CTSI Annual Pilot Awards to Improve the Conduct of Research

An Open Proposal Opportunity

Translating Research into Law and Policy

Proposal Status: 

Rationale: Currently, there is no direct pathway for health sciences research to move from scholarly publications into policy and law. Although some evidence is cherry-picked by advocates and policymakers, legislation often reflects rhetoric rather than evidence. While some translational researchers study the effects of laws or write white papers summarizing the state of the evidence, we know of none who take the approach of working with investigators to leverage their research and write model legislation. Here we propose the development of a replicable process that will translate research directly into evidence-based model policies, regulations, and laws that improve health and/or health outcomes. Model policies, regulations, and legislation are proposed pieces of law drafted by researchers working with legal scholars to incorporate the latest scientific evidence with the goal of improving health and/or health outcomes. The drafted language would then be made freely and widely available to legislators, advocates, and others involved in the enactment of law, regulations, and policy.  


1. Kick-off Meeting: March 30, 2012 to introduce the project and workshop additional ideas for a pilot project.

2. Pilot projects: This grant will fund one-two demonstration/pilot projects that bring together UC Hastings faculty, UCSF researchers, and students from both institutions to write evidence-based model legislation, regulations, and/or policies. This group will analyze both the current scientific evidence and the legal frameworks related to a health issue being investigated by a UCSF researcher; the group will then write model legislation that revises or changes current laws or that proposes new laws in order to improve health and health outcomes. One pilot project we are pursuing is on the toxic effects of sugar on health based upon Dr. Lustig's research (PDF attached). We are considering  a second pilot project. Current ideas include mandatory reporting laws in the emergency medicine setting, the effects of hospital and ED closure, the efficacy of orthopedic procedures, restrictions on activities of individuals with epilepsy, and implementation issues realted to the Affordable Care Act.


Criteria and Metrics for Success: The broad goal of this demonstration project is a proof of concept that then allows for replication and dissemination of this new approach for translating research directly into legislation:


1. Creation of model legislation and/or regulations resulting from biweekly meetings of the UCSF investigators, UC Hastings faculty, and students from both institutions and the dissemination of the work-product . Timeline: Spring 2012-spring 2013.

Documentation & Dissemination:

2. Document year-long process via a detailed white paper. 

3. Host 4 calls/virtual meetings to discuss and publicize model to organizations and institutions that would replicate this model.  This would occur via the CTSA Health Policy network. Timeline: Winter 2012-summer 2013.


4. Create a student group focused on the legislative process and the translation of research into the policy, regulatory, and legal realm.  Recruit 15-25 interested students to participate. Timeline: To start in spring 2012.

5. Identify internal and external funding options to sustain and expand the project. Apply for at least 2 grants during the pilot period. before grant period is up.  

Total Budget: $38,506

Salary support for UCSF faculty, Co-PIs and research assistants involved in developing the pilot projects, the Program Analyst to coordinate activities of this project, consultants, project supplies and communication.


1. UC Hastings: Jamie King, Jennifer Dunn, David Faigman, Sarah Hooper

2. UCSF: Dan Dohan (co-PI), Rob Lustig, Dennis Hsieh (co-PI), Richard Barnes, Jessaca Machado


This is a challenging and worthwhile endeavor. Investigators benefit from understanding how current policies come about and how their research can be supported (or not) by future policy and law. I think presenting specific case studies would be a tremendous benefit. Would love to help brainstorm. - Ruben.

Hi Ruben - thanks so much for offering to brainstorm! Is there a good time this week to reach you? Thanks. Dennis

Dennis - sounds great - I'll connect with you via email.

