DoDI 3216.02, "Protection of Human Subjects and Adherence to Ethical Standards in DoD-Conducted and -Supported Research," April 15, 2020, Incorporating Change 1 on June 29, 2022

DOD INSTRUCTION 3216.02

ROTECTION OF HUMAN SUBJECTS AND ADHERENCE TO

ETHICAL STANDARDS IN DOD-CONDUCTED AND -SUPPORTED

RESEARCH

Originating Component: Office of the Under Secretary of Defense for Research and Engineering

Effective: April 15, 2020

Change 1 Effective: June 29, 2022

Releasability: Cleared for public release. Available on the Directives Division Website

at https://www.esd.whs.mil/DD/.

Reissues and Cancels: DoD Instruction 3216.02, “Protection of Human Subjects and Adherence

to Ethical Standards in DoD-Conducted and Supported Research”,

November 8, 2011

Approved by: Michael Griffin, Under Secretary of Defense for Research and

Engineering

Change 1 Approved By: Heidi Shyu, Under Secretary of Defense for Research and Engineering

Purpose: In accordance with the authority in DoD Directive 5137.02 and Part 219 of Title 32, Code of

Federal Regulations (CFR), also known and referred to in this issuance as “the Common Rule,” this

issuance establishes policy, assigns responsibilities, and provides procedures for the protection of human

subjects and adherence to ethical standards in DoD-conducted and supported research.

DoDI 3216.02, April 15, 2020

Change 1, June 29, 2022

TABLE OF CONTENTS 2

TABLE OF CONTENTS

SECTION 1: GENERAL ISSUANCE INFORMATION .............................................................................. 4

1.1. Applicability. .................................................................................................................... 4

1.2. Policy. ............................................................................................................................... 4

1.3. Summary of Change 1. ..................................................................................................... 6

SECTION 2: RESPONSIBILITIES ......................................................................................................... 7

2.1. USD(R&E). ....................................................................................................................... 7

2.2. DoD Component Heads. ................................................................................................... 8

SECTION 3: PROCEDURES .............................................................................................................. 10

3.1. DoD SDOs. ..................................................................................................................... 10

3.2. CMP. ............................................................................................................................... 11

3.3. Commanders or Directors of DoD Institutions. .............................................................. 12

3.4. Federal Assurance. .......................................................................................................... 13

a. When a Federal Assurance Is Required. ...................................................................... 13

b. When a Federal Assurance Is Not Required. ............................................................... 14

3.5. DoD-Conducted Research. ............................................................................................. 14

a. DoD Institutional Approval and Oversight. ................................................................. 14

b. DoD Component Administrative Review and Oversight. ........................................... 15

3.6. DoD-Supported Research. .............................................................................................. 16

a. DoD Component Approval and Oversight. .................................................................. 16

b. DoD Institutional Approval and Oversight. ................................................................. 16

3.7. DoD-Assisted Research. ................................................................................................. 19

3.8. Selection of Human Subjects and Evaluating Risk. ........................................................ 19

a. Selection of Human Subjects. ...................................................................................... 19

b. Evaluating Risk. ........................................................................................................... 19

3.9. Additional Protections for Human Subjects. .................................................................. 19

a. Additional Safeguards. ................................................................................................. 19

b. Pregnant Women, Fetuses, and Neonates Involved in Research. ................................ 20

c. Prisoners as Human Subjects. ...................................................................................... 20

d. Children Involved as Subjects in Research. ................................................................. 21

e. Detainees or Prisoners of War. ..................................................................................... 21

f. DoD-affiliated Personnel as Subjects in DoD-conducted or –supported HSR. ........... 21

3.10. Research Involving LSGD Collected on DoD-Affiliated Personnel. ........................... 22

3.11. Unique DoD Limitations on Waiver of Informed Consent. ......................................... 23

3.12. Protecting Human Subjects from Medical Expenses if Injured. ................................... 23

a. DoD-Supported Research Involving Human Subjects. ................................................ 23

b. DoD-Conducted Research Involving Human Subjects. ............................................... 24

3.13. Classified HSR. ............................................................................................................. 24

3.14. Additional Protections for Privacy and Confidentiality in Research. ........................... 25

a. Confidential Information Protection and Statistical Efficiency Act for Non-Statistical

Agencies. ..................................................................................................................... 25

b. CoC. ............................................................................................................................. 25

3.15. Record-Keeping. ........................................................................................................... 25

3.16. Noncompliance. ............................................................................................................ 26

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TABLE OF CONTENTS 3

3.17. CCHRPP Membership. ................................................................................................. 26

GLOSSARY ..................................................................................................................................... 27

G.1. Acronyms. ...................................................................................................................... 27

G.2. Definitions. ..................................................................................................................... 28

REFERENCES .................................................................................................................................. 34

DoDI 3216.02, April 15, 2020

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SECTION 1: GENERAL ISSUANCE INFORMATION 4

SECTION 1: GENERAL ISSUANCE INFORMATION

1.1. APPLICABILITY.

a. This issuance applies to:

(1) OSD, the Military Departments, the Office of the Chairman of the Joint Chiefs of

Staff and the Joint Staff, the Combatant Commands, the Office of the Inspector General of the

Department of Defense, the Defense Agencies, the DoD Field Activities, and all other

organizational entities within the DoD (referred to collectively in this issuance as the “DoD

Components”).

(2) DoD Components and other organizational entities that issue, implement, update, and

monitor a component human research protection program (HRPP) management plan (CMP) in

order to conduct or support DoD research involving human subjects, such as the Defense Health

Agency, the National Security Agency, the Defense Intelligence Agency, the DoD Human

Resources Activity, the DoD Educational Activity, the Uniformed Services University of the

Health Sciences, the Defense Acquisition University, the National Defense University, and the

Special Operations Command.

(3) Human subject research (HSR) conducted or supported by the DoD (for DoD

exclusions, see Glossary).

(4) Activities conducted or supported by the DoD, such as research, development,

testing, and evaluation that involve humans, human data, human biospecimens, or activities

regulated by the Food and Drug Administration (FDA).

b. This issuance’s applicability is not dependent upon the budget activities funding the

research, the security classification of the research, the location of the research in the United

States or a foreign country, or whether the research is conducted or supported by a program that

is not considered research for other purposes. Guidance regarding this issuance is available on

the Under Secretary of Defense for Research and Engineering (USD(R&E)) DoD Office for

Human Research Protections (DOHRP) website https://rt.cto.mil/ddre-rt/dd-rtl/hsd/hrp/.

1.2. POLICY.

The DoD will:

a. Follow Part 219 of Title 32, CFR, and the Belmont Report (44 Federal Register 23192,

April 18, 1979) principles, including respect for persons, beneficence, and justice.

b. Recognize that certain categories of human research subjects are vulnerable populations,

in accordance with Subparts B, C, and D in Part 46 of Title 45, CFR, who are thus afforded

additional protections, as specified in this issuance.

c. Recognize and adhere to Subpart E in Part 46 of Title 45, CFR.

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SECTION 1: GENERAL ISSUANCE INFORMATION 5

d. Prohibit HSR for the testing of chemical or biological agents, pursuant to Section 1520a

of Title 50, United States Code (U.S.C.). Some exceptions for research for prophylactic,

protective, or other peaceful purposes apply. Before any excepted testing of chemical or

biological agents involving HSR can begin, the DoD Component seeking to conduct the HSR

must receive explicit written approval from the DOHRP. The DOHRP will send a copy of the

protocol and approvals for such research to the Assistant Secretary of Defense for Nuclear,

Chemical, and Biological Defense Programs or any successor office.

e. Comply with all applicable biosafety and biosecurity requirements for activities conducted

pursuant to this issuance; for example: DoD 6055.18-M, the current editions of Centers for

Disease Control and Prevention, “Biosafety in Microbiological and Biomedical Laboratories

(BMBL),” and the National Institutes of Health guidelines for research involving recombinant or

synthetic nucleic acid molecules.

f. Conduct and support HSR outside of the United States in accordance with federal and

DoD regulatory requirements and the host nation’s laws, as applicable. Host nation HSR laws

are not typically applicable to DoD-conducted research that only involves DoD-affiliated

personnel as research subjects. In cases when a DoD-affiliated person who is also a citizen of

the host nation is a research subject, however, it is more likely that the host nation’s HSR laws

will be applicable. DoD Components conducting and supporting HSR outside of the United

States will consult with legal counsel, on a case-by-case basis, to determine whether host nation

HSR laws are applicable. Where differences in applicable standards exist, the standard that is

most protective of human subjects will be applied.

g. Require the key investigator to provide written notification to the U.S. Central, U.S.

