HRPP Manual Section 12-11

U.S. Department of Defense Requirements: U.S. Navy

The Navy has issued SECNAVINST 3900.39E CH-1, Human Research Protection Program (29 May 2018) to establish policy and assign responsibility for the protection of human subjects in research conducted or supported by the Department of the Navy.

This guidance provides Department of Navy requirements in addition to the DoD Instruction. Relevant sections of the SECNAVINST 3900.39E CH-1 are included below; however, see SECNAVINST 3900.39E CH-1 for full requirements. When the SECNAVINST 3900.39E CH-1 applies to an IRB submission, the IRB Administrator will also work with the PI to assure requirements specific to the SECNAVINST 3900.39E CH-1 are met.


SECNAVINST 3900.39E CH-1 applies to all Department of Navy-conducted or -supported research involving human subjects. This includes activities such as:

  • Research, Development, Testing, and Evaluation (RDT&E) that meet the definition of research involving human subjects

  • Clinical investigations or medical activities regulated by the Food and Drug Administration (FDA)

  • Activities including social-behavioral, educational, and human factors research that meet the definition of research involving human subjects.

See SECNAVINST 3900.39E CH-1 for exclusions.

While SECNAVINST 3900.39E CH-1 does not apply to research using cadavers, institutions proposing to support or conduct this research shall meet requirements for scientific merit, comply with applicable State and local laws regulating organ donation for science or research, and verify that the research is limited to cadavers.

DON Supported Research

Under SECNAVINST 3900.39E CH-1, an activity is not considered to be DON-supported:

  • When DON personnel have been formally granted authorization to pursue an outside activity that is separate from their DON position and which does not otherwise involve the DON.

  • When DON personnel are in an off-duty status or otherwise not working in a DON capacity or conducting research under a DoD-DON Assurance.

  • Legal transfer through sale or donation of a piece of equipment from the DON to an outside organization, which would sever the relationship to the DON, would not be considered to be DON-supported if the transfer is not for the purpose of enabling a specific human subject research protocol.

Research in Foreign Countries

When the research is conducted outside of the United States, it must also comply with applicable requirements of the foreign country and its national laws and requirements.

In the event of an unresolved conflict between this instruction, including its references and other applicable laws and requirements, such that compliance with both is impossible, the requirements most protective of the human subjects shall be followed.

When there is an unresolved conflict, DON institutions shall consult with their legal counsel and coordinate with the Director, DON Human Research Protection Program (HRPP) to seek guidance from the Assistant Secretary of Defense for Research and Engineering (ASD(R&E)).

When the research involving human subjects is being conducted in a foreign country, the following requirements must be met:

  • Confirm all applicable national laws and requirements of the foreign country have been met

  • IRB shall consider the cultural sensitivities in the setting where the research will take place.

  • IRB shall seek information on any issues specific to the targeted population (e.g., cultural sensitivities, religious issues, language) that may add risk to the research.

Strategies that a non-DoD institution may use to confirm that all applicable national laws and requirements of the foreign country have been met may include, but are not limited to:

  • Establishing collaborative relationships with a foreign university or institution

  • Consulting with the country’s health ministry, consulate, or embassy, working with NGOs or CBOs in the area where the research will be conducted, or with researchers independent of the research team who are experienced in conducting research involving human subjects in the country where the work will take place.

  • Additionally, information about laws and guidelines in a number of countries can be found in the Office of Human Research Protections (OHRP) International Compilation of Human Research Standards.

Non-DoD institutions shall document compliance with these requirements and provide supporting materials to the HRPO.

Testing of Chemical or Biological Warfare Agents

Research involving human subjects for testing of chemical or biological warfare agents is generally prohibited, subject to possible exceptions for research for prophylactic, protective, or other peaceful purposes.

Research Involving the Use of Investigational Test Articles

All research involving the use of investigational test articles (drugs, devices and biologics) shall comply with applicable FDA regulations.

In addition, the following requirements apply:

  • An Investigational New Drug (IND) application or an Investigational Device Exemption (IDE) must be filed with the FDA whenever research involving human subjects is conducted outside the United States with drugs, devices or biologics, which would require filing of an IND or an IDE if the research were conducted in the United States.

  • The Surgeon General of the Navy (Navy SG), Commanders, and Commanding Officers may serve as sponsors for INDs and IDEs.

  • The Navy SG may consider an IND/IDE equivalency in circumstances where the requirements may not be possible or feasible in international research.

  • Investigators may not be designated as sponsors for INDs and IDEs.

