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.

CSU Channel Islands Policies

The IRB, in coordination with CI's Research and Sponsored Programs office, has developed policies which provide a framework for fulfilling its obligations to review human subjects’ research on campus. The following are descriptions of the main policies determining IRB review processes at CI. If you would like to see the actual policies, just click on the links.

Policy on Use of Human Subjects (PDF, 533KB)
This policy provides guidelines for the use of human subjects in research. Its purpose is to provide information and set forth policies and procedures to insure that human subjects participating 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 Misconduct in Research and Creative Activity (PDF, 465KB)
This policy is a policy for investigating and reporting instances of alleged or apparent misconduct in research and creative activity. This policy is also intended to conform to the requirements of the United States Department of Health and Human Services (HHS), the U.S. Public Health Service (PHS), the National Science Foundation (NSF) and Federal regulations including, but not limited to, the “Responsibilities of Public Health Service Awardee and Applicant Institutions for Dealing with and Reporting Possible Misconduct in Science” [42 CFR (Code of Federal Regulations) Part 50, Subpart A] and the “National Science Foundation regulations on Misconduct in Science and Engineering Research” [45 CFR, Part 689].