volume appendix is available from the Government Printing Office as DHEW Publication Nos. (OS) 78- 0013 and (OS)
p.000006: 78-0014
p.000006: 3 Also known as “The Intergovernmental Personnel Act of 1970, as amended”
p.000006:
p.000006: Change 1, 10/15/2018 6
p.000007: ENCLOSURE 1
p.000007:
p.000007: DoDI 3216.02, November 8, 2011
p.000007:
p.000007: (x) DoD Instruction 5025.01, “DoD Directives Program,” October 28, 2007
p.000007: (y) DoD Instruction 6200.02, “Application of Food and Drug Administration (FDA) Rules to Department of Defense Force
p.000007: Health Protection Program,” February 27, 2008
p.000007: (z) DoD Instruction 6025.13, “Medical Quality Assurance (MQA) and Clinical Quality Management in the Military Health
p.000007: System (MHS),” February 17, 2011
p.000007: (aa) DoD Directive 5240.01, “DoD Intelligence Activities,” August 27, 2007
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
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p.000007:
p.000007:
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p.000007:
p.000007:
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p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007: Change 1, 10/15/2018 7
p.000008: ENCLOSURE 1
p.000008:
p.000008: DoDI 3216.02, November 8, 2011
p.000008:
p.000008: ENCLOSURE 2
p.000008:
p.000008: RESPONSIBILITIES
p.000008:
p.000008:
p.000008: 1. ASD(R&E). The ASD(R&E), under the authority, direction, and control of the Under Secretary of Defense for
p.000008: Acquisition, Technology, and Logistics, shall:
p.000008:
p.000008: a. Be the single DoD point of contact for all matters related to DoD compliance with this Instruction and shall act as
p.000008: the principal DoD liaison with organizations outside the Department of Defense on matters pertaining to research
p.000008: involving human subjects.
p.000008:
...
p.000002: change in the study to allow this prisoner-subject to continue to participate in the research. This approval is
p.000002: limited to the individual prisoner-subject and does not allow recruitment of prisoners as subjects.
p.000002:
p.000002: (d) This type of request for change in the research protocol cannot be reviewed and approved by the IRB using
p.000002: expedited review procedures. The research involving human subjects does not have to meet one of the six allowable
p.000002: categories of research as described in subparagraph 7.b.(2) of this enclosure.
p.000002:
p.000002: (e) If the research involving human subjects is conducted by a non-DoD institution, the non-DoD institution shall
p.000002: promptly report all decisions in this matter to the HRPO. If the research is conducted by a DoD institution, the IRB
p.000002: shall promptly report all decisions in this matter to the IO and to the DoD Component office conducting the reviews
p.000002: identified in paragraph 3.b. of this enclosure. For all DoD-conducted or -supported research involving human subjects,
p.000002: the applicable DoD Component office conducting the reviews identified in paragraphs
p.000002: 3.b. or 4.c. of this enclosure must concur with the IRB before the human subject can continue to participate while a
p.000002: prisoner. This approved change to a research protocol does not require ASD(R&E) approval.
p.000002:
p.000002: c. Treatment of Detainees
p.000002:
p.000002: (1) Research involving a detainee, as defined in DoD Directive 2310.01E (Reference (q)), as a human subject is
p.000002: prohibited.
p.000002:
p.000002: (2) The prohibition in paragraph c.(1) of this section does not apply to activities covered by investigational new
p.000002: drug or investigational device provisions of Reference (d) when for the purpose of diagnosis or treatment of a medical
p.000002: condition in a patient. Such treatment (e.g., an investigational new drug) may be offered to detainees with the
p.000002: detainees’ informed consent when the medical products are subject to Reference (d) as investigational new drugs or
p.000002: investigational medical devices, and only when the same product would be offered to members of the U.S. Military
p.000002: Services in the same location for the same medical condition and only when consistent with established medical practice
p.000002: involving investigational drugs and devices. Such permitted treatment involving detainees as subjects shall comply
p.000002: with all sections of this Instruction, including paragraphs 6.a., b., and d. of this section, as applicable.
p.000002:
p.000002: d. Children as Subjects
p.000002:
p.000002: (1) Research involving human subjects conducted or supported by the Department of Defense that recruits children to be
p.000002: subjects must meet the additional relevant protections of subpart D of Reference (i), unless modified by this
p.000002: Instruction. If the minor is a pregnant woman, then paragraph 7.a. of this section also applies. If the minor is a
p.000002: prisoner, paragraph 7.b. of this section also applies.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: Change 1, 10/15/2018 22
p.000003: ENCLOSURE 3
p.000003:
p.000003: DoDI 3216.02, November 8, 2011
p.000003:
p.000003: (2) The footnote in section 219.101(i) of Reference (c), prohibiting specific exemptions described in section
...
p.000002: represent their Component to the ASD(R&E). The Chair shall be designated by the ASD(R&E). The CCHRPP shall be
p.000002: supported by an Executive Secretariat (O-6 or equivalent level) composed of representatives from the DoD Components’
p.000002: human research protection oversight offices.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: Change 1, 10/15/2018 32
p.000003: ENCLOSURE 3
p.000003:
p.000003: DoDI 3216.02, November 8, 2011
p.000003:
p.000003: GLOSSARY
p.000003:
p.000003: PART I. ABBREVIATIONS AND ACRONYMS
p.000003:
p.000003:
p.000003: ASD(HA) Assistant Secretary of Defense for Health Affairs ASD(R&E) Assistant Secretary of Defense for Research
p.000003: and Engineering
p.000003:
p.000003: CCHRPP Coordinating Committee for Human Research Protection Programs CFR Code of Federal
p.000003: Regulations
p.000003: CIPSEA Confidential Information Protection and Statistical Efficiency Act of 2002
p.000003:
p.000003: DFARS Defense Federal Acquisition Regulation Supplement DoDD Department of Defense Directive
p.000003:
p.000003: FDA Food and Drug Administration GO/FO general or flag officer
p.000003: HHS Health and Human Services HRPO human research protection official
p.000003: HRPP Human Research Protection Program
p.000003:
p.000003: IO institutional official
p.000003: IRB institutional review board
p.000003:
p.000003: NCOs noncommissioned officers NIH National Institutes of Health
p.000003:
p.000003: OMB Office of Management and Budget OT&E operational test and evaluation
p.000003:
p.000003: RDT&E research, development, test and evaluation SES Senior Executive Service
p.000003: UPIRTSO unanticipated problems involving risks to subjects or others
p.000003: U.S.C. United States Code
p.000003: USD(P&R) Under Secretary of Defense for Personnel and Readiness
p.000003:
p.000003:
p.000003: PART II. DEFINITIONS
p.000003:
p.000003: Unless otherwise noted, these terms and their definitions are for the purpose of this Instruction.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: Change 1, 10/15/2018 33
p.000004: GLOSSARY
p.000004:
p.000004: DoDI 3216.02, November 8, 2011
p.000004:
p.000004:
p.000004:
p.000004: administrative review. A review of a research protocol and supporting documents (e.g., safety review, scientific
p.000004: review, IRB minutes) related to DoD-supported research involving human subjects which ensures the institution engaged
p.000004: in the research involving human subjects has met the requirements of all applicable regulations and policies. This
p.000004: review is NOT an IRB review.
p.000004:
...
p.000005: the person(s) with the defined responsibilities.
p.000005:
p.000005: HRPP. An institution’s system of interdependent elements that implement policies and practices to protect human
p.000005: subjects involved in research. An HRPP may or may not include a Federal assurance. If the HRPP includes a Federal
p.000005: assurance, it may contain policies and procedures for an IRB belonging to the institution or for a relationship with an
p.000005: IRB external to the institution.
p.000005:
p.000005: human subject. A living individual about whom an investigator conducting research obtains data through intervention or
p.000005: interaction with the individual or obtains identifiable private information as defined in section 219.102(f) of
p.000005: Reference (c). (FDA regulations include a different definition
p.000005:
p.000005:
p.000005:
p.000005: Change 1, 10/15/2018 35
p.000006: GLOSSARY
p.000006:
p.000006: DoDI 3216.02, November 8, 2011
p.000006:
p.000006: of human subject. With respect to research subject to FDA regulations, the FDA definition in section 50.3(g) of
p.000006: Reference (d) also applies.)
p.000006:
p.000006: identifiable private information. Defined in section 219.102(f) of Reference (c).
p.000006:
p.000006: intervention and interaction. An intervention includes both physical procedures by which data are gathered and
p.000006: manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction
p.000006: includes communication or interpersonal contact between investigator and subject. See section 219.102(f) of Reference
p.000006: (c) for more information.
p.000006: Examples include, but are not limited to, a physical procedure, a drug, a manipulation of the human subject or
p.000006: subject’s environment, the withholding of an intervention that would have been undertaken if not for the research
p.000006: purpose, or communication such as a survey or interview.
p.000006:
p.000006: intramural research. Research (see “research involving human subjects”) that is conducted by an entity that is part of
p.000006: the Department of Defense.
p.000006:
p.000006: institution. An organization or entity defined in a Federal assurance or HRPP.
p.000006:
p.000006: IO. The senior person authorized to establish and responsible to maintain the HRPP for the institution. Responsible
p.000006: for a Federal assurance and the IRBs internal to the institution, if these elements are part of the HRPP.
p.000006:
p.000006: neonate. Newborns as defined in subpart B of Reference (i).
p.000006:
p.000006: non-affiliated IRB member. Defined in section 219.107(d) of Reference (c). This member is not connected with the
p.000006: institution(s), as defined in the institution’s Federal assurance that is creating or relying on the IRB, or a member
p.000006: of the immediate family of a person who is associated with the institution creating or relying on the IRB.
p.000006:
p.000006: noncompliance. Failure of a person, group, or institution to act in accordance with this Instruction, its references,
p.000006: or applicable requirements.
p.000006:
p.000006: non-DoD institution. An entity that is not part of the Department of Defense.
p.000006:
p.000006: non-exempt research involving human subjects. An activity that meets the definitions of research and human subject but
p.000006: does not meet the criteria where the only involvement of the human subjects in the research are in one or more of the
...
p.000007: obtains data through intervention or interaction with the individual or identifiable private information. Activities
p.000007: covered by section 219.101(a) of Reference (c) (including exempt research involving human subjects) and this
p.000007: Instruction.
p.000007:
p.000007: The following activities conducted or supported by the Department of Defense are NOT research involving human subjects:
p.000007:
p.000007: Activities carried out solely for purposes of diagnosis, treatment, or prevention of injury and disease in Service
p.000007: members and other mission essential personnel under force health protection programs of the Department of Defense,
p.000007: including health surveillance pursuant to section 1074f of Reference (g) and the use of medical products consistent
p.000007: with DoD Instruction 6200.02 (Reference (y)).
p.000007:
p.000007: Authorized health and medical activities as part of the reasonable practice of medicine or other health professions
p.000007: undertaken for the sole purpose of patient treatment.
p.000007:
p.000007: Activities performed for the sole purpose of medical quality assurance consistent with section 1102 of Reference (g)
p.000007: and DoDD 6025.13 (Reference (z)).
p.000007:
p.000007: Activities performed solely for an OT&E project where the activities and project meet the definition of OT&E as defined
p.000007: in section 139(a)(2)(A) of Reference (g).
p.000007:
p.000007: Activities performed solely for assessing compliance of individuals and organizations with requirements applicable to
p.000007: military, civilian, or contractor personnel or to organizational units, including such activities as occupational drug
p.000007: testing, occupational health and safety reviews, network monitoring, and monitoring for compliance with requirements
p.000007: for protection of classified information.
p.000007:
p.000007: Activities, including program evaluation, customer satisfaction surveys, user surveys, outcome reviews, and other
p.000007: methods, designed solely to assess the performance of DoD programs where the results of the evaluation are only for the
p.000007: use of Government officials
p.000007:
p.000007:
p.000007:
p.000007: Change 1, 10/15/2018 37
p.000008: GLOSSARY
p.000008:
p.000008: DoDI 3216.02, November 8, 2011
p.000008:
p.000008: responsible for the operation or oversight of the program being evaluated and are not intended for generalized use
p.000008: beyond such program.
p.000008:
p.000008: Survey, interview, or surveillance activities and related analyses performed solely for authorized foreign intelligence
p.000008: collection purposes, as authorized by DoDD 5240.01 (Reference (aa)).
p.000008:
p.000008: research involving a human being as an experimental subject. An activity, for research purposes, where there is an
p.000008: intervention or interaction with a living individual for the primary purpose of obtaining data regarding the effect of
p.000008: the intervention or interaction. Research involving a human being as an experimental subject is a subset of research
p.000008: involving human subjects. This definition relates only to the application of section 980 of Reference (g); it does not
p.000008: affect the application of part 219 of Reference (c). This definition does not include activities that are not
p.000008: considered research involving human subjects, activities that meet the exemption criteria at section 219.101(b) of
...
Health / Mentally Disabled
Searching for indicator disability:
(return to top)
p.000009: zone) or having a medical condition (e.g., frequent medical tests or constant pain).
p.000009:
p.000009:
p.000009: 7. ADDITIONAL PROTECTIONS FOR HUMAN SUBJECTS. In addition to the requirements of part 219 of Reference (c),
p.000009: additional safeguards described in this section shall be provided for human subjects in all DoD-conducted research
p.000009: involving human subjects who may be considered vulnerable due to their association with groups or populations
p.000009: specifically defined by Federal regulations in subparts B-D of Reference (i) and this Instruction. Similarly, as
p.000009: provided in Reference (o) or Parts 22 (Appendix B) and 37 (Appendix D) of Reference (c), such additional safeguards
p.000009: shall also be provided in comparable DoD-supported research involving human subjects. For purposes of this
p.000009: Instruction, actions authorizing or requiring any action by an official of HHS about any requirements of subparts B-D
p.000009: of Reference (i) shall be under the authority of the ASD(R&E). Investigators, IRBs, IOs, and DoD Component personnel
p.000009: reviewing research protocols shall consider the need for appropriate similar safeguards for other vulnerable
p.000009: populations, such as: research involving human subjects and investigators in supervisor- subordinate relationships,
p.000009: human subjects with decisional or mental impairments, human
p.000009:
p.000009:
p.000009:
p.000009: Change 1, 10/15/2018 19
p.000010: ENCLOSURE 3
p.000010:
p.000010: DoDI 3216.02, November 8, 2011
p.000010:
p.000010: subjects with a physical disability, or any other kind of human subjects in circumstances that may warrant provision of
p.000010: additional protections. As appropriate, qualified individuals (e.g., research monitors, ombudsmen, advocates) may be
p.000010: appointed to perform oversight functions or assist the human subjects.
p.000010:
p.000010: a. Pregnant Women, Fetuses, and Neonates as Subjects
p.000010:
p.000010: (1) Non-exempt research involving pregnant women, fetuses, or neonates as human subjects must meet the additional
p.000010: relevant protections of subpart B of Reference (i), unless modified by this Instruction. Research involving pregnant
p.000010: women as subjects may be exempt from the requirements of part 219 of Reference (c) and subpart B of Reference (i) if
p.000010: the research meets the exemption criteria at section 219.101(b) of Reference (c). If the pregnant woman is a prisoner,
p.000010: then paragraph 7.b. of this section also applies. If the pregnant woman is a minor, paragraph 7.d. of this section
p.000010: also applies. For purposes of applying paragraph 7.a., the phrase “biomedical knowledge” in subpart B of Reference (i)
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.000006:
p.000006: identifiable private information. Defined in section 219.102(f) of Reference (c).
p.000006:
p.000006: intervention and interaction. An intervention includes both physical procedures by which data are gathered and
p.000006: manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction
p.000006: includes communication or interpersonal contact between investigator and subject. See section 219.102(f) of Reference
p.000006: (c) for more information.
p.000006: Examples include, but are not limited to, a physical procedure, a drug, a manipulation of the human subject or
p.000006: subject’s environment, the withholding of an intervention that would have been undertaken if not for the research
p.000006: purpose, or communication such as a survey or interview.
p.000006:
p.000006: intramural research. Research (see “research involving human subjects”) that is conducted by an entity that is part of
p.000006: the Department of Defense.
p.000006:
p.000006: institution. An organization or entity defined in a Federal assurance or HRPP.
p.000006:
p.000006: IO. The senior person authorized to establish and responsible to maintain the HRPP for the institution. Responsible
p.000006: for a Federal assurance and the IRBs internal to the institution, if these elements are part of the HRPP.
p.000006:
p.000006: neonate. Newborns as defined in subpart B of Reference (i).
p.000006:
p.000006: non-affiliated IRB member. Defined in section 219.107(d) of Reference (c). This member is not connected with the
p.000006: institution(s), as defined in the institution’s Federal assurance that is creating or relying on the IRB, or a member
p.000006: of the immediate family of a person who is associated with the institution creating or relying on the IRB.
p.000006:
p.000006: noncompliance. Failure of a person, group, or institution to act in accordance with this Instruction, its references,
p.000006: or applicable requirements.
p.000006:
p.000006: non-DoD institution. An entity that is not part of the Department of Defense.
p.000006:
p.000006: non-exempt research involving human subjects. An activity that meets the definitions of research and human subject but
p.000006: does not meet the criteria where the only involvement of the human subjects in the research are in one or more of the
p.000006: categories identified in section 219.101(b) of Reference (c).
p.000006:
p.000006: ombudsman. A person who acts as an impartial and objective advocate for human subjects participating in research.
p.000006:
p.000006: OSD Component. Defined in DoD Instruction 5025.01 (Reference (x)).
p.000006:
p.000006: OT&E. Defined in section 139(a)(2)(A) of Reference (g).
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: Change 1, 10/15/2018 36
p.000007: GLOSSARY
p.000007:
p.000007: DoDI 3216.02, November 8, 2011
p.000007:
p.000007: prisoner. Defined in subpart C of Reference (i). Includes military personnel in either civilian or military custody
p.000007: or detainment.
p.000007:
p.000007: prisoner representative. An individual member on the IRB who shall have working knowledge of the human subject
p.000007: population to be recruited, a reasonable familiarity with the operations of the prison or confinement facility, and
p.000007: any other legally imposed restrictive conditions involved in the research, and appropriate background and expertise to
...
Health / Pregnant
Searching for indicator pregnant:
(return to top)
p.000004: 10
p.000004: ENCLOSURE 3: PROCEDURES
p.000004: 11
p.000004: DoD COMPONENT HRPP MANAGEMENT PLAN 11
p.000004: REQUIREMENTS FOR A FEDERAL ASSURANCE 12
p.000004: Activities for Which an Institution is Required to Have a Federal Assurance 12
p.000004: Activities for Which an Institution is not Required to Have a Federal Assurance 13
p.000004: DoD-CONDUCTED RESEARCH INVOLVING HUMAN SUBJECTS 13
p.000004: DoD Institutional Approval and Oversight 13
p.000004: DoD Component Review and Oversight 15
p.000004: RESEARCH INVOLVING HUMAN SUBJECTS CONDUCTED BY A NON-DoD INSTITUTION
p.000004: 16
p.000004: Clause in Contracts and Agreements 16
p.000004: Non-DoD Institutional Responsibilities 17
p.000004: DoD Component Review, Approval, and Oversight 17
p.000004: EDUCATION AND TRAINING 18
p.000004: SELECTION OF HUMAN SUBJECTS AND EVALUATING RISK 19
p.000004: Selection of Human Subjects
p.000004: 19
p.000004: Evaluating Risk
p.000004: 19
p.000004: ADDITIONAL PROTECTIONS FOR HUMAN SUBJECTS 19
p.000004: Pregnant Women, Fetuses, and Neonates as Subjects 20
p.000004: Prisoners as Subjects
p.000004: 20
p.000004: Treatment of Detainees
p.000004: 22
p.000004: Children as Subjects
p.000004: 22
p.000004: DoD Personnel as Subjects
p.000004: 23
p.000004: RESEARCH MONITOR
p.000004: 24
p.000004: UNIQUE DoD LIMITATIONS ON WAIVER OF INFORMED CONSENT 25
p.000004: PROTECTING HUMAN SUBJECTS FROM MEDICAL EXPENSES IF INJURED 26
p.000004: DoD-Supported Research Involving Human Subjects 26
p.000004: DoD-Conducted Research Involving Human Subjects 26
p.000004: DoD-Collaborative Research Involving Human Subjects 26
p.000004: COMPENSATION TO HUMAN SUBJECTS FOR PARTICIPATION IN RESEARCH 27
p.000004: DoD-Conducted Research Involving Human Subjects 27
p.000004: Non-DoD-Conducted Research Involving Human Subjects 28
p.000004: SERVICE MEMBERS AND THEIR STATUS AS ADULTS 29
p.000004: Change 1, 10/15/2018 4
p.000005: CONTENTS
p.000005:
p.000005: DoDI 3216.02, November 8, 2011
p.000005: CLASSIFIED RESEARCH INVOLVING HUMAN SUBJECTS 29
...
p.000009: involving human subjects who may be considered vulnerable due to their association with groups or populations
p.000009: specifically defined by Federal regulations in subparts B-D of Reference (i) and this Instruction. Similarly, as
p.000009: provided in Reference (o) or Parts 22 (Appendix B) and 37 (Appendix D) of Reference (c), such additional safeguards
p.000009: shall also be provided in comparable DoD-supported research involving human subjects. For purposes of this
p.000009: Instruction, actions authorizing or requiring any action by an official of HHS about any requirements of subparts B-D
p.000009: of Reference (i) shall be under the authority of the ASD(R&E). Investigators, IRBs, IOs, and DoD Component personnel
p.000009: reviewing research protocols shall consider the need for appropriate similar safeguards for other vulnerable
p.000009: populations, such as: research involving human subjects and investigators in supervisor- subordinate relationships,
p.000009: human subjects with decisional or mental impairments, human
p.000009:
p.000009:
p.000009:
p.000009: Change 1, 10/15/2018 19
p.000010: ENCLOSURE 3
p.000010:
p.000010: DoDI 3216.02, November 8, 2011
p.000010:
p.000010: subjects with a physical disability, or any other kind of human subjects in circumstances that may warrant provision of
p.000010: additional protections. As appropriate, qualified individuals (e.g., research monitors, ombudsmen, advocates) may be
p.000010: appointed to perform oversight functions or assist the human subjects.
p.000010:
p.000010: a. Pregnant Women, Fetuses, and Neonates as Subjects
p.000010:
p.000010: (1) Non-exempt research involving pregnant women, fetuses, or neonates as human subjects must meet the additional
p.000010: relevant protections of subpart B of Reference (i), unless modified by this Instruction. Research involving pregnant
p.000010: women as subjects may be exempt from the requirements of part 219 of Reference (c) and subpart B of Reference (i) if
p.000010: the research meets the exemption criteria at section 219.101(b) of Reference (c). If the pregnant woman is a prisoner,
p.000010: then paragraph 7.b. of this section also applies. If the pregnant woman is a minor, paragraph 7.d. of this section
p.000010: also applies. For purposes of applying paragraph 7.a., the phrase “biomedical knowledge” in subpart B of Reference (i)
p.000010: shall be replaced with “generalizable knowledge” throughout the subpart.
p.000010:
p.000010: (2) The applicability of subpart B of Reference (i) is limited to research involving:
p.000010:
p.000010: (a) Pregnant women as human subjects involved in research that is more than minimal risk and includes interventions or
p.000010: invasive procedures to the woman or the fetus; or
p.000010:
p.000010: (b) Fetus or neonate (see Glossary) as human subjects.
p.000010:
p.000010: (3) Research involving human subjects using fetal tissue shall comply with sections 289g–289g-2 of Reference (k).
p.000010:
p.000010: b. Prisoners as Subjects
p.000010:
p.000010: (1) Research Intending to Include Prisoners as Subjects
p.000010:
p.000010: (a) Research involving human subjects that includes prisoners must meet the additional relevant protections of subpart
p.000010: C of Reference (i), unless modified by this Instruction. If the prisoner is a pregnant woman, then paragraph 7.a. of
p.000010: this section also applies. If the prisoner is a minor, then paragraph 7.d. of this section also applies.
p.000010:
p.000010: (b) Research intending to include prisoners as subjects cannot be reviewed by the IRB through an expedited review
p.000010: procedure.
p.000010:
p.000010: (c) The IRB reviewing research intending to include prisoners as subjects shall be composed of at least one prisoner
p.000010: representative (see Glossary). The prisoner representative may be a prisoner, an employee of the prison, or an
p.000010: individual not affiliated with the prison. The prisoner representative shall have knowledge of the culture(s) of the
p.000010: prisoners and knowledge of the prison operations. At least one prisoner representative must be present for a quorum.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000000: Change 1, 10/15/2018 20
p.000001: ENCLOSURE 3
p.000001:
p.000001: DoDI 3216.02, November 8, 2011
p.000001:
p.000001: (d) Research involving prisoners at prisons or other types of institutions may be subject to additional review by
p.000001: institution authorities (e.g., Bureau of Prisons).
p.000001:
p.000001: (2) Categories of Allowable Research Involving a Prisoner. In addition to the four categories of permissible research
p.000001: involving human subjects identified in subpart C of Reference (i), two additional categories are allowable.
...
p.000002: prohibited.
p.000002:
p.000002: (2) The prohibition in paragraph c.(1) of this section does not apply to activities covered by investigational new
p.000002: drug or investigational device provisions of Reference (d) when for the purpose of diagnosis or treatment of a medical
p.000002: condition in a patient. Such treatment (e.g., an investigational new drug) may be offered to detainees with the
p.000002: detainees’ informed consent when the medical products are subject to Reference (d) as investigational new drugs or
p.000002: investigational medical devices, and only when the same product would be offered to members of the U.S. Military
p.000002: Services in the same location for the same medical condition and only when consistent with established medical practice
p.000002: involving investigational drugs and devices. Such permitted treatment involving detainees as subjects shall comply
p.000002: with all sections of this Instruction, including paragraphs 6.a., b., and d. of this section, as applicable.
p.000002:
p.000002: d. Children as Subjects
p.000002:
p.000002: (1) Research involving human subjects conducted or supported by the Department of Defense that recruits children to be
p.000002: subjects must meet the additional relevant protections of subpart D of Reference (i), unless modified by this
p.000002: Instruction. If the minor is a pregnant woman, then paragraph 7.a. of this section also applies. If the minor is a
p.000002: prisoner, paragraph 7.b. of this section also applies.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: Change 1, 10/15/2018 22
p.000003: ENCLOSURE 3
p.000003:
p.000003: DoDI 3216.02, November 8, 2011
p.000003:
p.000003: (2) The footnote in section 219.101(i) of Reference (c), prohibiting specific exemptions described in section
p.000003: 219.101(b) from applying to children, is also applicable to DoD-conducted or -supported research involving human
p.000003: subjects unless otherwise clarified in this Instruction.
p.000003:
p.000003: e. DoD Personnel as Subjects
p.000003:
p.000003: (1) Military Personnel as Subjects
p.000003:
p.000003: (a) Service members shall follow their command policies regarding the requirement to obtain command permission to
p.000003: participate in research involving human subjects while
p.000003: on-duty. Additionally a Service member’s ability to perform his or her military duties may be affected by
p.000003: participating during off-duty time (i.e., on leave or during non-duty hours).
p.000003: Therefore, Service members shall follow their Component and command’s policies for approving off-duty employment or
p.000003: activities. The IRBs of DoD institutions or HRPOs may require Principal Investigators to confirm that a Service
p.000003: member’s commander supports the member’s participation in DoD-supported research involving human subjects.
p.000003:
...
Health / injured
Searching for indicator injured:
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p.000004: 16
p.000004: Clause in Contracts and Agreements 16
p.000004: Non-DoD Institutional Responsibilities 17
p.000004: DoD Component Review, Approval, and Oversight 17
p.000004: EDUCATION AND TRAINING 18
p.000004: SELECTION OF HUMAN SUBJECTS AND EVALUATING RISK 19
p.000004: Selection of Human Subjects
p.000004: 19
p.000004: Evaluating Risk
p.000004: 19
p.000004: ADDITIONAL PROTECTIONS FOR HUMAN SUBJECTS 19
p.000004: Pregnant Women, Fetuses, and Neonates as Subjects 20
p.000004: Prisoners as Subjects
p.000004: 20
p.000004: Treatment of Detainees
p.000004: 22
p.000004: Children as Subjects
p.000004: 22
p.000004: DoD Personnel as Subjects
p.000004: 23
p.000004: RESEARCH MONITOR
p.000004: 24
p.000004: UNIQUE DoD LIMITATIONS ON WAIVER OF INFORMED CONSENT 25
p.000004: PROTECTING HUMAN SUBJECTS FROM MEDICAL EXPENSES IF INJURED 26
p.000004: DoD-Supported Research Involving Human Subjects 26
p.000004: DoD-Conducted Research Involving Human Subjects 26
p.000004: DoD-Collaborative Research Involving Human Subjects 26
p.000004: COMPENSATION TO HUMAN SUBJECTS FOR PARTICIPATION IN RESEARCH 27
p.000004: DoD-Conducted Research Involving Human Subjects 27
p.000004: Non-DoD-Conducted Research Involving Human Subjects 28
p.000004: SERVICE MEMBERS AND THEIR STATUS AS ADULTS 29
p.000004: Change 1, 10/15/2018 4
p.000005: CONTENTS
p.000005:
p.000005: DoDI 3216.02, November 8, 2011
p.000005: CLASSIFIED RESEARCH INVOLVING HUMAN SUBJECTS 29
p.000005: ADDITIONAL PROTECTIONS FOR CONFIDENTIALITY 30
p.000005: Confidential Information Protection and Statistical Efficiency Act (CIPSEA) for
p.000005: Non-Statistical Agencies
p.000005: 30
p.000005: CIPSEA for Statistical Agencies
p.000005: 30
p.000005: Certificates for Confidentiality
p.000005: 30
p.000005: RECORD KEEPING
p.000005: 31
p.000005: NONCOMPLIANCE WITH THIS INSTRUCTION 31
p.000005: APPLICABILITY TO OTHER REQUIREMENTS 31
p.000005: CCHRPP MEMBERSHIP
p.000005: 32
p.000005: GLOSSARY
p.000005: 33
p.000005: PART I. ABBREVIATIONS AND ACRONYMS 33
p.000005: PART II. DEFINITIONS
p.000005: 33
p.000005:
p.000005:
p.000005:
...
p.000005: consistent with part 219 of Reference (c) if the subject cannot consent. If consent is to be obtained from the
p.000005: experimental subject’s legal representative, the research must intend to benefit the individual subject. The
p.000005: determination that research is intended to be beneficial to the individual experimental subject must be made by an IRB
p.000005: consistent with part 219 of Reference (c).
p.000005:
p.000005: c. The requirement of paragraph 9.b. of this section may be waived by the ASD(R&E) if all the following conditions are
p.000005: met:
p.000005:
p.000005: (1) The research is necessary to advance the development of a medical product for the Military Services.
p.000005:
p.000005: (2) The research may directly benefit the individual experimental subject.
p.000005:
p.000005: (3) The research is conducted in compliance with all other applicable laws and regulations.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Change 1, 10/15/2018 25
p.000006: ENCLOSURE 3
p.000006:
p.000006: DoDI 3216.02, November 8, 2011
p.000006:
p.000006: d. The ASD(R&E) may delegate the waiver authority described in paragraph 9.c. to the Heads of the OSD and DoD
p.000006: Components if they have appropriate policies and procedures in their management plans. This authority is further
p.000006: delegable only to a DoD Component official who is a Presidential Appointee with Senate Confirmation.
p.000006:
p.000006:
p.000006: 10. PROTECTING HUMAN SUBJECTS FROM MEDICAL EXPENSES IF INJURED
p.000006:
p.000006: a. DoD-Supported Research Involving Human Subjects. All non-exempt research involving human subjects shall, at a
p.000006: minimum, meet the requirement of section 219.116(a)(6) of Reference (c). The Common Rule does not require payment or
p.000006: reimbursement of medical expenses, provision of medical care, or compensation for research-related injuries.
p.000006:
p.000006: b. DoD-Conducted Research Involving Human Subjects. The DoD Components shall establish procedures to protect human
p.000006: subjects from medical expenses (not otherwise provided or reimbursed) that are the direct result of participation in
p.000006: DoD-conducted non-exempt research involving human subjects that involves more than minimal risk. Such procedures may
p.000006: consist of utilizing the Secretarial Designee program as described by section 108.4(i) of Reference (c) during the
p.000006: period of the human subject’s involvement in the research, which may be extended further upon the approval of the
p.000006: USD(P&R). DoD Components may supplement this Secretarial Designee procedure with additional procedures consistent with
p.000006: applicable authority. This requirement does not apply when the Department of Defense is supporting the research but is
p.000006: not engaged in the non-exempt research involving human subjects (i.e., when the non-exempt research involving human
p.000006: subjects is performed solely by non-DoD institutions).
p.000006:
p.000006: c. DoD Collaborative Research Involving Human Subjects
p.000006:
p.000006: (1) When collaborating with a non-DoD institution, the DoD Components shall establish procedures comparable to those
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.000003:
p.000003: b. Activities for Which an Institution is not Required to Have a Federal Assurance
p.000003:
p.000003: (1) An institution is not required to have a Federal assurance if its personnel only conduct research that does not
p.000003: involve human subjects or the research involving human subjects meets at least one of the exemption criteria in section
p.000003: 219.101(b) of Reference (c).
p.000003:
p.000003: (2) An institution that is only providing resources to support research involving human subjects (see Glossary
p.000003: definition of DoD-supported research involving human subjects) is not required to have a Federal assurance unless its
p.000003: involvement also meets the definition of being engaged in non-exempt research involving human subjects. When a DoD
p.000003: institution passes resources to another institution that will not be engaged in research, but will only transfer the
p.000003: resources to a third institution that will engage in research involving human subjects, the pass through institution is
p.000003: not required to have a Federal assurance. The institution engaged in
p.000003: non-exempt research involving human subjects must have a Federal assurance.
p.000003:
p.000003: (3) An institution is not required to have a Federal assurance if it is collaborating in a research protocol that is
p.000003: non-exempt research involving human subjects and the institution’s role in the collaborative research is limited to any
p.000003: of the following:
p.000003:
p.000003: (a) Specific tasks that do not involve research involving human subjects; or
p.000003:
p.000003: (b) Specific tasks that do not include the collection or handling of identifiable data or specimens. Research in
p.000003: which the human subjects’ data or specimens are coded and the institution is prevented from having access to the code
p.000003: are considered non-identifiable for the purpose of this subparagraph.
p.000003:
p.000003: (4) A DoD institution that does not meet the criteria for requiring a Federal assurance but conducts only exempt
p.000003: research involving human subjects or supports research involving human subjects must have an HRPP approved by its DoD
p.000003: Component that includes relevant policies and procedures to ensure compliance with this Instruction.
p.000003:
p.000003:
p.000003: 3. DoD-CONDUCTED RESEARCH INVOLVING HUMAN SUBJECTS
p.000003:
p.000003: a. DoD Institutional Approval and Oversight
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: Change 1, 10/15/2018 13
p.000004: ENCLOSURE 3
p.000004:
p.000004: DoDI 3216.02, November 8, 2011
p.000004:
p.000004: (1) DoD institutions conducting intramural research as defined in the Glossary involving human subjects shall have
p.000004: procedures to ensure appropriate regulatory determinations for activities that constitute research, activities that
p.000004: constitute research involving human subjects, or activities that are research involving human subjects but that meet
p.000004: the exemption criteria in section 219.101(b) of Reference (c). Such procedures shall include the designation,
p.000004: oversight, and appropriate training of DoD personnel.
p.000004:
p.000004: (2) The DoD institution shall have policies and procedures to require scientific review of non-exempt research
p.000004: involving human subjects and to ensure this review is considered during the IRB review process.
p.000004:
p.000004: (3) IRBs may use expedited review procedures under section 219.110(a) of Reference (c) to review minimal risk,
...
p.000009:
p.000009: b. Waivers of informed consent are prohibited.
p.000009:
p.000009: c. Informed consent procedures shall include:
p.000009:
p.000009: (1) Identification of the Department of Defense as the supporting institution of the research, unless the research
p.000009: involves no more than minimal risk. The Secretary of Defense may grant an exception to this requirement on the grounds
p.000009: that providing this information could compromise intelligence sources or methods.
p.000009:
p.000009: (2) A statement that the research involving human subjects is classified and an explanation of the impact of the
p.000009: classification.
p.000009:
p.000009: d. IRB approval process shall meet the following requirements:
p.000009:
p.000009: (1) IRB review shall be conducted using a full board review. Use of an expedited review procedure is prohibited.