Dennis, et al: This looks very good and presents some interesting ideas and challenges. I agree with the comments that taking it through the legislative process is very long and messy. However, it might be beneficial and educational to try to engage a legislative aide in the process so that learners can get some information about how best to take it to the next steps. For the medical students, I think it would be important to possibly work with one pathway, most likely advocacy, and try to engage them at an early stage in their medical education. It is important for the first topic to serve as a pilot and remain somewhat focussed so that it can be successful. Good work on putting this together. Bill Shore, MD

Thank you for your comment. I think for the course part we would like to have a legislative aide or someone familiar with the process engage with learners for several reasons. I think it would be good for learners to understand the legislative process. Additionally, I think it would make sense for the learners to have a good understanding of the process as I think it would help inform how the model legislation would ultimately drafted. Agreed that the first pilot should be focused in order for it to be successful. Also, I think your email about speaking with Dr. Bodenheimer or Dr. Grumbach about a second pilot around primary care medical homes is a good one and one I will work with the team to explore. Dennis

You have come such a far way with this grant and it looks great! I think it is a very novel idea, has the potential for great impact and it appears you have a well thought out of plan on how to proceed and how you will measure your success with the program. My one suggestion and I'm not sure if the proposal is the place to improve it, but of giving at least 1 concrete example of an issue you will tackle (ex. food disparities and policy, obesity and policy, smoking cessation etc.) I think this could help focus people on what exactly you mean by turning research into policy. Again - it looks phenomenal! Best of Luck!

Definitely - just added in specifics on one of our pilots - sugar in foods and its effects on health. We are looking for a second pilot to run concurrently so if you have any suggestions on those who might be interested, please have them post here / contact me! Thanks. Dennis

There seems to be growing interest in trying to centralize published research around similar topics and, further, aggregate expert / researcher commentary on these results, in order to avoid "cherry-picking" and "rhetoric based" decisions (very well put!). Another proposal on this site, "Encouraging research collaboration and integrity by optimizing post-publication peer review for researcher participation", is tackling this same problem, but in regard to influencing research publishing and funding organizations, as opposed to law and policy makers. Is seems like there could be a lot of synergy between our two groups.

Definitely - I love your idea. I think it provides a public forum for discussion on articles and figures that is missing. Similar to news articles and other forums, having the ability to discuss outside of journal club/conferences but across institutions and across the field I think is a great way to critically evaluate papers. Additionally, I think having these comments available for those reading the paper would be helpful who may not have as much experience (ie students/junior investigators) or those who do not have the benefits of discussing the paper in a conference/at journal club. I think one challenge is figuring out how to organize the comment threads so that the comments themselves can be easy to browse through and can serve as a resource as well. Would love to chat more if you have time the next few weeks. I could see us working together to figure out how to gather and evaluate the evidence and then use for a variety of purposes. -Dennis

Great seeing your detailed project deliverables! Minor comment is to see a tentative timeline attached to each of the metrics. Its an ambitious set of tasks - I might tier them into primary and secondary objectives. In addition to the paid staffer - what sort of individuals, skills, involvement do you imagine among the core team members. Thanks so much for fulfilling such a critical need/ gap in translating research from UCSF into meaningful policy.

Timeline makes sense. Will update later. Like the idea of tier-ing objectives as well - will give it some thought. Will get back to you in terms of individuals/skills/involvement.

I think this is an excellent idea. Having worked with activists/advocates in several situations I've often been concerned with their lack of attention to the evidence related to the area in which they were interested. At the same time their cause may be greatly strengthened by having an evidence base for their advocacy. My suggetsion would be to add some advocates/activists to the mix in the meetings you plan to have. Involving journalists would also be good.

That's a great suggestion - we will definitely look for some advocates/activists depending on the pilot projects we proceed but I think it also makes sense to come up with a process/infrastructure of how to involve them. Do you think journalists would be useful in the development phase of model policies/legislation or more for helping pass the product or both? Also, do you know of any journalists who might be interested?

This project looks like it's off to a good start. I'm curious about how the process works in choosing which health topics to legislate/research. Is a topic chosen by panel? Super majority? Moreover, given the length it takes to draft, submit, have a piece of legislation pass committee, house, senate, etc., how will this program be sustained? Particularly with a rotating set of students (both at UCSF and UCH), is one year sufficient to get this running? Since a metric of success is hosting a year-end symposium on a piece of "model legislation," who weighs in on the final piece?

