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Identifiable and/or Sensitive Human Subjects Research Data

Oversight

At UC Santa Cruz, all research activities involving human subjects must be reviewed and approved by the UCSC Institutional Review Board (IRB) before such activities begin. In some cases, the Office of Research Compliance Administration (ORCA), which supports the IRB, may determine that research activities involving human subjects are exempt from IRB review.

The IRB and ORCA review research involving human subjects to ensure there are adequate protections for study participants and that the research is compliant with UCSC IRB Policies and University of California Policies and Guidelines for Human Subjects Research and associated regulations. The IRB and ORCA work with the UCSC ITS and Privacy Officer to determine whether data security measures are adequate for the research activities and participants.

If research activities include accessing, collecting, or creating data that is individually identifiable, and/or sensitive, additional protections are required. For more information see ORCA’s Protecting Subject Data page. Investigators should determine the appropriate data Protection Level and follow UC Security Requirements. When appropriate, this should include appropriate Practices for Protecting Electronic P3-P4 Data.

Get Help

If you have questions about human subject research data compliance, please contact the Office of Research Compliance Administration (ORCA).

If you have questions about how to implement human research data security, you can:

Additional Resources