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: Today’s conversation addresses one of the most significant and challenging developments we have seen in years: the widespread and unprecedented termination of federally funded studies across the United States. These cuts have affected tens of thousands of participants, strained research teams, and placed new pressures on institutional review boards (IRBs) to manage communication, protocol modifications, and participant protections in real time.
Dan McLean: Last month, it was widely reported that the National Institutes of Health (NIH) terminated grants for nearly 400 clinical trials this year. When human subjects research studies are stopped—regardless of the reason—IRBs work with researchers to follow clear protocols for informing participants and winding down a study safely. We are glad to have Dr. Brandon Brown with us today.
Dan McLean: Dr. Brown is a professor of medicine in the Department of Social Medicine, Population, and Public Health at UC Riverside School of Medicine. This year, he was named a fellow of The Hastings Center.
Catherine Batsford: Dr. Brown recently wrote an essay published by The Hastings Center on this topic. In today’s episode, Dr. Brown will help us unpack what these terminations mean for research oversight, how IRBs can prepare, and what institutions can do now to strengthen their policies and processes.
Dan McLean: I’m your host, Dan McLean.
Catherine Batsford: And I’m your co-host, Catherine Batsford.
Dan McLean: Dr. Brown, thanks for being with us today.
Brandon Brown: Happy to be here. Thank you.
Dan McLean: Can you start with what has happened with respect to NIH funding that has affected a wide range of studies across the country?
Brandon Brown, PhD: Sure. The NIH has had a lot of funding cuts. As we note in the article, more than 74,000 people enrolled in biomedical research were removed from those studies, including 2,600 biomedical grants totaling $9 billion. This is significant.
Dan McLean: Put this in context, if you could, for the last couple decades of scientific research.
Brandon Brown: I think this is unprecedented in the history of U.S. research. While any study can be terminated for different reasons—and that possibility is reflected in regulations—what we are seeing now is termination being enacted at scale. Part of this appears to be tied to targeting certain terms in grants, such as “accessible,” “bias,” “disability,” “LGBTQ,” or “gender diversity,” among others. This kind of targeting—particularly of research involving different populations or research focused on diversity—feels new. Many junior faculty and junior researchers, and even many senior researchers, have not seen cuts like this, including widespread terminations of grants.
Dan McLean: With these human subjects research studies that were cut recently, can you speak about what they were exploring—what they were attempting to learn?
Brandon Brown: A broad range—everything and anything. As long as a research project included some of these terms, the topic could involve vaccines, HIV, cancer—the full range of research. There is no single type of project that was targeted. It was research in general—research that included some of these terms. That is what was targeted and what was terminated.
Catherine Batsford: Termination can happen, and protocols are usually written into research. But you mentioned that many researchers are earlier in their careers. Is this new for them—something you know, but that they may not have navigated with the IRB?
Brandon Brown: Yes. In my case, I’m a full professor and I serve on my institution’s IRB. I talk with IRB colleagues at other institutions. We have not seen anything like this before. Researchers and IRB members were not prepared for this unprecedented scope of terminations. That is one reason we addressed informed consent and the need to communicate to participants that termination is a possibility—now that it is more pronounced.
Dan McLean: But in the normal informed consent process and IRB operations, isn’t it already part of participation that a study may not conclude?
Brandon Brown: In some contexts, yes. For example, many clinical trials have a data and safety monitoring board. A study might stop because results are clearly beneficial, or because there is evidence of harm. What we are seeing now is different. We are not seeing those typical reasons. We are seeing terminations based on the topic and the language in a project—terms that are viewed as inconsistent with current federal priorities.
Dan McLean: Are you suggesting that moving forward, potential participants should be told there may be an increased likelihood of termination?
Brandon Brown: Yes. For participants currently enrolled, there should be more communication about this possibility in informed consent documents. Historically, consent language may cover risks, benefits, and the possibility of a trial stopping. Now we need clearer language that a study could be terminated at any time for any reason.
Catherine Batsford: How can researchers balance realistic consent language while still encouraging enrollment? I would think this could deter people.
Brandon Brown: It could. For existing participants, adding this language could require re-consenting those already enrolled. For prospective participants, teams can plan the consent form up front. But it may make recruitment more difficult, and it may contribute to loss of trust as people see other studies terminated. Termination can occur before recruitment, during recruitment, mid-intervention, or during follow-up. Each point carries different implications.
Dan McLean: What does this mean for regions of the country where there is a need to develop more trial sites?
Brandon Brown: Could you rephrase that?
Dan McLean: Do you have ideas for how we can move forward and continue trials and capacity?
Brandon Brown: These terminations make it difficult for new and established researchers to stay motivated to pursue research. In the past, researchers wrote proposals, underwent peer review, and aimed for a payline. Now that process can feel destabilized and demoralizing. We are not planning for growth; we are planning for additional cuts. We have already seen cuts in 2025 and proposals for 2026 that would reduce federal health research substantially. For 2025, there was a 50% cut from the National Institute on Minority Health and Health Disparities. For 2026, there have been proposed cuts across agencies of about 40%, if approved.
Catherine Batsford: What is the most common harm a participant could experience if a study stops quickly?
