Human Performance Training and Biosystems Directorate:
Regulatory Affairs

Human Use

Vision

Maintain the highest level of protection to human subjects who participate in DoD sponsored research.

Mission

Optimal establishment and execution of policy related to research, through accordance with all applicable directives, statues, and laws leading to the safe and effective usage of humans in DoD sponsored research.

References/Reports

Past Events

2009 DoD-wide Training

Achieving Excelence in DoD Human Research Protection Programs: The Role of the Institutional Official

Date: December 1, 2009
Location: Washington Marriott at Metro Center, Washington, DC

View the 'The Role of the Institutional Official' agenda.

2008 Public Responsibility in Medicine and Research (PRIMR), November 17-19, 2008

Click here for information about the 2008 Annual HRPP Conference.

DoD moderated two sessions at PRIMR.

Click here for the presentation at Session A9, Similarities and Differences in Interpreting and Applying Federal Regulations: Does the Funding Source Matter?

Click here for the presentation at Session D3, A Conversation with the Department of Defense (DoD).

2008 DoD-wide Training

Achieving Excellence in DoD Human Research Protection Programs: Taking an Active Role

Date: June 26-27, 2008
Location: Marriott Crystal Gateway, Arlington, VA

Click here for the 'Taking an Active Role' agenda .

2007 Public Responsibility in Medicine and Research (PRIMR), December 2-4, 2007

Click here for information about the 2007 Annual HRPP Conference.

DoD moderated two sessions at PRIMR:

Click here for the presentation at Session D3, "A Conversation with Department of Defense: So You re Engaged in Research with the DoD Now What? "

Click here for the presentation at Session E3, "A Conversation with Department of Defense: Achieving Economies in DoD Human Research Review."

2006 DoD-wide training event, November 14, 2006

2006 National Conference on Alternative IRB Models: Optimizing Human Subject Protections, November 19-21, 2006

Click here for a copy of the '2006 National Conference on Alternative IRB Models' conference guide and workshop summary report.

This two-day conference is intended to enhance the protection of human subjects of research by exploring the use of innovative IRB models as alternatives to local IRBs under appropriate circumstances. The goals are:

  1. to optimize and facilitate institutions' access to appropriate ethical and scientific expertise for reviewing increasingly sophisticated projects, and
  2. to optimize institutions' resources to review such projects.

The conference is sponsored by the Office of Human Research Protections (OHRP), the National Institutes of Health (NIH), the Association of American Medical Colleges (AAMC), the American Society of Clinical Oncology (ASCO), and the Department of Veterans Affairs (VA); it is co-sponsored by the Association of American Universities (AAU), the Council on Government Relations (COGR), the Consortium of Social Science Associations (COSSA), the Department of Defense (DoD), the National Association of College and University Attorneys (NACUA), and Public Responsibility in Medicine and Research (PRIM&R).



References

DoD Reference Documents

DoD Directive 3216.02, "Protection of Human Subjects and Adherence to Ethical Standards in DoD - Supported Research"

Title 32, Code of Federal Regulations, Part 219, "Protection of Human Subjects," also known as the “Common Rule - PDF

Section 980 of title 10, United States Code - Title 10 PDF

DoD Instruction 6000.08, "Funding and Administration of Clinical Investigation Programs"

Section 3109 of title 5, United States Code, "Employment of Experts and Consultants, Temporary or Intermittent"

"A Comparison of National Policies on Research Involving Human Subjects to Facilitate Review and Approval of Collaborative Research." A Comparison of National Policies on Research Involving Human Subjects to Facilitate Review and Approval of Collaborative Research. This document, by The Technical Cooperation Program (TTCP) Human Resources and Performance (HUM) Group, identifies and compares the major national and defense policies of the five member nations that researchers must follow to have a compliant protocol for research with human subjects.


Other Federal Reference Documents

Title 45, Code of Federal Regulations, Part 46, Subpart B, Additional Protections for Pregnant Women, Fetuses, and Neonates

Title 45, Code of Federal Regulations, Part 46, Subpart C, Additional Protections for Prisoners

Title 45, Code of Federal Regulations, Part 46, Subpart D, Additional Protections for Children

Title 21, Code of Federal Regulations, Subchapters A, D, F, and H, "Food and Drug Administration"

The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research is the basis for the ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles.



Links to DoD Component Organizations

U.S. Army

U.S. Army Medical Research and Materiel Command (USAMRMC)

U.S. Navy

Bureau of Medicine and Surgery (BUMED)
Office of Naval Research (ONR), Research Protections

Under Secretary of Defense for Personnel and Readiness (USD(P&R))

U.S. Joint Forces Command



Links to Other Executive Departments and Agencies that Follow the Common Rule

Department of Agriculture (USDA)
Department of Energy
National Aeronautics and Space Administration (NASA)
Department of Commerce
Consumer Product Safety Commission
U.S. Agency for International Development (USAID)
Department of Housing and Urban Development (HUD)
Department of Justice
Department of Education
Department of Veterans Affairs
Environmental Protection Agency (EPA)

Department of Health and Human Services:
       Office of Human Research Protections (OHRP)
       Food and Drug Administration (FDA)
       Centers for Disease Control and Prevention (CDC)

National Science Foundation (NSF)
Department of Transportation (DoT)
Central Intelligence Agency (CIA)
Social Security Administration



Related Federal Links

National Research Council – The National Academies
Secretary’s Advisory Committee for Human Research Protection (SACHRP)

Animals

Vision

Department of Defense research and training using animals is of the highest standard in the world, supported by a culture of caring and compliance that provides animals with humane, compassionate care.

Mission

The mission of every institution within the Department of Defense is to ensure a culture of compliance with federal laws, Department of Defense policies, and best practices, carefully balancing the benefits of animal use with the impact that each study will have on the animals.

References/Reports

DoD Reference Documents

DoD Instruction 3216.01, "Use of Animals in DoD Programs"

DoD Component Policy implementing DoD Instruction 3216.01

Army Regulation 40-33
SECNAVINST 3900.38C
AFMAN 40-401(I)
DARPAINST 18
USUHSINST 3203

DoD Standard Animal Use Protocol Format, DoD organizations must use this protocol format when proposing to use animals covered under DoD Instruction 3216.01. Non-DoD organizations being sponsored by DoD shall either use the DoD Standard Protocol format or provide all pertinent information contained in the DoD Standard Protocol.

DoD Standard Animal Use Protocol Format (PDF with explanations)

DoD Semi-Annual Program/Facility Inspection Checklist (DD Form 2856)

Other Federal Reference Documents

About ICCVAM, the ICCVAM Authorization Act states that the DoD participates in the Interagency Coordinating Committee on the Validation of Alternative Methods to establish, wherever feasible, guidelines, recommendations, and regulations that promote the regulatory acceptance of new or revised scientifically valid toxicological tests that protect human and animal health and the environment while reducing, refining, or replacing animal tests and ensuring human safety and product effectiveness.

Animal Welfare Act and Regulations

Guide for the Care and Use of Laboratory Animals, developed by the Institute of Laboratory Animal Resources, National Academy of Sciences.

USDA Animal Care Policy Manual, developed to help interpret the Animal Welfare Act and regulations.

U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training

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