I think in terms of the pilot project topics, we have selected one already - sugar - and are looking for a second topic that will be decided upon after discussion with those who are interested as well as the entire team. The goal is to have model language for legislation drafted and feedback incorporated. It would then be made available to advocates, legislators, and those who may be interested in taking the legislation and running with it. So I think the time frame when it comes to actually passing legislation is not as big of a concern for the program itself. In terms of longer term, I think Dr. Dohan's comment gets at this - the determination would be made by those at a center and be sustained through a center housed under the UCSF/UC Hastings Consortium. I think students will be an integral part but the center and key faculty members with rotating student leadership will help provide continuity. I think in terms of the final piece of model legislation, it would be nice to have a panel of individuals - including researchers, policymakers, advocates, and legislators weigh in and help provide comments in addition to all those attending the symposium.

Hi Dennis, As an economics PhD interested in helping to fight obesity and chronic disease burden in America, I applaud this proposal and sincerely root for its success. I would strongly suggest that your center includes at least 1 or 2 people with rigorous economics training to provide pragmatic advice about appropriate policy, especially in terms of taxation and quantity restrictions. For example, Lustig has proposed a tax on added sugar. It is important that tax proposals like this be analyzed critically by someone who understands both intended and unintended consequences of new policy. I am happy to recommend contacts in your search for economics-trained faculty/researchers. Best, Christina J.

Awesome idea. I recall how much [wasted] time we spent in law school legislative advocacy clinics trying to find and analyze alternative policy frameworks in use in other states. Working from the bottom up and generating policy ideas based on facts/reality/modern research is clearly superior. The big thing I would say is that you should resist any efforts to push this all the way to actual legislation. You should stay firmly on the side of putting model legislation together, something which Hastings and UCSF can probably put some serious talent together for, and leave the actual lobbying to activist groups that have expertise in that area (the skill sets for developing model legislation and for lobbying for legislative change are largely non-overlapping). The legislative process is slow and messy, and it's almost certainly not worthwhile for you to get directly involved. Further, if your success metric ever ends up becoming a question of how frequently you successfully foment positive policy change, you're probably doomed to look unsuccessful. The legislative process is too messy to result in many clear wins. I imagine a good first step would be to reach out to existing activist groups and figure out what the model legislation you deliver should look like in order to meet their needs. You'll probably want to develop a package of documents for each model piece that you work up. I'm not sure exactly what should go in it, but probably (1) some actual model language, (2) a legal appendix explaining why relevant regulatory authority exists (e.g. for simple sugar content in foodstuffs), (3) a similar appendix citing and summarizing relevant research papers used as the factual basis for the model, and (4) a list of alternatives or trade offs that could be considered by different groups pushing for similar change in different states. I think it's an excellent idea and I'll post again if I have more comments.

Thanks for your comment! Our focus is really on taking and analyzing the scientific data/evidence and then working on coming up with actual language for model legislation and policies. We will not be involved in the actual passage of legislation and will partner with advocates, community groups, and legislative staff on that piece. I complete agree with you that writing model legislation and passing model legislation require two separate skill sets. As we know, right now much legislation is written and passed by the same group and this is why the evidence gets left out. Thus, I think the proposal here tries to get at the division of labor you outlined and allows expertise to be applied properly. I think your suggestion in terms of reaching out to legislators, advocates, and other groups who actually pass legislation to figure out what format model legislation should be in is a great idea. We definitely want to make our end-product as user friendly and as easily adoptable as possible. I think in terms of creating not just model language but also the citations to both the legal and scientific framework makes sense - it is work we will be doing already to draft and will make it easier to justify the model legislation as drafted. I also like the idea of alternatives/tradeoffs as these pros/cons will be discussed by our core group. This way the legislation can be easily modified by an audience looking to adopt different versions of the draft language depending on the specific political considerations in their state. Thank you so much for the thoughtful comments! -Dennis