Africa, U.S. European, U.S. Indo-Pacific, and U.S. Southern Commands of HSR that is to be

conducted or supported in their area of responsibility before HSR proceeds. This does not apply

to research performed within the United States or at DoD institutions overseas.

h. Require research involving large-scale genomic data (LSGD) collected from DoD-

affiliated personnel to be subject to DoD Component security review and DOHRP approval,

including the secondary use or sharing of de-identified data or specimens.

i. Permit the use of broad consent, in accordance with Part 219 of Title 32, CFR, in DoD-

supported research. DoD will permit use of broad consent in DoD-conducted and collaborative

research pursuant to DOHRP guidance and with DoD Component notification to the DOHRP

that a DoD institution intends to use broad consent in a research protocol.

j. Require use of a single institutional review board (IRB) in accordance with

Section 219.114 of Title 32, CFR. If a DoD institution believes that the research is not subject to

the provision listed in Section 219.114(b) of Title 32, CFR, the applicable DoD Component

Office of Human Research Protections (COHRP) may determine and document, in accordance

with Section 219.114(b)(2)(ii) of Title 32, CFR, that use of a single IRB is not appropriate for the

particular context of the proposed HSR. Studies already in progress before January 20, 2020,

will not be required to transition to a single IRB, nor submit exception documentation.

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SECTION 1: GENERAL ISSUANCE INFORMATION 6

k. Recognize that COHRPs have the authority to determine appropriate redactions when

posting informed consent forms pursuant to Part 219 of Title 32, CFR, as presented by DoD

institutions under their purview.

l. Recognize that certain activities subject to this issuance are excluded from the

requirements outlined in DoD Instruction (DoDI) 8910.01, Volumes 1 and 2 of DoD Manual

8910.01, and DoDI 1100.13. These include public or internal information collections of facts or

opinions, obtained initially or in follow-up requests, from individuals (including individuals in

control groups) under treatment or clinical examination in connection with research on, or

prophylaxis to prevent, a clinical disorder; direct treatment of that disorder; or the interpretation

of biological analyses of body fluids, tissues, or other specimens; or the identification or

classification of such specimens. These issuances may include other exclusions.

m. Not support or use funds for:

(1) The creation of a human embryo or embryos for research purposes, to include gene

editing research; or

(2) Research in which a human embryo or embryos are destroyed, discarded, or

knowingly subjected to risk of suffering, injury, or death greater than that allowed for research

on fetuses in utero in accordance with Section 46.204(b) of Title 45, CFR, and Section 289g(b)

of Title 42, U.S.C.

n. Ensure DoD-supported fetal research complies with Section 289g(b) of Title 42, U.S.C.

and Subpart B of Section 46 of Title 45, CFR, as described in Paragraphs 3.1, 3.5, 3.6, and 3.9 of

this issuance.

1.3. SUMMARY OF CHANGE 1.

This change updates policy to better reflect current restrictions on the creation of a human

embryo or embryos for research purposes, to include gene editing or research in which a human

embryo or embryos are destroyed, discarded, or knowingly subjected to risk of suffering, injury,

or death greater than that allowed for research on fetuses in utero. This change also updates

references.

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SECTION 2: RESPONSIBILITIES 7

SECTION 2: RESPONSIBILITIES

2.1. USD(R&E).

The USD(R&E):

a. Is the:

(1) DoD point of contact for all matters related to DoD compliance with this issuance.

(2) Principal DoD liaison with agencies and organizations outside the DoD on matters

pertaining to HSR, including ethics and privacy concerns in research as they relate to HSR.

b. Provides procedures and guidance necessary to implement this issuance.

c. Exercises:

(1) The authorities of:

(a) The department head identified in Part 219 of Title 32, CFR.

(b) The Secretary of Defense identified in Section 980 of Title 10, U.S.C.

(2) The authority, direction, and control of the DOHRP to:

(a) Halt studies and rescind or limit authorities granted to DoD Components’ HRPPs,

as needed.

(b) Accept and approve each DoD Component’s CMP, implementing and supporting

policies or any modifications thereto, and provide oversight of the plan’s implementation for

compliance with this issuance. A DOHRP-approved CMP must be in place before DoD

Components conduct or support any research involving human participants. The direct oversight

of the DoD Component’s implementation of its CMP and subsequent HRPP is with the DOHRP.

1. DoD Component human subject protection training.

2. DoD Component security review of research involving LSGD collected on

DoD-affiliated personnel, to include administrative, technical, and physical safeguards for

protecting their confidentiality both during and after the conduction of research.

3. DoD Component review of the ethical, legal, and social implications of

emerging, readily available technologies or controversial research, development, testing, and

evaluation.

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SECTION 2: RESPONSIBILITIES 8

4. Mandatory submittal document for all DoD-supported HSR.

(d) Performance of site visits to and inspections of DoD and non-DoD institutions

that conduct research, or receive DoD support, as applicable, with or without prior notice.

d. Grants exceptions, consistent with law, to requirements in this issuance based on a

written, appropriate justification from the senior designated official (SDO).

e. Delegates DOHRP authorities as appropriate.

f. Provides procedures in accordance with this issuance for use of certificates of

confidentiality (CoCs).

g. Designates DoD representatives to federal committees as appropriate.

h. Establishes and coordinates the activities of the DoD Coordinating Committee for HRPPs

(CCHRPP), along with its Executive Secretariat, the DOHRP Cabinet (DC). The DC is the

central advisory body to the DoD, USD(R&E), and the DOHRP on matters outlined in this

issuance.

i. Conducts Component HRPP assessments every other year.

j. Maintains:

(1) A list of classified HSR.

(2) Lists of DoD IRBs and DoD Institutional Biosafety Committees.

k. Designates:

(1) The Director, Human Systems Directorate, who chairs the CCHRPP and oversees the

Director, DOHRP.

(2) The Director, DOHRP the authority for the operations of the DOHRP, and the

designated manager for this issuance.

2.2. DOD COMPONENT HEADS.

The heads of DoD Components that conduct or support HSR:

a. Issue, implement, update, and monitor the CMP for implementing this issuance and

guidance or memoranda pursuant to this issuance.

b. Identify the SDO, who will either hold the rank of general officer/flag officer or be a

member of the Senior Executive Service, and will have the authority to implement the CMP.

c. Establish a COHRP with authority and responsibility for the CMP and regulatory

oversight of Component HSR at its office and its institutions.

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SECTION 2: RESPONSIBILITIES 9

d. Provide well-qualified, experienced staff and sufficient resources commensurate with the

Component’s research portfolio, appointing at least a GS-15 or equivalent federal employee to

direct the CMP and subsequent HRPP. This individual’s experience in DoD-conducted and

DoD-supported HSR, staff management, and systems of record must be commensurate with the

scope of the HRPP.

e. Provide members to intra- and interagency committees, the CCHRPP, and the DC when

requested.

f. Require that all Component institutions and sub-institutions that conduct or support HSR

have a Component-approved HRPP.

g. Provide an index of all DoD-conducted or DoD-supported HSR to the DOHRP before the

end of each fiscal year.

