This document summarizes a presentation by Ann Pollack (UCLA) and Elizabeth Boyd (UCSF) regarding the University of California’s approach to assessing relatedness under the revised Public Health Service (PHS) Conflict of Interest (COI) regulations. Given the large volume of PHS-supported research, the UC system is implementing streamlined, web-based disclosure systems and adopting a “just-in-time” approach to review significant financial interests (SFIs) to ease administrative workload without delaying research funding. The revised regulations require institutions to determine whether disclosed SFIs are related to PHS-funded research, whereby “related” means that the SFI could be affected by the research or is held in an entity affected by the research. The term “reasonably” in this context is interpreted as requiring decisions made through a consistent and regular process, avoiding arbitrary judgments.
The process emphasizes the necessary involvement of investigators, who initially indicate which SFIs are related to their PHS-funded research, though their input alone is deemed insufficient by UC. Additional information and follow-up consultations may be required to ensure thorough evaluation. UC campuses are developing lists of criteria—such as involvement of intellectual property, company relationships, and researcher roles—to assess relatedness, though these lists are evolving with experience. The majority of relatedness reviews are expected to be handled by administrative staff, with escalation to committees or experts for high-value or human subjects research. The presentation concludes by raising questions for peer institutions about investigator involvement, assumptions and criteria for relatedness, assessment procedures, and documentation, underscoring the collaborative and adaptive nature of compliance under these new federal requirements.
