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1.14 Research Subject to Department of Defense Regulatory Requirements

1.0 Purpose

The purpose of this policy and procedure is to specify the Organization’s requirements for the review, approval, conduct and oversight of human subject research funded by or involving the U.S. Department of Defense (DoD) and the U.S. Department of the Navy (DoN).

2.0 Policy

  • 2.1. It is the policy of the Organization that it will comply fully with all approval requirements of DoD and DoN when its IRBs review, approve and provide oversight of human subjects research funded by or otherwise contractually subject to DoD or DoN regulations and requirements or uses a DoD/DoN property, facility or asset.
  • 2.2. It is the policy of the Organization that the research specified in Section 2.1 above will comply with the following codes, regulations and guidance:
    • 2.2.1. The Belmont Report
    • 2.2.2. Title 32 Code of Federal Regulations Part 219 (32 CFR 219), Department of Defense Regulations, “Protection of Human Subjects” (DoD adoption of the “Common Rule”)
    • 2.2.3. Title 45 Code of Federal Regulations Part 46, (45 CFR 46) Department of Health and Human Services Regulations, “Protection of Human Subjects,” Subparts B, C, and D as made applicable by DoD Directive (DoDD) 3216.02
    • 2.2.4. Title 21 Code of Federal Regulations 50, 56, 312, and 812, Food and Drug Administration (FDA) Regulations
    • 2.2.5. DoDD 3216.02, “Protection of Human Subjects and Adherence to Ethical Standards in DoD-supported Research”
    • 2.2.6. Title 10 United States Code Section 980 (10 USC 980), “Limitation on Use of Humans as Experimental Subjects”
    • 2.2.7. DoDD 3210.7, “Research Integrity and Misconduct”
    • 2.2.8. DoDD 6200.2, “Use of Investigational New Drugs in Force Health Protection”
    • 2.2.9. Department of the Navy
      • 2.2.9.1. SECNAVINST 3900.39D of 6 November 2006
      • 2.2.9.2. SECNAVINST 5720.44B of 1 November 2005
      • 2.2.9.3. SECNAV M-5210.1 of 1 December 2005
      • 2.2.9.4. OPNAVINST 5300.8B of 23 April 1997
  • 2.3. It is the policy of the Organization that research specified in Section 2.1 above will comply with the following requirements, as applicable:

    • 2.3.1. Education and Training [DoDD 3216.02, para.4.5]

      • 2.3.1.1. For initial and continuing research ethics education for all personnel who conduct, review, approve, oversee, support, or manage human participant research, there may be specific DoD educational requirements or certification required. All research personnel must complete training in accordance with HRPP policy #1.23 (HRPP Training Requirements and Opportunities for Research Personnel). In addition, any other specific training will be determined by the ORA.
      • 2.3.1.2. If during the process of submission or during the course of IRB review it becomes apparent that the investigator does not understand DoD requirements one-on-one training will be provided by ORA staff. The DoD may have specific training requirements in consideration of the complexity and risk of the research.

    • 2.3.2. Additional Protections for Pregnant Women, Prisoners, and Children [(Subparts B, C and D) of 45 CFR 46) DoDD 3216.02, para. 4.4.1; SECNAVINST 3900.39D, para 6a(6)] For purposes of this paragraph, actions authorizing or requiring any action by an official of the Department of Health and Human Services (“DHHS”) shall be under the authority of the Director, Defense Research and Engineering.

      • 2.3.2.1. Subpart B

        • 2.3.2.1.1. The applicability of Subpart B is limited to research involving pregnant women as subjects in research that is more than minimal risk and included interventions or invasive procedures to the woman or fetus or involving fetuses or neonates as subjects.
        • 2.3.2.1.2. For the purpose of applying Subpart B, DoD replaces the phrase “biomedical knowledge” with “generalizable knowledge”.
        • 2.3.2.1.3. Fetal research must comply with US Code Title 42, Chapter 6A, Subchapter 111, part H, 1289g.