Dennis, Believe this addresses a real need in the public dialogue - opportunity for data driven, thoughtful discourse, with intent to serve a greater good for the broader collective. One strength of the peer review publishing process is an opportunity for critical feedback on the submitted manuscript. Anticipating that your proposed topic - e.g. toxicity of sugar - will be politically charged, both by the proponents in your initiative as well as those affected by your drafted legislation, wondering how you will incorporate divergent views into your process of topic selection, data review and synthesis and drafting of the legislation? The capacity to invite such views, in turn the creative holding of divergent views, would both strengthen dialogue and add legitamcy to the process and the output. Certainly starting with the evidence, the data or the "facts", is right. Yet annual research conferences are predicated on the fact that researchers looking at the same data, facts and evidence will have energetic discourse leading to divergent conclusions. We know in the political arena this will also be true. Interested in your thoughts of how to harness and direct this to the benefit of your worthy proposal. Jeff Critchfield

I think one underlying principle that will help guide the discussions is the goal of improving health and health outcomes. I understand that there are many interests in areas such as sugar which may lead to various viewpoints, especially when money is involved, but the overall mission/goal for us is to improve health and health outcomes which will provide a lens for the discussion. However, I recognize that even within this area, there will be divergent viewpoints. I agree that incorporating and discussing these views will both strengthen the dialogue as well as add legitimacy to the process and output. To this, we think there will be various forums to encourage and allow for this discussion: The course will allow the students and faculty to have a rich discussion. During the seminars we are hosting, we also hope to devote a portion to discussion. Additionally, the symposium will provide another forum for discussion. The calls we intend to have will also generate discussion. Finally, the website will allow for comments and discussion on the work as well.

It is heartening to see this proposal attract interest and develop. We wanted to share some further thoughts that we've been working on but that didn't neatly fit in to the original posted proposal. We'll put them into separate notes to make it easier to track and comment. As the UCSF/UC Hastings Consortium continues to develop, we're really interested in opportunities to bring faculty and learners from the two campuses together. In addition to the educational/training activities listed above, we see potential for this proposal to initiate a sustainable curriculum and practicum related to legislative translation. A first step is for funding from this grant to support UC Hastings and UCSF faculty to develop and co-teach a Law and Policy course. This will bring learners from both campuses together to work on projects. Two collaborators on this proposal -- Richard Barnes (based at the UCSF Center for Tobacco Control Research and Education) and Jaime King (an associate director of the Consortium) -- are well suited to take this on.

Comment # 2: An earlier commentator asked about how projects would be selected, which is an issue we have discussed at some length. For this proposal to birth a sustainable Center, establishing a pipeline of research issues that are "translatable" is crucial. Rob Lustig's work is an obvious candidate and we have good momentum around that. Other UCSF research with public health implications -- such as Kirsten Bibbins-Domingo's work on salt intake or Laura Schmidt's work with the San Francisco Department of Public Health on harm-reduction related to alcohol consumption -- are other candidates in this realm. A second realm to develop could be model legislation related to the Affordable Care Act (ACA). What does health service and health policy research tell us about legislation to implement various parts of the ACA? This is not necessarily as important a need at the federal level as it might be for states. It might even be something that could lead to helping smaller entities such as health departments or hospital districts in developing administrative policies that are consistent with ACA. The National Association of Community Health Centers-- http://www.nachc.com/ -- provides this kind of support for their constituency, but obviously they bring a particular agenda. Andy Bindman is actively involved in ACA work in DC and also has great insights into the situation in California via his work with the California Medicaid Research Institute (CaMRI), so this is another possible avenue to develop. In addition to public health and ACA, a third translational realm might be related to innovation and discovery -- Law and Policy at the T1 translational level. There was a great symposium at UC Hastings last week highlighting innovative Industry/Academic Collaborations (you can see it at http://bit.ly/yZXT90 -- there is a live stream available of the event). UCSF's Erik Lium was one of the speakers. The conference highlighted how industry and academe are finding ways to partner but also touched on a number of challenges such partnerships face. We believe this offers a third potential "pipeline" for translatable research as it might engage UCSF researchers who do T1 work, those who incubate T1 translation via industry partnerships, or those who have expertise related to research integrity.

