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Discussion Guide and Transcript

Season Two - Episode Eight

Research Ethics Reimagined Season Two - Episode Eight "Trust, Translation, and the Future of Federal Research with Dr. Josh Fessel, MD, PhD"

  • In this episode of PRIM&R's podcast, "Research Ethics Reimagined," we explore trust in science, translational medicine, and the challenges facing federal research with Dr. Josh Fessel. Dr. Fessel is a physician scientist who most recently served as chief medical officer and director of the Office of Translational Medicine in the National Center for Advancing Translational Sciences at NIH. He discusses lessons from the COVID-19 pandemic, ethical considerations in AI implementation, and his decision to leave federal service when directives conflicted with his values as a physician and researcher. Listen on Spotify | Listen on Apple| Listen on Amazon
Discussion Questions
  • 1.) Building and Maintaining Trust in Science
  • Dr. Fessel emphasizes that "sticking feathers in your waistband doesn't make you a chicken" when discussing trust - you have to actually do things to be trustworthy. What concrete actions can research institutions take to build genuine trust rather than just talking about it?
  • He notes that we learned during the pandemic that "not all of the things that worked could be ported to normal operations." How can research organizations balance the efficiency and collaboration lessons from the pandemic with sustainable long-term practices?
2.) Ethical Implementation of AI in Healthcare and Research
  • Dr. Fessel warns that "just because you can bring AI to a situation doesn't necessarily mean that you should." How can researchers and clinicians determine when AI is the right tool versus when it might introduce unnecessary risks?
  • Dr. Fessel compares AI oversight to patient safety, noting it's "a thing you do, not a thing you did" - requiring continuous monitoring rather than one-time assessment. What systems should research institutions establish to ensure ongoing evaluation of AI tools for bias and performance issues?
3.) Supporting Research Careers and Federal Science
  • Dr. Fessel describes leaving NIH when directives to remove language felt like "an effort to erase people." How can research institutions support staff who face conflicts between institutional directives and their professional or ethical values?
  • He advises early career researchers to "think very flexibly about what career success could look like" given current uncertainties. How can institutions and senior researchers help create sustainable alternative pathways for emerging scientists beyond traditional academic tracks?

Key Terms

Translational Medicine: The process of turning discoveries into action to treat and prevent diseases - getting from "good idea to a thing that's actually able to help people when they need help, where they need help, in a way that they can access" Peacetime Operations: Term that emerged during COVID to describe non-pandemic research and healthcare operations, contrasting with the wartime-like intensity of pandemic response
Additional Resources
  • National Center for Advancing Translational Sciences (NCATS) - The NIH center where Dr. Fessel served, focused on translational science innovation
  • SMART IRB - Streamlined, ethical, multisite trials through reliance agreements
  • PRIM&R's Research Ethics Timeline - A resource for exploring the milestones of research ethics, including developments in federal research protections