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009:
p.000009: Change 1, 10/15/2018 29
p.000010: ENCLOSURE 3
p.000010:
p.000010: DoDI 3216.02, November 8, 2011
p.000010:
p.000010: (2) At least one non-affiliated member shall be a non-Federal employee (other than as an individual appointed as an
p.000010: expert or consultant in accordance with section 3109 of Reference (n) for purposes of service on the IRB).
p.000010:
p.000010: (3) Any IRB member who disagrees with a majority decision approving a project may appeal the decision to the Secretary
p.000010: of Defense. The appeal shall be included in the DoD Component’s submission to the Secretary of Defense.
p.000010:
p.000010: (4) The IRB shall determine whether potential human subjects need access to classified information to make a valid,
p.000010: informed consent decision.
p.000010:
p.000010: e. Disclosure or use of classified information must comply with the requirements of Reference (s) for access to and
p.000010: protection of classified information.
p.000010:
p.000010:
p.000010: 14. ADDITIONAL PROTECTIONS FOR CONFIDENTIALITY. This section outlines certain authorities that the DoD Components may
p.000010: consider using, subject to applicable requirements, for particular sensitive research activities when additional
p.000010: protections for confidentiality would improve participation and results.
p.000010:
p.000010: a. Confidential Information Protection and Statistical Efficiency Act (CIPSEA) for Non- Statistical Agencies. Any DoD
p.000010: Component may use the authority pursuant to sections 501-513 of Reference (l) to assure that data or information
p.000010: acquired by the DoD Component under a pledge of confidentiality for exclusively statistical purposes shall be used
p.000010: exclusively for statistical purposes and may not be disclosed in identifiable form for any other purpose, except with
p.000010: the informed consent of the respondent. Use of this authority is subject to the requirements of sections 512 and
p.000010: 523-525 of Reference (l) and of Reference (m), including that the research involving human subjects is conducted by a
p.000010: DoD Component or other Federal agency and not by a contractor, grantee, or other non-Federal entity, and that use of
p.000010: the authority is reported annually to OMB by the DoD Component.
p.000010:
p.000010: b. CIPSEA for Statistical Agencies. Any DoD Component or unit thereof designated a statistical agency by the OMB
...
p.000004: part-time, intermittent, or on-call positions; and individuals serving under personal services contracts consistent
p.000004: with section 2.101 of Reference (o). It excludes employees of contractors (other than personal services contractors)
p.000004: and foreign nationals of host countries.
p.000004:
p.000004: Service members. Individuals appointed, enlisted, or inducted for military service under the authority of the
p.000004: Department of Defense. The Military Services are the Army, the Navy, the Air Force, the Marine Corps, the Coast Guard,
p.000004: and the Reserve Components, which includes the Army and the Air National Guards of the United States. Members of the
p.000004: Reserve Components are included when in a duty status.
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Change 1, 10/15/2018 34
p.000005: GLOSSARY
p.000005:
p.000005: DoDI 3216.02, November 8, 2011
p.000005:
p.000005: DoD-supported research involving human subjects. Research involving human subjects for which the Department of Defense
p.000005: is providing at least some of the resources (see “research involving human subjects”). Resources may include but are
p.000005: not limited to funding, facilities, equipment, personnel (investigators or other personnel performing tasks identified
p.000005: in the research protocol), access to or information about DoD personnel for recruitment, or identifiable data or
p.000005: specimens from living individuals. It includes both DoD-conducted research involving human subjects (intramural
p.000005: research) and research conducted by a non-DoD institution.
p.000005:
p.000005: engaged in research involving human subjects. An institution is engaged in research involving human subjects when its
p.000005: personnel are conducting activities covered by section 219.101(a) of Reference (c) and this Instruction. An
p.000005: institution that is funding, providing equipment, providing access to or information about potential human subjects
p.000005: (but not recruiting human subjects), providing data or specimens (either identifiable or not), or overseeing the
p.000005: research from a regulatory or compliance standpoint is not engaged in the research involving human subjects (but is
p.000005: supporting the research (see “DoD-supported research involving human subjects”)).
p.000005:
p.000005: exempt research involving human subjects. Research involving human subjects where the only involvement of the human
p.000005: subjects in the research will be in one or more of the categories identified in section 219.101(b) of Reference (c).
p.000005:
p.000005: experimental subject. See “research involving a human being as an experimental subject.”
p.000005:
p.000005: Federal assurance. A written document in which an institution (not an IRB) commits to a Federal department or agency
p.000005: their compliance with the requirements set forth in the Common Rule. Institutions engaged in non-exempt research
p.000005: involving human subjects conducted or supported by the Department of Defense or other Federal departments and agencies
p.000005: that have adopted the Common Rule must have a Federal assurance approved or accepted by the Federal agency supporting
p.000005: the research. The elements of a Federal assurance are outlined in section 219.103(b) of Reference (c).
p.000005:
p.000005: fetus. The product of conception from implantation until delivery as defined in subpart B of Reference (i).
p.000005:
p.000005: HRPO. An individual who is delegated the responsibilities as defined in paragraph (a)(2) of section 252.235-7004 of
...
Social / Age
Searching for indicator age:
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p.000008: off-duty Federal personnel for general research participation must not be directly from a Federal source (payment from
p.000008: a Federal contractor or other non-Federal source is permissible).
p.000008:
p.000008: (3) When the Human Subjects Are Not Federal Personnel
p.000008:
p.000008: (a) Non-Federal personnel participating as human subjects in DoD-funded research may be compensated up to $50 for each
p.000008: blood draw if the research meets the purpose of Reference (r).
p.000008:
p.000008: (b) Additionally non-Federal personnel may be compensated for participation in DoD-supported research for other than
p.000008: blood draws in a reasonable amount as approved by the IRB according to local prevailing rates and the nature of the
p.000008: research. Payment for general research participation may come directly from a Federal or non-Federal source.
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: Change 1, 10/15/2018 28
p.000009: ENCLOSURE 3
p.000009:
p.000009: DoDI 3216.02, November 8, 2011
p.000009:
p.000009: 12. SERVICE MEMBERS AND THEIR STATUS AS ADULTS. For purposes of legal capacity to participate in DoD-conducted or
p.000009: -supported research involving human subjects, all active duty Service members and all Reserve Component members in a
p.000009: Federal duty status are considered for purposes of this Instruction to be adults. The participation of such members is
p.000009: not subject to requirements of paragraph 7.d. of this enclosure or subpart D of Reference (i) regarding research
p.000009: involving children or minors. When Service members are under 18 years of age, students at Service Academies, or
p.000009: trainees, the IRB shall carefully consider the recruitment process and the necessity to include such members as human
p.000009: subjects.
p.000009:
p.000009:
p.000009: 13. CLASSIFIED RESEARCH INVOLVING HUMAN SUBJECTS. For all DoD-conducted non-exempt research involving human subjects
p.000009: that involves classified information as defined in Executive Order 13526 (Reference (s)), and, to the extent provided
p.000009: pursuant to Parts 22, 37, and 219 of Reference (c) and Reference (o), comparable DoD-supported research, the additional
p.000009: requirements in this section apply. The involvement of classified information may be limited to information needed for
p.000009: IRB approval and oversight of the research; information needed to inform the human subjects during the consent process;
p.000009: and information provided by the human subjects during the course of the research. If this activity is part of a
p.000009: classified program, this section does not apply if the information required to be contained in the research protocol or
p.000009: needed by either the IRB or the human subjects is not classified.
p.000009:
p.000009: a. Secretary of Defense approval is required for all classified non-exempt research involving human subjects.
p.000009: Submission for approval shall be from the Head of the OSD or DoD Component conducting or supporting the non-exempt
p.000009: research involving human subjects. The request shall be coordinated with the ASD(R&E) and General Counsel of the
p.000009: Department of Defense after the IRB has approved the research.
p.000009:
p.000009: b. Waivers of informed consent are prohibited.
p.000009:
p.000009: c. Informed consent procedures shall include:
...
Social / Child
Searching for indicator children:
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p.000004: DoD Institutional Approval and Oversight 13
p.000004: DoD Component Review and Oversight 15
p.000004: RESEARCH INVOLVING HUMAN SUBJECTS CONDUCTED BY A NON-DoD INSTITUTION
p.000004: 16
p.000004: Clause in Contracts and Agreements 16
p.000004: Non-DoD Institutional Responsibilities 17
p.000004: DoD Component Review, Approval, and Oversight 17
p.000004: EDUCATION AND TRAINING 18
p.000004: SELECTION OF HUMAN SUBJECTS AND EVALUATING RISK 19
p.000004: Selection of Human Subjects
p.000004: 19
p.000004: Evaluating Risk
p.000004: 19
p.000004: ADDITIONAL PROTECTIONS FOR HUMAN SUBJECTS 19
p.000004: Pregnant Women, Fetuses, and Neonates as Subjects 20
p.000004: Prisoners as Subjects
p.000004: 20
p.000004: Treatment of Detainees
p.000004: 22
p.000004: Children as Subjects
p.000004: 22
p.000004: DoD Personnel as Subjects
p.000004: 23
p.000004: RESEARCH MONITOR
p.000004: 24
p.000004: UNIQUE DoD LIMITATIONS ON WAIVER OF INFORMED CONSENT 25
p.000004: PROTECTING HUMAN SUBJECTS FROM MEDICAL EXPENSES IF INJURED 26
p.000004: DoD-Supported Research Involving Human Subjects 26
p.000004: DoD-Conducted Research Involving Human Subjects 26
p.000004: DoD-Collaborative Research Involving Human Subjects 26
p.000004: COMPENSATION TO HUMAN SUBJECTS FOR PARTICIPATION IN RESEARCH 27
p.000004: DoD-Conducted Research Involving Human Subjects 27
p.000004: Non-DoD-Conducted Research Involving Human Subjects 28
p.000004: SERVICE MEMBERS AND THEIR STATUS AS ADULTS 29
p.000004: Change 1, 10/15/2018 4
p.000005: CONTENTS
p.000005:
p.000005: DoDI 3216.02, November 8, 2011
p.000005: CLASSIFIED RESEARCH INVOLVING HUMAN SUBJECTS 29
p.000005: ADDITIONAL PROTECTIONS FOR CONFIDENTIALITY 30
p.000005: Confidential Information Protection and Statistical Efficiency Act (CIPSEA) for
p.000005: Non-Statistical Agencies
p.000005: 30
p.000005: CIPSEA for Statistical Agencies
p.000005: 30
p.000005: Certificates for Confidentiality
p.000005: 30
p.000005: RECORD KEEPING
p.000005: 31
...
p.000002: the applicable DoD Component office conducting the reviews identified in paragraphs
p.000002: 3.b. or 4.c. of this enclosure must concur with the IRB before the human subject can continue to participate while a
p.000002: prisoner. This approved change to a research protocol does not require ASD(R&E) approval.
p.000002:
p.000002: c. Treatment of Detainees
p.000002:
p.000002: (1) Research involving a detainee, as defined in DoD Directive 2310.01E (Reference (q)), as a human subject is
p.000002: prohibited.
p.000002:
p.000002: (2) The prohibition in paragraph c.(1) of this section does not apply to activities covered by investigational new
p.000002: drug or investigational device provisions of Reference (d) when for the purpose of diagnosis or treatment of a medical
p.000002: condition in a patient. Such treatment (e.g., an investigational new drug) may be offered to detainees with the
p.000002: detainees’ informed consent when the medical products are subject to Reference (d) as investigational new drugs or
p.000002: investigational medical devices, and only when the same product would be offered to members of the U.S. Military
p.000002: Services in the same location for the same medical condition and only when consistent with established medical practice
p.000002: involving investigational drugs and devices. Such permitted treatment involving detainees as subjects shall comply
p.000002: with all sections of this Instruction, including paragraphs 6.a., b., and d. of this section, as applicable.
p.000002:
p.000002: d. Children as Subjects
p.000002:
p.000002: (1) Research involving human subjects conducted or supported by the Department of Defense that recruits children to be
p.000002: subjects must meet the additional relevant protections of subpart D of Reference (i), unless modified by this
p.000002: Instruction. If the minor is a pregnant woman, then paragraph 7.a. of this section also applies. If the minor is a
p.000002: prisoner, paragraph 7.b. of this section also applies.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: Change 1, 10/15/2018 22
p.000003: ENCLOSURE 3
p.000003:
p.000003: DoDI 3216.02, November 8, 2011
p.000003:
p.000003: (2) The footnote in section 219.101(i) of Reference (c), prohibiting specific exemptions described in section
p.000003: 219.101(b) from applying to children, is also applicable to DoD-conducted or -supported research involving human
p.000003: subjects unless otherwise clarified in this Instruction.
p.000003:
p.000003: e. DoD Personnel as Subjects
p.000003:
p.000003: (1) Military Personnel as Subjects
p.000003:
p.000003: (a) Service members shall follow their command policies regarding the requirement to obtain command permission to
p.000003: participate in research involving human subjects while
p.000003: on-duty. Additionally a Service member’s ability to perform his or her military duties may be affected by
p.000003: participating during off-duty time (i.e., on leave or during non-duty hours).
p.000003: Therefore, Service members shall follow their Component and command’s policies for approving off-duty employment or
p.000003: activities. The IRBs of DoD institutions or HRPOs may require Principal Investigators to confirm that a Service
p.000003: member’s commander supports the member’s participation in DoD-supported research involving human subjects.
p.000003:
p.000003: (b) Superiors (e.g., military and civilian supervisors, unit officers, and noncommissioned officers (NCOs)) are
p.000003: prohibited from influencing the decisions of their subordinates (e.g., junior enlisted personnel and equivalent
p.000003: civilians) regarding participation as subjects in research involving human subjects covered by this Instruction.
p.000003:
p.000003: (c) Superiors of Service members (e.g., unit officers, senior NCOs, and equivalent civilians) in the chain of command
p.000003: shall not be present at any human subject recruitment sessions or during the consent process in which members of units
...
p.000008: amount as approved by the IRB according to local prevailing rates and the nature of the research). However, payment to
p.000008: off-duty Federal personnel for general research participation must not be directly from a Federal source (payment from
p.000008: a Federal contractor or other non-Federal source is permissible).
p.000008:
p.000008: (3) When the Human Subjects Are Not Federal Personnel
p.000008:
p.000008: (a) Non-Federal personnel participating as human subjects in DoD-funded research may be compensated up to $50 for each
p.000008: blood draw if the research meets the purpose of Reference (r).
p.000008:
p.000008: (b) Additionally non-Federal personnel may be compensated for participation in DoD-supported research for other than
p.000008: blood draws in a reasonable amount as approved by the IRB according to local prevailing rates and the nature of the
p.000008: research. Payment for general research participation may come directly from a Federal or non-Federal source.
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: Change 1, 10/15/2018 28
p.000009: ENCLOSURE 3
p.000009:
p.000009: DoDI 3216.02, November 8, 2011
p.000009:
p.000009: 12. SERVICE MEMBERS AND THEIR STATUS AS ADULTS. For purposes of legal capacity to participate in DoD-conducted or
p.000009: -supported research involving human subjects, all active duty Service members and all Reserve Component members in a
p.000009: Federal duty status are considered for purposes of this Instruction to be adults. The participation of such members is
p.000009: not subject to requirements of paragraph 7.d. of this enclosure or subpart D of Reference (i) regarding research
p.000009: involving children or minors. When Service members are under 18 years of age, students at Service Academies, or
p.000009: trainees, the IRB shall carefully consider the recruitment process and the necessity to include such members as human
p.000009: subjects.
p.000009:
p.000009:
p.000009: 13. CLASSIFIED RESEARCH INVOLVING HUMAN SUBJECTS. For all DoD-conducted non-exempt research involving human subjects
p.000009: that involves classified information as defined in Executive Order 13526 (Reference (s)), and, to the extent provided
p.000009: pursuant to Parts 22, 37, and 219 of Reference (c) and Reference (o), comparable DoD-supported research, the additional
p.000009: requirements in this section apply. The involvement of classified information may be limited to information needed for
p.000009: IRB approval and oversight of the research; information needed to inform the human subjects during the consent process;
p.000009: and information provided by the human subjects during the course of the research. If this activity is part of a
p.000009: classified program, this section does not apply if the information required to be contained in the research protocol or
p.000009: needed by either the IRB or the human subjects is not classified.
p.000009:
p.000009: a. Secretary of Defense approval is required for all classified non-exempt research involving human subjects.
p.000009: Submission for approval shall be from the Head of the OSD or DoD Component conducting or supporting the non-exempt
p.000009: research involving human subjects. The request shall be coordinated with the ASD(R&E) and General Counsel of the
p.000009: Department of Defense after the IRB has approved the research.
p.000009:
p.000009: b. Waivers of informed consent are prohibited.
p.000009:
...
Social / Fetus/Neonate
Searching for indicator fetus:
(return to top)
p.000010: relevant protections of subpart B of Reference (i), unless modified by this Instruction. Research involving pregnant
p.000010: women as subjects may be exempt from the requirements of part 219 of Reference (c) and subpart B of Reference (i) if
p.000010: the research meets the exemption criteria at section 219.101(b) of Reference (c). If the pregnant woman is a prisoner,
p.000010: then paragraph 7.b. of this section also applies. If the pregnant woman is a minor, paragraph 7.d. of this section
p.000010: also applies. For purposes of applying paragraph 7.a., the phrase “biomedical knowledge” in subpart B of Reference (i)
p.000010: shall be replaced with “generalizable knowledge” throughout the subpart.
p.000010:
p.000010: (2) The applicability of subpart B of Reference (i) is limited to research involving:
p.000010:
p.000010: (a) Pregnant women as human subjects involved in research that is more than minimal risk and includes interventions or
p.000010: invasive procedures to the woman or the fetus; or
p.000010:
p.000010: (b) Fetus or neonate (see Glossary) as human subjects.
p.000010:
p.000010: (3) Research involving human subjects using fetal tissue shall comply with sections 289g–289g-2 of Reference (k).
p.000010:
p.000010: b. Prisoners as Subjects
p.000010:
p.000010: (1) Research Intending to Include Prisoners as Subjects
p.000010:
p.000010: (a) Research involving human subjects that includes prisoners must meet the additional relevant protections of subpart
p.000010: C of Reference (i), unless modified by this Instruction. If the prisoner is a pregnant woman, then paragraph 7.a. of
p.000010: this section also applies. If the prisoner is a minor, then paragraph 7.d. of this section also applies.
p.000010:
p.000010: (b) Research intending to include prisoners as subjects cannot be reviewed by the IRB through an expedited review
p.000010: procedure.
p.000010:
p.000010: (c) The IRB reviewing research intending to include prisoners as subjects shall be composed of at least one prisoner
p.000010: representative (see Glossary). The prisoner representative may be a prisoner, an employee of the prison, or an
p.000010: individual not affiliated with the prison. The prisoner representative shall have knowledge of the culture(s) of the
...
p.000005: personnel are conducting activities covered by section 219.101(a) of Reference (c) and this Instruction. An
p.000005: institution that is funding, providing equipment, providing access to or information about potential human subjects
p.000005: (but not recruiting human subjects), providing data or specimens (either identifiable or not), or overseeing the
p.000005: research from a regulatory or compliance standpoint is not engaged in the research involving human subjects (but is
p.000005: supporting the research (see “DoD-supported research involving human subjects”)).
p.000005:
p.000005: exempt research involving human subjects. Research involving human subjects where the only involvement of the human
p.000005: subjects in the research will be in one or more of the categories identified in section 219.101(b) of Reference (c).
p.000005:
p.000005: experimental subject. See “research involving a human being as an experimental subject.”
p.000005:
p.000005: Federal assurance. A written document in which an institution (not an IRB) commits to a Federal department or agency
p.000005: their compliance with the requirements set forth in the Common Rule. Institutions engaged in non-exempt research
p.000005: involving human subjects conducted or supported by the Department of Defense or other Federal departments and agencies
p.000005: that have adopted the Common Rule must have a Federal assurance approved or accepted by the Federal agency supporting
p.000005: the research. The elements of a Federal assurance are outlined in section 219.103(b) of Reference (c).
p.000005:
p.000005: fetus. The product of conception from implantation until delivery as defined in subpart B of Reference (i).
p.000005:
p.000005: HRPO. An individual who is delegated the responsibilities as defined in paragraph (a)(2) of section 252.235-7004 of
p.000005: Reference (o). There may be more than one HRPO in a DoD Component. Some DoD Components may use a different title for
p.000005: the person(s) with the defined responsibilities.
p.000005:
p.000005: HRPP. An institution’s system of interdependent elements that implement policies and practices to protect human
p.000005: subjects involved in research. An HRPP may or may not include a Federal assurance. If the HRPP includes a Federal
p.000005: assurance, it may contain policies and procedures for an IRB belonging to the institution or for a relationship with an
p.000005: IRB external to the institution.
p.000005:
p.000005: human subject. A living individual about whom an investigator conducting research obtains data through intervention or
p.000005: interaction with the individual or obtains identifiable private information as defined in section 219.102(f) of
p.000005: Reference (c). (FDA regulations include a different definition
p.000005:
p.000005:
p.000005:
p.000005: Change 1, 10/15/2018 35
p.000006: GLOSSARY
p.000006:
p.000006: DoDI 3216.02, November 8, 2011
p.000006:
p.000006: of human subject. With respect to research subject to FDA regulations, the FDA definition in section 50.3(g) of
p.000006: Reference (d) also applies.)
p.000006:
p.000006: identifiable private information. Defined in section 219.102(f) of Reference (c).
p.000006:
p.000006: intervention and interaction. An intervention includes both physical procedures by which data are gathered and
...
Searching for indicator neonate:
(return to top)
p.000010: relevant protections of subpart B of Reference (i), unless modified by this Instruction. Research involving pregnant
p.000010: women as subjects may be exempt from the requirements of part 219 of Reference (c) and subpart B of Reference (i) if
p.000010: the research meets the exemption criteria at section 219.101(b) of Reference (c). If the pregnant woman is a prisoner,
p.000010: then paragraph 7.b. of this section also applies. If the pregnant woman is a minor, paragraph 7.d. of this section
p.000010: also applies. For purposes of applying paragraph 7.a., the phrase “biomedical knowledge” in subpart B of Reference (i)
p.000010: shall be replaced with “generalizable knowledge” throughout the subpart.
p.000010:
p.000010: (2) The applicability of subpart B of Reference (i) is limited to research involving:
p.000010:
p.000010: (a) Pregnant women as human subjects involved in research that is more than minimal risk and includes interventions or
p.000010: invasive procedures to the woman or the fetus; or
p.000010:
p.000010: (b) Fetus or neonate (see Glossary) as human subjects.
p.000010:
p.000010: (3) Research involving human subjects using fetal tissue shall comply with sections 289g–289g-2 of Reference (k).
p.000010:
p.000010: b. Prisoners as Subjects
p.000010:
p.000010: (1) Research Intending to Include Prisoners as Subjects
p.000010:
p.000010: (a) Research involving human subjects that includes prisoners must meet the additional relevant protections of subpart
p.000010: C of Reference (i), unless modified by this Instruction. If the prisoner is a pregnant woman, then paragraph 7.a. of
p.000010: this section also applies. If the prisoner is a minor, then paragraph 7.d. of this section also applies.
p.000010:
p.000010: (b) Research intending to include prisoners as subjects cannot be reviewed by the IRB through an expedited review
p.000010: procedure.
p.000010:
p.000010: (c) The IRB reviewing research intending to include prisoners as subjects shall be composed of at least one prisoner
p.000010: representative (see Glossary). The prisoner representative may be a prisoner, an employee of the prison, or an
p.000010: individual not affiliated with the prison. The prisoner representative shall have knowledge of the culture(s) of the
...
p.000005: Reference (c). (FDA regulations include a different definition
p.000005:
p.000005:
p.000005:
p.000005: Change 1, 10/15/2018 35
p.000006: GLOSSARY
p.000006:
p.000006: DoDI 3216.02, November 8, 2011
p.000006:
p.000006: of human subject. With respect to research subject to FDA regulations, the FDA definition in section 50.3(g) of
p.000006: Reference (d) also applies.)
p.000006:
p.000006: identifiable private information. Defined in section 219.102(f) of Reference (c).
p.000006:
p.000006: intervention and interaction. An intervention includes both physical procedures by which data are gathered and
p.000006: manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction
p.000006: includes communication or interpersonal contact between investigator and subject. See section 219.102(f) of Reference
p.000006: (c) for more information.
p.000006: Examples include, but are not limited to, a physical procedure, a drug, a manipulation of the human subject or
p.000006: subject’s environment, the withholding of an intervention that would have been undertaken if not for the research
p.000006: purpose, or communication such as a survey or interview.
p.000006:
p.000006: intramural research. Research (see “research involving human subjects”) that is conducted by an entity that is part of
p.000006: the Department of Defense.
p.000006:
p.000006: institution. An organization or entity defined in a Federal assurance or HRPP.
p.000006:
p.000006: IO. The senior person authorized to establish and responsible to maintain the HRPP for the institution. Responsible
p.000006: for a Federal assurance and the IRBs internal to the institution, if these elements are part of the HRPP.
p.000006:
p.000006: neonate. Newborns as defined in subpart B of Reference (i).
p.000006:
p.000006: non-affiliated IRB member. Defined in section 219.107(d) of Reference (c). This member is not connected with the
p.000006: institution(s), as defined in the institution’s Federal assurance that is creating or relying on the IRB, or a member
p.000006: of the immediate family of a person who is associated with the institution creating or relying on the IRB.
p.000006:
p.000006: noncompliance. Failure of a person, group, or institution to act in accordance with this Instruction, its references,
p.000006: or applicable requirements.
p.000006:
p.000006: non-DoD institution. An entity that is not part of the Department of Defense.
p.000006:
p.000006: non-exempt research involving human subjects. An activity that meets the definitions of research and human subject but
p.000006: does not meet the criteria where the only involvement of the human subjects in the research are in one or more of the
p.000006: categories identified in section 219.101(b) of Reference (c).
p.000006:
p.000006: ombudsman. A person who acts as an impartial and objective advocate for human subjects participating in research.
p.000006:
p.000006: OSD Component. Defined in DoD Instruction 5025.01 (Reference (x)).
p.000006:
p.000006: OT&E. Defined in section 139(a)(2)(A) of Reference (g).
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: Change 1, 10/15/2018 36
p.000007: GLOSSARY
p.000007:
p.000007: DoDI 3216.02, November 8, 2011
p.000007:
p.000007: prisoner. Defined in subpart C of Reference (i). Includes military personnel in either civilian or military custody
p.000007: or detainment.
p.000007:
...
