On Research Podcast – When Research Ends: Institutional Responsibility, Participant Protection, and Research Integrity

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1. Introduction and Episode Framing (00:00:20) Host Alexa McClellan welcomes listeners to On Research with CITI Program and introduces the episode’s focus on what happens when research ends abruptly.
2. Guest Introduction: Dr. Brandon Brown (00:00:49) Introduces Dr. Brandon Brown, his Hastings Center article, and his work on ethical challenges of abrupt study termination.
3. Guest Background and Expertise (00:01:44) Dr. Brown discusses his academic background, IRB service, and research focus on ethics and participant protections.
4. Why Study Termination Is a Blind Spot (00:02:02) Explains why termination planning is historically underdeveloped in research oversight and training.
5. Who Is Responsible When a Study Ends? (00:04:17) Considers the roles of PIs, sponsors, institutions, and IRBs when termination occurs.
6. Funding Gaps and Ethical Obligations (00:05:33) Highlights challenges around paying staff, compensating participants, and covering unexpected costs after termination.
7. Institutional Responsibility and Risk Management (00:07:36) Discusses why institutions have incentives to support ethical termination to protect trust and reputation.
8. What Participant Protection Looks Like at Termination (00:08:12) Explores participant protection beyond notification, including follow-up care and risk mitigation.
9. Consequences of Poorly Managed Terminations (00:11:35) Examines impacts on participant trust, community relationships, and perceptions of science.
10. On Campus Promo (00:14:19)
11. Disproportionate Harm to Participants (00:14:42) Discusses particular participant populations that are disproportionately harmed when studies end prematurely.
12. Policy and Infrastructure Gaps (00:18:04) How to build in unexpected terminations into institutional policies and workflows.
13. Similarity to Emergency Management (00:21:44) Lessons can be learned from emergency management planning.
14. Emergency Funding (00:22:09) Consideration of the need for institutional emergency funding for a termination response.
15. Looking Forward (00:23:47) Presents a vision of a future where policies are in place to smoothly handle abrupt research study terminations; where participants are protected, researchers are prepared, and institutions collaborate.
16. Ethical Mandate to Proactively Address Terminations (00:27:50) Given the continued probability of abrupt terminations, the ethical thing to do is start preparing now.
17. Closing Remarks and Resources (00:28:35) Host wraps up the conversation and points listeners to CITI Program resources.

Alexa McClellan: Welcome to On Research with CITI Program, the podcast where we explore the ideas, policies, and practices shaping the research enterprise. I’m your host, Alexa McClellan.

We spend a lot of time in research talking about how studies begin, protocol design, consent, enrollment, and approval. But we spend far less time talking about how studies end. And when research ends abruptly, the consequences can be profound for participants, for researchers, and for institutions.

My guest today is Dr. Brandon Brown, author of the recent Hastings Center article, Your Study is Terminated: Researchers Need to Prepare Participants, and a leading voice on the ethical challenges surrounding abrupt study termination. Brandon has spoken recently about the ethical and communication challenges researchers face when studies are cut short.

Today, we’re going to zoom out. We’ll be looking at what abrupt termination reveals about our research systems themselves, our policies, our institutional responsibilities, and the integrity of the research enterprise. In other words, this is not just a conversation about what happens when research ends, it’s a conversation about what our institutions owe participants and what it means for trust and science when we’re not prepared for the end.

Brandon, welcome to On Research.

Brandon Brown: Thank you for having me.

Alexa McClellan: If you could start off just by introducing yourself and telling us a little bit about your background.

Brandon Brown: Sure. My name is Brandon Brown, I’m a professor at the University of California, Riverside School of Medicine, which is inland of Los Angeles. I’m on my institutional IRB and I study ethical payment practices in research broadly with a focus on HIV.

Alexa McClellan: Great, thank you. So to start us off, we spend a lot of time in research talking about how studies begin, but much less time about how they end. Why do you think study termination has historically been such a blind spot in research oversight and training?

