Skip to main content

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),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 DirectiveInstruction (DoDD)DoDI) 3216.0202, 15 April 2020.
    • 2.2.4. Title 21 Code of Federal Regulations 50, 56, 312, and 812, Food and Drug Administration (FDA) Regulations
    • 2.2.5. DoDDDoDI 3216.02, “Protection of Human Subjects and Adherence to Ethical Standards in DoD-supportedConducted and -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. DoDI 1100.13, “DoD Surveys”, March 31, 2017.
    • 2.2.10. When conducting research supported by the Department of the Navy
      • 2.2.9.10.1. SECNAVINST 3900.39D39E of 629 NovemberMay 20062018
      • 2.2.9.10.2. SECNAVINST 5720.44B of 1 November 2005
      • 2.2.9.3. SECNAV M-5210.1 of 1 December 2005
      • 2.2.9.4. OPNAVINST 5300.8B8C of 2324 April 19972008

  • 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.Requirements ForIn initialaddition to investigator and continuing research ethicsstaff education for all personnel who conduct, review, approve, oversee, support, or manage human participant research, there may be specific DoD educationaltraining requirements oras certification required. All research personnel must complete trainingdescribed in accordance with HRPP policy #1.1.23 (HRPP Training Requirements and Opportunities for Research Personnel)., Init addition,is anythe otherPrincipal specificInvestigator’s trainingresponsibility willto beensure determinedthat research staff has completed all appropriate educational requirements as mandated by theDoD ORA.
        • policy.
      • (per 2.3.1.2.DoDI If3216.02, during15 theApril process of submission2020, or duringlater; 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.
      http://www.onr.navy.mil/About-ONR/compliance-protections/Research-Protections/Research-Protection-Training-References.aspx.)

    • 2.3.2. Additional Protections for Pregnant Women, Prisoners, and Children [(Subparts B, C and D) of 45 CFR 46) DoDD 3216.02, para.section 3.9] In addition to protections described in HRPP policies 4.2 (Research Involving Pregnant Women, Human Fetuses, and Neonates), 4.1;3 SECNAVINST(Research 3900.39D,Involving paraPrisoners), 6a(6)]4.4 For(Research purposesInvolving ofChildren), thisand paragraph,other actionspolicies authorizingas or requiring any action by an official ofapplicable, the Departmentfollowing ofadditional Healthprotections and Human Services (“DHHS”) shall be under the authority of the Director, Defense Research and Engineering.apply:

      • 2.3.2.1. SubpartRegarding Research Involving Pregnant Women and Human Fetuses: Research involving pregnant women, fetuses, or neonates as human subjects must comply with 45 CFR 46 subpart B

          except
        • as 2.3.2.1.1.below: (1) For purposes of applying this section, the phrase “biomedical knowledge” is replaced with “generalizable knowledge.” (2) The applicability of Subpart45 CFR 46 subpart B is limited to research involving pregnant women as human subjects involved in researchHSR that is moregreater than minimal riskrisk, and includedincludes interventionsinterventions, as defined in 32 CFR 219, or invasive procedures toinvolving: the(a) The woman or fetusthe fetus; or involving(b) fetusesFetuses or neonates as human subjects.
        • (3) 2.3.2.1.2.HSR Forusing thefetal purpose of applying Subpart B, DoD replaces the phrase “biomedical knowledge” with “generalizable knowledge”.
        • 2.3.2.1.3. Fetal researchtissue must comply with USSections Code289g–289g-2 of Title 42, Chapter 6A, Subchapter 111, part H, 1289g.
        U.S.C.

      • 2.3.2.2. SubpartRegarding Research Involving Prisoners Research involving prisoners as human subjects must comply with 45 CFR 46 subpart C except as below:

        • 2.3.2.2.1. ResearchIn addition to the categories of permissible HSR involving prisoners cannotidentified in 45 CFR 46 subpart C two additional categories are permissible: (a) Epidemiological research that meets the waiver criteria in accordance with Federal Register 68: 36929-36931, may be reviewedapproved in accordance with the applicable requirements of 45 CFR 46 subpart C, DoDI 3612.02 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 expeditedrequirements reviewin procedure.45 CFR 46 subpart C, DoDI 3612.02, and other applicable requirements.
        • 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 participantsubject becomes a prisoner, ifand the researcherprotocol assertshas tonot been reviewed and approved by the IRB in accordance with 45 CFR 46 subpart C, the PI must promptly notify the IRB., and the Organization must notify the Human Research Protection Official (HRPO).
          • 2.3.2.2.2.1. All research interactions and interventions with the prisoner-subject (including obtaining identifiable private information) must cease until and unless: The IRB Executive Chair or designee determines that it is in the best interest of the prisoner-participant to continue to participate in the research while a prisoner:prisoner.
              In
            • this 2.3.2.2.4.1. The IRB chair may determine thatcase, 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.; ORor The convened IRB review and approves the protocol in accordance with 45 CFR 46 subpart C, DoDI 3612.02, and HRPP policy 4.3 (Research Involving Prisoners).
          • 2.3.2.2.3. Research may not involve detainees, unless the research involves an investigational drug or device when the same product would be offered to members of the US military in the same location for the same medical condition.
          • 2.3.2.2.4.2. TheResearch IRBmay chairnot mustinvolve requirePrisoners thatof 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.War.
          • 2.3.2.2.4.3.5. TheResearch convenedinvolving IRB,prisoners uponcannot receiptbe ofreviewed notification that a previously enrolled human participant has become a prisoner, must promptly re-reviewby the researchexpedited protocolreview toprocedure.
            • 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. SubpartRegarding DResearch

