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Discussion Guide and Transcript
Season Two - Episode Four
Research Ethics Reimagined Season Two - Episode Four “ First 100 Days: Navigating Uncertainty in Research Oversight with Mark Barnes, JD, LLM ”
- In this episode of PRIM&R's podcast, "Research Ethics Reimagined," we explore ongoing legal challenges and federal policy changes affecting the research oversight community in the several months of the new administration. Our guest is Mark Barnes, partner in the healthcare and life sciences practice at Ropes and Gray LLP in Boston, who has spent 40 years as a leader in research misconduct, human and animal research oversight, healthcare law, and conflict of interest. Listen on Spotify | Listen on Apple| Listen on Amazon
Discussion Questions
- 1.) Historical Context and Current Challenges
- Barnes compares the current legal challenges to historical episodes including the AIDS epidemic and the COVID-19 pandemic. What lessons from these previous crises might help research institutions navigate current challenges?
- Barnes discusses how different federal agencies (NIH, NSF, Department of Energy, Department of Defense) are implementing various policy changes. How might these varied approaches across agencies create additional compliance challenges for multi-funded institutions?
2.) Legal Landscape and Compliance
- Barnes mentions that more than 100 legal cases have been filed regarding recent research directives, with many focused on indirect cost rate reductions and grant terminations. What strategies might institutions use to maintain research operations while these legal challenges are resolved?
3.) Research Protection and Future Outlook
- Barnes expresses concerns about NIH suspending certificates of confidentiality for non-federal funded research. What implications might this have for research involving sensitive populations or stigmatized conditions?
- Barnes emphasizes the need for research institutions to work with stakeholders in states where major research centers exist, regardless of political alignment. How might this collaborative approach help protect the research enterprise during political transitions?
Additional Resources
- NIH Grants and Funding - Information about NIH grant policies and requirements.
- Secretary's Advisory Committee on Human Research Protections (SACHRP) - Federal advisory committee that provides recommendations on research protections.
- American Society of Law, Medicine & Ethics - Organization providing resources on legal and ethical issues in healthcare and research.
- PRIM&R's Research Ethics Timeline - A resource for exploring the milestones of research ethics, including developments in women's health research.
Transcript
Ivy Tillman: 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: Welcome back to Research Ethics Reimagined. Today, we are pleased to be joined by Mark Barnes. During Mark's 40-year career, he has been an unparalleled leader in the areas of research misconduct, human and animal research oversight, health care law, conflict of interest, international research, and data privacy. Mark is a partner in the health care and life sciences practice at Ropes & Gray LLP in Boston. Over the course of his career, he has played an active role in national advisory groups on human research protections, including the Secretary's Advisory Committee on Human Research Protections and the National Human Research Protections Advisory Committee.
Since 1989, Mark has also taught health care law and biomedical research law at institutions such as NYU, Harvard, and Yale. He was also the recipient of the 2023 PRIM&R Service Award for being an inspiring and influential leader in the research field. Mark was kind enough to be a guest on PRIM&R’s first federal policy briefing this year back in February. Today, we are glad to have Mark on the podcast to continue sharing his thoughts with a broader audience. I'm your host, Catherine Batsford. Dan McLean: And I’m your co-host today, Dan McLean. Catherine Batsford: Thank you so much for joining us, Mark. There is an awful lot to keep track of during the first 100 days of the new administration. Can you help identify the ongoing legal challenges that affect the research oversight community? Mark Barnes: Well, yes, I can. First of all, thank you for having me again. It’s a pleasure to be here. I’m very fond of PRIM&R and everything that you all have done. Your first executive director, Joan Rachlin, is a close friend of mine and remains a close friend. You all have had such fantastic people on your staff, board, and among your membership for so many years. So, we are swimming—either with or against—a huge tide at this point. There are so many things happening in the research area. Some affect human subjects research directly, others affect grants and contracts, and still others influence the content of research itself. For instance, activities perceived as aligning with illegal diversity, equity, and inclusion (DEI) efforts may be scrutinized. So, there is a great deal going on. Within the research grant and contract landscape, there's a doubling down on issues related to indirect cost rates—also known as facilities and administration costs. Many research institutions, including academic medical centers and universities, have received numerous inquiries from federal agencies about justifying their drawdowns on the federal treasury for already awarded grants. We're really trying to respond constructively to the federal government at all levels within the research enterprise. I'm happy to take these things one by one if you have questions, but there's a lot happening. Catherine Batsford: So much. Dan McLean: Sure. Before we jump into some of those, I just want to reference your long career in this space. I know you've been involved across decades. As administrations have come and gone, have you ever seen this much activity or this level of potential impact on the research oversight community? Mark Barnes: I've never seen anything quite like this. I've seen three previous episodes that somewhat rival what we’re experiencing now. One was the AIDS epidemic, which greatly impacted drug discovery, participant rights in trials, and the access to experimental therapies at early stages.
All of these things—both of you are probably too young to remember that—but I remember those years extremely clearly. I was an AIDS advocate at that time. I taught at Columbia Law School full time, and I opened an AIDS law clinic to assist people with HIV or AIDS when they lost their jobs, their housing, or their access to healthcare. That was a real struggle in the early '80s and the mid-'80s and all the way, really, until the development of antiretroviral therapies, which really didn't come online until 1995. There was a ten year period in which there was a lot of HIV.
There were a lot of people sick with HIV. There was a lot of research being done, a lot of incredibly fast drug development, and a real crisis atmosphere. And we tend to forget about that because—thank God—the antiretrovirals have largely solved the public health problem in the U.S. That's one episode. The second episode, which actually coincided somewhat with that—with the end of that period—was in November of 1994, when the Republicans, under Newt Gingrich, took over the House of Representatives by a massive margin.
And there was a budgetary crisis. Many of the organizations that were service and demonstration projects were fearful of their funding being cut. Much funding was cut during that time. I happened, at that time, to be the chief AIDS lobbyist in Washington. I was the director of the AIDS Action Council, which, at that point, was the umbrella lobbying organization for HIV/AIDS funding, treatment, research money, et cetera.
I could tell you a bit about that, but we actually survived that, and our programs survived that pretty much intact. But it was a massive effort to try to persuade the folks who were all of a sudden in power—who were not Nancy Pelosi and the Democrats. They were Newt Gingrich, Bob Livingston from Louisiana, and others—to persuade them that this funding was entirely appropriate and was really meant to assist communities in America in need, not anything else. And so we did that.
It caused incredible programmatic disruptions because what were we going to do with people who were enrolled in clinical trials when essentially the world was shut? How were we going to continue any kind of primary research that included interaction—live interaction—with subjects, whether it's children or adults, whether it's educational settings, social service settings, or health settings?
