SCCM Resource Library-Changing Models of Consent for Medical Research

Video Transcription

Hello, everybody. Welcome to today's webcast, Changing Models of Consent for Medical Research.  My name is Matthew Lee. I'm a Clinical Pharmacy Specialist for the Trauma, Surgical, and Burn  ICU at Westchester Medical Center in Valhalla, New York, and today I'll be your moderator  for the webcast. A recording of this webcast will be available within five to seven business  days. You can log into mysccm.org and navigate to the My Learning tab to access the recording.  Just a few housekeeping items before we get started. There will be a Q&A at the end of the presentation. To submit questions throughout the presentation, type into the question box  located on your control panel. Just as a disclaimer noted on the slide here that this presentation is for educational purposes only. And now I'd like to introduce your speakers  for today. Dr. Erin DiMartino is a Pulmonary Critical Care Physician and Ethics Researcher at Mayo Clinic, where her primary research focuses are in health policy, fairness in  pandemic-scarce resource allocation, and surrogate decision-making for incapacitated patients.  Dr. Allison Turnbull is an Associate Professor of Medicine at Johns Hopkins Medicine in Baltimore,  Maryland. Dr. Turnbull is a Critical Care Epidemiologist. She's an Associate Professor in Pulmonary Critical Care. Her research focuses on clinical research methodology issues with  specific interests and studies of patient-family engagement in ICU and evaluating the long-term  outcomes of ICU survivors and their families. And now I'll turn things over to our first presenter.  Thank you for that kind introduction. We're going to talk about ethical frameworks that were present and underlying the consent process before 2020, what changed as the  pandemic hit our clinical settings and our research settings, and then the impact of  the cultural climate changes that started in 2020 on the consent process. We're going to finish up  with talking about the ramifications of new consent processes for unique populations who are sometimes specifically vulnerable or potentially helped by the changes of the  last few years. Traditionally, we've thought of the ethics of consent as being very different in  the research and the clinical care realms. They've been treated as kind of two separate issues. The  traditional principles that surrounded human subjects protections in the U.S. became really  cemented as the cornerstones of research ethics in the 1970s when there was a period of really  intense societal focus on civil rights, egregious violations of patients' rights that had happened  and created big public scandals. So since then, the dominant concern has always been to protect patients and other subjects from the risks potentially created by research. This has  really kind of become how people think about research. It's dangerous, we need to protect  patients from it, we don't always assume that researchers have the best interest of patients in mind, whereas very different processes are often used for clinical care.  The current paradigm is the common rule, which I suspect most people are familiar with. It was  published in 1991 and it says that within most circumstances, consent is not required for minimal  risk research. If you don't fit this definition, we expect a pretty intensive process that I suspect  a lot of people on the call are familiar with, long consent forms, an informed consent process  that often involves multiple steps and signatures, usually in person. So the definition of minimal  research under the common rule is that the probability and magnitude of harm or discomfort  anticipated in the research is not greater than those ordinarily encountered in daily life or the performance of routine physical or psychological examinations or tests.  The way we see this operationalized is often to think of a physical. Is this going to be  any more invasive, any more dangerous, any more likely to cause harm or discomfort than a routine  physical? If yes, if it's anything that wouldn't otherwise happen, that's not minimal risk and  you need to go through a kind of full research consent process. I think it's important as we go  forward to remember that the comparison group here is ordinary daily life. That's a pretty  broad description and I think it's important to keep in mind that different people's lives,  different people's ordinary daily lives can look very different. So assuming that there is one  ordinary daily life is already requires a mental leap and for us to forget the diversity in people's  lives. So before the pandemic, kind of about 15 years ago, maybe more, we started seeing this  concept of a learning healthcare system. So this is defined by the Institute of Medicine as a  healthcare system in which knowledge generation is so embedded. So just part of providing care,  such a core part of practice that it's just a natural outgrowth of healthcare delivery and it  just leads to a continual process where we're always doing quality improvement, always learning  from the data that we collect in normal day-to-day practice. A lot of this kind of thinking about the  learning healthcare system, what is it, how do we create it, was prompted by the widespread  introduction of the electronic medical record. If all of this stuff is now electronic, of course  we're going to use it, we have all this data at our fingertips, of course we should use it to try  and improve care and figure out what care works best. So we saw this big leap in quality improvement  processes and comparative effectiveness trials and thinking about pragmatic trials. None of this has  to do with 2020, this was all happening prior to that, but we were starting to see this kind of overlap in the Venn diagram. If we are doing research just as we go about our daily  clinical care, why do we have these kind of two sets of ethical frameworks for thinking about  consent and the respectful treatment of patients? So in 2013 there was a paper published that said  we kind of need a new ethical framework to think about this and the major proposal in that paper  said the framework we propose rejects the assumption that clinical research and clinical practice are from an ethical standpoint fundamentally different enterprises. We  can't keep treating these things as totally separate, as we go about clinical care we're  already collecting data that is going to inform our practice and help us provide better care.  