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Office for Human Subject Protection
In the conduct of research involving human subjects, the University of Rochester is guided
by the ethical principles stated in the Belmont Report. The University's fundamental
commitment to the protection of human subjects applies to all human subject research conducted
by University faculty or staff, regardless of funding source or site of the research. The University
follows the Department of Health and Human Services (DHHS) regulations at 45 CFR Part 46, and the Food
and Drug Administration (FDA) regulations at 21 CFR Parts 50 and 56. In developing its policies and
procedures, the University considers the guidance provided by the Office of Human Research Protection (OHRP)
and by the FDA as part of our commitment. The University will provide written assurance documents
to the OHRP to comply with the requirement of 45 CFR 46.103. Assurance documents will be maintained and
renewed in accordance with regulations.