Department of the Navy
Human Research Protection Program

Reference Material


Regulations, Instructions and Guidance

  • The Belmont Report - Ethical Principles and Guidelines for the Protection of Human Subjects of Research (18 Apr 1979)
  • 45 CFR 46 - Department of Health and Human Services (DHHS) Regulations for the Protection of Human Subjects (contains four subparts).  Subpart A is The Common Rule, or the Federal Policy for the Protection of Human Subjects (regulations for the protection of human subjects agreed to by 17 agencies) (1 Oct 2005)
  • 32 CFR 219 - DoD Version of Subpart A of 45 CFR 46 (1 Jul 2005)
  • 21 CFR 50 - FDA Regulations on Informed Consent in Clinical Investigations and Additional Protections for Children in Clinical Investigations (1 Apr 2005)
  • 21 CFR 56 - Institutional Review Boards (1 Apr 2005)
  • Federal Register Notice (Vol 63, No 216, pp 60364-60367) - Department of Health and Human Services - National Institutes of Health - Protection of Human Subjects:  Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure (9 Nov 1998)
  • 10 USC 980 - Limitation on Use of Humans as Experimental Subjects (19 Dec 2002)
  • DoDI 3216.02 - Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research (20 Oct 2011)
  • DODD 6200.2Application of Food and Drug Administration Rules to Department of Defense Force Health Protection Programs (February 27, 2008)
  • DODI 6000.08 - Funding and Administration of Clinical Investigation Programs (3 Dec 2007)
  • SECNAVINST 3900.39D - Protection of Human Subjects (6 Nov 2006)
  • MCO 3900.18 - Human Research Protection Program (HRPP) (21 Jan 2011)
  • BUMEDINST 6710.69 - Use of Investigational Agents in Humans (26 Nov 1997)
  • BUMEDINST 6000.12B - Clinical Investigation Program and Other Research Activities Supporting Graduate Medical Education, Graduate Dental Education, and Graduate Health Science Professional Education (25 Jun 2009) 
  • NSHSBETHINST 6000.41B - Clinical Investigation Program (CIP) (2 May 2000)
  • ONRINST 3900.34B - Protection of Human Subjects (13 Jul 2004)
  • SECDEF Memo on Classified Research (13 Dec 1999)
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Research Misconduct

  • 42 CFR 93 - Public Health Service Policies on Research Misconduct (1 Oct 2005)
  • DODI 3210.7 - Research Integrity and Misconduct (14 May 2004)
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FDA Regulations

  • 21 CFR 11 - Electronic Records; Electronic Signatures (1 Apr 2005)
  • 21 CFR 54 - Financial Disclosure by Clinical Investigators (1 Apr 2012)
  • 21 CFR 312 - FDA Regulations on Investigational New Drugs (1 Apr 2005)
  • 21 CFR 600 - Biological Products:  General (1 Apr 2005)
  • 21 CFR 812 - Investigational Device Exemptions (1 Apr 2005)
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Publication Guidance

  • DODI 5230.9 - Clearance of DoD Information for Public Release (August 22, 2008)
  • SECNAVINST 5720.44C - Department of the Navy Public Affairs Policy and Regulations (21 February 2012)
  • BUMEDINST 5721.3B - Approval Process for Presentations and Publication of Professional Manuscripts, Authored Works, and Articles (8 Jan 2007)
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Other Related Guidance

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