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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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This document lists categories of activities that are exempt from IRB review.

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Policy Guidance_Duplicate HRPO and Administrative Reviews

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This Policy Guidance Document explains the requirements for Administrative Reviews of studies approved by a DoD Institutional Review Board (IRB) and Human Research Protection Official (HRPO) Review of studies approved by a non-DoD IRB. It also explains the Office of the Under Secretary of Defense for Personnel and Readiness (OUSD(P&R)) implementation of the requirement to eliminate duplicative reviews in the absence of justification.

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Policy Guidance OUSDPR Institutional Training Requirements

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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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Research Protocol Contact Information Template

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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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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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To be used by investigators to submit a non-exempt study that has not already been reviewed and approved by an IRB.

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