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Human Research Protection Program

In SECNAVINST 3900.39D, dated 6 November 2006, the Secretary of the Navy delegated the sole authority and responsibility for execution and oversight of the DON Human Research Protection Program (HRPP) to the Surgeon General of the Navy (SG). The SG's authority applies to all human subject research conducted by naval activities or personnel, involving naval military personnel or DON employees as research subjects, or supported by naval activities through any agreement, regardless of the source of funding, funding appropriation, the nature of support, performance site, or security classification.

Mission

The mission of DON HRPP is to ensure the provision of ethical treatment of human subjects in DON research by promoting adherence to ethical principles, laws, regulations and policies for the protection of human subjects.

Vision

DON HRPP is a world-class research protection program, dedicated to preserving the rights and protecting the welfare of human subjects in the Navy and Marine Corps supported research.

Functions
The functions of the DON HRPP include: 
  1. Supporting the Surgeon General in reviewing and approving DoD-DON Assurances for the protection of human research subjects submitted by performing institutions; accepting other federal assurances, if appropriate, or suspending or terminating DON assurances as required,
  2. Providing interpretation of statutes, federal regulations, DOD directives, and DON instructions concerning human research protection,
  3. Developing and implementing DON policies and procedures for the protection of human research subjects,
  4. Providing subject matter expertise and guidance on human protections in DON-supported research,
  5. Monitoring the accountability of the DON HRPP at performance sites,
  6. Monitoring and overseeing human research protocols through a headquarters-level administrative review process,
  7. Supporting the review and approval of research protocols when necessary,
  8. Reviewing and addressing unanticipated problems involving risks to subjects or others, adverse events, and allegations of non-compliance and research misconduct,
  9. Reviewing and approving agreements between performing institutions prior to assigning Institutional Review Board (IRB) review, approval, and/or oversight to other institutions,
  10. Developing and providing initial and continuing education and training programs in human research ethics to all levels of staff involved in the review, approval, conduct, management, or support of human research in the DON, and
  11. Maintaining communication with The Assistant Secretary of Defense for Research and Engineering ASD(R&E) and other DoD and federal agencies on significant issues concerning assurances and research protocols.
 

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)

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)

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)

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)

Other Related Guidance

 

General Guidance

  • DON-Supported Research - Includes all research for which the Navy or Marine Corps provides:
    • personnel (including researchers or subjects), or
    • materiel (including nonpublic information used to identify or contact prospective subjects), or
    • property / facilities, or
    • funding, regardless of source (intramural or extramural)
  • Are You Engaged in Human Research?  Research that requires an Institutional Assurance - Decision Charts (Under Construction)
  • SOP for Requesting SECNAV Designee Status for Human Subjects Enrolled In Research Protocols

Guidance for Training and Education

Guidance for Navy Commands

  • Assurances - Do you need an Assurance?  What kind?
  • Key Command HRPP Responsibilities - Areas of research responsibility for command with its own IRB, command relying on another command's IRB, and command providing only IRB services to another command.
  • Research Protocol Documentation Table - Department of the Navy commands, through their investigators and Institutional Review Boards (IRB), must maintain adequate documentation of human subject research protocols and IRB records.  [32 CFR 219 and SECNAVINST 3900.39D]  This table lists which protocol-related documents need to be maintained by PIs and IRBs and which need to be sent to DON HRPP for headquarters-level administrative review.

Guidance for Extramural Performers

 

Institutional Agreement for IRB Review (IAIR)
    Individual Investigator Agreement (IIA)
    Human Research Protections Official (HRPO) Nomination
       

    Education and Training

    Department of the Navy Human Research Protection Program (DON HRPP) Training and Education Guidance - 22 Mar2013 

    Per SECNAVINST 3900.39 (series), "Human Research Protection Program", all personnel who conduct, review, approve, support, manage, or oversee DON-supported human subject research are required to complete initial and continuing research ethics training appropriate to their roles and responsibilities.

    Among the options available, is the web-based training provided by the Collaborative Institutional Training Initiative (CITI). 

    DON HRPP users may access Web-Based Research Ethics Training provided by CITI

    Prior to using this CITI training site, please review / or print out the CITI site login - registration instructions (updated 29 May 2013).

     

     Presentations

     
    Disclaimer:  The appearance of hyperlinks does not constitute endorsement by the United States Department of Defense, the United States Department of the Navy and the Bureau of Medicine and Surgery of non-U.S. Government sites or the information, products, or services contained therein. Although the United States Department of Defense, the United States Department of the Navy and the Bureau of Medicine and Surgery may or may not use these sites as additional distribution channels for Department of Defense information, it does not exercise editorial control over all of the information that you may find at these locations. Such links are provided consistent with the stated purpose of this website.

    Links for the Research Protection Community

       Federal Government Agencies

       DoD Agencies

       Professional and Educational Organizations

     

     

    Disclaimer:  Links to Non-governmental Websites - The appearance of external hyperlinks does not constitute endorsement by the United States Department of Defense, the United States Department of the Navy and the Bureau of Medicine and Surgery of the linked web sites, or the information, products or services contained therein. For other than authorized activities such as military exchanges and Morale, Welfare and Recreation (MWR) sites, the United States Department of Defense, the Department of the Navy and the Bureau of Medicine and Surgery does not exercise any editorial control over the information you may find at these locations. Such links are provided consistent with the stated purpose of this DoD web site.

     

     
     

    Organizational Contacts

    Bureau of Medicine and Surgery (BUMED)
    Skyline Detachment
    Department of the Navy
    Human Research Protection Program (M00RPH)
    7700 Arlington Blvd. Ste. 5160
    Falls Church, VA 22042-5160

    Tel:  703-681-9629   (DSN 761)
    Fax:  703-681-2597   (DSN 761)

    Office of Naval Research (ONR)
    Director, Research Protections Division
    Code 343

    875 North Randolph Street
    Arlington, VA  22203-1995

    Tel:    703-696-4038
    Fax: 703-696-1212

     

    web:  DON HRPP Web Pages

    e-mail:  343_contact@onr.navy.mil

    web:  ONR Research Protections Web Pages

     

    Updated: March 24, 2014


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