• Secondary Use of Investigator’s Own Specimens/Data (Table 5)

This document provides guidance to investigators who plan to collect, use, share and/or conduct secondary analyses of human biological specimens and/or human subject data in their research, or have a change in their research plans for use of specimens or data (sometimes reported as “secondary use”). All data/specimen analysis activities which are determined to constitute research with human subjects require prospective UCLA IRB review and approval or Certification of Exemption from UCLA IRB review. Federal regulations define specific Expedited and Exempt Review categories for research analyses of human subject data and human biological specimens. See UCLA OHRPP Guidance: Determining Which Activities Require UCLA OHRPP/IRB Review for additional assistance in determining if the project in question fits the definition of “human research.” If data/specimen analysis activities do not meet the definition of human subject research, researchers may use Section 9.1 of webIRB to assist in determining if the study in question may actually be considered non-human subject research. If so, webIRB will provide the investigator with a self-certification or direct the investigator to apply for IRB review or exempt certification. Investigators should consider the provisions for sharing of data early on and up front whe