      • 2.3.2.2. Subpart C

        • 2.3.2.2.1. Research involving prisoners cannot be reviewed by the expedited review procedure.
        • 2.3.2.2.2. During IRB review, at least one prisoner representative must be present for quorum. The prisoner representative may be a prisoner, an employee of the prison, or an individual not affiliated with the prison.
        • 2.3.2.2.3. Epidemiological research is also allowable when:
          • 2.3.2.2.3.1. The research describes the prevalence or incidence of a disease by identifying all cases or studies potential risk factor association for a disease.
          • 2.3.2.2.3.2. The research presents no more than minimal risk.
          • 2.3.2.2.3.3. The research presents no more than an inconvenience to the participant.
        • 2.3.2.2.4. When a previously enrolled human participant becomes a prisoner, 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:
          • 2.3.2.2.4.1. 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. OR
          • 2.3.2.2.4.2. The IRB chair must require that all research interactions and interventions with the prisoner-subject (including obtaining identifiable private information) cease until the convened IRB can review this request to approve a change in the research protocol.
          • 2.3.2.2.4.3. The convened IRB, upon receipt of notification that a previously enrolled human participant has become a prisoner, must promptly re-review the research protocol to ensure that the rights and wellbeing of the human subject, now a prisoner, are not in jeopardy.
          • 2.3.2.2.4.4. 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.
          • 2.3.2.2.4.5. 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.
        • 2.3.2.3. Subpart D

        The DoD does not apply Subpart D to active duty personnel under the age of 18 years of age, as it considers all active duty military to be adults with legal capacity to consent to participate in DoD supported research. However, in the state of Nebraska, the age of majority is 19 years. Therefore, the Organization restricts participation in DoD research to 19 years of age or older.

        • 2.3.2.4. Other Vulnerable Subjects

        Refer to DoDD 3216.02 for specific requirements.

        If consent is to be obtained from the legal representative of the experimental subjects as defined in DODI 3216.02, the research must intend to benefit each participant enrolled in the study.

    • 2.3.3. Additional Safeguards for Research Conducted with International Populations [DoDD 3216.02 para, 4.9; SECNAVINST 3900.39D, para 6i]

      Research involving human subjects who are not U.S. citizens or DoD personnel, conducted outside the United States, and its territories and possessions requires permission of the host country. The laws, customs, and practices of the host country and those required by this policy will be followed. An ethics review by the host country, or local Naval IRB with host country representation, is required.

    • 2.3.4. Limitation of Waivers and Exceptions from Informed Consent [DoDD 3216.02, para. 4.2; SECNAVINST 3900.39D, para. 6a(3) and 7a(1); 10 U.S.C. 980]

      If the research participant meets the definition of “experimental subject,” a waiver of informed consent is prohibited unless a waiver is obtained from the Assistant Secretary of Defense for Research and Engineering. Research involving a human being as an experimental subject is 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.

      If the research participant does not meet the definition of “experimental subject,” the IRB may waive the requirement to obtain informed consent.

      Note: The Assistant Secretary of Defense for Research and Engineering may waive the requirements for 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 subject,
      • The research is conducted in compliance with all other applicable laws and regulations.

      Note: An exception from consent in emergency medicine research is prohibited unless a waiver is obtained by the Secretary of Defense.

      Waivers of the requirement for informed consent and exceptions from informed consent requirements for emergency research must be approved by the Secretary of the Navy.

      *Note: The IRB cannot waive the requirement for informed consent or grant an exception from informed consent for emergency research unless it has documentation that the Secretary of the Navy has approved it. *

    • 2.3.5. Limitations on Compensation for U.S. Military Personnel [Dual Compensation Act and 24 U.S.C. 30]

      • 2.3.5.1. The Dual Compensation Act prohibits an individual from receiving pay from more than one position for more than an aggregate of 40 hours of work in one calendar week. This prohibition applies to employees paid from either appropriated or non-appropriated funds, or a combination thereof, and includes temporary, part-time and intermittent appointments. This law is not applicable to enlisted off-duty military personnel in relation to their military duty.
      • 2.3.5.2. Federal employees while on duty and non-Federal individuals may be compensated for blood draws for research for up to $50 for each blood draw.
      • 2.3.5.3. 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.