I teach policymaking and political advocacy at both UCSF (the CP 151.03 referenced in the Plan) and UC Hastings. I take a practical approach to real policymaking in the real world. I have been involved in discussions at Hastings for the UCSF/UC Hastings Consortium on Law, Science, and Health Policy to propose a policy advocacy clinic to engage faculty and students from both schools to work on actually turning health science into health policy by working with policymakers. What we propose here is one of the first steps that such a policy advocacy clinic would do, which is to research the current state of the law affecting the health issue, if any, and then draft the policy instrument (statute or regulation) to fix the problem identified by health scientists. It makes a lot of sense to start with what this proposal embodies as a kind of pilot project for the broader advocacy clinic. Prof. Richard L. Barnes

VERY cool, Dennis! What a novel and important idea, and the feedback you've gotten is also very valuable. In terms of your looking for pilot topic #2, there are a ton of ideas within the realm of emergency care that I can think of already that are in need of legislation that are backed up by clinical/health policy research. One example would be (although I'm not sure if this is what you mean) the literature on how alcohol impairs the mind and its relationship with driving. One potential policy implication/legislation could be, for example, mandatory reporting in the ED. Currently, as healthcare providers, there are some federal and state reporting mandates for certain conditions/diagnoses - e.g., child abuse, elder abuse, domestic violence, public-health related diseases such as HIV, Hepatitis B, syphilis, etc. We also are required to report patients to the DMV (Department of Motor Vehicles) if we believe they have a condition that impairs their driving ability. As far as I know, there is NOT a mandatory reporting requirement for drunk driving. Of course, if a policeman/highway patrol officer sees someone drunk and pulls them over, they can be cited by the authorities for a misdemeanor (or felony if on federal property). But thousands of times a day across the country, people arrive in the ED because the ambulance took them in after an accident, and they are intoxicated. And in those cases (where they do not arrive by police), we just treat them and they leave. Of course, we WANT to treat their injuries. But perhaps there is also a case for mandatory reporting. It would require understanding the basis on which current reporting exists and applying that same rationale to reporting drunk driving in a healthcare setting. Another example in a different arena could be the application of the knowledge that ED closures occur more often in vulnerable communities. What is the proper legislative, if any, response? It's tricky since there are a lot of market forces in this area, and that is how our healthcare system is currently structured. Is there a role for regulation in this area? New York and New Jersey already have commissions (the Berger Commission and Reinhardt Commissions, respectively) that are set up to evaluate proposed closures, but is this a place where legislation would be helpful or desirable? The legislation behind this could go beyond simple regulation but perhaps by managing incentives of insurers and of course very politicized and complicated. But just another thought. - Renee Hsia

Thanks so much for your comments - I think both areas would make for very interesting experiences for students and faculty working on model legislation. 1. Mandatory reporting makes sense from a public policy standpoint. I could definitely see a counterargument being made in terms of deterring people from using the ED - but this is exactly the type of issue that makes it interesting, especially when students are involved. I'm not super familiar with the literature on impairment - but I'm sure that the evidence is not very controversial. However, the implications of reporting and what happens to those seeking care would make for a very interesting piece of policy. 2. In terms of ED closures, I know you have done some work and this is an area that is near and dear to my heart - I think that given there are stringent requirements for hospital openings, a parallel process should be available for closures. The Berger Commission was pretty arbitrary, if I remember correctly, from having worked in NY fighting a few of those closures, but I think working from the evidence of the detriment of the closure of EDs and hospitals to what the process should look like would result in a much more rational process. ----------------------------------------------------------- Dr. Hsia's response: Yes, there's definitely lots of counterarguments for each of them and it's a field that isn't clear cut, but definitely should be more informed by the evidence that we've amassed over the years as researchers and clinicians. I'd be happy to work on either of them - you're the expert and I can only provide what I know in terms of the data - but is certainly a very novel and unique way to start addressing some of these gaps. In a sense, it's a new kind of implementation science! - Renee Hsia