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SECTION 3: PROCEDURES 10

SECTION 3: PROCEDURES

3.1. DOD SDOS.

The SDO of a DoD Component that conducts or supports HSR:

a. Will provide to the DOHRP, through the COHRP, copies of human subject protections-

related substantive communications or reports provided to the White House, federal courts, the

FDA, congressional staff, committees, or State or local representatives within 5 business days

after learning of the communications or reports.

b. Will provide to the DOHRP, through the COHRP, copies of waivers to this issuance

granted to a COHRP on behalf of the SDO, if given the authority by the DOHRP, within 5

business days of issuing the waiver. This reporting requirement does not apply to waivers as

described throughout Part 219 of Title 32, CFR, issued by institutional officials (IOs) or IRBs

(i.e., waivers of documentation of informed consent or waivers of informed consent).

c. Will provide to the DOHRP, through the COHRP, approvals and documentation of HSR

in fetal research as described in Sections 289g–289g-2 of Title 42, U.S.C. The SDO must obtain

written approval from the DOHRP before HSR activities involving fetal research may begin.

d. Will provide to the DOHRP, through the COHRP, approvals and documentation of

protocols requiring certification from the SDO that the reviewing IRB has fulfilled its duties in

accordance with Subpart B of Part 46 of Title 45, CFR, for research that would not otherwise be

approved but for the fact that it presents an opportunity to understand, prevent, or alleviate a

serious problem affecting the health or welfare of pregnant women, fetuses, or neonates. The

SDO must obtain written approval from the DOHRP before permitting any HSR to be conducted

that involves research that would not otherwise be approved but for the fact that it presents an

opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare

of pregnant women, fetuses, or neonates.

e. Will provide to the DOHRP, through the COHRP, approvals of HSR requiring a waiver to

Section 512 of the E-Government Act of 2002 (Public Law 107-347), and the notice to the

Office of Management and Budget, pursuant to the E-Government Act of 2002 and Pages 33362-

33377 in Volume 72, Federal Register, within 5 business days of approving the HSR.

f. Will provide to the DOHRP, through the COHRP, reports of for-cause audits, reviews, or

assessments conducted by or on behalf of the COHRP within 5 business days of writing the

document.

g. Will provide to the DOHRP, through the COHRP, reports of audits of DoD-conducted or

DoD-supported HSR by another federal or State agency, official governing body of a Native

American or Alaskan native tribe, other official entity, or foreign government, within 5 business

days of discovering that such audit reports exist.

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h. Will provide to the DOHRP, through the COHRP, reports required in accordance with

Title 32, CFR, or similar reports upon request by the DOHRP, within 5 business days of the

report’s completion, pertaining to:

(1) Allegations of serious or continuing noncompliance related to HSR that are

substantiated by investigation, and subsequent actions taken based on the findings;

(2) Unanticipated problems involving risks to human subjects or others and subsequent

actions taken based on the findings; or

(3) Suspensions or terminations of IRB approval.

i. Will submit written justification to the DOHRP to establish a new IRB, or substantially

modify an IRB, at a minimum of 120 business days before establishment or modification for

DOHRP concurrence. Will notify the DOHRP at least 120 business days before disestablishing

an IRB.

j. Will provide details of DoD Component security reviews to the DOHRP, no fewer than 30

business days before beginning research involving LSGD collected from DoD-affiliated

personnel.

3.2. CMP.

a. The CMP must:

(1) Include or reference DoD Component policies to implement this issuance and

identify the responsible DoD Component office(s) for actions identified in this issuance.

(2) Identify the SDO with the authority and responsibility for implementing the CMP.

(3) Be consistent with DOHRP guidance and include or reference DoD Component

policies and procedures, if applicable, that:

(a) Establish authority for, and include or reference policies under which, the

COHRP will issue, limit, or revoke DoD assurances upon assessment of institutions’ HRPPs.

(b) Describe the DoD Component’s program or provisions for exercising authorities

delegated from the DOHRP to the SDO.

implementation of security review of research involving LSGD collected from DoD-affiliated

personnel and procedures to obtain SDO and DOHRP approval.

(d) Establish DoD Component and institutional requirements for human subject

protection training.

(e) Establish procedures for certification in accordance with Part 219 of Title 32,

CFR.

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(f) Establish policy for designating human protections directors (HPDs), human

research protection official(s) (HRPOs), and exemption determination officials (EDOs) to

include specifying qualifications, training, and responsibilities.

(g) Establish policy and institutional requirements for managing allegations of, and

reporting noncompliance with, federal regulations, State and local laws, Native American or

Alaskan native tribal laws, foreign laws, and DoD issuances and policies.

(h) Establish DoD Component and institutional responsibilities for required reporting

to the DOHRP, including reports pursuant to Title 32, CFR.

(i) Establish policy and institutional requirements for managing conflicts of interest,

including financial and non-financial interest conflicts, personal considerations, or perceptions of

a possible conflict.

(j) Establish policy for the maintenance of HSR records, including records and

workflows maintained in electronic form, required by governing regulations and this issuance.

(k) Establish policy in accordance with DoDI 6025.23 for addressing subjects’

research-related injuries in DoD-conducted research.

(l) Establish policy and institutional requirements for HRPO review of DoD-

supported HSR conducted by non-DoD institutions.

(m) Establish policy and institutional requirements for administrative review of

DoD-supported and DoD-conducted HSR performed by DoD and non-DoD institutions.

b. Required CMP elements may be modified upon waiver request by the COHRP or the

prospective COHRP on behalf of the SDO for DOHRP approval.

c. A DoD Component may, in a written arrangement approved by the DOHRP, rely on

another DoD Component to implement elements of the relying DoD Component’s CMP, except

for designating the relying DoD Component’s SDO. The DoD Component relying on another

DoD Component to implement elements of its CMP must specify the existence and extent of any

such reliance in its CMP.

3.3. COMMANDERS OR DIRECTORS OF DOD INSTITUTIONS.

Under the authority, direction, and control of the SDO in the DoD Component, each commander

or director of a DoD institution that conducts or supports HSR must:

a. Establish, implement, and maintain an HRPP to ensure the institution’s compliance with

this issuance.

b. Provide experienced, well-qualified HRPP staff and appropriate resources needed to

ensure compliance with this issuance.

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c. Designate an HPD as the primary point of contact for the institution’s HRPP.

d. As applicable, identify an IO to establish and maintain a DoD assurance and other

appropriate assurances. An alternate IO (AIO) may be appointed.

e. Evaluate and improve the institution’s HRPP, its policies, and its standard operating

procedures.

f. Establish a program of post-approval compliance monitoring of HSR conducted or

supported by the institution.

3.4. FEDERAL ASSURANCE.

a. When a Federal Assurance Is Required.

(1) A DoD institution conducting non-exempt HSR must have a DoD assurance for the

protection of human subjects. All DoD assurances must be executed using templates approved

by the DOHRP. Regional or multi-site DoD assurances are allowed as long as they are

reasonable and can be overseen adequately; these must be approved by the DOHRP.

(2) A DoD institution must have a Department of Health and Human Services (HHS)

assurance, also known as a federal-wide assurance (FWA), when conducting non-exempt HSR

supported by HHS.

(3) A non-DoD institution must rely on an FWA, or a comparable federal assurance,

when engaged in non-exempt DoD-supported HSR.

(4) Researchers affiliated with institutions that do not hold a federal assurance may enter

into individual investigator agreements (IIA) to associate with an institution with a federal

assurance. All researchers conducting non-exempt HSR must be covered by their own

institution’s federal assurance or by another institution’s federal assurance through an IIA.

(5) All institutions with a DoD assurance must identify at least one IRB on their DoD

assurance, and must list all DoD IRBs operated by their institution, as well as agreements for

IRB support.

(6) An institution with a DoD assurance must, on its assurance(s), identify the IO as the

senior individual authorized to represent the institution; establish and be responsible for the

institution’s HRPP; and identify the HPD as the primary contact for the institution’s HRPP.

(7) DoD institutions and all non-DoD institutions conducting HSR that receive support

from the DoD must comply with the terms of their federal assurances, if they hold one, this

issuance, and relevant policies of the cognizant DoD Component.

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b. When a Federal Assurance Is Not Required.

(1) A federal assurance is not required when an institution’s role is limited to the conduct

or support of exempt HSR or activities determined by designated HRPP personnel to be research

not involving human subjects.

(2) DoD institutions that only support HSR conducted by an institution with an

assurance, also known as an assured institution, are not required to maintain their own federal

assurance.

3.5. DOD-CONDUCTED RESEARCH.

a. DoD Institutional Approval and Oversight.