        • Involving
      Children

      Research involving children as human subjects must comply with 45 CFR 45 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 militaryservice members and all reserve component members in a Federal duty status to be adultsadults; withand legaltherefore capacitynot subject to consentthe toprotections participateof in45 DoDCFR supported46 research.subpart D. 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 [DoDDIn 3216.02addition para,to 4.9;the SECNAVINSTrequirements 3900.39D,described parain 6i]HRPP policy 1.5 (Requirements for Research Conducted at International Sites) the following apply:

    • 2.3.3.1. 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.
    • 2.3.3.2. The laws,institution customs,shall confirm that all applicable national laws and practicesrequirements of the hostforeign country andhave thosebeen requiredmet. byThe thisIRB policyshall also consider the cultural sensitivities in the setting where the research will betake followed.place An(SECNAVINST ethics3900.39E, reviewsection by3d).
      • 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]

    • 2.3.4.1. 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 (or the Secretary of the Navy for Researchresearch andsubject Engineering.to Department of the Navy requirements).
      • 2.3.4.1.1. 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.

    • 2.3.4.2. 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 emergencyaccordance medicinewith researchHRPP ispolicy prohibited5.2 unless(Waiver aor waiver is obtained by the SecretaryAlteration of Defense.

      Informed

      Waivers of the requirement for informed consentConsent and exceptionsHIPAA fromAuthorization).

      • 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(including non-Federalmilitary individualspersonnel) may be compensated for blood draws for research for up to $50 for each blood draw. Compensation is not allowed for general research participation.
    • 2.3.5.2. Federal employees while off-duty (including military personnel) may be compensated for blood draws for research for up to $50 for each blood draw. Compensation is allowed for general research participation, as approved by the IRB; however, payment may not come directly from a federal source.
    • 2.3.5.3. Non-Federal personspersonnel may be compensated for research participation other than blood draws infor aresearch reasonablefor amountup to $50 for each blood draw. Compensation is allowed for general research participation, as approved by the IRBIRB; accordingpayment tomay localcome prevailingfrom ratesany andfederal theor naturenon-federal of the research.source.

  • 2.3.6. Requirements for Informed Consent Forms In addition to requirements described in HRPP policy 5.1 (Obtaining Informed Consent From Research Subjects) the following apply:

    • 2.3.6.1. If the research includes any risks to the fitness for duty for DoD personnel (e.g. health, availability to perform job, data breach), the informed consent document must inform DoD-affiliated personnel about these risks and that they should seek command or Component guidance before participating.
    • 2.3.6.2. The informed consent document must include, if applicable, potential risks for the revocation of clearance, credentials, or other privileged access or duty
    • 2.3.6.3. The informed consent document must include a statement that the DoD or a DoD organization is funding the study, and a statement that representatives of the DoD are authorized to review research records.

  • 2.3.7. 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.

  • 2.3.7.8. Prohibition ofClassified 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.

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

      Classified research must receive prior approval from the SecretaryDoD ofOffice Defensefor andHuman Research Protections.

    • 2.3.8.2. Classified research will be conducted following the requirements of DoD Instruction 3216.02 section 3.13.
      • It
    • 2.3.8.3. Classified research 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

    • 2.3.9.2. researchSuperiors involvingare moreprohibited thanfrom minimal risk and also involving military personnel, unit officers and noncommissioned officers (NCOs) shall not influenceinfluencing the decisions of their subordinates toregarding participate or not to participateparticipation as research subjects. Unit officers and senior NCOssubjects in theresearch chaininvolving ofhuman commandsubjects and shall not be present at theany time of researchhuman subject solicitation and consent during any research recruitment sessions inor whichduring the consent process.
    • 2.3.9.3. For research involving service members ofas unitshuman undersubjects theirthat commandhas arebeen afforded the opportunitydetermined to participatebe asgreater researchthan subjects.minimal When applicable, officersrisk and NCOswhen sorecruitment excluded shall be afforded the opportunity to participate as research subjectsoccurs in a separategroup recruitment session. During recruitment briefings to a unit where a percentage ofsetting, the unitIRB isshall being recruited to participate as a group,appoint an ombudsman. The ombudsman shall not connectedbe associated in any way withto the proposed research or the unitand shall be present during the recruitment in order to monitor that the voluntary natureinvolvement or recruitment of individualthe participantsService members is clearly and adequately stressed and that the information provided about the research is adequateclear, adequate, and accurate.

