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POLICY

Research that is funded or supported by the Department of Defense (DoD) or one of its components, must comply with the DoD Regulations for “Protection of Human Subjects” at 32 CFR 219 and DoD Directive 3216.2.

UTHealth Houston has signed the DoD addendum to its Federal-Wide Assurance (FWA) assuring that it will apply the DoD regulations to human subjects research involving the DoD.

UTHealth Houston does not conduct classified research or research involving chemical or biological agents, including research for prophylactic, protective, or other peaceful purposes involving chemical or biological agents.

Key Terms

Research Involving a Human Being as an Experimental Subject is defined as an activity, for research purposes, where there is an intervention or interaction with a human being for the primary purpose of obtaining data regarding the effect of the intervention or interaction [32 CFR 219.102]. Examples include, but are not limited to, a physical procedure, a drug, a manipulation of the subject or subject’s environment, the withholding of an intervention that would have been undertaken if not for the research purpose.

DoD Components refers collectively to the organizational entities within the DoD that are subject to the human subjects protections laid out in Department of Defense Directive.

Minimal Risk: Those risks ordinarily encountered in daily life or during the performance of routine physical or physiological examinations or tests. Minimal risk should not be evaluated against the inherent risks encountered in participants’ work environment (e.g., soldier in a combat zone) or medical condition.

PROCEDURE

Educational Requirements: UTHealth Houston requires all key study personnel to have current human subjects training during the course of the research. Researchers with DoD funded research, should familiarize themselves with the additional DoD requirements for human subjects research. The Principal Investigator is responsible for ensuring that all study team members have completed educational requirements required by the specific DoD component related to their research.

Researchers may contact the Program Officer at DoD or DoD Component for more information on the educational requirement specific for the DoD component. Researchers, research staff, and IRB members refer to this policy to ensure that the specific requirements contained in DoD regulations and directives are met when research involves DoD.

Scientific Review: Initial proposals and subsequent substantive amendments to approved research must undergo scientific review. This requirement may be met by scientific review by the departmental committee or scientific review conducted by appropriately qualified IRB members as part of the IRB review process. The IRB may rely on outside experts to provide an evaluation of scientific merit.

Informed Consent: If the research involves a human being as an experimental subject and is supported by DoD-appropriated funds, informed consent must be obtained from the participant in advance, in accordance with 10 USC 980. In addition to the basic and additional consent disclosures, consent documents must include:

A statement that the DoD or a DoD organization is funding the study.
A statement that DoD representatives are authorized to review research records.
Provisions for research related injury as required by the DoD component funding the study.
For greater than minimal risk research, consent documents must include the disclosure that participants may, for the duration of the study, be eligible for health care services for research-related injuries at a military treatment facility, and this eligibility for health care services extends beyond participants’ participation in the study to such time after the study has ended.
- Written materials must document how organizations will care for participants 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.

The research study must offer potential for direct benefit to participants if participants are not able to provide consent for themselves and will need consent from legally authorized representative.

Waiver of Consent: If the research participant meets the definition of “experimental subject,” the IRB may approve waiver of the consent process unless the waiver is approved by the Secretary of Defense. If the research participant does not meet the definition of “experimental subject”, the IRB is allowed to waive the consent process pursuant to 10 USC 980 Subsection (b).

When conducting emergency medicine research, researchers must obtain approval from the DOHRP on behalf of the Secretary of Defense for a waiver of the advance informed consent provision of 10 USC 980. Researchers may reach out to the DoD Program Officer for guidance on this process.

DOHRP may waive the requirements for prospective consent for research involving human beings as “experimental subjects” when all of the following are met:

The research is necessary to advance the development of a medical product for the Military Services.
The research may directly benefit the individual “experimental subject”.
The research is conducted in compliance with all other applicable laws and regulations.