(1) DoD institutions must have policies and procedures to ensure that all applicable HSR

approvals are in place before HSR begins.

(2) A DoD IO or AIO, on behalf of their institution, may enter into an agreement to rely

on another DoD institution’s IRB without executing an Institutional Agreement for IRB Review

(IAIR) because both institutions rely on DoD assurances that delineate the responsibilities of the

reviewing and relying DoD IRBs.

(3) A DoD IO or AIO, on behalf of their institution, may establish an agreement for IRB

support with an institution that does not hold a federal assurance. This agreement is not an IAIR;

rather it is an agreement between an assured institution and a non-assured institution providing

IRB services. The agreement must specify that the IRB must apply the requirements in this

issuance for DoD-conducted research. The DoD IO and AIO must be given approval by the

COHRP, on behalf of the SDO, to have the ability to establish such agreements.

(4) DoD IRBs must comply with Section 219.107 of Title 32, CFR.

(5) DoD IRBs will document their consideration of scientific merit; within the

consideration of scientific merit, feasibility of study completion should be considered.

(6) If the HSR involves DoD-affiliated personnel, the key investigator must receive

approval from the DoD-affiliated personnel’s command or DoD Component to conduct the

research. If the HSR takes place on a DoD facility, the key investigator must also receive

approval from the command or DoD Component responsible for the facility.

(7) Only designated federal DoD HRPP personnel are authorized to make determinations

regarding whether or not an activity is HSR or is exempt HSR.

(8) DoD institutions collaborating in HSR with non-DoD institutions may rely on the

collaborating non-DoD institution’s IRB if all of the following conditions are met:

(a) The DoD institution determines the non-DoD institution has an appropriate

federal assurance or that a federal assurance is not required.

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(b) The non-DoD institution’s IRB is registered in accordance with Subpart E of

Part 46 of Title 45, CFR.

requirements are addressed in the protocol.

(d) The DoD institution and the non-DoD institution (including if the non-DoD

institution uses an independent IRB) enter into an IAIR specifying that the non-DoD IRB will

apply the DoD requirements specified in this issuance.

(e) If the research constitutes classified HSR, the COHRP, on behalf of the SDO,

approves the agreement to rely on the non-DoD institution’s IRB.

(9) DoD institutions conducting HSR in collaboration with non-DoD institutions with or

without DoD support must comply with all requirements in this issuance pertaining to DoD-

conducted research.

b. DoD Component Administrative Review and Oversight.

(1) The DoD Component must conduct an administrative review (also known as a

component-level administrative review (CLAR)) of all non-exempt HSR when any of the

following conditions occur:

(a)

HSR is conducted in a foreign country, unless conducted by a DoD overseas

institution, or only involves DoD-affiliated personnel who are U.S. citizens.

(b) The research requires a waiver of informed consent pursuant to Subsection (b) of

Section 980 of Title 10, U.S.C.

U.S.C.

(d) LSGD is collected from DoD-affiliated personnel.

(e) The research constitutes classified HSR as defined by this issuance.

(f) Research is required to be approved by the DOHRP.

(2) DoD administrative and DoD Component security reviews must be conducted before

research involving LSGD collected from DoD-affiliated personnel may begin.

(3) The DoD Component may, with DOHRP approval, delegate Component review and

oversight of Sections 3.5.b.(1)(a) - (f) to a DoD institution.

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3.6. DOD-SUPPORTED RESEARCH.

a. DoD Component Approval and Oversight.

(1) The DoD Component must conduct a CLAR of all non-exempt HSR when any of the

following conditions occur:

(a)

Research is conducted in a foreign country, unless it is conducted by a DoD

overseas institution, or involves subjects who are DoD-affiliated personnel that are U.S.

citizens.

(b) The research requires a waiver of informed consent pursuant to Paragraph (b) of

Section 980 of Title 10, U.S.C.

U.S.C.

(d) LSGD is collected from DoD-affiliated personnel.

(e) The research constitutes classified HSR as defined by this issuance.

(f) Research is required to be approved by the DOHRP.

(2) DoD administrative and DoD Component security reviews must be conducted before

research involving LSGD collected from DoD-affiliated personnel may begin.

(3) The DoD Component may, with DOHRP approval, delegate DoD Component review

and oversight of Sections 3.5.b.(1)(a) - (f) to a DoD institution.

b. DoD Institutional Approval and Oversight.

DoD institutions planning to support HSR must comply with the requirements in this

paragraph, as applicable.

(1) Support for activities including research involving human subjects must consider

Defense Federal Acquisition Regulation Supplement (DFARS) Section 207.172 requirements as

part of the acquisition planning process. All Federal Acquisition Regulation (FAR)–based

contracts for DoD-supported research that include or may include HSR must contain the DFARS

clause 252.235-7004 in its entirety in accordance with DFARS Section 235.072(e).

(a) All solicitations, including broad agency announcements, for DoD-supported

research that include or may include HSR must contain the DFARS clause 252.235-7004, if the

solicitation is for a FAR-based contract or substantially similar language if the solicitation is for

a non-FAR-based agreement; and language referencing the National Policy Requirements

Concerning Live Organisms Terms and Conditions, Section A.1., Human Subjects, at 81 Federal

institutions’ responsibilities, the role of the HRPO is described in these two directives.

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(b) Agreements other than contracts that include or may include HSR, but are not

subject to DFARS clause 252.235-7004 (e.g., grants, assistance agreements), must state the non-

DoD institution’s responsibilities. Including language referencing the National Policy

Requirements Concerning Live Organisms Terms satisfies the requirements of this paragraph.

(2) Contracts and other agreements (e.g., grants, assistance agreements) must:

(a) Restrict the performance of prospective DoD-supported HSR before the HRPO’s

concurrence is provided.

(b) Be awarded before an official HRPO review is provided, although a non-binding

HRPO review may be conducted before award.

(3) DoD institutions must appoint or designate HRPO(s) to confirm that DoD-supported

HSR complies with this issuance.

(4) DFARS clause 252.235-7004 is not required to be included in a DoD agreement with

another federal agency for DoD-supported HSR. However, these agreements must include

language requiring the federal agency to apply Sections 3.8, 3.9, 3.10, 3.11, and 3.13 of this

issuance, and Section 1520a of Title 50, U.S.C.

(5) When a DoD IRB serves as the reviewing IRB pursuant to Part 219 of Title 32, CFR,

the DoD IRB approval will constitute the HRPO review; an additional HRPO review is not

required.

(6) The non-DoD institution:

(a) For non-exempt HSR, must submit to the HRPO:

1. Documentation that the DoD-supported HSR has been reviewed and approved

by an IRB, including scientific merit, amendments, and additional reviews.

2. Documentation of key investigators’ human research protection training.

3. IRB-approved protocol documents.

4. Current FWA and IRB registration numbers.

(b) For DoD-supported research that is exempt or does not involve human subjects,

must submit institutional documentation of the determination that the research is either not HSR,

exempt HSR, or limited IRB review to the HRPO, to include all protocol documents.

addition to the HRPO reporting and submission requirements in this section.

(d) Must promptly notify the HRPO of the following:

1. IRB-approved changes to HSR that involve changes to key investigators or

institutions; decreased benefit or increased risk to subjects in greater than minimal risk research

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as defined in Part 219 of Title 32; addition of vulnerable populations, or DoD-affiliated

personnel as subjects.

2. Transfer of HSR oversight to a different IRB.

3. Notification by any federal body, State agency, official governing body of a

Native American or Alaskan native tribe, other entity, or foreign government that the non-DoD

institution’s DoD-supported HSR is under investigation.

4. Any problems involving risks to subjects or others, suspension or termination

of IRB approval, or any serious or continuing noncompliance pertaining to DoD-supported HSR.

5. The results of the IRB’s continuing review, if required.

6. Change in status when a previously enrolled human subject becomes pregnant,

or when the researcher learns that a previously enrolled human subject is pregnant, and the

protocol was not reviewed and approved by the IRB in accordance with Subpart B, Subpart 46 of

Title 45, CFR.

