Kate Heffernan, Member, Epstein Becker Green, and Elizabeth McEvoy, Partner, Hinckley Allen, discuss how research misconduct is regulated in the United States. They cover research integrity as it relates to the law, how approaches to research integrity have changed over the years, how the legal stakes have been raised for institutions and scientists, and proposed regulations related to research misconduct. Kate and Elizabeth spoke about this topic at AHLA’s 2024 Advising Providers: Legal Strategies for AMCs, Physicians, and Hospitals, in New Orleans, LA.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
Kate Heffernan, Member, Epstein Becker Green, and Elizabeth McEvoy, Partner, Hinckley Allen, discuss how research misconduct is regulated in the United States. They cover research integrity as it relates to the law, how approaches to research integrity have changed over the years, how the legal stakes have been raised for institutions and scientists, and proposed regulations related to research misconduct. Kate and Elizabeth spoke about this topic at AHLA’s 2024 Advising Providers: Legal Strategies for AMCs, Physicians, and Hospitals, in New Orleans, LA.
To learn more about AHLA and the educational resources available to the health law community, visit americanhealthlaw.org.
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Speaker 2:This episode of A HLA speaking of health law is brought to you by a HLA members and donors like you. For more information, visit american health law.org.
Speaker 3:Hi, and welcome to ALA's speaking of Health Law podcast. I am Kate Heffernan. I'm a member at the law firm of Epstein Becker and Green in our Boston office, and I'm joined here today by my colleague and friend, Elizabeth McAvoy . Elizabeth, do you wanna introduce yourself?
Speaker 4:Yes. Good afternoon, Kate, and good afternoon to everyone. Um, my name is Elizabeth McAvoy. I am a partner at Hinckley Allen and Snyder in our Boston office, and I'm also the chair of our research compliance and integrity group. And we are thrilled to talk today a little bit today about not just health law, but also all things research integrity.
Speaker 3:And I had the pleasure of presenting in February with Elizabeth at the A HLA Advising Providers Program in New Orleans, where we were able to speak with some of our colleagues about the research misconduct regulations. So we're here today just to have another more informal conversation about research misconduct and how we regulate it here in the United States. So let's start with some basic concepts just to level set and make sure everyone is aware of what we're even discussing today . Can you give us a little bit of background, Elizabeth, about what research integrity really is and what that is , um, in the law as opposed to say, research compliance more broadly?
Speaker 4:Yes. I think this is a critical distinction and , and truly kind of a baseline for anyone that's gonna be discussing research misconduct. Research integrity is really kind of focused on the data. So research misconduct and research integrity are terms of art. They're really talking about the reliability, accuracy , um, and really kind of the scientific value and scientific principles behind the data. So it is very , um, tied to the scientific exercise and , you know, behind the data. Whereas when we think of research compliance, what we're really saying there, and I think as a side note, most people are more familiar with the, with the word compliance. Compliance is really often used in paired with whether research is complying that is adhering to federal requirements, institutional requirements, and potentially other funding requirements and how it's carried out. So, you know, research compliance, I like to think of it as a big umbrella of the way we should do research, but when we talk about research integrity, we're cutting out a slightly different slice of that. We're saying, you know, is the research itself kind of progressing in a way that it's reputable, that it's accurate, that it's reliable? So it is a truly kind of unique vantage point when we look at research. Um, and , and you know, when we look at what is valuable to those that are gonna be using the byproducts of that research.
Speaker 3:That's so interesting. And you note, you know, this really is kind of focused on the science, right? It's about the data. It's about , um, the reliability and the accuracy of those data. So can you explain a little bit, you know, why we even need laws in this area? Why isn't this just a matter for science to govern itself?
