The Big Tent

CTSI 2016 NIH Renewal Proposal Launchpad

Harnessing the Law for Translational Science: The UC Initiative on Translational Science and the Law (ITSL)

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.


Overview for CTSI retreat discussion:

Summarize the problem being addressed.  Please make sure this is NOT disease-specific.

  • Legal barriers can slow translation across T1-T4 continuum, e.g. contracts, intellectual property, human subjects, healthcare regulation
  • Law can also accelerate translation, e.g. align incentives for quality or mandate reduced exposure to health harms
  • Researchers need help overcoming barriers & leveraging opportunities

Summarize the solution being proposed.  Please make sure this is NOT disease-specific, although you can provide examples of specific test cases.

  • The UC Initiative on Translational Science and the Law (ITSL) will provide tailored legal support to researchers at all points of translational continuum
  • Assemble UC-wide network of appropriate legal experts (see Partners)
  • Outreach to researchers UC-wide (see Partners)
  • Provide scalable solutions based on size & scope of barrier/opportunity

What partners are involved in the solution?

  • UCSF/UC Hastings Consortium on Law, Science & Health Policy illustrates proof of concept and will provide coordinating center for ITSL
  • Legal experts: Health law programs at UCLA and UCSD/Western School of Law
  • Researchers: Outreach via UC BRAID, EngageUC, and precision medicine

What is the potential impact?

  • In 3 years, Consortium has helped support $6m+ of new NIH/other funding and produced 50+ symposia and 12+ white papers & publications
  • UC-wide scope gives ITSL higher potential for funding & dissemination impact
  • We know of no similar program in the US; further scaling nationwide may be possible, e.g. via CTSA Regulatory Knowledge KFC

The Big Tent:  CTSI 2016 NIH Renewal Proposal Launchpad


 1.     How do we maximize impact and broad applicability of the proposal?


  • Make research more relevant by engaging with the law. Hard to see relevance right at beginning for some researchers
  • Demonstrate an impact through policy
  • Make sure we span the continuum between T1-T4
  • Create some bridges between the IP folks
  • Bridge the group to individual divide (T1 problem)
  • T1 – people don’t always want their data stored, help them understand what it means to have biobanking
  • Apply proposal to all 12 CTSI programs, not just through the lens of one program (such as CEHP)
  • Disseminate examples of how the network could help researchers
  • Make sure proposal engages basic sciences
  • Stay away from buzz words if they trigger unintended outcomes
  • Explore how this proposal bears on child research
  • Accelerating discovery can’t happen without engagement with FDA
  • Science informing public policy, changing law
  • Overarching impact around patient-engaged research


 2.     What foundation exists on campus already that will ensure success of the initiative?

  • Expand UCSF/UC Hastings partnership following UC BRAID model (new 1 year degree)
  • What is out there? Outward-looking, establish point of perspective and legal system is one of those.
  • SFHIP provides example of working across many organizations, including SFPD
  • Clinical trials recruitment groups (e.g. Rena Pasick), also Participant Recruitment Service, ATHENA network
  • It’s about the populations you deal with, university has larger responsibility
  • Clinical research infrastructure advisory committee – partner on them, such as on biobanking and how do we do consenting?
  • Build on UC BRAID biobanking effort, common structures, common SOPs so that utility of that material is much higher. Can DNA be used in five years, for multiple studies
  • Work with regulatory groups across campuses

 3.     What creative and/or innovative partnerships could be leveraged to ensure success?

  • Have advisory board that goes to different schools
  • UCB school of public policy
  • Engage with industry and their legal teams. How do their legal teams influence public policy?
  • Create infrastructure that is supportive of industry partnerships that are already happening and that ensure patient-engaged research, such as community panels



Perhaps one path for the ITSL to engage with researchers might be a model similar to CTSI's Consultation Services program ( Or better still, by partnering directly with CS, the ITSL may be able to reach more researchers on campus who are unaware there are legal & policy experts who wish to help. A goal might be to extend the CS model for the ITSL to include all 5 UC biomedical campuses. CTSI may be able to advise or actively participate in setting up a way for the ITSL to charge a subsidized rate for services to the 5 UCs (and other interested parties).



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