Those are three episodes that were, I think, traumatic for the community. I'm not sure I've quite seen anything like this, but at the time, I have to say that AIDS/HIV seemed perhaps bigger than this even. And it's useful to remember that we survived all those. Catherine Batsford: It is good. It sounds like there's moments of education that had to happen with each one of these, you know, for the general public, for the scientists to communicate back out what's going on and what we're working on and why it's important. Mark Barnes: Right. I think that's right. I've looked here carefully because I'm in the middle of many different controversies right now, representing our clients—our Ropes & Gray clients—who are some of the premier academic medical centers and universities that engage in human subjects research, animal research, and basic science research. And one thing that—if it's okay—I'll ask your question for you. Catherine Batsford: Yeah! Thank you. Mark Barnes: You can tell me if it's the wrong question. But one question is: What's the endgame here? And how can we really, as an overall research enterprise community—academic research community, but that includes the industry research as well—how can we stand up to this challenge? And how can we make sure that our activities are preserved?
And I do think that—having been through this before, in January 1995, when the new Congress took over—I have to say that I think the key here is that there are many red states with U.S. Senators, primarily Republican congressional delegations, in those states that contain centers of academic and scientific excellence that are hurting or will be hurt just as much as the institutions in Massachusetts, New York, California, and Washington state.
I think getting to the governors of those states, getting to the U.S. Senators in those states—like Tennessee, with Vanderbilt and the University of Tennessee; like Texas, with the University of Texas, all of its many campuses, and its incredible research enterprise; Florida, with FSU, the University of Florida, the University of Miami, Moffitt Cancer Center in Tampa, and others; and Alabama, with the University of Alabama at Birmingham, which is a major recipient of federal research funding—
I think getting to those people and explaining to them—and not having folks from the East Coast and West Coast lecture them, but having their own people, from their own institutions, in their own states—explain to them what's really going on here, and advocate that the baby not be thrown out with the bathwater, if you will. That’s—that’s where—that’s the endgame.
And I do have a fear that we’re not quite sufficiently organized to get there right now. Catherine Batsford: Right. So as people are looking to get organized, what is the message that they should be focusing on? Certainly, looking at the recent executive orders, but what funding and operations should they be moving forward with requesting support? Mark Barnes: Well, the NIH funding is definitely the core funding for most of the biomedical research that is not done by industry in the United States—I mean, frankly, abroad as well. That’s one of the issues here. NIH has basically said that, prospectively—except for special circumstances—it is not going to approve either direct grants to entities abroad or even subawards from American institutions that receive a grant. They're going to prevent that. The theory is: Buy American. That we should keep the money at home. But I would say NIH is the core.
Then you have many institutions, though—like MIT and Caltech and others, and some of the state universities—that get a lot of funding from the Department of Energy. Others get a lot of money from the Department of Defense and the National Science Foundation, as well as the Department of Education and Department of Justice. There are a few other funding agencies, but I would say that the sort of big four are NIH, National Science Foundation, Department of Energy, and Department of Defense.
Mostly, this particular administration has focused on using NIH as the conduit for new policy directives, but that's because NIH is probably about 70% or so of the federal research dollars that go into higher education and academic medicine. But NSF has been active as well. Department of Defense—not so much. I have a feeling that the reason for that is that many things from the Department of Defense are actually in the form of contracts rather than grants. They also are serving—those contracts and grants—a core national defense, national welfare purpose, so I think this administration has largely kept its hands off of those grants and contracts.
I think there are a couple of messages we can respond back with.
One is all about money: that the money that goes to the University of Alabama at Birmingham and all these other schools—both in blue states and also in red states—really is a driver of the local and state economies in many ways. More than that, it's not just that the money hires people and pays for buildings and lights and heat. It's also that the developments—the technology developments that come out of government-funded research—the patents that are created, the technological know-how that’s amassed and then licensed out to industry—drive industry. It has a multiplier effect downstream when the money is used wisely and well by researchers and by the research institutions. So it's an engine for development—and for economic development.
But the other major argument really is that making lives better through science—lives for Americans, and the lives and welfare of people around the world—with these research dollars is extremely important. Without the American funding for these things... let me just put it this way: the American government funding for these things dwarfs the basic science funding by other nations, even in the aggregate. So there is a humanitarian and a scientific imperative to continue spending research dollars and using them wisely. Dan McLean: I was trying to get a handle on all the different court challenges and executive orders. And I think for a lot of listeners, it may have been relatively easy to keep track a month or two ago, but now there's a lot of different a flurry of additional activities and different steps in the process of different court challenges that may be a pending appeal or they have a district court ruling. Can you just take a moment and kind of in for the 30,000 foot view, just share how many cases you're tracking, how many cases you think are most relevant to this community, and just let people know where they are in the process and the same question with the executive orders. Mark Barnes: Right. Well, the last count that I've heard—I cannot keep count anymore. I knew at the beginning, you know, the handful of cases that had been filed or the people who were considering filing. But right now, I think that there are well over a hundred cases that have been filed at this point. And in that number, many are in regard to these various research directives and decrees by the federal government affecting research funding.
There may even be as many as 200 cases that have been filed. Almost all of them have been filed—perhaps all of them—in the federal court system because, of course, this is federal money. So if one wanted, as a lawyer or an interest group to challenge—or a plaintiff to challenge—one of these things, then one would go to federal court. So they're really in the federal district courts, and then they get a decision—probably a decision on a temporary restraining order or an injunction—that then gets appealed to the circuit courts. Then it is sent to the federal appeals courts. Undoubtedly, some of these things will be appealed eventually to the U.S. Supreme Court, and they'll be decided by the Supreme Court.
There have been a couple of things that have been decided by the Supreme Court, but not after a full briefing schedule. They've just been decided on essentially a kind of motion practice, with very quick and not very detailed orders from the Supreme Court. So we don't know where all of the legal issues are going, but I think I'll tell you the ones that I'm trying to keep track of.
I think that there is one lawsuit—and I think all these lawsuits, by the way, are in the Federal District Court in Massachusetts. And that is, in some cases, because the entities that are challenging these things are in Massachusetts. And so they're going to sue in the court where they have what lawyers call venue or the right to file the case.
In other cases, it's because the effects of the policies are in Massachusetts. And there are so many effects in Massachusetts because there is so much higher education and academic medicine in Massachusetts. It also means, by the way, that the judges in the District Court of Massachusetts—they have heard many cases way before this year in regard to these kinds of issues. You also get a somewhat more learned bench if you go to the District Court of Massachusetts. You would probably get it if you went to the federal district court in New York City, or in San Francisco, Chicago—places that are centers of academic and scientific excellence.
But the ones that I'm keeping track of—number one, there is the continuing case that my team had filed, along with some other lawyers, that is challenging the NIH's reduction in the indirect cost rate from the negotiated rate system to a flat 15%. In that case, there was a temporary restraining order issued to stop NIH from doing that. Then there was an injunction issued, and now the government has appealed that to the First Circuit Court of Appeals. That is being briefed, and it's probably going to be argued in July of 2025.