Searching for indicator fetuses:
(return to top)
p.000004: REQUIREMENTS FOR A FEDERAL ASSURANCE 12
p.000004: Activities for Which an Institution is Required to Have a Federal Assurance 12
p.000004: Activities for Which an Institution is not Required to Have a Federal Assurance 13
p.000004: DoD-CONDUCTED RESEARCH INVOLVING HUMAN SUBJECTS 13
p.000004: DoD Institutional Approval and Oversight 13
p.000004: DoD Component Review and Oversight 15
p.000004: RESEARCH INVOLVING HUMAN SUBJECTS CONDUCTED BY A NON-DoD INSTITUTION
p.000004: 16
p.000004: Clause in Contracts and Agreements 16
p.000004: Non-DoD Institutional Responsibilities 17
p.000004: DoD Component Review, Approval, and Oversight 17
p.000004: EDUCATION AND TRAINING 18
p.000004: SELECTION OF HUMAN SUBJECTS AND EVALUATING RISK 19
p.000004: Selection of Human Subjects
p.000004: 19
p.000004: Evaluating Risk
p.000004: 19
p.000004: ADDITIONAL PROTECTIONS FOR HUMAN SUBJECTS 19
p.000004: Pregnant Women, Fetuses, and Neonates as Subjects 20
p.000004: Prisoners as Subjects
p.000004: 20
p.000004: Treatment of Detainees
p.000004: 22
p.000004: Children as Subjects
p.000004: 22
p.000004: DoD Personnel as Subjects
p.000004: 23
p.000004: RESEARCH MONITOR
p.000004: 24
p.000004: UNIQUE DoD LIMITATIONS ON WAIVER OF INFORMED CONSENT 25
p.000004: PROTECTING HUMAN SUBJECTS FROM MEDICAL EXPENSES IF INJURED 26
p.000004: DoD-Supported Research Involving Human Subjects 26
p.000004: DoD-Conducted Research Involving Human Subjects 26
p.000004: DoD-Collaborative Research Involving Human Subjects 26
p.000004: COMPENSATION TO HUMAN SUBJECTS FOR PARTICIPATION IN RESEARCH 27
p.000004: DoD-Conducted Research Involving Human Subjects 27
p.000004: Non-DoD-Conducted Research Involving Human Subjects 28
p.000004: SERVICE MEMBERS AND THEIR STATUS AS ADULTS 29
p.000004: Change 1, 10/15/2018 4
p.000005: CONTENTS
p.000005:
p.000005: DoDI 3216.02, November 8, 2011
p.000005: CLASSIFIED RESEARCH INVOLVING HUMAN SUBJECTS 29
p.000005: ADDITIONAL PROTECTIONS FOR CONFIDENTIALITY 30
...
p.000009: specifically defined by Federal regulations in subparts B-D of Reference (i) and this Instruction. Similarly, as
p.000009: provided in Reference (o) or Parts 22 (Appendix B) and 37 (Appendix D) of Reference (c), such additional safeguards
p.000009: shall also be provided in comparable DoD-supported research involving human subjects. For purposes of this
p.000009: Instruction, actions authorizing or requiring any action by an official of HHS about any requirements of subparts B-D
p.000009: of Reference (i) shall be under the authority of the ASD(R&E). Investigators, IRBs, IOs, and DoD Component personnel
p.000009: reviewing research protocols shall consider the need for appropriate similar safeguards for other vulnerable
p.000009: populations, such as: research involving human subjects and investigators in supervisor- subordinate relationships,
p.000009: human subjects with decisional or mental impairments, human
p.000009:
p.000009:
p.000009:
p.000009: Change 1, 10/15/2018 19
p.000010: ENCLOSURE 3
p.000010:
p.000010: DoDI 3216.02, November 8, 2011
p.000010:
p.000010: subjects with a physical disability, or any other kind of human subjects in circumstances that may warrant provision of
p.000010: additional protections. As appropriate, qualified individuals (e.g., research monitors, ombudsmen, advocates) may be
p.000010: appointed to perform oversight functions or assist the human subjects.
p.000010:
p.000010: a. Pregnant Women, Fetuses, and Neonates as Subjects
p.000010:
p.000010: (1) Non-exempt research involving pregnant women, fetuses, or neonates as human subjects must meet the additional
p.000010: relevant protections of subpart B of Reference (i), unless modified by this Instruction. Research involving pregnant
p.000010: women as subjects may be exempt from the requirements of part 219 of Reference (c) and subpart B of Reference (i) if
p.000010: the research meets the exemption criteria at section 219.101(b) of Reference (c). If the pregnant woman is a prisoner,
p.000010: then paragraph 7.b. of this section also applies. If the pregnant woman is a minor, paragraph 7.d. of this section
p.000010: also applies. For purposes of applying paragraph 7.a., the phrase “biomedical knowledge” in subpart B of Reference (i)
p.000010: shall be replaced with “generalizable knowledge” throughout the subpart.
p.000010:
p.000010: (2) The applicability of subpart B of Reference (i) is limited to research involving:
p.000010:
p.000010: (a) Pregnant women as human subjects involved in research that is more than minimal risk and includes interventions or
p.000010: invasive procedures to the woman or the fetus; or
p.000010:
...
Searching for indicator neonates:
(return to top)
p.000004: Activities for Which an Institution is Required to Have a Federal Assurance 12
p.000004: Activities for Which an Institution is not Required to Have a Federal Assurance 13
p.000004: DoD-CONDUCTED RESEARCH INVOLVING HUMAN SUBJECTS 13
p.000004: DoD Institutional Approval and Oversight 13
p.000004: DoD Component Review and Oversight 15
p.000004: RESEARCH INVOLVING HUMAN SUBJECTS CONDUCTED BY A NON-DoD INSTITUTION
p.000004: 16
p.000004: Clause in Contracts and Agreements 16
p.000004: Non-DoD Institutional Responsibilities 17
p.000004: DoD Component Review, Approval, and Oversight 17
p.000004: EDUCATION AND TRAINING 18
p.000004: SELECTION OF HUMAN SUBJECTS AND EVALUATING RISK 19
p.000004: Selection of Human Subjects
p.000004: 19
p.000004: Evaluating Risk
p.000004: 19
p.000004: ADDITIONAL PROTECTIONS FOR HUMAN SUBJECTS 19
p.000004: Pregnant Women, Fetuses, and Neonates as Subjects 20
p.000004: Prisoners as Subjects
p.000004: 20
p.000004: Treatment of Detainees
p.000004: 22
p.000004: Children as Subjects
p.000004: 22
p.000004: DoD Personnel as Subjects
p.000004: 23
p.000004: RESEARCH MONITOR
p.000004: 24
p.000004: UNIQUE DoD LIMITATIONS ON WAIVER OF INFORMED CONSENT 25
p.000004: PROTECTING HUMAN SUBJECTS FROM MEDICAL EXPENSES IF INJURED 26
p.000004: DoD-Supported Research Involving Human Subjects 26
p.000004: DoD-Conducted Research Involving Human Subjects 26
p.000004: DoD-Collaborative Research Involving Human Subjects 26
p.000004: COMPENSATION TO HUMAN SUBJECTS FOR PARTICIPATION IN RESEARCH 27
p.000004: DoD-Conducted Research Involving Human Subjects 27
p.000004: Non-DoD-Conducted Research Involving Human Subjects 28
p.000004: SERVICE MEMBERS AND THEIR STATUS AS ADULTS 29
p.000004: Change 1, 10/15/2018 4
p.000005: CONTENTS
p.000005:
p.000005: DoDI 3216.02, November 8, 2011
p.000005: CLASSIFIED RESEARCH INVOLVING HUMAN SUBJECTS 29
p.000005: ADDITIONAL PROTECTIONS FOR CONFIDENTIALITY 30
p.000005: Confidential Information Protection and Statistical Efficiency Act (CIPSEA) for
...
p.000009: provided in Reference (o) or Parts 22 (Appendix B) and 37 (Appendix D) of Reference (c), such additional safeguards
p.000009: shall also be provided in comparable DoD-supported research involving human subjects. For purposes of this
p.000009: Instruction, actions authorizing or requiring any action by an official of HHS about any requirements of subparts B-D
p.000009: of Reference (i) shall be under the authority of the ASD(R&E). Investigators, IRBs, IOs, and DoD Component personnel
p.000009: reviewing research protocols shall consider the need for appropriate similar safeguards for other vulnerable
p.000009: populations, such as: research involving human subjects and investigators in supervisor- subordinate relationships,
p.000009: human subjects with decisional or mental impairments, human
p.000009:
p.000009:
p.000009:
p.000009: Change 1, 10/15/2018 19
p.000010: ENCLOSURE 3
p.000010:
p.000010: DoDI 3216.02, November 8, 2011
p.000010:
p.000010: subjects with a physical disability, or any other kind of human subjects in circumstances that may warrant provision of
p.000010: additional protections. As appropriate, qualified individuals (e.g., research monitors, ombudsmen, advocates) may be
p.000010: appointed to perform oversight functions or assist the human subjects.
p.000010:
p.000010: a. Pregnant Women, Fetuses, and Neonates as Subjects
p.000010:
p.000010: (1) Non-exempt research involving pregnant women, fetuses, or neonates as human subjects must meet the additional
p.000010: relevant protections of subpart B of Reference (i), unless modified by this Instruction. Research involving pregnant
p.000010: women as subjects may be exempt from the requirements of part 219 of Reference (c) and subpart B of Reference (i) if
p.000010: the research meets the exemption criteria at section 219.101(b) of Reference (c). If the pregnant woman is a prisoner,
p.000010: then paragraph 7.b. of this section also applies. If the pregnant woman is a minor, paragraph 7.d. of this section
p.000010: also applies. For purposes of applying paragraph 7.a., the phrase “biomedical knowledge” in subpart B of Reference (i)
p.000010: shall be replaced with “generalizable knowledge” throughout the subpart.
p.000010:
p.000010: (2) The applicability of subpart B of Reference (i) is limited to research involving:
p.000010:
p.000010: (a) Pregnant women as human subjects involved in research that is more than minimal risk and includes interventions or
p.000010: invasive procedures to the woman or the fetus; or
p.000010:
p.000010: (b) Fetus or neonate (see Glossary) as human subjects.
p.000010:
...
Social / Incarcerated
Searching for indicator prison:
(return to top)
p.000010: invasive procedures to the woman or the fetus; or
p.000010:
p.000010: (b) Fetus or neonate (see Glossary) as human subjects.
p.000010:
p.000010: (3) Research involving human subjects using fetal tissue shall comply with sections 289g–289g-2 of Reference (k).
p.000010:
p.000010: b. Prisoners as Subjects
p.000010:
p.000010: (1) Research Intending to Include Prisoners as Subjects
p.000010:
p.000010: (a) Research involving human subjects that includes prisoners must meet the additional relevant protections of subpart
p.000010: C of Reference (i), unless modified by this Instruction. If the prisoner is a pregnant woman, then paragraph 7.a. of
p.000010: this section also applies. If the prisoner is a minor, then paragraph 7.d. of this section also applies.
p.000010:
p.000010: (b) Research intending to include prisoners as subjects cannot be reviewed by the IRB through an expedited review
p.000010: procedure.
p.000010:
p.000010: (c) The IRB reviewing research intending to include prisoners as subjects shall be composed of at least one prisoner
p.000010: representative (see Glossary). The prisoner representative may be a prisoner, an employee of the prison, or an
p.000010: individual not affiliated with the prison. The prisoner representative shall have knowledge of the culture(s) of the
p.000010: prisoners and knowledge of the prison operations. At least one prisoner representative must be present for a quorum.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000000: Change 1, 10/15/2018 20
p.000001: ENCLOSURE 3
p.000001:
p.000001: DoDI 3216.02, November 8, 2011
p.000001:
p.000001: (d) Research involving prisoners at prisons or other types of institutions may be subject to additional review by
p.000001: institution authorities (e.g., Bureau of Prisons).
p.000001:
p.000001: (2) Categories of Allowable Research Involving a Prisoner. In addition to the four categories of permissible research
p.000001: involving human subjects identified in subpart C of Reference (i), two additional categories are allowable.
p.000001:
p.000001: (a) Epidemiological research that meets the following criteria can also be approved in accordance with the
p.000001: requirements of subpart C of Reference (i) and the requirements of this Instruction:
p.000001:
p.000001: 1. The research describes the prevalence or incidence of a disease by identifying all cases or studies potential risk
p.000001: factor associations for a disease.
p.000001:
p.000001: 2. The research presents no more than minimal risk.
p.000001:
p.000001: 3. The research presents no more than an inconvenience to the human subject.
p.000001:
p.000001: 4. Prisoners are not a particular focus of the research.
p.000001:
p.000001: (b) Research involving human subjects that would meet the criteria described at section 219.101(b) of Reference (c)
p.000001: can be conducted, but must be approved by a convened IRB and meet the requirements of subpart C of Reference (i), this
...
p.000006: of the immediate family of a person who is associated with the institution creating or relying on the IRB.
p.000006:
p.000006: noncompliance. Failure of a person, group, or institution to act in accordance with this Instruction, its references,
p.000006: or applicable requirements.
p.000006:
p.000006: non-DoD institution. An entity that is not part of the Department of Defense.
p.000006:
p.000006: non-exempt research involving human subjects. An activity that meets the definitions of research and human subject but
p.000006: does not meet the criteria where the only involvement of the human subjects in the research are in one or more of the
p.000006: categories identified in section 219.101(b) of Reference (c).
p.000006:
p.000006: ombudsman. A person who acts as an impartial and objective advocate for human subjects participating in research.
p.000006:
p.000006: OSD Component. Defined in DoD Instruction 5025.01 (Reference (x)).
p.000006:
p.000006: OT&E. Defined in section 139(a)(2)(A) of Reference (g).
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: Change 1, 10/15/2018 36
p.000007: GLOSSARY
p.000007:
p.000007: DoDI 3216.02, November 8, 2011
p.000007:
p.000007: prisoner. Defined in subpart C of Reference (i). Includes military personnel in either civilian or military custody
p.000007: or detainment.
p.000007:
p.000007: prisoner representative. An individual member on the IRB who shall have working knowledge of the human subject
p.000007: population to be recruited, a reasonable familiarity with the operations of the prison or confinement facility, and
p.000007: any other legally imposed restrictive conditions involved in the research, and appropriate background and expertise to
p.000007: serve in this capacity.
p.000007:
p.000007: private information. Defined in section 219.102(f) of Reference (c).
p.000007:
p.000007: research. Any activity that is a systematic investigation, including RDT&E, designed to develop or contribute to
p.000007: generalizable knowledge as defined in section 219.102(d) of Reference (c).
p.000007:
p.000007: research involving human subjects. Activities that include both a systematic investigation designed to develop or
p.000007: contribute to generalizable knowledge AND involve a living individual about whom an investigator conducting research
p.000007: obtains data through intervention or interaction with the individual or identifiable private information. Activities
p.000007: covered by section 219.101(a) of Reference (c) (including exempt research involving human subjects) and this
p.000007: Instruction.
p.000007:
p.000007: The following activities conducted or supported by the Department of Defense are NOT research involving human subjects:
p.000007:
p.000007: Activities carried out solely for purposes of diagnosis, treatment, or prevention of injury and disease in Service
p.000007: members and other mission essential personnel under force health protection programs of the Department of Defense,
p.000007: including health surveillance pursuant to section 1074f of Reference (g) and the use of medical products consistent
p.000007: with DoD Instruction 6200.02 (Reference (y)).
p.000007:
p.000007: Authorized health and medical activities as part of the reasonable practice of medicine or other health professions
p.000007: undertaken for the sole purpose of patient treatment.
p.000007:
...
Social / Laboratory Staff
Searching for indicator research staff:
(return to top)
p.000006: USD(P&R). DoD Components may supplement this Secretarial Designee procedure with additional procedures consistent with
p.000006: applicable authority. This requirement does not apply when the Department of Defense is supporting the research but is
p.000006: not engaged in the non-exempt research involving human subjects (i.e., when the non-exempt research involving human
p.000006: subjects is performed solely by non-DoD institutions).
p.000006:
p.000006: c. DoD Collaborative Research Involving Human Subjects
p.000006:
p.000006: (1) When collaborating with a non-DoD institution, the DoD Components shall establish procedures comparable to those
p.000006: required by paragraph 10.b. of this section to protect human subjects from medical expenses (not otherwise provided or
p.000006: reimbursed) that are the direct result of participation in non-exempt research involving human subjects and that are a
p.000006: direct result of research activities performed by DoD personnel. This does not apply to expenses resulting from the
p.000006: injury due to actions performed by the non-DoD institution(s).
p.000006:
p.000006: (2) When DoD personnel are conducting the research involving human subjects at the collaborating institution and the
p.000006: Department of Defense does not have the primary involvement, the DoD Components are not required to have procedures to
p.000006: protect human subjects from medical expenses. For this purpose the determination of primary involvement shall be based
p.000006: on consideration of the type and portion of the DoD involvement in the collaborative research (e.g., research staff,
p.000006: human subjects, facilities, equipment, IRB, and all other assets).
p.000006:
p.000006: (3) When the collaboration is such that it is difficult to separate DoD involvement from that of the non-DoD
p.000006: institution, the Head of the OSD or DoD Component may waive this requirement to have procedures to protect human
p.000006: subjects from medical expenses. This waiver authority may be delegated, as described in the Component’s HRPP
p.000006: management plan, but not at or below the position of the institution’s DoD IO.
p.000006:
p.000006:
p.000006:
p.000006: Change 1, 10/15/2018 26
p.000007: ENCLOSURE 3
p.000007:
p.000007: DoDI 3216.02, November 8, 2011
p.000007:
p.000007:
p.000007:
p.000007:
p.000007: 11. COMPENSATION TO HUMAN SUBJECTS FOR PARTICIPATION IN RESEARCH
p.000007:
p.000007: a. DoD-Conducted Research Involving Human Subjects
p.000007:
p.000007: (1) When the Human Subjects Are On-Duty Federal Personnel
p.000007:
p.000007: (a) Federal personnel (civil servants or Service members) participating as human subjects in DoD-conducted research
p.000007: while on duty (i.e., not on leave and participating during their duty hours) may be compensated up to $50 for each
p.000007: blood draw if the research meets the purpose of section 30 of title 24, U.S.C. (Reference (r)). Payment for blood
p.000007: draws may come directly from a Federal or non-Federal source. By permitting compensation for blood draws, Reference
p.000007: (r) provides an exception to section 5536 of Reference (n), which prohibits Federal personnel from being paid by any
p.000007: source other than their regular Federal salaries while they are on duty.
p.000007:
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.000006:
p.000006: (2) The DoD Component administrative review must be conducted before the research involving human subjects can begin
p.000006: to ensure compliance with all applicable regulations and policies, including any applicable laws and requirements and
p.000006: cultural sensitivities of a foreign country if conducted in a foreign country. This Component review is not intended
p.000006: to be an additional IRB review.
p.000006:
p.000006:
p.000006: 4. RESEARCH INVOLVING HUMAN SUBJECTS CONDUCTED BY A NON-DoD INSTITUTION
p.000006:
p.000006: a. Clause in Contracts and Agreements. The DoD Component must ensure the institution conducting the research
p.000006: involving human subjects is aware of its obligation to comply with the requirements of this Instruction and part 219 of
p.000006: Reference (c).
p.000006:
p.000006: (1) Contracts for DoD-supported research involving human subjects must contain the Defense Federal Acquisition
p.000006: Regulation Supplement (DFARS) clause in accordance with section 252.235-7004 of title 48, CFR (Reference (n)). In
p.000006: addition to identifying contractor requirements and responsibilities, this clause also describes the role of the DoD
p.000006: Human Research
p.000006:
p.000006:
p.000006:
p.000006: Change 1, 10/15/2018 16
p.000007: ENCLOSURE 3
p.000007:
p.000007: DoDI 3216.02, November 8, 2011
p.000007:
p.000007: Protection Official (HRPO). Comparable agreements not subject to section 252.235-7004 of Reference (n) (e.g., grants,
p.000007: assistance agreements, and cooperative research and development agreements) must contain language affirming the
p.000007: responsibilities of the non-DoD institution as required by Parts 22 (Appendix B), 37 (Appendix D), and 219 of Reference
p.000007: (c).
p.000007:
p.000007: (2) The DFARS clause (or similar language) is not required to be included in an agreement with another Federal
p.000007: department or agency that has adopted the Common Rule. Approval by the HRPO is not required. The Federal department or
p.000007: agency may apply its own HRPP requirements in lieu of this Instruction. However, the Federal department or agency must
p.000007: comply with the requirements in sections 7, 9, 13, and 17 of this enclosure and the requirements of Reference (f).
p.000007:
p.000007: b. Non-DoD Institutional Responsibilities
p.000007:
p.000007: (1) The non-DoD institution shall comply with the terms of the DFARS clause or comparable language used in the
p.000007: agreement with the DoD Component supporting the research involving human subjects, as provided in subparagraph 4.a.(1)
p.000007: of this section.
p.000007:
p.000007: (2) When a non-DoD institution is conducting non-exempt research involving human subjects, the IRB review must
p.000007: consider the scientific merit of the research, as required by section
p.000007: 219.111 of Reference (c). The IRB may rely on outside experts to provide an evaluation of the scientific merit.
p.000007:
p.000007: (3) IRBs may use expedited review procedures under section 219.110(a) of Reference (c) to review minimal risk,
p.000007: non-exempt research involving human subjects using materials (e.g., data, documents, records, or specimens) that have
p.000007: previously been collected for any purpose, provided the materials were not collected for the currently proposed
p.000007: research.
p.000007:
p.000007: (4) To the extent provided in section 219.103 of Reference (c), the non DoD-institution shall promptly notify the HRPO
p.000007: of the following: when significant changes to the research protocol are approved by the IRB, the results of the IRB
p.000007: continuing review, if the IRB used to review and approve the research changes to a different IRB, when the institution
p.000007: is notified by any Federal department or agency or national organization that any part of its HRPP is under
p.000007: investigation for cause involving a DoD-supported research protocol, and all UPIRTSOs, suspensions, terminations, and
p.000007: serious or continuing noncompliance regarding DoD-supported research involving human subjects.
p.000007:
p.000007: (5) Non-DoD institutions shall comply with requirements of this Instruction applicable to them. They are not required
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.000007:
p.000007: DoDI 3216.02, November 8, 2011
p.000007:
p.000007: (x) DoD Instruction 5025.01, “DoD Directives Program,” October 28, 2007
p.000007: (y) DoD Instruction 6200.02, “Application of Food and Drug Administration (FDA) Rules to Department of Defense Force
p.000007: Health Protection Program,” February 27, 2008
p.000007: (z) DoD Instruction 6025.13, “Medical Quality Assurance (MQA) and Clinical Quality Management in the Military Health
p.000007: System (MHS),” February 17, 2011
p.000007: (aa) DoD Directive 5240.01, “DoD Intelligence Activities,” August 27, 2007
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007: Change 1, 10/15/2018 7
p.000008: ENCLOSURE 1
p.000008:
p.000008: DoDI 3216.02, November 8, 2011
p.000008:
p.000008: ENCLOSURE 2
p.000008:
p.000008: RESPONSIBILITIES
p.000008:
p.000008:
p.000008: 1. ASD(R&E). The ASD(R&E), under the authority, direction, and control of the Under Secretary of Defense for
p.000008: Acquisition, Technology, and Logistics, shall:
p.000008:
p.000008: a. Be the single DoD point of contact for all matters related to DoD compliance with this Instruction and shall act as
p.000008: the principal DoD liaison with organizations outside the Department of Defense on matters pertaining to research
p.000008: involving human subjects.
p.000008:
p.000008: b. Provide guidance and procedures necessary to implement this Instruction. The ASD(R&E) will consult with the
p.000008: Assistant Secretary of Defense for Health Affairs (ASD(HA)) for matters affecting medical research involving human
p.000008: subjects.
p.000008:
p.000008: c. Exercise the authorities of the Head of the Department identified in part 219 of Reference (c), the Secretary as
p.000008: identified in subparts B-D of part 46 of title 45, CFR (Reference (i)) for research described in section 7 of Enclosure
p.000008: 3 of this Instruction, and the Secretary of Defense identified in section 980 of Reference (g).
p.000008:
p.000008: d. Grant exceptions to any procedures or requirements in this Instruction based upon an appropriate justification from
p.000008: the Head of an OSD or DoD Component and consistent with law.
p.000008:
p.000008: e. Establish a process to oversee the DoD Components’ implementation of their respective Component human research
p.000008: protection program (HRPP) management plan and compliance with this Instruction.
p.000008:
p.000008: f. Establish a framework for educational training requirements for DoD personnel in key HRPP roles commensurate with
p.000008: their duties and responsibilities.
p.000008:
p.000008: g. Work with the DoD Components supporting international research involving human subjects to resolve conflicts
p.000008: between this Instruction, including its references, and other applicable foreign laws and requirements.
p.000008:
...
p.000010: g. Maintain all records identified in this Instruction or required by a reference in this Instruction as described in
p.000010: section 15 of Enclosure 3.
p.000010:
p.000010:
p.000010: 4. IOs OF DoD INSTITUTIONS. Each IO, under the authority, direction, and control of the Heads of the OSD and DoD
p.000010: Components shall:
p.000010:
p.000010: a. Establish and maintain an HRPP to ensure the institution’s compliance with this Instruction.
p.000010:
p.000010: b. Provide the resources needed to ensure compliance with this Instruction.
p.000010:
p.000010: c. Establish and maintain a DoD assurance and other appropriate Federal assurances, if the institution is engaged in
p.000010: non-exempt research involving human subjects (see Glossary).
p.000010:
p.000010: d. Evaluate and improve the institution’s HRPP.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000000: Change 1, 10/15/2018 10
p.000001: ENCLOSURE 2
p.000001:
p.000001: DoDI 3216.02, November 8, 2011
p.000001:
p.000001: ENCLOSURE 3
p.000001:
p.000001: PROCEDURES
p.000001:
p.000001:
p.000001: 1. DoD COMPONENT HRPP MANAGEMENT PLAN
p.000001:
p.000001: a. The DoD Component HRPP management plan shall include, by reference, DoD Component policies to implement the
p.000001: procedures set forth in this enclosure and identify the responsible DoD Component office(s) for actions identified in
p.000001: this Instruction. DoD Component policies may be more restrictive than the requirements in this Instruction, but they
p.000001: may not be less restrictive. They may also impose additional requirements needed to implement this Instruction.
p.000001:
p.000001: b. The plan shall identify a single, senior official having the authority and responsibility for implementing the DoD
p.000001: Component HRPP management plan. This authority shall not be delegated lower than the general or flag officer (GO/FO),
p.000001: Senior Executive Service (SES), or equivalent level. All authorities delegated by the Head of the OSD or DoD Component
p.000001: must be identified in the management plan.
p.000001:
p.000001: c. The plan shall reference DoD Component policies and procedures that:
p.000001:
p.000001: (1) Direct each institution within the DoD Component conducting or supporting research involving human subjects to
p.000001: establish an HRPP that is compliant with this Instruction and the DoD Component’s HRPP management plan.
p.000001:
p.000001: (2) Describe DoD Component oversight of each institution’s HRPP.
p.000001:
p.000001: (3) Describe DoD Component administrative review of DoD-conducted and -supported research involving human subjects
p.000001: (see sections 3 and 4 of this enclosure for details).
p.000001:
p.000001: (4) Delineate institutional responsibilities when performing research involving human subjects in collaboration with
p.000001: another DoD Component. These responsibilities shall include establishing written agreements for tasks such as
p.000001: minimizing the number of institutional review boards (IRBs) and DoD Components that review and approve the research
p.000001: (see sections 3 and 4 of this enclosure for details). DoD Component policies and procedures shall include a
p.000001: requirement to justify the duplication of reviews of protocols (for example, IRB and Component Headquarters reviews).
p.000001:
p.000001: (5) Outline education and training for implementation, management, and oversight of this Instruction (see paragraph
p.000001: 1.f. of Enclosure 2 and section 5 of this enclosure for details).
p.000001:
p.000001: (6) Address the management of allegations and findings of noncompliance concerning DoD-conducted and -supported
p.000001: research involving human subjects (see section 16 of this enclosure for details).
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: Change 1, 10/15/2018 11
p.000002: ENCLOSURE 3
p.000002:
p.000002: DoDI 3216.02, November 8, 2011
p.000002:
p.000002: (7) Identify and manage conflicts of interest, not limited to financial, for DoD personnel involved in the HRPP.
p.000002:
p.000002: (8) Require a process to evaluate and improve the DoD Component’s implementation of its HRPP management plan down to
p.000002: the level of the institutional HRPP.
p.000002:
p.000002: d. A DoD Component may rely on another DoD Component for implementation of elements of the management plan except for
p.000002: designation of the single, senior official responsible for the management plan identified in paragraph 1.b. of this
p.000002: enclosure. Any such reliance must be reflected in the DoD Component’s HRPP management plan.
p.000002:
p.000002:
p.000002: 2. REQUIREMENTS FOR A FEDERAL ASSURANCE
p.000002:
p.000002: a. Activities for Which an Institution is Required to Have a Federal Assurance. Any institution engaged in non-exempt
p.000002: research involving human subjects that is conducted or supported by the Department of Defense shall have a Federal
p.000002: assurance consistent with section
p.000002: 219.103 of Reference (c) and acceptable to the funding agency.
p.000002:
p.000002: (1) A DoD institution engaged in non-exempt research involving human subjects shall have a DoD assurance of
p.000002: compliance. Additionally, a DoD institution shall have an HHS assurance when engaged in non-exempt research involving
p.000002: human subjects funded by HHS (unless HHS will accept a DoD assurance). When conducting HHS-funded research involving
p.000002: human subjects, the DoD institution must follow this Instruction and any additional HHS requirements.
p.000002:
p.000002: (2) In complying with the requirements of section 219.103 of Reference (c), a non-DoD institution that is engaged in
p.000002: DoD-supported non-exempt research involving human subjects:
p.000002:
p.000002: (a) Need not have a DoD assurance if it has an existing Federal assurance appropriate for the research being
p.000002: conducted. If the institution does not have a Federal assurance, the institution must provide either a DoD assurance
p.000002: to the DoD Component supporting the research or a Federal wide assurance to HHS, Office for Human Research Protections.
p.000002: Alternatively, if the institution does not have a Federal assurance, the researcher may use an Individual Investigator
...
Social / Police Officer
Searching for indicator officer:
(return to top)
p.000010: Components shall:
p.000010:
p.000010: a. Establish and maintain an HRPP to ensure the institution’s compliance with this Instruction.
p.000010:
p.000010: b. Provide the resources needed to ensure compliance with this Instruction.
p.000010:
p.000010: c. Establish and maintain a DoD assurance and other appropriate Federal assurances, if the institution is engaged in
p.000010: non-exempt research involving human subjects (see Glossary).
p.000010:
p.000010: d. Evaluate and improve the institution’s HRPP.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000000: Change 1, 10/15/2018 10
p.000001: ENCLOSURE 2
p.000001:
p.000001: DoDI 3216.02, November 8, 2011
p.000001:
p.000001: ENCLOSURE 3
p.000001:
p.000001: PROCEDURES
p.000001:
p.000001:
p.000001: 1. DoD COMPONENT HRPP MANAGEMENT PLAN
p.000001:
p.000001: a. The DoD Component HRPP management plan shall include, by reference, DoD Component policies to implement the
p.000001: procedures set forth in this enclosure and identify the responsible DoD Component office(s) for actions identified in
p.000001: this Instruction. DoD Component policies may be more restrictive than the requirements in this Instruction, but they
p.000001: may not be less restrictive. They may also impose additional requirements needed to implement this Instruction.
p.000001:
p.000001: b. The plan shall identify a single, senior official having the authority and responsibility for implementing the DoD
p.000001: Component HRPP management plan. This authority shall not be delegated lower than the general or flag officer (GO/FO),
p.000001: Senior Executive Service (SES), or equivalent level. All authorities delegated by the Head of the OSD or DoD Component
p.000001: must be identified in the management plan.
p.000001:
p.000001: c. The plan shall reference DoD Component policies and procedures that:
p.000001:
p.000001: (1) Direct each institution within the DoD Component conducting or supporting research involving human subjects to
p.000001: establish an HRPP that is compliant with this Instruction and the DoD Component’s HRPP management plan.
p.000001:
p.000001: (2) Describe DoD Component oversight of each institution’s HRPP.
p.000001:
p.000001: (3) Describe DoD Component administrative review of DoD-conducted and -supported research involving human subjects
p.000001: (see sections 3 and 4 of this enclosure for details).
p.000001:
p.000001: (4) Delineate institutional responsibilities when performing research involving human subjects in collaboration with
p.000001: another DoD Component. These responsibilities shall include establishing written agreements for tasks such as
p.000001: minimizing the number of institutional review boards (IRBs) and DoD Components that review and approve the research
p.000001: (see sections 3 and 4 of this enclosure for details). DoD Component policies and procedures shall include a
p.000001: requirement to justify the duplication of reviews of protocols (for example, IRB and Component Headquarters reviews).
p.000001:
p.000001: (5) Outline education and training for implementation, management, and oversight of this Instruction (see paragraph
p.000001: 1.f. of Enclosure 2 and section 5 of this enclosure for details).
p.000001:
p.000001: (6) Address the management of allegations and findings of noncompliance concerning DoD-conducted and -supported
...
p.000002: supported by an Executive Secretariat (O-6 or equivalent level) composed of representatives from the DoD Components’
p.000002: human research protection oversight offices.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: Change 1, 10/15/2018 32
p.000003: ENCLOSURE 3
p.000003:
p.000003: DoDI 3216.02, November 8, 2011
p.000003:
p.000003: GLOSSARY
p.000003:
p.000003: PART I. ABBREVIATIONS AND ACRONYMS
p.000003:
p.000003:
p.000003: ASD(HA) Assistant Secretary of Defense for Health Affairs ASD(R&E) Assistant Secretary of Defense for Research
p.000003: and Engineering
p.000003:
p.000003: CCHRPP Coordinating Committee for Human Research Protection Programs CFR Code of Federal
p.000003: Regulations
p.000003: CIPSEA Confidential Information Protection and Statistical Efficiency Act of 2002
p.000003:
p.000003: DFARS Defense Federal Acquisition Regulation Supplement DoDD Department of Defense Directive
p.000003:
p.000003: FDA Food and Drug Administration GO/FO general or flag officer
p.000003: HHS Health and Human Services HRPO human research protection official
p.000003: HRPP Human Research Protection Program
p.000003:
p.000003: IO institutional official
p.000003: IRB institutional review board
p.000003:
p.000003: NCOs noncommissioned officers NIH National Institutes of Health
p.000003:
p.000003: OMB Office of Management and Budget OT&E operational test and evaluation
p.000003:
p.000003: RDT&E research, development, test and evaluation SES Senior Executive Service
p.000003: UPIRTSO unanticipated problems involving risks to subjects or others
p.000003: U.S.C. United States Code
p.000003: USD(P&R) Under Secretary of Defense for Personnel and Readiness
p.000003:
p.000003:
p.000003: PART II. DEFINITIONS
p.000003:
p.000003: Unless otherwise noted, these terms and their definitions are for the purpose of this Instruction.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: Change 1, 10/15/2018 33
p.000004: GLOSSARY
p.000004:
p.000004: DoDI 3216.02, November 8, 2011
p.000004:
p.000004:
p.000004:
p.000004: administrative review. A review of a research protocol and supporting documents (e.g., safety review, scientific
p.000004: review, IRB minutes) related to DoD-supported research involving human subjects which ensures the institution engaged
p.000004: in the research involving human subjects has met the requirements of all applicable regulations and policies. This
p.000004: review is NOT an IRB review.
p.000004:
p.000004: classified research involving human subjects. Research involving human subjects where the protocol or other
...
