Human Subjects in Research Policy

In compliance with the Code of Federal Regulations 45 Part 46, and promulgated by the Federal Office for Human Research Protections at the U.S. Department of Health and Human Services (DHHS), CSUMB assumes responsibility for the protection of the rights and welfare of human subjects in research.

All CSUMB researchers undertaking studies involving human beings as participants shall take all necessary steps to ensure their protection and well-being throughout the study. Researchers shall fully honor the DHHS regulations and the values set forth in the Belmont Report: respect for persons, beneficence, and justice.

Aligned with federal regulations governing the use of human subjects in research, the Provost has appointed CSUMB's Committee for the Protection of Human Subjects (CPHS) to serve as the university's Institutional Review Board (IRB) and to ensure the protection of the rights of human subjects as determined by local, state, and federal requirements.

Go to the Human Subjects in Research policy: http://policy.csumb.edu/site/x21106.xml. Read the Provost's memo regarding the Human Subjects in Research policy.

Policy Changes of Note:

Excluded Research (Research Activities no longer requiring CPHS review):

  • Oral History: Oral histories which seek to record and archive historical experiences and to explore memory and meaning in narratives, rather than to systematize interview data into general sociological or scientific knowledge, no longer require CPHS review.

  • Research Practica: Undergraduate student projects conducted for official university course work may meet the definition of research practica and therefore no longer require CPHS review. Important: Research practica is defined specifically in the policy (Section 4.30) and student projects must meet ALL the eligibility requirements in order to qualify for exclusion from CPHS review.
Faculty & Staff Responsibilities:

  • It is the responsibility of the researcher and faculty sponsor to ensure that appropriate human subject research protocol review requirements are adhered to.

  • All researchers must complete human subject protections training and submit proof of completion with protocol applications.

  • If in doubt, it is the faculty sponsor's responsibility to contact a CPHS member, the Office of Grants & Contracts, or submit the protocol application for CPHS review.

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Guidelines

The CPHS has prepared guidelines to assist CSUMB students, faculty and staff with compliance relative to university policy and federal regulations pertaining to the use of human subjects in research. Periodic revisions will be issued to reflect changes in CSUMB policy, government regulations or procedures as they occur.

Download the entire document (100 pages, 668KB, PDF) of CSUMB's guidelines for research involving human subjects: Human Subject Research Guidance, Standards & Practices.

View the guidelines sections individually.

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Posted by Jennifer Bliss on Jan 12, 2012 -