Brandon Brown: Yeah, it’s a good question. I think gearing up for a study is typically one of the main obstacles in research, and it’s something that investigators really focus their time and energy on. Because in some ways, once a study starts, it gains momentum and takes on a life of its own. So submitting the grant, obtaining IRB approval, getting the money, hiring the study staff and training folks for conducting the research is a big focus. And then the study can start with finally the recruitment of participants. And those are all big steps with lots of time and effort. And once all that work is done, I think we hope that the mighty powers that be will help things go smoothly for us in our study. Sometimes they don’t and there are protocol violations that we need to deal with. But at the same time, we believe that we have some aspect of control over our research. Because if the funding is there and if we’re doing everything right, why would it stop?

I think study terminations are such a blind spot because they’ve typically occurred so infrequently. When they did occur in the past, it might’ve been due to something like slow enrollment or participants being harmed in the study. But that’s different than what we’re seeing right now.

The funders we know and have experience with, who have continued to support our work, maybe we’re seeing that they’re given too much of our trust, that everything will work out like everything else in life. Maybe there’s a hope that if we do everything right, it won’t happen to us. But right now we could do everything right and our research can still be terminated because of whom or what we study. That doesn’t make sense for a lot of us who haven’t had this experience before. Because once our research is funded, in recent times, we’ve been able to complete it because if we do our job correctly and do everything right, we’re just able to get to the finish line.

Alexa McClellan: Yeah. So when a study is terminated abruptly, where does the responsibility really sit, with PIs or sponsors or the institutions or the IRBs or everybody? And what do you think institutions most often underestimate in their role in that process?

Brandon Brown: Yeah, I think that the responsibility should be shared. But if I had to choose one of those groups, I would say that the PI of a study knows much more about their study than any other stakeholder group in the research enterprise. So that includes the study sponsor who funds it, the IRB that reviews it and approves it, and the institution that receives the funds and elects the PI as the one to do the study.

So when a study is terminated, it’s the PI and their team who are most likely to know who the participants are, how to contact them, and perhaps, and hopefully so, they have already established a strong professional relationship and developed trust over time with their participants.

But there are different types of responsibility in research. Maybe what you must do and what you should do. And some things the PI may be able to do and other things they may want to do, but they can’t do.

So what we should do when terminations occur is to complete all of our obligations to our participants. That is to honor what we have mentioned in the consent form in terms of their understanding. Sometimes that means committing money and time outside of the funding that we receive. But if that’s not possible on the side of the PI through other grants, where do we go for those funds and resources? Perhaps to the institution for assistance. But if not them, do we as the PI go to our personal bank accounts to help keep things running, like to pay our study staff, to pay our students and post-docs, to pay the participant incentives that they were counting on and perhaps reimburse their travel for expenses that they’ve incurred.

The participant may not care so much where the resources come from, they just need the resources period. And that’s completely understandable. I don’t really worry, for example, where my paycheck comes from, I worry when it’s not there.

Alexa McClellan: That’s a big ask though, to ask for PIs to dip into their own bank account.

Brandon Brown: It is a big ask. And I would probably say that most PIs would not be able or willing to do so. Particularly those who conduct a lot of community-centered research because that sort of research is not historically and typically overfunded by the research enterprise and super appreciated by institutions since that research takes a long time. So the people that do that research, the PIs may have fewer resources to support their participants compared to other groups. But yeah, it’s a big ask. That’s why I said first we should probably go to the institutions first because they have more resources than we do in our personal bank accounts.

Alexa McClellan: For sure. And I would expect that they have a vested interest in supporting their investigators as well to make sure that there’s no blow-back on the institution when participants or investigators are like, “Hey, we’re having to pull out really suddenly and these are the consequences.”

Brandon Brown: We would hope so, yeah. I think we hope that that’s the case. We’ve seen some examples where that’s not the case. But I would hope that most institutions do want to really support their investigators and to support the communities in the research that occurs by the institution.

Alexa McClellan: Yeah. Speaking of supporting the participants. From your perspective, what does participant protection actually look like when a study ends unexpectedly? We talked about institutions, we would think that they should help support their researchers, but are they ethically obligated to provide support beyond simply letting participants know that the study is over?

Brandon Brown: Yeah, I think the context of the participant protection probably depends on the study. So for example, in the Hastings Bioethics Forum article we mentioned that what happens to a participant that has a device implanted in their brain and that study is terminated? Upon termination there may be an ethical obligation to do more than inform the participant with that device in their brain that the study’s over, and there could be no more contact or procedures. Because if a device is left implanted, can it possibly harm the participant if left in their body? When they were led to believe that it would be removed per the understanding of the informed consent form. So in that case, I think there’s an ethical obligation to do more than notify.