Social / Racial Minority
Searching for indicator minority:
(return to top)
p.000008: (see paragraph 1.f. of Enclosure 2 for details).
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: Change 1, 10/15/2018 18
p.000009: ENCLOSURE 3
p.000009:
p.000009: DoDI 3216.02, November 8, 2011
p.000009:
p.000009: a. Initial and continuing education and training shall be commensurate with the duties and responsibilities of the DoD
p.000009: personnel.
p.000009:
p.000009: b. All training and education of DoD personnel shall be documented.
p.000009:
p.000009: c. Professional certification in the field of human research protection is encouraged for all DoD personnel involved
p.000009: in review and oversight of research involving human subjects.
p.000009:
p.000009: d. When assessing whether to support or collaborate with a non-DoD institution for research involving human subjects,
p.000009: the DoD Components should evaluate the non-DoD institution’s education and training policies to ensure the personnel
p.000009: are qualified to perform the research. The rigor of the evaluation should be appropriate for the complexity and risk
p.000009: of the research.
p.000009:
p.000009:
p.000009: 6. SELECTION OF HUMAN SUBJECTS AND EVALUATING RISK
p.000009:
p.000009: a. Selection of Human Subjects. The selection of human subjects reflecting gender and minority participation in
p.000009: DoD-conducted or -supported clinical research involving human subjects shall comply with section 252 of Public Law
p.000009: 103-160 (Reference (p)). The Head of the OSD or DoD Component may exercise the waiver authority under this law. This
p.000009: waiver authority may be delegated, as described in the Component’s HRPP management plan, but not to an individual at
p.000009: the level of the institutional HRPP.
p.000009:
p.000009: b. Evaluating Risk. The phrase “ordinarily encountered in daily life or during the performance of routine physical or
p.000009: physiological examinations or tests” in the definition of minimal risk (section 219.102(j)) of Reference (c)) shall not
p.000009: be interpreted to include the inherent risks certain categories of human subjects face in their everyday life. For
p.000009: example, the risks imposed in research involving human subjects focused on a special population should not be evaluated
p.000009: against the inherent risks encountered in their work environment (e.g., emergency responder, pilot, soldier in a combat
p.000009: zone) or having a medical condition (e.g., frequent medical tests or constant pain).
p.000009:
p.000009:
p.000009: 7. ADDITIONAL PROTECTIONS FOR HUMAN SUBJECTS. In addition to the requirements of part 219 of Reference (c),
p.000009: additional safeguards described in this section shall be provided for human subjects in all DoD-conducted research
...
Social / Soldier
Searching for indicator army:
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p.000004:
p.000004: detainee. Defined in Reference (q).
p.000004:
p.000004: DoD-conducted research involving human subjects. Research involving human subjects that is performed by DoD personnel.
p.000004: Intramural research is one type of DoD-conducted research involving human subjects. See “engaged in research
p.000004: involving human subjects.”
p.000004:
p.000004: DoD personnel. DoD civilian employees and members of the military services.
p.000004:
p.000004: DoD civilian employee. An individual meeting the definition of “employee” consistent with section 2105 of Reference
p.000004: (n). It includes employees of DoD Non-Appropriated Fund Instrumentalities; DoD civilian employees filling full-time,
p.000004: part-time, intermittent, or on-call positions; and individuals serving under personal services contracts consistent
p.000004: with section 2.101 of Reference (o). It excludes employees of contractors (other than personal services contractors)
p.000004: and foreign nationals of host countries.
p.000004:
p.000004: Service members. Individuals appointed, enlisted, or inducted for military service under the authority of the
p.000004: Department of Defense. The Military Services are the Army, the Navy, the Air Force, the Marine Corps, the Coast Guard,
p.000004: and the Reserve Components, which includes the Army and the Air National Guards of the United States. Members of the
p.000004: Reserve Components are included when in a duty status.
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Change 1, 10/15/2018 34
p.000005: GLOSSARY
p.000005:
p.000005: DoDI 3216.02, November 8, 2011
p.000005:
p.000005: DoD-supported research involving human subjects. Research involving human subjects for which the Department of Defense
p.000005: is providing at least some of the resources (see “research involving human subjects”). Resources may include but are
p.000005: not limited to funding, facilities, equipment, personnel (investigators or other personnel performing tasks identified
p.000005: in the research protocol), access to or information about DoD personnel for recruitment, or identifiable data or
p.000005: specimens from living individuals. It includes both DoD-conducted research involving human subjects (intramural
p.000005: research) and research conducted by a non-DoD institution.
p.000005:
p.000005: engaged in research involving human subjects. An institution is engaged in research involving human subjects when its
p.000005: personnel are conducting activities covered by section 219.101(a) of Reference (c) and this Instruction. An
p.000005: institution that is funding, providing equipment, providing access to or information about potential human subjects
p.000005: (but not recruiting human subjects), providing data or specimens (either identifiable or not), or overseeing the
p.000005: research from a regulatory or compliance standpoint is not engaged in the research involving human subjects (but is
p.000005: supporting the research (see “DoD-supported research involving human subjects”)).
p.000005:
...
Searching for indicator military:
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p.000002:
p.000002: Department of Defense
p.000002: INSTRUCTION
p.000002:
p.000002: NUMBER 3216.02
p.000002: November 8, 2011
p.000002: Incorporating Change 1, October 15, 2018
p.000002:
p.000002: USD(R&E)
p.000002:
p.000002: SUBJECT: Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research
p.000002:
p.000002: References: See Enclosure 1
p.000002:
p.000002:
p.000002: 1. PURPOSE. This Instruction reissues DoD Directive (DoDD) 3216.02 (Reference (a)) as a DoD Instruction in accordance
p.000002: with the authority in DoDD 5134.01 (Reference (b)) to establish policy and assign responsibilities for the protection
p.000002: of human subjects in DoD-supported programs to implement part 219 of title 32, Code of Federal Regulations (CFR) (also
p.000002: known and hereinafter referred to as “the Common Rule” (Reference (c)).
p.000002:
p.000002:
p.000002: 2. APPLICABILITY
p.000002:
p.000002: a. This Instruction applies to:
p.000002:
p.000002: (1) OSD, the Military Departments, the Office of the Chairman of the Joint Chiefs of Staff and the Joint Staff, the
p.000002: Combatant Commands, the Office of the Inspector General of the Department of Defense, the Defense Agencies, the DoD
p.000002: Field Activities, and all other organizational entities within the Department of Defense (hereinafter referred to
p.000002: collectively as the “DoD Components”).
p.000002:
p.000002: (2) All DoD-conducted or -supported research involving human subjects as defined in the Glossary. All such activities
p.000002: must include both systematic investigation designed to develop or contribute to generalizable knowledge AND involve a
p.000002: living individual about whom an investigator conducting research obtains data through intervention or interaction with
p.000002: the individual or about whom identifiable private information is obtained. All activities meeting both of these
p.000002: conditions will hereinafter be referred to as “research involving human subjects” in this Instruction.
p.000002:
p.000002: (3) Activities such as research, development, testing, and evaluation (RDT&E) that meet the definition of research
p.000002: involving human subjects (as defined in the Glossary), as well as clinical investigations or medical activities
p.000002: regulated by the Food and Drug Administration (FDA) in parts 50, 56, 312, 600, and 812 of title 21, CFR (Reference
p.000002: (d)).
p.000002:
p.000002: DoDI 3216.02, November 8, 2011
p.000002:
p.000002:
p.000002:
p.000002: b. Applicability is not dependent upon the budget activities funding the research, the mission of the DoD organization
p.000002: conducting or supporting the research, the security classification of the research, the location of the research in the
...
p.000006: (r) Section 30 of title 24, United States Code
p.000006: (s) Executive Order 13526, “Classified National Security Information,” December 29, 2009
p.000006: (t) DoD 6025.18-R, “DoD Health Information Privacy,” January 24, 2003
p.000006: (u) Executive Order 12333, “United States Intelligence Activities,” as amended, August 18, 2010
p.000006: (v) DoD 5400.11-R, “Department of Defense Privacy Program,” May 14, 2007
p.000006: (w) DoDI 6000.08, “Funding and Administration of Clinical Investigation Programs,” December 3, 2007
p.000006:
p.000006:
p.000006: 1Also known as “the Common Rule”
p.000006: 2 Available on the Internet at http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm. The Belmont Report’s
p.000006: 2-volume appendix is available from the Government Printing Office as DHEW Publication Nos. (OS) 78- 0013 and (OS)
p.000006: 78-0014
p.000006: 3 Also known as “The Intergovernmental Personnel Act of 1970, as amended”
p.000006:
p.000006: Change 1, 10/15/2018 6
p.000007: ENCLOSURE 1
p.000007:
p.000007: DoDI 3216.02, November 8, 2011
p.000007:
p.000007: (x) DoD Instruction 5025.01, “DoD Directives Program,” October 28, 2007
p.000007: (y) DoD Instruction 6200.02, “Application of Food and Drug Administration (FDA) Rules to Department of Defense Force
p.000007: Health Protection Program,” February 27, 2008
p.000007: (z) DoD Instruction 6025.13, “Medical Quality Assurance (MQA) and Clinical Quality Management in the Military Health
p.000007: System (MHS),” February 17, 2011
p.000007: (aa) DoD Directive 5240.01, “DoD Intelligence Activities,” August 27, 2007
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007:
p.000007: Change 1, 10/15/2018 7
p.000008: ENCLOSURE 1
p.000008:
p.000008: DoDI 3216.02, November 8, 2011
p.000008:
p.000008: ENCLOSURE 2
p.000008:
p.000008: RESPONSIBILITIES
p.000008:
p.000008:
p.000008: 1. ASD(R&E). The ASD(R&E), under the authority, direction, and control of the Under Secretary of Defense for
p.000008: Acquisition, Technology, and Logistics, shall:
p.000008:
p.000008: a. Be the single DoD point of contact for all matters related to DoD compliance with this Instruction and shall act as
p.000008: the principal DoD liaison with organizations outside the Department of Defense on matters pertaining to research
p.000008: involving human subjects.
p.000008:
p.000008: b. Provide guidance and procedures necessary to implement this Instruction. The ASD(R&E) will consult with the
p.000008: Assistant Secretary of Defense for Health Affairs (ASD(HA)) for matters affecting medical research involving human
p.000008: subjects.
p.000008:
...
p.000002:
p.000002: (e) If the research involving human subjects is conducted by a non-DoD institution, the non-DoD institution shall
p.000002: promptly report all decisions in this matter to the HRPO. If the research is conducted by a DoD institution, the IRB
p.000002: shall promptly report all decisions in this matter to the IO and to the DoD Component office conducting the reviews
p.000002: identified in paragraph 3.b. of this enclosure. For all DoD-conducted or -supported research involving human subjects,
p.000002: the applicable DoD Component office conducting the reviews identified in paragraphs
p.000002: 3.b. or 4.c. of this enclosure must concur with the IRB before the human subject can continue to participate while a
p.000002: prisoner. This approved change to a research protocol does not require ASD(R&E) approval.
p.000002:
p.000002: c. Treatment of Detainees
p.000002:
p.000002: (1) Research involving a detainee, as defined in DoD Directive 2310.01E (Reference (q)), as a human subject is
p.000002: prohibited.
p.000002:
p.000002: (2) The prohibition in paragraph c.(1) of this section does not apply to activities covered by investigational new
p.000002: drug or investigational device provisions of Reference (d) when for the purpose of diagnosis or treatment of a medical
p.000002: condition in a patient. Such treatment (e.g., an investigational new drug) may be offered to detainees with the
p.000002: detainees’ informed consent when the medical products are subject to Reference (d) as investigational new drugs or
p.000002: investigational medical devices, and only when the same product would be offered to members of the U.S. Military
p.000002: Services in the same location for the same medical condition and only when consistent with established medical practice
p.000002: involving investigational drugs and devices. Such permitted treatment involving detainees as subjects shall comply
p.000002: with all sections of this Instruction, including paragraphs 6.a., b., and d. of this section, as applicable.
p.000002:
p.000002: d. Children as Subjects
p.000002:
p.000002: (1) Research involving human subjects conducted or supported by the Department of Defense that recruits children to be
p.000002: subjects must meet the additional relevant protections of subpart D of Reference (i), unless modified by this
p.000002: Instruction. If the minor is a pregnant woman, then paragraph 7.a. of this section also applies. If the minor is a
p.000002: prisoner, paragraph 7.b. of this section also applies.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: Change 1, 10/15/2018 22
p.000003: ENCLOSURE 3
p.000003:
p.000003: DoDI 3216.02, November 8, 2011
p.000003:
p.000003: (2) The footnote in section 219.101(i) of Reference (c), prohibiting specific exemptions described in section
p.000003: 219.101(b) from applying to children, is also applicable to DoD-conducted or -supported research involving human
p.000003: subjects unless otherwise clarified in this Instruction.
p.000003:
p.000003: e. DoD Personnel as Subjects
p.000003:
p.000003: (1) Military Personnel as Subjects
p.000003:
p.000003: (a) Service members shall follow their command policies regarding the requirement to obtain command permission to
p.000003: participate in research involving human subjects while
p.000003: on-duty. Additionally a Service member’s ability to perform his or her military duties may be affected by
p.000003: participating during off-duty time (i.e., on leave or during non-duty hours).
p.000003: Therefore, Service members shall follow their Component and command’s policies for approving off-duty employment or
p.000003: activities. The IRBs of DoD institutions or HRPOs may require Principal Investigators to confirm that a Service
p.000003: member’s commander supports the member’s participation in DoD-supported research involving human subjects.
p.000003:
p.000003: (b) Superiors (e.g., military and civilian supervisors, unit officers, and noncommissioned officers (NCOs)) are
p.000003: prohibited from influencing the decisions of their subordinates (e.g., junior enlisted personnel and equivalent
p.000003: civilians) regarding participation as subjects in research involving human subjects covered by this Instruction.
p.000003:
p.000003: (c) Superiors of Service members (e.g., unit officers, senior NCOs, and equivalent civilians) in the chain of command
p.000003: shall not be present at any human subject recruitment sessions or during the consent process in which members of units
p.000003: under their command are afforded the opportunity to participate as human subjects. When applicable, the superiors so
p.000003: excluded shall be afforded the opportunity to participate as human subjects in a separate recruitment session.
p.000003:
p.000003: (d) For research involving Service members as human subjects that has been determined to be greater than minimal risk
p.000003: and when recruitment occurs in a group setting, the IRB shall appoint an ombudsman. The ombudsman shall not be
p.000003: associated in any way to the research and shall be present during the recruitment in order to monitor that the
p.000003: voluntary involvement or recruitment of the Service members is clearly and adequately stressed and that the information
p.000003: provided about the research is clear, adequate, and accurate. The ombudsman may also be the research monitor (see
p.000003: section 8 of this enclosure). For research involving Service members as human subjects, that has been determined to be
p.000003: NO greater than minimal risk and when recruitment occurs in a group setting, the IRB shall determine when it is
p.000003: appropriate to appoint an ombudsman for the purposes described in this paragraph. The decision to require the
p.000003: appointment of an ombudsman should be based in part on the human subject population, the consent process, and the
p.000003: recruitment strategy.
p.000003:
p.000003: (2) DoD Civilians as Subjects
p.000003:
p.000003: (a) DoD Civilians shall follow their organization’s policies regarding the requirement to obtain permission to
p.000003: participate in research involving human subjects.
p.000003:
p.000003:
p.000003:
p.000003: Change 1, 10/15/2018 23
p.000004: ENCLOSURE 3
p.000004:
p.000004: DoDI 3216.02, November 8, 2011
p.000004:
p.000004:
p.000004:
p.000004: (b) Supervisors (e.g., military and civilian supervisors or anyone in the supervisory structure) are prohibited from
p.000004: influencing the decisions of their subordinates regarding participation as subjects in research involving human
p.000004: subjects covered by this Instruction.
p.000004:
p.000004: (c) Supervisors (e.g., military and civilian supervisors or anyone in the supervisory structure) shall not be present
p.000004: at any human subject recruitment sessions or during the consent process in which DoD civilians under their supervision
p.000004: are afforded the opportunity to participate as human subjects. When applicable, supervisors so excluded shall be
p.000004: afforded the opportunity to participate as human subjects in a separate recruitment session.
p.000004:
p.000004: (d) For research involving civilians as human subjects and when recruitment occurs in a group setting, the IRB shall
p.000004: discuss appointing an ombudsman for the purposes described in subparagraph e.(1)(d) of this section. The decision to
p.000004: require the appointment of an ombudsman should be based in part on the human subject population, the consent process,
p.000004: and the recruitment strategy.
p.000004:
p.000004:
p.000004: 8. RESEARCH MONITOR
p.000004:
p.000004: a. For DoD-conducted research involving human subjects determined by the IRB to involve more than minimal risk to
p.000004: human subjects (as defined in section 219.102(i) of Reference (c)), and, to the extent provided pursuant to Parts 22
p.000004: (Appendix B), 37 (Appendix D), and 219 of Reference (c) and Reference (o), comparable DoD-supported research, the IRB
p.000004: shall approve an independent research monitor by name. Additionally, the research monitor may be identified by an
p.000004: investigator or appointed by an IRB or IO for research involving human subjects determined to involve minimal risk.
p.000004: There may be more than one research monitor (e.g., if different skills or experiences are necessary). The monitor may
...
p.000005: DoD-conducted and DoD-supported research involving human subjects. Section 980 of Reference (g) imposes limitations on
p.000005: waiving informed consent when using DoD appropriated funds. Section 980 of Reference (g) is applicable ONLY to DoD
p.000005: funded research involving a human being as an experimental subject as defined in the Glossary. The definition of
p.000005: research involving a human subject as an experimental subject is not the same as the definition of research involving
p.000005: human subjects. Section 980 of Reference (g) is not applicable to exempt research involving human subjects.
p.000005:
p.000005: b. When the research meets the Glossary definition of research involving a human being as an experimental subject,
p.000005: informed consent must be obtained in advance from the experimental subject or the subject’s legal representative
p.000005: consistent with part 219 of Reference (c) if the subject cannot consent. If consent is to be obtained from the
p.000005: experimental subject’s legal representative, the research must intend to benefit the individual subject. The
p.000005: determination that research is intended to be beneficial to the individual experimental subject must be made by an IRB
p.000005: consistent with part 219 of Reference (c).
p.000005:
p.000005: c. The requirement of paragraph 9.b. of this section may be waived by the ASD(R&E) if all the following conditions are
p.000005: met:
p.000005:
p.000005: (1) The research is necessary to advance the development of a medical product for the Military Services.
p.000005:
p.000005: (2) The research may directly benefit the individual experimental subject.
p.000005:
p.000005: (3) The research is conducted in compliance with all other applicable laws and regulations.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Change 1, 10/15/2018 25
p.000006: ENCLOSURE 3
p.000006:
p.000006: DoDI 3216.02, November 8, 2011
p.000006:
p.000006: d. The ASD(R&E) may delegate the waiver authority described in paragraph 9.c. to the Heads of the OSD and DoD
p.000006: Components if they have appropriate policies and procedures in their management plans. This authority is further
p.000006: delegable only to a DoD Component official who is a Presidential Appointee with Senate Confirmation.
p.000006:
p.000006:
p.000006: 10. PROTECTING HUMAN SUBJECTS FROM MEDICAL EXPENSES IF INJURED
p.000006:
p.000006: a. DoD-Supported Research Involving Human Subjects. All non-exempt research involving human subjects shall, at a
p.000006: minimum, meet the requirement of section 219.116(a)(6) of Reference (c). The Common Rule does not require payment or
p.000006: reimbursement of medical expenses, provision of medical care, or compensation for research-related injuries.
p.000006:
p.000006: b. DoD-Conducted Research Involving Human Subjects. The DoD Components shall establish procedures to protect human
p.000006: subjects from medical expenses (not otherwise provided or reimbursed) that are the direct result of participation in
...
p.000004: classified information, as defined in Reference (r).
p.000004:
p.000004: clinical investigations. Any research or experiments that involve a test article, one or more human subjects, and are
p.000004: performed under the requirements of Reference (d). Clinical investigations are a subcategory of research involving
p.000004: human subjects.
p.000004:
p.000004: continuing noncompliance. A pattern of noncompliance (see definition of noncompliance) that suggests the likelihood
p.000004: that, without intervention, instances of noncompliance will recur. A repeated unwillingness to comply with this
p.000004: Instruction or a persistent lack of knowledge of how to comply with this Instruction.
p.000004:
p.000004: Common Rule. The regulation adopted by multiple Federal departments and agencies for the protection of human subjects
p.000004: in research. The Department of Defense’s implementation of the Common Rule is part 219 of Reference (c); the
p.000004: Department of HHS’s implementation of the Common Rule is subpart A of Reference (i).
p.000004:
p.000004: detainee. Defined in Reference (q).
p.000004:
p.000004: DoD-conducted research involving human subjects. Research involving human subjects that is performed by DoD personnel.
p.000004: Intramural research is one type of DoD-conducted research involving human subjects. See “engaged in research
p.000004: involving human subjects.”
p.000004:
p.000004: DoD personnel. DoD civilian employees and members of the military services.
p.000004:
p.000004: DoD civilian employee. An individual meeting the definition of “employee” consistent with section 2105 of Reference
p.000004: (n). It includes employees of DoD Non-Appropriated Fund Instrumentalities; DoD civilian employees filling full-time,
p.000004: part-time, intermittent, or on-call positions; and individuals serving under personal services contracts consistent
p.000004: with section 2.101 of Reference (o). It excludes employees of contractors (other than personal services contractors)
p.000004: and foreign nationals of host countries.
p.000004:
p.000004: Service members. Individuals appointed, enlisted, or inducted for military service under the authority of the
p.000004: Department of Defense. The Military Services are the Army, the Navy, the Air Force, the Marine Corps, the Coast Guard,
p.000004: and the Reserve Components, which includes the Army and the Air National Guards of the United States. Members of the
p.000004: Reserve Components are included when in a duty status.
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Change 1, 10/15/2018 34
p.000005: GLOSSARY
p.000005:
p.000005: DoDI 3216.02, November 8, 2011
p.000005:
p.000005: DoD-supported research involving human subjects. Research involving human subjects for which the Department of Defense
p.000005: is providing at least some of the resources (see “research involving human subjects”). Resources may include but are
p.000005: not limited to funding, facilities, equipment, personnel (investigators or other personnel performing tasks identified
p.000005: in the research protocol), access to or information about DoD personnel for recruitment, or identifiable data or
p.000005: specimens from living individuals. It includes both DoD-conducted research involving human subjects (intramural
p.000005: research) and research conducted by a non-DoD institution.
p.000005:
p.000005: engaged in research involving human subjects. An institution is engaged in research involving human subjects when its
p.000005: personnel are conducting activities covered by section 219.101(a) of Reference (c) and this Instruction. An
p.000005: institution that is funding, providing equipment, providing access to or information about potential human subjects
...
p.000006:
p.000006: neonate. Newborns as defined in subpart B of Reference (i).
p.000006:
p.000006: non-affiliated IRB member. Defined in section 219.107(d) of Reference (c). This member is not connected with the
p.000006: institution(s), as defined in the institution’s Federal assurance that is creating or relying on the IRB, or a member
p.000006: of the immediate family of a person who is associated with the institution creating or relying on the IRB.
p.000006:
p.000006: noncompliance. Failure of a person, group, or institution to act in accordance with this Instruction, its references,
p.000006: or applicable requirements.
p.000006:
p.000006: non-DoD institution. An entity that is not part of the Department of Defense.
p.000006:
p.000006: non-exempt research involving human subjects. An activity that meets the definitions of research and human subject but
p.000006: does not meet the criteria where the only involvement of the human subjects in the research are in one or more of the
p.000006: categories identified in section 219.101(b) of Reference (c).
p.000006:
p.000006: ombudsman. A person who acts as an impartial and objective advocate for human subjects participating in research.
p.000006:
p.000006: OSD Component. Defined in DoD Instruction 5025.01 (Reference (x)).
p.000006:
p.000006: OT&E. Defined in section 139(a)(2)(A) of Reference (g).
p.000006:
p.000006:
p.000006:
p.000006:
p.000006: Change 1, 10/15/2018 36
p.000007: GLOSSARY
p.000007:
p.000007: DoDI 3216.02, November 8, 2011
p.000007:
p.000007: prisoner. Defined in subpart C of Reference (i). Includes military personnel in either civilian or military custody
p.000007: or detainment.
p.000007:
p.000007: prisoner representative. An individual member on the IRB who shall have working knowledge of the human subject
p.000007: population to be recruited, a reasonable familiarity with the operations of the prison or confinement facility, and
p.000007: any other legally imposed restrictive conditions involved in the research, and appropriate background and expertise to
p.000007: serve in this capacity.
p.000007:
p.000007: private information. Defined in section 219.102(f) of Reference (c).
p.000007:
p.000007: research. Any activity that is a systematic investigation, including RDT&E, designed to develop or contribute to
p.000007: generalizable knowledge as defined in section 219.102(d) of Reference (c).
p.000007:
p.000007: research involving human subjects. Activities that include both a systematic investigation designed to develop or
p.000007: contribute to generalizable knowledge AND involve a living individual about whom an investigator conducting research
p.000007: obtains data through intervention or interaction with the individual or identifiable private information. Activities
p.000007: covered by section 219.101(a) of Reference (c) (including exempt research involving human subjects) and this
p.000007: Instruction.
p.000007:
p.000007: The following activities conducted or supported by the Department of Defense are NOT research involving human subjects:
p.000007:
p.000007: Activities carried out solely for purposes of diagnosis, treatment, or prevention of injury and disease in Service
p.000007: members and other mission essential personnel under force health protection programs of the Department of Defense,
p.000007: including health surveillance pursuant to section 1074f of Reference (g) and the use of medical products consistent
p.000007: with DoD Instruction 6200.02 (Reference (y)).
p.000007:
p.000007: Authorized health and medical activities as part of the reasonable practice of medicine or other health professions
p.000007: undertaken for the sole purpose of patient treatment.
p.000007:
p.000007: Activities performed for the sole purpose of medical quality assurance consistent with section 1102 of Reference (g)
p.000007: and DoDD 6025.13 (Reference (z)).
p.000007:
p.000007: Activities performed solely for an OT&E project where the activities and project meet the definition of OT&E as defined
p.000007: in section 139(a)(2)(A) of Reference (g).
p.000007:
p.000007: Activities performed solely for assessing compliance of individuals and organizations with requirements applicable to
p.000007: military, civilian, or contractor personnel or to organizational units, including such activities as occupational drug
p.000007: testing, occupational health and safety reviews, network monitoring, and monitoring for compliance with requirements
p.000007: for protection of classified information.
p.000007:
p.000007: Activities, including program evaluation, customer satisfaction surveys, user surveys, outcome reviews, and other
p.000007: methods, designed solely to assess the performance of DoD programs where the results of the evaluation are only for the
p.000007: use of Government officials
p.000007:
p.000007:
p.000007:
p.000007: Change 1, 10/15/2018 37
p.000008: GLOSSARY
p.000008:
p.000008: DoDI 3216.02, November 8, 2011
p.000008:
p.000008: responsible for the operation or oversight of the program being evaluated and are not intended for generalized use
p.000008: beyond such program.
p.000008:
p.000008: Survey, interview, or surveillance activities and related analyses performed solely for authorized foreign intelligence
p.000008: collection purposes, as authorized by DoDD 5240.01 (Reference (aa)).
p.000008:
p.000008: research involving a human being as an experimental subject. An activity, for research purposes, where there is an
p.000008: intervention or interaction with a living individual for the primary purpose of obtaining data regarding the effect of
p.000008: the intervention or interaction. Research involving a human being as an experimental subject is a subset of research
p.000008: involving human subjects. This definition relates only to the application of section 980 of Reference (g); it does not
p.000008: affect the application of part 219 of Reference (c). This definition does not include activities that are not
...
Searching for indicator soldier:
(return to top)
p.000009: of the research.
p.000009:
p.000009:
p.000009: 6. SELECTION OF HUMAN SUBJECTS AND EVALUATING RISK
p.000009:
p.000009: a. Selection of Human Subjects. The selection of human subjects reflecting gender and minority participation in
p.000009: DoD-conducted or -supported clinical research involving human subjects shall comply with section 252 of Public Law
p.000009: 103-160 (Reference (p)). The Head of the OSD or DoD Component may exercise the waiver authority under this law. This
p.000009: waiver authority may be delegated, as described in the Component’s HRPP management plan, but not to an individual at
p.000009: the level of the institutional HRPP.
p.000009:
p.000009: b. Evaluating Risk. The phrase “ordinarily encountered in daily life or during the performance of routine physical or
p.000009: physiological examinations or tests” in the definition of minimal risk (section 219.102(j)) of Reference (c)) shall not
p.000009: be interpreted to include the inherent risks certain categories of human subjects face in their everyday life. For
p.000009: example, the risks imposed in research involving human subjects focused on a special population should not be evaluated
p.000009: against the inherent risks encountered in their work environment (e.g., emergency responder, pilot, soldier in a combat
p.000009: zone) or having a medical condition (e.g., frequent medical tests or constant pain).
p.000009:
p.000009:
p.000009: 7. ADDITIONAL PROTECTIONS FOR HUMAN SUBJECTS. In addition to the requirements of part 219 of Reference (c),
p.000009: additional safeguards described in this section shall be provided for human subjects in all DoD-conducted research
p.000009: involving human subjects who may be considered vulnerable due to their association with groups or populations
p.000009: specifically defined by Federal regulations in subparts B-D of Reference (i) and this Instruction. Similarly, as
p.000009: provided in Reference (o) or Parts 22 (Appendix B) and 37 (Appendix D) of Reference (c), such additional safeguards
p.000009: shall also be provided in comparable DoD-supported research involving human subjects. For purposes of this
p.000009: Instruction, actions authorizing or requiring any action by an official of HHS about any requirements of subparts B-D
p.000009: of Reference (i) shall be under the authority of the ASD(R&E). Investigators, IRBs, IOs, and DoD Component personnel
p.000009: reviewing research protocols shall consider the need for appropriate similar safeguards for other vulnerable
p.000009: populations, such as: research involving human subjects and investigators in supervisor- subordinate relationships,
p.000009: human subjects with decisional or mental impairments, human
p.000009:
p.000009:
p.000009:
p.000009: Change 1, 10/15/2018 19
p.000010: ENCLOSURE 3
p.000010:
p.000010: DoDI 3216.02, November 8, 2011
p.000010:
...
