Research Program Office
The CRDAMC Research Program includes Clinical Investigation and Research Compliance Offices. The mission of the program is to facilitate research and ensure that all regulatory standards are met at Carl R. Darnall Army Medical Center (CRDAMC). The program office staff includes research scientists, human protections professionals, and protocol specialists who work in a coordinated effort to help researchers. This interdisciplinary team provides assistance in protocol development, biostatistics, research education, and scientific review. They additionally support the work of Institutional Review Boards (IRBs), expedite the review and approval of research protocols, determine whether or not research involves CRDAMC, and endorse research projects that will be reviewed by an external IRB.
The Human Protections Director and staff are regulatory experts responsible for ensuring that CRDAMC adheres to all Federal, State, Department of Defense, Defense Health Agency, local and institutional regulations, laws, and policies related to human subjects protection and the ethical conduct of research.
Key Ethical Federal Regulations and DOD-Specific Regulations of Human Subjects Research
- Title 32, Part 219 of the Code of Federal Regulations (32 CFR 219)
- Food and Drug Administration (FDA) Regulations: (21 CFR’s 50, 56, 312, 812)
- The Belmont Report
- The Declaration of Helsinki
- The Nuremburg Code
- Department of Defense Instruction (DoDI) 3216.02 Protection of Human Subjects and Adherence to Ethical Standards in DoD-Conducted and –Supported Research
- DoDI 6000.08 Defense Health Program Research and Clinical Investigation Programs
- Defense Health Agency Procedural Instruction (DHA-PI) 3200.01 Research and Development Enterprise Activity
- DHA-PI 3200.02 Clinical Investigation Program (CIP) in Military Treatment Facilities
- DHA-PI 3201.05 Technology Transfer (T2) Program
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