Another case that is in the District Court of Massachusetts is a challenge that has been filed on a TRO—a temporary restraining order granted—regarding the Department of Energy's more recent issuance of a 15% indirect cost rate on grants that come from the Department of Energy.
There is a case that has just been filed against the National Science Foundation for its issuance of a 15% indirect cost rate. I think you realize, as we talked about in the first podcast we had, indirect cost rates—the negotiated rates—they range from, on the low end, maybe 25–30%, and on the high end, 75% or higher. For some of the not-for-profit consulting firms or for-profit consulting firms, they can go up to 100 or 110%. So 15% is a huge cut. The Ivies and the leading academic places have rates that are somewhere between, I'd say, 45% to 70%, so cutting that down to 15% is significant.
So these are big dollars at issue, and we can talk about the merits of the cases and what they all mean. But if these 15% rates across the board are sustained, not only will it hurt the research establishment and the ability of institutions even to accept research money when they don't get the other money that goes along with it—that's necessary to provide all the services: the heat, the light, the animal facilities, the radiation equipment, the CT scans, all of the things that are needed—all the equipment that's needed to do modern biomedical and other basic science research—
But also, the 15% doesn't have any adjustment built into it. For example, for the market wage basket index, which is essentially the difference in the labor cost and the facilities cost between, for example, having an organization in Galveston, Texas, versus having one in Boston or New York City or San Francisco. It's just much more expensive to hire people and pay people and to run facilities in dense urban areas. But the 15% is across the board.
There's no alteration or accommodation of differences—of legitimate differences—in cost. I don't mean manufactured differences; I mean real differences in cost in the research support services.
So that's one set of cases.
The other set of cases—there's one very important case that's been filed by the American Public Health Association. It's been joined by the Infectious Diseases Society of America, and many others—FASEB, I think—F-A-S-E-B—and others have joined this case.
Also, I believe, filed in the District Court of Massachusetts. And this complaint is challenging all of the terminations of individual grants that have come down—especially from NIH, but not only from NIH. It's challenging them on many grounds. The majority of the grants that have been terminated—the termination notices for them—have cited illegal or inappropriate diversity, equity, and inclusion components or aims or budget items for these grants.
Others have challenged and terminated grants based on the relationship of the grant content to COVID research—specifically, the relation to vaccine hesitancy research, that is, research that's looking at improving uptake in vaccine rates and voluntary vaccination rates.
There are others—other terminations—that have focused on what's called gender ideology, and especially things that others would call gender-affirming care and research into gender-affirming care. Then there are others that focus on what's called—well, what many places call—health disparities research or health equity research, which are classified by many termination letters that I have seen, and that I counsel clients about, as being related to illegal diversity, equity, and inclusion aims or goals.
And I'm not giving you the only ones—there are other rationales as well that have been offered. In some cases, the rationales are that it's too much money, or the money is not being well spent or has not been well spent.
In some cases, these termination letters will just say the grant content is no longer consistent with the priorities of this particular funding agency.
So this APHA case is challenging, on many legal grounds—including constitutional grounds and statutory grounds—the mass terminations of grants. I would say those are the four cases that I'm looking at right now.
There are also some individual schools or universities that are on the high-priority list for the administration, because the administration thinks—or says—that they have failed in their duty to protect folks of all creeds, colors, and religions. And it may be that one or more of those will end up in litigation involving single institutions.
So that is also possible. But those are the cases that I would look at.
But there's just so much going on, Dan. I mean, there are just so many things that are happening. It is hard to keep track of it.
And I'll bet you that although I've cited four cases, I'll bet you there are going to be 15 more out of left field that I haven't cited—that are probably going to end up being more important than those four. Dan McLean: Well, just to follow-up on the on the executive orders, and we have received a lot of comments and questions from our community about this, so we wanted to to share this with you. This is the NIH's notice of civil rights term and condition award. And the way it reads, the section says, grant recipients, quote, do not, will not, during the term of this financial assistance award, operate any programs that advance or promote DEI, DEIA, or discriminatory equity ideology in violation of federal anti discrimination laws. So the question from the community is how to proceed. And I don't know what guidance since these may be in legal limbo or not fully resolved. With that in mind, how do folks who are out there go forward with ongoing research or research oversight? Mark Barnes: Well, I'll give you an answer to that, but I wanna preface it by saying that I am not giving legal advice in this—in this—in this session. I'm just giving you the information that I have, as I understand it.
I think that when one looks at that language, which reflects language in earlier executive office orders from the president's office, then I think the operative language on which one should focus is DEI, DEIA, or "discriminatory equity ideology that violates federal civil rights law." Even that condition that's imposed on federal grant recipients—it doesn't say "no DEI." It doesn't say "don't try to promote access for underserved populations or folks who have been left behind."
It doesn't say that. It says: don't do that if it violates federal civil rights laws.
So what everybody needs to look at, in my opinion, when they try to make sure that they are in compliance with this certification, is—they need to look at all their programs and activities. They need to make sure that if they are trying to run a program or activity that does promote access among either underserved populations or folks who may be individually underserved in their lives—with health services or social services or anything else—they’re doing it in a way, and operationalizing those activities in a way, that is consistent with the history of civil rights law in our country, and all of the case precedents, guidance documents, and court decisions that are still in place and have not been overturned by the courts.
Those laws and decisions say that there is nothing wrong with promoting inclusivity in programs. There is something wrong—there has been something wrong under the Biden administration, under the Nixon administration, under all the administrations that were in power in the U.S. after the adoption of the civil rights laws—primarily around the 1964–65 period, though some came later, like the Americans with Disabilities Act.
What is illegal and is questionable is to run programs that are exclusive—that are racially exclusive, or exclusive by culture and things like that.
So everybody's looking at the programs they have created and run before, to make sure that the theme of these programs that promote access is one of inclusivity, and not exclusivity. And I think that's what everyone’s hurrying to do—and they should do it—because trying to distinguish the eligibility for program activity based on, for example, race, has been a suspect activity for a long time. Catherine Batsford: Mhmm. So what advice do you have for IRBs and compliance professionals who are trying to maintain their institutional values while adhering to new and possibly conflicting federal grant conditions that you were talking about? How can they keep keep moving forward in the best way possible? Mark Barnes: Well, you know, this is an interesting question. I get this question with some frequency in public settings and also in private. People ask me: Is it illegal to do research—to do DEI-related research, for example? The reason I'm giving you this example is because, if you're in an IRB or you're an IRB administrator, that's what you see—are all of these programs that are presented to you, these protocols presented to you that encapsulate or describe programs that are being run and that constitute human subjects research.
So actually—intellectually—it's an interesting question.
There's nothing—it is not illegal. There's a First Amendment in the country, and there's nothing illegal about running studies to try to understand who's underserved and why they're underserved. It's not illegal to run a program like that—whether it's an epidemiology program that relies on de-identified data and never goes to an IRB, or whether it's a program that involves interviewing groups of people, interviewing individuals, and trying to draw some conclusions from survey data, for example—survey data that are collected as part of the human research activity.