    • 2.3.9.4. For research involving service members as human subjects, that has been determined to be NO greater than minimal risk and when recruitment occurs in a group setting, and for research involving DoD civilians, the IRB shall determine when it is appropriate to appoint an ombudsman for the purposes described above. The decision to require the appointment of an ombudsman should be based in part on the human subject population, the consent process, and the recruitment strategy.

3.0 Definitions

  • 2.3.10. Requirements for Research Related Injury

    • 2.3.10.1. ResearchConsent Involvingfor DoD-supported research that is greater than minimal risk must include information about available compensation or medical treatments if a Humanresearch-related Beinginjury asoccurs.
      • an
    • 2.3.10.2. Experimental Subject is defined as an activity, forFor research purposes,subject whereto there is an intervention or interaction with a human being for the primary purpose of obtaining data regarding the effectDepartment of the interventionNavy (DON) requirements, every project involving greater than minimal risk shall include an arrangement for emergency treatment and necessary follow-up of any research-related injury. The IRB will determine whether research involving minimal risk also might include a similar arrangement for research-related injury.

  • 2.3.11. Requirements for Reporting

    • 2.3.11.1. When participating in DoD supported non-exempt human subject research, the organization must provide 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; and (4) current FWA and IRB registration numbers.
    • 2.3.11.2. When participating in DoD supported exempt human subject research, the organization must submit institutional documentation of the determination that the research is exempt HSR to the HRPO, to include all protocol documents.
    • 2.3.11.3. When participating in DoD supported non-exempt human subject research the Organization must promptly notify the HRPO of the following:
      • 2.3.11.3.1. IRB-approved changes to HSR that involve changes to key investigators or interactioninstitutions; [decreased benefit or increased risk to subjects in greater than minimal risk research as defined in 32 CFR 219; addition of vulnerable populations, or DoD-affiliated personnel as subjects.
      • 2.19.102(f)].3.11.3.2. ResearchTransfer of HSR oversight to a different IRB.
      • 2.3.11.3.3. 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.
      • 2.3.11.3.4. 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.
      • 2.3.11.3.5. The results of the IRB’s continuing review, if required.
      • 2.3.11.3.6. Change in status when a previously enrolled human beingsubject asbecomes anpregnant, experimentalor 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 45 CFR 46 subpart B.
      • 2.3.11.3.7. Change in status when a subsetpreviously ofenrolled human subject becomes a prisoner, and the protocol was not reviewed and approved by the IRB in accordance with 45 CFR 46 subpart C.
      • 2.3.11.3.8. A DoD-supported study’s closure.
    • 2.3.11.4. When participating in DoD supported non-exempt human subject research involvingthe Organization must make records that document compliance or noncompliance with DoDI 3612.02 accessible for inspection and copying, as determined by DoD Human Research Protection Program personnel, by authorized DoD representatives.
    • 2.3.11.5. When participating in DoN supported non-exempt human subjects.subject This definition does not include activities that are not considered research involving human subjects, activities that meet exemption criteria, and research involvingresearch, the collectionorganization ormust studyinform ofthe existing data, documents, records, or specimens from living individuals.

      Examples include, but are not limited to, a physical procedure, a drug, a manipulationDepartment of the subjectNavy (DON) HRPP Office (within 30 days of the incident) of any of the following:

      • 2.3.11.5.1. The initiation and results of investigations into allegations of noncompliance.
      • 2.3.11.5.2. Serious adverse events; or subject’saudits, environment,investigations, or inspections of research.
      • 2.3.11.5.3. Audits, investigations, or inspections of the withholdingOrganization HRPP conducted by outside entities.
      • 2.3.11.5.4. Significant communication between institutions conducting research and other federal departments and agencies regarding compliance and oversight.
      • 2.3.11.5.5. All restrictions, suspensions, or terminations of anthe interventionOrganization thatassurances.
        • would
      • have
    • been
  • undertaken

    2.3.12. if notRequirements for thea Medical Monitor For DoD-supported research, prior to April 15, 2020, a named independent research purpose.monitor was required for greater than minimal risk research and was optional for minimal risk research. As of April 15, 2020, a research monitor is no longer required by the DoD for DoD-supported research, regardless of risk level.

  • 2.3.2.13. Requirements for Survey Research MinimalThe RiskPrincipal meansInvestigator thatfor any DoD-supported research involving surveys is responsible for arranging for 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 definitionreview of the minimalsurvey riskby mustthe notappropriate beDoD interpretedcomponent. This review is in addition to includereview by the inherentIRB. risks certain categories of human subjects face in their everyday life.

