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The UCSD Human Research Protections Program (HRPP) Announces New Policies and Procedures for Human Subjects Research

The Department of Health and Human Services has notified UCSD that at least one research protocol was out of compliance with IRB-approved procedures. On behalf of UCSD, we remind all faculty and research staff that federal rules require IRB review and approval of all proposed changes in research activity prior to initiation of such changes, except when necessary to eliminate apparent immediate hazard to the subjects. Conducting research procedures without IRB approval can negatively impact the rights, welfare, and safety of human subjects who participate in research at this Institution. Any modification to an approved protocol must be reviewed and approved by the IRB prior to implementing the change, regardless of the nature of the modification. We strongly recommend that faculty responsible for ongoing human subject research at UCSD discuss this requirement with their research staff, and that they conduct periodic audits of their approved protocols to ensure compliance. Instances of non-adherence to IRB-approved protocols must be rectified and reported to the IRB immediately. Please remember, research compliance is a shared responsibility.

Thank you for your attention to this matter.

For further information, please contact Dr. Michael Caligiuri mcaligiuri@ucsd.edu.

Gary S. Firestein, MD Director, CTRI, and UCSD Institutional Official Michael P. Caligiuri, PhD Director, UCSD HRPP