Transcript

Please note, a transcript generator was used to help create written show transcript. The transcript of this podcast is approximate, condensed, and not meant for attribution. Listen to the full conversation with Dr. Fessel on PRIM&R’s Research Ethics Reimagined podcast.
PRIM&R: Welcome to Research Ethics Reimagined, a podcast created by Public Responsibility in Medicine and Research, or PRIM&R. Here, we talk with scientists, researchers, bioethicists, and some of the leading minds exploring the new frontiers of science. Join us to examine research ethics in the 21st century and learn why it matters to you.
Catherine Batsford: I'm your host, Catherine Batsford. Dan McLean: And I'm your co host today, Dan McLean Catherine Batsford: Today, we are pleased to have with us Dr. Josh Fessel. Dr. Fessel is a physician-scientist with experience across disciplines, phases of research, and sectors—including academia, the federal government, and public-private partnerships—and across domains such as person-centered strategic policy, regulatory operations, and communications.
Most recently, Dr. Fessel served as chief medical officer and director of the Office of Translational Medicine in the National Center for Advancing Translational Sciences at the NIH. Simply put, Dr. Fessel describes his overarching goal as developing more effective ways to turn discoveries into action to treat and prevent diseases of all types.
Josh, thank you so much for being with us today on the podcast. We are excited to share your story with our listeners. As a physician, did you always imagine your work would be so closely tied to research and eventually to serving at the NIH? Josh Fessel: The short answer is no. The federal service trajectory was never part of my plan, and I didn’t start out with research as a primary goal. I came from a family with no physicians or scientists, so I was blazing a new trail. I grew up in small towns in rural Illinois and Indiana and went to the University of Evansville, a small liberal arts school best known for its theater program.
It was a great preparation for medicine and science because it involved a lot of one-on-one and small-group work, which is much of what you do in both fields. I went to undergrad planning to go to medical school and did research because it was a “done thing” that strengthened your application. I hadn’t planned on falling in love with lab-based research—but I did.
That created a small crisis because I thought, “Wait, I’m supposed to do medicine.” Then I found out you could do both, and that’s what I pursued. I didn’t even know what the NIH was when I first fell in love with research.
I was well on my way to a traditional academic physician-scientist career when I realized I wanted more impact. I wanted to see my field—pulmonary disease—from a broader perspective. Joining the government happened by accident. I received an email from the National Heart, Lung, and Blood Institute about an opening for a medical officer. I applied mostly out of politeness, figuring I’d thank them and go home. But by the end of the interview day, I’d fallen in love with the job.
I called my wife while waiting for a ride to the airport, told her about the day, and she said, “We’re moving to Washington, D.C., aren’t we?” And she was right.
What drew me in was meeting people who were incredibly skilled scientists but focused on integrity and advancing the science itself—not on authorship or prestige. The mission was science first, always. Whether it meant designing a clinical trial or nurturing the next generation of scientists, it was about doing good work. Catherine Batsford: And that was before COVID-19?
Josh Fessel: Yes, I moved to the NIH in September 2018. I had a little over a year to learn the job—and I was grateful for that because when a global public health catastrophe breaks out that primarily affects the lungs, you get busy overnight. Dan McLean: Take us back to that time. When did you realize something was different—something big was happening?
Josh Fessel: We started talking about it internally in late 2019. I remember a coworker asking if we should stockpile food and medical supplies at home. I laughed and said, “No, no, no—it won’t be like that.” I thought it might be like the H1N1 flu in 2009, which had been my benchmark for a major public health event.
I was wrong.
As things progressed, COVID-19 became the dominant topic every day—how to support the response, investigators, and ongoing studies. It was an intense time. Meetings were happening around the clock. Global coordination meant talking with colleagues in the European Union at odd hours. It was exhausting but meaningful.
I was privileged to be part of efforts that were some of the highlights of my career. The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership brought together leaders from government, private industry, and academia to move research forward faster than ever before.
It mirrored what drew me to critical care medicine—making decisions under pressure, focusing on the details while aiming for big goals, and working as a team. The stakes were enormous, and every decision mattered. Catherine Batsford: It sounds like a moment when science came together and moved fast.
Josh Fessel: Absolutely. We learned there are ways to do things faster and more efficiently than we thought possible in early 2019. Getting the right teams together is critical. But not everything that worked during the pandemic can—or should—be part of normal operations.
Regulatory agencies met weekly because they had to, but that pace isn’t sustainable for every condition or study. You match the effort to the task at hand. Still, I’m hopeful some of what we learned can translate into “peacetime” operations. The pandemic truly felt like going to war. Dan McLean: Now that it’s 2025, what are your reflections on how the pandemic affected public trust in science?
Josh Fessel: Trust is indispensable. Science and medicine don’t work without it. We saw what happens when you try to do something vital for public health without sufficient trust—or after it’s been lost.
Trust isn’t something you can measure easily, but you know when it’s missing. We have a lot of work to do to rebuild it. Just saying the words “trust” and “trustworthy” doesn’t make it so. You have to do the work—acknowledge what went wrong, understand why, and address the fear and anger people feel. It’s hard to trust someone if you’re mad at them—or if you don’t even know who they are. Catherine Batsford: You mentioned earlier that, as a student, you didn’t know what the NIH was. Many people still don’t.
Josh Fessel: That’s true. We need to do a better job of explaining who we are and what we do. Everyone loves a good story. If we can tell our story in a way people recognize and connect with, science becomes less abstract and less intimidating. Catherine Batsford: Reflecting on your role as director of the Office of Translational Medicine at NCATS, can you explain translational medicine in lay terms?
Josh Fessel: Even people at NCATS would ask that. I described it as figuring out how to get from a good idea to something that actually helps people—when and where they need it—in a way that’s accessible. Then, think about how to make that process faster, cheaper, and more equitable.
We also worked to innovate in bioethics. NCATS’ translational bioethics research portfolio looked at how to push ethical thinking forward in areas like artificial intelligence and gene therapy. For example, gene therapy trials raise unique ethical questions because you can’t “redose” in the traditional sense. Participants need to understand what their involvement means for their future selves. Dan McLean: Speaking of AI, what ethical guardrails do you think are most important?
Josh Fessel: First, just because you can use AI doesn’t mean you should. These are tools, and they must be used appropriately. Second, we have to monitor them continuously. You don’t just “do” patient safety once; it’s ongoing. The same should be true for AI systems.
Transparency is also essential. Most of us don’t know which AI tools are used in our own healthcare—or how our data are handled. That’s a problem. We know these systems can fabricate results and mirror human biases. We wouldn’t tolerate that from a physician, so we shouldn’t from algorithms either. Catherine Batsford: Do current regulations go far enough?
Josh Fessel: No, but that’s complicated. We need frameworks that protect people without stifling innovation. Any regulation must be reviewed regularly, because in six months the technology will have changed. Catherine Batsford: Can you talk about your tenure at the NIH and your decision to step down?
Josh Fessel: I joined NIH as a medical officer at the Heart, Lung, and Blood Institute and later moved to NCATS. It was a fantastic experience—I learned everything from overseeing clinical trials to data science.
But I chose to leave because some directives from new leadership were not compatible with my moral compass, my federal oath, or my oath as a physician. When you’re told to remove language referencing gender identity or diversity, equity, and inclusion, it feels like erasing real people. I couldn’t be part of that.
Still, the people at NIH, FDA, CDC—they’re the same good people they’ve always been. We must be intentional about restoring trust in these agencies. They’re vital, and the public needs to understand what they do. Dan McLean: You’ve talked about the importance of telling stories. How do we amplify the stories of scientists and public health professionals?
Josh Fessel: Storytelling matters. Data alone don’t move people. Many federal workers have been told they can’t do their jobs or have had to step away because of ethical conflicts. Sharing their stories—safely and across media—reminds us why public service matters and why we need a strong, diverse research and public health workforce. That’s how we maintain health, prosperity, and national security. Catherine Batsford: Finally, what advice would you give young researchers facing funding cuts and uncertainty?
Josh Fessel: A career in science and medicine is still worth it. It’s meaningful, impactful work. But think flexibly about what success looks like—it doesn’t have to follow one path.
Institutional leaders also need to protect early-career researchers and create better on-ramps back into research for those who take detours. Small course corrections early in a career make a huge difference later. The future of science depends on supporting the next generation.
Research Ethics Reimagined guests are esteemed members of our community who generously share their insights. Their views are their own and do not necessarily reflect those of PRIM&R or its staff.

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