Department of Defense (DoD) Research

The University's Federalwide Assurance (FWA) with the Department of Health and Human Services (DHHS), Office for Human Research Protections (OHRP), meets the DoD requirement that the University maintain a federal assurance of compliance. The University shall complete a DoD addendum to its FWA for DoD research. The DoD addendum outlines the unique DoD component requirements that are not specifically included in the FWA. 

The HRPP Director or designee shall review the requirements of the DoD addendum and will provide the DoD addendum to the Senior Vice President and Provost or designee for review and signature. 

• Funding: The research is funded by a component of the DoD. 
  • Example: A grant from the Office of Naval Research
• Collaboration: The research involves cooperation, collaboration, or other type of agreement with a component of the DoD. 
  • Example: An Army Medical Lab will conduct malaria antigen detection tests for a study. 
• Facilities: The research uses property, facilities, or assets of a component of DoD.
• Personnel: The subject population will intentionally included personnel (military and/or civilian) from a component of the DoD.
  • NOTE: DoD policies and requirements do not apply when DoD personnel incidentally participate as subjects in research that is not support by DoD, and DoD personnel are not an intended population of the research. 

• Navy
• Office of Naval Research
• Naval Academy
• U.S. Naval Observatory
• Army
• U.S. Army Corps of Engineers 
• Military Academy (West Point)
• Air Force
• Air Force Academy
• Marines
• Coast Guard
• Coast Guard Academy
• National Guard
• Missile Defense Agency
• Defense Advanced Research Projects Agency (DARPA) 
• Pentagon Force Protection Agency
• Defense Intelligence Agency
• National Geospatial-Intelligence Agency 
• National Security Agency 
• National War College 
• Tricare Health System 

The DoD component must conduct an appropriate administrative review of DoD research involving humans as experimental subjects. The DoD component-level administrative review must be conducted before the research can begin and when:

• Human participants research is conducted in a foreign country, unless conducted by a DoD overseas institution, or only involves DoD-affiliated personnel who are US citizens. 
• The research requires a waiver of informed consent (pursuant to 10 USC 980, Subsection (b).)
• The research is fetal research, as described in 42 USC 289g through 289g-2. 
• Large scale genomic data (LSGD) is collected from DoD-affiliated personnel. LSGD includes data derived from genome-wide association studies; single nucelotide polymorphisms. 
• The research constitutes classified research involving human participants (DoDI 3216.02 section 3.13). 
• The research is required to be approved by the DoD Office of Human Research Protections (DOHRP) in addition to the Component Office of Human Research Protections (COHRP), in accordance with DoDI 3216.02. 

When conducting multi-site research, a formal agreement between institutions is required and must specify the roles and responsibilities of each party in accordance with all legal requirements. This agreement must be approved by the DoD component prior to the University's engagement in the research. 

DoD institutions may rely on a collaborating non-DoD institution's IRB if the following conditions are met: 

• Each institution engaged in non-exempt research must have a current federal assurance of compliance.
• The non-DoD institution's IRB is registered with the Department of Health and Human Services (DHHS). 
• The DoD institution reviews the protocol to ensure all applicable local and DoD requirements are addressed in the protocol.
• The DoD institution, and the non-DoD institution's IRB have a written agreement in place defining the responsibilities and authorities of each institution. The agreement must specify the non-DoD IRB will apply 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 research, the COHRP must approve the agreement to rely on the non-DoD IRB. 

Detainees and Prisoners of War:  Research involving detainees or prisoners of war is prohibited.

• Exception: Research activities covered by investigational new drug (IND) or investigational device provisions of FDA regulations, when the purpose is for diagnosis or treatment of a medical condition in a patient. 
  • Such treatment may be offered to detainees or prisoners of war with their informed consent when the medical products are subject to FDA regulations, and only when the same product may be available to DoD-affiliated personnel consistent with established medical practices. 
     

Surveys performed on DoD personnel must be submitted, reviewed, and approved by the DoD Information Management Control Officer (IMCO) after the research is approved by the IRB. When a survey crosses DoD components, additional review is required. 

