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“Research Ethics Reimagined” is a podcast created by Public Responsibility in Medicine and Research (PRIM&R), hosted by Ivy R. Tillman, PRIM&R's executive director. Here, we talk with scientists, researchers, bioethicists and some of the leading minds exploring new frontiers of science. This season, we are going examine research ethics in the 21st century -- and learn why it matters to you.
Welcome to Research Ethics Reimagined, a podcast created by Public Responsibility in Medicine and Research, or PRIMR. Here, we talk with scientists, researchers, bioethicists, and some of the leading minds exploring the new front frontiers of science. Join us to examine research ethics in the twenty first century and learn why it matters to you.
Catherine Batsford:Welcome back to Research Ethics Reimagined. Today, 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 science practice at Ropes and 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.
Catherine Batsford:Since 1989, Mark has also taught health care law and biomedical research law at the schools such as NYU, Harvard, and Yale. Mark was also the winner 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 continue to share his thoughts for a broader audience. I'm your host, Katherine Batsford.
Dan McLean:And I'm your cohost today, Dan McLean.
Catherine Batsford:So thank you so much for joining us, Mark. There is an awful lot to keep track of during the first hundred 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 guys have done. Your first executive director, Joan Rackland, is a close friend of mine and remains a close friend.
Mark Barnes:And you guys have had such such fantastic people on your staff and board and membership for so many years. So we are we are swimming in either with or against a huge tide at this point. There are so many things that are happening in the research area, some of which affect affect human subjects research directly, some of which affect affect grants, research grants, and contracts extremely directly, some of which actually affect the content of our research. We can talk about this, Katherine and Dan, but it affects some of the content of our research, meaning that research activities that might be perceived as crossing the line into illegal diversity, equity, inclusion activities may be called into question and have been called into question. So there is so much going on.
Mark Barnes:There's also, just on the in within the research grant area and contract area, there is a doubling down on on issues related to indirect cost rates or or what are also called facilities administration costs. There also are a number of research institutions, academic medical centers, well as universities that have received an incredible amount of inquiries from the federal agencies justifying their drawdowns, their daily drawdowns on the federal treasury for grants already awarded. We are really trying to respond constructively to the federal government at all levels of the research enterprise within the universities and the academic medical centers and the other research institutions. I'm happy to take these things one by one if you guys have questions about particular things, but but there's a lot going on.
Catherine Batsford:So much.
Dan McLean:Sure. Before we jump into some of those, I I just wanna reference the long career you've had in this space, and I know you've been involved throughout the decades. As administrations have come and gone, have you seen this much activity or this much potential impact to the research oversight community from the change in administrations?
Mark Barnes:I've never seen that. I have seen two previous episodes. Or actually, I would say I've seen three previous episodes, and it may be interesting to your to your listeners, to your, to those who are tuned into this to hear about this. I would say there are three historical phenomena that at least somewhat rival what we're going through right now in the research area. One, frankly, was the AIDS epidemic and everything the AIDS epidemic did for foreign to drug discovery, the rights of participants who were in trials, increased emphasis and incredible emphasis on access to experimental therapies at an early stage.
Mark Barnes: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 to when they lost their jobs or 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 the antiretroviral therapies, which really didn't come online until 1995. There was a ten year period which there was a lot of HIV.
Mark Barnes: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 US. That's one episode. The second episode, which actually coincided somewhat with that, with the end of that period, is was in November of nineteen ninety four when the Republican Republicans under Newt Gingrich took over the the House of Representatives by a massive margin.
Mark Barnes:And there was there was a budgetary crisis. Many of the 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 HIVAIDS funding, treatment, research money, etcetera.
Mark Barnes:I could tell you a bit about that, but we actually survived that and our program 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 on Newt Gingrich and Bob Livingston from Louisiana and others to persuade them that this funding was was entirely appropriate and and and was really meant to assist communities in America in need, not anything else. And so we did that. And then I would say that the other thing that was massive that we also, all of us do remember, are the first six months or so of the COVID pandemic and the incredible disruption that that caused to the research enterprise. It didn't really cause a funding disruption.
Mark Barnes: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 these 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 but at the time, I have to say that that AIDS HIV seemed perhaps bigger than this is even. Yeah. 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 I've looked here carefully because I'm in the middle of many different controversies right now representing our clients, our ropes and great clients who are some of the premier academic medical centers and universities that engage in human subject research, animal research, and basic science research. And one thing that I if you if it I'll ask your question for you.
Catherine Batsford:Yeah. Thank you.