They also proposed an ethics framework for this kind of learning health care system, how we should  think about ethics and how we treat people if we're going to do this. So the proposal was that  you should assess whether a learning activity, notice they're not saying research, right,  because we think of research as different from what you do in clinical practice, but now we're  saying part of what you do in clinical practice is a form of research. So a learning activity,  if it's unduly limiting the choice of patients and if it's some kind of choice that patients  really value, the value of those choices to patients. But it also says that there are many  decisions in health care that just aren't engaging with values of central importance to patients. So  for example, if you're testing two different vent settings and you literally have, you very  sincerely have no idea which is better, most people don't have like strong religious convictions  about vent settings. If you're talking about two brand names of drugs, right, or I don't know,  something else about like the timing of dosing, six hours versus eight hours, you know, Q6 or  Q8, these are just not things that the average person on the street has like a strong, very,  you know, central conviction about and therefore would care much if that's what you're testing.  So this kind of new framework, this new way of thinking about these learning activities said  to clinicians and researchers, you need to think about two things. First, is it going to limit  choice? And second, is it limiting a choice that people care about a lot? I like to point out that  this is really not that different from how we think about consent in the clinical setting. So  when I'm on our ethics committee, and I get called about things, I sometimes get called about big  fights or big disagreements between doctors and patients or their family members over what seemed  like very small things about things like the timing of a dose, is it Q6, is it Q8, or which  antibiotic? And we talk about, well, is this really a preference sensitive decision? There are certain  things that are very preference sensitive, they're of great value to patients, we think about this a  lot at the end of life, right? Of course, you're going to practice shared decision making there, of  course, you're going to get consent, because this is a core decision that is connects to people's  deeply held beliefs and values. But the timing of that antibiotic dose, or which antibiotic you're  using, it's not really tied to anything that most people have very, very strong feelings about or  central to their senses of self or morality. So why are you having this discussion with these  patients? This is not preference sensitive, you're going to provide standard of care, don't get into  these long discussions with patients or their surrogates in this particular sense, in this  particular area. So we really encourage clinicians in the clinical setting, not the research setting,  to try and think about is this preference sensitive, in which case I need to engage in  shared decision making? Or is it not? I don't need to have a discussion every single time I change  the event setting. Okay, so the other kind of interesting conundrum raised by the learning  healthcare system is that it's often very hard to get informed consent for these kind of pragmatic  trials that we're now doing embedded in electronic medical records. And so it forces us to think more  about how to how to show respect for patients and, and make sure that we're behaving ethically  without the informed consent process. I would argue that in general, we have become overly dependent  on long informed consent processes, and have kind of come to equate them with showing respect for  patients, i.e., if we go through this process, everything is fine without thinking about all the  other ways that we can show respect for patients and their families. So this is a list that has  been suggested for ways to show respect without informed consent when you're conducting a  pragmatic trial. So engaging patient communities and research design and execution, practicing  transparency and open communication. And that's something that, you know, I would argue we don't  always think about enough. So examples of things that IRBs have asked pragmatic trials to do when  they're not doing a full consent process, but they want to encourage transparency and open  communications. So posting signs in rooms that explain, if you're getting a certain procedure  here, you may get X or Y, if you feel strongly about it and don't want to participate, let us  know, right? Maximize agency. So instead of having people opt in, let people opt out, you know, let  them know that this is going to happen in the background, again, whether it's via a sign or just  verbally, and they don't have to do it if they don't want. Continue to protect patient privacy, of  course, you know, we do that in clinical settings anyways, that shouldn't be jeopardized if you're  doing a pragmatic trial. Minimizing burdens, physical, emotional and financial burdens is a big  one. And again, there's a lot of things that we take for granted and kind of think of as the way  things have to be that are quite burdensome for patients. So people have argued that actually that  20 page consent process you do, that's a burden. And it is one of the ways you can show respect is  by not making people go through that. Long surveys are burdensome and annoying. Making people come  back to a hospital multiple times when it's not of a direct benefit to them. It's burdensome  sometimes, and sometimes financially a burden, too, if you're paying for transportation and  parking again, and again, all of those things, minimizing them is a way to show respect for your  patients, interpersonal interactions, this is one that empiric research has repeatedly shown  patients care about a lot. This is how they want us to show respect. So my favorite example is it's  not really respectful to make someone sit in a waiting room for an hour, make eye contact, you  know, think about their experience and, and how you speak to them. Sometimes when people say like,  how could you say anything we don't do is not respectful to our patients. And, you know, the  example I like to give is well, imagine that these geriatric patients are Queen Elizabeth, would you  make Queen Elizabeth sit in your waiting room for two