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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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Research or Human Subjects Determination Template

Form/Template
10/7/2015

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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Human Research Protections

Examples of PII

Fact Sheet
5/1/2014

Personally identifiable information (PII) is information that identifies, links, relates, or is unique to, or describes you. This also includes information which can be used to distinguish or trace your identity and any other personal information which is linked or linkable to you.

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Privacy Act at DHA | Privacy Impact Assessments | HIPAA Compliance within the MHS | How HIPAA Protects You | Submit a Data Sharing Application | Breaches of PII and PHI | Freedom of Information Act | DHA Privacy Contract Language | Human Research Protections | Privacy Act and HIPAA Privacy Training

Guide for DoD Researchers on Using MHS Data

Publication
4/30/2014

This document is a guide for Department of Defense (DoD) researchers who plan to request Military Health System (MHS) data for research purposes, in particular, for database research. This guide provides an overview of the MHS as well as guidance regarding the types of research data available within the MHS, reviews specific to the protection of human subjects, and requirements of the Defense Health Agency (DHA) Privacy and Civil Liberties Office (Privacy Office) for requesting MHS data.

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DoD Instruction 3216.02: Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research

Policy

This Instruction reissues DoD Directive (DoDD) 3216.02 as a DoD Instruction in accordance with the authority in DoDD 5134.01 to establish policy and assign responsibilities for the protection of human subjects in DoD-supported programs to implement part 219 of title 32, Code of Federal Regulations (CFR) (also known and hereinafter referred to as “the Common Rule.”

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