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 principal 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 Maritime Academy Policies

The IRB, in coordination with Cal Maritime’s 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 Cal Maritime.

Policy AA 09-010 Institutional Review Board

This policy describes the duties of the Institutional Review Board, the membership, and protocols and procedures.