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Additional Requirements For Research Involving the Department of Defense (DoD)

Background

In 2006, the Department of the Defense (DoD) enhanced its human subject protection requirements, including the application of those requirements to extramural performers. UCI has signed an addendum with the DoD which requires that UCI apply DoD regulations and policies for the protection of human research participants when conducting, reviewing, approving, overseeing, supporting or managing DoD supported human subject research. The addendum is recognized by all branches of the DoD: the Navy, Army and Air Force. Each branch of the DoD may have their own specific requirements for reviewing research protocols that they support, and these requirements must be followed. For specific branch requirements see below or contact your program officer.

The information in this guidance is for investigators involved in human subjects research supported by or in collaboration with DoD. View the DoD Directive 3216.02.

Copy of the DoD Addendum to UCI's Federalwide Assurance

A copy of the DoD Addenum to UCI's Federalwide Assurance is available should you be required to provide it.

What Qualifies as DoD Research

Human Subject Research involves the DoD when any of the following apply:

  • The research is funded by a component of the DoD (e.g.; Navy, Army, Air Force)
  • The research involves cooperation, collaboration, or other type of agreement with a component of DoD
  • The research uses property, facilities, or assets of a component of DoD
  • The subject population will intentionally include personnel (military or civilian) from a component of DoD
  • Note: DoD policies and requirements do not apply when DoD personnel incidentally participate as subjects in research that is not supported by DoD, and DoD personnel are not an intended population of the research.

Instructions for all DoD Research

When Investigators conducting, reviewing, approving, overseeing, supporting or managing DoD supported research with human subjects (including research that qualifies for exempt status) submit a study to the UCI IRB, the DoD requires that the institution meet the following:

  1. EDUCATION: In addition to completing the UCI HRP education requirements, conduct initial and continuing research ethics education for personnel who are engaged in human subject research. This training must be completed by all study team members initially and on a continuing basis every three years. Documentation of this completion must be uploaded with the e-IRB application.  For the Department of Navy (DoN), completion of the CITI Training + 4 Additional Modules is required.
    For information on DoN education requirements, refer to the attached documents and links:
      Department of Navy - Instructions for Principal Investigator education and training
      Step by Step - Instructions on How to Access the DoN Training Requirements
      Step by Step - Instructions on how to Access the DoN CITI Refresher Course
      DoN Education and Training Policy for Research Ethics and the Responsible Conduct of Research
        Research under the purview of the Under Secretary of State (Personnel and Readiness): Requires annual training on human subject protections for all investigators and research staff directly involved in human subject research. Be prepared to document how annual human subject protection training is maintained.
        For other military branches (e.g. Army, Air Force), contact your program officer for specific information about their respective education requirements.
      • SCIENTIFIC MERIT: New research and substantive scientific amendments to approved research shall undergo scientific review and the review is considered by the IRB. Upload evidence of this approval with your e-IRB application (scientific review and approval by PRMC or by the IRB through BERD does suffice for this requirement but must occur prior to IRB review). In the absence of an external review or an established internal review mechanism, you should make arrangements with your chair or dean for an ad hoc scientific review.  Information on DoN requirements regarding SecNav Instruction 3900.39D are available online.  For other military branches (e.g. Army, Air Force), contact your program officer for specific information about their respective scientific merit requirements.
      • MEDICAL MONITOR: Appoint a medical monitor when appropriate for studies involving more than minimal risk to subjects. See page 4 of the DoD Directive for specific guidance related to this requirement.
      • INTERNATIONAL RESEARCH: Safeguard for research conducted with international populations. Information on DoN requirements regarding SecNav Instruction 3900.39D are available online. For other military branches (e.g. Army, Air Force), contact your program officer for specific information about their respective requirements.
      • VULNERABLE POPULATIONS: Protect pregnant women, prisoners and children
      • Ensure additional protections for military research subjects to minimize undue influence
      • COGNITIVE IMPAIRMENT: If research involves cognitively impaired adults, there is a direct benefit to the subject
      • LEGALLY AUTHORIZED REPRESENTATIVE: Comply with DoD limitations on research where consent by legally authorized representatives is proposed
      • WAIVER OF CONSENT: Comply with DoD limitations on exceptions from informed consent. If the research involves interventions or interactions with subjects the research does not involve a waiver of consent or parental permission unless a waiver is obtained from the Secretary of Defense.  Information on DoN requirements regarding SecNav Instruction 3900.39D are available online.
        For other military branches (e.g. Army, Air Force), contact your program officer for specific information about their respective requirements.
      • COMPENSATION: Comply with limitations on dual compensation for U.S. military personnel.
      • SURVEY RESEARCH: Follow DoD requirements for additional review for DoD-sponsored survey research or survey research within DoD. Research involving the administration of surveys to, or interviews of, DoD personnel (military or civilian) may require DoD approval of the surveys or interview questions. This involves research where DoD personnel and civilian personnel (working with the DoD) are asked to complete surveys; not when researchers funded by the DoD are conducting survey on non-DoD personnel.
        Survey requirements are different depending on the branch of the DoD. For Air Force requirements, contact your program officer.
        Please follow the below specific guidance, as applicable: Army:
        Request for Approval to Survey Department of Army Form
        Obtaining Approval for a Survey of U.S. Army Personnel
        Navy:
        Navy Survey Policy
        DoD Wide:
        DoD Instruction on Surveys of Military Personnel (surveys across branches of the DoD)
      • COMPLIANCE AND MISCONDUCT: Address and report allegations of non-compliance with human research protections.
      • Address and report allegations of research misconduct.
      • Support oversight by the sponsoring DoD component.
      • CONFLICT OF INTEREST: Follow procedures for addressing financial and other conflicts of interest.
      • POWS: Prohibit research with Prisoners of War (POW). This includes any person captured, detained, held or otherwise under the control of the DoD personnel (military and civilian or contractor employee). Including; enemy prisoners, civilian internees, retained persons and lawful and unlawful combatants. Such persons do not include DoD personnel being held for law enforcement purposes.
      • DRUGS, DEVICES AND BIOLOGICS: Comply with all provisions for research with human subjects using investigational test articles (drugs, device and biologics).
      • DOCUMENTATION: Follow recordkeeping requirements (see below).
      • Document determination by a designated Institutional Official (other than the investigators) whether research meets the criteria for exemption.
      • INJURY AND ADVERSE EVENTS: Explain to subjects any provisions for medical care for research-related injury.
      • Report unanticipated problems, adverse events, research-related injury and suspensions or terminations of research.