Speaker 4:I think that's a really great observation, and I'm sure there's plenty of scientists and others out there who kind of have asked the same question. Like, how does, how do these areas lend themselves to legal oversight? Um, I think the reality is, you know, unlike research compliance where we're really kind of looking at everything, this is an area that for a long time, just going back historically didn't have oversight. And what happened is there were serious concerns raised about 20 plus years ago about how the academic research world was progressing and how valuable the output was that these scholarly papers and these projects were really producing. And I think it led to some real concern on both the congressional and federal level as well. It's kind of in the industry, in the , um, you know, industry of those conducting the research about how do we police, how do we ensure that when people are publishing results, when they are holding out data, that it's something that we can rely on and we don't have to kind of worry and second guess ourselves and, you know, how can we progress science right at that fundamental level? And that really led itself to kind of coming up with a framework for what is required. And the way that framework really is handed down , um, is, is through the oversight agencies and through the institutions. And I won't get too much into the details of the fundamentals of the process, but you know, the way that the matters of science really come about as a legal matter is that each funding agency, for the most part, and each institution that receives those funds to perform research, to have a set of requirements that they have to follow to make sure that they're supporting responsible research, and to ensure that the research is meeting basic criteria that are , um, are not affected by fabrication, falsification and plagiarism. The quote FFP, which really defines research misconduct. Um, and, and the reason it's a legal issue, getting back to your question, Kate, is because, you know, we need to have, I think this goes back to kind of government in general. This is a way that our government has said they're going to continue to support the advancement of science, but only in a responsible way. So these are conditions that the government essentially has kind of imposed through the mechanism it has available its oversight agencies like NIH, like NSF and others. Um, and it's really, I think a , a emerging of two worlds, and it's been quite rocky over the course of, of history. And I think it often , um, is something that can be really difficult for lawyers to deal with and for scientists to deal with because it is unique in that respect.
Speaker 3:And you, you raise a great point that I think it bears , uh, pausing on, which is that, you know, the, the nexus for their true legal requirements does come from the federal dollars that support the research, right? So our government , um, as you noted, seeks to support the, the progression of science with money that it grants to institutions to support scientists work. Um, and it is through those funding terms and through the connection to the funding dollars that the government can impose these requirements. That said, I think it's fair to say that in light of that floor of requirements that the government has set forth, we see most institutions applying through policy the same types of standards to all of its research regardless of funding.
Speaker 4:Yeah, I think that's right. And, you know, just to kind of expand, I think one thing that's interesting to talk about, Kate, maybe you can kind of chime in here, is these institutional policies and kind of how the institutions who are directly involved in a lot of the research that we're talking about here , um, you know, what they have today in 2024 in their books is, is very different in how they approach research. Integrity is very different than it has been. Um, as I mentioned, kind historically, there wasn't even federal oversight. What are some of kind of the trends and differences you've seen in your practice , um, as these research integrity matters have gained more and more traction?
Speaker 3:That's a great question, and it , uh, talk about a rocky road. It really has evolved and changed dramatically since I started being involved in these types of matters. You know, it has been , uh, about 20 years now <laugh> . So , um, you know, what we used to see, and I think what the law that you know, was, was put into place around 2000, and then in 2005 on the, on the Department of Health and Human Services side is really a , uh, an internal faculty scientist to scientist peer review process that is guided by the law. So, you know, I think originally the regulations that the government had put forward, which again started with a federal policy put out by the Office of Science and Technology, and then was , uh, adopted in, in a variety of forms by, by the different funding agencies. We really saw a deference, I think, to scientific peer review and to an approach that allowed for , um, scientists and the institutions at which they work to manage , um, concerns as they were raised internally for the most part , um, around, around research that had been performed with federal money and whether or not there were concerns that rose to the level of research misconduct. And again, as Elizabeth pointed out, research misconduct itself is a very specific , uh, and specifically defined type of concern. It's not misconduct writ large. It's not just bad behavior. It's not just acting in a way that , um, you know, may suggests sloppiness in one's approach to science. It's very specific. It is falsification of data, fabrication of data or plagiarism. Um, and all of those three things have to do very specifically with how one is representing the output of research experimentation in the scientific research record and in the scientific literature. Um, and so originally it was a , it was sort of an in-house , uh, type of process where there were, as a general matter, you know, faculty panels that looked at the concerns that were raised, the regulations, you know, provided a framework and a prescriptive one at that, but still a framework within which those proceedings tended to play themselves out. And there were, you know, reporting requirements to the government. But again, there was a lot of deference given, I think, to the institutions and how the institutions managed those processes. Um, in the first, you know, sort of 10 to 15 years of how we saw the law implemented, I think what we've seen in recent years , um, and it's been a really interesting development, is a much more public , um, undertaking of the vetting of these concerns. So in addition to , uh, online peer review websites such as Pub peer and others, where the intent of these online resources was to allow for scientists to exchange information and feedback on published papers and on published results, again, in the furtherance of the scientific process, we have seen sort of a move from that to , uh, a public allegation , uh, platform where, you know, those types of websites as well as Twitter, as well as blogs and other types of very public spaces are being used by individuals to allege claims of research misconduct. So not just that there may be questions about a paper, but that , um, the implication is that those questions arise from a scientist's ill intent. And there's a purposefulness behind the concerns that have been identified, and that has really changed the way in which I think institutions are forced to grapple with these proceedings. Because before you're even beginning to digest as an institution what the concerns are, and whether they are ones that under the law need to be reviewed and need to be addressed, you're usually already dealing with media inquiries related to, you know, very public , um, airings of those concerns.