All of these executive orders don't make that activity illegal.
And so—and one, of course, has to ask: Is it ethical? Not only is it legal, but is it ethical? And that's what IRBs are asking—both of those questions, hopefully, in analysis.
One can have—and this is where it becomes more complicated—one can have research studies that are handing out benefits. If the research studies are handing out benefits—in other words, it's a demonstration project that is also human subjects research—then one has to be very careful with those kinds of programs.
I'll give you an example. One wants to show, in the context of an acute care hospital, that discharging people with active intensive case management leads to better health outcomes than discharging people the way we do now—by giving referrals and making sure that they actually end up, in the first instance, with a roof over their head and somebody who's taking care of them, which is sort of the standard discharge planning.
So in this more intense setting of intensive case management, let's say that one has a racial or gender criterion for entry into that program—as a human participant who gets the benefit of the intensive case management strategy. Is it legal? Is it ethical to limit enrollment that way?
One can imagine situations in which there are good explanations and good reasons why, for example, access to that kind of case management might be limited to X group—by gender, or whatever, or sex, whatever it is. It’s harder to think about how one might justify limiting enrollment by race in a program like that.
But my point is this: when one is actually delivering benefits, then you have to be very careful to have extremely tight questioning and supervision over the eligibility criteria, to make sure that they are scientifically valid. Because if you don't, then you can have human research interventions that actually might constitute some kind of discriminatory activity or program.
So—again—epidemiology and just studying something, surveys and things like that—that’s not a benefit. That’s more of a detriment than a benefit to anybody who's involved in it, because it takes time and trouble. So, you know, one is less concerned about that.
But I'm just trying to give you an example—for the PRIM&R audience, really—about the kinds of things that one does need to worry about. The question is, you know: How do federal civil rights laws apply to human subjects research? Right?
And interestingly, about three years ago, I think, I actually wondered about this in the context of demands for more diversity in clinical trial enrollment. You’re familiar with this debate? Catherine Batsford: Yes. Mark Barnes: That women, for example, might be underrepresented, men might be underrepresented, African Americans might be underrepresented, et cetera. In cancer studies, for example, there was a lot of attention to that. The NCI gave a lot of attention to that.
I wondered at that point about how equal access laws like Title VI—which is the federal law that governs discrimination based on race, color, and national origin—apply to clinical trial enrollment.
And I wrote a paper about this that was published in the Journal of Law, Medicine & Ethics, but that paper was oriented toward the need to include folks who were underrepresented in the clinical trial eligibility and enrollment efforts—as opposed to folks who may not be underrepresented by population, but may want enrollment, which is sort of the flip side of that that's being tested now.
But my point is just this: I have to say the reason I wrote that article is because I had not seen any secondary literature about this topic—about how civil rights law applies to clinical trial enrollment, to human subjects research.
So I wrote about it, but I've never seen anything else written about the issue per se. Catherine Batsford: And now it's at the forefront of conversations. Dan McLean: Yes. Mark, we also had some questions about certificates of confidentiality. I wondered if you could weigh in on that. One of the hypotheticals that was posed to us that if federal law enforcement, for example, was not able to provide a warrant, is a research institution obligated to divulge information that may be part of a research study? Mark Barnes: Dan, I would direct whoever asked that question—I’d direct them to their own general counsel to answer that question. That gets into such a level of kind of giving legal advice. I—I don't want to go there.
I will tell you—just to be clear, and not breaching confidentiality—that I'm worried. And I think I'm not the only one who's worried. Because the one thing that's happened in the last just week or two is that NIH, which grants the Certificates of Confidentiality, has indicated that it will suspend—at least for the time being—the granting of Certificates of Confidentiality to non–federally funded research studies.
That is, for example, industry trials of addiction medicine. For example, routinely, industry—if it's sophisticated, if the regulatory compliance function in the clinical trial operations is sophisticated—they will go to NIH, and they will ask for a Certificate of Confidentiality for studies that are recruiting folks whose very eligibility may indicate either a stigmatized condition or even illegal activity, like the use of illegal drugs.
And NIH, in the past, has considered those applications and granted them—even though these studies are industry-funded and not funded by the federal government.
And NIH has now said, very recently, that they're not going to issue that. So they're not revoking ones that have already been issued, but they're not going to issue any new ones to non–federally funded studies.
Also, by the way, it would be state-funded studies. Catherine Batsford: Right. From the public health. Mark Barnes: And so I think that what that presages, potentially, is—maybe, I don't know—but it may be a reluctance, even in federally funded studies, which kind of automatically get a Certificate of Confidentiality as of a few years ago. The NIH-funded studies automatically are awarded the Certificate of Confidentiality.
It may presage a lack of enthusiasm by the federal authorities at NIH or the Department of Justice to defend and champion the confidentiality protections under Certificates of Confidentiality.
So—I just don't know where this is headed.
Certificates of Confidentiality have not been well tested in the courts. They have had a deterrent effect on folks—lawyers, basically—trying to get clinical trial information about who the identities are of folks who are in a trial or involved in research. And Certificates have been used by research institutions and investigators to say, "You can't get the identities of the people in this trial—in this substance addiction treatment trial, or this methadone therapy trial, or this trial whose eligibility criterion is gender dysphoria. You are not allowed to get the identities because we have a Certificate of Confidentiality."
And many lawyers on the other side will look at the regulations and they'll just walk away. And so it never gets challenged in court.
There are a few cases that have been decided, but here's my point: it's not like there are a hundred judicial decisions interpreting Certificates of Confidentiality and how well—or poorly—they protect the people they're supposed to protect.
And so when you have the NIH, without any apparent pressure that I'm aware of, saying spontaneously, "We're not gonna issue them anymore for industry studies," I think we have to wonder how much NIH and other parts of the federal government will champion the protections these Certificates are supposed to offer.
And we just don't know.