UCI IRB DoD Supplement Form

All new UCI IRB applications for research that involves the DoD must include this Supplement Form as an attachment. The Supplement Form includes additional submission requirements so please review this form thoroughly and complete any additional required information as needed.

  • Lead Researcher and Co-investigator CVs
  • Data Collection Forms/Case Report Forms
  • FDA letter for IND or IDE
  • FDA Form 1571 and FDA Form 1572

Post-Approval Instructions

Documentation

Principal Investigators (PIs) and the UCI HRP are responsible for maintaining certain documentation in their files. PIs are also responsible for submitting documentation to DoD prior to starting an IRB-approved study and upon subsequent reviews by the IRB (addenda, continuing reviews, etc.). DoD uses such documentation to conduct a "headquarters-level administrative review." DoD HRPP requires certain IRB documentation that is not maintained by the PI (such as IRB meeting minutes). These items will be sent directly from the UCI HRP to DoD. UCI HRP will notify the PI when these documents are sent.

For instance, the Department of Navy (DoN) has documentation requirements. For other military branches (e.g. Army, Air Force), contact your program officer for specific information about their respective requirements.

For more information on DoN documentation requirements, refer to the following links:

IRB Reporting Requirements

The IRB may be required to notify DoN and the sponsor (if there is a non-DoN sponsor) of serious adverse events, non-compliance, unanticipated problems involving risks to subjects or other and protocol deviations and actions taken regarding the reports.

The DoN must be notified of any audits, investigations or inspections of DoN – supported research. The IRB will report such inspections to DoN only when the IRB conduct or are aware of the inspection.

DoN HRPP requires certain IRB documentation that is not maintained by the PI (e.g. IRB meeting minutes). These items will be sent directly from the IRB to DoN generally within 1 week of IRB approval. The IRB will provide the PI with a copy of the correspondence (without the attached documentation).

The contact information for submission to ONR is provided at the ONR website above.

The contact information for submission to the DoN HRPP is:

Department of the Navy
Office of Research Protection (M00R)
Bureau of Medicine and Surgery
2300 E St., NW
Washington, DC 20372-5300
Fax: 202-762-0976 E-Mail: human.research@med.navy.mil

Modifications to Approved Research

When submitting modifications to previously approved research, review your Defense Supplement to ensure that it still accurately reflects the research. Submit a revised supplement (and any additional documentation) if necessary.

If the modification involves substantive changes (e.g., new procedures, a new subject population), also submit documentation of scientific review and approval of the changes with the modification request as per item # 3 above.

Additional Information

If you have questions regarding DoD requirements or branch specific requirements (other than what is provided here), please contact your program officer.

As always, HRP Staff are available for any questions or to assist with requests for additional information.

For reference, review the following links:

General Information / Links for DoN

List and Citations of Key Defense Protections

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