Dennis, this is very creative! Thanks for sharing. It is also a creative way of developing pilot studies. I read a few of the others and the comments. We fund research pilot studies within Columbia University School of Nursing as well and I like this idea for gaining feedback. In terms of the proposal itself; I was thinking that it might be fun once this gets going (assuming it is funded) to build in an evaluation piece for the adoption of model laws. I agree with the comment that advised not to get involved in implementation of the models themselves; but it would be interesting to see if any of them "take off" so to speak, get picked up and adopted and whether they accomplish what was intended. This, of course, goes far beyond what you are proposing; but thoughts for your next grant! Good luck on this. - Bobbie Berkowitz

This is an enormously important endeavor. As a health services researcher who spent a year working at the White House Office of Management & Budget, I certainly observed the underuse and misuse of evidence in the policy-making process. One other potential area of focus for your proposal might be regulatory writing and review. For example, legislation sets the broad principles for a given healthcare function. The way in which regulations are written by federal and state agencies, however, often determine the effectiveness of the law. In my work at OMB, I observed that the very best scientific evidence was not always used or brought to bear in the regulatory writing and review process. Just a thought and suggestion. Good luck. Excellent project.

Thank you for the comment. Regulations are a key part of the process, especially when flushing out legislation, and will definitely be included in our work.

Hi Dennis! I think this is a fantastic idea! I have wanted to get something similar to this off the ground for a long time. Having used health services research to demonstrate significant flaws in our informed consent laws as part of my dissertation and shepherding that project all the way through the Washington state legislature, I am very eager to continue translating scientific and health services research into meaningful policies. I am really thrilled to be a part of this and to incorporate it into a class for both UCSF and UC Hastings learners. Wonderful idea!

I think this is a wonderful idea. In my experience researchers are very pleased when their work leads to policy change You are creating a framework that will make that much more likely to happen. Mitch Katz

Hi Dennis, Proposal looks awesome. The only thought I have is re: levels of evidence (e.g. cohort study, RCT, meta-analysis) and whether any assessment of this should be incorporated into the process. Obviously, a meta-analysis showing that A is associated with B is a much more robust finding than a secondary analysis of a single data set that shows the same association. That being said, many policy & legislation relevant research questions are difficult to study using "gold standard" study designs (e.g. you can't randomize subjects to housing vs. homelessness.) This is probably too subtle for the brief proposal you're submitting, but something that crossed my mind.

Dan and Dennis, I am interested in participating in the demonstration project. The number of patients who may potentially benefit from Hip/knee replacement and spine surgery are increasing with the median age of the US population. Health policy colleagues have provided evidence that innovations in our field have increased procedure costs without producing notable improvements in efficacy. My provider colleagues need your help to better understand what data is needed as payers and perhaps legislation begins to limit patients' access to the potential benefits of these procedures.

Definitely - will reach out to you offline to see if we can set up a time to discuss! Thank you for your interest - I think this area is very important, especially with the balancing of costs and benefit reaching the forefront of the healthcare debate.

Dennis, this looks great! I like that you have included education and dissemination into your project so that we can all become more aware of how to translate research into legislation. For the kick-off event, it might be helpful to have more details regarding the logistics of getting involved for faculty and students. For example, will people sign up for this as a course or as an interest group? Are there different levels of involvement? What will the time commitment look like? I look forward to hearing about your progress!