International Research: Researchers have additional responsibilities while conducting research that involves subjects in international setting:

Researcher must obtain component level administrative review (CLAR) when research is conducted in a foreign country, unless conducted by a DoD overseas institution, or only involves DoD-affiliated personnel who are US citizens.
Researcher must obtain permission to conduct research in that country by certification or local ethics review.
Researcher must follow all local laws, regulations, customs, and practices.

Multi-site Research: When conducting multi-site research, a formal agreement between organizations is required to specify the roles and responsibilities of each party. DoD institutions collaborating with non-DoD institutions may rely on a collaborating non-DoD institution’s IRB if the following conditions are met:

Each institution engaged in non-exempt human participant research must have a current federal assurance of compliance.
The involvement of DoD personnel in the conduct of the research is secondary to that of the non-DoD institution.

When the UTHealth Houston IRB is the reviewing IRB for a DoD supported research study, the written agreement will define the responsibilities and authorities of the DoD institution, non-DoD institution, and the UTHealth Houston IRB in complying with all legal requirements and will include the following:

Each institution engaged in non-exempt human participant research must have a current federal assurance of compliance.
The non-DoD institution’s IRB should be registered in accordance with Subpart E of 45 CFR 46.
The DoD institution reviews the protocol to ensure all applicable local and DoD requirements are addressed in the protocol.
The non-DoD IRB/EC will apply the DoD requirements specified in DoDI 3216.02, including but not limited to non-DoD institutional responsibilities defined under DoDI 3216.02 section 3.6(b).
If the research constitutes classified human participant research, the COHRP must approve the agreement to rely on the non-DoD institution’s IRB/EC.

The DoD institution, non-DoD institution, and the non-DoD institution’s IRB have a written agreement defining the responsibilities and authorities of each organization in complying with all legal requirements. This agreement must be approved by the DoD component prior to the DoD institution’s engagement in the research.

When UTHealth Houston IRB is the reviewing IRB for DoD-supported research, the following must be promptly reported to the COHRP. (DoDI 3216.02 section 3.6)

When significant changes to the research protocol are approved by the IRB:
Changes to key investigators or institutions.
Decreased benefit or increased risk to participants in greater than minimal risk research.
Addition of vulnerable populations as participants.
Addition of DoD-affiliated personnel as participants.
Change of reviewing IRB/EC.
When the organization is notified by any federal body, state agency, official governing body of a Native American or Alaskan native tribe, other entity, or foreign government that any part of an HRPP is under investigation for cause involving a DoD-supported research protocol.
Any problems involving risks to participants or others, suspension or termination of IRB/EC approval, or any serious or continuing noncompliance pertaining to DoD-supported human participant research.
The results of the IRB’s/EC’s continuing review, if required.
Change in status when a previously enrolled participant becomes pregnant, or when the researcher learns that a previously enrolled participant is pregnant, and the protocol was not reviewed and approved by the IRB/EC in accordance with 45 CFR 46, Subpart B.
Change in status when a previously enrolled participant becomes a prisoner, and the protocol was not reviewed and approved by the IRB/EC in accordance with 32 CFR 219, Subpart C.
Closure of a DoD-supported study.

Research Involving DoD Personnel: Service members and DoD-affiliated personnel are considered to be vulnerable to coercion and undue influence by the DoD due to the nature of the command structure of the organization. Therefore, additional protections for DoD-affiliated personnel are required, as follows (DoDI 3216.02 section 3.9 (f)):

