Human subjects research is any research or clinical investigation that involves human subjects. Most human subjects research falls within the two broad categories of behavioral research or biomedical research. Behavioral research includes studies of the behavior of individuals or of groups, organizations or societies. Biomedical research includes both studies designed to increase basic scientific understanding about normal or abnormal physiology and development, and studies to evaluate the safety, effectiveness or usefulness of a medical product, procedure, or intervention.
There is not always a clear distinction between behavioral and biomedical research. Some biomedical research pertains to behavior, and many methods used in behavioral research are also used in biomedical research. Historically, most of the human subjects research at UCSB has fallen under the broad behavioral category. However, a growing number of studies at UCSB are biomedical in nature.
The University of California Santa Barbara is committed to the ethical principles for the protection of human subjects in research set forth in the Belmont Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and protections provided in 45 CFR Part 46. Operating under a Federalwide Assurance (#FWA00006361) with the Office for Human Research Protections (OHRP), UCSB recognizes and accepts responsibility, which it shares with its investigators and other researchers, for determining that research involving human subjects fulfills these ethical principles and protections.
The UCSB Human Subjects Committee (HSC) is an independent administrative committee mandated by the Department of Health and Human Services and responsible to OHRP. The HSC is composed of a variety of professional and lay people knowledgeable in the fields that commonly use humans in behavioral or social research. The HSC is coordinated by a staff member in the Office of Research (Melissa Warren, email@example.com). This Coordinator acts as liaison between the HSC, various governmental agencies, and the University community. Biomedical human subjects research, including pre-clinical or clinical, undergoes a different process, as described on the following flowchart: Biomedical Flowchart
While acting independently, the HSC interacts with and plays an important role in both the Sponsored Projects and Research Development aspects of the Office of Research. In the development stage of any research project, the HSC Coordinator is available to the investigator for advice and assistance in planning the use of human subjects within Federal, State, and University regulations. The exchange of information between the HSC Coordinator and the Sponsored Projects Office ensures that extramural funding is not released for the conduct of research without proper review and approval of the use of human subjects.
FOR RESEARCHERS WHO PLAN TO PERFORM PRE-CLINICAL OR CLINICAL RESEARCH, PROJECTS INVOLVING MEDICAL RESEARCH IN HUMANS OR RESEARCH THAT REQUIRES FDA OVERSIGHT
These categories of research require unique approval steps beyond the UCSB IRB process. Please contact Melodie Blakemore at 893-4285=6 or firstname.lastname@example.org prior to submitting sponsorship proposals.