Mark Barnes:Can tell me if it's the wrong questions. But I mean, one question is what's the endgame here and what 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, are preserved? And I do think that that having been through this before in in in January of nineteen ninety five when the new congress took over, I have to say that I think that the the key here is that there are many red states with US Senators and primarily Republican congressional delegations that in those states contain centers of academic and scientific excellence that are hurting in some cases or will be hurt just as much as the institutions in Massachusetts and New York and California and Washington State. I think getting to the governors of those states, getting to The US 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 incredible research enterprise.
Mark Barnes:Florida with FSU and the University of Florida and University of Miami and 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 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 and advocating that the baby not be thrown out with the bathwater, if you will. That's that's where that's the end game. And I do have a I I have a a fear that that that we're not quite sufficiently organized to get there right now.
Catherine Batsford:Right. So as people are looking to get organized, what what is the message that they should be focusing on? Certainly, looking at the recent executive orders, What funding and operations should they be moving forward asking, requesting for 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 US. I mean, frankly, abroad as well, and that's one of the issues here is that NIH has basically said that prospectively, except for special circumstances, NIH is not going to approve either direct grants to entities abroad or even sub awards from American institutions that receive a grant. They're going to prevent that. The theory is by American, that is that we should keep the money at home. But I would say NIH is the core.
Mark Barnes: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, Department of Education and Department of Justice. There are a few other funding agencies, but I would say that the sort of the 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.
Mark Barnes:We can talk about this and Department of Energy. 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 are serving such a core national defense, national welfare purpose that I think that this administration has kind of largely kept its hands off of those grants and contracts. I think the message that we there are couple of messages.
Mark Barnes:One is all about money, and that is that the money that goes to the University of Alabama at Birmingham and all these other these other schools, both in blue states and also in red states, really is a driver of the of the local and state economies in many ways. More than that, it's not just that 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 out licensed to industry drives 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.
Mark Barnes: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 is is extremely important. And without the American funding for these things, you know, there's there's the American let me just put it this way. The American government funding for these things dwarfs the actual basic science funding by other by other nations, even in the aggregate. So there is a there's 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 have been filed or the people who are considering filing. But right now, I think that there are well over a hundred cases have been filed at this point. And in the the number may in regard to these these various research directives and decrees by the federal government that affects research funding.
Mark Barnes:There may even be as many as 200 cases that have been filed. Almost all of them have been filed and perhaps all of them have been filed 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 decision on a temporary restraining order or an injunction that then gets appealed to the circuit courts that that is the federal appeals courts. And then they may get undoubtedly, some of these things will be appealed eventually to the US Supreme Court, and they'll be decided by the Supreme Court.
Mark Barnes:There's been a couple of things that have been decided by the Supreme Court, but not after a full briefing schedule, and they've just been decided on essentially a kind of motion practice with a 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 district the Federal Court in Massachusetts. And that is, in some cases, it's because the entities that are challenging these things are in Massachusetts. And so they're going to sue in the court or they have what lawyers call venue or the the right to file the the case.
Mark Barnes:In other cases, it's because the effects of the policies are 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 centers of academic and scientific excellence.
Mark Barnes: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 warriors 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. And that is being briefed, and it's probably going to be argued in July of this year of twenty twenty five. Another case that is in the Federal Reserve 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 grants that come from the Department of Energy.
Mark Barnes: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, but as we talked about it in the first podcast we had, indirect cost rates, the negotiated rates, they range from on the low end, the negotiated federal rates, maybe 25, 30 percent, and at 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 from what the IVs and the leading academic places have rates that are somewhere between, I'd say, 5% to 70%. So it goes down to 15%.
Mark Barnes: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 that's necessary to provide all the services, the heats, 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 in it. For example, for the market wage basket index, which is the difference essentially 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 or 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.
Mark Barnes: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 Disease Society of America and many other FASEB, I think, A S E B and others have joined this case.
Mark Barnes: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 from, especially from NIH, but not only from NIH. It's challenging them on many grounds. 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 the grants and terminated grants based on the relationship of the grant content to COVID research, the relation to vaccine hesitancy research, that is, research that's looking at improving the uptake in vaccine rates and voluntary vaccination rates.
Mark Barnes:There are others that have 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 the grant termination letters that I have seen and that I counsel clients about, it is related in these letters to illegal diversity, equity, and inclusion aims or goals. So we've seen and and I'm not giving you the only ones. There there are other rationales as well that have been offered for others. 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.
Mark Barnes:In some cases, these termination letters will just say the grant content is no longer consistent with the with the priorities of this particular funding agency. So this APHA case is challenging on many legal legal grounds, including constitutional grounds and statutory grounds, the mass terminations of grants. I would say that those are the four cases that I'm looking at right now. So there are some individual schools or universities that are that are on the high priority list for the administration because the administration thinks or says that that they have failed in their duty to protect folks of all creeds, colors, and and religions. Those and it may be that that one or more of those will end up in in litigation involving single institutions.
