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U.S. Army
MEDICAL RESEARCH AND DEVELOPMENT COMMAND

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Regulations & Resources

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IRB Policies and Procedures

Guidance & Resources

Forms & Templates

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Ethical Guidelines

Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects (2004)

CIOMS. International Ethical Guidelines for Biomedical Research Involving Human Subjects (2016)

Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (1998)

International Compilation of Human Research Standards (2019)

International Conference on Harmonisation Guideline for Good Clinical Practice (E-6) (9 November 2016)

Department of Defense Regulations and Directives

32 CFR 219 - DOD, Protection of Human Subjects (pre-2018 Common Rule)

32 CFR 219 - DoD, Protection of Human Subjects 2018 COMMON RULE

Categories of Research that May be Reviewed by the IRB through an Expedited Review Procedure, 63 Federal Regulation 60364-60367 (1998)

DOD Instruction 3216.02 - Protection of Human Subjects and Adherence to Ethical Standards in DOD Supported Research (JUN 2023)

DOD Directive 6200.2 -Use of Investigational New Drugs for Force Health Protection (2000) (Force Health Protection)

DOD Directive 6200.02 - Application of FDA Rules to DOD Force Health Protection Programs

DOD Instruction 6025.18 - Health Insurance Portability and Accountability Act (HIPPA) Privacy Rule Compliance In DOD Health Care Programs (2019)

DOD Manual 6025.18 - Implementation of the Health Insurance Portability and Accountability Act (HIPPA) Privacy Rule In DOD Health Care Programs (2019)

Defense Finance Acquisition Regulation Supplement (DFARS) Clause 252.235-7004 (48 CFR)

United States Codes (USC)

10 USC 980 - Limitation on use of humans as experimental subjects

24 USC 30 - Compensation to military personnel for participation in research

Army Regulations (AR) and Memoranda

AR 40-38 - Clinical Investigation Program

AR 40-7 - Use of Investigational Drugs & Devices and the Use of Schedule I Controlled Drug Substances (2009)

Army Policy for the Use of Human Cadavers for Research, Development, Test and Evaluation, Education and Training

Food and Drug Administration Regulations and Guidance

21 CFR 50 FDA - Protection of Human Subjects

21 CFR 56 - Institutional Review Boards

21 CFR 312 - Investigational New Drug Application

21 CFR 812 - Investigational Device Exemptions

FDA Guidance: IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More than Minimal Risk to Human Subjects

FDA Guidance: Significant Risk and Nonsignificant Risk Medical Device Studies

FDA Guidance: Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable

FDA Guidance: General Wellness: Policy for Low Risk Devices

FDA Guidance: Determining Whether Human Research Studies Can Be Conducted Without an IND

FDA Guidance Investigator Responsibilities

Department of Health and Human Services Regulations

Health Insurance Portability & Accountability Act (HIPAA) Privacy Rule, DHHS (2000)

45 CFR 46 and Subparts B, C, & D - DHHS, Protection of Human Subjects

Last Modified Date: 22-Jul-2023