Social / Women
Searching for indicator women:
(return to top)
p.000004: DoD COMPONENT HRPP MANAGEMENT PLAN 11
p.000004: REQUIREMENTS FOR A FEDERAL ASSURANCE 12
p.000004: Activities for Which an Institution is Required to Have a Federal Assurance 12
p.000004: Activities for Which an Institution is not Required to Have a Federal Assurance 13
p.000004: DoD-CONDUCTED RESEARCH INVOLVING HUMAN SUBJECTS 13
p.000004: DoD Institutional Approval and Oversight 13
p.000004: DoD Component Review and Oversight 15
p.000004: RESEARCH INVOLVING HUMAN SUBJECTS CONDUCTED BY A NON-DoD INSTITUTION
p.000004: 16
p.000004: Clause in Contracts and Agreements 16
p.000004: Non-DoD Institutional Responsibilities 17
p.000004: DoD Component Review, Approval, and Oversight 17
p.000004: EDUCATION AND TRAINING 18
p.000004: SELECTION OF HUMAN SUBJECTS AND EVALUATING RISK 19
p.000004: Selection of Human Subjects
p.000004: 19
p.000004: Evaluating Risk
p.000004: 19
p.000004: ADDITIONAL PROTECTIONS FOR HUMAN SUBJECTS 19
p.000004: Pregnant Women, Fetuses, and Neonates as Subjects 20
p.000004: Prisoners as Subjects
p.000004: 20
p.000004: Treatment of Detainees
p.000004: 22
p.000004: Children as Subjects
p.000004: 22
p.000004: DoD Personnel as Subjects
p.000004: 23
p.000004: RESEARCH MONITOR
p.000004: 24
p.000004: UNIQUE DoD LIMITATIONS ON WAIVER OF INFORMED CONSENT 25
p.000004: PROTECTING HUMAN SUBJECTS FROM MEDICAL EXPENSES IF INJURED 26
p.000004: DoD-Supported Research Involving Human Subjects 26
p.000004: DoD-Conducted Research Involving Human Subjects 26
p.000004: DoD-Collaborative Research Involving Human Subjects 26
p.000004: COMPENSATION TO HUMAN SUBJECTS FOR PARTICIPATION IN RESEARCH 27
p.000004: DoD-Conducted Research Involving Human Subjects 27
p.000004: Non-DoD-Conducted Research Involving Human Subjects 28
p.000004: SERVICE MEMBERS AND THEIR STATUS AS ADULTS 29
p.000004: Change 1, 10/15/2018 4
p.000005: CONTENTS
p.000005:
p.000005: DoDI 3216.02, November 8, 2011
p.000005: CLASSIFIED RESEARCH INVOLVING HUMAN SUBJECTS 29
p.000005: ADDITIONAL PROTECTIONS FOR CONFIDENTIALITY 30
...
p.000009: specifically defined by Federal regulations in subparts B-D of Reference (i) and this Instruction. Similarly, as
p.000009: provided in Reference (o) or Parts 22 (Appendix B) and 37 (Appendix D) of Reference (c), such additional safeguards
p.000009: shall also be provided in comparable DoD-supported research involving human subjects. For purposes of this
p.000009: Instruction, actions authorizing or requiring any action by an official of HHS about any requirements of subparts B-D
p.000009: of Reference (i) shall be under the authority of the ASD(R&E). Investigators, IRBs, IOs, and DoD Component personnel
p.000009: reviewing research protocols shall consider the need for appropriate similar safeguards for other vulnerable
p.000009: populations, such as: research involving human subjects and investigators in supervisor- subordinate relationships,
p.000009: human subjects with decisional or mental impairments, human
p.000009:
p.000009:
p.000009:
p.000009: Change 1, 10/15/2018 19
p.000010: ENCLOSURE 3
p.000010:
p.000010: DoDI 3216.02, November 8, 2011
p.000010:
p.000010: subjects with a physical disability, or any other kind of human subjects in circumstances that may warrant provision of
p.000010: additional protections. As appropriate, qualified individuals (e.g., research monitors, ombudsmen, advocates) may be
p.000010: appointed to perform oversight functions or assist the human subjects.
p.000010:
p.000010: a. Pregnant Women, Fetuses, and Neonates as Subjects
p.000010:
p.000010: (1) Non-exempt research involving pregnant women, fetuses, or neonates as human subjects must meet the additional
p.000010: relevant protections of subpart B of Reference (i), unless modified by this Instruction. Research involving pregnant
p.000010: women as subjects may be exempt from the requirements of part 219 of Reference (c) and subpart B of Reference (i) if
p.000010: the research meets the exemption criteria at section 219.101(b) of Reference (c). If the pregnant woman is a prisoner,
p.000010: then paragraph 7.b. of this section also applies. If the pregnant woman is a minor, paragraph 7.d. of this section
p.000010: also applies. For purposes of applying paragraph 7.a., the phrase “biomedical knowledge” in subpart B of Reference (i)
p.000010: shall be replaced with “generalizable knowledge” throughout the subpart.
p.000010:
p.000010: (2) The applicability of subpart B of Reference (i) is limited to research involving:
p.000010:
p.000010: (a) Pregnant women as human subjects involved in research that is more than minimal risk and includes interventions or
p.000010: invasive procedures to the woman or the fetus; or
p.000010:
p.000010: (b) Fetus or neonate (see Glossary) as human subjects.
p.000010:
p.000010: (3) Research involving human subjects using fetal tissue shall comply with sections 289g–289g-2 of Reference (k).
p.000010:
p.000010: b. Prisoners as Subjects
p.000010:
p.000010: (1) Research Intending to Include Prisoners as Subjects
p.000010:
p.000010: (a) Research involving human subjects that includes prisoners must meet the additional relevant protections of subpart
p.000010: C of Reference (i), unless modified by this Instruction. If the prisoner is a pregnant woman, then paragraph 7.a. of
p.000010: this section also applies. If the prisoner is a minor, then paragraph 7.d. of this section also applies.
p.000010:
p.000010: (b) Research intending to include prisoners as subjects cannot be reviewed by the IRB through an expedited review
p.000010: procedure.
p.000010:
p.000010: (c) The IRB reviewing research intending to include prisoners as subjects shall be composed of at least one prisoner
...
Social / Youth/Minors
Searching for indicator minor:
(return to top)
p.000010: ENCLOSURE 3
p.000010:
p.000010: DoDI 3216.02, November 8, 2011
p.000010:
p.000010: subjects with a physical disability, or any other kind of human subjects in circumstances that may warrant provision of
p.000010: additional protections. As appropriate, qualified individuals (e.g., research monitors, ombudsmen, advocates) may be
p.000010: appointed to perform oversight functions or assist the human subjects.
p.000010:
p.000010: a. Pregnant Women, Fetuses, and Neonates as Subjects
p.000010:
p.000010: (1) Non-exempt research involving pregnant women, fetuses, or neonates as human subjects must meet the additional
p.000010: relevant protections of subpart B of Reference (i), unless modified by this Instruction. Research involving pregnant
p.000010: women as subjects may be exempt from the requirements of part 219 of Reference (c) and subpart B of Reference (i) if
p.000010: the research meets the exemption criteria at section 219.101(b) of Reference (c). If the pregnant woman is a prisoner,
p.000010: then paragraph 7.b. of this section also applies. If the pregnant woman is a minor, paragraph 7.d. of this section
p.000010: also applies. For purposes of applying paragraph 7.a., the phrase “biomedical knowledge” in subpart B of Reference (i)
p.000010: shall be replaced with “generalizable knowledge” throughout the subpart.
p.000010:
p.000010: (2) The applicability of subpart B of Reference (i) is limited to research involving:
p.000010:
p.000010: (a) Pregnant women as human subjects involved in research that is more than minimal risk and includes interventions or
p.000010: invasive procedures to the woman or the fetus; or
p.000010:
p.000010: (b) Fetus or neonate (see Glossary) as human subjects.
p.000010:
p.000010: (3) Research involving human subjects using fetal tissue shall comply with sections 289g–289g-2 of Reference (k).
p.000010:
p.000010: b. Prisoners as Subjects
p.000010:
p.000010: (1) Research Intending to Include Prisoners as Subjects
p.000010:
p.000010: (a) Research involving human subjects that includes prisoners must meet the additional relevant protections of subpart
p.000010: C of Reference (i), unless modified by this Instruction. If the prisoner is a pregnant woman, then paragraph 7.a. of
p.000010: this section also applies. If the prisoner is a minor, then paragraph 7.d. of this section also applies.
p.000010:
p.000010: (b) Research intending to include prisoners as subjects cannot be reviewed by the IRB through an expedited review
p.000010: procedure.
p.000010:
p.000010: (c) The IRB reviewing research intending to include prisoners as subjects shall be composed of at least one prisoner
p.000010: representative (see Glossary). The prisoner representative may be a prisoner, an employee of the prison, or an
p.000010: individual not affiliated with the prison. The prisoner representative shall have knowledge of the culture(s) of the
p.000010: prisoners and knowledge of the prison operations. At least one prisoner representative must be present for a quorum.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000000: Change 1, 10/15/2018 20
p.000001: ENCLOSURE 3
p.000001:
p.000001: DoDI 3216.02, November 8, 2011
p.000001:
p.000001: (d) Research involving prisoners at prisons or other types of institutions may be subject to additional review by
p.000001: institution authorities (e.g., Bureau of Prisons).
p.000001:
p.000001: (2) Categories of Allowable Research Involving a Prisoner. In addition to the four categories of permissible research
p.000001: involving human subjects identified in subpart C of Reference (i), two additional categories are allowable.
p.000001:
p.000001: (a) Epidemiological research that meets the following criteria can also be approved in accordance with the
...
p.000002: c. Treatment of Detainees
p.000002:
p.000002: (1) Research involving a detainee, as defined in DoD Directive 2310.01E (Reference (q)), as a human subject is
p.000002: prohibited.
p.000002:
p.000002: (2) The prohibition in paragraph c.(1) of this section does not apply to activities covered by investigational new
p.000002: drug or investigational device provisions of Reference (d) when for the purpose of diagnosis or treatment of a medical
p.000002: condition in a patient. Such treatment (e.g., an investigational new drug) may be offered to detainees with the
p.000002: detainees’ informed consent when the medical products are subject to Reference (d) as investigational new drugs or
p.000002: investigational medical devices, and only when the same product would be offered to members of the U.S. Military
p.000002: Services in the same location for the same medical condition and only when consistent with established medical practice
p.000002: involving investigational drugs and devices. Such permitted treatment involving detainees as subjects shall comply
p.000002: with all sections of this Instruction, including paragraphs 6.a., b., and d. of this section, as applicable.
p.000002:
p.000002: d. Children as Subjects
p.000002:
p.000002: (1) Research involving human subjects conducted or supported by the Department of Defense that recruits children to be
p.000002: subjects must meet the additional relevant protections of subpart D of Reference (i), unless modified by this
p.000002: Instruction. If the minor is a pregnant woman, then paragraph 7.a. of this section also applies. If the minor is a
p.000002: prisoner, paragraph 7.b. of this section also applies.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: Change 1, 10/15/2018 22
p.000003: ENCLOSURE 3
p.000003:
p.000003: DoDI 3216.02, November 8, 2011
p.000003:
p.000003: (2) The footnote in section 219.101(i) of Reference (c), prohibiting specific exemptions described in section
p.000003: 219.101(b) from applying to children, is also applicable to DoD-conducted or -supported research involving human
p.000003: subjects unless otherwise clarified in this Instruction.
p.000003:
p.000003: e. DoD Personnel as Subjects
p.000003:
p.000003: (1) Military Personnel as Subjects
p.000003:
p.000003: (a) Service members shall follow their command policies regarding the requirement to obtain command permission to
p.000003: participate in research involving human subjects while
p.000003: on-duty. Additionally a Service member’s ability to perform his or her military duties may be affected by
p.000003: participating during off-duty time (i.e., on leave or during non-duty hours).
p.000003: Therefore, Service members shall follow their Component and command’s policies for approving off-duty employment or
p.000003: activities. The IRBs of DoD institutions or HRPOs may require Principal Investigators to confirm that a Service
p.000003: member’s commander supports the member’s participation in DoD-supported research involving human subjects.
p.000003:
p.000003: (b) Superiors (e.g., military and civilian supervisors, unit officers, and noncommissioned officers (NCOs)) are
...
Social / education
Searching for indicator education:
(return to top)
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: Change 1, 10/15/2018 3
p.000004:
p.000004: DoDI 3216.02, November 8, 2011
p.000004: TABLE OF CONTENTS
p.000004: ENCLOSURE 1: REFERENCES
p.000004: 6
p.000004: ENCLOSURE 2: RESPONSIBILITIES
p.000004: 8
p.000004: ASD(R&E)
p.000004: 8
p.000004: ASD(HA)
p.000004: 9
p.000004: HEADS OF THE OSD AND DoD COMPONENTS 9
p.000004: IOs OF DoD INSTITUTIONS
p.000004: 10
p.000004: ENCLOSURE 3: PROCEDURES
p.000004: 11
p.000004: DoD COMPONENT HRPP MANAGEMENT PLAN 11
p.000004: REQUIREMENTS FOR A FEDERAL ASSURANCE 12
p.000004: Activities for Which an Institution is Required to Have a Federal Assurance 12
p.000004: Activities for Which an Institution is not Required to Have a Federal Assurance 13
p.000004: DoD-CONDUCTED RESEARCH INVOLVING HUMAN SUBJECTS 13
p.000004: DoD Institutional Approval and Oversight 13
p.000004: DoD Component Review and Oversight 15
p.000004: RESEARCH INVOLVING HUMAN SUBJECTS CONDUCTED BY A NON-DoD INSTITUTION
p.000004: 16
p.000004: Clause in Contracts and Agreements 16
p.000004: Non-DoD Institutional Responsibilities 17
p.000004: DoD Component Review, Approval, and Oversight 17
p.000004: EDUCATION AND TRAINING 18
p.000004: SELECTION OF HUMAN SUBJECTS AND EVALUATING RISK 19
p.000004: Selection of Human Subjects
p.000004: 19
p.000004: Evaluating Risk
p.000004: 19
p.000004: ADDITIONAL PROTECTIONS FOR HUMAN SUBJECTS 19
p.000004: Pregnant Women, Fetuses, and Neonates as Subjects 20
p.000004: Prisoners as Subjects
p.000004: 20
p.000004: Treatment of Detainees
p.000004: 22
p.000004: Children as Subjects
p.000004: 22
p.000004: DoD Personnel as Subjects
p.000004: 23
p.000004: RESEARCH MONITOR
p.000004: 24
p.000004: UNIQUE DoD LIMITATIONS ON WAIVER OF INFORMED CONSENT 25
p.000004: PROTECTING HUMAN SUBJECTS FROM MEDICAL EXPENSES IF INJURED 26
p.000004: DoD-Supported Research Involving Human Subjects 26
p.000004: DoD-Conducted Research Involving Human Subjects 26
p.000004: DoD-Collaborative Research Involving Human Subjects 26
p.000004: COMPENSATION TO HUMAN SUBJECTS FOR PARTICIPATION IN RESEARCH 27
...
p.000001: Component HRPP management plan. This authority shall not be delegated lower than the general or flag officer (GO/FO),
p.000001: Senior Executive Service (SES), or equivalent level. All authorities delegated by the Head of the OSD or DoD Component
p.000001: must be identified in the management plan.
p.000001:
p.000001: c. The plan shall reference DoD Component policies and procedures that:
p.000001:
p.000001: (1) Direct each institution within the DoD Component conducting or supporting research involving human subjects to
p.000001: establish an HRPP that is compliant with this Instruction and the DoD Component’s HRPP management plan.
p.000001:
p.000001: (2) Describe DoD Component oversight of each institution’s HRPP.
p.000001:
p.000001: (3) Describe DoD Component administrative review of DoD-conducted and -supported research involving human subjects
p.000001: (see sections 3 and 4 of this enclosure for details).
p.000001:
p.000001: (4) Delineate institutional responsibilities when performing research involving human subjects in collaboration with
p.000001: another DoD Component. These responsibilities shall include establishing written agreements for tasks such as
p.000001: minimizing the number of institutional review boards (IRBs) and DoD Components that review and approve the research
p.000001: (see sections 3 and 4 of this enclosure for details). DoD Component policies and procedures shall include a
p.000001: requirement to justify the duplication of reviews of protocols (for example, IRB and Component Headquarters reviews).
p.000001:
p.000001: (5) Outline education and training for implementation, management, and oversight of this Instruction (see paragraph
p.000001: 1.f. of Enclosure 2 and section 5 of this enclosure for details).
p.000001:
p.000001: (6) Address the management of allegations and findings of noncompliance concerning DoD-conducted and -supported
p.000001: research involving human subjects (see section 16 of this enclosure for details).
p.000001:
p.000001:
p.000001:
p.000001:
p.000001: Change 1, 10/15/2018 11
p.000002: ENCLOSURE 3
p.000002:
p.000002: DoDI 3216.02, November 8, 2011
p.000002:
p.000002: (7) Identify and manage conflicts of interest, not limited to financial, for DoD personnel involved in the HRPP.
p.000002:
p.000002: (8) Require a process to evaluate and improve the DoD Component’s implementation of its HRPP management plan down to
p.000002: the level of the institutional HRPP.
p.000002:
p.000002: d. A DoD Component may rely on another DoD Component for implementation of elements of the management plan except for
p.000002: designation of the single, senior official responsible for the management plan identified in paragraph 1.b. of this
p.000002: enclosure. Any such reliance must be reflected in the DoD Component’s HRPP management plan.
p.000002:
p.000002:
p.000002: 2. REQUIREMENTS FOR A FEDERAL ASSURANCE
p.000002:
p.000002: a. Activities for Which an Institution is Required to Have a Federal Assurance. Any institution engaged in non-exempt
p.000002: research involving human subjects that is conducted or supported by the Department of Defense shall have a Federal
p.000002: assurance consistent with section
p.000002: 219.103 of Reference (c) and acceptable to the funding agency.
p.000002:
p.000002: (1) A DoD institution engaged in non-exempt research involving human subjects shall have a DoD assurance of
...
p.000008:
p.000008: (c) Review and accept IRB-approved substantive changes to an approved research protocol before they are implemented.
p.000008:
p.000008: (d) Ensure the IRB conducts an appropriate continuing review at least annually.
p.000008:
p.000008: (e) When the research involving human subjects is being conducted in a foreign country, confirm all applicable
p.000008: national laws and requirements of the foreign country have been met and confirm the IRB considered the cultural
p.000008: sensitivities in the setting where the research will take place.
p.000008:
p.000008: (3) Upon receipt of notifications directed in subparagraph 4.b.(4) of this section, the supporting DoD Component shall
p.000008: promptly review the report and determine if further review of any or all the institution’s research involving human
p.000008: subjects that is supported by the DoD Component is warranted. When appropriate, the DoD Component may defer its
p.000008: investigation to an ongoing Federal investigation. The DoD Component shall notify the ASD(R&E) in accordance with
p.000008: paragraph 3.f. of Enclosure 2 and section 16 of this enclosure.
p.000008:
p.000008: (4) DoD Components conducting a for-cause review of research conducted by a non-DoD institution shall evaluate and
p.000008: ensure the adequacy of human protection in
p.000008: DoD-supported programs and provide recommendations to the DoD Component about allowing continued DoD support of
p.000008: research involving human subjects, suspending the research until necessary changes have been made, or terminating the
p.000008: research.
p.000008:
p.000008:
p.000008: 5. EDUCATION AND TRAINING. The DoD Components shall ensure that all DoD personnel involved in the conduct, review, or
p.000008: approval of research involving human subjects, including the non-affiliated and prisoner representative members on the
p.000008: DoD IRB, receive initial and continuing education and training in compliance with the standards set forth by ASD(R&E)
p.000008: (see paragraph 1.f. of Enclosure 2 for details).
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: Change 1, 10/15/2018 18
p.000009: ENCLOSURE 3
p.000009:
p.000009: DoDI 3216.02, November 8, 2011
p.000009:
p.000009: a. Initial and continuing education and training shall be commensurate with the duties and responsibilities of the DoD
p.000009: personnel.
p.000009:
p.000009: b. All training and education of DoD personnel shall be documented.
p.000009:
p.000009: c. Professional certification in the field of human research protection is encouraged for all DoD personnel involved
p.000009: in review and oversight of research involving human subjects.
p.000009:
p.000009: d. When assessing whether to support or collaborate with a non-DoD institution for research involving human subjects,
p.000009: the DoD Components should evaluate the non-DoD institution’s education and training policies to ensure the personnel
p.000009: are qualified to perform the research. The rigor of the evaluation should be appropriate for the complexity and risk
p.000009: of the research.
p.000009:
p.000009:
p.000009: 6. SELECTION OF HUMAN SUBJECTS AND EVALUATING RISK
p.000009:
p.000009: a. Selection of Human Subjects. The selection of human subjects reflecting gender and minority participation in
p.000009: DoD-conducted or -supported clinical research involving human subjects shall comply with section 252 of Public Law
p.000009: 103-160 (Reference (p)). The Head of the OSD or DoD Component may exercise the waiver authority under this law. This
p.000009: waiver authority may be delegated, as described in the Component’s HRPP management plan, but not to an individual at
p.000009: the level of the institutional HRPP.
p.000009:
p.000009: b. Evaluating Risk. The phrase “ordinarily encountered in daily life or during the performance of routine physical or
p.000009: physiological examinations or tests” in the definition of minimal risk (section 219.102(j)) of Reference (c)) shall not
p.000009: be interpreted to include the inherent risks certain categories of human subjects face in their everyday life. For
p.000009: example, the risks imposed in research involving human subjects focused on a special population should not be evaluated
...
p.000010: Department of HHS a Certificate of Confidentiality pursuant to section 241(d) of Reference (k). Such a Certificate of
p.000010: Confidentiality authorizes persons engaged in biomedical, behavioral, clinical, or other research related to mission
p.000010: areas of the NIH to protect the privacy of human subjects of sensitive research against compulsory disclosure in any
p.000010: Federal, State, or local judicial, administrative, or legislative proceeding to
p.000010:
p.000010:
p.000000: Change 1, 10/15/2018 30
p.000001: ENCLOSURE 3
p.000001:
p.000001: DoDI 3216.02, November 8, 2011
p.000001:
p.000001: identify human subjects. Issuance of any Certificate of Confidentiality is at NIH’s discretion and is subject to the
p.000001: requirement of section 241(d) of Reference (k) and any other NIH guidelines.
p.000001:
p.000001:
p.000001: 15. RECORD KEEPING
p.000001:
p.000001: a. Part 219 of Reference (c) requires all institutions engaged in DoD-conducted or
p.000001: -supported research involving human subjects to retain records for at least 3 years after the completion of the
p.000001: research. Research involving human subjects may be covered by other Federal regulations that impose longer record
p.000001: keeping requirements. The DoD Components may rely on the non-DoD institutions to keep the required records that were
p.000001: generated by the institution, or the DoD Components may make arrangements to transfer the records.
p.000001:
p.000001: b. The DoD Components shall also retain records regarding the oversight of DoD Component-supported research involving
p.000001: human subjects for at least 3 years after the completion of the research, HRPP education or training program, or other
p.000001: action relevant to the HRPP. Additionally, the DoD Components shall keep all records regarding DoD Component waivers,
p.000001: exemptions, and extensions, and all DoD Component requests for exceptions, waivers, exemptions, and extensions
p.000001: submitted to the ASD(R&E) for action for at least 3 years after the completion of the research.
p.000001:
p.000001: c. The DoD Components may be required to retain records for longer than specified in paragraphs 15.a. and 15.b. of
p.000001: this section. For example, some Health Insurance Portability and Accountability Act documentation is required to be
p.000001: retained for 6 years (in accordance with DoD 6025.18-R (Reference (s))). For complete recordkeeping guidance and
p.000001: instruction, the DoD Components shall consult their respective records disposition schedules.
p.000001:
p.000001: d. Records maintained by non-DoD institutions that document compliance or noncompliance with this Instruction shall be
p.000001: made accessible for inspection and copying by authorized representatives of the Department of Defense at reasonable
p.000001: times and in a reasonable manner as determined by the supporting DoD Component.
p.000001:
p.000001:
p.000001: 16. NONCOMPLIANCE WITH THIS INSTRUCTION. The DoD Components shall respond to allegations of noncompliance with this
p.000001: Instruction. For allegations that involve more than one DoD Component or a non-DoD institution, the involved
p.000001: institutions should jointly determine and assign executive responsibility for responding to the allegation(s). For
p.000001: allegations involving a non-DoD institution, the DoD Component supporting the research involving human subjects shall
p.000001: ensure the allegation is properly investigated and reported to the DoD Component. All findings of serious or
...
Searching for indicator educational:
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p.000008:
p.000008: ENCLOSURE 2
p.000008:
p.000008: RESPONSIBILITIES
p.000008:
p.000008:
p.000008: 1. ASD(R&E). The ASD(R&E), under the authority, direction, and control of the Under Secretary of Defense for
p.000008: Acquisition, Technology, and Logistics, shall:
p.000008:
p.000008: a. Be the single DoD point of contact for all matters related to DoD compliance with this Instruction and shall act as
p.000008: the principal DoD liaison with organizations outside the Department of Defense on matters pertaining to research
p.000008: involving human subjects.
p.000008:
p.000008: b. Provide guidance and procedures necessary to implement this Instruction. The ASD(R&E) will consult with the
p.000008: Assistant Secretary of Defense for Health Affairs (ASD(HA)) for matters affecting medical research involving human
p.000008: subjects.
p.000008:
p.000008: c. Exercise the authorities of the Head of the Department identified in part 219 of Reference (c), the Secretary as
p.000008: identified in subparts B-D of part 46 of title 45, CFR (Reference (i)) for research described in section 7 of Enclosure
p.000008: 3 of this Instruction, and the Secretary of Defense identified in section 980 of Reference (g).
p.000008:
p.000008: d. Grant exceptions to any procedures or requirements in this Instruction based upon an appropriate justification from
p.000008: the Head of an OSD or DoD Component and consistent with law.
p.000008:
p.000008: e. Establish a process to oversee the DoD Components’ implementation of their respective Component human research
p.000008: protection program (HRPP) management plan and compliance with this Instruction.
p.000008:
p.000008: f. Establish a framework for educational training requirements for DoD personnel in key HRPP roles commensurate with
p.000008: their duties and responsibilities.
p.000008:
p.000008: g. Work with the DoD Components supporting international research involving human subjects to resolve conflicts
p.000008: between this Instruction, including its references, and other applicable foreign laws and requirements.
p.000008:
p.000008: h. Maintain a list of foreign country and international standards that are at least equivalent to those in part 219 of
p.000008: Reference (c).
p.000008:
p.000008: i. Designate DoD representatives to Federal committees, such as the Human Subject Research Subcommittee of the
p.000008: National Science and Technology Council’s Committee on Science or other committees established by the White House.
p.000008:
p.000008: j. Designate a DoD representative to the Secretary’s Advisory Committee on Human Research Protection established by
p.000008: the Secretary of Health and Human Services (HHS) and successor entities established by the Secretary of HHS.
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: Change 1, 10/15/2018 8
p.000009: ENCLOSURE 2
p.000009:
p.000009: DoDI 3216.02, November 8, 2011
p.000009:
p.000009: k. Establish the DoD Coordinating Committee for Human Research Protection Programs (CCHRPP) to act as the central
p.000009: advisory committee to the ASD(R&E) on all matters regarding the ethical involvement of human subjects in research.
p.000009: Membership shall be appointed as described in section 18 of Enclosure 3 of this Instruction.
p.000009:
p.000009:
...
Social / employees
Searching for indicator employees:
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p.000004: have been met in addition to the requirements in this Instruction. The IRB shall also consider the cultural
p.000004: sensitivities in the setting where the research will take place.
p.000004:
p.000004: (5) The DoD institution shall have policies and procedures to ensure the research involving human subjects has been
p.000004: approved by all required organizations before human subjects are recruited or any other research activities with human
p.000004: subjects begin. The IRB may approve a research protocol contingent upon its approval by other organizations (e.g.,
p.000004: required reviews can be conducted in parallel).
p.000004:
p.000004: (6) An IRB, in accordance with part 219 of Reference (c), shall approve all non-exempt research involving human
p.000004: subjects before any activities that involve human subjects can begin. An official cannot approve research that has been
p.000004: disapproved by the IRB in accordance with part 219 of Reference (c) (i.e., an IRB disapproval of a protocol cannot be
p.000004: overturned). The IRB must provide oversight of the ongoing research and review such research at intervals appropriate
p.000004: to the degree of risk, but not less than once per year.
p.000004:
p.000004: (7) DoD institutions shall rely on an IRB whose membership meets the requirements in subparagraphs 3.a.(7)(a) through
p.000004: (d). In special circumstances, DoD institutions may rely on a non-Federal IRB if the conditions in subparagraph
p.000004: 3.a.(8) of this section are met.
p.000004:
p.000004: (a) DoD IRBs shall consist of members who are Federal employees; Service members; individuals covered by sections
p.000004: 3371-3376 of title 5, U.S.C. (also known as “The Intergovernmental Personnel Act of 1970, as amended”) (Reference (n));
p.000004: or individuals appointed as experts or consultants in accordance with section 3109 of Reference (n).
p.000004:
p.000004: (b) For DoD IRBs, the requirement to have a non-affiliated IRB member (section 219.107(d) of Reference (c)) can be
p.000004: fulfilled by a person who meets the criteria in subparagraph
p.000004:
p.000004:
p.000004:
p.000004: Change 1, 10/15/2018 14
p.000005: ENCLOSURE 3
p.000005:
p.000005: DoDI 3216.02, November 8, 2011
p.000005:
p.000005: 3.a.(7)(a) of this section and is from an organization that is not part of the institution as defined on the
p.000005: institution’s Federal assurance. DoD IRBs shall designate at least one alternate for the non-affiliated member.
p.000005: Although the presence of a non-affiliated member is not a requirement to have a quorum, the designation of one or more
p.000005: alternates will increase the likelihood that a
p.000005: non-affiliated member is present at the meetings.
p.000005:
p.000005: (c) The IRB shall also have a scientist and a non-scientist to meet the requirements in section 219.107(c) of
p.000005: Reference (c). A member whose primary concerns are in a non-scientific area (i.e., the non-scientist) must be present
p.000005: to have a quorum at convened meetings. The
p.000005: non-affiliated position and the non-scientist position may be filled by the same person, or the non-affiliated position
p.000005: and the scientist position may be filled by the same person.
p.000005:
p.000005: (d) The DoD institution shall consider including one or more community members on the IRB who are familiar with the
p.000005: perspectives of the human subjects (i.e., the community being recruited) commonly recruited and vulnerable subjects
p.000005: recruited by the institution. Community members may or may not be affiliated with the institution or have a scientific
p.000005: background. The appointment of the community members must comply with subparagraph 3.a.(7)(a) of this section.
p.000005:
p.000005: (e) DoD IRBs may consult with subject matter experts (e.g., in science, in statistics, in ethics, for the subject
p.000005: population) who are not Federal employees or board members, but these consultants may not vote.
p.000005:
p.000005: (8) DoD institutions engaged in non-exempt research involving human subjects and collaborating with a non-DoD
p.000005: institution may rely on a collaborating non-DoD institution’s IRB if these minimum conditions are met:
p.000005:
p.000005: (a) The DoD Component determines the collaborating non-DoD institution has an appropriate Federal assurance.
p.000005:
p.000005: (b) The involvement of DoD personnel in the conduct of the research involving human subjects is secondary to that of
p.000005: the non-DoD institution.
p.000005:
p.000005: (c) The DoD institution, the non-DoD institution, and the non-DoD institution’s IRB have a written agreement defining
p.000005: the responsibilities and authorities of each organization in complying with the terms of the Federal assurances and
p.000005: this Instruction (i.e., have an Institutional Agreement for IRB Review or similar agreement). The DoD Component shall
p.000005: approve the terms of the agreement prior to the DoD institution’s engagement in the research involving human subjects.
p.000005:
p.000005: (d) The DoD Component must conduct an appropriate administrative review of the research involving human subjects to
p.000005: ensure it is in compliance with DoD policies and procedures prior to the DoD institution’s engagement in the research.
p.000005:
p.000005: b. DoD Component Review and Oversight
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Change 1, 10/15/2018 15
p.000006: ENCLOSURE 3
p.000006:
p.000006: DoDI 3216.02, November 8, 2011
p.000006:
p.000006: (1) At a minimum, the DoD Components must conduct an administrative review and approve all research involving
p.000006: non-exempt human subjects approved by a DoD institution when any of these conditions occur:
p.000006:
p.000006: (a) The research will be conducted in a foreign country unless one of the following conditions apply:
p.000006:
p.000006: 1. The research will be conducted by an established DoD overseas research institution and the research will be
p.000006: conducted in the host country, or
p.000006:
p.000006: 2. The research will be conducted by a DoD overseas institution and will include only DoD personnel or U.S. citizens
p.000006: as human subjects.
p.000006:
p.000006: (b) The research involves a collaboration with a non-DoD institution and the DoD institution is relying on the non-DoD
p.000006: institution’s IRB, which is not composed of Federal employees (i.e., the research is approved by the IRB using the
p.000006: criteria described in subparagraph 3.a.(8)) of this section.
p.000006:
p.000006: (c) The research permits a waiver of informed consent under paragraph (b) of section 980 of Reference (g).
p.000006:
p.000006: (d) The research involves any fetal research covered under sections 289g–289g-2 of Reference (k).
p.000006:
p.000006: (e) The research is required to be approved by either the ASD(R&E) or the Head of the OSD or DoD Component as
p.000006: delegated by the ASD(R&E) (e.g., the requirements in sections 7, 9, or 13 of this enclosure apply).
p.000006:
p.000006: (2) The DoD Component administrative review must be conducted before the research involving human subjects can begin
p.000006: to ensure compliance with all applicable regulations and policies, including any applicable laws and requirements and
p.000006: cultural sensitivities of a foreign country if conducted in a foreign country. This Component review is not intended
p.000006: to be an additional IRB review.
p.000006:
p.000006:
p.000006: 4. RESEARCH INVOLVING HUMAN SUBJECTS CONDUCTED BY A NON-DoD INSTITUTION
p.000006:
p.000006: a. Clause in Contracts and Agreements. The DoD Component must ensure the institution conducting the research
p.000006: involving human subjects is aware of its obligation to comply with the requirements of this Instruction and part 219 of
p.000006: Reference (c).
p.000006:
p.000006: (1) Contracts for DoD-supported research involving human subjects must contain the Defense Federal Acquisition
p.000006: Regulation Supplement (DFARS) clause in accordance with section 252.235-7004 of title 48, CFR (Reference (n)). In
...
p.000004: information required by the IRB for review and oversight or required or provided by the research subjects includes
p.000004: classified information, as defined in Reference (r).
p.000004:
p.000004: clinical investigations. Any research or experiments that involve a test article, one or more human subjects, and are
p.000004: performed under the requirements of Reference (d). Clinical investigations are a subcategory of research involving
p.000004: human subjects.
p.000004:
p.000004: continuing noncompliance. A pattern of noncompliance (see definition of noncompliance) that suggests the likelihood
p.000004: that, without intervention, instances of noncompliance will recur. A repeated unwillingness to comply with this
p.000004: Instruction or a persistent lack of knowledge of how to comply with this Instruction.
p.000004:
p.000004: Common Rule. The regulation adopted by multiple Federal departments and agencies for the protection of human subjects
p.000004: in research. The Department of Defense’s implementation of the Common Rule is part 219 of Reference (c); the
p.000004: Department of HHS’s implementation of the Common Rule is subpart A of Reference (i).
p.000004:
p.000004: detainee. Defined in Reference (q).
p.000004:
p.000004: DoD-conducted research involving human subjects. Research involving human subjects that is performed by DoD personnel.
p.000004: Intramural research is one type of DoD-conducted research involving human subjects. See “engaged in research
p.000004: involving human subjects.”
p.000004:
p.000004: DoD personnel. DoD civilian employees and members of the military services.
p.000004:
p.000004: DoD civilian employee. An individual meeting the definition of “employee” consistent with section 2105 of Reference
p.000004: (n). It includes employees of DoD Non-Appropriated Fund Instrumentalities; DoD civilian employees filling full-time,
p.000004: part-time, intermittent, or on-call positions; and individuals serving under personal services contracts consistent
p.000004: with section 2.101 of Reference (o). It excludes employees of contractors (other than personal services contractors)
p.000004: and foreign nationals of host countries.
p.000004:
p.000004: Service members. Individuals appointed, enlisted, or inducted for military service under the authority of the
p.000004: Department of Defense. The Military Services are the Army, the Navy, the Air Force, the Marine Corps, the Coast Guard,
p.000004: and the Reserve Components, which includes the Army and the Air National Guards of the United States. Members of the
p.000004: Reserve Components are included when in a duty status.