Mark Barnes:So that is also possible. But those are the cases that I that I would look at. But there's just so much going on, Dan. I mean, there's just so many things that are happening. It's hard it is hard to keep track of it.
Mark Barnes:And I'll I'll bet you that although I've cited four cases, I'll bet you there's gonna be 15 more out of left field that I haven't cited that are probably probably gonna 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.
Dan McLean:With that in mind, how do folks who are out there go forward with ongoing research or research oversight?
Mark Barnes:Well, I'm gonna I'll 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 try to promote access for underserved populations or folks who have been left behind.
Mark Barnes: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 when they try, in my opinion, when they try to to make sure that they are in compliance with this, with this certification is they they need to look at all their programs and activities. They need to make sure that if that if they are trying to have a a run a program or activity that does promote access among either underserved populations or folks that are that may not that may be individually underserved in in their in their lives with health services or social services or anything else, that 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 all of the the case precedents and all of the guidance documents and case decisions, court decisions that are still in place and have not been overturned by the courts that say that there is nothing wrong with promoting inclusivity in programs. There is something wrong.
Mark Barnes:There was something wrong under the Biden administration, under the Nixon administration, under under all the administrations that were in power in The US after the adoption of the civil rights laws primarily around the 6465 period, but came some came after like the Americans with Disabilities Act. But there have been what is illegal and is questionable is to run programs that are exclusive, that are racially exclusive, or exclusive by, by by culture and things like that. So everybody's looking at what programs that they have created and run before to make sure that the that the theme of these programs that promote access is one 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? Well,
Mark Barnes: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 are that constitute human subject research. So it's actually it's a intellectually, it's an interesting question.
Mark Barnes: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. That's not illegal to run a program like that. Whether it's a epidemiology program that relies on on de identified data and never goes to an IRB or whether it's a program that 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.
Mark Barnes: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 our and IRBs are asking both of those questions, hopefully, 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.
Mark Barnes: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?
Mark Barnes:One can 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. Harder to think about how one might justify limiting enrollment by race in a in a in a program like that. But my point is this, is that 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 it's but again, epidemiology and just studying something, surveys and things like that, that's not a benefit.
Mark Barnes: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 the an an example for the 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.
Mark Barnes: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, that African Americans might be underrepresented, etcetera. In cancer studies, for example, there was a lot of attention to that. 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 commores discrimination based on race, color, and national origin. How does Title VI apply to clinical trial enrollment?
Mark Barnes:And I wrote a paper about this that was published in the Journal of Law, Medicine and 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 sort of the flip side of that that's being tested now. But my point is just this. It is that I have to say the reason I wrote that article is because I had not seen any any secondary literature about this topic, about how civil rights applies to to clinical trial enrollment, to human subject research. So I 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 I would direct whoever asked that question. I 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 wanna go there. I will tell you about sure because of confidentiality that I I'm worried, and I think I'm not the only
Mark Barnes: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.
Mark Barnes: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 gonna 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
Mark Barnes: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 are awarded the certificate of confidentiality. It may presage a a lack of enthusiasm by the federal authorities at NIH or Department of Justice to defend and champion the confidentiality protections under certificates of confidentiality. So so I just don't know where this is headed.
Mark Barnes:There there have not certificates of confidentiality have not been well tested in the courts. They have had a a a deterrent effect on folks, lawyers basically, trying to get clinical trial information about who's 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.
Mark Barnes:There are a few cases that have been that have been decided, but here's my point is that it's not like there are a hundred cases interpreting judicial decisions, interpreting certificates of confidentiality, and how well or poorly they protect people whom they're supposed to whose identities they these certificates are supposed to protect. And so when you have the NIH without any apparent pressure, of which I'm aware, saying spontaneously, we're not gonna issue them anymore for industry studies, I think we have to wonder how how how much NIH and and other parts of the federal government will champion the protections the 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.
Mark Barnes: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. And Bob went to jail rather than than than he 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.
Mark Barnes: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.
Mark Barnes: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, I think, you know, we're asking people to trust in the process and to be involved in trials. And in that, we need to protect their privacy, you know, 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 and when you've lived long enough and your career is long enough as as mine for better or worse has been, you know, 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.
Mark Barnes:We need to try to protect our research endeavors. We need to understand 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.
Mark Barnes: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.
Mark Barnes:But I think that, 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 he 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, so I think that I I wouldn't despair. I just think that we have to do our best.
Catherine Batsford:Dan, did you have a final
Dan McLean:I think that's a good last message. Mark, I thank you for your time. You spent time with us and the the Purver community earlier this year, and I know people found it valuable. And then 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.
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