Thank you for your comments. I think we are beginning to publicize the kick-off event this week and will hopefully reach out over email, through this forum, physical posters, as well as word of mouth. Longer term, I think creating a student interest group around these issues is a great idea. We are planning on having a course but I think a translational interest group would be a good way to engage students and could allow for different levels of involvement from a student perspective.

Dennis and Dan, very nice. Possible topic would be related to mandatory reporting of child abuse. Most states require this but lack specific criteria of known injuries that are well correlated with abuse (such as bruises in neonates, retinal hemorrhages, etc.). The suggestion would be that existing laws become more specific as to those injuries/findings which require reporting. I also like Renee's suggestion about mandatory reporting of drunk drivers. The concern there is that such a law (as might also be true of my suggestion) might discourage injured drivers from seeking help, or prevent parents from bringing children in for care. Alan Gelb

I agree with the many positive sentiments about this proposal - innovative, generative and cross-disciplinary, and with the potential for substantial impact. Epilepsy is another area worth considering - issues related to determination of driving privileges, job discrimination, provision of care in the school setting, etc.

Thank you for the suggestion - would love to chat with you about the possibilities as the process moves forward. Will be in touch offline! -Dennis

This is a great proposal to bring together UCSF and UC-Hastings faculty, staff and students which could spawn additional collaborations. I really like the team/shared leadership and implementation. In Item #2, "participate in 3-4 classes", I hope you find a way to give a seminar or two in one or more of the CTSI Implementation Science courses in the Training in Clinical Research Program--such as EPI 249--Translating Evidence into Policy or the Intro Course. One area I would like to be made a little more explicit is how you envision this program will be self-sustaining after the proof-of-concept funding is completed? Would it be funded through a Center with donor/foundation type support, are there industries or other non-profits that might support this type of work? In terms of evaluation, you list mostly process measures (which seem appropriate at this stage). But what are some of the key outcome measures that might be used to support the impact of your group's work?

Thank you for the comments. We would be delighted to participate in the CTSI Implementation Science courses in the Training in Clinical Program, such as Epi 249. With the development of a course over the grant period, I think a certain level could be self-sustained through. However, to expand the project on a larger scale, we would seek institutional support from UCSF and UC Hastings as well as looking for other types of grants and philanthropic funding would be the immediate next steps. RWJ may be one source of funding. Furthermore, in the long term, we hope for funding for translation to be part of the funding interested researchers receive, and this could also help fund the process. Overall, however I think this is something we would work on during the course of the year. Any thoughts/suggestions you have in this area would be appreciated. I think having a successful symposium that draws legislators, legislative staff, advocates, as well as members of the UCSF and UC Hastings community is one key outcome measure to support the impact of our work. I think based on the discussions about the legislative process, in the short term I would like to stay away from judging whether is passed. I think in the longer term, it would be valid to see what kind of impact the model language that is produced is having and improve the process as appropriate.

This is a great idea and certainly would be a step in the right direction getting policy in line with evidence based research. Perhaps this is thinking too far ahead but what are your thoughts on disseminating information on policy changes to stakeholders affected. For example if policy changes impacted physician practices, how would you ensure that enough effort were made to educate physicians before imposing penalties on them. Is there existing legislation on due diligence for affected stakeholders?

Thank you for the comments. I am not sure about due diligence legislation for affected stakeholders. This is an issue we will have to investigate. I think your thought is a good one. I'm not sure if any penalties would be imposed - I think it would depend on what the specific issue is. For example, a piece of legislation could limit the sugar content of soft drinks. This would not necessarily be targeted as clinicians. However, I am curious how physicians and other health care professionals become aware of requirements. One mechanism I think of is when these requirements are tied to reimbursement. But will look more into this - definitely something we need to consider when drafting the language.

Dennis, Sarah and team: this is very creative and exciting. I've enjoyed reading the prior comments and wish you much luck. As a front line clinician and advocate, there are many instances I can recall where state legislation took time to catch up with current medical understanding (seat belts, vaccines requirements to attend school, etc). It may be challenging to develop a set of criteria by which to evaluate candidate issues to work on as this process matures.