Speaker 4:It's really interesting what you just mentioned about kind of the public nature and how the shift really went from, in-House internal matters largely handled by scientists, right. Less kind of legal in nature originally, and now they're , you know, full-blown , um, institutional matters involving pr. And there's a lot of , um, I think non-traditional players who are weighing in, even if it's informally on kind of what it means for the institution. And I think , um, you know, certainly putting the matter of misconduct really out there for public consumption, like , um, something that's never really previously been been out there.
Speaker 3:Yeah, I agree. And, you know, it's, it's not just the institutions I think that are feeling that public pressure. I mean, I think , um, the Office of Research Integrity, which is the office within , uh, the Department of Health and Human Services that enforces the regulations , uh, for PHS funded research , uh, I mean, my impression is they feel that same pressure. You know, they are also under scrutiny as to, you know, the time in which it takes to review these matters , the speed in which , um, actions may be taken against scientists. And so, again, whereas you used to have maybe a final reporting obligation out to the government, and they would at that point decide whether additional federal action might be necessary. We're now seeing a much earlier involvement of ORI and other federal funding agencies when concerns get raised because they're well aware of them , um, again, because of the public nature,
Speaker 4:Right. And that early involvement, just to kind of segue into the , this larger picture, right, we're talking about health law, and many of you made listening have a legal backgrounds or partner with legal , um, professionals and your pursuits. And I think this is part of the touch points where these matters, even though they deal primarily with science and the integrity of science become legal concerns for both the stakeholders at institutions, for the individuals involved. Um, and I think to, to put a finer point on what Kate was just kind of highlighting , uh, for everyone, it really has raised the stakes for institutions and for individuals , um, to be under such scrutiny and to be looking at this as kind of an area of government oversight or government enforcement, which is a lens that I don't think prior, you know, to maybe seven, eight years ago , um, a lot of individuals in academic science would, would have, you know, subscribed to, I think it some , it seemed for a long time that kind of science could progress on the science alone and on the novelty of the science and of the impact of the underlying findings. And all of a sudden kind of this area that has, you know, been autonomous is now one of the many highly regulated areas that the government by virtue of ORI and by virtue of N-I-H-O-I-G and others is really focusing on. And I think it brings an incredible new lens and a lot of additional pressures and responsibility to both the institutions that are overseeing it and guiding the research as well as the individuals carrying out that research on every level from a principal investigator to, you know, a senior scientist to postdoc all the way to junior trainees who are wading into this new profession. Um, and each one has a responsibility and, and with incredible scrutiny at every stage. So, you know, I think this becomes a challenging environment to perform academic science, and yet, you know, the need for advances is always there. And I think, you know, certainly still very important to the institutions that support science.
Speaker 3:It , it's such an important point, and it circles back to one you made earlier just about this , um, you know, kind of increasing tension between the scientific pursuit and the regulation of it. I've heard repeatedly, you know, from scientists at institutions who grapple with the way in which these proceedings unfold , um, you know, we're entering into an era where scientists are going to be afraid to make mistakes. They're gonna be afraid to fail forward, which is such, you know, a critical principle in their, you know, from their perspective to the scientific endeavor. The number of times you need to , um, make mistakes and go the wrong direction with science for you to end up at a moment of true discovery, you know, is a refrain that I hear over and over, you know, from the scientists who are concerned that the hyper regulation of this area is going to have a terribly chilling effect on , uh, junior scientists in particular, you know, who really need to know that that is sort of part of the scientific endeavor. And when I think scientists see, you know, every single, what they perceive as every single mistake and error and correction, you know, being highlighted in online publications as , um, you know, a potential indication of malfeasance that raises some, you know, I think legitimate concerns from their perspective as far as how does failure and mistakes and , um, the ability to have your work questioned, which again, is part of the traditional scientific peer review process , um, you know, become in some ways cabined by the concerns around integrity. And then I think on the other hand, you see, you know, legitimate concerns by the government that they don't want to be funding work where , um, you know, reproducibility is truly in question and where there are concerns that , um, that falsification has occurred, because obviously that's not why the government puts money towards the scientific endeavor. They want to fund research that, you know, meets the highest standards of ethics and integrity. But I think we are sort of at this crossroads where , um, you know, we are seeing proposed changes in the regulations, and I know we wanna segue to that, you know, in a moment. Um, and, you know, we have a lot of these unanswered questions within the regulated community and within the scientific community about what is the best way to protect the integrity of the scientific enterprise from a legal standpoint.