Surveys performed on DoD personnel must be submitted, reviewed, and approved by the Department of Defense after the research protocol is reviewed and approved by the IRB. When a survey crosses DoD components, additional review is required. The researcher must ensure that they obtain appropriate approvals.
If the research involves DoD-affiliated personnel, the researcher must receive command or component approval to execute the research.
Military and civilian supervisors, officers, and others in the chain of command are prohibited from influencing their subordinates to participate in research.
Military and civilian supervisors, officers, and others in the chain of command must not be present at any participant recruitment sessions or during the consent process for DoD-affiliated personnel. Excluded supervisors or those in the chain of command may participate in separate recruitment sessions, if applicable.
Service members and all Reserve component and National Guard members in a federal duty status are considered 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/EC must carefully consider the HSR recruitment process and the necessity of including such member as a human participant.
The consent documentation must include the following, in addition to the required and additional elements, if applicable:
- potential risks for revocation of clearance, credentials, or other privileged access or duty.
- If the research involves 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.
- If applicable, a statement of potential risks for the revocation of clearance, credentials, or other privileged access or duty.
- A statement that the DoD or a DoD organization is funding the study.
- A statement that representatives of the DoD are authorized to review research records.
For research involving recruitment of DoD-affiliated personnel in research determined to be greater than minimal risk, and when recruitment occurs in a group setting, the IRB must appoint an ombudsperson. The ombudsperson:
- Must not have a conflict of interest with the research or be a part of the research team.
- Must be present during the 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.
- Should be available to address DoD-affiliated personnel’s concerns about participation.
Research involving large-scale genomic data from DoD-affiliated personnel is subject to additional requirements:
The disclosure of DoD-affiliated personnel’s genomic data may pose a risk to national security; accordingly, written materials must describe administrative, technical, and physical safeguards commensurate with risk, including the secondary use or sharing of de-identified data or specimens.
All research involving large-scale genomic data collected from DoD-affiliated personnel must have a Certificate of Confidentiality from DHHS (Title 42, U.S.C., and Public Law 114-255).
Research involving large-scale genomic data 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.
Civilian researchers attempting to access military volunteers should seek collaboration with a military researcher familiar with service-specific requirements.
If the research involves DoD-affiliated personnel as participants, in addition to the basic and required consent disclosures, consent documents must include:
Compensation to DoD-affiliated personnel for participation in research while on duty is prohibited in accordance with 5 USC, with particular reference to Subparts G and H, with some exceptions for purposes consistent with 24 USC 30. When research involves U.S. military personnel, policies and procedures require limitations on dual compensation:
- Participants are not permitted to receive pay or compensation for research during duty hours; however, participants may be compensated for research if the participant is involved in the research when not on duty.
- Federal employees while on duty and non federal persons may be compensated for blood draws for research up to $50 for each blood draw.
- Non federal persons may be compensated for research participation other than blood draws in a reasonable amount as approved by the IRB according to local prevailing rates and the nature of the research study.

Research Involving Pregnant Women: For purposes of applying Subpart B, the phrase “biomedical knowledge” shall be replaced with “generalizable knowledge.” The applicability of Subpart B is limited to research involving pregnant women as participants in research that is more than minimal risk and included interventions or invasive procedures to the woman or the fetus or involving fetuses or neonates as participants. Fetal research must comply with the US Code Title 42, Chapter 6A, Subchapter III, Part H, 289g.

Research or experimentation may not be conducted, in the United States or in any other country, on a nonviable living human fetus ex utero or a living human fetus ex utero for whom viability has not been ascertained unless the research or experimentation:
- May enhance the well-being or meet the health needs of the fetus or enhance the probability of its survival to viability; or
- Will pose no added risk of suffering, injury, or death to the fetus and the purpose of the research or experimentation is the development of important biomedical knowledge which cannot be obtained by other means.
The risk standard must be the same for fetuses which are intended to be aborted and fetuses which are intended to be carried to term.
For human participant research 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, written approval from the DOHRP must be obtained through the COHPR prior to research starting.

Research involving prisoners: Research involving prisoners must be reviewed by the convened IRB. When the IRB reviews research involving prisoners, at least one prisoner representative must be present for quorum. Human participant research involving prisoners that would otherwise meet exemption criteria may be conducted, but must first be approved by an IRB and meet the requirements of Subpart C and DoDI 3216.02.

In addition to allowable categories of research on prisoners in Subpart C, epidemiological research is also allowable when:

The sole purpose of the research is to describe the prevalence or incidence of a disease by identifying all cases or studies potential risk factor association for a disease.
The research presents no more than minimal risk.
The research presents no more than an inconvenience to the participant.
Prisoners are not a particular focus of the research.

