Regulatory Agencies and Federal Regulations

Within the Department of Health and Human Services the principle federal regulatory agency overseeing human subjects’ protection is the Office for Human Research Protections (OHRP).

The principle regulations which the OHRP enforces are written in the Code of Federal Regulations (CFR) Title 45 Part 46.

Those regulations were drawn from the 1979 report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, more commonly known as the Belmont Report.

The Belmont Report, and the ensuing federal regulations, emphasized three primary principles in ethical human subjects’ research: respect, beneficence, and justice. Among other things, those regulations require that all institutions receiving any federal support create and register an IRB with the OHRP, and that IRB has the responsibility for reviewing all human subject research within that institution.

The IRB, in coordination with CSCUCI's Research and Sponsored Programs office, has developed a policy that provides a framework for fulfilling its obligations to review human subjects’ research on campus. The policy provides information and procedures to insure that participants in research activities conducted at and/or sponsored by the University or its auxiliaries are protected from undue risks and deprivation of personal rights and dignity.

Policy on Use of Human Subjects (PDF, 533KB)

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