1. Scale and Significance: Law shapes the effectiveness and impact of research translation across the T1-T4 continuum. Effective T1 involves contracts and intellectual property; T2 researchers navigate human subjects regulation; healthcare policy shapes T3 impact; and law itself is a powerful lever for change at T4.
Recognizing law’s impact, we seek to accelerate research by providing tailored legal support at all points of the translational continuum. To do so, we propose a UC-wide Initiative on Translational Science and the Law (ITSL). This Initiative will enable investigators to more-readily address legal challenges to research translation and to recognize and leverage opportunities to use the law to enhance their translational impact.
2. Current Approaches: The Initiative on Translational Science and the Law (ITSL) extends the work of the UCSF/UC Hastings Consortium on Law, Science, and Health Policy – the only effort of its kind in the US, to our knowledge (see below). The Consortium has brought together health researchers at UCSF and law faculty at UC Hastings to address challenges and leverage opportunities at all four translational points.
- T1: The Consortium sponsored a UCSF forum on gene patenting and is contributing to a precision medicine workgroup on regulation and policy.
- T2: The Consortium is contributing to EngageUC, an NIH project that is leveraging UC BRAID to develop harmonized processes for biobanking.
- T3: With CTSI pilot funding, the Consortium is working with health policy researchers to identify legal strategies to foster price transparency in healthcare purchasing.
- T4: With CTSI pilot funding, the Consortium has brought together obesity researchers with local regulators and public interest lawyers to develop legal strategies to reduce the health burden of excess sugar consumption.
3. Proposed Approach and Why it is Innovative: ITSL will build on the success and structure of the UCSF/UC Hastings Consortium. First, we will establish a network of legal experts at multiple UC campuses and will make this expertise broadly available to translational researchers (see Potential Partners, below). Second, ITSL will perform outreach to health researchers throughout UC to raise awareness of this service. Proactive outreach – e.g. attending presentations where investigators discuss research with legal implications, leveraging information in CTSA Profiles, etc. – will be particularly important. Our Consortium experience suggests that researchers often recognize when they face legal challenges but may be unaware that their problem is actually solvable. Finally, once investigators recognize that help is available, ITSL staff based at the Consortium will field questions, clarify requests, work with Consortium faculty to identify appropriate ITSL-network experts, and propose tailored solutions. The Consortium has developed a range of such tailored solutions. Well-circumscribed questions, e.g. a human subjects question, may be solved via brief consultation. But ITSL will also be able to respond to ongoing needs, e.g. developing a legal core to bolster T4 translation in a multi-site public health intervention study.
A recent examination of CTSA law and policy initiatives found no partnerships similar to the Consortium or ITSL. All CTSAs help guide investigators across regulatory hurdles, but few make legal expertise available to accelerate translational research per se. It is likely that legal issues in research translation are currently siloed: T1 in technology transfer, T2 in ethics and compliance, and T3-T4 in policy and public health research. ITSL seeks to change that.
4. Potential Partners: The UCSF/UC Hastings Consortium will provide a foundation for ITSL. UC Hastings and CTSI connections with law schools and translational researchers, respectively, will allow ITSL to recruit experts and conduct outreach. On the legal side, the Program on Understanding Law, Science, and Evidence (PULSE) at UCLA School of Law and the Health Law Program at UC San Diego and California Western Law School offer strong partnership opportunities. On the translational science side, UC BRAID, EngageUC and precision medicine create teams of investigators whose research programs will benefit from ITSL support. Other CTSAs or networks, such as the eMERGE network of DNA biobanks, provide additional opportunities for partnerships nationwide.
5. Project Impact: The experiences of the UCSF/UC Hastings Consortium illustrate the potential impact of this initiative. The Consortium has contributed to NIH and private grants totaling more than $6 million in the last three years. The Consortium has sponsored 50+ lectures and symposia and contributed to over a dozen white papers and publications. Based on this experience, we project the potential impact of ITSL could be substantial.
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