    • 2.3.6. Provisions for Research with Human Subjects using Investigational Test Articles (Drugs, Device and Biologics) [DoDD 3216.02, para 4.9; DoDD 6200.2; SECNAVINST 3900.39D, para. 6h]

      PIs may not be sponsors for INDs and IDEs.

    • 2.3.7. Prohibition of Research with Prisoners of War (POW) and Detainees [DoDD 3216.02, para 4.4.2; SECNAVINST 3900.39D, para. 6a(8)]

      Research involving any person captured, detained, held or otherwise under the control of DoD personnel (military and civilian, or contractor employee) is prohibited.

      Note: The prohibition on research involving a detainee as a human subject does not apply to research involving investigational drugs and devices when the same products would be offered to U.S. Military personnel in the same location for the same condition.

    • 2.3.8. Classified research [SECNAVINST 3900.39D, para 6j]

      Classified research must receive prior approval from the Secretary of Defense and be conducted following the requirements of Instruction 3216.02 13. It is not eligible for review under expedited review procedures, or for a waiver of consent.

    • 2.3.9. Responsibilities

      It is the responsibility of the Principal Investigator to ensure compliance with all additional Department of Defense (DoD)-Department of the Navy (DoN) requirements for human subject protection. It also is the responsibility of the IRB to ensure that all additional Department of Defense (DoD)-Department of the Navy (DoN) requirements for human subject protection have been met before IRB approval of the research project.

    • 2.3.10. Undue Influence [DoDD 3216.02, para.4.4.4]

      For research involving more than minimal risk and also involving military personnel, unit officers and noncommissioned officers (NCOs) shall not influence the decisions of their subordinates to participate or not to participate as research subjects. Unit officers and senior NCOs in the chain of command shall not be present at the time of research subject solicitation and consent during any research recruitment sessions in which members of units under their command are afforded the opportunity to participate as research subjects. When applicable, officers and NCOs so excluded shall be afforded the opportunity to participate as research subjects in a separate recruitment session. During recruitment briefings to a unit where a percentage of the unit is being recruited to participate as a group, an ombudsman not connected in any way with the proposed research or the unit shall be present to monitor that the voluntary nature of individual participants is adequately stressed and that the information provided about the research is adequate and accurate.

3.0 Definitions

  • 3.1. 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 2.19.102(f)]. Research involving a human being as an experimental subject is a subset of research involving human subjects. This definition does not include activities that are not considered research involving human subjects, activities that meet exemption criteria, and research involving the collection or study of existing data, documents, records, or specimens from living individuals.

    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.

  • 3.2. Minimal Risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. This definition of the minimal risk must 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).

  • 3.3. 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 3216.02. These entities include the Office of the Secretary of Defense, the Military Departments, the Chairman of the Joint Chiefs of 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.

  • 3.4. Support of a study generally means the provision of at least a portion of the funding, personnel, facilities, and all other resources. Under this definition, studies that may be wholly funded internally or by a non-DoD component, such as an agency within the Department of Health and Human Services, but focus, for example, on a health concern prevalent in military populations may still fall under DoD purview.

    Such studies may, for example, require the commitment of DoD personnel as subjects, access to or information about DoD personnel for Recruitment, identifiable data or specimens from living individuals, or the use of other DoD data resources.

  • 3.5. Research Monitor refers to an individual designated to oversee a specific protocol that involves more than minimal risk, especially issues of individual subject/patient management and safety. The research monitor functions independently of the research team and shall possess expertise consistent with the nature of risk(s) identified within the research protocol, in order to protect the safety and well-being of human subjects.

  • 3.6. Detainee is defined as any person captured, detained, held or otherwise under the control of DoD personnel (military, civilian, or contractor employee). It does not include persons being held primarily for law enforcement purpose, except where the United States is the occupying power.

  • 3.7. DoD Personnel includes DoD civilian employees and members of the military services, unit officers, and noncommissioned officers (NCOs).

