Human Use
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
Click here for the agenda.
Click here for presentations.
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 agenda.
Click here for presentations.
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
Click here for the agenda.
Click here for presentations
2006 National Conference on Alternative IRB Models: Optimizing Human Subject Protections, November 19-21, 2006
Click here for a copy of the agenda
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:
- to optimize and facilitate institutions' access to appropriate ethical and scientific expertise for reviewing
increasingly sophisticated projects, and
- 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
- 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)
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