Speaker 4:Yeah, I do, I agree completely. The crossroads, you know, has certainly presented itself. Um, and you know, I think there's a lot of really valid questions being raised about what research looks like 10, 15, or even 20 years from now, given the current environment. And just to kind of circle back to something Kate just mentioned, when we talk about the risks and regulation that the government , uh, pursues of academic science, you know, there's of course kind of the interactive internet litigating matters through Pier and other forums. Um, and then, you know, just generally the institutional proceedings, which we talked about, there's also some, you know, a real shift, I think, across the country in the law enforcement in the Department of Justice, as well as aided by the various offices of Inspector General , um, to looking at some of the larger instances of substantiated misconduct as false claims. So when we talk about kind of why the government is concerned, we're really focusing on another form of what the government views as fraud and abuse because they're funding, you know , program, you know, through the various funding agencies and often at the hundreds of millions of dollar level. And when there are substantiated findings that the outcome is essentially waste and that it's not usable for scientific advancement. There is a couple valid, you know, legal series that can be applied in the government with increasing frequency is looking at these like other types of kind of health law fraud , uh, cases that under the False Claims Act , um, you know, looking at these kind of as civil as , as well as criminal violations. Um, and really the theory is not new or novel, but it is new and novel that the government would look at science in this way when it doesn't involve, you know, patient harm or pharmaceuticals or , um, you know, something more typical when we think of, you know, fraud and abuse and health laws . So, you know, it's really, the stakes have never been higher, as we've said, and that's been borne out by various legal proceedings , um, across the country and , and a lot here in Boston as well. So let's talk about the new rules, Kate, because I think this is, you know, you mentioned 2005 was the last time that the public health service, you know, that the official kind of regulatory framework. And here we are , um, almost 20 years later talking about , um, potential new framework and how everyone involved has to carry out the oversight of research integrity and specifically ferret out misconduct. So , um, you know, what, what are the kind of changes on a broad level, what , what impact are they gonna have? And , um, you know , who's subject to these potential new changes,
Speaker 3:Right? So yeah, I mean, I love living through a moment of major regulatory change , um, as do as do most health lawyers. So it is exciting. We haven't , um, you know, seen major changes to this framework in quite some time. Um, and again, I think, you know, the question's going to be how does this new era of regulation serve , uh, all the stakeholders that you mentioned earlier, how does it serve the institutions? How does it serve the government? How does it serve the scientists? How does it serve the funding agencies? So I think all of those, you know, questions are, are still, you know, to be seen. We have proposed rules, as you noted. Um, they cover a number of changes. And I think, you know, when we knew this was, you know, kind of on the horizon, but I think people weren't entirely sure, you know, what the scope of the proposed , uh, revisions would involve. And some of the proposed changes were, you know, as expected, and others I think were, you know, surprising , uh, to the regulated community. And I , and the, I will note that the proposed rule generated , um, you know, a , a pretty significant response from the regulated community. There were a number of comments , uh, submitted to the government in response to the proposed rule. So it, you know, it remains to be seen which of those, you know, have any impact on the final rule , um, if they have any impact at all. And I think, you know, we're operating under the assumption there may be a final rule as early as this summer. So , um, that will be really interesting to see. I will note, you know, just to kind of cover some of the, the higher changes that we've been looking at , um, and, and expect to see, you know , some form of, in the final rule, there's a number of, you know, new definitions that didn't exist in the , uh, 2005 current regulation. And they've been definitions that I think have been , um, you know, part of some of the , uh, challenges that institutions , um, reviewing these matters have encountered. Uh, for example, you know, what does it really mean to , um, act in a reckless manner? So , uh, as you know, we, we've sort of noted in passing throughout today's conversation, in order to, for something to really be misconduct, there has to be an in an intentionality to it, but it's not limited to acting intentionally. You can also act recklessly under the regulations, and you can act knowingly. And, you know, until the proposed regulation, we really didn't have definitions as to what those words mean. And