Thank you for the comment - if you have any suggestions as to what potentially should be included as part of the criteria for selecting candidate issues, would love to hear your thoughts. I think some have been raised including the scientific quality of the evidence and whether a better mechanism for implementing change exists. Would love to chat more to hear your ideas!

Dennis, after having talked with you about your ideas for this program from early on, it is exciting to see it carefully worked out in detail. The plan has great potential both to accomplish important research-based reform and to provide a pedagogically rich experience for students across a number of disciplines. I have one thought, a question really. In a number of places, the proposal refers to creating evidence-based laws and policy, but then the concrete focus is on legislation. I think I probably urged you to have a narrow legislative focus, but as I think about it now, it seems that not all issues are necessarily susceptible of legislative solutions and that teams ought to have room to think of strategic options. In some cases, advocating for non-legislative reforms in regulations or policy may be more effective or efficient, so it might be worthwhile to be open to such options.

hi Dennis, I think the idea is really great concept. I believe others touched on the parts that gives me the greatest concern. The first is that not all research is at the right stage (has the right info) to be made into law yet. I think there usually needs to be a large RCT or several large observation studies before most there's enough power to support possible legislation. That being said, I agree that there are several things that are passed that don't have that much support because they are pets. I guess my point is that I would include a section that somehow screens your projects otherwise you subject yourself to the same arbitrariness that you are opposed to. Two, my understanding for model laws is that you write one law and other states, cities, govt bodies, etc use that as a template/base to write their laws. From my understanding, that works in some topics but that is not always the optimal strategy for dissemination of health policies. So here I'm wondering if you aren't limiting yourself by specifying model laws? Third, you might want to think more broadly who you want to include, especially from an ethics standpoint, so you should consider incorporating a bioethicist in your project. Hope this helps and good luck!

Thank you for the comments. I think what issues have scientifically rigorous evidence is part of the guidelines that the Center will have to consider when it is choosing future projects. Both you and Dr. Moskowitz raise this point, which I completely agree with. Additionally, both you and Professor Silk raise the point that model legislation/regulations are not necessarily the best way to achieve change or disseminate health policies. I think that this is true and depends on the specific health policy/issue involved. I think this is something again that will be discussed both in choosing the second pilot/future projects as well as through the process of the pilots. Model legislation/regulations can be very powerful. However, this does not mean they should be used in isolation. I think it is definitely worthwhile for the faculty learners to discuss other approaches. However, whether these other approaches are left to advocates and others or whether these approaches are developed in more detail will depend on the specific project and the relationship with the core goal of drafting model legislation/regulations. I think your last point in terms of including an ethicist in the process is a good one and we will definitely make sure that one is on the advisory/review board if not helping/consulting in a longitudinal manner.

I love the concept! While I understand that you will not be "promoting" or attempting to pass the drafted model legislation, I would still add as part of the proposal training, especially for doctors, something on how to testify effectively with respect to the evidence used to create the legislation. Doctors can be very powerful opinion swayers on health legislation, and doctors who can easily quote and make research evidence understandable to both the lay public and legislators are few and far between!

Thank you for the comment. I think this would be a good piece of the course that we are thinking about - it is an important component to the legislative process and falls under what Professor Silk, Eva Chang, and others have discussed in terms of other methods that may be an effective may to effectuate change. Of course, when testifying will be effective is dependent on the specific issue but I think this is something we will include in our course.

This sounds like a great idea. I would encourage you to look not only at legislation but also at administrative rules/interpretations. Much of the "law" in many health-related fields, like diet and nutrition, is generated at the level of administrative interpretations and administrative rule-making rather than at the level of direct legislation. Because of deference awarded to agencies because of their so-called "expertise" in interpreting and implementing laws within their respective fields, it is important, when those rules deviate from received scientific wisdom, for there to be clear statements from the scientific community in opposition to the agency's "interpretation" for legal challenges to those "interpretations" to succeed.


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