    For example,DON thefunded risks imposed insurvey 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.surveys. 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.confidentiality (OPNAVINST 5300.8C).

  • 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. Additional14. Requirements for DoD and DoN Sponsored Research

    • 4.11.1.Oversight The HRPP will support the oversight by the sponsoring DoD Componentcomponent, mustincluding conductcommunicating anto appropriatethe administrativesponsoring reviewDoD component about:

      • 2.3.14.1. information needed to assure that the approval of the initial submission is in compliance with all applicable requirements; and
      • 2.3.14.2. IRB-approved substantive changes, including a notification that the Principal Investigator is informed that the changes cannot be implemented prior to acceptance by the sponsoring DoD component; and
      • 2.3.14.3. the results of the continuing review; and
      • 2.3.14.4. other information reported as required by section 2.3.11 (Requirements for Reporting) above.

3.0 Definitions

  • 3.1. For DoD supported research, the following definitions apply (and supersede definitions in other HRPP policies)
    • 3.1.1. 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.
    • 3.1.2. Minimal Risk - 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 (32 CFR 219). This definition does not include 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 (DoDI 3216.02 section 3.8b).
    • 3.1.3. 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 Instructions (DoDI) 3216.02. These entities include the Office of the Secretary of Defense (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.
    • 3.1.4. Support of a Study - 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.
    • 3.1.5. Detainee - any individual captured by, or transferred to the custody or control of, DoD personnel pursuant to the law of war. This does not include persons being held solely for law enforcement purposes, except where the United States is the occupying power. Detainees who are U.S. citizens or U.S. resident aliens will continue to enjoy all applicable rights and privileges under U.S. law and DoD regulations (DoDD 2310.01E).
    • 3.1.6. DoD Personnel - Service members, Reserve Service members, National Guard members, DoD civilians, and DoD contractors. (DoDI 3216.02).
    • 3.1.7. 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.
    • 3.1.8. Human Research Protection Official (HRPO) - A federal employee designated by a DoD Component or institution to conduct administrative review mustof DoD-supported research and whose review of DoD-supported research is intended to ensure compliance with DoD HSR requirements.

4.0 Procedures

  • 4.1. When reviewing research subject to DoD regulatory requirements, IRB members will be conductedprovided beforewith a copy of this policy (HRPP policy 1.14) along with the researchIRB involvingapplication, humanconsent subjectsform, canprotocol, begin,and all other related documents.
  • 4.2. The IRB will review the application and consult the Research Subject to Department of Defense Research Regulatory Requirements Checklist to ensure compliance with all applicable regulationsDoD andrequirements, policies,DoN including any applicable lawsrequirements, and requirements of this and culturalall sensitivitiesother HRPP policies.
  • 4.3. As appropriate and required (per section 2.3.9 above) the IRB will appoint an ombudsman to protect the rights of aservice foreignmembers.
    • country
  • 4.4. whenThe IRB Administrator responsible for the researchprotocol iswill 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) andassure that the PI has:
    Notified appropriate DoD entities, as described above, and confirmed that the DoD component has conducted an administrative review isas consideredrequired by theDoDI 3612.02 section 3.5b.
  • 4.5. The IRB inadministrator accordanceresponsible withfor HRPPthe policyprotocol 1.10will: (ScientificAssure andthe OtherOrganization Committeehas Reviewa ofvalid Research).
    • FWA
  • as 4.11.3. For DoD-supported non-exempt research involving human participants involving classified information reviewedrequired by aDoDI non-DoD3612.02 IRB,section the3.4a. involvementAssure 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 followsthat the requirements of this policy are met. Assure that the DoD/DoNinformed component.
    • consent
  • form 4.11.5.complies Thewith DoD/DoN Protection Officer will be promptly notified (within 30 days)provisions of significantsection changes2.3.6 to the research approved by the IRB, results of IRB continuing review, and any part of the HRPP under investigation(Requirements for causeInformed involvingConsent aForms) DoD/DoNabove. supportedMake 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 priorreports to the DoD institution’s(or engagement inhave the research.PI make reports to the DoD) as described above.

  • 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, MDMD; IRB EXECUTIVE CHAIR & ASSISTANT VICE CHANCELLOR FOR REGULATORY AFFAIRS
CHRISTOPHER KRATOCHVIL, MDMD; INSTITUTIONAL OFFICIAL

POLICY AMENDED:

  • Revised June 4, 2021 - Reorganized; extensive revisions based on revisions to DoDI 3216.02, 15 April 2020, SECNAVINST 3900.39E, 29 May 2018,
  • REVISED MARCH 3, 2018

  • INITIAL APRIL 13, 2016

Back to top