The Committee for Protection of Human Subjects (CPHS), an administrative committee of the Office of the Vice Chancellor for Research, oversees the use of human subjects in research. Human subjects research is defined as a systematic investigation including research development, testing, and evaluation, designed to develop or contribute to general knowledge. Therefore, if a researcher plans to interact or intervene with individuals or collect private information that can be readily identified with individuals, then the researcher is engaged in human subjects research. Generally, the results of such research will be disseminated by means of an article, book, thesis, web posting, conference presentation, or poster session. CPHS must review and make a determination of the proposed research being exempt from some of the federal regulation's requirements; or review and approve the researcher's Human Subjects Research Protocol before the research begins (i.e., before advertising the study or recruiting any potential subjects). Some funding agencies, notably the National Institutes of Health (NIH), require all key personnel on funded human subjects research projects to complete Human Subjects training (in addition to getting CPHS approval for their protocol). CPHS also requires that all undergraduate and graduate students who are engaged in human subjects research as key personnel on any protocol—funded or unfunded—must complete and pass the Collaborative IRB Training Initiative (CITI) Program before approval is issued for the protocol. Check the Human Research Protection Program website for information about the CITI and NIH training as well as for other information such as guidance and forms from the Office for the Protection of Human Subjects (OPHS) and CPHS.

Research involves "human subjects" if people are used to test devices, products, or materials; information is collected through interviews, surveys, tests, questionnaires; biological specimens are collected; invasive procedures or psychological or physiological experiments are conducted; or certain types of electronic data are obtained or describe living individuals. Research conducted by UC Berkeley investigators with people anywhere in the world, and even with "anonymous" people on the internet, falls under CPHS jurisdiction to review. Most undergraduate student investigator class projects do not fall under CPHS purview, since they are designed to teach research methodology and not intended to contribute to general knowledge of a field or discipline that would be publishable. However, Undergraduate Honors Theses are subject to review if they meet the federal definition of human subjects research (45 CFR 46). In courses where students are encouraged to do projects involving research activities with people (conducting interviews or focus groups, for example), faculty should devote some classroom time to the ethical and legal principles of human subjects protection and refer students to relevant materials on the CPHS website and elsewhere on the web. Faculty and students must be aware of when a classroom exercise goes beyond teaching methodology and becomes a human subjects research activity. OPHS Staff are available for workshops and presentations to classes and/or departments and a small reference library and copies of relevant materials are available from OPHS staff (OPHS@berkeley.edu or 642-7461). If faculty, staff, or students have any questions, OPHS encourages you to call or stop by their office for assistance.

last updated on 3/20/07