Author: Lyric Jorgenson, PhD

It is hard for me to believe that it has already been three months since being named the NIH Associate Director for Science Policy.  Since time doesn’t seem to be moving any slower, I wanted to make sure to take a breather and talk about a subject I am very passionate about!  Engaging people and communities in novel and meaningful ways to drive responsive and impactful policies.  In my years at NIH, I have heard many misconceptions (and even downright myths) about how OSP engages communities and ultimately utilizes the input we receive.  With misinformation rife, this feels like an opportune time to debunk some of those myths (as an aside, this does raise the age-old question “is bunk good or bad”?)

Now that we have that out of the way, let’s get started!  At risk of seeming cringe, I will be using gifs to boost engagement with the debunking.

CLAIM: The NIH Office of Science Policy aims to engage all its stakeholders in meaningful, bi-directional dialogue to ensure that communities affected by our policies feel they have a voice.

This is 100% fact.  My philosophy on community engagement is that it must be continuous, accessible, and honest.  Us simply talking at you is not true engagement.  At OSP, we want to establish relationships that enable people to feel comfortable telling us about their thoughts on the policies we develop.  To ensure bi-directional communication, we work to seek feedback through request for information or stakeholder meetings, and have also developed numerous resources to foster engagement.  You can reach us on X, LinkedIn, or through email.  In addition, you can always contact an OSP staff member directly by utilizing our employee directory.

CLAIM: When OSP asks for public feedback, it goes into a black-box and the public must do a lot of guess work on what OSP does with the comments.

One of the things, I am most proud about OSP is our commitment to transparency around policymaking.  As a person with lots of opinions, I know how frustrating it is to take the time to carefully carve out options for improvement and feel like they descend into a black hole.  After considering all of the comments we receive on our proposal, we post them, in full, to our website. Not only can individuals find their own comments, but they can also see what other interested members of the public feel about our proposals. 

Once we have finalized our proposals, we publish the final policies in the NIH Guide to Grants and Contracts.  The final policy includes a summary of the comments we received as well as what changes NIH made because of the feedback we received.

CLAIM: I am very interested in the work OSP does but feel that I sometimes have missed something important from them.

In addition to the multiple social media channels mentioned above, you can also subscribe to the OSP listserv so that you never miss any of the announcements we make regarding policy matters, training opportunities, webinars, and more.  OSP also maintains a robust, comprehensive list of partner organizations.  If you would like your organization added to that list, it can be done easily through an email request. I wish every problem in my job could be as easy to solve as this one! 

CLAIM: It feels like the people OSP engage with are either other policymakers and/or researchers affected by their policies.  It would be nice to see more commitment to a broader set of the public.

One of my highest priorities when it comes to OSP is making sure everyone has an equal opportunity and meaningful voice in contributing to the policy development process.  OSP, and the broader NIH, has made this commitment a priority and I’m excited to share with you a few of our latest successes. 

Last September, the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC) issued its final report on Data Science in Emerging Technology in Biomedical Research, which among other things, provided recommendations on how NIH should approach community engagement. To inform the recommendations of this report, NIH held a series of “community conversations” across the U.S. to learn more about people’s preferences when it came to health data.  This activity paid large dividends as we received in-depth, candid feedback from participants.

Building on these efforts, the NExTRAC has now been charged with establishing the ENGAGE Working Group (WG) to develop a vision and framework for including public voices in the design and planning of NIH-funded clinical research, as well as widespread dissemination of study findings.   The ENGAGE WG will assess the opportunities and challenges of varying levels of engagement activities for different types of clinical research studies as well as identify the impact and value of engagement with patients, communities, and the broader public.

CLAIM: Based on NIH’s size and the number of Institutes funding and conducting research it is probably impossible for OSP to accurately gauge the pulse the research community

I have certainly heard this one a few times. There is the perception that an agency like NIH operates individually, instead of as a whole.  Being in the NIH Office of the Director, I can happily dispel this notion! While OSP does not fund scientific proposals that undergo NIH’s rigorous peer-review process, we do collaborate and coordinate with our IC partners daily. Since OSP is situated in the Office of the Director, it is well positioned to survey the research landscape and provide the policy infrastructure that allows vital research to move forward in an ethical and safe manner.

To make sure OSP is achieving its mission, we not only need to ensure maximum engagement with people within our own house, but also ensure that we are listening to policymakers, researchers, ethicists, patients, community members, and people just like you!

I am proud to say that OSP is in lockstep with the vision that NIH Director Dr. Monica Bertagnolli has expressed with respect to ensuring that NIH engages all people and communities in research to inform biomedical research.  As we move forward in making this vision a reality, I hope the information above has been helpful in clarifying OSP’s role at NIH and our future plans and activities.  I encourage anyone who wants to learn more about OSP and our mission to contact OSP’s Director for Strategic Engagement, Ryan Bayha (bayhar@mail.nih.gov), to chat more about how we can work together to optimize community engagement.

If I were to tell you that I have a very important similarity to people like Steven Spielberg, Oprah Winfrey, Tom Hanks, and Mindy Kaling, what would you say?  Your first reaction might be, “Obviously, Lyric. We already know that you are all so wildly famous that you can’t go to the grocery store without a sharpie to sign autographs for your fans.” Unfortunately, I have not (yet) achieved that level of fame, wealth, or recognition.  In actuality, the real connection I have to these celebrities is that we all started our careers off with an internship!

