In general, if you intend to conduct research on human subjects and/or collect personal information regarding human subjects, you must obtain the approval of a registered Institutional Review Board (IRB). Please consult Designating an IRB: UCSF’s CHR or WIRB? for instructions on submitting study proposals for IRB approval. An appropriate IRB can also determine if your research is falls into a category of exemption established by federal regulation.
With limited exceptions, a study requires IRB review when:
If the study meets these criteria, the researcher/investigator must submit an application to an IRB for review and approval. Note that surveys are not automatically exempt from IRB approval, although this is a common misconception among new researchers. The investigator must obtain approval before initiating, modifying, or extending the research project. Re-approval, called continuing review, is necessary at least annually. No activity – including patient follow-up or data analysis – is allowed to continue if approval has expired.
If you have questions or concerns regarding the IRB process at Hastings, please contact Jennifer Dunn, JD at firstname.lastname@example.org or Elise Traynum, JD, General Counsel, UC Hastings College of the Law at email@example.com.
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