This comment letter responds to the California Institute for Regenerative Medicine (CIRM)'s proposed adoption of Section 100505 (CIRM Award Management Policy). The University of California (UC) generally supports the proposed policy but recommends revisions to ensure facilities and indirect cost reimbursement accurately reflects the true costs of conducting research, simplify implementation timelines for existing awards, clarify liability and indemnification provisions, and provide more practical requirements for returning unobligated funds, in order to promote fair, efficient, and sustainable research administration.
This comment letter responds to the California Department of Cannabis Control’s proposed regulations governing research funding under the state’s Medicinal and Adult-Use Commercial Cannabis Regulations. UC recommends aligning the program with standard research administration practices by requiring peer review, providing feedback to unsuccessful applicants, using the California Model Agreement for UC and CSU awards, clarifying records-retention and personnel requirements, and leveraging UC’s existing grantmaking expertise.
This comment letter responds to the California Department of Justice’s proposed modifications to regulations governing access to identified individual-level data in the Controlled Substance Utilization Review and Evaluation System (CURES). UC recommends that researchers accessing CURES data through established research-review procedures not be required to use DOJ’s proposed consent form, arguing that the form is inconsistent with standard human-subject research practices, creates unnecessary participant burdens, and may increase privacy risks by requiring excessive identifying information.
This comment letter responds to the California Department of Justice’s proposed modifications to regulations governing researcher access to the Controlled Substance Utilization Review and Evaluation System (CURES). UC argues that requiring individual patient consent would effectively prevent population-level research using identified CURES data and recommends restoring provisions that permit access under existing privacy, security, and human-subject protections, including the option to restrict access to DOJ’s secure laboratory.
This comment letter responds to the California Institute of Regenerative Medicine (CIRM)'s Third Notice of Proposed Regulation Amendments regarding the revised CIRM Intellectual Property (IP) Policy. The University of California (UC) expresses support for CIRM’s continued revisions to the policy, recommends adoption of “Option A” for the definition of “Collaborator,” and commends CIRM for its collaborative engagement with stakeholders throughout the rulemaking process.
This comment letter responds to the California Institute of Regenerative Medicine (CIRM)'s Second Notice of Proposed Regulation Amendments concerning the revised CIRM Intellectual Property (IP) Policy. The University of California (UC) expresses appreciation that CIRM addressed many concerns raised in UC’s earlier comments, but recommends several additional clarifications to improve the policy’s implementation, including narrowing and clarifying the definition of collaborators, correcting inconsistencies in publication-related materials provisions, aligning public-access requirements with NIH standards, facilitating material-transfer requests, and clarifying appeal procedures under CIRM’s march-in rights framework. UC’s recommendations are intended to promote research collaboration, technology transfer, and practical compliance with the policy.
This comment letter responds to the California Institute of Regenerative Medicine (CIRM)'s proposed amendments to its Intellectual Property (IP) Policy, including the addition of Section 100650 to the California Code of Regulations. The University of California (UC) expresses significant concern that the proposed policy imposes overly broad intellectual property, data-sharing, licensing, and commercialization obligations that extend beyond CIRM-funded research and could discourage research collaborations, technology transfer, commercialization, and scientific dissemination. UC recommends narrowing the policy's scope, limiting obligations to technologies directly resulting from CIRM-funded projects, preserving academic freedom and open scientific exchange, and avoiding retroactive application of new requirements to existing awards.
