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Department of Defense (DoD) Requirements for the Conduct of Human Subjects Research

December 2020

Research sponsored or funded by the Department of Defense (the DoD) must be reviewed by the IRB under an additional set of federal regulations [32 CFR 219]. The Principal Investigator must meet additional DoD research requirements prior to initiation of the research. The DoD follows the DHHS and FDA regulations on human subjects research, but also applies DoD Directive (DoDD) 3216.02 “Protection of Human Subjects and Adherence to Ethical Standards in DoD-Conducted and DoD-Supported Research.”[1] DoD Directive 3216.02 contains additional requirements that include, but are not limited to the items below:

  • Limitations on use of humans as experimental subjects.
  • Limitations or restrictions on some Federal employees (both uniformed and civilian) regarding payment for research participation.
  • Appointment of a medical monitor for all research that is greater than minimal risk to participants. The definition of minimal risk based on the phrase “ordinarily encountered in daily life or during the performance of routine physical or physiological examination or tests” shall not be interpreted to include the inherent risks certain categories of human subjects face in their everyday life. For example the risks imposed in research involving human subjects focused on a special population should not be evaluated against the inherent risks encountered in their work environment (e.g., emergency responder, pilot, soldier in a combat zone) or having a medical condition (e.g., frequent medical tests or constant pain). The definition of a medical monitor within the DoD directive differs from the industry definition and may be found in DoDD 3126.02, Section 4.4.3 “For research involving more than minimal risk (as defined in 31 CFR 219.102(i), reference (c)) to subjects, an independent medical monitor shall be appointed by name. Medical monitors shall be physicians, dentists, psychologists, nurses, or other healthcare providers capable of overseeing the progress of research protocols, especially issues of individual subject/patient management and safety. Medical monitors shall be independent of the investigative team and shall possess sufficient educational and professional experience to serve as the subject/patient advocate.
  • When the research meets the DoD definition of “Research Involving a Human Being as an Experimental Subject,” the IRB may not waive the consent process. (The definition may be found in DoDD 3216.02, Enclosure 2. Definitions. Paragraph E2.1.3: “An activity, for research purposes, where there is an intervention or interaction with a human subject for the primary purpose of obtaining the effect of the intervention of interaction (32 CFR 219.102(f)).”)
  • Initial and continuing research ethics education is required for all personnel who conduct, review, approve, oversee, support, or manage human participants research.
  • Specific DoD educational requirements or certification is required.
  • The DoD component may evaluate the education policies to ensure the personnel are qualified to perform the research, based on the complexity and risk of the research.
  • Human participant research involving the testing of chemical or biological agents is prohibited, 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, explicit written approval must be obtained from the DoD Office for Human Research Protections (DOHRP).
  • Records maintained that document compliance or noncompliance with DoD requirements and shall be made accessible for inspection and copying by representatives of the DoD at reasonable times and in a reasonable manner as determined by the supporting DoD component.
  • If the research involves DoD-affiliated personnel, the key investigator must receive command or Component approval to execute the research.
  • 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 must carefully consider the HSR recruitment process and the necessity of including such member as a human participant.
  • Research involving large-scale genomic data from DoD-affiliated personal requires additional protections:
    • 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 deidentified data or specimens.
    • All research involving large-scale genomic data collected from DoD-affiliated personnel must have a certificate of confidentiality.
    • 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.

There are also specific requirements for informed consent documents:

For participants who are DoD-affiliated personnel, the informed consent documents must:

  • If the research includes any risks to their fitness for duty (e.g. health, availability to perform job, data breach), inform DoD-affiliated personnel about these risks and that they should seek command or Component guidance before participating.
  • Include, if applicable, potential risks for the revocation of clearance, credentials, or other privileged access or duty.
  • Include a statement that the DoD (and if applicable the U.S. Army Research and Materiel Command if that Component is involved) will have access to participant records for audit purposes.

For all participants in DoD-funded research, the informed consent documents must:

  • Indicate that the DoD a DoD Component is funding the study.
  • For greater than minimal risk research, include 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.
  • Include standard Hopkins institutional federal injury indemnification language in order to document how participants with research-related injuries will be cared for, including injuries that are the direct result of activities performed by DoD-affiliated personnel in studies that are collaborative with a non-DoD institution.