Dan McLean: If that's the case and certificates of confidentiality become either weakened to the point that people know they're reliable or they are not issued, what would that do to research? Mark Barnes: Well, yeah, I mean, look at look at why they were adopted, and they were adopted back in the back in the late seventies or eighties is when the certificates were first adopted, and they were and I I'll get this I'll get this story wrong, but I'll I'll get it'll be what I'm about to say will be 80% right, but I always have to remind myself to to read, you know, the the history of it. But there is a friend of mine whose name is a physician. He later was president of Beth Israel Hospital in New York. He was a fine and wonderful man. And he Bob Newman, Robert Newman was his name. And he was a the one of the assistant or deputy health commissioners in the New York City health department many years ago in the seventies. And he refused to hand over a list of people who were enrolled in methadone treatment in New York City at some of the public methadone clinics because handing over the list of people enrolled in methadone facilities was in fact going to lead to potential arrests of those people because they were, by definition, addicted to illegal drugs. Bob went to jail rather thanhe went to he went he was at Rikers Island, I think, or maybe in Manhattan Detention Center downtown. And he was there for for a while. And he said, I'm not gonna turn over those those records. Now, those were not people enrolled in studies. They were people who were enrolled in, I believe, in methadone maintenance, which by definition means that these folks were addicted to heroin and or heroin heroin products. And the and so as a consequence of that, that's why the federal drug and alcohol confidentiality regulations, statute and regulations were adopted specifically, historically, triggered by that episode with Bob Newman and his attempt to shield the list of folks who were who were on methadone maintenance in New York City and, in the public clinics. And that led to a a set of of confidentiality regulations that specifically apply to federally funded drug and alcohol treatment. And those things are that those confidentiality regulations are still in the books. The next generation after that was attention to research that was done with folks who were also in either alcoholism treatment or substance addiction treatment. And that's what led to certificates of confidentiality. So not sure how I how I got off on that. Catherine Batsford: It's a great story. Well, we're asking people to trust in the process and to be involved in trials. In that, we need to protect their privacy to the point of going to jail. I mean, that that signifies a commitment, that's significant. So, yeah, I think as we're moving forward in in this murky time, is there any advice or just words of wisdom that you could leave our listeners as as they've learned so much more about what's going on right now? Mark Barnes: Well, this is what I would say. I would say that that the pendulum is always swinging. And when you've lived long enough and your career is long enough as as mine for better or worse has been, I would say I I tell people, don't despair about about this. We just need to keep our eye on ball. We need to protect our research subjects. We need to try to protect our research endeavors. We need to try to understand some of the anger that has animated some of these actions. Folks, try not to demonize people because I don't think that gets us very far. So I try to understand why folks are legislating or issuing orders in the way that that they're issuing them. And I try to figure out whether there's anything that I think is something that we could compromise or or which they have a valid point that there's money being wasted, you know, for example, in some research. Undoubtedly, there's money wasted in some research. So the question about it, you know, let's be honest with one another about it. But so I think we have to be honest. We have to be kind, but I think we just have to do our best to muddle through day by day. We need to develop some strategies as as I talked about before about what our endgame is to try to work our way back to what I think most of us think would be a more rational way of making public policy in this area, to making funding decisions in this area. But I think that right will prevail. It may take it a while, but things the courses do self correct. You know, Winston Churchill often said in America, they'll do everything the wrong way until they finally do it right. Okay. I think you could always count on the Americans, ultimately, to do it right, but it takes them a long, long time. Catherine Batsford: There's a lot of stubbornness on both sides. Mark Barnes: There’s a lot of stubbornness. So, you know, I—I wouldn’t despair. I just think that we have to do our best. Catherine Batsford: Dan, did you have a final question? Dan McLean: I think that's a good last message. Mark, I thank you for your time. You spent time with us and the PRIM&R community earlier this year, and I know people found it valuable. I'm sure they'll find this conversation valuable as well. So, thank you very much. Mark Barnes: Sure. Thank you. Thanks for having me. Catherine Batsford: Thank you. PRIM&R: Thank you for listening to Research Ethics Reimagined, a podcast created by PRIM&R and produced by Syntax in Motion. Please subscribe and share with your friends and colleagues. To learn how to become a member of PRIM&R, please visit us at www.primr.org. Be sure to join us next month as we continue our conversation with scientists, researchers, bioethicists, and some of the leading minds exploring new frontiers of science.
Those are three episodes that were, I think, traumatic for the community. I'm not sure I've quite seen anything like this, but at the time, I have to say that AIDS/HIV seemed perhaps bigger than this even. And it's useful to remember that we survived all those. Catherine Batsford: It is good. It sounds like there's moments of education that had to happen with each one of these, you know, for the general public, for the scientists to communicate back out what's going on and what we're working on and why it's important. Mark Barnes: Right. I think that's right. I've looked here carefully because I'm in the middle of many different controversies right now, representing our clients—our Ropes & Gray clients—who are some of the premier academic medical centers and universities that engage in human subjects research, animal research, and basic science research. And one thing that—if it's okay—I'll ask your question for you. Catherine Batsford: Yeah! Thank you. Mark Barnes: You can tell me if it's the wrong question. But one question is: What's the endgame here? And how can we really, as an overall research enterprise community—academic research community, but that includes the industry research as well—how can we stand up to this challenge? And how can we make sure that our activities are preserved?
And I do think that—having been through this before, in January 1995, when the new Congress took over—I have to say that I think the key here is that there are many red states with U.S. Senators, primarily Republican congressional delegations, in those states that contain centers of academic and scientific excellence that are hurting or will be hurt just as much as the institutions in Massachusetts, New York, California, and Washington state.
I think getting to the governors of those states, getting to the U.S. Senators in those states—like Tennessee, with Vanderbilt and the University of Tennessee; like Texas, with the University of Texas, all of its many campuses, and its incredible research enterprise; Florida, with FSU, the University of Florida, the University of Miami, Moffitt Cancer Center in Tampa, and others; and Alabama, with the University of Alabama at Birmingham, which is a major recipient of federal research funding—
I think getting to those people and explaining to them—and not having folks from the East Coast and West Coast lecture them, but having their own people, from their own institutions, in their own states—explain to them what's really going on here, and advocate that the baby not be thrown out with the bathwater, if you will. That’s—that’s where—that’s the endgame.
And I do have a fear that we’re not quite sufficiently organized to get there right now. Catherine Batsford: Right. So as people are looking to get organized, what is the message that they should be focusing on? Certainly, looking at the recent executive orders, but what funding and operations should they be moving forward with requesting support? Mark Barnes: Well, the NIH funding is definitely the core funding for most of the biomedical research that is not done by industry in the United States—I mean, frankly, abroad as well. That’s one of the issues here. NIH has basically said that, prospectively—except for special circumstances—it is not going to approve either direct grants to entities abroad or even subawards from American institutions that receive a grant. They're going to prevent that. The theory is: Buy American. That we should keep the money at home. But I would say NIH is the core.
Then you have many institutions, though—like MIT and Caltech and others, and some of the state universities—that get a lot of funding from the Department of Energy. Others get a lot of money from the Department of Defense and the National Science Foundation, as well as the Department of Education and Department of Justice. There are a few other funding agencies, but I would say that the sort of big four are NIH, National Science Foundation, Department of Energy, and Department of Defense.
Mostly, this particular administration has focused on using NIH as the conduit for new policy directives, but that's because NIH is probably about 70% or so of the federal research dollars that go into higher education and academic medicine. But NSF has been active as well. Department of Defense—not so much. I have a feeling that the reason for that is that many things from the Department of Defense are actually in the form of contracts rather than grants. They also are serving—those contracts and grants—a core national defense, national welfare purpose, so I think this administration has largely kept its hands off of those grants and contracts.
I think there are a couple of messages we can respond back with.