The DoD applies the provisions in 45 CFR 46, Subpart B for research involving pregnant women, fetuses, and neonates, with the following specifications: 

• The phrase "biomedical knowledge" is replaced with "generalizable knowledge". 
• The application of Subpart B is limited to research involving pregnant women as participants in research that is more than minimal risk and includes interventions or invasive procedures involving the woman or the fetus as participants, or involving fetuses or neonates as participants. 
• Fetal research must comply with US Code Title 42, Chapter 6A, Subchapter III, Part H, 289g. 

Research may not be conducted in the US or any country, on a nonviable living human fetus ex utero or a living human fetus ex utero for whom viability has not be ascertained, unless the research:

• May enhance the well-being or meet the health needs of the fetus or enhance the probability of survival; or 
• Will pose no added risk of suffering, injury, or death to the fetus and the purpose of the research 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 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 DOHRP must be obtained prior to initiating the research. 

The DoD applies the provisions in DHHS regulations 45 CFR 46, Subpart C for research involving prisoners. In addition to the permissible categories identified in DHHS regulations, two additional categories are permissible per DoDI 3216.02 section 3.9(c): 

1. Epidemiological research is permitted under the following conditions: 
   • The sole purpose of the research is to describe the prevalence or incidence of a disease by identifying all cases, or study potential risk factor associations for a disease. 
   • The research presents no more than minimal risk. 
   • The research involves no more that inconvenience to prisoner-participants. 
   • Prisoners are not a particular focus of the research. 
2. 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.

• The investigator must promptly notify the IRB. 
• For DoD-conducted research, the HRPP Director must notify the COHRP. 
• For DoD-supported research, the non-DoD organization must notify DOHRP and other federal agencies. 
• The DOHRP must concur with the IRB before the participant can continue participation while a prisoner. 

In its review of research conducted outside the United States, the IRB must confirm the national laws and requirements of the foreign country have been met and consider the cultural sensitivities in the setting where the research will take place. 

The investigator must provide to the IRB: 

• Proof of permission to conduct research in the foreign country by certification or local ethics reviews. 
• Local applicable laws, regulations, customs, and practices for the foreign country where research will occur, as well as an outline of how the investigator will follow all local laws, regulations, customs, and practices. 

Service members and DoD-affiliated personnel are considered to be vulnerable to coercion and undue influence by the DoD due to the nature of command structure of the organization. Therefore, the following additional protections for DoD-affiliated personnel are required. 

DoD-Affiliated Personnel: Service members, Reserve Service members, National Guard members, DoD civilians, and DoD contractors.  

• If the research involves DoD-affiliated personnel as participants and if the research includes any risks to their fitness for duty (ex: health, availability to perform job, data breach), the consent form must inform DoD-affiliated personnel about these risks should they seek command or component guidance before participating. 
   
• If the research involves DoD-affiliated personnel, the researcher 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 a federal study status, student at a Service Academy, or trainee is under 18 years old, the IRB must carefully consider the HSR recruitment process and the necessity of including such member as a research participant.  
   
• 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. 
  • Must not be present at any research participant recruitment sessions or during the consent process for DoD-affiliated personnel. Excluded supervisors or those in chain of command may participate in separate research recruitment sessions, if applicable.  
     
• For greater than minimal risk research and where recruitment will be conducted 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 research recruitment, monitoring that recruitment and informed consent explain that participation is voluntary and 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. 
     
• Consent Requirement: In order for the IRB to approve research involving DoD-affiliated personnel, the consent documentation must include, if applicable, potential risks for revocation of clearance, credentials, or other privileged access or duty. 
   
• Limitations on Dual Compensation: Compensation to DoD-affiliated personnel for participating in research during duty hours is prohibited. Compensation for participating in research is only permitted if participation occurs while off duty, provided payment does not conflict with prohibitions about dual compensation. 
  • Federal employees while on duty and non-federal persons may be compensation 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.

DoD-conducted or DoD-supported research involving large scale genomic data (LSGD) collected on DoD-affiliated personnel is subject to additional requirements. 

• What is Large Scale Genomic Data (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. 
   
