When Is IRB Review Required?

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:

• the project is research (a systematic investigation designed to contribute to generalizable knowledge, i.e., will be shared outside the institution or published); and
• the study involves human subjects (including studying human biological specimens, medical records and/or other private information; this is not limited to interactions or interventions with humans). 

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 dunnj@uchastings.edu or Elise Traynum, JD, General Counsel, UC Hastings College of the Law at traynume@uchastings.edu.