7. Change in status when a previously enrolled human subject becomes a

prisoner, and the protocol was not reviewed and approved by the IRB in accordance with Subpart

C, Subpart 46 of Title 45, CFR.

8. A DoD-supported study’s closure.

9. Must make records that document compliance or noncompliance with this

issuance accessible for inspection and copying, as determined by DoD HRPP personnel, by

authorized DoD representatives.

10. Will recognize that failure to comply with applicable requirements may result

in the DoD:

a. Wholly or partially terminating or suspending the award;

b. Temporarily withholding payment under the award pending correction of

the deficiency;

c. Disallowing all or part of the cost of the activity or action that is not in

compliance; and/or

d. Contacting publishers of articles that reference the noncompliant HSR.

11. Will recognize that DoD-supported research should comply with the whole of

this issuance when applicable.

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3.7. DOD-ASSISTED RESEARCH.

Each COHRP must establish policy to oversee the DoD Component’s execution of DoD-assisted

research, or delegate the responsibility to create such policy to the DoD Component’s

institutions. To the extent consistent with this issuance, a DoD Component may waive some

procedures applicable to DoD-supported HSR when the DoD support is limited to assistance (as

defined in this issuance).

3.8. SELECTION OF HUMAN SUBJECTS AND EVALUATING RISK.

a. Selection of Human Subjects.

The selection of human subjects in DoD-conducted or DoD-supported HSR must comply

with Section 252 of the National Defense Authorization Act for Fiscal Year 1994 (Public Law

103-160), with respect to gender, minority participation, and membership in the Armed Services.

The authority to waive the requirements of this statute may be delegated in the CMP.

b. Evaluating Risk.

The definition of minimal risk in Part 219 of Title 32, CFR, does not include the inherent

occupational risks that certain subjects face in their everyday life, such as those:

(1) Encountered by Service members, law enforcement, or first responders while on

duty.

(2) Resulting from or associated with high-risk behaviors or pursuits.

(3) Experienced by individuals whose medical conditions involve frequent tests or

constant pain.

3.9. ADDITIONAL PROTECTIONS FOR HUMAN SUBJECTS.

a. Additional Safeguards.

Provide additional safeguards for subjects who are likely to be vulnerable to coercion or

undue influence in accordance with Subparts B, C, and D of Part 46 of Title 45, CFR, and this

issuance.

(1) The additional safeguards set forth in Sections 3.9(b)-(f) must be provided in DoD-

conducted and DoD-supported HSR.

(2) The DOHRP may delegate the authority for implementation of Subparts B, C, and D

of Part 46 of Title 45, CFR, to the DoD Components’ SDOs within their CMP.

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b. Pregnant Women, Fetuses, and Neonates Involved in Research.

Research involving pregnant women, fetuses, or neonates as human subjects must comply

with Subpart B of Part 46, Title 45, CFR, unless modified by this issuance.

(1) For purposes of applying this section, the phrase “biomedical knowledge” in

Subpart B of Part 46, Title 45, CFR, is replaced with “generalizable knowledge.”

(2) The applicability of Subpart B of Part 46, Title 45, CFR, is limited to research

involving pregnant women as human subjects involved in HSR that is greater than minimal risk,

and includes interventions, as defined in Part 219 of Title 32, CFR, or invasive procedures

involving:

(a) The woman or the fetus; or

(b) Fetuses or neonates as human subjects.

(3) HSR using fetal tissue must comply with Sections 289g–289g-2 of Title 42, U.S.C.

(4) For HSR that would not otherwise be approved but presents an opportunity to

understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant

women, fetuses, or neonates, DoD institutions must demonstrate to the SDO that the IRB has

fulfilled its duties in accordance with Subpart B of Part 46, Title 45, CFR. Before HSR activities

may begin, the SDO must receive explicit written approval from the DOHRP.

c. Prisoners as Human Subjects.

HSR involving prisoners as human subjects must comply with Subpart C of Part 46 of Title

45, CFR, unless modified by this issuance.

(1) In addition to the categories of permissible HSR involving prisoners identified in

Subpart C of Part 46 of Title 45, CFR, two additional categories are permissible:

(a) Epidemiological research that meets the waiver criteria in accordance with

Pages 36929-36931 of Volume 68, Federal Register, may be approved in accordance with the

applicable requirements of Subpart C of Part 46 of Title 45, CFR, this issuance, and other

applicable requirements.

(b) HSR that would otherwise meet exemption criteria may be conducted, but must

first be approved by an IRB and must meet the requirements in Subpart C of Part 46 of Title 45,

CFR, this issuance, and other applicable requirements.

(2) DoD institutions conducting research involving prisoners must demonstrate to the

SDO that the IRB has fulfilled its duties in accordance with Subpart C of Part 46 of Title 45,

CFR.

(3) When a previously enrolled human subject becomes a prisoner, and the protocol has

not been reviewed and approved by the IRB in accordance with Subpart C of Part 46 of Title 45,

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CFR, the key investigator must promptly notify the IRB. For DoD-conducted research, the HPD

must notify the COHRP. For DoD-supported research, the non-DoD institution must notify the

HRPO and other federal agencies, if required.

d. Children Involved as Subjects in Research.

HSR involving children as human subjects must comply with Subpart D of Part 46 of Title

45, CFR. DoD institutions must demonstrate to the SDO that the IRB has fulfilled its duties in

accordance with Part 407 of Subpart D of Part 46 of Title 45, CFR, and Section 50.54 of Title

21, CFR.

e. Detainees or Prisoners of War.

Research involving a detainee or a prisoner of war as a human subject is prohibited.

(1) The prohibition in this paragraph does not apply to activities covered by

investigational new drug or investigational device provisions of Title 21, CFR, when the purpose

is for diagnosis or treatment of a medical condition in a patient.

(2) Such treatment may be offered to detainees or prisoners of war with their informed

consent when the medical products are subject to Title 21, CFR, and only when the same product

may be available to DoD-affiliated personnel consistent with established medical practices.

f. DoD-affiliated Personnel as Subjects in DoD-conducted or –supported HSR.

(1) If the HSR involves DoD-affiliated personnel as subjects and if the HSR includes any

risks to their fitness for duty (e.g. health, availability to perform job, data breach), the informed

consent document (ICD) must inform DoD-affiliated personnel about these risks and that they

should seek command or Component guidance before participating.

(2) If the HSR involves DoD-affiliated personnel, the key investigator must receive

command or Component approval to execute the research.

(3) Military and civilian supervisors, officers, and others in the chain of command are

prohibited from influencing their subordinates to participate in HSR.

(4) Military and civilian supervisors, officers, and others in the chain of command must

not be present at any HSR participant recruitment sessions or during the HSR consent process for

DoD-affiliated personnel. Excluded supervisors or those in the chain of command may

participate in separate HSR recruitment sessions, if applicable.

(5) Service members and all Reserve Component and National Guard members in a

federal duty status are considered for purposes of this issuance, to be adults. If a Service

member, Reserve Component or National Guard member in federal duty status, student at a

Service Academy, or trainee is under 18 years of age, the IRB must carefully consider the HSR

recruitment process and the necessity of including such member as a human subject.

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(6) In order to approve research involving DoD-affiliated personnel as human subjects,

the IRB or HRPO must determine whether the following requirements have been satisfied:

(a) The consent documentation must include, if applicable, potential risks for the

revocation of clearance, credentials, or other privileged access or duty.

(b) For research involving recruitment of DoD-affiliated personnel in HSR

determined greater than minimal risk, as defined by Part 219 of Title 32, CFR, and when HSR

recruitment occurs in a group setting, the IRB must appoint an ombudsperson. The

ombudsperson:

1. Must not have a conflict of interest with the research or be a part of the

research team.

2. Must be present during the HSR recruitment, monitoring that the recruitment

and informed consent explain that participation is voluntary and that the information provided

about the research is consistent with the IRB-approved script and materials, including digitally

provided materials.

3. Should be available to address DoD-affiliated personnel’s concerns about

participation.

(7) Compensation to DoD-affiliated personnel for participation in research while on duty

is prohibited in accordance with Title 5, U.S.C., with particular reference to Subparts G and H,

with some exceptions for purposes consistent with Section 30 of Title 24, U.S.C.