hours without any clue what's happening? That  would be seen as really disrespectful. Obviously, we can't do that for every patient, but try and  think about what would you do if your patient was somebody who was considered very, very important,  you know, you wouldn't make the Queen sit there, provide compensation, and maximize social value. So  when you're thinking about, we were already in a place pre 2020, we were where we were thinking  about what can we do besides informed consent for these pragmatic trials that will show respect for  our patients, kind of maximize their autonomy, and ensure that this entire process is an ethical  one. So different considerations for consent and pragmatic clinical trials. Risk is evaluated in  relation if you remember going back to when I was talking about the common rule where the comparison  group was normal daily life or that exam. When you're deciding whether what what is necessary for  consent in a pragmatic clinical trial, it's been proposed that instead, we need to consider what  they would have experienced in ongoing clinical care if they had not been a participate. So instead  of that daily life or during routine physical exam, just think, if we weren't doing this trial, what  would they have experienced? If it is not significantly more harmful, if it's not, you know,  dangerous, if it's not more burdensome, that's a sign that this is probably something that doesn't  require kind of the traditional full informed consent process. And then what else are you doing  from that list we just talked about? What else are you doing to show respect for persons? And then  finally, the third question, does this intervention engage values of central importance? Is this  something that people feel strongly about? Or is this something that the average person doesn't have  a stance on before they get to the hospital? Nobody says the hill they'll die on is the timing of this  dose of whatever, until the moment they have illness, it's not a core value for them. Of course,  that gets has gotten more complicated in the past few years, as people's, you know, very strong  political feelings have become tied to treatment. So Dr. DiMartino is going to talk more about that going forward.  Thank you. So as Dr. Turnbull was just talking about, we had evolved to the place, especially  with the, you know, kind of growing prominence in the critical care literature and other other areas  of literature of pragmatic critical clinical trials that we were starting to experiment with and  evolve paradigms around what constitutes appropriate consent processes and what is ethical conduct of  research for critical care population. And then of course, the critical care population changed  entirely in early 2020. And around our ICUs, the world itself changed irreversibly in 2020. And so I  think it's worth examining, we decided to structure this talk as a kind of before after intentionally,  because we see ways in which the pandemic has shaped and, and potentially has the possibility of  continuing to shape consent processes going forward, because of that influence and pressure of the  pandemic. So what was it specifically about COVID-19 that shook up the way clinical research took  place? So first, we had a novel lethal and highly transmissible pathogen for which we had no effective  treatments at the beginning of 2020. And we had scarcity of all manner of supplies, and in particular of  protective equipment, which in turn dictated changes and huge shifts in practice that influenced the research  community as well, of course, as the clinical community. So at our institution, as well as  institutions across our state, our country, and around the globe, there was a complete change of the  practice of medicine, and therefore, the practice of research relating to medicine. So first of all, for weeks at a  time, early in 2020, there was a complete cessation of outpatient visits and elective surgeries. So care, any  care that could was non emergent life or limb threatening, was deferred in many jurisdictions, under decree of the  government or based on an institutional assessment of the ability to provide such care in preparation for an  onslaught of patients with the first wave of COVID-19 patients. In some jurisdictions that came to fruition, and the health  care system was indeed overwhelmed in the spring of 2020. And in other jurisdictions that did not occur, and that kind of  downshift in clinical contact with our patients did, maybe was an overreaction to the to the stress that was on our system, but was  certainly resultant in forecasting of severe scarcity. And no matter where that that delay of care occurred, there were  complications of that deferred care that were felt by the patients, most importantly, but also the clinicians caring for them. And  therefore, there was, I think, a focus not only on COVID-19, but also as the spring and summer evolves on all the care that didn't  occur because of COVID-19. And so there was a spillover effect where participation in research studies and clinical studies were just  deprioritized across the patient and a lot of the clinician workforce as well. We observed a tremendous downshift in onsite presence in  both kind of outpatient clinical settings, as well as inpatient clinical settings. So for the reasons mentioned just a moment ago, with  deferring routine clinical care, or even not so routine clinical care, necessary clinical care that that was deferred because of the  pandemic, there were fewer patients arriving at the doorsteps of their clinics and of hospitals. Even when patients were presenting  for care, they were presenting solo. So they were often not accompanied by any family or friend, and were coming and going or even coming and  staying for long periods of time by themselves. And we'll return to that in a minute. Finally, our research staff were annexed as well. And  we're not, we're not accessing clinical spaces and research spaces that were traditionally part of our workflow. And this was for several reasons. It  was for infection control purposes. And then there were also reasons around and there were many jurisdictions that restricted movement of  individuals. So not just institutional policies, but, but government policies restricting movement of individuals who did not have work deemed  essential at that moment in time to be traveling back and forth to their workplace. There was a tremendous pressure to reallocate supplies and even  qualified staff from research spaces to clinical spaces in and shifting those supplies and qualified staff to respond to anticipated surges in clinical need. And all of  this led to kind of a degree of adaptation that I kind of began to think of as a DIY or do-it-yourself adaptation to how to continue your research pursuits while you  were facing so many different limitations. So I think it's important to acknowledge that while I'm going to focus in the next few slides on COVID-19 specific  research, this clearly had a ripple effect across the entire research community. But there were some even more highly specialized and highly challenging  difficulties faced by teams who were attempting to address the urgent questions that were posed by the introduction of COVID-19 into our population.  