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Duke has an agreement with the Office
for Human Research Protections(OHRP) called an Assurance.
OHRP is part of the Department of Health and Human Services. In addition
to negotiating assurances, the office provides guidance
in applying the regulations. It is also audits institutions and has the
authority to suspend any assurance and all protocols operating under the
assurance.
The Assurance does three things:
- Adopt a set of ethical principles: the The
Belmont Report
- Adopt the federal
regulations for the protection of human subjects: Title 45 Code
of Federal Regulations Part 46 (45 CFR 46)
- Declare that these ethical principles and regulations
apply to all research with human subjects regardless of the source of
funding.
The Duke University
Medical Center operates under a separate assurance, although the terms
are similar.
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