One is all about money: that the money that goes to the University of Alabama at Birmingham and all these other schools—both in blue states and also in red states—really is a driver of the local and state economies in many ways. More than that, it's not just that the money hires people and pays for buildings and lights and heat. It's also that the developments—the technology developments that come out of government-funded research—the patents that are created, the technological know-how that’s amassed and then licensed out to industry—drive industry. It has a multiplier effect downstream when the money is used wisely and well by researchers and by the research institutions. So it's an engine for development—and for economic development.
But the other major argument really is that making lives better through science—lives for Americans, and the lives and welfare of people around the world—with these research dollars is extremely important. Without the American funding for these things... let me just put it this way: the American government funding for these things dwarfs the basic science funding by other nations, even in the aggregate. So there is a humanitarian and a scientific imperative to continue spending research dollars and using them wisely. Dan McLean: I was trying to get a handle on all the different court challenges and executive orders. And I think for a lot of listeners, it may have been relatively easy to keep track a month or two ago, but now there's a lot of different a flurry of additional activities and different steps in the process of different court challenges that may be a pending appeal or they have a district court ruling. Can you just take a moment and kind of in for the 30,000 foot view, just share how many cases you're tracking, how many cases you think are most relevant to this community, and just let people know where they are in the process and the same question with the executive orders. Mark Barnes: Right. Well, the last count that I've heard—I cannot keep count anymore. I knew at the beginning, you know, the handful of cases that had been filed or the people who were considering filing. But right now, I think that there are well over a hundred cases that have been filed at this point. And in that number, many are in regard to these various research directives and decrees by the federal government affecting research funding.
There may even be as many as 200 cases that have been filed. Almost all of them have been filed—perhaps all of them—in the federal court system because, of course, this is federal money. So if one wanted, as a lawyer or an interest group to challenge—or a plaintiff to challenge—one of these things, then one would go to federal court. So they're really in the federal district courts, and then they get a decision—probably a decision on a temporary restraining order or an injunction—that then gets appealed to the circuit courts. Then it is sent to the federal appeals courts. Undoubtedly, some of these things will be appealed eventually to the U.S. Supreme Court, and they'll be decided by the Supreme Court.
There have been a couple of things that have been decided by the Supreme Court, but not after a full briefing schedule. They've just been decided on essentially a kind of motion practice, with very quick and not very detailed orders from the Supreme Court. So we don't know where all of the legal issues are going, but I think I'll tell you the ones that I'm trying to keep track of.
I think that there is one lawsuit—and I think all these lawsuits, by the way, are in the Federal District Court in Massachusetts. And that is, in some cases, because the entities that are challenging these things are in Massachusetts. And so they're going to sue in the court where they have what lawyers call venue or the right to file the case.
In other cases, it's because the effects of the policies are in Massachusetts. And there are so many effects in Massachusetts because there is so much higher education and academic medicine in Massachusetts. It also means, by the way, that the judges in the District Court of Massachusetts—they have heard many cases way before this year in regard to these kinds of issues. You also get a somewhat more learned bench if you go to the District Court of Massachusetts. You would probably get it if you went to the federal district court in New York City, or in San Francisco, Chicago—places that are centers of academic and scientific excellence.
But the ones that I'm keeping track of—number one, there is the continuing case that my team had filed, along with some other lawyers, that is challenging the NIH's reduction in the indirect cost rate from the negotiated rate system to a flat 15%. In that case, there was a temporary restraining order issued to stop NIH from doing that. Then there was an injunction issued, and now the government has appealed that to the First Circuit Court of Appeals. That is being briefed, and it's probably going to be argued in July of 2025.
Another case that is in the District Court of Massachusetts is a challenge that has been filed on a TRO—a temporary restraining order granted—regarding the Department of Energy's more recent issuance of a 15% indirect cost rate on grants that come from the Department of Energy.
There is a case that has just been filed against the National Science Foundation for its issuance of a 15% indirect cost rate. I think you realize, as we talked about in the first podcast we had, indirect cost rates—the negotiated rates—they range from, on the low end, maybe 25–30%, and on the high end, 75% or higher. For some of the not-for-profit consulting firms or for-profit consulting firms, they can go up to 100 or 110%. So 15% is a huge cut. The Ivies and the leading academic places have rates that are somewhere between, I'd say, 45% to 70%, so cutting that down to 15% is significant.
So these are big dollars at issue, and we can talk about the merits of the cases and what they all mean. But if these 15% rates across the board are sustained, not only will it hurt the research establishment and the ability of institutions even to accept research money when they don't get the other money that goes along with it—that's necessary to provide all the services: the heat, the light, the animal facilities, the radiation equipment, the CT scans, all of the things that are needed—all the equipment that's needed to do modern biomedical and other basic science research—
But also, the 15% doesn't have any adjustment built into it. For example, for the market wage basket index, which is essentially the difference in the labor cost and the facilities cost between, for example, having an organization in Galveston, Texas, versus having one in Boston or New York City or San Francisco. It's just much more expensive to hire people and pay people and to run facilities in dense urban areas. But the 15% is across the board.
There's no alteration or accommodation of differences—of legitimate differences—in cost. I don't mean manufactured differences; I mean real differences in cost in the research support services.
So that's one set of cases.
The other set of cases—there's one very important case that's been filed by the American Public Health Association. It's been joined by the Infectious Diseases Society of America, and many others—FASEB, I think—F-A-S-E-B—and others have joined this case.
Also, I believe, filed in the District Court of Massachusetts. And this complaint is challenging all of the terminations of individual grants that have come down—especially from NIH, but not only from NIH. It's challenging them on many grounds. The majority of the grants that have been terminated—the termination notices for them—have cited illegal or inappropriate diversity, equity, and inclusion components or aims or budget items for these grants.
Others have challenged and terminated grants based on the relationship of the grant content to COVID research—specifically, the relation to vaccine hesitancy research, that is, research that's looking at improving uptake in vaccine rates and voluntary vaccination rates.
There are others—other terminations—that have focused on what's called gender ideology, and especially things that others would call gender-affirming care and research into gender-affirming care. Then there are others that focus on what's called—well, what many places call—health disparities research or health equity research, which are classified by many termination letters that I have seen, and that I counsel clients about, as being related to illegal diversity, equity, and inclusion aims or goals.
And I'm not giving you the only ones—there are other rationales as well that have been offered. In some cases, the rationales are that it's too much money, or the money is not being well spent or has not been well spent.
In some cases, these termination letters will just say the grant content is no longer consistent with the priorities of this particular funding agency.
So this APHA case is challenging, on many legal grounds—including constitutional grounds and statutory grounds—the mass terminations of grants. I would say those are the four cases that I'm looking at right now.
There are also some individual schools or universities that are on the high-priority list for the administration, because the administration thinks—or says—that they have failed in their duty to protect folks of all creeds, colors, and religions. And it may be that one or more of those will end up in litigation involving single institutions.
So that is also possible. But those are the cases that I would look at.