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Change 1, 10/15/2018 34
p.000005: GLOSSARY
p.000005:
p.000005: DoDI 3216.02, November 8, 2011
p.000005:
p.000005: DoD-supported research involving human subjects. Research involving human subjects for which the Department of Defense
p.000005: is providing at least some of the resources (see “research involving human subjects”). Resources may include but are
p.000005: not limited to funding, facilities, equipment, personnel (investigators or other personnel performing tasks identified
p.000005: in the research protocol), access to or information about DoD personnel for recruitment, or identifiable data or
p.000005: specimens from living individuals. It includes both DoD-conducted research involving human subjects (intramural
p.000005: research) and research conducted by a non-DoD institution.
p.000005:
...
Social / ex-combatant
Searching for indicator combatant:
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p.000002:
p.000002: Department of Defense
p.000002: INSTRUCTION
p.000002:
p.000002: NUMBER 3216.02
p.000002: November 8, 2011
p.000002: Incorporating Change 1, October 15, 2018
p.000002:
p.000002: USD(R&E)
p.000002:
p.000002: SUBJECT: Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research
p.000002:
p.000002: References: See Enclosure 1
p.000002:
p.000002:
p.000002: 1. PURPOSE. This Instruction reissues DoD Directive (DoDD) 3216.02 (Reference (a)) as a DoD Instruction in accordance
p.000002: with the authority in DoDD 5134.01 (Reference (b)) to establish policy and assign responsibilities for the protection
p.000002: of human subjects in DoD-supported programs to implement part 219 of title 32, Code of Federal Regulations (CFR) (also
p.000002: known and hereinafter referred to as “the Common Rule” (Reference (c)).
p.000002:
p.000002:
p.000002: 2. APPLICABILITY
p.000002:
p.000002: a. This Instruction applies to:
p.000002:
p.000002: (1) OSD, the Military Departments, the Office of the Chairman of the Joint Chiefs of Staff and the Joint Staff, the
p.000002: Combatant Commands, the Office of the Inspector General of the Department of Defense, the Defense Agencies, the DoD
p.000002: Field Activities, and all other organizational entities within the Department of Defense (hereinafter referred to
p.000002: collectively as the “DoD Components”).
p.000002:
p.000002: (2) All DoD-conducted or -supported research involving human subjects as defined in the Glossary. All such activities
p.000002: must include both systematic investigation designed to develop or contribute to generalizable knowledge AND involve a
p.000002: living individual about whom an investigator conducting research obtains data through intervention or interaction with
p.000002: the individual or about whom identifiable private information is obtained. All activities meeting both of these
p.000002: conditions will hereinafter be referred to as “research involving human subjects” in this Instruction.
p.000002:
p.000002: (3) Activities such as research, development, testing, and evaluation (RDT&E) that meet the definition of research
p.000002: involving human subjects (as defined in the Glossary), as well as clinical investigations or medical activities
p.000002: regulated by the Food and Drug Administration (FDA) in parts 50, 56, 312, 600, and 812 of title 21, CFR (Reference
p.000002: (d)).
p.000002:
p.000002: DoDI 3216.02, November 8, 2011
p.000002:
p.000002:
p.000002:
p.000002: b. Applicability is not dependent upon the budget activities funding the research, the mission of the DoD organization
p.000002: conducting or supporting the research, the security classification of the research, the location of the research in the
...
Social / gender
Searching for indicator gender:
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p.000008: DoD IRB, receive initial and continuing education and training in compliance with the standards set forth by ASD(R&E)
p.000008: (see paragraph 1.f. of Enclosure 2 for details).
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: Change 1, 10/15/2018 18
p.000009: ENCLOSURE 3
p.000009:
p.000009: DoDI 3216.02, November 8, 2011
p.000009:
p.000009: a. Initial and continuing education and training shall be commensurate with the duties and responsibilities of the DoD
p.000009: personnel.
p.000009:
p.000009: b. All training and education of DoD personnel shall be documented.
p.000009:
p.000009: c. Professional certification in the field of human research protection is encouraged for all DoD personnel involved
p.000009: in review and oversight of research involving human subjects.
p.000009:
p.000009: d. When assessing whether to support or collaborate with a non-DoD institution for research involving human subjects,
p.000009: the DoD Components should evaluate the non-DoD institution’s education and training policies to ensure the personnel
p.000009: are qualified to perform the research. The rigor of the evaluation should be appropriate for the complexity and risk
p.000009: of the research.
p.000009:
p.000009:
p.000009: 6. SELECTION OF HUMAN SUBJECTS AND EVALUATING RISK
p.000009:
p.000009: a. Selection of Human Subjects. The selection of human subjects reflecting gender and minority participation in
p.000009: DoD-conducted or -supported clinical research involving human subjects shall comply with section 252 of Public Law
p.000009: 103-160 (Reference (p)). The Head of the OSD or DoD Component may exercise the waiver authority under this law. This
p.000009: waiver authority may be delegated, as described in the Component’s HRPP management plan, but not to an individual at
p.000009: the level of the institutional HRPP.
p.000009:
p.000009: b. Evaluating Risk. The phrase “ordinarily encountered in daily life or during the performance of routine physical or
p.000009: physiological examinations or tests” in the definition of minimal risk (section 219.102(j)) of Reference (c)) shall not
p.000009: be interpreted to include the inherent risks certain categories of human subjects face in their everyday life. For
p.000009: example, the risks imposed in research involving human subjects focused on a special population should not be evaluated
p.000009: against the inherent risks encountered in their work environment (e.g., emergency responder, pilot, soldier in a combat
p.000009: zone) or having a medical condition (e.g., frequent medical tests or constant pain).
p.000009:
p.000009:
p.000009: 7. ADDITIONAL PROTECTIONS FOR HUMAN SUBJECTS. In addition to the requirements of part 219 of Reference (c),
p.000009: additional safeguards described in this section shall be provided for human subjects in all DoD-conducted research
...
General/Other / Dependent
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p.000002:
p.000002:
p.000002: 2. APPLICABILITY
p.000002:
p.000002: a. This Instruction applies to:
p.000002:
p.000002: (1) OSD, the Military Departments, the Office of the Chairman of the Joint Chiefs of Staff and the Joint Staff, the
p.000002: Combatant Commands, the Office of the Inspector General of the Department of Defense, the Defense Agencies, the DoD
p.000002: Field Activities, and all other organizational entities within the Department of Defense (hereinafter referred to
p.000002: collectively as the “DoD Components”).
p.000002:
p.000002: (2) All DoD-conducted or -supported research involving human subjects as defined in the Glossary. All such activities
p.000002: must include both systematic investigation designed to develop or contribute to generalizable knowledge AND involve a
p.000002: living individual about whom an investigator conducting research obtains data through intervention or interaction with
p.000002: the individual or about whom identifiable private information is obtained. All activities meeting both of these
p.000002: conditions will hereinafter be referred to as “research involving human subjects” in this Instruction.
p.000002:
p.000002: (3) Activities such as research, development, testing, and evaluation (RDT&E) that meet the definition of research
p.000002: involving human subjects (as defined in the Glossary), as well as clinical investigations or medical activities
p.000002: regulated by the Food and Drug Administration (FDA) in parts 50, 56, 312, 600, and 812 of title 21, CFR (Reference
p.000002: (d)).
p.000002:
p.000002: DoDI 3216.02, November 8, 2011
p.000002:
p.000002:
p.000002:
p.000002: b. Applicability is not dependent upon the budget activities funding the research, the mission of the DoD organization
p.000002: conducting or supporting the research, the security classification of the research, the location of the research in the
p.000002: United States or a foreign country, or whether the research is conducted or supported under a program that is not
p.000002: considered research for other purposes.
p.000002:
p.000002:
p.000002: 3. DEFINITIONS. See Glossary.
p.000002:
p.000002:
p.000002: 4. POLICY. It is DoD policy that:
p.000002:
p.000002: a. All research involving human subjects that is conducted or supported by the Department of Defense shall comply with
p.000002: part 219 of Reference (c), which incorporates the ethical principles of respect for persons, beneficence, and justice,
p.000002: as codified in page 23192 of the Federal Register (also known as “The Belmont Report” (Reference (e)).
p.000002:
p.000002: b. Certain categories of human subjects in research are recognized as vulnerable populations, groups, or individuals
p.000002: and are afforded additional protections as specified in section 7 of Enclosure 3 of this Instruction.
p.000002:
p.000002: c. Research involving human subjects for testing of chemical or biological warfare agents is generally prohibited by
p.000002: section 1520a of title 50, United States Code (U.S.C.) (Reference (f)), subject to possible exceptions for research for
p.000002: prophylactic, protective, or other peaceful purposes.
p.000002:
p.000002: d. DoD-appropriated funds shall not be used to support research involving a human being as an experimental subject, as
...
General/Other / Other Country
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p.000002: Combatant Commands, the Office of the Inspector General of the Department of Defense, the Defense Agencies, the DoD
p.000002: Field Activities, and all other organizational entities within the Department of Defense (hereinafter referred to
p.000002: collectively as the “DoD Components”).
p.000002:
p.000002: (2) All DoD-conducted or -supported research involving human subjects as defined in the Glossary. All such activities
p.000002: must include both systematic investigation designed to develop or contribute to generalizable knowledge AND involve a
p.000002: living individual about whom an investigator conducting research obtains data through intervention or interaction with
p.000002: the individual or about whom identifiable private information is obtained. All activities meeting both of these
p.000002: conditions will hereinafter be referred to as “research involving human subjects” in this Instruction.
p.000002:
p.000002: (3) Activities such as research, development, testing, and evaluation (RDT&E) that meet the definition of research
p.000002: involving human subjects (as defined in the Glossary), as well as clinical investigations or medical activities
p.000002: regulated by the Food and Drug Administration (FDA) in parts 50, 56, 312, 600, and 812 of title 21, CFR (Reference
p.000002: (d)).
p.000002:
p.000002: DoDI 3216.02, November 8, 2011
p.000002:
p.000002:
p.000002:
p.000002: b. Applicability is not dependent upon the budget activities funding the research, the mission of the DoD organization
p.000002: conducting or supporting the research, the security classification of the research, the location of the research in the
p.000002: United States or a foreign country, or whether the research is conducted or supported under a program that is not
p.000002: considered research for other purposes.
p.000002:
p.000002:
p.000002: 3. DEFINITIONS. See Glossary.
p.000002:
p.000002:
p.000002: 4. POLICY. It is DoD policy that:
p.000002:
p.000002: a. All research involving human subjects that is conducted or supported by the Department of Defense shall comply with
p.000002: part 219 of Reference (c), which incorporates the ethical principles of respect for persons, beneficence, and justice,
p.000002: as codified in page 23192 of the Federal Register (also known as “The Belmont Report” (Reference (e)).
p.000002:
p.000002: b. Certain categories of human subjects in research are recognized as vulnerable populations, groups, or individuals
p.000002: and are afforded additional protections as specified in section 7 of Enclosure 3 of this Instruction.
p.000002:
p.000002: c. Research involving human subjects for testing of chemical or biological warfare agents is generally prohibited by
p.000002: section 1520a of title 50, United States Code (U.S.C.) (Reference (f)), subject to possible exceptions for research for
p.000002: prophylactic, protective, or other peaceful purposes.
p.000002:
p.000002: d. DoD-appropriated funds shall not be used to support research involving a human being as an experimental subject, as
p.000002: defined in this Instruction, without the prior informed consent of the experimental subject or in accordance with
p.000002: section 980 of title 10, U.S.C. (Reference (g)) and this Instruction (see section 9 of Enclosure 3 of this Instruction
p.000002: for details). The definitions of research involving a human being as an experimental subject and research involving
p.000002: human subjects are different; see the Glossary for an explanation.
p.000002:
p.000002: e. Research involving human subjects covered under this Instruction shall also comply with applicable Federal and
p.000002: State laws and regulations. When the research is conducted outside of the United States, it must also comply with
p.000002: applicable requirements of the foreign country and its national laws and requirements. In the event of an unresolved
p.000002: conflict between this Instruction, including its references, and other applicable laws and requirements such that
p.000002: compliance with both is impossible, the requirements most protective of the human subjects shall be followed. When
p.000002: there is an unresolved conflict, DoD Components shall consult with legal counsel and seek guidance from the Assistant
p.000002: Secretary of Defense for Research and Engineering (ASD(R&E)).
p.000002:
p.000002:
p.000002: 5. RESPONSIBILITIES. See Enclosure 2.
p.000002:
p.000002:
p.000002:
p.000002:
p.000002: Change 1, 10/15/2018 2
p.000003:
p.000003: DoDI 3216.02, November 8, 2011
p.000003: 6. PROCEDURES. See Enclosure 3.
p.000003:
p.000003:
p.000003: 7. RELEASABILITY. UNLIMITED. This Instruction is approved for public release and is available on the Internet from
p.000003: the DoD Issuances Website at http://www.esd.whs.mil/DD/.
p.000003:
p.000003:
p.000003: 8. SUMMARY OF CHANGE 1. This change reassigns the office of primary responsibility for this instruction to the Under
p.000003: Secretary of Defense for Research and Engineering in accordance with the July 13, 2018 Deputy Secretary of Defense
p.000003: Memorandum (Reference (h)).
p.000003:
p.000003:
p.000003: 9. EFFECTIVE DATE. This Instruction is effective upon its publication to the DoD Issuances Website.
p.000003:
p.000003:
p.000003:
p.000003: Frank Kendall
p.000003: Acting Under Secretary of Defense
p.000003: for Acquisition, Technology, and Logistics
p.000003:
p.000003: Enclosures
p.000003: 1. References
p.000003: 2. Responsibilities
p.000003: 3. Procedures Glossary
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
p.000003:
...
p.000008: the principal DoD liaison with organizations outside the Department of Defense on matters pertaining to research
p.000008: involving human subjects.
p.000008:
p.000008: b. Provide guidance and procedures necessary to implement this Instruction. The ASD(R&E) will consult with the
p.000008: Assistant Secretary of Defense for Health Affairs (ASD(HA)) for matters affecting medical research involving human
p.000008: subjects.
p.000008:
p.000008: c. Exercise the authorities of the Head of the Department identified in part 219 of Reference (c), the Secretary as
p.000008: identified in subparts B-D of part 46 of title 45, CFR (Reference (i)) for research described in section 7 of Enclosure
p.000008: 3 of this Instruction, and the Secretary of Defense identified in section 980 of Reference (g).
p.000008:
p.000008: d. Grant exceptions to any procedures or requirements in this Instruction based upon an appropriate justification from
p.000008: the Head of an OSD or DoD Component and consistent with law.
p.000008:
p.000008: e. Establish a process to oversee the DoD Components’ implementation of their respective Component human research
p.000008: protection program (HRPP) management plan and compliance with this Instruction.
p.000008:
p.000008: f. Establish a framework for educational training requirements for DoD personnel in key HRPP roles commensurate with
p.000008: their duties and responsibilities.
p.000008:
p.000008: g. Work with the DoD Components supporting international research involving human subjects to resolve conflicts
p.000008: between this Instruction, including its references, and other applicable foreign laws and requirements.
p.000008:
p.000008: h. Maintain a list of foreign country and international standards that are at least equivalent to those in part 219 of
p.000008: Reference (c).
p.000008:
p.000008: i. Designate DoD representatives to Federal committees, such as the Human Subject Research Subcommittee of the
p.000008: National Science and Technology Council’s Committee on Science or other committees established by the White House.
p.000008:
p.000008: j. Designate a DoD representative to the Secretary’s Advisory Committee on Human Research Protection established by
p.000008: the Secretary of Health and Human Services (HHS) and successor entities established by the Secretary of HHS.
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: Change 1, 10/15/2018 8
p.000009: ENCLOSURE 2
p.000009:
p.000009: DoDI 3216.02, November 8, 2011
p.000009:
p.000009: k. Establish the DoD Coordinating Committee for Human Research Protection Programs (CCHRPP) to act as the central
p.000009: advisory committee to the ASD(R&E) on all matters regarding the ethical involvement of human subjects in research.
p.000009: Membership shall be appointed as described in section 18 of Enclosure 3 of this Instruction.
p.000009:
p.000009:
p.000009: 2. ASD(HA). The ASD(HA), under the authority, direction, and control of the Under Secretary of Defense for Personnel
p.000009: and Readiness (USD(P&R)), shall:
p.000009:
p.000009: a. Advise the ASD(R&E) on matters related to the participation of human subjects in research, especially regarding
p.000009: medical safety, bioethics, and standards of professional health care and conduct.
p.000009:
p.000009: b. Represent the Department of Defense on matters relating to implementation of FDA regulatory requirements in
...
p.000003: Component that includes relevant policies and procedures to ensure compliance with this Instruction.
p.000003:
p.000003:
p.000003: 3. DoD-CONDUCTED RESEARCH INVOLVING HUMAN SUBJECTS
p.000003:
p.000003: a. DoD Institutional Approval and Oversight
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: Change 1, 10/15/2018 13
p.000004: ENCLOSURE 3
p.000004:
p.000004: DoDI 3216.02, November 8, 2011
p.000004:
p.000004: (1) DoD institutions conducting intramural research as defined in the Glossary involving human subjects shall have
p.000004: procedures to ensure appropriate regulatory determinations for activities that constitute research, activities that
p.000004: constitute research involving human subjects, or activities that are research involving human subjects but that meet
p.000004: the exemption criteria in section 219.101(b) of Reference (c). Such procedures shall include the designation,
p.000004: oversight, and appropriate training of DoD personnel.
p.000004:
p.000004: (2) The DoD institution shall have policies and procedures to require scientific review of non-exempt research
p.000004: involving human subjects and to ensure this review is considered during the IRB review process.
p.000004:
p.000004: (3) IRBs may use expedited review procedures under section 219.110(a) of Reference (c) to review minimal risk,
p.000004: non-exempt research involving human subjects using materials (e.g., data, documents, records, or specimens) that have
p.000004: previously been collected for any purpose, provided the materials were not collected for the currently proposed
p.000004: research.
p.000004:
p.000004: (4) When the research is being conducted in a foreign country whose laws and regulations are applicable to that
p.000004: research, the DoD institution shall confirm that all applicable national laws and requirements of the foreign country
p.000004: have been met in addition to the requirements in this Instruction. The IRB shall also consider the cultural
p.000004: sensitivities in the setting where the research will take place.
p.000004:
p.000004: (5) The DoD institution shall have policies and procedures to ensure the research involving human subjects has been
p.000004: approved by all required organizations before human subjects are recruited or any other research activities with human
p.000004: subjects begin. The IRB may approve a research protocol contingent upon its approval by other organizations (e.g.,
p.000004: required reviews can be conducted in parallel).
p.000004:
p.000004: (6) An IRB, in accordance with part 219 of Reference (c), shall approve all non-exempt research involving human
p.000004: subjects before any activities that involve human subjects can begin. An official cannot approve research that has been
p.000004: disapproved by the IRB in accordance with part 219 of Reference (c) (i.e., an IRB disapproval of a protocol cannot be
p.000004: overturned). The IRB must provide oversight of the ongoing research and review such research at intervals appropriate
p.000004: to the degree of risk, but not less than once per year.
p.000004:
p.000004: (7) DoD institutions shall rely on an IRB whose membership meets the requirements in subparagraphs 3.a.(7)(a) through
p.000004: (d). In special circumstances, DoD institutions may rely on a non-Federal IRB if the conditions in subparagraph
p.000004: 3.a.(8) of this section are met.
p.000004:
p.000004: (a) DoD IRBs shall consist of members who are Federal employees; Service members; individuals covered by sections
...
p.000005: (8) DoD institutions engaged in non-exempt research involving human subjects and collaborating with a non-DoD
p.000005: institution may rely on a collaborating non-DoD institution’s IRB if these minimum conditions are met:
p.000005:
p.000005: (a) The DoD Component determines the collaborating non-DoD institution has an appropriate Federal assurance.
p.000005:
p.000005: (b) The involvement of DoD personnel in the conduct of the research involving human subjects is secondary to that of
p.000005: the non-DoD institution.
p.000005:
p.000005: (c) The DoD institution, the non-DoD institution, and the non-DoD institution’s IRB have a written agreement defining
p.000005: the responsibilities and authorities of each organization in complying with the terms of the Federal assurances and
p.000005: this Instruction (i.e., have an Institutional Agreement for IRB Review or similar agreement). The DoD Component shall
p.000005: approve the terms of the agreement prior to the DoD institution’s engagement in the research involving human subjects.
p.000005:
p.000005: (d) The DoD Component must conduct an appropriate administrative review of the research involving human subjects to
p.000005: ensure it is in compliance with DoD policies and procedures prior to the DoD institution’s engagement in the research.
p.000005:
p.000005: b. DoD Component Review and Oversight
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Change 1, 10/15/2018 15
p.000006: ENCLOSURE 3
p.000006:
p.000006: DoDI 3216.02, November 8, 2011
p.000006:
p.000006: (1) At a minimum, the DoD Components must conduct an administrative review and approve all research involving
p.000006: non-exempt human subjects approved by a DoD institution when any of these conditions occur:
p.000006:
p.000006: (a) The research will be conducted in a foreign country unless one of the following conditions apply:
p.000006:
p.000006: 1. The research will be conducted by an established DoD overseas research institution and the research will be
p.000006: conducted in the host country, or
p.000006:
p.000006: 2. The research will be conducted by a DoD overseas institution and will include only DoD personnel or U.S. citizens
p.000006: as human subjects.
p.000006:
p.000006: (b) The research involves a collaboration with a non-DoD institution and the DoD institution is relying on the non-DoD
p.000006: institution’s IRB, which is not composed of Federal employees (i.e., the research is approved by the IRB using the
p.000006: criteria described in subparagraph 3.a.(8)) of this section.
p.000006:
p.000006: (c) The research permits a waiver of informed consent under paragraph (b) of section 980 of Reference (g).
p.000006:
p.000006: (d) The research involves any fetal research covered under sections 289g–289g-2 of Reference (k).
p.000006:
p.000006: (e) The research is required to be approved by either the ASD(R&E) or the Head of the OSD or DoD Component as
p.000006: delegated by the ASD(R&E) (e.g., the requirements in sections 7, 9, or 13 of this enclosure apply).
p.000006:
p.000006: (2) The DoD Component administrative review must be conducted before the research involving human subjects can begin
p.000006: to ensure compliance with all applicable regulations and policies, including any applicable laws and requirements and
p.000006: cultural sensitivities of a foreign country if conducted in a foreign country. This Component review is not intended
p.000006: to be an additional IRB review.
p.000006:
p.000006:
p.000006: 4. RESEARCH INVOLVING HUMAN SUBJECTS CONDUCTED BY A NON-DoD INSTITUTION
p.000006:
p.000006: a. Clause in Contracts and Agreements. The DoD Component must ensure the institution conducting the research
p.000006: involving human subjects is aware of its obligation to comply with the requirements of this Instruction and part 219 of
p.000006: Reference (c).
p.000006:
p.000006: (1) Contracts for DoD-supported research involving human subjects must contain the Defense Federal Acquisition
p.000006: Regulation Supplement (DFARS) clause in accordance with section 252.235-7004 of title 48, CFR (Reference (n)). In
p.000006: addition to identifying contractor requirements and responsibilities, this clause also describes the role of the DoD
p.000006: Human Research
p.000006:
p.000006:
p.000006:
p.000006: Change 1, 10/15/2018 16
p.000007: ENCLOSURE 3
p.000007:
p.000007: DoDI 3216.02, November 8, 2011
p.000007:
p.000007: Protection Official (HRPO). Comparable agreements not subject to section 252.235-7004 of Reference (n) (e.g., grants,
p.000007: assistance agreements, and cooperative research and development agreements) must contain language affirming the
p.000007: responsibilities of the non-DoD institution as required by Parts 22 (Appendix B), 37 (Appendix D), and 219 of Reference
p.000007: (c).
p.000007:
p.000007: (2) The DFARS clause (or similar language) is not required to be included in an agreement with another Federal
...
p.000007: determines either the activity is not research involving
p.000007:
p.000007:
p.000007:
p.000007: Change 1, 10/15/2018 17
p.000008: ENCLOSURE 3
p.000008:
p.000008: DoDI 3216.02, November 8, 2011
p.000008:
p.000008: human subjects or is exempt research involving human subjects, the HRPO must concur with the performing institution’s
p.000008: determination before activity can begin.
p.000008:
p.000008: (2) If the non-DoD institution determines the activity is non-exempt research involving human subjects, the HRPO must
p.000008: perform an administrative review of the research before the activities that involve human subjects can begin (e.g.,
p.000008: human subject recruitment and data collection). Such review and approval shall be based on confirmation that the
p.000008: research and
p.000008: non-DoD institution are in compliance with applicable requirements of this Instruction and Parts 22 (Appendix B), 37
p.000008: (Appendix D), and 219 of Reference (c). At a minimum, the HRPO must:
p.000008:
p.000008: (a) Confirm the non-DoD institution has a Federal assurance appropriate for the research in question (see paragraph
p.000008: 2.a. of this enclosure).
p.000008:
p.000008: (b) Review the research protocol and accept the IRB determination of level of risk and approval of the study for
p.000008: compliance with this Instruction.
p.000008:
p.000008: (c) Review and accept IRB-approved substantive changes to an approved research protocol before they are implemented.
p.000008:
p.000008: (d) Ensure the IRB conducts an appropriate continuing review at least annually.
p.000008:
p.000008: (e) When the research involving human subjects is being conducted in a foreign country, confirm all applicable
p.000008: national laws and requirements of the foreign country have been met and confirm the IRB considered the cultural
p.000008: sensitivities in the setting where the research will take place.
p.000008:
p.000008: (3) Upon receipt of notifications directed in subparagraph 4.b.(4) of this section, the supporting DoD Component shall
p.000008: promptly review the report and determine if further review of any or all the institution’s research involving human
p.000008: subjects that is supported by the DoD Component is warranted. When appropriate, the DoD Component may defer its
p.000008: investigation to an ongoing Federal investigation. The DoD Component shall notify the ASD(R&E) in accordance with
p.000008: paragraph 3.f. of Enclosure 2 and section 16 of this enclosure.
p.000008:
p.000008: (4) DoD Components conducting a for-cause review of research conducted by a non-DoD institution shall evaluate and
p.000008: ensure the adequacy of human protection in
p.000008: DoD-supported programs and provide recommendations to the DoD Component about allowing continued DoD support of
p.000008: research involving human subjects, suspending the research until necessary changes have been made, or terminating the
p.000008: research.
p.000008:
p.000008:
p.000008: 5. EDUCATION AND TRAINING. The DoD Components shall ensure that all DoD personnel involved in the conduct, review, or
p.000008: approval of research involving human subjects, including the non-affiliated and prisoner representative members on the
p.000008: DoD IRB, receive initial and continuing education and training in compliance with the standards set forth by ASD(R&E)
p.000008: (see paragraph 1.f. of Enclosure 2 for details).
p.000008:
p.000008:
p.000008:
p.000008:
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p.000009: are qualified to perform the research. The rigor of the evaluation should be appropriate for the complexity and risk
p.000009: of the research.
p.000009:
p.000009:
p.000009: 6. SELECTION OF HUMAN SUBJECTS AND EVALUATING RISK
p.000009:
p.000009: a. Selection of Human Subjects. The selection of human subjects reflecting gender and minority participation in
p.000009: DoD-conducted or -supported clinical research involving human subjects shall comply with section 252 of Public Law
p.000009: 103-160 (Reference (p)). The Head of the OSD or DoD Component may exercise the waiver authority under this law. This
p.000009: waiver authority may be delegated, as described in the Component’s HRPP management plan, but not to an individual at
p.000009: the level of the institutional HRPP.
p.000009:
p.000009: b. Evaluating Risk. The phrase “ordinarily encountered in daily life or during the performance of routine physical or
p.000009: physiological examinations or tests” in the definition of minimal risk (section 219.102(j)) of Reference (c)) shall not
p.000009: be interpreted to include the inherent risks certain categories of human subjects face in their everyday life. For
p.000009: example, the risks imposed in research involving human subjects focused on a special population should not be evaluated
p.000009: against the inherent risks encountered in their work environment (e.g., emergency responder, pilot, soldier in a combat
p.000009: zone) or having a medical condition (e.g., frequent medical tests or constant pain).