In the beginning of my career, I knew I loved science but had a sense that being at the bench wasn’t the path I wanted to pursue.  As a scientist pursuing a Ph.D., this was a scary thought!  What other careers were out there for people who wanted to advance science by identifying problems, generating evidence, and communicating findings outside of the lab?  Fortunately, I had already discovered the value of a professional network, and mine turned me on to an internship with AAAS that allowed me to explore the policy world.  I think it is fair to say that I never looked back after learning about how much I can contribute to furthering research through policy. 

When I began my leadership role at OSP, one of my primary goals was to develop a world-class paid internship program that could provide access for budding policy professionals to gain exposure to the exciting world of science policy.  Last summer, we launched the first official OSP Summer Internship Program, and I think it was a phenomenal success.  The applicant pool was fierce, and the interns selected gained valuable experience in how a government policy office operates: the good, the bad, and the ugly.  Conversely, OSP also learned from our interns some valuable lessons from their perspectives and experiences, (at the end of this piece, please see some testimonials from our inaugural class of interns) and they substantially contributed to some of the major issues we were working on at the time. 

With our first year under our belts, I am beaming with excitement to launch year two.  We are now accepting applications for the 2024 Summer Internship Program!  After looking at the 2023 Program, we made some enhancements that will make things even better.  The biggest change is the 2024 Program will be open to undergraduates as well as students in a graduate or professional degree-seeking program.  Another change we have made is the application process.  OSP has developed an easy-to-use portal that allows applicants to easily determine eligibility and submit documentation and references.    

Applications for the 2024 OSP Summer Internship Program will be accepted until February 12, 2024.  Full information on the opportunities available, eligibility, and how to apply can be found at: https://osp.od.nih.gov/the-2024-nih-office-of-science-policy-summer-internship-program/.

I encourage anyone with an interest in a policy career to apply for the 2024 OSP Summer Internship Program.  One day you could add your name to mine, Steven’s, Tom’s, and Oprah’s and Mindy’s as intern alums.

PS: Another benefit of an internship is that you get to call celebrities who also interned by their first names even if you have never meet them!

Straight From the Class of ‘23

	Name: Nina D’Amiano, MPH (MD expected May 2024) Institution: Johns Hopkins University What would you say was your biggest takeaway from the OSP Internship Program? At OSP, I learned about the appropriations process and selection of policy priorities. My main project was to coordinate with various NIH ICOs to prepare the annual NIH Congressional Justification. I recognized the need for experts to participate in policy and the legislative processes and gained experience translating technical, scientific knowledge into language that is understandable and useful to decision makers and the public alike. I saw how research-derived scientific knowledge can be applied to real-world policies that directly impact Americans. I hope to pursue a career in medicine through which I can impact health outcomes through policy and advocacy.
	Name: Abigail McElroy (PhD student in Neuroscience) Institution: Emory University What did you enjoy most during your time as an intern at OSP? I started this internship having a longstanding curiosity about science policy, but not really knowing anything about what it was or how it worked. I was excited to get to see what the field was like close-up and enjoyed getting to interface with people in the policy office and find out what they did. I especially liked reading the Request for Information responses and getting to be a part of how those public comments would be incorporated into the policies OSP were crafting.

When I think of December, my thoughts usually turn to the holiday season, time with friends and family, and the anticipation of one year ending and a new one about to begin (it also brings to mind cold weather and limited daylight but that is for another blog).  When it comes to life at NIH though, December means the biannual meeting of the Advisory Committee to the NIH Director (ACD) and updating the public on some of the key activities the agency is spearheading in service to science and society.

For readers that are unfamiliar with the ACD, this committee provides expert advice on some of the most pressing issues facing the NIH and the research we conduct and fund.   While all ACD meetings involve interesting presentations and thought-provoking questions, this one will be a very special one as it will be the first ACD meeting for Dr. Monica Bertagnolli in her capacity of NIH Director!

In addition to the excitement of having Dr. Bertagnolli at the meeting, I am very proud that the agenda is chockablock with issues in which OSP is either the lead for the agency or a substantial contributor.  Everyday I see the brilliance of the OSP staff in dealing with extraordinarily complex issues.  It is a gratifying to be able to stand up in front of one of NIH’s most expert committees and detail the fruits of that labor.  

During the December 14-15 meeting of the ACD, I will be busy participating in three presentations.  The first talk, on the afternoon of the 14^th, will be a status update on the work of the Novel Alternative Methods (NAMs) Working Group (WG) that I will be presenting with my WG co-chair, Dr. Howard Chang.  During this presentation, Dr. Chang and I will detail the WG’s recommendations on how NIH can best catalyze and develop NAMs and transform our understanding of human health in the process.

The second presentation will kick-off the morning session on the 15^th.  Dr. Garth Graham and I, as co-chairs of the HeLa Genome Data Access WG, will discuss the requests we have received for the full HeLa who genome sequence since the previous ACD meeting.  Since 2023 marks the 10^th anniversary of the NIH-Lacks Family Agreement, the bulk of the presentation will focus on how NIH can continue to promote this unique partnership. 

The final presentation in my trifecta is near and dear not only my heart, but Dr. Bertagnolli’s as well.  The talk will focus on how NIH is fostering engagement, transparency, and trust in clinical research.  This is an exciting topic, and I will describe some of the steps we hope to take to more fully incorporate public voices in the design, planning, and dissemination of NIH-funded clinical research. I can’t lie, I am a little nervous that my voice might not make it through all these presentations! Nevertheless, I am willing to risk sounding like Kermit the frog for a few days so that I can help spread the word about the important work OSP and NIH are undertaking.  I invite you to join me at the ACD meeting taking place on December 14-15. The full agenda and webcast information can be found at: https://acd.od.nih.gov/meetings.html

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.