But there's just so much going on, Dan. I mean, there are just so many things that are happening. It is hard to keep track of it.
And I'll bet you that although I've cited four cases, I'll bet you there are going to be 15 more out of left field that I haven't cited—that are probably going to end up being more important than those four. Dan McLean: Well, just to follow-up on the on the executive orders, and we have received a lot of comments and questions from our community about this, so we wanted to to share this with you. This is the NIH's notice of civil rights term and condition award. And the way it reads, the section says, grant recipients, quote, do not, will not, during the term of this financial assistance award, operate any programs that advance or promote DEI, DEIA, or discriminatory equity ideology in violation of federal anti discrimination laws. So the question from the community is how to proceed. And I don't know what guidance since these may be in legal limbo or not fully resolved. With that in mind, how do folks who are out there go forward with ongoing research or research oversight? Mark Barnes: Well, I'll give you an answer to that, but I wanna preface it by saying that I am not giving legal advice in this—in this—in this session. I'm just giving you the information that I have, as I understand it.
I think that when one looks at that language, which reflects language in earlier executive office orders from the president's office, then I think the operative language on which one should focus is DEI, DEIA, or "discriminatory equity ideology that violates federal civil rights law." Even that condition that's imposed on federal grant recipients—it doesn't say "no DEI." It doesn't say "don't try to promote access for underserved populations or folks who have been left behind."
It doesn't say that. It says: don't do that if it violates federal civil rights laws.
So what everybody needs to look at, in my opinion, when they try to make sure that they are in compliance with this certification, is—they need to look at all their programs and activities. They need to make sure that if they are trying to run a program or activity that does promote access among either underserved populations or folks who may be individually underserved in their lives—with health services or social services or anything else—they’re doing it in a way, and operationalizing those activities in a way, that is consistent with the history of civil rights law in our country, and all of the case precedents, guidance documents, and court decisions that are still in place and have not been overturned by the courts.
Those laws and decisions say that there is nothing wrong with promoting inclusivity in programs. There is something wrong—there has been something wrong under the Biden administration, under the Nixon administration, under all the administrations that were in power in the U.S. after the adoption of the civil rights laws—primarily around the 1964–65 period, though some came later, like the Americans with Disabilities Act.
What is illegal and is questionable is to run programs that are exclusive—that are racially exclusive, or exclusive by culture and things like that.
So everybody's looking at the programs they have created and run before, to make sure that the theme of these programs that promote access is one of inclusivity, and not exclusivity. And I think that's what everyone’s hurrying to do—and they should do it—because trying to distinguish the eligibility for program activity based on, for example, race, has been a suspect activity for a long time. Catherine Batsford: Mhmm. So what advice do you have for IRBs and compliance professionals who are trying to maintain their institutional values while adhering to new and possibly conflicting federal grant conditions that you were talking about? How can they keep keep moving forward in the best way possible? Mark Barnes: Well, you know, this is an interesting question. I get this question with some frequency in public settings and also in private. People ask me: Is it illegal to do research—to do DEI-related research, for example? The reason I'm giving you this example is because, if you're in an IRB or you're an IRB administrator, that's what you see—are all of these programs that are presented to you, these protocols presented to you that encapsulate or describe programs that are being run and that constitute human subjects research.
So actually—intellectually—it's an interesting question.
There's nothing—it is not illegal. There's a First Amendment in the country, and there's nothing illegal about running studies to try to understand who's underserved and why they're underserved. It's not illegal to run a program like that—whether it's an epidemiology program that relies on de-identified data and never goes to an IRB, or whether it's a program that involves interviewing groups of people, interviewing individuals, and trying to draw some conclusions from survey data, for example—survey data that are collected as part of the human research activity.
All of these executive orders don't make that activity illegal.
And so—and one, of course, has to ask: Is it ethical? Not only is it legal, but is it ethical? And that's what IRBs are asking—both of those questions, hopefully, in analysis.
One can have—and this is where it becomes more complicated—one can have research studies that are handing out benefits. If the research studies are handing out benefits—in other words, it's a demonstration project that is also human subjects research—then one has to be very careful with those kinds of programs.
I'll give you an example. One wants to show, in the context of an acute care hospital, that discharging people with active intensive case management leads to better health outcomes than discharging people the way we do now—by giving referrals and making sure that they actually end up, in the first instance, with a roof over their head and somebody who's taking care of them, which is sort of the standard discharge planning.
So in this more intense setting of intensive case management, let's say that one has a racial or gender criterion for entry into that program—as a human participant who gets the benefit of the intensive case management strategy. Is it legal? Is it ethical to limit enrollment that way?
One can imagine situations in which there are good explanations and good reasons why, for example, access to that kind of case management might be limited to X group—by gender, or whatever, or sex, whatever it is. It’s harder to think about how one might justify limiting enrollment by race in a program like that.
But my point is this: when one is actually delivering benefits, then you have to be very careful to have extremely tight questioning and supervision over the eligibility criteria, to make sure that they are scientifically valid. Because if you don't, then you can have human research interventions that actually might constitute some kind of discriminatory activity or program.
So—again—epidemiology and just studying something, surveys and things like that—that’s not a benefit. That’s more of a detriment than a benefit to anybody who's involved in it, because it takes time and trouble. So, you know, one is less concerned about that.
But I'm just trying to give you an example—for the PRIM&R audience, really—about the kinds of things that one does need to worry about. The question is, you know: How do federal civil rights laws apply to human subjects research? Right?
And interestingly, about three years ago, I think, I actually wondered about this in the context of demands for more diversity in clinical trial enrollment. You’re familiar with this debate? Catherine Batsford: Yes. Mark Barnes: That women, for example, might be underrepresented, men might be underrepresented, African Americans might be underrepresented, et cetera. In cancer studies, for example, there was a lot of attention to that. The NCI gave a lot of attention to that.
I wondered at that point about how equal access laws like Title VI—which is the federal law that governs discrimination based on race, color, and national origin—apply to clinical trial enrollment.
And I wrote a paper about this that was published in the Journal of Law, Medicine & Ethics, but that paper was oriented toward the need to include folks who were underrepresented in the clinical trial eligibility and enrollment efforts—as opposed to folks who may not be underrepresented by population, but may want enrollment, which is sort of the flip side of that that's being tested now.
But my point is just this: I have to say the reason I wrote that article is because I had not seen any secondary literature about this topic—about how civil rights law applies to clinical trial enrollment, to human subjects research.
So I wrote about it, but I've never seen anything else written about the issue per se. Catherine Batsford: And now it's at the forefront of conversations. Dan McLean: Yes. Mark, we also had some questions about certificates of confidentiality. I wondered if you could weigh in on that. One of the hypotheticals that was posed to us that if federal law enforcement, for example, was not able to provide a warrant, is a research institution obligated to divulge information that may be part of a research study? Mark Barnes: Dan, I would direct whoever asked that question—I’d direct them to their own general counsel to answer that question. That gets into such a level of kind of giving legal advice. I—I don't want to go there.