4.0 Procedures

  • 4.1. When reviewing research subject to DoD regulatory requirements, IRB members will be provided with a copy of this policy (HRPP policy 1.14) along with the IRB application, consent form, protocol, and all other related documents.

  • 4.2. The IRB will review the application and complete the Research Subject to Department of Defense Research Regulatory Requirements Checklist and ensure compliance with all applicable DoD requirements, DoN requirements, and HRPP policies.

  • 4.3. Appointment of a Medical (Research) Monitor [DoDD 3216.02, para.4.43]

    • 4.3.1. For research involving more than minimal risk to subjects, an independent medical monitor(s) shall be appointed by name. 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. Monitors shall be independent of the investigative team and shall possess sufficient educational and professional experience to serve as the subject/patient advocate. More than one monitor may be appointed. Note: An individual(s) serving as an ombudsman or a member of the data safety monitoring board may also be appointed as a monitor.
    • 4.3.2. The IRB must approve the monitor(s) and a written summary of the monitor’s duties, authorities and responsibilities.
    • 4.3.3. The IRB Executive Chair/designee will communicate and confirm to the monitor(s) their duties, authorities, and responsibilities.
    • 4.3.4. The duties of a research monitor(s) will be determined on the basis of specific risks or concerns about the research. The monitor has the authority to:
      • 4.3.4.1. Discuss the research study with researchers.
      • 4.3.4.2. Observe subject recruitment and enrollment procedures.
      • 4.3.4.3. Oversee study interventions and interactions.
      • 4.3.4.4. Oversee data collection and analysis.
      • 4.3.4.5. Interview human subjects.
      • 4.3.4.6. Stop a research study in progress.
      • 4.3.4.7. Remove subjects from a study.
      • 4.3.4.8. Take any necessary steps to protect the safety and well-being of subjects until the IRB can assess the monitor’s report.
      • 4.3.4.9. Consult with others outside of the research study.
    • 4.3.5. The research monitor(s) will promptly report to the IRB any findings or concerns related to human subject protection.

  • 4.4. When recruitment involves US military personnel the following requirements apply:

    • 4.4.1. When recruitment involves a percentage of a unit an independent ombudsman is present.
    • 4.4.2. Individuals are prohibited from receiving compensation for participating in research during duty hours.

  • 4.5. Waivers of consent

    • 4.5.1. Waivers of consent are prohibited for classified research.
    • 4.5.2. Waivers of consent must meet the requirements of the Common Rule (HRPP policy 5.2; Waiver or Alteration of Informed Consent and HIPAA Authorization) and DoD approval requirements.

  • 4.6. Navy-Wide Survey Research Requires Additional Review [SECNAVINST 3900.39D, para 6e; OPNAVINST 5300.8B]

    A Privacy Act Statement must be displayed prominently on all Navy personnel surveys without exception regardless of whether personal identifiers are requested. The statement will identify the authority for survey administration (including OPNAV RCS), advise respondents of the purpose and routine uses of the survey, indicate that the survey is voluntary, explain the intended use(s) of the data, and describe measures used to safeguard confidentiality.

  • 4.7. Requirement for Reporting Unanticipated Problems, Adverse Events, and Research Related Injury [SECNAVINST 3900.39.D, para 8d(2), para,. 8e(6), and para. 8g(6)] The IO will report the following to the DoD and DoN Human Research Protections Officer and appropriate sponsor(s) within thirty days the following:

    • 4.7.1. All suspensions or terminations of previously approved DoD and DoN supported research protocols.
    • 4.7.2. The initiation and results of investigations of alleged non-compliance with human subject protections.
    • 4.7.3. Unanticipated problems involving risks to subjects or others, or serious adverse events in DoD and DoN supported research.
    • 4.7.4. All audits, investigations, or inspections of DoD and DoN supported research protocols.
    • 4.7.5. All audits, investigations, or inspections of the institution’s HRPP conducted by outside entities (for example, the FDA or OHRP).
    • 4.7.6. Significant communication between institutions conducting research and other federal departments and agencies regarding compliance and oversight.
    • 4.7.7. All restrictions, suspensions, or terminations of institutions’ assurances.