p.000009:
p.000009:
p.000009: 7. ADDITIONAL PROTECTIONS FOR HUMAN SUBJECTS. In addition to the requirements of part 219 of Reference (c),
p.000009: additional safeguards described in this section shall be provided for human subjects in all DoD-conducted research
p.000009: involving human subjects who may be considered vulnerable due to their association with groups or populations
p.000009: specifically defined by Federal regulations in subparts B-D of Reference (i) and this Instruction. Similarly, as
p.000009: provided in Reference (o) or Parts 22 (Appendix B) and 37 (Appendix D) of Reference (c), such additional safeguards
p.000009: shall also be provided in comparable DoD-supported research involving human subjects. For purposes of this
p.000009: Instruction, actions authorizing or requiring any action by an official of HHS about any requirements of subparts B-D
p.000009: of Reference (i) shall be under the authority of the ASD(R&E). Investigators, IRBs, IOs, and DoD Component personnel
p.000009: reviewing research protocols shall consider the need for appropriate similar safeguards for other vulnerable
p.000009: populations, such as: research involving human subjects and investigators in supervisor- subordinate relationships,
p.000009: human subjects with decisional or mental impairments, human
p.000009:
p.000009:
p.000009:
p.000009: Change 1, 10/15/2018 19
p.000010: ENCLOSURE 3
p.000010:
p.000010: DoDI 3216.02, November 8, 2011
p.000010:
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.000002:
p.000002: Department of Defense
p.000002: INSTRUCTION
p.000002:
p.000002: NUMBER 3216.02
p.000002: November 8, 2011
p.000002: Incorporating Change 1, October 15, 2018
p.000002:
p.000002: USD(R&E)
p.000002:
p.000002: SUBJECT: Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research
p.000002:
p.000002: References: See Enclosure 1
p.000002:
p.000002:
p.000002: 1. PURPOSE. This Instruction reissues DoD Directive (DoDD) 3216.02 (Reference (a)) as a DoD Instruction in accordance
p.000002: with the authority in DoDD 5134.01 (Reference (b)) to establish policy and assign responsibilities for the protection
p.000002: of human subjects in DoD-supported programs to implement part 219 of title 32, Code of Federal Regulations (CFR) (also
p.000002: known and hereinafter referred to as “the Common Rule” (Reference (c)).
p.000002:
p.000002:
p.000002: 2. APPLICABILITY
p.000002:
p.000002: a. This Instruction applies to:
p.000002:
p.000002: (1) OSD, the Military Departments, the Office of the Chairman of the Joint Chiefs of Staff and the Joint Staff, the
p.000002: Combatant Commands, the Office of the Inspector General of the Department of Defense, the Defense Agencies, the DoD
p.000002: Field Activities, and all other organizational entities within the Department of Defense (hereinafter referred to
p.000002: collectively as the “DoD Components”).
p.000002:
p.000002: (2) All DoD-conducted or -supported research involving human subjects as defined in the Glossary. All such activities
p.000002: must include both systematic investigation designed to develop or contribute to generalizable knowledge AND involve a
p.000002: living individual about whom an investigator conducting research obtains data through intervention or interaction with
p.000002: the individual or about whom identifiable private information is obtained. All activities meeting both of these
p.000002: conditions will hereinafter be referred to as “research involving human subjects” in this Instruction.
p.000002:
p.000002: (3) Activities such as research, development, testing, and evaluation (RDT&E) that meet the definition of research
...
p.000006: 78-0014
p.000006: 3 Also known as “The Intergovernmental Personnel Act of 1970, as amended”
p.000006:
p.000006: Change 1, 10/15/2018 6
p.000007: ENCLOSURE 1
p.000007:
p.000007: DoDI 3216.02, November 8, 2011
p.000007:
p.000007: (x) DoD Instruction 5025.01, “DoD Directives Program,” October 28, 2007
p.000007: (y) DoD Instruction 6200.02, “Application of Food and Drug Administration (FDA) Rules to Department of Defense Force
p.000007: Health Protection Program,” February 27, 2008
p.000007: (z) DoD Instruction 6025.13, “Medical Quality Assurance (MQA) and Clinical Quality Management in the Military Health
p.000007: System (MHS),” February 17, 2011
p.000007: (aa) DoD Directive 5240.01, “DoD Intelligence Activities,” August 27, 2007
p.000007:
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p.000007:
p.000007:
p.000007:
p.000007: Change 1, 10/15/2018 7
p.000008: ENCLOSURE 1
p.000008:
p.000008: DoDI 3216.02, November 8, 2011
p.000008:
p.000008: ENCLOSURE 2
p.000008:
p.000008: RESPONSIBILITIES
p.000008:
p.000008:
p.000008: 1. ASD(R&E). The ASD(R&E), under the authority, direction, and control of the Under Secretary of Defense for
p.000008: Acquisition, Technology, and Logistics, shall:
p.000008:
p.000008: a. Be the single DoD point of contact for all matters related to DoD compliance with this Instruction and shall act as
p.000008: the principal DoD liaison with organizations outside the Department of Defense on matters pertaining to research
p.000008: involving human subjects.
p.000008:
p.000008: b. Provide guidance and procedures necessary to implement this Instruction. The ASD(R&E) will consult with the
p.000008: Assistant Secretary of Defense for Health Affairs (ASD(HA)) for matters affecting medical research involving human
p.000008: subjects.
p.000008:
p.000008: c. Exercise the authorities of the Head of the Department identified in part 219 of Reference (c), the Secretary as
p.000008: identified in subparts B-D of part 46 of title 45, CFR (Reference (i)) for research described in section 7 of Enclosure
p.000008: 3 of this Instruction, and the Secretary of Defense identified in section 980 of Reference (g).
p.000008:
p.000008: d. Grant exceptions to any procedures or requirements in this Instruction based upon an appropriate justification from
p.000008: the Head of an OSD or DoD Component and consistent with law.
p.000008:
p.000008: e. Establish a process to oversee the DoD Components’ implementation of their respective Component human research
p.000008: protection program (HRPP) management plan and compliance with this Instruction.
p.000008:
p.000008: f. Establish a framework for educational training requirements for DoD personnel in key HRPP roles commensurate with
p.000008: their duties and responsibilities.
p.000008:
p.000008: g. Work with the DoD Components supporting international research involving human subjects to resolve conflicts
p.000008: between this Instruction, including its references, and other applicable foreign laws and requirements.
p.000008:
p.000008: h. Maintain a list of foreign country and international standards that are at least equivalent to those in part 219 of
p.000008: Reference (c).
p.000008:
p.000008: i. Designate DoD representatives to Federal committees, such as the Human Subject Research Subcommittee of the
p.000008: National Science and Technology Council’s Committee on Science or other committees established by the White House.
p.000008:
p.000008: j. Designate a DoD representative to the Secretary’s Advisory Committee on Human Research Protection established by
p.000008: the Secretary of Health and Human Services (HHS) and successor entities established by the Secretary of HHS.
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: Change 1, 10/15/2018 8
p.000009: ENCLOSURE 2
p.000009:
p.000009: DoDI 3216.02, November 8, 2011
p.000009:
p.000009: k. Establish the DoD Coordinating Committee for Human Research Protection Programs (CCHRPP) to act as the central
p.000009: advisory committee to the ASD(R&E) on all matters regarding the ethical involvement of human subjects in research.
p.000009: Membership shall be appointed as described in section 18 of Enclosure 3 of this Instruction.
p.000009:
p.000009:
p.000009: 2. ASD(HA). The ASD(HA), under the authority, direction, and control of the Under Secretary of Defense for Personnel
p.000009: and Readiness (USD(P&R)), shall:
p.000009:
p.000009: a. Advise the ASD(R&E) on matters related to the participation of human subjects in research, especially regarding
p.000009: medical safety, bioethics, and standards of professional health care and conduct.
p.000009:
p.000009: b. Represent the Department of Defense on matters relating to implementation of FDA regulatory requirements in
p.000009: Reference (d) and the Memorandum of Understanding between the FDA and the Department of Defense (Reference (j)).
p.000009:
p.000009:
p.000009: 3. HEADS OF THE OSD AND DoD COMPONENTS. The Heads of the OSD and DoD Components that conduct or support research
p.000009: involving human subjects covered by this Instruction shall:
p.000009:
p.000009: a. Develop, issue, and monitor a Component HRPP management plan (see section 1 of Enclosure 3 of this Instruction for
p.000009: details).
p.000009:
p.000009: b. Establish and oversee DoD Component policies and procedures that ensure compliance with this Instruction and any
p.000009: other supplementing or implementing issuances (see section 1 of Enclosure 3 for details).
p.000009:
p.000009: c. Exercise the authority as outlined in this Instruction.
p.000009:
p.000009: d. Oversee each institutional official’s (IO) (see Glossary) implementation of their organization’s HRPP.
p.000009:
p.000009: e. Provide members to intra- and interagency committees and to the CCHRPP when requested by the ASD(R&E) consistent
p.000009: with section 18 of Enclosure 3.
p.000009:
p.000009: f. Provide in a timely manner to the ASD(R&E) the following:
p.000009:
p.000009: (1) A copy of all reports provided to the appropriate Congressional Committees in accordance with Reference (f) for
p.000009: any research involving human subjects for testing of chemical or biological warfare agents. DoD Components shall also
p.000009: send a copy to the Assistant Secretary of Defense for Nuclear, Chemical, and Biological Defense Programs.
p.000009:
p.000009: (2) Copies of any waivers from requirements that have been granted in accordance with this Instruction.
p.000009:
p.000009:
p.000009:
p.000009: Change 1, 10/15/2018 9
p.000010: ENCLOSURE 2
p.000010:
p.000010: DoDI 3216.02, November 8, 2011
p.000010:
p.000010:
p.000010:
p.000010: (3) Copies of any approved fetal research covered under sections 289g–289g-2 of title 42, U.S.C. (Reference (k)).
p.000010:
p.000010: (4) Copies of any research involving human subjects conducted consistent with section 512 of Public Law 107-347
p.000010: (Reference (l)). DoD Components shall also send a copy to the Office of Management and Budget (OMB), as required by
p.000010: Reference (l) and pages 33362-33377 of Volume 72, Federal Register (Reference (m)).
p.000010:
p.000010: (5) Any allegation of serious or continuing noncompliance related to research involving human subjects that has been
p.000010: substantiated by inquiry or investigation and any subsequent actions taken based on the findings consistent with
p.000010: section 16 of Enclosure 3. The DoD Component may send an initial notification of potential serious or continuing
p.000010: noncompliance to ASD(R&E) based on the gravity or magnitude of the initial allegation.
p.000010:
p.000010: (6) Any notifications to a DoD Component by another Federal agency or by an appropriate State agency or foreign
p.000010: government that an institution of the Component is under investigation for cause or for noncompliance with the
p.000010: applicable laws and regulations, including the Common Rule.
p.000010:
p.000010: (7) Any substantiated unanticipated problems involving risks to human subjects or others (UPIRTSO).
p.000010:
p.000010: g. Maintain all records identified in this Instruction or required by a reference in this Instruction as described in
p.000010: section 15 of Enclosure 3.
p.000010:
p.000010:
p.000010: 4. IOs OF DoD INSTITUTIONS. Each IO, under the authority, direction, and control of the Heads of the OSD and DoD
p.000010: Components shall:
p.000010:
p.000010: a. Establish and maintain an HRPP to ensure the institution’s compliance with this Instruction.
p.000010:
p.000010: b. Provide the resources needed to ensure compliance with this Instruction.
p.000010:
p.000010: c. Establish and maintain a DoD assurance and other appropriate Federal assurances, if the institution is engaged in
p.000010: non-exempt research involving human subjects (see Glossary).
p.000010:
p.000010: d. Evaluate and improve the institution’s HRPP.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000000: Change 1, 10/15/2018 10
p.000001: ENCLOSURE 2
p.000001:
p.000001: DoDI 3216.02, November 8, 2011
p.000001:
p.000001: ENCLOSURE 3
p.000001:
p.000001: PROCEDURES
p.000001:
p.000001:
p.000001: 1. DoD COMPONENT HRPP MANAGEMENT PLAN
p.000001:
p.000001: a. The DoD Component HRPP management plan shall include, by reference, DoD Component policies to implement the
p.000001: procedures set forth in this enclosure and identify the responsible DoD Component office(s) for actions identified in
p.000001: this Instruction. DoD Component policies may be more restrictive than the requirements in this Instruction, but they
p.000001: may not be less restrictive. They may also impose additional requirements needed to implement this Instruction.
p.000001:
p.000001: b. The plan shall identify a single, senior official having the authority and responsibility for implementing the DoD
p.000001: Component HRPP management plan. This authority shall not be delegated lower than the general or flag officer (GO/FO),
p.000001: Senior Executive Service (SES), or equivalent level. All authorities delegated by the Head of the OSD or DoD Component
p.000001: must be identified in the management plan.
p.000001:
p.000001: c. The plan shall reference DoD Component policies and procedures that:
p.000001:
p.000001: (1) Direct each institution within the DoD Component conducting or supporting research involving human subjects to
p.000001: establish an HRPP that is compliant with this Instruction and the DoD Component’s HRPP management plan.
p.000001:
p.000001: (2) Describe DoD Component oversight of each institution’s HRPP.
p.000001:
p.000001: (3) Describe DoD Component administrative review of DoD-conducted and -supported research involving human subjects
p.000001: (see sections 3 and 4 of this enclosure for details).
p.000001:
p.000001: (4) Delineate institutional responsibilities when performing research involving human subjects in collaboration with
p.000001: another DoD Component. These responsibilities shall include establishing written agreements for tasks such as
p.000001: minimizing the number of institutional review boards (IRBs) and DoD Components that review and approve the research
p.000001: (see sections 3 and 4 of this enclosure for details). DoD Component policies and procedures shall include a
p.000001: requirement to justify the duplication of reviews of protocols (for example, IRB and Component Headquarters reviews).
p.000001:
p.000001: (5) Outline education and training for implementation, management, and oversight of this Instruction (see paragraph
p.000001: 1.f. of Enclosure 2 and section 5 of this enclosure for details).
p.000001:
...
p.000009: ENCLOSURE 3
p.000009:
p.000009: DoDI 3216.02, November 8, 2011
p.000009:
p.000009: a. Initial and continuing education and training shall be commensurate with the duties and responsibilities of the DoD
p.000009: personnel.
p.000009:
p.000009: b. All training and education of DoD personnel shall be documented.
p.000009:
p.000009: c. Professional certification in the field of human research protection is encouraged for all DoD personnel involved
p.000009: in review and oversight of research involving human subjects.
p.000009:
p.000009: d. When assessing whether to support or collaborate with a non-DoD institution for research involving human subjects,
p.000009: the DoD Components should evaluate the non-DoD institution’s education and training policies to ensure the personnel
p.000009: are qualified to perform the research. The rigor of the evaluation should be appropriate for the complexity and risk
p.000009: of the research.
p.000009:
p.000009:
p.000009: 6. SELECTION OF HUMAN SUBJECTS AND EVALUATING RISK
p.000009:
p.000009: a. Selection of Human Subjects. The selection of human subjects reflecting gender and minority participation in
p.000009: DoD-conducted or -supported clinical research involving human subjects shall comply with section 252 of Public Law
p.000009: 103-160 (Reference (p)). The Head of the OSD or DoD Component may exercise the waiver authority under this law. This
p.000009: waiver authority may be delegated, as described in the Component’s HRPP management plan, but not to an individual at
p.000009: the level of the institutional HRPP.
p.000009:
p.000009: b. Evaluating Risk. The phrase “ordinarily encountered in daily life or during the performance of routine physical or
p.000009: physiological examinations or tests” in the definition of minimal risk (section 219.102(j)) of Reference (c)) shall not
p.000009: be interpreted to include the inherent risks certain categories of human subjects face in their everyday life. For
p.000009: example, the risks imposed in research involving human subjects focused on a special population should not be evaluated
p.000009: against the inherent risks encountered in their work environment (e.g., emergency responder, pilot, soldier in a combat
p.000009: zone) or having a medical condition (e.g., frequent medical tests or constant pain).
p.000009:
p.000009:
p.000009: 7. ADDITIONAL PROTECTIONS FOR HUMAN SUBJECTS. In addition to the requirements of part 219 of Reference (c),
p.000009: additional safeguards described in this section shall be provided for human subjects in all DoD-conducted research
p.000009: involving human subjects who may be considered vulnerable due to their association with groups or populations
p.000009: specifically defined by Federal regulations in subparts B-D of Reference (i) and this Instruction. Similarly, as
p.000009: provided in Reference (o) or Parts 22 (Appendix B) and 37 (Appendix D) of Reference (c), such additional safeguards
p.000009: shall also be provided in comparable DoD-supported research involving human subjects. For purposes of this
p.000009: Instruction, actions authorizing or requiring any action by an official of HHS about any requirements of subparts B-D
p.000009: of Reference (i) shall be under the authority of the ASD(R&E). Investigators, IRBs, IOs, and DoD Component personnel
p.000009: reviewing research protocols shall consider the need for appropriate similar safeguards for other vulnerable
p.000009: populations, such as: research involving human subjects and investigators in supervisor- subordinate relationships,
p.000009: human subjects with decisional or mental impairments, human
p.000009:
p.000009:
p.000009:
p.000009: Change 1, 10/15/2018 19
p.000010: ENCLOSURE 3
p.000010:
p.000010: DoDI 3216.02, November 8, 2011
p.000010:
p.000010: subjects with a physical disability, or any other kind of human subjects in circumstances that may warrant provision of
p.000010: additional protections. As appropriate, qualified individuals (e.g., research monitors, ombudsmen, advocates) may be
p.000010: appointed to perform oversight functions or assist the human subjects.
p.000010:
p.000010: a. Pregnant Women, Fetuses, and Neonates as Subjects
p.000010:
p.000010: (1) Non-exempt research involving pregnant women, fetuses, or neonates as human subjects must meet the additional
p.000010: relevant protections of subpart B of Reference (i), unless modified by this Instruction. Research involving pregnant
...
p.000004:
p.000004:
p.000004: 8. RESEARCH MONITOR
p.000004:
p.000004: a. For DoD-conducted research involving human subjects determined by the IRB to involve more than minimal risk to
p.000004: human subjects (as defined in section 219.102(i) of Reference (c)), and, to the extent provided pursuant to Parts 22
p.000004: (Appendix B), 37 (Appendix D), and 219 of Reference (c) and Reference (o), comparable DoD-supported research, the IRB
p.000004: shall approve an independent research monitor by name. Additionally, the research monitor may be identified by an
p.000004: investigator or appointed by an IRB or IO for research involving human subjects determined to involve minimal risk.
p.000004: There may be more than one research monitor (e.g., if different skills or experiences are necessary). The monitor may
p.000004: be an ombudsman or a member of the data safety monitoring board.
p.000004:
p.000004: (1) The duties of the research monitor shall be determined on the basis of specific risks or concerns about the
p.000004: research. The research monitor may perform oversight functions (e.g., observe recruitment, enrollment procedures, and
p.000004: the consent process for individuals, groups or units; oversee study interventions and interactions; review monitoring
p.000004: plans and UPIRTSO reports; and oversee data matching, data collection, and analysis) and report their observations and
p.000004: findings to the IRB or a designated official.
p.000004:
p.000004: (2) The research monitor may discuss the research protocol with the investigators, interview human subjects, and
p.000004: consult with others outside of the study about the research. The research monitor shall have authority to stop a
p.000004: research protocol in progress, remove individual human subjects from a research protocol, and take whatever steps are
p.000004: necessary to protect the safety and well-being of human subjects until the IRB can assess the monitor’s report.
p.000004: Research monitors shall have the responsibility to promptly report their observations and findings to the IRB or other
p.000004: designated official.
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Change 1, 10/15/2018 24
p.000005: ENCLOSURE 3
p.000005:
p.000005: DoDI 3216.02, November 8, 2011
p.000005:
p.000005: (3) The IRB must approve a written summary of the monitors’ duties, authorities, and responsibilities. The IRB or
p.000005: HRPP official shall communicate with research monitors to confirm their duties, authorities, and responsibilities.
p.000005:
p.000005: (4) The research monitors shall have expertise consonant with the nature of risk(s) identified within the research
p.000005: protocol, and they shall be independent of the team conducting the research involving human subjects.
p.000005:
p.000005: b. The Heads of the OSD and DoD Components may waive the requirement to have a research monitor on a case-by-case
p.000005: basis when the inclusion of a research monitor is not necessary to provide additional protections for human subjects.
p.000005: This waiver authority may be delegated to a DoD official, as described in the Component’s HRPP management plan, but not
p.000005: at or below the position of the institution’s DoD IO.
p.000005:
p.000005:
p.000005: 9. UNIQUE DoD LIMITATIONS ON WAIVER OF INFORMED CONSENT
p.000005:
p.000005: a. Sections 219.116(c) and (d) of Reference (c) identify conditions where an IRB may waive informed consent for
p.000005: DoD-conducted and DoD-supported research involving human subjects. Section 980 of Reference (g) imposes limitations on
p.000005: waiving informed consent when using DoD appropriated funds. Section 980 of Reference (g) is applicable ONLY to DoD
p.000005: funded research involving a human being as an experimental subject as defined in the Glossary. The definition of
p.000005: research involving a human subject as an experimental subject is not the same as the definition of research involving
p.000005: human subjects. Section 980 of Reference (g) is not applicable to exempt research involving human subjects.
p.000005:
p.000005: b. When the research meets the Glossary definition of research involving a human being as an experimental subject,
p.000005: informed consent must be obtained in advance from the experimental subject or the subject’s legal representative
p.000005: consistent with part 219 of Reference (c) if the subject cannot consent. If consent is to be obtained from the
p.000005: experimental subject’s legal representative, the research must intend to benefit the individual subject. The
p.000005: determination that research is intended to be beneficial to the individual experimental subject must be made by an IRB
p.000005: consistent with part 219 of Reference (c).
p.000005:
p.000005: c. The requirement of paragraph 9.b. of this section may be waived by the ASD(R&E) if all the following conditions are
p.000005: met:
p.000005:
p.000005: (1) The research is necessary to advance the development of a medical product for the Military Services.
p.000005:
p.000005: (2) The research may directly benefit the individual experimental subject.
p.000005:
p.000005: (3) The research is conducted in compliance with all other applicable laws and regulations.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Change 1, 10/15/2018 25
p.000006: ENCLOSURE 3
p.000006:
p.000006: DoDI 3216.02, November 8, 2011
p.000006:
p.000006: d. The ASD(R&E) may delegate the waiver authority described in paragraph 9.c. to the Heads of the OSD and DoD
p.000006: Components if they have appropriate policies and procedures in their management plans. This authority is further
p.000006: delegable only to a DoD Component official who is a Presidential Appointee with Senate Confirmation.
p.000006:
p.000006:
p.000006: 10. PROTECTING HUMAN SUBJECTS FROM MEDICAL EXPENSES IF INJURED
p.000006:
p.000006: a. DoD-Supported Research Involving Human Subjects. All non-exempt research involving human subjects shall, at a
p.000006: minimum, meet the requirement of section 219.116(a)(6) of Reference (c). The Common Rule does not require payment or
p.000006: reimbursement of medical expenses, provision of medical care, or compensation for research-related injuries.
p.000006:
p.000006: b. DoD-Conducted Research Involving Human Subjects. The DoD Components shall establish procedures to protect human
p.000006: subjects from medical expenses (not otherwise provided or reimbursed) that are the direct result of participation in
p.000006: DoD-conducted non-exempt research involving human subjects that involves more than minimal risk. Such procedures may
p.000006: consist of utilizing the Secretarial Designee program as described by section 108.4(i) of Reference (c) during the
p.000006: period of the human subject’s involvement in the research, which may be extended further upon the approval of the
p.000006: USD(P&R). DoD Components may supplement this Secretarial Designee procedure with additional procedures consistent with
p.000006: applicable authority. This requirement does not apply when the Department of Defense is supporting the research but is
p.000006: not engaged in the non-exempt research involving human subjects (i.e., when the non-exempt research involving human
p.000006: subjects is performed solely by non-DoD institutions).
p.000006:
p.000006: c. DoD Collaborative Research Involving Human Subjects
p.000006:
p.000006: (1) When collaborating with a non-DoD institution, the DoD Components shall establish procedures comparable to those
p.000006: required by paragraph 10.b. of this section to protect human subjects from medical expenses (not otherwise provided or
p.000006: reimbursed) that are the direct result of participation in non-exempt research involving human subjects and that are a
p.000006: direct result of research activities performed by DoD personnel. This does not apply to expenses resulting from the
p.000006: injury due to actions performed by the non-DoD institution(s).
p.000006:
p.000006: (2) When DoD personnel are conducting the research involving human subjects at the collaborating institution and the
p.000006: Department of Defense does not have the primary involvement, the DoD Components are not required to have procedures to
p.000006: protect human subjects from medical expenses. For this purpose the determination of primary involvement shall be based
p.000006: on consideration of the type and portion of the DoD involvement in the collaborative research (e.g., research staff,
p.000006: human subjects, facilities, equipment, IRB, and all other assets).
p.000006:
p.000006: (3) When the collaboration is such that it is difficult to separate DoD involvement from that of the non-DoD
p.000006: institution, the Head of the OSD or DoD Component may waive this requirement to have procedures to protect human
p.000006: subjects from medical expenses. This waiver authority may be delegated, as described in the Component’s HRPP
p.000006: management plan, but not at or below the position of the institution’s DoD IO.
p.000006:
p.000006:
p.000006:
p.000006: Change 1, 10/15/2018 26
p.000007: ENCLOSURE 3
p.000007:
p.000007: DoDI 3216.02, November 8, 2011
p.000007:
p.000007:
p.000007:
p.000007:
p.000007: 11. COMPENSATION TO HUMAN SUBJECTS FOR PARTICIPATION IN RESEARCH
p.000007:
p.000007: a. DoD-Conducted Research Involving Human Subjects
p.000007:
p.000007: (1) When the Human Subjects Are On-Duty Federal Personnel
p.000007:
p.000007: (a) Federal personnel (civil servants or Service members) participating as human subjects in DoD-conducted research
p.000007: while on duty (i.e., not on leave and participating during their duty hours) may be compensated up to $50 for each
p.000007: blood draw if the research meets the purpose of section 30 of title 24, U.S.C. (Reference (r)). Payment for blood
p.000007: draws may come directly from a Federal or non-Federal source. By permitting compensation for blood draws, Reference
p.000007: (r) provides an exception to section 5536 of Reference (n), which prohibits Federal personnel from being paid by any
p.000007: source other than their regular Federal salaries while they are on duty.
p.000007:
p.000007: (b) Federal personnel participating as human subjects in DoD-conducted research while on duty may only be compensated
p.000007: for blood draws as described in this paragraph and may not be otherwise compensated for general research participation.
p.000007:
p.000007: (2) When the Human Subjects Are Off-Duty Federal Personnel
p.000007:
p.000007: (a) Federal personnel (civil servants or Service members) participating as human subjects in DoD-conducted research
...
p.000010: ENCLOSURE 3
p.000010:
p.000010: DoDI 3216.02, November 8, 2011
p.000010:
p.000010: (2) At least one non-affiliated member shall be a non-Federal employee (other than as an individual appointed as an
p.000010: expert or consultant in accordance with section 3109 of Reference (n) for purposes of service on the IRB).
p.000010:
p.000010: (3) Any IRB member who disagrees with a majority decision approving a project may appeal the decision to the Secretary
p.000010: of Defense. The appeal shall be included in the DoD Component’s submission to the Secretary of Defense.
p.000010:
p.000010: (4) The IRB shall determine whether potential human subjects need access to classified information to make a valid,
p.000010: informed consent decision.
p.000010:
p.000010: e. Disclosure or use of classified information must comply with the requirements of Reference (s) for access to and
p.000010: protection of classified information.
p.000010:
p.000010:
p.000010: 14. ADDITIONAL PROTECTIONS FOR CONFIDENTIALITY. This section outlines certain authorities that the DoD Components may
p.000010: consider using, subject to applicable requirements, for particular sensitive research activities when additional
p.000010: protections for confidentiality would improve participation and results.
p.000010:
p.000010: a. Confidential Information Protection and Statistical Efficiency Act (CIPSEA) for Non- Statistical Agencies. Any DoD
p.000010: Component may use the authority pursuant to sections 501-513 of Reference (l) to assure that data or information
p.000010: acquired by the DoD Component under a pledge of confidentiality for exclusively statistical purposes shall be used
p.000010: exclusively for statistical purposes and may not be disclosed in identifiable form for any other purpose, except with
p.000010: the informed consent of the respondent. Use of this authority is subject to the requirements of sections 512 and
p.000010: 523-525 of Reference (l) and of Reference (m), including that the research involving human subjects is conducted by a
p.000010: DoD Component or other Federal agency and not by a contractor, grantee, or other non-Federal entity, and that use of
p.000010: the authority is reported annually to OMB by the DoD Component.
p.000010:
p.000010: b. CIPSEA for Statistical Agencies. Any DoD Component or unit thereof designated a statistical agency by the OMB
p.000010: pursuant to section 522 of Reference (l) and Reference (m) may designate agents (e.g., contractor, grantee, or other
p.000010: non-Federal entity under a qualifying agreement) that may assure that data or information acquired for the Component
p.000010: under a pledge of confidentiality for exclusively statistical purposes shall be used exclusively for statistical
p.000010: purposes, and may not be disclosed in identifiable form for any other purpose, except with the informed consent of the
p.000010: respondent. Use of this authority is subject to the requirements of sections 512 and 523-525 of Reference (l) and of
p.000010: Reference (m).
p.000010:
p.000010: c. Certificate of Confidentiality. A DoD Component or a contractor, grantee, or other non- Federal entity conducting
p.000010: DoD-supported research involving human subjects may request from the National Institutes of Health (NIH) of the
p.000010: Department of HHS a Certificate of Confidentiality pursuant to section 241(d) of Reference (k). Such a Certificate of
p.000010: Confidentiality authorizes persons engaged in biomedical, behavioral, clinical, or other research related to mission
p.000010: areas of the NIH to protect the privacy of human subjects of sensitive research against compulsory disclosure in any
p.000010: Federal, State, or local judicial, administrative, or legislative proceeding to
p.000010:
p.000010:
p.000000: Change 1, 10/15/2018 30
p.000001: ENCLOSURE 3
p.000001:
p.000001: DoDI 3216.02, November 8, 2011
p.000001:
p.000001: identify human subjects. Issuance of any Certificate of Confidentiality is at NIH’s discretion and is subject to the
p.000001: requirement of section 241(d) of Reference (k) and any other NIH guidelines.
p.000001:
p.000001:
p.000001: 15. RECORD KEEPING
p.000001:
p.000001: a. Part 219 of Reference (c) requires all institutions engaged in DoD-conducted or
p.000001: -supported research involving human subjects to retain records for at least 3 years after the completion of the
p.000001: research. Research involving human subjects may be covered by other Federal regulations that impose longer record
p.000001: keeping requirements. The DoD Components may rely on the non-DoD institutions to keep the required records that were
...
p.000004: in research. The Department of Defense’s implementation of the Common Rule is part 219 of Reference (c); the
p.000004: Department of HHS’s implementation of the Common Rule is subpart A of Reference (i).
p.000004:
p.000004: detainee. Defined in Reference (q).
p.000004:
p.000004: DoD-conducted research involving human subjects. Research involving human subjects that is performed by DoD personnel.
p.000004: Intramural research is one type of DoD-conducted research involving human subjects. See “engaged in research
p.000004: involving human subjects.”
p.000004:
p.000004: DoD personnel. DoD civilian employees and members of the military services.
p.000004:
p.000004: DoD civilian employee. An individual meeting the definition of “employee” consistent with section 2105 of Reference
p.000004: (n). It includes employees of DoD Non-Appropriated Fund Instrumentalities; DoD civilian employees filling full-time,
p.000004: part-time, intermittent, or on-call positions; and individuals serving under personal services contracts consistent
p.000004: with section 2.101 of Reference (o). It excludes employees of contractors (other than personal services contractors)
p.000004: and foreign nationals of host countries.
p.000004:
p.000004: Service members. Individuals appointed, enlisted, or inducted for military service under the authority of the
p.000004: Department of Defense. The Military Services are the Army, the Navy, the Air Force, the Marine Corps, the Coast Guard,
p.000004: and the Reserve Components, which includes the Army and the Air National Guards of the United States. Members of the
p.000004: Reserve Components are included when in a duty status.
p.000004:
p.000004:
p.000004:
p.000004:
p.000004:
p.000004: Change 1, 10/15/2018 34
p.000005: GLOSSARY
p.000005:
p.000005: DoDI 3216.02, November 8, 2011
p.000005:
p.000005: DoD-supported research involving human subjects. Research involving human subjects for which the Department of Defense
p.000005: is providing at least some of the resources (see “research involving human subjects”). Resources may include but are
p.000005: not limited to funding, facilities, equipment, personnel (investigators or other personnel performing tasks identified
p.000005: in the research protocol), access to or information about DoD personnel for recruitment, or identifiable data or
p.000005: specimens from living individuals. It includes both DoD-conducted research involving human subjects (intramural
p.000005: research) and research conducted by a non-DoD institution.
p.000005:
p.000005: engaged in research involving human subjects. An institution is engaged in research involving human subjects when its
p.000005: personnel are conducting activities covered by section 219.101(a) of Reference (c) and this Instruction. An
p.000005: institution that is funding, providing equipment, providing access to or information about potential human subjects
...