• 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. 
   
• A Certificate of Confidentiality (CoC) will be applied to all research involving LSGD collected from DoD-affiliated personnel, pursuant to Title 42, USC, and Public Law 114-255. 
   
• The disclosure of DoD-affiliated personnel's genomic data may pose a risk to notional 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. 

DoD components may have stricter requirements that the Common Rule requirements for research-related injuries. The IRB shall apply the stricter requirements for research-related injuries as outlined by the DoD component conducting or supporting the research. The investigator shall include the stricter provisions in the consent form. 

When following DoD requirements: 

• If consent is to be obtained from the legally authorized representative (LAR), the intent of the research must be to benefit each participant enrolled in the study. 
   
• The determination that research is intended to be beneficial to the individual participant must be made by the IRB. 
   
• The consent form must include a statement that the DoD or a DoD organization is funding the study. 
   
• The consent form must include a statement that representatives of DoD are authorized to review research records.

When research involves no more than minimal risk, the IRB may waive or alter some elements of informed consent so long as it preserves the informed consent of the participant (ex: the consent indicates that participation in the research is voluntary and participants/LAR are informed of the research risks). DoDI 3216.02, section 3.11(d), says "For research...that involves no more than minimal risk". 

The DOHRP may waive the requirements for prospective consent 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 participant; and 
• The research is conducted in compliance with all other applicable laws and regulations. 

DoD requires additional confidentiality protections (DoDI 3216.02 section 3.14):

• 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 informed consent of the participant. 
   
• All studies involving large scale genomic data collected on or from DoD-affiliated personnel will apply a Certificate of Confidentiality (CoC). 

The investigator must promptly report the following within 30 days to the Component Office of Human Research Protections (COHRP): 

• IRB approval of significant changes to the protocol, such as: 
  • 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. 
     
• Results of IRB continuing review, if required. 
   
• A change of the reviewing IRB. 
   
• 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. 
   
• Reports of audits of DoD-conducted or DoD-supported research by another federal or state agency, official governing body of a Native American or Alaskan Native tribe, other official entity, or foreign government. 
   
• When a previously enrolled participant becomes pregnant, or when the investigator learns that a previously enrolled participant is pregnant, and the research was not reviewed and approved by the IRB in accordance with 45 CFR 46, Subpart B, for research involving pregnant women. 
   
• When a previously enrolled participant becomes a prisoner, and the protocol was not reviewed and approved by the IRB in accordance with 32 CFR 219, Subpart C, for research involving prisoners. 
   
• Closure of a DoD-supported study. 
   
• Any determinations of serious or continuing non-compliance of DoD-supported research and subsequent actions taken based on the findings. 
   
• Any determinations of unanticipated problems involving risks to participants or others and any subsequent actions taken based on the findings. 
   
• Suspensions or terminations of IRB approval.

• The investigator may not initiate research until the DOHRP within the DoD component reviews and approves the IRB approval and other documentation and notifies the University of such approval. 
   
• The investigator may be required to submit relevant IRB and research records to the DoD component for archiving purposes. 
   
• The DoD may request documentation to verify compliance with federal and DoD policies, including IRB meeting minutes related to the research. As appropriate, the HRPP Director or designee shall provide pertinent IRB review information to the DoD.  
   
• Records maintained by non-DoD organizations that document compliance or non-compliance with DoD regulations must be made accessible for inspection and copying by representatives of the DoD. 

DoD-Affiliated Personnel: Includes Service members, Reserve Service members, National Guard members, DoD civilians, and DoD contractors.

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 "experimental subjects" is a subset of research involving human participants. This definition relates only to the application of Section 980 of Title 10, USC; it does not affect the application of 32 CFR 219.

Minimal Risk: The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves that those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. 

• For DoD-funded or DoD-supported research, this does not include the inherent occupational risks that certain individuals face in their everyday life, such as those:
  • Encountered by Service members, law enforcement, or first responders while on duty.
  • Resulting from or associated with high-risk behaviors or pursuits.
  • Experienced by individuals whose medical conditions involve frequent tests or constant pain.