Brandon Brown: It depends on the study. In the Hastings article, we discussed implantable devices, such as a device implanted in the brain. If a stop-work order occurs, monitoring and follow-up could also stop. The immediate risks are greatest for participants in research that is more than minimal risk. The broader harm to science is also substantial. If proposed research cannot proceed, we lose potential clinical benefits. We also risk losing trainees—students and fellows whose tuition and stipends are supported by grants—meaning fewer future scientists.
Dan McLean: So ending trials midstream could deter future participation and deter researchers from launching studies.
Brandon Brown: Yes. For junior faculty, research funding can be tied to salary support. People may lose positions in academia if funding disappears.
Catherine Batsford: From the IRB and compliance office perspective, has rapid termination created more work? Do they need to assist researchers in closing studies?
Brandon Brown: Yes. Once a termination notice goes to the principal investigator, how is that communicated to the IRB? What happens if participants incurred expenses and have not been reimbursed? If contacting participants is not in the approved protocol or consent process, a researcher could risk a protocol deviation by reaching out without IRB approval—even to inform them the study is terminated. Researchers need to notify the IRB and seek approval for participant communications outside the original protocol. This increases workload for IRBs, which are often overextended.
Catherine Batsford: So even if termination is mentioned generally, the communication itself could still require IRB review?
Brandon Brown: Yes. Every communication with participants must be reviewed and approved to protect participants and ensure appropriate messaging.
Dan McLean: Have you personally been involved in research that had to end and required you to contact the IRB?
Brandon Brown: I have not. But we have been discussing this within our IRB. While writing the Hastings Bioethics Forum piece, I looked for guidance on IRB websites about what to do when research is terminated. Some institutions address it, but many simply say: If you receive a termination notice, contact the IRB. That makes it difficult for researchers across institutions to learn from one another.
Dan McLean: If a researcher’s funding is terminated, does the researcher notify participants, or does the IRB do it?
Brandon Brown: Typically, the researcher communicates with participants. IRBs may not have direct access to participant contact information. Sometimes the principal investigator does not have it either—it may be held by study staff, which adds complexity. If funding ends, staff may not be paid to conduct termination communications, which creates ethical and operational challenges.
Catherine Batsford: What happens to participants’ data or work completed before termination?
Brandon Brown: We may need new protocols. In general, data collected prior to termination may be retained, but no new data can be collected after a stop-work order. Another key issue is ensuring protections for data already collected—particularly for studies terminated because they involve certain populations or terms. Participant privacy and identifiers must be protected as strongly as possible.
Dan McLean: In your article, you wrote that bioethicists can take the lead on step-by-step protocols for researchers who receive termination notices. What can groups like PRIM&R do to help?
Brandon Brown: PRIM&R and similar groups could convene stakeholders—researchers, IRB members, trainees, staff, and participants—to co-develop a practical protocol for responding to termination notices. That protocol could be made publicly available and updated iteratively as more terminations occur and more is learned. Accessible language for participants is essential.
Dan McLean: Could this reduce the burden on individual IRBs?
Brandon Brown: Yes. A shared protocol would help both researchers and IRBs, particularly for those experiencing a first termination or preparing for one.
Dan McLean: What would termination notifications to participants look like—three paragraphs, a long PDF?
Brandon Brown: The goal should be accessible, direct language. The content also depends on where the study is—before recruitment, during recruitment, mid-intervention, or during follow-up. A participant mid-intervention needs clear answers: What happens next? What are the safety steps? For example, if someone has an implanted device, the message must address monitoring and clinical follow-up. The details must be study-specific, but there should also be common language across studies to communicate that termination can occur.
Dan McLean: What’s next on your mind as you continue this work?
Brandon Brown: The Hastings piece focused on participants, who must remain the top priority. But terminations also affect other stakeholders—job loss, loss of health insurance, loss of educational pathways. That harms science and makes it harder for the next generation. I hope this moment leads to clearer informed consent language and better planning for what happens if funding ends. Researchers will also need to be nimble and explore other ways to conduct research if funding becomes less available. Another outcome is that more scientists are speaking out about the importance of their work and the impact of terminating research involving certain populations. That visibility matters.
Catherine Batsford: The public is increasingly seeing that research and public health are intertwined—and that funding decisions have direct, real-world consequences.
Brandon Brown: We are also seeing innovation in response—for example, efforts to track the impact of terminations with data, so we can quantify how many trials and participants are affected.
Dan McLean: In the weeks and months ahead, PRIM&R will continue exploring this issue and convening the community to think through next steps.
Brandon Brown: Bringing stakeholders to the table—including participants—is essential. If I am a participant and my study is terminated, this is what I need to hear, and this is what I need from the research team.
Catherine Batsford: Absolutely.
Dan McLean: Thank you for joining us and highlighting this issue.
Catherine Batsford: Abrupt study terminations raise critical questions for IRBs, research administrators, and institutions about preparedness, communication, and responsibility to participants.
Dan McLean: We hope today’s discussion helps you identify opportunities to strengthen oversight and feel more equipped to navigate emerging pressures in the research environment. This is an important topic, and PRIM&R plans to explore it further with the PRIM&R community in the months ahead.
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