If a participant becomes a prisoner during the course of the research:

If the researcher asserts to the IRB that it is in the best interest of the prisoner-participant to continue to participate in the research while a prisoner, the IRB chair may determine that the prisoner-participant may continue to participate until the convened IRB can review this request to approve a change in the research protocol and until the organizational official and DoD Component office review the IRB’s approval to change the research protocol.
Otherwise, the IRB chair shall require that all research interactions and interventions with the prisoner-participant (including obtaining identifiable private information) cease until the convened IRB can review this request to approve a change in the research protocol. The convened IRB, upon receipt of notification that a previously enrolled human participant has become a prisoner, shall promptly (no longer than 30 days) re-review the research protocol to ensure that the rights and wellbeing of the human participant, now a prisoner, are not in jeopardy.
The IRB should consult with a subject matter expert having the expertise of a prisoner representative if the IRB reviewing the research protocol does not have a prisoner representative. If the prisoner-participant can continue to consent to participate and is capable of meeting the research protocol requirements, the terms of the prisoner-participant’s confinement does not inhibit the ethical conduct of the research, and there are no other significant issues preventing the research involving human participants from continuing as approved, the convened IRB may approve a change in the study to allow this prisoner-participant to continue to participate in the research.
This approval is limited to the individual prisoner-participant and does not allow recruitment of prisoners as participants.

Research involving a detainee as a human participant is prohibited. This prohibition does not apply to research involving investigational drugs and devices when the same products would be offered to US military personnel in the same location for the same condition.

Research involving prisoners of war is prohibited. Any person captured, detained, held or otherwise under the control of the DOD personnel (military and civilian or contractor employee) is considered a prisoner of war. This includes enemy prisoners, civilian internees, retained persons and lawful and unlawful combatants.

DoD Component Review:

The DoD Component must conduct an appropriate administrative review of the research involving human participants. The DoD Component administrative review must be conducted before the research involving human participants can begin to ensure compliance with all applicable regulations and policies, including any applicable laws and requirements and cultural sensitivities of the country when the research is conducted in a country other than the United States
DoD component-level administrative review (CLAR) must be conducted when large scale genomic data (LSGD) is collected from DoD-affiliated personnel. LSGD includes data derived from genome-wide association studies; single nucleotide polymorphisms arrays; genome sequencing; transcriptomic, metagenomic, epigenomic analyses; and gene expression data; etc. (See definition in DoDI 3216.02 G.2 Definitions)
DoD CLAR review must be conducted when research requires a waiver of informed consent pursuant to 10 USC 980, Subsection (b), when the research is fetal research, as described in 42 USC 289g-289g-2 and when the research is required to be approved by the DOHRP (in addition to the COHRP) in accordance with DoDI 3216.02.

Records: Records that document compliance or noncompliance with DoD requirements shall be made accessible for inspection and copying by representatives of the DoD.

Reporting: The following must be reported to the Component Office of Human Research Protections within 30 days:

Significant changes to the protocol, approved by the IRB
Results of IRB continuing review
Any change in the reviewing IRB
Any unanticipated problems involving risks to participants or others for any DoD-supported research.
Any determinations of serious or continuing non-compliance
Any suspension or termination of DoD-supported research
Reports of audits of DoD-conducted or DoD-supported human participant research by another federal or state agency, official governing body of a Native American or Alaskan native tribe, other official entity, or foreign government.
Any notification to the institution by any Federal department, agency or national organization that any part of the institutions’ HRPP is under investigation for cause involving a DoD supported protocol.

REFERENCES

If you find errors in this document, contact [email protected]

Document Number:	101-C16
Document Name:	Department of Defense
Reviewed by:	Associate Vice President, Research Compliance
Effective:	1 Nov 2011
Revision History:	1 Jun 2016, 21 Jan 2019, 1 Jun 2021, 1 Sept 2021, 1 Jun 2026

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