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Regulations & Resources
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- Nuremberg Code
- Belmont Report
- 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)
- 32 CFR 219 - DOW, Protection of Human Subjects (pre-2018 Common Rule)
- 32 CFR 219 - DoW, 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)
- DOW Instruction 3216.02 - Protection of Human Subjects and Adherence to Ethical Standards in DOW Supported Research (JUN 2023)
- DOW Directive 6200.2 -Use of Investigational New Drugs for Force Health Protection (2000) (Force Health Protection)
- DOW Directive 6200.02 - Application of FDA Rules to DOW Force Health Protection Programs
- DOW Instruction 6025.18 - Health Insurance Portability and Accountability Act (HIPPA) Privacy Rule Compliance In DOW Health Care Programs (2019)
- DOW Manual 6025.18 - Implementation of the Health Insurance Portability and Accountability Act (HIPPA) Privacy Rule In DOW Health Care Programs (2019)
- Defense Finance Acquisition Regulation Supplement (DFARS) Clause 252.235-7004 (48 CFR)
- 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
Last Modified Date: 05-Mar-2026