General/Other / belmont
Searching for indicator belmont:
(return to top)
p.000002: the individual or about whom identifiable private information is obtained. All activities meeting both of these
p.000002: conditions will hereinafter be referred to as “research involving human subjects” in this Instruction.
p.000002:
p.000002: (3) Activities such as research, development, testing, and evaluation (RDT&E) that meet the definition of research
p.000002: involving human subjects (as defined in the Glossary), as well as clinical investigations or medical activities
p.000002: regulated by the Food and Drug Administration (FDA) in parts 50, 56, 312, 600, and 812 of title 21, CFR (Reference
p.000002: (d)).
p.000002:
p.000002: DoDI 3216.02, November 8, 2011
p.000002:
p.000002:
p.000002:
p.000002: b. Applicability is not dependent upon the budget activities funding the research, the mission of the DoD organization
p.000002: conducting or supporting the research, the security classification of the research, the location of the research in the
p.000002: United States or a foreign country, or whether the research is conducted or supported under a program that is not
p.000002: considered research for other purposes.
p.000002:
p.000002:
p.000002: 3. DEFINITIONS. See Glossary.
p.000002:
p.000002:
p.000002: 4. POLICY. It is DoD policy that:
p.000002:
p.000002: a. All research involving human subjects that is conducted or supported by the Department of Defense shall comply with
p.000002: part 219 of Reference (c), which incorporates the ethical principles of respect for persons, beneficence, and justice,
p.000002: as codified in page 23192 of the Federal Register (also known as “The Belmont Report” (Reference (e)).
p.000002:
p.000002: b. Certain categories of human subjects in research are recognized as vulnerable populations, groups, or individuals
p.000002: and are afforded additional protections as specified in section 7 of Enclosure 3 of this Instruction.
p.000002:
p.000002: c. Research involving human subjects for testing of chemical or biological warfare agents is generally prohibited by
p.000002: section 1520a of title 50, United States Code (U.S.C.) (Reference (f)), subject to possible exceptions for research for
p.000002: prophylactic, protective, or other peaceful purposes.
p.000002:
p.000002: d. DoD-appropriated funds shall not be used to support research involving a human being as an experimental subject, as
p.000002: defined in this Instruction, without the prior informed consent of the experimental subject or in accordance with
p.000002: section 980 of title 10, U.S.C. (Reference (g)) and this Instruction (see section 9 of Enclosure 3 of this Instruction
p.000002: for details). The definitions of research involving a human being as an experimental subject and research involving
p.000002: human subjects are different; see the Glossary for an explanation.
p.000002:
p.000002: e. Research involving human subjects covered under this Instruction shall also comply with applicable Federal and
p.000002: State laws and regulations. When the research is conducted outside of the United States, it must also comply with
p.000002: applicable requirements of the foreign country and its national laws and requirements. In the event of an unresolved
p.000002: conflict between this Instruction, including its references, and other applicable laws and requirements such that
...
p.000005: 30
p.000005: Certificates for Confidentiality
p.000005: 30
p.000005: RECORD KEEPING
p.000005: 31
p.000005: NONCOMPLIANCE WITH THIS INSTRUCTION 31
p.000005: APPLICABILITY TO OTHER REQUIREMENTS 31
p.000005: CCHRPP MEMBERSHIP
p.000005: 32
p.000005: GLOSSARY
p.000005: 33
p.000005: PART I. ABBREVIATIONS AND ACRONYMS 33
p.000005: PART II. DEFINITIONS
p.000005: 33
p.000005:
p.000005:
p.000005:
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p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Change 1, 10/15/2018 5
p.000006: CONTENTS
p.000006:
p.000006: DoDI 3216.02, November 8, 2011
p.000006:
p.000006: ENCLOSURE 1
p.000006:
p.000006: REFERENCES
p.000006:
p.000006:
p.000006: (a) DoD Directive 3216.02, “Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported
p.000006: Research,” March 25, 2002 (hereby cancelled)
p.000006: (b) DoD Directive 5134.01, “Under Secretary of Defense for Acquisition, Technology and Logistics (USD(AT&L)),”
p.000006: December 9, 2005
p.000006: (c) Parts 22 (Appendix B), 37 (Appendix D), 108 and 2191 of title 32, Code of Federal Regulations
p.000006: (d) Parts 50, 56, 312, 600, and 812 of title 21, Code of Federal Regulations
p.000006: (e) Page 23192 of Volume 44, Federal Register, April 18, 1979 (also known as “The Belmont Report”) 2
p.000006: (f) Section 1520a of title 50, United States Code
p.000006: (g) Sections 139(a)(2)(A), 980, 1074f , and 1102 of title 10, United States Code
p.000006: (h) Deputy Secretary of Defense Memorandum, “Establishment of the Office of the Under Secretary of Defense for
p.000006: Research and Engineering and the Office of the Under Secretary of Defense for Acquisition and Sustainment,” July 13,
p.000006: 2018
p.000006: (i) Part 46, subparts A-D of title 45, Code of Federal Regulations
p.000006: (j) Memorandum of Understanding between the Food and Drug Administration and the Department of Defense, “Concerning
p.000006: Investigational Use of Drugs, Antibiotics, Biologics, and Medical Devices by the Department of Defense,” May 21, 1987
p.000006: (k) Sections 241(d) and 289g–289g-2 of title 42, United States Code
p.000006: (l) Public Law 107-347, “Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA),”
p.000006: December 17, 2002
p.000006: (m) Pages 33362-33377 of Volume 72, Federal Register, June 15, 2007
p.000006: (n) Sections 2105, 3109, 3371-3376,3 and 5536 of title 5, United States Code
p.000006: (o) Sections 2.101 and 252.235-7004 of title 48, Code of Federal Regulations
p.000006: (p) Section 252 of Public Law 103-160, “National Defense Authorization Act for Fiscal Year 1994,” November 30, 1993
p.000006: (q) DoD Directive 2310.01E, “The Department of Defense Detainee Program,” September 5, 2006
p.000006: (r) Section 30 of title 24, United States Code
p.000006: (s) Executive Order 13526, “Classified National Security Information,” December 29, 2009
p.000006: (t) DoD 6025.18-R, “DoD Health Information Privacy,” January 24, 2003
p.000006: (u) Executive Order 12333, “United States Intelligence Activities,” as amended, August 18, 2010
p.000006: (v) DoD 5400.11-R, “Department of Defense Privacy Program,” May 14, 2007
p.000006: (w) DoDI 6000.08, “Funding and Administration of Clinical Investigation Programs,” December 3, 2007
p.000006:
p.000006:
p.000006: 1Also known as “the Common Rule”
p.000006: 2 Available on the Internet at http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm. The Belmont Report’s
p.000006: 2-volume appendix is available from the Government Printing Office as DHEW Publication Nos. (OS) 78- 0013 and (OS)
p.000006: 78-0014
p.000006: 3 Also known as “The Intergovernmental Personnel Act of 1970, as amended”
p.000006:
p.000006: Change 1, 10/15/2018 6
p.000007: ENCLOSURE 1
p.000007:
p.000007: DoDI 3216.02, November 8, 2011
p.000007:
p.000007: (x) DoD Instruction 5025.01, “DoD Directives Program,” October 28, 2007
p.000007: (y) DoD Instruction 6200.02, “Application of Food and Drug Administration (FDA) Rules to Department of Defense Force
p.000007: Health Protection Program,” February 27, 2008
p.000007: (z) DoD Instruction 6025.13, “Medical Quality Assurance (MQA) and Clinical Quality Management in the Military Health
p.000007: System (MHS),” February 17, 2011
p.000007: (aa) DoD Directive 5240.01, “DoD Intelligence Activities,” August 27, 2007
p.000007:
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p.000007:
p.000007: Change 1, 10/15/2018 7
p.000008: ENCLOSURE 1
p.000008:
p.000008: DoDI 3216.02, November 8, 2011
p.000008:
p.000008: ENCLOSURE 2
p.000008:
p.000008: RESPONSIBILITIES
...
General/Other / common rule
Searching for indicator commonXrule:
(return to top)
p.000002:
p.000002: Department of Defense
p.000002: INSTRUCTION
p.000002:
p.000002: NUMBER 3216.02
p.000002: November 8, 2011
p.000002: Incorporating Change 1, October 15, 2018
p.000002:
p.000002: USD(R&E)
p.000002:
p.000002: SUBJECT: Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research
p.000002:
p.000002: References: See Enclosure 1
p.000002:
p.000002:
p.000002: 1. PURPOSE. This Instruction reissues DoD Directive (DoDD) 3216.02 (Reference (a)) as a DoD Instruction in accordance
p.000002: with the authority in DoDD 5134.01 (Reference (b)) to establish policy and assign responsibilities for the protection
p.000002: of human subjects in DoD-supported programs to implement part 219 of title 32, Code of Federal Regulations (CFR) (also
p.000002: known and hereinafter referred to as “the Common Rule” (Reference (c)).
p.000002:
p.000002:
p.000002: 2. APPLICABILITY
p.000002:
p.000002: a. This Instruction applies to:
p.000002:
p.000002: (1) OSD, the Military Departments, the Office of the Chairman of the Joint Chiefs of Staff and the Joint Staff, the
p.000002: Combatant Commands, the Office of the Inspector General of the Department of Defense, the Defense Agencies, the DoD
p.000002: Field Activities, and all other organizational entities within the Department of Defense (hereinafter referred to
p.000002: collectively as the “DoD Components”).
p.000002:
p.000002: (2) All DoD-conducted or -supported research involving human subjects as defined in the Glossary. All such activities
p.000002: must include both systematic investigation designed to develop or contribute to generalizable knowledge AND involve a
p.000002: living individual about whom an investigator conducting research obtains data through intervention or interaction with
p.000002: the individual or about whom identifiable private information is obtained. All activities meeting both of these
p.000002: conditions will hereinafter be referred to as “research involving human subjects” in this Instruction.
p.000002:
p.000002: (3) Activities such as research, development, testing, and evaluation (RDT&E) that meet the definition of research
p.000002: involving human subjects (as defined in the Glossary), as well as clinical investigations or medical activities
p.000002: regulated by the Food and Drug Administration (FDA) in parts 50, 56, 312, 600, and 812 of title 21, CFR (Reference
p.000002: (d)).
p.000002:
p.000002: DoDI 3216.02, November 8, 2011
p.000002:
p.000002:
p.000002:
...
p.000006: 2018
p.000006: (i) Part 46, subparts A-D of title 45, Code of Federal Regulations
p.000006: (j) Memorandum of Understanding between the Food and Drug Administration and the Department of Defense, “Concerning
p.000006: Investigational Use of Drugs, Antibiotics, Biologics, and Medical Devices by the Department of Defense,” May 21, 1987
p.000006: (k) Sections 241(d) and 289g–289g-2 of title 42, United States Code
p.000006: (l) Public Law 107-347, “Confidential Information Protection and Statistical Efficiency Act of 2002 (CIPSEA),”
p.000006: December 17, 2002
p.000006: (m) Pages 33362-33377 of Volume 72, Federal Register, June 15, 2007
p.000006: (n) Sections 2105, 3109, 3371-3376,3 and 5536 of title 5, United States Code
p.000006: (o) Sections 2.101 and 252.235-7004 of title 48, Code of Federal Regulations
p.000006: (p) Section 252 of Public Law 103-160, “National Defense Authorization Act for Fiscal Year 1994,” November 30, 1993
p.000006: (q) DoD Directive 2310.01E, “The Department of Defense Detainee Program,” September 5, 2006
p.000006: (r) Section 30 of title 24, United States Code
p.000006: (s) Executive Order 13526, “Classified National Security Information,” December 29, 2009
p.000006: (t) DoD 6025.18-R, “DoD Health Information Privacy,” January 24, 2003
p.000006: (u) Executive Order 12333, “United States Intelligence Activities,” as amended, August 18, 2010
p.000006: (v) DoD 5400.11-R, “Department of Defense Privacy Program,” May 14, 2007
p.000006: (w) DoDI 6000.08, “Funding and Administration of Clinical Investigation Programs,” December 3, 2007
p.000006:
p.000006:
p.000006: 1Also known as “the Common Rule”
p.000006: 2 Available on the Internet at http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm. The Belmont Report’s
p.000006: 2-volume appendix is available from the Government Printing Office as DHEW Publication Nos. (OS) 78- 0013 and (OS)
p.000006: 78-0014
p.000006: 3 Also known as “The Intergovernmental Personnel Act of 1970, as amended”
p.000006:
p.000006: Change 1, 10/15/2018 6
p.000007: ENCLOSURE 1
p.000007:
p.000007: DoDI 3216.02, November 8, 2011
p.000007:
p.000007: (x) DoD Instruction 5025.01, “DoD Directives Program,” October 28, 2007
p.000007: (y) DoD Instruction 6200.02, “Application of Food and Drug Administration (FDA) Rules to Department of Defense Force
p.000007: Health Protection Program,” February 27, 2008
p.000007: (z) DoD Instruction 6025.13, “Medical Quality Assurance (MQA) and Clinical Quality Management in the Military Health
p.000007: System (MHS),” February 17, 2011
p.000007: (aa) DoD Directive 5240.01, “DoD Intelligence Activities,” August 27, 2007
p.000007:
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...
p.000009: any research involving human subjects for testing of chemical or biological warfare agents. DoD Components shall also
p.000009: send a copy to the Assistant Secretary of Defense for Nuclear, Chemical, and Biological Defense Programs.
p.000009:
p.000009: (2) Copies of any waivers from requirements that have been granted in accordance with this Instruction.
p.000009:
p.000009:
p.000009:
p.000009: Change 1, 10/15/2018 9
p.000010: ENCLOSURE 2
p.000010:
p.000010: DoDI 3216.02, November 8, 2011
p.000010:
p.000010:
p.000010:
p.000010: (3) Copies of any approved fetal research covered under sections 289g–289g-2 of title 42, U.S.C. (Reference (k)).
p.000010:
p.000010: (4) Copies of any research involving human subjects conducted consistent with section 512 of Public Law 107-347
p.000010: (Reference (l)). DoD Components shall also send a copy to the Office of Management and Budget (OMB), as required by
p.000010: Reference (l) and pages 33362-33377 of Volume 72, Federal Register (Reference (m)).
p.000010:
p.000010: (5) Any allegation of serious or continuing noncompliance related to research involving human subjects that has been
p.000010: substantiated by inquiry or investigation and any subsequent actions taken based on the findings consistent with
p.000010: section 16 of Enclosure 3. The DoD Component may send an initial notification of potential serious or continuing
p.000010: noncompliance to ASD(R&E) based on the gravity or magnitude of the initial allegation.
p.000010:
p.000010: (6) Any notifications to a DoD Component by another Federal agency or by an appropriate State agency or foreign
p.000010: government that an institution of the Component is under investigation for cause or for noncompliance with the
p.000010: applicable laws and regulations, including the Common Rule.
p.000010:
p.000010: (7) Any substantiated unanticipated problems involving risks to human subjects or others (UPIRTSO).
p.000010:
p.000010: g. Maintain all records identified in this Instruction or required by a reference in this Instruction as described in
p.000010: section 15 of Enclosure 3.
p.000010:
p.000010:
p.000010: 4. IOs OF DoD INSTITUTIONS. Each IO, under the authority, direction, and control of the Heads of the OSD and DoD
p.000010: Components shall:
p.000010:
p.000010: a. Establish and maintain an HRPP to ensure the institution’s compliance with this Instruction.
p.000010:
p.000010: b. Provide the resources needed to ensure compliance with this Instruction.
p.000010:
p.000010: c. Establish and maintain a DoD assurance and other appropriate Federal assurances, if the institution is engaged in
p.000010: non-exempt research involving human subjects (see Glossary).
p.000010:
p.000010: d. Evaluate and improve the institution’s HRPP.
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000010:
p.000000: Change 1, 10/15/2018 10
p.000001: ENCLOSURE 2
p.000001:
p.000001: DoDI 3216.02, November 8, 2011
p.000001:
p.000001: ENCLOSURE 3
p.000001:
p.000001: PROCEDURES
p.000001:
p.000001:
p.000001: 1. DoD COMPONENT HRPP MANAGEMENT PLAN
p.000001:
p.000001: a. The DoD Component HRPP management plan shall include, by reference, DoD Component policies to implement the
p.000001: procedures set forth in this enclosure and identify the responsible DoD Component office(s) for actions identified in
p.000001: this Instruction. DoD Component policies may be more restrictive than the requirements in this Instruction, but they
...
p.000006: to be an additional IRB review.
p.000006:
p.000006:
p.000006: 4. RESEARCH INVOLVING HUMAN SUBJECTS CONDUCTED BY A NON-DoD INSTITUTION
p.000006:
p.000006: a. Clause in Contracts and Agreements. The DoD Component must ensure the institution conducting the research
p.000006: involving human subjects is aware of its obligation to comply with the requirements of this Instruction and part 219 of
p.000006: Reference (c).
p.000006:
p.000006: (1) Contracts for DoD-supported research involving human subjects must contain the Defense Federal Acquisition
p.000006: Regulation Supplement (DFARS) clause in accordance with section 252.235-7004 of title 48, CFR (Reference (n)). In
p.000006: addition to identifying contractor requirements and responsibilities, this clause also describes the role of the DoD
p.000006: Human Research
p.000006:
p.000006:
p.000006:
p.000006: Change 1, 10/15/2018 16
p.000007: ENCLOSURE 3
p.000007:
p.000007: DoDI 3216.02, November 8, 2011
p.000007:
p.000007: Protection Official (HRPO). Comparable agreements not subject to section 252.235-7004 of Reference (n) (e.g., grants,
p.000007: assistance agreements, and cooperative research and development agreements) must contain language affirming the
p.000007: responsibilities of the non-DoD institution as required by Parts 22 (Appendix B), 37 (Appendix D), and 219 of Reference
p.000007: (c).
p.000007:
p.000007: (2) The DFARS clause (or similar language) is not required to be included in an agreement with another Federal
p.000007: department or agency that has adopted the Common Rule. Approval by the HRPO is not required. The Federal department or
p.000007: agency may apply its own HRPP requirements in lieu of this Instruction. However, the Federal department or agency must
p.000007: comply with the requirements in sections 7, 9, 13, and 17 of this enclosure and the requirements of Reference (f).
p.000007:
p.000007: b. Non-DoD Institutional Responsibilities
p.000007:
p.000007: (1) The non-DoD institution shall comply with the terms of the DFARS clause or comparable language used in the
p.000007: agreement with the DoD Component supporting the research involving human subjects, as provided in subparagraph 4.a.(1)
p.000007: of this section.
p.000007:
p.000007: (2) When a non-DoD institution is conducting non-exempt research involving human subjects, the IRB review must
p.000007: consider the scientific merit of the research, as required by section
p.000007: 219.111 of Reference (c). The IRB may rely on outside experts to provide an evaluation of the scientific merit.
p.000007:
p.000007: (3) IRBs may use expedited review procedures under section 219.110(a) of Reference (c) to review minimal risk,
p.000007: non-exempt research involving human subjects using materials (e.g., data, documents, records, or specimens) that have
p.000007: previously been collected for any purpose, provided the materials were not collected for the currently proposed
p.000007: research.
p.000007:
p.000007: (4) To the extent provided in section 219.103 of Reference (c), the non DoD-institution shall promptly notify the HRPO
p.000007: of the following: when significant changes to the research protocol are approved by the IRB, the results of the IRB
p.000007: continuing review, if the IRB used to review and approve the research changes to a different IRB, when the institution
...
p.000005: determination that research is intended to be beneficial to the individual experimental subject must be made by an IRB
p.000005: consistent with part 219 of Reference (c).
p.000005:
p.000005: c. The requirement of paragraph 9.b. of this section may be waived by the ASD(R&E) if all the following conditions are
p.000005: met:
p.000005:
p.000005: (1) The research is necessary to advance the development of a medical product for the Military Services.
p.000005:
p.000005: (2) The research may directly benefit the individual experimental subject.
p.000005:
p.000005: (3) The research is conducted in compliance with all other applicable laws and regulations.
p.000005:
p.000005:
p.000005:
p.000005:
p.000005:
p.000005: Change 1, 10/15/2018 25
p.000006: ENCLOSURE 3
p.000006:
p.000006: DoDI 3216.02, November 8, 2011
p.000006:
p.000006: d. The ASD(R&E) may delegate the waiver authority described in paragraph 9.c. to the Heads of the OSD and DoD
p.000006: Components if they have appropriate policies and procedures in their management plans. This authority is further
p.000006: delegable only to a DoD Component official who is a Presidential Appointee with Senate Confirmation.
p.000006:
p.000006:
p.000006: 10. PROTECTING HUMAN SUBJECTS FROM MEDICAL EXPENSES IF INJURED
p.000006:
p.000006: a. DoD-Supported Research Involving Human Subjects. All non-exempt research involving human subjects shall, at a
p.000006: minimum, meet the requirement of section 219.116(a)(6) of Reference (c). The Common Rule does not require payment or
p.000006: reimbursement of medical expenses, provision of medical care, or compensation for research-related injuries.
p.000006:
p.000006: b. DoD-Conducted Research Involving Human Subjects. The DoD Components shall establish procedures to protect human
p.000006: subjects from medical expenses (not otherwise provided or reimbursed) that are the direct result of participation in
p.000006: DoD-conducted non-exempt research involving human subjects that involves more than minimal risk. Such procedures may
p.000006: consist of utilizing the Secretarial Designee program as described by section 108.4(i) of Reference (c) during the
p.000006: period of the human subject’s involvement in the research, which may be extended further upon the approval of the
p.000006: USD(P&R). DoD Components may supplement this Secretarial Designee procedure with additional procedures consistent with
p.000006: applicable authority. This requirement does not apply when the Department of Defense is supporting the research but is
p.000006: not engaged in the non-exempt research involving human subjects (i.e., when the non-exempt research involving human
p.000006: subjects is performed solely by non-DoD institutions).
p.000006:
p.000006: c. DoD Collaborative Research Involving Human Subjects
p.000006:
p.000006: (1) When collaborating with a non-DoD institution, the DoD Components shall establish procedures comparable to those
p.000006: required by paragraph 10.b. of this section to protect human subjects from medical expenses (not otherwise provided or
p.000006: reimbursed) that are the direct result of participation in non-exempt research involving human subjects and that are a
...
p.000003:
p.000003:
p.000003: PART II. DEFINITIONS
p.000003:
p.000003: Unless otherwise noted, these terms and their definitions are for the purpose of this Instruction.
p.000003:
p.000003:
p.000003:
p.000003:
p.000003: Change 1, 10/15/2018 33
p.000004: GLOSSARY
p.000004:
p.000004: DoDI 3216.02, November 8, 2011
p.000004:
p.000004:
p.000004:
p.000004: administrative review. A review of a research protocol and supporting documents (e.g., safety review, scientific
p.000004: review, IRB minutes) related to DoD-supported research involving human subjects which ensures the institution engaged
p.000004: in the research involving human subjects has met the requirements of all applicable regulations and policies. This
p.000004: review is NOT an IRB review.
p.000004:
p.000004: classified research involving human subjects. Research involving human subjects where the protocol or other
p.000004: information required by the IRB for review and oversight or required or provided by the research subjects includes
p.000004: classified information, as defined in Reference (r).
p.000004:
p.000004: clinical investigations. Any research or experiments that involve a test article, one or more human subjects, and are
p.000004: performed under the requirements of Reference (d). Clinical investigations are a subcategory of research involving
p.000004: human subjects.
p.000004:
p.000004: continuing noncompliance. A pattern of noncompliance (see definition of noncompliance) that suggests the likelihood
p.000004: that, without intervention, instances of noncompliance will recur. A repeated unwillingness to comply with this
p.000004: Instruction or a persistent lack of knowledge of how to comply with this Instruction.
p.000004:
p.000004: Common Rule. The regulation adopted by multiple Federal departments and agencies for the protection of human subjects
p.000004: in research. The Department of Defense’s implementation of the Common Rule is part 219 of Reference (c); the
p.000004: Department of HHS’s implementation of the Common Rule is subpart A of Reference (i).
p.000004:
p.000004: detainee. Defined in Reference (q).
p.000004:
p.000004: DoD-conducted research involving human subjects. Research involving human subjects that is performed by DoD personnel.
p.000004: Intramural research is one type of DoD-conducted research involving human subjects. See “engaged in research
p.000004: involving human subjects.”
p.000004:
p.000004: DoD personnel. DoD civilian employees and members of the military services.
p.000004:
p.000004: DoD civilian employee. An individual meeting the definition of “employee” consistent with section 2105 of Reference
p.000004: (n). It includes employees of DoD Non-Appropriated Fund Instrumentalities; DoD civilian employees filling full-time,
p.000004: part-time, intermittent, or on-call positions; and individuals serving under personal services contracts consistent
p.000004: with section 2.101 of Reference (o). It excludes employees of contractors (other than personal services contractors)
p.000004: and foreign nationals of host countries.
p.000004:
p.000004: Service members. Individuals appointed, enlisted, or inducted for military service under the authority of the
p.000004: Department of Defense. The Military Services are the Army, the Navy, the Air Force, the Marine Corps, the Coast Guard,
...
p.000005: not limited to funding, facilities, equipment, personnel (investigators or other personnel performing tasks identified
p.000005: in the research protocol), access to or information about DoD personnel for recruitment, or identifiable data or
p.000005: specimens from living individuals. It includes both DoD-conducted research involving human subjects (intramural
p.000005: research) and research conducted by a non-DoD institution.
p.000005:
p.000005: engaged in research involving human subjects. An institution is engaged in research involving human subjects when its
p.000005: personnel are conducting activities covered by section 219.101(a) of Reference (c) and this Instruction. An
p.000005: institution that is funding, providing equipment, providing access to or information about potential human subjects
p.000005: (but not recruiting human subjects), providing data or specimens (either identifiable or not), or overseeing the
p.000005: research from a regulatory or compliance standpoint is not engaged in the research involving human subjects (but is
p.000005: supporting the research (see “DoD-supported research involving human subjects”)).
p.000005:
p.000005: exempt research involving human subjects. Research involving human subjects where the only involvement of the human
p.000005: subjects in the research will be in one or more of the categories identified in section 219.101(b) of Reference (c).
p.000005:
p.000005: experimental subject. See “research involving a human being as an experimental subject.”
p.000005:
p.000005: Federal assurance. A written document in which an institution (not an IRB) commits to a Federal department or agency
p.000005: their compliance with the requirements set forth in the Common Rule. Institutions engaged in non-exempt research
p.000005: involving human subjects conducted or supported by the Department of Defense or other Federal departments and agencies
p.000005: that have adopted the Common Rule must have a Federal assurance approved or accepted by the Federal agency supporting
p.000005: the research. The elements of a Federal assurance are outlined in section 219.103(b) of Reference (c).
p.000005:
p.000005: fetus. The product of conception from implantation until delivery as defined in subpart B of Reference (i).
p.000005:
p.000005: HRPO. An individual who is delegated the responsibilities as defined in paragraph (a)(2) of section 252.235-7004 of
p.000005: Reference (o). There may be more than one HRPO in a DoD Component. Some DoD Components may use a different title for
p.000005: the person(s) with the defined responsibilities.
p.000005:
p.000005: HRPP. An institution’s system of interdependent elements that implement policies and practices to protect human
p.000005: subjects involved in research. An HRPP may or may not include a Federal assurance. If the HRPP includes a Federal
p.000005: assurance, it may contain policies and procedures for an IRB belonging to the institution or for a relationship with an
p.000005: IRB external to the institution.
p.000005:
p.000005: human subject. A living individual about whom an investigator conducting research obtains data through intervention or
p.000005: interaction with the individual or obtains identifiable private information as defined in section 219.102(f) of
p.000005: Reference (c). (FDA regulations include a different definition
p.000005:
p.000005:
p.000005:
p.000005: Change 1, 10/15/2018 35
p.000006: GLOSSARY
p.000006:
p.000006: DoDI 3216.02, November 8, 2011
p.000006:
p.000006: of human subject. With respect to research subject to FDA regulations, the FDA definition in section 50.3(g) of
p.000006: Reference (d) also applies.)
p.000006:
...
Orphaned Trigger Words
p.000007:
p.000007: Activities, including program evaluation, customer satisfaction surveys, user surveys, outcome reviews, and other
p.000007: methods, designed solely to assess the performance of DoD programs where the results of the evaluation are only for the
p.000007: use of Government officials
p.000007:
p.000007:
p.000007:
p.000007: Change 1, 10/15/2018 37
p.000008: GLOSSARY
p.000008:
p.000008: DoDI 3216.02, November 8, 2011
p.000008:
p.000008: responsible for the operation or oversight of the program being evaluated and are not intended for generalized use
p.000008: beyond such program.
p.000008:
...
p.000008: affect the application of part 219 of Reference (c). This definition does not include activities that are not
p.000008: considered research involving human subjects, activities that meet the exemption criteria at section 219.101(b) of
p.000008: Reference (c), and research involving the collection or study of existing data, documents, records, or specimens from
p.000008: living individuals.
p.000008:
p.000008: research monitor. Individuals with expertise consonant with the nature of risk(s) identified within the research
p.000008: protocol, whose role is to protect the safety and well-being of human subjects.
p.000008:
p.000008: secretarial designee program. Defined in section 108.3 of Reference (c).
p.000008:
p.000008: serious noncompliance. Failure of a person, group, or institution to act in accordance with this Instruction and its
p.000008: references such that the failure could adversely affect the rights, safety, or welfare of a human subject; place a
p.000008: human subject at increased risk of harm; cause harm to a human subject; affect a human subject’s willingness to
p.000008: participate in research; or damage or compromise the scientific integrity of research data.
p.000008:
p.000008: UPIRTSO. Any incident, experience, or outcome that meets ALL three of the following conditions:
p.000008:
p.000008: Is unexpected (in terms of nature, severity, or frequency) given the procedures described in the research protocol
p.000008: documents (e.g., the IRB-approved research protocol and informed consent document) and the characteristics of the human
p.000008: subject population being studied.
p.000008:
p.000008: Is related or possibly related to participation in the research (in this Instruction, possibly related means there is a
p.000008: reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the
p.000008: research).
p.000008:
p.000008: Suggests that the research places human subjects or others at a greater risk of harm (including physical,
p.000008: psychological, economic, or social harm) than was previously known or recognized, even if no harm has actually
p.000008: occurred.
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008:
p.000008: Change 1, 10/15/2018 38
...
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| age | Age |
| army | Soldier |
| authority | Relationship to Authority |
| belmont | belmont |
| children | Child |
| combatant | ex-combatant |
| commonXrule | common rule |
| dependent | Dependent |
| disability | Mentally Disabled |
| drug | Drug Usage |
| education | education |
| educational | education |
| emergency | Public Emergency |
| employees | employees |
| family | Motherhood/Family |
| fetus | Fetus/Neonate |
| fetuses | Fetus/Neonate |
| foreign country | Other Country |
| gender | gender |
| injured | injured |
| language | Linguistic Proficiency |
| military | Soldier |
| minor | Youth/Minors |
| minority | Racial Minority |
| neonate | Fetus/Neonate |
| neonates | Fetus/Neonate |
| officer | Police Officer |
| pregnant | Pregnant |
| prison | Incarcerated |
| prisoners | Criminal Convictions |
| research staff | Laboratory Staff |
| single | Marital Status |
| soldier | Soldier |
| vulnerable | vulnerable |
| women | Women |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| army | ['military', 'soldier'] |
| education | ['educational'] |
| educational | ['education'] |
| fetus | ['neonate', 'fetuses', 'neonates'] |
| fetuses | ['fetus', 'neonate', 'neonates'] |
| military | ['army', 'soldier'] |
| neonate | ['fetus', 'fetuses', 'neonates'] |
| neonates | ['fetus', 'neonate', 'fetuses'] |
| soldier | ['army', 'military'] |
Trigger Words
capacity
consent
cultural
ethics
harm
justice
protect
protection
risk
sensitive
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input