  • The IND determination for nutritional or dietary supplements under “Food, Drug, and Cosmetic Act,” 21 U.S.C. 321 (ff), the “Dietary Supplement Health and Education Act of 1994,” Public Law 103-417 and the “FDA Food Safety Modernization Act,” Public Law 111-353, is based on the intent of the clinical investigation. If a clinical investigation is intended to evaluate the dietary supplements’ (e.g., vitamins, minerals, amino acids, botanicals, etc.) or over-the-counter drugs’ ability to diagnose, cure, mitigate, treat, or prevent a disease, an IND is required per reference (d), unless the FDA determines otherwise.

  • When it is uncertain whether an IND is required, it is recommended that the Principal Investigator contact the appropriate review division in the appropriate FDA Center for advice.

Scientific Review

Scientific review of non-exempt research involving human subjects is an independent review that must be conducted prior to IRB review. Scientific review can be conducted in a variety of ways appropriate to the research and the Command. The review can be conducted by a group such as a committee or board, or by single knowledgeable individual(s). At a minimum, scientific review must meet applicable conflict of interest rules and regulations, and should consider the significance of the research, the adequacy of the approach used in the research and the competence of the investigator to conduct such research.


DON institutions seeking to rely upon a non-DoD institution’s IRB should work with the Director, DON HRPP in advance of the submission of the DON Component administrative review package to ensure the arrangement is appropriate.

HRPO Review

In addition to documents identified in DoD Instruction 3216.02, the non-DoD institution must submit to program office personnel and to the HRPO:

  • Documentation of special determinations such as waivers made by the IRB when the IRB approves protocols recruiting populations such as pregnant women, prisoners, children, DoD personnel.

  • An IRB approved informed consent document (if not included in the protocol), except when not required consistent with law and regulation.

The non-DoD institution shall submit required documentation for the HRPO’s review and consideration, including significant and substantive changes

A significant change means an amendment to research conducted by a non-DoD institution that requires prompt notification to the HRPO. This includes all substantive changes (see “substantive change”), including change in PI, major non-administrative amendments (e.g., changes in protocol design) and administrative changes that affect the HRPO’s ability to adequately oversee the research.

A substantive change means an amendment to research conducted by a non-DoD institution that requires HRPO review and acceptance after IRB review to ensure continuing compliance with applicable DoD and DON requirements. Substantive changes are a subset of significant changes. This includes but is not limited to:

  • Addition of any condition identified in SECNAVINST 3900.39E CH-1

  • Addition of any condition that may impact issues initially reviewed by the HRPO including:

    • Addition of personnel representing institutions not identified upon initial HRPO review.

    • Change in the IRB’s review procedure (e.g., from exempt to expedited, expedited to convened board, etc.).

    • Change in research related activities that significantly affects an assessment of the risks and benefits of the study or substantially changes the specific aims or design of the study.

    • Addition of subjects who cannot provide informed consent

    • Addition of a research site in a foreign country and will include non-DoD personnel or non-U.S. citizens as human subjects.

When DON Personnel are Targeted Subject Population

When DON personnel are the targeted subject population, the IRB shall review and approve the recruitment process to ensure compliance with DoD and DON requirements.

A DON IRB review of research being conducted by a non-DoD institution is not required solely because DON personnel are the targeted subject population. Other additional reviews are discouraged.

When the research is supported by the DON and the targeted subject population consists of DoD personnel, written DoD institutional permission is required before the research can begin.

Additional Protections for Confidentiality

Proposals for using the authority under the Confidential Information Protection and

Statistical Efficiency Act (CIPSEA) or a Certificate of Confidentiality shall be coordinated in advance with the Director, DON HRPP.

Applicability to Other Requirements

Research shall not begin until there is IRB approval, all other approvals are in place (e.g., surveys, radiation safety), and institutional approval has been obtained.

Additionally, research involving human subjects may be subject to other Federal, DoD, or DON requirements such as DoDI 1000.30, “Reduction of Social Security Number Use Within DoD,” DoD 6025.18-R, “DoD Health Information Privacy Regulation,” DoD 5400.11-R, "Department of Defense Privacy Program," SECNAVINST 5211.5E, “DON Privacy Program.”


SECNAVINST 3900.39E CH-1 provides the following definitions related to noncompliance:

  • Continuing Non-compliance. A pattern of non-compliance (see non-compliance) that suggests the likelihood that, without intervention, instances of non-compliance will recur. A repeated unwillingness to comply with this instruction or a persistent lack of knowledge of how to comply with this instruction.

  • Non-compliance. Failure of a person, group or institution to act in accordance with this instruction, its references or applicable requirements.

  • Serious Noncompliance. Failure of a person, group, or institution to act in accordance with this instruction and its references such that the failure could adversely affect the rights, safety, or welfare of a human subject; place a human subject at increased risk of harm; cause harm to a human subject; affect a human subject’s willingness to participate in research; or damage or compromise the scientific integrity of research data.

This guidance document supersedes those previously drafted.

Version Date: 9-21-2022

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