And if the study, for example, is about depression, as was mentioned in the article, what steps will be taken to address the depression under study if we have to go full stop? Thinking of resources and referrals.

So if we’re looking at a different kind of study, for example a study to address the trauma of people who have experienced domestic violence, if we stop midway, then participants may be left more harmed than before the study began. So again, we may need to do more than simply notify.

And I’m trying to think of maybe an example where investigators may just need to notify participants of a termination. Probably would be a study of the lowest possible risk to the participant, so let’s say maybe like a weekly food diary study to better understand people’s eating habits. That seems like much less risky than the other two studies mentioned right now. So maybe those participants can simply be notified that, “We are sorry, but the study’s been terminated and we can no longer have study visits.”

But notification itself I think is something else that has to be flushed out. So how are people notified? What do we tell them? Who notifies them? How are things explained? If we use the term terminated, and folks are from my generation where the movie Terminator was popular, is that an appropriate term to use, does it sound too harsh? Or do we need to really explain a bit more on what that looks like for people outside of our field? Like we apologize, but the funding that we received for your study was canceled by the federal government, we can no longer continue to work with you.

And how much do we go into detail? Do we tell them, for example, “By the way, I’m also losing my job because of this cancellation, so please know that I’ve done everything in my power to support you and will continue to do so to the best of my ability,” is that too much info? Do we tell them if our institution is helping to float any outstanding expenses? Or do we tell them if it’s not? That’s an open question. And if not, maybe community and others who could be potentially harmed can come together and put the necessary pressure on institutions and grantors to make it so.

Alexa McClellan: Yeah. So what are the consequences if it’s handled badly, if the institutions don’t step up and there’s no managed process for ethically ending the study, what implications are there on the research enterprise as a whole and the integrity and the trust that people might have in science?

Brandon Brown: Yeah, that’s a good question. I think many PIs have worked to build trust with community over years and some decades and sometimes leverage their personal reputation for folks to participate in research with institution XYZ, who may not have the best reputation for keeping community at the center of the work. I think our community partners in research actually do that often in community partnered research, leveraging their reputations in community for working with researchers who they believe in and that they can possibly help the community. So saying it’s okay to trust this person.

I think institutions don’t always have the best reputation with working with community. And maybe more often than not, over time trust has been broken, maybe not on purpose, but that doesn’t really matter. When trust is broken, it’s broken. And institutions may already be seen as like this ivory tower by the surrounding community. So when they break that trust, it may reinforce those negative stereotypes that academia does not care about community.

So poorly handled terminations with messages like, “Sorry, the study’s over, we can’t help you, we would refer you to your local public health department for questions,” Definitely can impact trust in the research. Just like if we make any other agreement that someone breaks and we’re like, “Hey, what happens? We had this agreement and you’re breaking this agreement.”

I think this is why we in the research community need to be working on comprehensive and accessible embedded language without our academic and research jargon to reach out to community in anticipation of a possible research termination. And that’s an example of being proactive versus reactive. And there’s been many examples of researchers taking advantage of community, being bad actors. So we not only have to work to repair past harm in research, but also work to prevent future harm because of these potential terminations that could occur for any study at any time.

Ed Butch: I hope you’re enjoying this episode of On Research. If you’re interested in important and diverse topics, the latest trends in the ever-changing landscape of universities, join me, Ed Butch, for CITI Program’s podcast, On Campus, new episodes released monthly. Now, back to On Research.

Alexa McClellan: I want to talk more about study design in a minute, but before we move on I’d like to talk more about power and vulnerability in our participants. Are there any particular participant populations who are disproportionately harmed when studies end abruptly? And how should institutions be accounting for those individuals?

Brandon Brown: Yes, I think that there are particular participant populations who could be and are disproportionately harmed. I could look at payment practices here. So in academia, we might think of payment practices and research as something that is the norm, thinking of reimbursement, compensation and incentives as examples of payment. We might think of that as secondary to our research purpose, to our research questions and planning how our current research leads to future work. But for our participants, sometimes the payment is the thing that gets them in the door to participate in research. Because research does take time and energy after all, and sometimes increased risk is involved. So it’s really important.

