Regulations, Policies and Procedures

U.S. Government Regulations

• Limitation on use of humans as experimental subjects (23 KB)
  Regulation Source: U.S.C. TITLE 10, §980
• Protection of Human Subjects
  Regulation Source: 21 CFR 50 (FDA Regulation)
• Protection of Human Subjects (41 KB)
  Regulation Source: 32 CFR 219 (DoD Regulation)
• Protection of Human Subjects
  Regulation Source: 45 CFR 46 (HHS Regulation)
• Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research
  Regulation Source: DoD Instruction 3216.02
• Use of Volunteers as Subjects of Research
  Regulation Source: AR 70-25
• Clinical Investigation Program
  Regulation Source: AR 40-38
• Protection of Human Subjects: Subparts B, C, D, & E
  Regulation Source: 45 CFR 46 (HHS Regulation)
• Human Drugs and Biologics; Determination That Informed Consent Is NOT Feasible or Is Contrary to the Best Interests of Recipients
  Regulation Source: 21 CFR Parts 50 and 312
• Investigational New Drug Application
  Regulation Source: 21 CFR 312 (FDA Regulation)
• Notice of use of an investigational new drug or a drug unapproved for its applied use
  Regulation Source: U.S.C. TITLE 10, §1107
• Use of Investigational Drugs and Devices in Humans and the Use of Schedule I Controlled Drug Substances
  Regulation Source: Army Regulation (AR) 40-7
• Application of Food and Drug Administration (FDA) Rules to Department of Defense Force Health Protection Programs
  Regulation Source: DoD Instruction 6200.02
• Institutional Review Boards
  Regulation Source: 21 CFR 56 (FDA Regulation)
• Research Integrity and Misconduct
  Regulation Source: DODI 3210.7
• Army Policy for Use of Human Cadavers for Research, Development, Test and Evaluation, Education or Training, 20 April 2012 (413 KB)
• Defense Federal Acquisition Regulation: Protection of Human Subjects Clause
• Message, ALARACT 031/2008, Army Human Subjects Protection Requirements, DTG 141557Z FEB 08