  • 4.8. Recordkeeping Requirements [DoDD 3216.02, para. 5.3.2; SECNAVINST 3900.39D, para. 8c(18)]

    • 4.8.1. Recordkeeping requirements for DoD/DoN-supported research with human subjects are longer than the Common Rule’s requirement. DOD may require submitting records to DOD for archiving. The ORA will advise investigators accordingly.
    • 4.8.2. Representatives of the DoD/DoN may inspect and copy records at reasonable times and in a reasonable manner.

  • 4.9. Addressing and Reporting Allegations of Non-Compliance with Human Research Protections [DoDD 3216.02, para. 4.10; SECNAVINST 3900.39D, para. 8d(2) and 6k]

    The IO will report the initiation of all investigations and report results regardless of the findings within thirty days to the DoD human protection officer, the Navy Secretary General, and appropriate sponsors.

  • 4.10. Addressing and Reporting Allegations of Research Misconduct [DoDD 3216.02, para. 4.8; DODD 3210.7; SECNAVINST 3900.39D, 8d(2) para. 6l]

    All findings of serious research misconduct under this section shall be reported by the IO to the Director, Defense Research and Engineering.

  • 4.11. Additional Requirements for DoD and DoN Sponsored Research

    • 4.11.1. The DoD Component must conduct an appropriate administrative review of the research involving human subjects. The DoD Component administrative review must be conducted before the research involving human subjects can begin, to ensure compliance with all applicable regulations and policies, including any applicable laws and requirements and cultural sensitivities of a foreign country when the research is conducted in a foreign country.”
    • 4.11.2. New research and substantive scientific amendments to approved research shall undergo scientific review (including review by outside experts as needed) and that the review is considered by the IRB in accordance with HRPP policy 1.10 (Scientific and Other Committee Review of Research).
    • 4.11.3. For DoD-supported non-exempt research involving human participants involving classified information reviewed by a non-DoD IRB, the involvement of classified information may be limited to information needed for IRB approval and oversight of the research; information needed to inform the human participants during the consent process; and information provided by human participants during the course of the research.
    • 4.11.4. Disclosure regarding the provisions for research-related injury follows the requirements of the DoD/DoN component.
    • 4.11.5. The DoD/DoN Protection Officer will be promptly notified (within 30 days) of significant changes to the research approved by the IRB, results of IRB continuing review, and any part of the HRPP under investigation for cause involving a DoD/DoN supported research protocol.
    • 4.11.6. The DoD/DoN Protection Officer will be notified promptly (within 30 days) any change of reviewing IRB.
    • 4.11.7. Surveys performed on DoD/DoN personnel will be submitted, reviewed, and approved by the DoD/DoN after the research protocol is reviewed and approved by the IRB.
    • 4.11.8. DoD institutions collaborating with non-DoD institutions may rely on a collaborating non-DoD institution’s IRB if the following conditions are met:
      • 4.11.8.1. Each institution engaged in non-exempt human participant research must have a current federal assurance of compliance.
      • 4.11.8.2. The involvement of DoD personnel in the conduct of the research is secondary to that of the non-DoD institution.
      • 4.11.8.3. 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.
    • 4.11.9. For DoD sponsored research, the following are required elements that must appear on the informed consent document:
      • 4.11.9.1. A statement that the DoD or a DoD organization is funding the study.
      • 4.11.9.2. A statement that representatives of the DoD are authorized to review research records.
    • 4.11.10. For DoD sponsored research, the following are the required elements that must be found in the consent form:
      • 4.11.10.1. A statement that the DoD or a DoD organization is funding the study.
      • 4.11.10.2. A statement that representatives of the DoD are authorized to review research records.
    • 4.11.11. Civilian researchers attempting to access military volunteers should seek collaboration with a military researcher familiar with service-specific requirements.

ADMINISTRATIVE APPROVAL: BRUCE G. GORDON, MD IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS CHRISTOPHER KRATOCHVIL, MD INSTITUTIONAL OFFICIAL

POLICY AMENDED:

 REVISED MARCH 3, 2018

 INITIAL APRIL 13, 2016

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