And institutions and agencies have legal teams that they’re there to protect institutions. And they can ensure they’re not on the hook for doing more for people once terminations occur. But most participants in research, like most humans in general, don’t have access to legal assistance. So they’re left without any options if things end abruptly.

So following that argument about payment of studies, that pay per study visit or that provide medical care as part of the research, terminations may put people, they may result in people being left worse off than before the research if they participate. So for example, I was getting care through you and now I no longer have it, and I gave up this other thing to be in your study, so I’m worse off.

So we could also think of, in the current political environment, immigration concern. So we can imagine one scenario, let’s say that a study takes place in a health clinic that was set up for the research, and participants do not provide their contact information for safety and security purposes. But they can show for their appointment on a certain day and time for study procedures. In the event that that study is terminated, perhaps the clinic closes from one day to the next, and when participants show up the clinic is closed, and there’s a note on the door explaining that the study was terminated. And there’s a number that you can call on the note, but maybe in the current political environment people might be hesitant to expose themselves to an unknown person on the other side of the phone. I think I would be.

So that just points to the need to really plan out what could happen when a study ends abruptly, specifically for participants who might be disproportionately harmed because of what they received in the study, the resources that they got, and now those resources are gone.

So how should institutions account for that reality? Maybe by leveraging their resources to help those people who donate their time, knowledge and literally their bodies to research that the institutions receive funding and indirect costs to undertake. So maybe there needs to be a change there.

Alexa McClellan: Yeah. Let’s talk about policies and infrastructure gaps. And I think we can include study design here as well. If we’re talking to an institution, what policies and workflows or infrastructures should be in place before a study ever starts to prepare for this possible abrupt termination, especially when you’re dealing with very vulnerable participants?

Brandon Brown: Sure. Yeah. And I’ve talked with my institution about this, and I’ve talked with academics and researchers at other institutions about this as well. I think some institutions are much better prepared than others because they have the experience of terminations in the past. So the experience of having studies terminated at an institution, that’s becoming more common these days. And when that happens, people at the institution have had to figure things out for their specific case of termination. And the amount of time to do that in the moment could be extensive. Not to mention that everything has to happen really quickly. So our response may be different if we were provided the time to think and collaborate with others and planning what to do in case of a termination. Versus, okay, the termination, this happened, let’s figure this out right now because we need to act immediately.

So now that we have this more widespread experience with terminations, I think now is the time for institutions to ask their PIs for a study termination plan. We have other such plans, like recruitment plans, data dissemination plans, study closure plans, even study visit worksheets. But having maybe a workflow of what to do when a termination happens at each step in the study is now more necessary probably than ever.

So what happens when the termination occurs at different stages, like before recruitment but after community has been engaged about the study and community is ready for it to come. Or at recruitment in the middle of the study or at the intervention stage or when data dissemination occurs. And again, the complexity of a termination is different for each type of study, using my examples of food diary versus a brain device implant.

So maybe a baby step is to ask PIs to provide a plan in case of an abrupt study ending as part of the IRB process. This could be due to study termination, but what about if the PI has to leave the institution? Or what about if the PI dies? I think about this all the time for my own research. If I die, what’s going to happen to my project? What then? Maybe the IRB and institution may be scrambling on what to do because the PI is often the one with access to study materials, including contact information for participants and all the data. So while terminations are what we’re talking about today, other life events can also lead to significant confusion. Meaning that maybe we need to also have a proxy PI or plan on what to do in many scenarios. And that’s not an exercise for the sake of busy work, that’s something that really happens. So preparing for an abrupt end is really even bigger than the current study terminations. But right now, the study terminations are on our mind and they’re significant.

Alexa McClellan: Right. And I’m just thinking for IACUCs and for IBCs, they all have to have emergency response plans submitted as part of their protocol. It’s similar to that. What do we do if an emergency happens, whether that’s an abrupt termination because of funding or because of a tornado. PI absence seems related.

Brandon Brown: Yeah, no, I agree.

Alexa McClellan: I was thinking too something that institutions might want to consider having a fund, some sort of a reservoir to draw from. Especially in the times that we find ourselves now where this is happening abruptly and frequently, depending on administration priorities. Maybe they should develop some sort of a pot of money that can be designated to help in these situations.