in particular, the term reckless has been one that's been , um, a subject of court cases and a subject of a lot of conversation amongst the regulated community because it is so close to that line of what it means to perhaps simply be acting , um, you know, in a scientifically sloppy way or just sort of doing bad science that isn't necessarily , um, intentional fraud. So there has been a proposed definition for recklessness put forward, and that was, you know, hotly debated as part of the comments that were submitted , um, in response. Um, there are other , um, additional types of changes with respect to sort of at what point the government gets involved in these matters. As I noted earlier, you know, again, until recently where there's been this , um, greater public scrutiny and , and public , um, publication really of these allegations, the, the government enforcement office really wasn't involved until , uh, pretty, pretty far down the line in one of these proceedings. So there's several steps to the process and, you know, you really didn't start to engage with the government until, you know, you were kind of halfway through to be fair. And now , um, you know, we've seen earlier engagement in part because of just awareness. And I think , um, with the proposed regulations, what we see the government seeking to do is really to formalize that, to put the government , um, you know, sort of much more in touch with institutions and much more involved in terms of their input at an earlier stage in the process. And again, you know, there are different views on whether that's a, a good thing or , um, might itself chill, you know, some of the earlier airing of concerns within institutions, but a , a pretty significant procedural change that's part of the proposed regulation.
Speaker 4:Yeah, we, I think the involvement of regulators and just kind of that regulatory oversight, it seems to kind of be trending towards, you know, greater and greater involvement. And then , you know, that will obviously really shift how everyone in the community views research misconduct. Another, I, you know, I know we're kind of nearing the end of our time, but I thought another interesting point for the proposed regulations , um, moving forward is around kind of confidentiality, because as we've been talking about today, you know, the , historically what's been interesting for those of us that, you know, practice in the area of research misconduct has been how it's become a very discreet science-based peer review based issue. And it's turned into a more kind of systemic institution-wide matter of concern that is litigated out in the public , uh, often through the internet, and not only have kind of regulators become more and more interested and involved, but now there's this kind of really about face and how the , um, institutional work is potentially shared beyond the institution. So, you know, we haven't gotten into a lot of the nuts and bolts, but one thing that has always been, I think, comforting from my perspective for scientists is that, you know, if they carry out the process and the institution at the end , um, of the institutional process, you know, does not find misconduct, there is , um, you know, the , the matter closes with the institution and the confidentiality will kind of remain around those proceedings. And now there is kind of a very radical proposal that institutions have to report out their activity and their findings , uh, to ORI to be publicly shared in the spirit of transparency. And I think that has a lot of concerns raised in the community about what that would mean for how , um, again, going back to the fundamental , uh, point we're at, you know, how can we conduct science when the stake seems so high?
Speaker 3:I agree. Uh , I think you, you know , you summarize it perfectly, which is, you know, we just have two competing interests here. We have the interest of science continuing and, and there not being a chilling effect. And we have the interests of the institutions carrying this out appropriately and ensuring that they're monitoring their scientists appropriately. Um, and we have the government, you know, wanting to exert their oversight , uh, understandably. But all of those three things, it's, it's challenging to balance them appropriately to ensure that , uh, we're meeting all the right aims.
Speaker 4:Yes. So, you know, I think we just scratched the surface here today of some really, you know, interesting, incredibly nuanced issues , um, in the matter, you know, in the, in the sphere of research misconduct and research integrity. But as we highlighted today, you know, certainly lots more to come and , and potentially a huge kind of new wave of regulatory enforcement that stands to be seen , um, as early as this summer. So thank you so much to everyone , um, for, for tuning in. Thank you Kate for a great conversation this afternoon. Um, and thanks to you too. Have a great day, everybody. Take care.
Speaker 2:Thank you for listening. If you enjoyed this episode, be sure to subscribe to a HLA speaking of health law wherever you get your podcasts. To learn more about AHLA and the educational resources available to the health law community, visit American health law.org.