3.10. RESEARCH INVOLVING LSGD COLLECTED ON DOD-AFFILIATED

PERSONNEL.

a. DoD-conducted or DoD-supported research involving LSGD collected on DoD-affiliated

personnel, or for which research the DoD provides assistance, is subject to additional

requirements in this issuance.

b. The disclosure of DoD-affiliated personnel’s genomic data may pose a risk to national

security; accordingly, such research requires administrative, technical, and physical safeguards

commensurate with risk, including the secondary use or sharing of de-identified data or

specimens.

c. All research involving LSGD collected from DoD-affiliated personnel will apply an HHS

CoC pursuant to Title 42, U.S.C., and Public Law 114-255.

d. Research involving LSGD collected from DoD-affiliated personnel is subject to DoD

Component security review to ensure the adequacy of the proposed administrative, technical, and

physical safeguards, including the secondary use or sharing of de-identified data or specimens.

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3.11. UNIQUE DOD LIMITATIONS ON WAIVER OF INFORMED CONSENT.

a. Sections 219.116(e) and (f) of Title 32, CFR, identify conditions where an IRB may waive

informed consent for DoD-conducted and DoD-supported HSR.

b. Section 980 of Title 10, U.S.C.:

(1) Imposes limitations on waiving informed consent when DoD appropriated funds are

used to finance the research.

(2) Is applicable only to DoD-conducted and DoD-supported research when involving a

human being as an experimental subject as defined in this issuance. Research involving a human

being as an experimental subject, governed by Section 980 of Title 10, U.S.C., is a subset of

research involving human subjects, regulated by Title 32, CFR.

(3) Is not applicable to exempt HSR.

c. For research involving a human being as an experimental subject to which Section 980 of

Title 10, U.S.C., applies, informed consent must be obtained in advance from the experimental

subject or the subject’s legal representative (consistent with Part 219 of Title 32, CFR, if the

subject cannot consent). If consent is obtained from the subject’s legal representative, the

intention of the key investigator must be for the research to be beneficial to the subject.

d. For research governed by Section 980 of Title 10, U.S.C., that involves no more than

minimal risk, as defined by Part 219 of Title 32, CFR, an IRB may alter or waive other required

elements of informed consent pursuant to Part 219 of Title 32, CFR, so long as it still preserves

informed consent of the subject (i.e., the consent indicates the subject’s participation in the

research is completely voluntary and includes the requirement that the subject is informed of

research risks).

e. The advance informed consent requirement pursuant to Section 980 of Title 10, U.S.C.,

may be waived by the DOHRP or its delegate, if the following conditions are met:

(1) The research is to advance the development of a medical product necessary to the

DoD.

(2) The research may directly benefit the individual experimental subject.

(3) The research is conducted in compliance with all other applicable laws and

regulations.

3.12. PROTECTING HUMAN SUBJECTS FROM MEDICAL EXPENSES IF INJURED.

a. DoD-Supported Research Involving Human Subjects.

All non-exempt HSR must meet the requirement in Section 219.116 of Title 32, CFR.

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b. DoD-Conducted Research Involving Human Subjects.

All HSR that is determined to be greater than minimal risk must meet the requirement of

Section 219.116 of Title 32, CFR, to provide subjects with an explanation as to whether any

compensation and any medical treatments are available for research–related injuries.

(1) Explanations must include a statement that subjects may, for the duration of the

study, be eligible for health care services for research-related injuries at a military treatment

facility, in accordance with Part 108 of Title 32, CFR. This eligibility for health care services

extends beyond subjects’ participation in the study to such time after the study has ended, in

accordance with Section 219.108 of Title 32, CFR.

(2) CMPs and institutional HRPPs must document how institutions will care for subjects

with research-related injuries, including injuries that are the direct result of activities performed

by DoD-affiliated personnel in studies that are collaborative with a non-DoD institution.

(3) Subjects injured in DoD-conducted research may obtain care for such injuries at a

DoD medical treatment facility on a space-available basis during the pendency of the research

study in accordance with DoDI 6025.23.

3.13. CLASSIFIED HSR.

a. Pursuant to Parts 22, 37, and 219 of Title 32, CFR, and Sections 2.101 and 252.235-7004

of Title 48, CFR, and Executive Order 13526, DoD-conducted or DoD-supported HSR is

considered classified HSR when:

(1) Classified information is required for IRB review and oversight of the research.

(2) Classified information must be provided to human subjects, or their guardians, during

the HSR recruitment or informed consent process in order to achieve fully effective legal

consent.

(3) Classified information is provided to, or by, research subjects.

b. DoD-conducted or –supported HSR is not considered classified HSR:

(1) If the HSR is a part of a classified program, but the research itself is not classified; if

the information required in the research protocol is not classified; if the information needed by

the IRB is not classified; or if the information required by the human subject is not classified.

For the purposes of the annual report for classified research, unclassified HSR that falls into the

criteria listed in this paragraph should be included in the report.

(2) HSR that requires subjects to hold a clearance as a means of creating ease of entry or

access to controlled spaces where the research will occur does not constitute classified HSR

unless one of the conditions described in Sections 3.13.b.(1) or (3) also exist.

(3) If the research constitutes an authorized operational activity, then it is not HSR.

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c. The DOHRP is the final approval authority for all DoD-conducted or DoD-supported

classified HSR. The SDO prospectively conducting or supporting the HSR must submit a

package to the DOHRP for approval to conduct the classified HSR.

d. No DoD agency within the Intelligence Community may sponsor, contract for, or conduct

non-exempt HSR except in accordance with Paragraph 2.10 of Executive Order 12333 and DoD

5240.1.

3.14. ADDITIONAL PROTECTIONS FOR PRIVACY AND CONFIDENTIALITY IN

RESEARCH.

There are certain authorities that the DoD Components may consider using for sensitive research.

a. Confidential Information Protection and Statistical Efficiency Act for Non-Statistical

Agencies.

Any DoD Component may use the authority pursuant to Sections 501-513 of the Confidential

Information Protection and Statistical Efficiency Act of 2002 (CIPSEA) (Public Law 107-347) to

assure that data or information acquired by the DoD Component under a pledge of

confidentiality for exclusively statistical purposes must be used exclusively for statistical

purposes and may not be disclosed in identifiable form for any other purpose, except with the

informed consent of the respondent. Use of this authority is subject to the requirements of

CIPSEA Sections 512 and 523-525 and of Volume 72, Federal Register.

b. CoC.

A DoD institution conducting HSR or non-DoD institution conducting HSR with DoD

support may request a CoC pursuant to Section 241 of Title 42, U.S.C. All studies involving

LSGD collected on DoD-affiliated personnel will apply an HHS CoC.

(1) A CoC prohibits disclosing or providing, in any federal, State, or local civil, criminal,

administrative, legislative, or other proceeding, or to any other person not connected with the

research, the name of any individual or any such information, document, or biospecimen that

contains identifiable information about the individual, created or compiled for purposes of

research.

(2) Exceptions to the CoC must be listed in all informed consent documents, pursuant to

this issuance and as stated in Section 241 of Title 42, U.S.C.

3.15. RECORD-KEEPING.

a. Part 219 of Title 32, CFR, requires all institutions engaged in DoD-conducted or

DoD-supported HSR to retain records for at least 3 years after the completion of the research, or

longer if required by DoD Manual 6025.18, the Privacy Act, FDA regulations, or other

applicable requirements.

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b. For complete record-keeping guidance and instruction, DoD institutions must consult their

records disposition schedules.

c. Records maintained by non-DoD institutions that document compliance or noncompliance

with this issuance must be accessible for inspection and copying by authorized representatives of

the DoD.

3.16. NONCOMPLIANCE.

a. DoD institutions must promptly respond to allegations of noncompliance with this

issuance.

b. For allegations involving a non-DoD institution, the non-DoD institution must conduct an

investigation in accordance with the applicable support agreement, to be furnished to the

supporting DoD organization via the HRPO. The DoD institution supporting the HSR must

ensure in its agreements with the non-DoD institution that allegations are promptly and properly

investigated. The DoD institution will then promptly report substantiated serious and/or

continuing non-compliance findings to the COHRP.

c. Substantiated allegations related to classified HSR must be reported immediately to the

DOHRP.

