Author: Lyric Jorgenson, PhD

Dr. Lyric Jorgenson has co-authored this blog with Dr. Cinnamon Bloss (r). Dr. Bloss is a Professor and Assistant Dean of Academic Affairs at the Herbert Wertheim School of Public Health and Human Longevity Science at the University of California, San Diego (UCSD).  Dr. Bloss also serves as the Chairwoman of the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC).

Effective policy is built on a trust, but trust means different things to different people, and the very thing that makes you trustworthy to some, might cause suspicion in others.  The only way to really understand these different assumptions is to talk to people who may have different views to understand their priorities. As such, it is critical to engage a diverse array of members of the public to hear their thoughts when undertaking policy development.

To gain perspective on how people view the novel use of their personal data for biomedical research, the NIH added a key element to the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC) charge to engage diverse communities about their views.  The topic of data science seemed especially appropriate for public engagement, since almost everyone has some type of smart device on them at any given time.  From a research perspective, the data obtained from these technologies represents a rich source of information that can be used to gain insights into individual and community health.  However, it also raises questions about privacy and autonomy, as well as potential risks and benefits.  All of these considerations lead to the central question of “what do people think about their data being used for research purposes?”

The NExTRAC Report on Data Science and Emerging Technology in Biomedical Research was approved at its latest meeting in August 2023.  The report details the approach the Committee and NIH took to engaging the public in a series of community conversations, made possible by community partners and expert facilitators.  They took place in diverse communities throughout the United States and involved discussion about the uses of personal health data in biomedical research.  This process and the information obtained demonstrate the benefits of getting real-time feedback on specific topics of importance to a community. Overall, the conversations fostered rich, candid, bi-directional dialogue.

The report also describes the critical need for NIH to assist investigators in engaging with research participants and communities through honest and transparent dialogue early in and throughout the research process.  To help realize that goal, the Committee recommended that NIH develop best practices for participant engagement on topics related to how their personal health data are being managed, reused, and linked to other data.  These best practices would be especially important in situations where they extend beyond regulatory requirements.

The Committee also noted that members of the public want to see a return of value from their research participation.  This would include, in some instances, the return of their research results.  With this in mind, the NExTRAC recommended that NIH support further public engagement efforts to inform best practices for the return of research results to participants, and to explore methods for providing benefits and return of value beyond the return of research results.

Another vital recommendation by the Committee was that NIH should examine its funded portfolio of projects that address public engagement related to data science research and consider possible synergies, lessons learned, and ways to coordinate them, as appropriate.  Such an effort could be valuable for investigators as they look to incorporate public engagement into their research efforts.  We encourage you to read the NExTRAC’s report to get the full context of the Committee’s comments and recommendations.  

While NIH has several ongoing efforts aligned with the NExTRAC’s recommendations, we know that more can be done. For example, while many of NIH’s Institutes and Centers have developed best practices for engaging with the communities they serve, it is useful to also take an agency-wide view on how best to support investigators in integrating engagement in their research. As another example, the NExTRAC notes that NIH has resources for drafting informed consent language, protecting research participant privacy, and responsible sharing of American Indian and Alaska Native participant data. However, more will be needed as the types of personal health data and practices for use and reuse of those data evolve. Additionally, to inform future policy frameworks on return of research results, NIH is supporting a contract to examine various aspects of responsibly returning individual research results to participants, and has solicited proposals aimed at developing an empirical evidence base for how environmental health results can be shared responsibly with participants. We look forward to considering additional next steps for returning individual research results.

Paradigm shifts like the one described in the Committee’s report take time.  However, the roadmap laid out by the NExTRAC will help ensure that NIH makes continuous progress towards its mission of better health for all. Importantly, the lessons we learned from this engagement process can inform how we approach policy making in general. We know that relying only on requests for comment in Federal Register notices, or even expert workshops, are not enough when true engagement with members of the public is the goal. Additionally, public engagement takes time, and must be done thoughtfully and in partnership with communities. Through these efforts, NIH aims to build a model of public engagement for policy making that is based on transparency, accountability, respect, and trust.

