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Human Research Protections

In January 2017, the modernized Federal Regulation concerning the “Protection of Human Subjects” was published, with the intent to reduce regulatory burden, calibrate the level of oversight to the level of risk to subjects and to catch up to advances in science and technology.  The Department of Defense (DoD) is currently working to update its policies to meet the new regulatory standards.  This site will be updated once the DoD policies are implemented.

The Department of Defense (DoD), the Office of the Assistant Secretary of Defense for Health Affairs (OASD[HA]) and the Defense Health Agency (DHA) support and encourage research, including human subjects research. All research protocols that include human subjects must be compliant with Federal laws, Federal Regulations and DoD policies intended to protect the volunteer subjects who participate in the studies.

  • All documents for review must be submitted using the Electronic Institutional Review Board (EIRB). Information on accessing the EIRB system and submitting documents for review can be found by following the link above.

This page describes the implementation of the Human Research Protection Program within OASD(HA) and DHA.  If you have questions, then please contact us at DHA.HRPP@mail.mil

The overarching Regulation governing the Protection of Human Subjects in federally-funded research is referred to as the “Common Rule,” because most Federal Departments and Agencies that support human subjects research, including the DoD, have adopted this regulatory framework. The DoD adopted the Common Rule through Part 219 of Title 32 of the Code of Federal Regulation (32 CFR 219). Within the DoD, that Regulation is implemented by DoD Instruction (DoDI) 3216.02 (“Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research”).

If your protocol involves U.S. Food and Drug Administration (FDA)-regulated activities, then it must comply with the FDA’s regulations regarding:

The foundation of HRPP compliance review is the Institutional Review Board (IRB).  Neither OASD(HA) nor DHA Headquarters (HQ) has an IRB.  Within the DHA, the Walter Reed National Military Medical Center maintains multiple IRBs, so non-exempt studies that originate within OASD(HA) or DHA  are reviewed by those IRBs.  

Many studies do not require IRB review.  In those cases, our office provides the following review and consultative services: 

  • Human Subject and/or Research Determination
  • Exemption Determination
  • Human Research Protection Official’s (HRPO) Review
  • Protocol Modification Review
  • Continuing Review
  • We also provide assistance to investigators throughout the protocol development and submission processes

NOTE : If your protocol involves the use of DHA data, then you may need to obtain a formal agreement with DHA for the sharing and use of those data elements.  The DHA Privacy and Civil Liberties Office manages the Data Sharing Agreement (DSA) program.  Information and instructions for executing a DSA may be found on the Submit a Data Sharing Application page.

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Researcher Responsibility Form

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The purpose of this form is to collect information from you in order to ensure that you are properly trained and qualified to conduct DoD-supported research involving human subjects.

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Scientific Review Checklist

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This checklist is appropriate for studies that include both biomedical and social/behavioral research.

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HRPO Review Checklist

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This checklist applies to situations in which the OASD(HA)/DHA is engaged or involved in research with another institution and the research has been reviewed and approved by one or more non-DoD Institutional Review Boards (IRBs).

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General Instructions for Submitting Documents

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This document will provide investigators a list of research-related review services provided, the documents necessary to complete those reviews, and the manner in which those documents should be submitted.

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Protocol Modification Request Template

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To be used when requesting a modification to a previously approved and still ongoing study.

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Investigators use this template to submit research protocol contact information.

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Exempt Determination Request Template

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Investigators who believe that their studies qualify for one of the exemptions from IRB review found in 32 CFR 219 should use this template to request a determination from the DHA HRPP.

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Protocol Continuing Review Template

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All approved studies have a corresponding approval expiration date. If the investigator wishes to continue work beyond that expiration date, then this template must be used to request the continuation.

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Research Protocol Submission Template

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Research or Human Subjects Determination Template

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Investigators and Human Research Protection Program personnel use this template to assist with determining if an activity meets the regulatory definition of “research involving human subjects”.

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