I will tell you—just to be clear, and not breaching confidentiality—that I'm worried. And I think I'm not the only one who's worried. Because the one thing that's happened in the last just week or two is that NIH, which grants the Certificates of Confidentiality, has indicated that it will suspend—at least for the time being—the granting of Certificates of Confidentiality to non–federally funded research studies.
That is, for example, industry trials of addiction medicine. For example, routinely, industry—if it's sophisticated, if the regulatory compliance function in the clinical trial operations is sophisticated—they will go to NIH, and they will ask for a Certificate of Confidentiality for studies that are recruiting folks whose very eligibility may indicate either a stigmatized condition or even illegal activity, like the use of illegal drugs.
And NIH, in the past, has considered those applications and granted them—even though these studies are industry-funded and not funded by the federal government.
And NIH has now said, very recently, that they're not going to issue that. So they're not revoking ones that have already been issued, but they're not going to issue any new ones to non–federally funded studies.
Also, by the way, it would be state-funded studies. Catherine Batsford: Right. From the public health. Mark Barnes: And so I think that what that presages, potentially, is—maybe, I don't know—but it may be a reluctance, even in federally funded studies, which kind of automatically get a Certificate of Confidentiality as of a few years ago. The NIH-funded studies automatically are awarded the Certificate of Confidentiality.
It may presage a lack of enthusiasm by the federal authorities at NIH or the Department of Justice to defend and champion the confidentiality protections under Certificates of Confidentiality.
So—I just don't know where this is headed.
Certificates of Confidentiality have not been well tested in the courts. They have had a deterrent effect on folks—lawyers, basically—trying to get clinical trial information about who the identities are of folks who are in a trial or involved in research. And Certificates have been used by research institutions and investigators to say, "You can't get the identities of the people in this trial—in this substance addiction treatment trial, or this methadone therapy trial, or this trial whose eligibility criterion is gender dysphoria. You are not allowed to get the identities because we have a Certificate of Confidentiality."
And many lawyers on the other side will look at the regulations and they'll just walk away. And so it never gets challenged in court.
There are a few cases that have been decided, but here's my point: it's not like there are a hundred judicial decisions interpreting Certificates of Confidentiality and how well—or poorly—they protect the people they're supposed to protect.
And so when you have the NIH, without any apparent pressure that I'm aware of, saying spontaneously, "We're not gonna issue them anymore for industry studies," I think we have to wonder how much NIH and other parts of the federal government will champion the protections these Certificates are supposed to offer.
And we just don't know.
Dan McLean: If that's the case and certificates of confidentiality become either weakened to the point that people know they're reliable or they are not issued, what would that do to research? Mark Barnes: Well, yeah, I mean, look at look at why they were adopted, and they were adopted back in the back in the late seventies or eighties is when the certificates were first adopted, and they were and I I'll get this I'll get this story wrong, but I'll I'll get it'll be what I'm about to say will be 80% right, but I always have to remind myself to to read, you know, the the history of it. But there is a friend of mine whose name is a physician. He later was president of Beth Israel Hospital in New York. He was a fine and wonderful man. And he Bob Newman, Robert Newman was his name. And he was a the one of the assistant or deputy health commissioners in the New York City health department many years ago in the seventies. And he refused to hand over a list of people who were enrolled in methadone treatment in New York City at some of the public methadone clinics because handing over the list of people enrolled in methadone facilities was in fact going to lead to potential arrests of those people because they were, by definition, addicted to illegal drugs. Bob went to jail rather thanhe went to he went he was at Rikers Island, I think, or maybe in Manhattan Detention Center downtown. And he was there for for a while. And he said, I'm not gonna turn over those those records. Now, those were not people enrolled in studies. They were people who were enrolled in, I believe, in methadone maintenance, which by definition means that these folks were addicted to heroin and or heroin heroin products. And the and so as a consequence of that, that's why the federal drug and alcohol confidentiality regulations, statute and regulations were adopted specifically, historically, triggered by that episode with Bob Newman and his attempt to shield the list of folks who were who were on methadone maintenance in New York City and, in the public clinics. And that led to a a set of of confidentiality regulations that specifically apply to federally funded drug and alcohol treatment. And those things are that those confidentiality regulations are still in the books. The next generation after that was attention to research that was done with folks who were also in either alcoholism treatment or substance addiction treatment. And that's what led to certificates of confidentiality. So not sure how I how I got off on that. Catherine Batsford: It's a great story. Well, we're asking people to trust in the process and to be involved in trials. In that, we need to protect their privacy to the point of going to jail. I mean, that that signifies a commitment, that's significant. So, yeah, I think as we're moving forward in in this murky time, is there any advice or just words of wisdom that you could leave our listeners as as they've learned so much more about what's going on right now? Mark Barnes: Well, this is what I would say. I would say that that the pendulum is always swinging. And when you've lived long enough and your career is long enough as as mine for better or worse has been, I would say I I tell people, don't despair about about this. We just need to keep our eye on ball. We need to protect our research subjects. We need to try to protect our research endeavors. We need to try to understand some of the anger that has animated some of these actions. Folks, try not to demonize people because I don't think that gets us very far. So I try to understand why folks are legislating or issuing orders in the way that that they're issuing them. And I try to figure out whether there's anything that I think is something that we could compromise or or which they have a valid point that there's money being wasted, you know, for example, in some research. Undoubtedly, there's money wasted in some research. So the question about it, you know, let's be honest with one another about it. But so I think we have to be honest. We have to be kind, but I think we just have to do our best to muddle through day by day. We need to develop some strategies as as I talked about before about what our endgame is to try to work our way back to what I think most of us think would be a more rational way of making public policy in this area, to making funding decisions in this area. But I think that right will prevail. It may take it a while, but things the courses do self correct. You know, Winston Churchill often said in America, they'll do everything the wrong way until they finally do it right. Okay. I think you could always count on the Americans, ultimately, to do it right, but it takes them a long, long time. Catherine Batsford: There's a lot of stubbornness on both sides. Mark Barnes: There’s a lot of stubbornness. So, you know, I—I wouldn’t despair. I just think that we have to do our best. Catherine Batsford: Dan, did you have a final question? Dan McLean: I think that's a good last message. Mark, I thank you for your time. You spent time with us and the PRIM&R community earlier this year, and I know people found it valuable. I'm sure they'll find this conversation valuable as well. So, thank you very much. Mark Barnes: Sure. Thank you. Thanks for having me. Catherine Batsford: Thank you. PRIM&R: Thank you for listening to Research Ethics Reimagined, a podcast created by PRIM&R and produced by Syntax in Motion. Please subscribe and share with your friends and colleagues. To learn how to become a member of PRIM&R, please visit us at www.primr.org. Be sure to join us next month as we continue our conversation with scientists, researchers, bioethicists, and some of the leading minds exploring new frontiers of science.
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.