3.17. CCHRPP MEMBERSHIP.

The CCHRPP is composed of senior officials at the general officer/flag officer, Senior Executive

Service, or equivalent level.

a. Each SDO must identify one regular and one alternate member to represent their

component to the CCHRPP, and must promptly notify the DOHRP if those designations change.

b. The CCHRPP Chair is the Director, Human Systems Directorate, Office of the

USD(R&E).

c. The Executive Secretariat to the CCHRPP is composed of the COHRP directors, or

equivalent authorities from the DoD Component HRPP oversight bodies, and those deemed

necessary to the Executive Secretariat’s missions by the DOHRP Director.

(1) The Executive Secretariat is referred to as the DC; its Chair is the Director, DOHRP.

(2) The DC acts as a central advisory committee to the DoD, the USD(R&E), and the

DOHRP on matters regarding HSR, privacy issues in research, ethical, legal, and social

implications in research.

(3) The DC may act as an ethics panel or body and designate subcommittees as needed.

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GLOSSARY 27

GLOSSARY

G.1. ACRONYMS.

CRONYM

EANING

AIO

alternate institutional official

CCHRPP

Coordinating Committee for Human Research Protection Programs

CFR

Code of Federal Regulations

CIPSEA

Confidential Information Protection and Statistical Efficiency Act of

2002

CLAR

component-level administrative review

CMP

component human research protection program management plan

CoC

certificate of confidentiality

COHRP

component office of human research protections

DoD Office for Human Research Protections Cabinet

DFARS

Defense Federal Acquisition Regulation Supplement

DoDI

DoD instruction

DOHRP

DoD Office for Human Research Protections

EDO

exemption determination official

FAR

Federal Acquisition Regulation

FDA

Food and Drug Administration

FWA

federal-wide assurance

HHS

Department of Health and Human Services

HPD

human protections director

HRPO

human research protection official

HRPP

human research protection program

HSR

human subject research

IAIR

institutional agreement for IRB review

ICD

informed consent document

IIA

individual investigator agreement

institutional official

IRB

institutional review board

LSGD

large-scale genomic data

SDO

senior designated official

U.S.C.

United States Code

USD(R&E)

Under Secretary of Defense for Research and Engineering

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GLOSSARY 28

G.2. DEFINITIONS.

Unless otherwise noted, these terms and their definitions are for the purpose of this issuance.

ERM

EFINITION

administrative

review

Review of research to ensure compliance with regulations and

policies applicable to HSR that is DoD conducted or research where

DoD provides support.

assistance

Non-financial resources that are provided by the DoD to non-DoD

institutions for research, including, but not limited to, facilities,

equipment, access to information about DoD-affiliated personnel for

recruitment, access to DoD-affiliated personnel, data, or specimens.

Funds that are provided by the DoD through a contract or similar

arrangement subject to the DFARS; grants, cooperative agreements,

technology investment agreements; or other non-procurement awards

are not considered assistance. Assistance is a subset of support.

authorized

operational activities

Activities carried out solely in support of the DoD mission to provide

military forces information needed to deter war and to protect the

security of the United States. These activities are subject to approval

by the DoD Component head or Secretary of Defense, including

subordinate agencies heads who have been delegated authority to

study, evaluate, improve, or otherwise assess DoD performance,

quality, and capability.

certification

Official notification by an institution that HSR has been reviewed

and approved by an IRB.

classified research

involving human

subjects

Research involving human subjects where classified material is

necessary to adequately perform IRB review and oversight, required

to obtain effective informed consent of participants, or, by design,

communicated by or to research participants.

detainee

Defined in DoD Directive 2310.01E.

DoD-affiliated

personnel

Service members, Reserve Service members, National Guard

members, DoD civilians, and DoD contractors.

DoD assurance

A written document stating an institution will comply with 32 CFR

Part 219 (the Common Rule), and DoD and DoD Component

policies.

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GLOSSARY 29

ERM

EFINITION

DoD institution

A DoD entity which conducts activities that may be HSR.

excluded activities

The following activities conducted or supported by the DoD are not

considered HSR:

Activities carried out solely for purposes of diagnosis, treatment, or

prevention of injury and disease under force health protection

programs of DoD, including health surveillance pursuant to Section

1074f of Title 10, U.S.C., and the use of medical products consistent

with DoDI 6200.02.

Health and medical activities as part of the reasonable practice of

medicine or other health professions undertaken for the sole purpose

of diagnosis, cure, mitigation, treatment, or prevention of disease in a

patient.

Activities performed for the sole purpose of medical quality

assurance (see Section 1102 of Title 10, U.S.C., and DoDI 6025.13).

Activities that meet the definition of operational test and evaluation

as defined in Section 139(a)(2)(A) of Title 10, U.S.C.

Activities performed solely for assessing compliance, including

occupational drug testing, occupational health and safety reviews,

network monitoring, and monitoring for compliance with

requirements for protection of classified information.

Activities, including program evaluation and surveys, user surveys,

outcome reviews, and other methods, designed solely to assess the

performance of DoD programs where the results are only for the use

of government officials responsible for the operation or oversight of

the program being evaluated.

exempt HSR

HSR that meets specific federal criteria in 32 CFR Part 219, falling

into one of the eight categories of Exempt research listed at 32 CFR

219.104. Exempt HSR must be initially determined as Exempt by an

IRB, its designee, or designated DoD HRPP personnel, and then is

exempt from further review. See also non-exempt HSR.

exemption

determination

official

A federal employee at a DoD institution who, sufficiently qualified

through experience and expertise, is designated to review research to

determine whether the research involves human subjects and, if so,

whether such research is exempt from Part 219 of Title 32, CFR.

DoDI 3216.02, April 15, 2020

Change 1, June 29, 2022

GLOSSARY 30

ERM

EFINITION

federal assurance

A written document in which an institution, not an IRB, commits to a

federal department or agency its compliance with the requirements

set forth in the Common Rule.

FWA

A Federal-Wide Assurance which is only issued by the Department

of Health and Human Services (HHS). This is required when

research is funded by HHS.

HPD

The federal employee at a DoD institution who is sufficiently

qualified through experience and expertise and serves as the primary

point of contact for the DoD institution’s HRPP, and who plays a key

role in ensuring that the institution fulfills its responsibilities under

the institution’s federal assurance or HRPP.

HRPO

A federal employee designated by a DoD Component or institution to

conduct administrative review of DoD-supported research in

accordance with the requirements of the DFARS, or comparable

requirement, and whose review of DoD-supported research is

intended to ensure compliance with DoD HSR requirements.

HRPP

An institution’s system of interdependent elements that implement

policies and practices to protect human subjects involved in research.

An institution with an HRPP may or may not hold a DoD or federal

assurance.

HSR

Activities that include both a systematic investigation designed to

develop or contribute to generalizable knowledge and involve a

living individual about whom an investigator conducting research

obtains information or biospecimens through intervention or

interaction with the individual, or identifiable private information, or

biospecimens.

human subject

A living individual about whom an investigator (whether professional

or student) conducting research:

Obtains information or biospecimens through intervention or

interaction with the individual, and uses, studies, or analyzes the

information or biospecimens; or

Obtains, uses, studies, analyzes, or generates identifiable private

information, personally identifiable information, or identifiable

biospecimens.

DoDI 3216.02, April 15, 2020

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GLOSSARY 31

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EFINITION

individual

investigator

agreement

An agreement between an investigator and an assured institution

where the investigator acknowledges that they are primarily

responsible for upholding the standards as set forth in the institution’s

assurance; meanwhile, the institution agrees to extend its assurance,

or “cover”, the individual investigator.

institution

Any public or private entity, which conducts activities that may be

HSR.

intervention

Includes both physical procedures by which information or

biospecimens are gathered (e.g., venipuncture) and manipulations of

the subject or the subject's environment that are performed for

research purposes.