As an unrepentant policy fanatic, I love talking about details, whether it be the implications of a strategically placed “shall” or where data should be in controlled access. However, most of the time, policymaking requires being a good listener.  Listening is an underrated skill and is more than just waiting for your turn to speak.  Typically, the scientific, ethical, legal, and social issues at the forefront of biomedical research are so complex that it is essential we turn to experts and members of the public to hear their perspectives before we can develop a policy responsive to their needs. Listening to this input and incorporating it into policymaking is vital to our work and to ensuring our policies hit the mark.

A recent case study in listening involves the Novel and Exceptional Technology and Research Advisory Committee, or as we like to call them, the NExTRAC.  In 2020, we asked this committee to think through the different scenarios that may be used in gene drive research to advise on whether/how we should think about updating our existing biosafety policy framework.  During its deliberations, the Committee also did a lot of listening, consulting with subject matter experts, and holding a public workshop. Ultimately, the NExTRAC produced some very thoughtful recommendations in its final report to the NIH.

Based on our internal deliberations and the NExTRAC’s recommendations, NIH is turning this listening into action by proposing some policy updates. The proposal is to revise the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to strengthen our infrastructure for ensuring this research continues to proceed responsibly. Specifically, the proposed revisions would incorporate specific considerations and requirements for NIH-supported research involving gene drive modified organisms in contained research settings. 

It is important to emphasize that all the proposed actions at this time focus on working with gene drive modified organisms in contained research settings. This research is already performed around the globe in labs with biosafety precautions in place. However, as technology evolves, we must make sure that our policies keep pace. Thanks to the work of the NExTRAC, we believe this proposal will allow researchers to safely proceed with contained gene drive research.  I encourage all interested stakeholders to view the full proposal and provide us with your feedback.  Comments on the full proposal will be accepted until October 10, 2023, and must be submitted electronically.  I look forward to hearing your thoughts!

The importance of bringing people together to inform policy is a mainstay of OSP’s policy approach. For instance, as the world’s largest funder of biomedical research, we have been thinking carefully about our role in making federally-funded inventions more accessible to the public – and how to bring all parties to the table to make sure we get it right. The issue of access to new drugs and treatments is of paramount importance to nearly every member of the public, and NIH is key in driving the knowledge underlying their development. However, the ecosystem that supports the process relies on a broader group of actors, including partnerships across academia, non-profits, industry, patient groups, and more to make it a success.

Under this lens, the agency is hosting a workshop on July 31 to discuss NIH policies and practices that shape biomedical innovation and promote equitable access. This is an ideal time to have a transparent and focused discussion on how NIH as a research institution approaches the patenting and licensing of biomedical inventions, especially considering the outsized role we can play in advancing lifesaving treatments and economic growth.  For example, a recent study of the NIH intramural research program found that technologies licensed from NIH helped avert over 25,000 deaths from cervical cancer between 2008-2019 while also generating about 75,000 employment positions between 2001-2021.  While these numbers are impressive, NIH is concerned about the rising costs of healthcare products, and we equally realize that our agency cannot achieve its mission if people cannot access the products that emerge from our work.

Through this workshop we hope to discuss best practices and lessons learned so that we can continue doing the things that work and course correct the things that are sub-optimal.  We will also be excited to hear new ideas from meeting participants about things we could try to enhance the impact of NIH’s patent licensing program. Importantly, we invite public participation in this workshop.  The agenda will feature a 45-minute public comment session and NIH will also accept written comments from members of the public both before and after the workshop.  Full details including the agenda, webcast information and how to submit public comments can be found on the OSP website. I am looking forward to the discussion and I hope you will be able to join us.  By working across disciplines and maintaining open lines of communications with our stakeholders we can improve health, spur innovation, increase equitable access, and fulfill the mission of the NIH.