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INSTITUTIONAL REVIEW BOARDS FOR HUMAN RESEARCH SUBJECTS

The United States Department of Health and Human Services has established a Code of Federal Regulation for the protection of human subjects (45 CFR 46) embodying the principles of respect for persons, beneficence, and justice. Compliance with this regulation is overseen by the Department's Office of Human Research Protections (OHRP). Under this regulation, any Smith College student, faculty or staff member (including visitors) conducting research on or off campus that involves human subjects must seek review of the research by the appropriate college Institutional Review Board (IRB). Researchers from outside the Smith College community conducting research on the Smith campus must also seek approval from the appropriate Smith College IRB for their work.

Under 45 CFR 46, a human subject “means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.” Research, also defined in 45 CRF 46, “means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”

The review of a research protocol by an IRB is often lengthy, and therefore, it is strongly recommended that you contact the appropriate IRB early on in the development of your project. Although many agencies allow you to apply for a grant without prior IRB approval, IRB review must take place prior to a project being initiated. Not all research involving human subjects requires full review by an IRB and, depending on the nature of your research, an IRB may be able to establish that your project is exempt from review. You should note, however, that the exemption must come from the IRB itself.

Where to Submit Research Protocols

To submit a research protocol or if you have any questions about the IRB review process, please contact the IRB chair identified below in the attached Word documents (see "Smith College IRB Committee Members," or if you are in the School for Social Work, see "School for Social Work IRB Committee Members").

The college's IRBs are overseen by the Sponsored Research Office (sro@email.smith.edu or extension 3010).

Parent Organization = Smith College, IORG0001811
Federalwide Assurance = FWA00002493

Smith College IRB
IRB Assurance = IRB00005164

Smith College School for Social Work IRB
IRB Assurance = IRB00002425

CITI Training Program for the Protection of Human Research Subjects

The CITI Program is a web-based training site for researchers working with human subjects. Training modules are available for biomedical researchers, social and behavior researchers, and IRB committee members. Upon completion of a training module(s), a certification completion report will be generated and forwarded to the Smith IRB committee.
http://www.citiprogram.org

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