Additional guidance on informed consent requirements may be found here: JHM IRB Consent Language Requirements for Department of Defense (DoD)-Funded Research.

The OHSR consent form specialists are aware of the requirements for DoD language and are available to assist JHM researchers who may have questions about the language requirements.

Recruitment of DoD personnel as participants

If DoD personnel will be recruited as participants, any DoD-affiliated personnel, military and civilian supervisors, officers, and others in the chain of command:

  • Are prohibited from influencing their subordinates to participate in research involving human participants.
  • Must not be present at any human participant recruitment sessions or during the consent process for DoD-affiliated personnel
  • May participate in separate human participant research recruitment sessions.

For greater than minimal risk research involving recruitment of DoD personnel in a group setting an ombudsperson must be appointed. 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 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.
  • Should be available to address DoD-affiliated personnel’s concerns about participation.

Compensation of U.S. military personnel as participants

When military personnel will be recruited as participants, limitations on dual compensation:

  • Prohibit an individual from receiving pay of compensation for research during duty hours.
  • U.S. military personnel 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.

Survey/questionnaire research involving DoD personnel must receive IRB approval prior to final approval by DoD. ((SECNAVINST 3900.39D, para. 6e; OPNAVINST 5300.8B).

JHM researchers conducting research with DoD funding should review this guidance and consult with a member of the OHSR Compliance team to discuss the DoD requirements. In the support section of the eIRB application, DoD should be listed as a funding source. The funding source will be listed on the IRB meeting agenda to alert IRB Chairs and members that DoD requirements must be addressed. The Compliance team has developed a DoD checklist, which includes the specific requirements of DoD research, to facilitate IRB review of the research.

For any DoD-supported study, the researcher shall promptly (within 30 days) report to the DoD human research protection officer (HRPO):

  • 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 as defined in Part 219 of Title 32; addition of vulnerable populations[2], or DoD-affiliated personnel as subjects.
  • Transfer of HSR oversight to a different IRB.
  • 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.
  • 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.
  • The results of the IRB’s continuing review, if required.
  • 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.
  • 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.
  • A DoD-supported study’s closure.

Human subjects research compliance initial and continuing training is required for all research investigators (who conduct research on human participants) and their research staff, the IRB Chairs, Co-Chairs, members, management, and staff. The DoD requires documented retraining in human subjects research every three years, and the retraining requirement applies to all members of the study team of a research protocol that will receive DoD funding. To meet the DoD retraining requirement, JHM research team members may take the refresher human subjects course on the CITI website.

SOM must have on file a Department of Defense Assurance Document, which is an additional requirement above the Federal Wide Assurance on file with DHHS. Contact the Assistant Dean for Human Subjects Research in OHSR regarding existing Assurance documents. In addition, when conducting DoD multi-site research, a formal agreement between the organizations is required to specify the roles and responsibilities of each party (see Organizational Policy on Cooperative Research and Multi-Center Studies, Policy No. 114.2).

Office of Research Administration (ORA) staff will provide the required notification of IRB approval of research in accord with DoD Directive 3216.02 in conjunction with funding negotiations with DoD. Before the research may begin, ORA must be notified by the DoD funding component that it accepts the institution’s: IRB approval (or exempt determination, as applicable) and Federal Assurance documentation.

DoD policies and links to the DoD Components policies may be found at: http://www.dtic.mil/whs/directives/.

 

[1] Note that the DoD does not consider the following activities to constitute human subjects research:

  • 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.

The JHM IRBs will consider these criteria, but will make all determinations as to what is human subjects research in accordance with institutional policy and state law.

[2] DoD Directive 3216.02 modifies the Common Rule Subpart B (pregnant women/fetuses) and Subpart C (prisoners) for the purposes of DoD-conducted or -funded research as follows:

  • 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.
  • The applicability of Subpart C is expanded to additional categories of research. See Organization Policy C304 for additional information.

The JHM IRBs will consider these criteria, but will make all determinations concerning these populations in accordance with institutional policy and state law.