An institution’s senior person who is legally authorized to represent

the institution and who is authorized to establish and is responsible to

maintain the HRPP for the institution. The IO is responsible for the

institution’s DoD or federal assurance and IRB, if these elements are

part of the institution’s HRPP.

key investigator

The person leading the performance of research.

LSGD

Data derived from genome-wide association studies; single

nucleotide polymorphisms arrays; genome sequencing;

transcriptomic, metagenomic, epigenomic analyses; and gene

expression data; etc. Research involving LSGD may or may not also

constitute HSR. Examples of research involving LSGD includes, but

is not limited to, projects that involve generating the whole genome

sequence data for more than one gene from more than 1,000

individuals, or analyzing 100 or more genetic variants in more than

1,000 individuals.

non-exempt HSR

HSR that meets specific federal criteria in 32 CFR Part 219 and this

issuance for minimal risk or greater than minimal risk.

ombudsperson

A person who acts as an impartial and objective advocate for human

subjects participating in research.

post-approval

compliance

monitoring

Formal and systematic HRPP monitoring of research to confirm that

HSR is being conducted in accordance with IRB approval or other

HRPP regulatory determinations, institutional HRPP policy and

procedures, applicable federal laws and regulations, and DoD policy.

DoDI 3216.02, April 15, 2020

Change 1, June 29, 2022

GLOSSARY 32

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EFINITION

protocol

A document that describes the background, rationale, objectives,

design, methodology, and organization of a research investigation. In

HSR, the protocol is frequently synonymous with the application for

approval of a research study to an IRB.

research

A systematic investigation, including research development, testing,

and evaluation, designed to develop or contribute to generalizable

knowledge. Activities that meet this definition constitute research for

purposes of this issuance, whether or not they are conducted or

supported under a program that is considered research for other

purposes. The following activities are deemed not to be research:

Scholarly and journalistic activities (e.g., oral history, journalism,

biography, literary criticism, legal research, and historical

scholarship), including the collection and use of information, that

focus directly on the specific individuals about whom the information

is collected.

Public health surveillance activities, including the collection and

testing of information or biospecimens, conducted, supported,

requested, ordered, required, or authorized by a public health

authority. Such activities are limited to those necessary to allow a

public health authority to identify, monitor, assess, or investigate

potential public health signals, onsets of disease outbreaks, or

conditions of public health importance (including trends, signals, risk

factors, patterns in diseases, or increases in injuries from using

consumer products). Such activities include those associated with

providing timely situational awareness and priority setting during the

course of an event or crisis that threatens public health (including

natural or man-made disasters).

Collection and analysis of information, biospecimens, or records by

or for a criminal justice agency for activities authorized by law or

court order solely for criminal justice or criminal investigative

purposes.

Authorized operational activities (as determined by each DoD

Component) in support of intelligence, homeland security, defense,

or other national security missions. Guidance and approval for

determining authorized operational activities with regard to HSR will

be issued by the DOHRP.

DoDI 3216.02, April 15, 2020

Change 1, June 29, 2022

GLOSSARY 33

ERM

EFINITION

research involving a

human being as an

experimental subject

An activity, for research purposes, where there is an intervention or

interaction with a living individual for the primary purpose of

obtaining data regarding the effect of the intervention or interaction.

Research involving a human being as an experimental subject is a

subset of research involving human subjects. This definition relates

only to the application of Section 980 of Title 10, U.S.C.; it does not

affect the application of Part 219 of Title 32, CFR.

security review

Administrative review of research involving large-scale genomic data

collected on DoD-affiliated personnel to ensure compliance, in

accordance with the CMP, as well as administrative, technical, and

physical safeguards for protecting confidentiality.

Service members

Individuals appointed, enlisted, or inducted for military service under

the authority of the DoD. The Military Services are the Army; the

Navy, including the Coast Guard under circumstances involving the

declaration of war; the Air Force; the Marine Corps; and the Reserve

Components. Members of the Reserve Components are included

when in a duty status.

support

Funds or assistance that are provided by the DoD to non-DoD

institutions for HSR through a grant, contract, or similar arrangement

subject to the DFARS or other applicable DoD regulations, such as

the DoD Grant and Agreement Regulations.

Included in this definition is the DoD’s provision of assistance to

non-DoD institutions, whether or not through collaboration between

DoD and non-DoD institutions, such as facilities, equipment,

personnel (investigators or other personnel performing tasks

identified in the research protocol), access to or information about

DoD-affiliated personnel for recruitment, or data or specimens.

This definition does not include DoD-conducted HSR, whether or not

conducted in collaboration between a DoD institution and non-DoD

institution.

DoDI 3216.02, April 15, 2020

Change 1, June 29, 2022

REFERENCES 34

REFERENCES

Belmont Report, 44 Fed Reg 23192

U.S. Department of Health and Human Services, Public Health Service, Centers for Disease

Control and Prevention, National Institutes of Health, HHS Publication No. (CDC) 21-1112,

“Biosafety in Microbiological and Biomedical Laboratories (BMBL),” current edition

Code of Federal Regulations, Title 21

Code of Federal Regulations, Title 24

Code of Federal Regulations, Title 32

Code of Federal Regulations, Title 45, Part 46, Subparts B, C, D, and E

Defense Federal Acquisition Regulation Supplement, current edition

Deputy Secretary of Defense Memorandum, “Establishment of the Office of the Under Secretary

of Defense for Research Engineering and the Office of the Under Secretary of Defense for

Acquisition and Sustainment,” July 13, 2018

DoD 5240.01-R, “Procedures Governing the Activities of DoD Intelligence Components that

Affect United States Persons,” December 7, 1982, as amended

DoD Directive 2310.01E, “DoD Detainee Program,” March 15, 2022

DoD Directive 5137.02, “Under Secretary of Defense for Research and Engineering

(USD(R&E)),” July 15, 2020

DoD Instruction 1100.13, “DoD Surveys,” January 15, 2015, as amended

DoD Instruction 6025.13, “Medical Quality Assurance (MQA) and Clinical Quality Management

in the Military Health System (MHS),” February 17, 2011, as amended

DoD Instruction 6025.23, “Healthcare Eligibility Under the Secretarial Designee (SECDES)

Program and Related Special Authorities,” September 16, 2011, as amended

DoD Instruction 6200.02, “Application of Food and Drug Administration (FDA) Rules to

Department of Defense Force Health Protection Program,” February 27, 2008

DoD Instruction 8910.01, “Information Collection and Reporting,” May 19, 2014, as amended

DoD Manual 6025.18, “Implementation of the Health Insurance Portability and Accountability

Act (HIPAA) Privacy Rule in DoD Health Care Programs,” March 13, 2019

DoD Manual 6055.18, “Safety Standards for Microbiological and Biomedical Laboratories,”

August 11, 2020

DoD Manual 8910.01, Volume 1, “DoD Information Collections Manual: Procedures for DoD

Internal Information Collections,” June 30, 2014, as amended

DoD Manual 8910.01, Volume 2, “DoD Information Collections Manual: Procedures for DoD

Public Information Collections,” June 30, 2014, as amended

Executive Order 12333, “United States Intelligence Activities,” December 4, 1981, as amended

Executive Order 13526, “Classified National Security Information,” December 29, 2009

Federal Register, Volume 44, Page 23192, April 18, 1979

Federal Register, Volume 68, Pages 36929-36931, June 20, 2003

Federal Register, Volume 72, Pages 33361-33377, June 15, 2007

Federal Register, Volume 81, Page 78380

DoDI 3216.02, April 15, 2020

Change 1, June 29, 2022

REFERENCES 35

National Institutes of Health, “The NIH Guidelines for Research Involving Recombinant or

Synthetic Nucleic Acid Molecules (NIH Guidelines),” April 2016

Public Law 103-160, Section 252, “National Defense Authorization Act for Fiscal Year 1994,”

November 30, 1993

Public Law 107-347, “Confidential Information Protection and Statistical Efficiency Act of 2002

(CIPSEA),” December 17, 2002

Public Law 114-255, “21st Century Cures Act,” December 13, 2016

United States Code, Title 10

United States Code, Title 24, Section 30

United States Code, Title 42

United States Code, Title 5

United States Code, Title 50, Section 1520a