- To assure the rights and well-being of human subjects participating in research are protected
- To educate researchers about how to improve study conduct
- To provide resources to the Research Community
Office for Human Subject Protection
In September of 2015, the Office for Human Research Protections (OHRP), which is part of the Department of Health and Human Services, issued proposed changes to the federal regulations that govern the conduct of research with human subjects. Comments were accepted from the public until January 6th 2016.
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.