Brandon Brown: You’re reading my mind. I really like that point that you brought up. So whether it be having a pot of money in grant applications set aside for a termination response. Having termination preparation as part of the IRB applications or maybe even legal protections for participants with grantors. And that the study cannot be terminated if that termination puts participants at increased risk.

But it is interesting that we haven’t really thought about what you just said. So having a pot of money in grant application set aside for a termination response. Or having a pot of money at the institution, separate from a grant. So if termination happens or if the PI leaves suddenly, here’s a pot of money where we can actually draw from.

Alexa McClellan: Just to ethically and slowly bring things to a close. It doesn’t have to even continue the research project, but it needs to be something in order to close it out in a way that protects participants and allows time for people supported from that research financially, our staff and our grad students, to find something else or to be transitioned into another role.

Brandon Brown: Yeah, important.

Alexa McClellan: So looking forward, looking into an ideal world, I always try and end these discussions on a hopeful note, so what would it look like if it all works, if we do it right, if we figure out a way to address this? What would you hope has changed in how institutions approach study terminations? And what do you think it would take to get there?

Brandon Brown: Yeah. So let’s say in the coming years, my first hope is that science and truth prevail and research more broadly. But zooming in on terminations, I think that over time we in science will have learned how to best protect study participants in research that is terminated. I believe that this is probably just going to be a normal thing in five or 10 years that we just do. That we just are prepared for abrupt study endings.

And whether it be the thing that you brought up, having a pot of money grant application set aside, whether it be having a termination preparation as part of IRB applications that we submit, or whether it be, I think I mentioned this before, even more legal protections for participants, so with grantors and with institutions.

Another step might be sharing appropriate language among institutions on how this communication of termination has happened so that we can all learn from each other and improve our practices. Maybe that’s something that is occurring right now, so that in five to 10 years, we will have some example language that is appropriate that we can use to reach out to people. Something like, “It’s possible that this study could be terminated by the group providing the funding. If that occurs, we’d like the opportunity to contact you and let you know.” And with that said, maybe participants need to consent to that additional contact. I’m not sure why they wouldn’t, but we have to ask their permission to contact for them. And then back at the IRB, we provide the exact text in our applications on how we will reach out to people and how the termination will be explained to them. And then the next steps as part of their ended research participation.

So yeah, money set aside, IRB protocol planning, legal protections for participants, and then institutional collaboration. Those are all maybe examples of what probably many people hope will happen. It will take an additional investment in science rather than the way that we’re going right now with the attack on science. Because we’ve seen these terminations in NIH and CDC and SAMHSA and the subsequent reinstatement of some of those funds.

But assuming participants were told when the termination happens, “Sorry, our study was terminated today,” and then the next day when it’s reinstated, “We’re just kidding, we can continue.” That doesn’t help their trust in research one bit. But still, it should be our duty to keep participants informed of the current environment, which may lead to their participation in research being abruptly terminated. It’s only fair to make sure that everyone is aware of this, not just the PIs. Who may be more keenly aware of what’s going on at the federal government and funding level compared to participants themselves that are like, “Hey, I signed up to participate in the study. My understanding is these are the steps, and then I’m going to do all these things and then the study will be over. But you’re telling me that it’s stopping right now, so please explain.” Makes sense.

Alexa McClellan: And let’s all just hope for a smoothing off the waters and a more consistent approach because all of this uncertainty just makes everything hard for the participants and for the researchers and for the institutions and ethical boards that are supporting them.

Brandon Brown: Yeah. And maybe the ethical thing to do is to work on all this stuff right now. It may even be unethical to wait until we have a termination, to not be prepared to communicate that with participants and to remove the resources that they would gain in the study at the moment when things are terminated. So this is the ethical thing to do, is to prepare for this right now because it’s actually happening.

Alexa McClellan: Yeah. Brandon, thank you so much. It’s been great talking to you. And I appreciate your perspective on this very vital thing that’s happening right now to so many people in our industry.

Brandon Brown: Yeah. Thanks for having me.

Alexa McClellan: How we handle the end of research says just as much about our integrity as how we handle the beginning. If institutions want to earn and keep public trust, they can’t treat study termination as an afterthought. It has to be a part of how we define responsible, ethical, and trustworthy research.

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