or through video chat all the time through work, we began to increasingly rely on video chat capability  early in the pandemic, including through clinical conversations and consent conversations. And so could we say pass a packet of paper  underneath the door to a patient, have them look through it and sign it and then hold it up and then we could take a screenshot of it.  Again, there were issues around the processing, the privacy and processing of such a screenshot. And then there are issues around the fact  that many of our patients were extremely frail and ill and unable to hold, maybe even hold a pen very steady, but certainly not hold up a consent form  steadily enough so that it was legible.  There were issues where some institutions, our own included, had electronic signature pads, but how could those be shared from one room to another  when there were such concerns around infection control and what was the best way to disinfect those and move the computer unit from room to room?  And then there are commercially available products,  DocuSign and things like that.  But in order to, as a researcher, to kind of get up and running with a commercially available, secure document signing product,  took a lot of back work and it just wasn't feasible. And so that's what the authors of these papers cited. Here, we're discussing just all these practical challenges.  And this is to say nothing about who the patients were. So as we know, early in the pandemic, I mean, one of the very first things we ran out of in our medical intensive care unit  were our iPad interpreters, because we had so many patients of limited English proficiency and it was so difficult, even if we had the patient there  and we were able to interact with them, if they wanted us to interact with a family member, it was difficult to reach them and to reach them with their proper interpreter services.  And so we were really challenged to provide top-level care because of that additional hurdle of making sure that we were doing the best that we could  to communicate risks and clinical context to patients and their families.  And this is, of course, to say nothing of third-party consent because so many individuals didn't have capacity to make their own medical decisions and continue to not have capacity  to make their own medical decisions when they're in the intensive care unit. And if you take that more than two-thirds of American adults haven't previously documented  who their preferred decision-maker would be, so who their durable power of attorney for health care would be,  then to whom exactly should we be turning? And how do we get that person the information we need? Do we ask that person to come to the hospital,  even though they can't see their loved one? Do we, just to pick up a form or to meet with a researcher?  And do we mail consent for a time-sensitive intervention to them and wait for it to arrive? And what if we get the wrong address or we mail it to the wrong relative?  There are issues even if we use email as an attach of 20-page long document, how do they get that document back to us? How do we walk them through it in a way that you can do  when you're sitting shoulder-to-shoulder with a patient or their loved one? And then a lot of the same concerns abound around telephone or video chat consent  that I've previously talked about around one of the teams mentioned the challenge of trying to get somebody to hold up a consigned consent form on a video chat  and having to take the picture over and over again because the signature wasn't legible. And you just think about the burden that that poses on family members  of a critically ill patient at a very scary time in their lives. And then let's just talk a little bit about the stance towards science,  which changed a lot in my own personal experience in the medical intensive care unit between 2020, 2021, and 2022. And how approaching a patient or family for consent  or even as a clinician being asked, is this a patient or family who might be interested in participating in medical research and participating in medical research?  The diplomacy of that approach really changed a lot as the pandemic wore on.  So early in the pandemic, there was a lot of uncertainty around the right course of action, the right way to treat patients, but there was also,  that was coupled with a tremendous urgency. So there was a feeling that we needed to gather information quickly to save lives,  not only of the patients who were sick right at that moment, but also to save lives of individuals who would become sick in the coming months and unfortunately years.  There was a tremendous amount of fear, but also a sense of solidarity that we heard from a lot of our patients as we talked to them about research participation,  even people saying things like, I expect that it won't help me, but it might help somebody in the future.  There was a real sense of kind of selflessness and resignation amongst patients who were participating in the earliest clinical investigations,  but that evolved. And at a certain point of time, the only way you could access any COVID specific intervention beyond best standard of care,  best practice critical care was research participation, but that changed. And we developed FDA emergency use authorizations for certain interventions and therapies.  And by later in the pandemic, we also had the dichotomy of patients who were accepting of vaccines versus patients who didn't accept vaccines, patients who were accepting  of different COVID directed therapies and patients who questioned their efficacy or their validity. And so we experienced in the clinical units, weariness, but also wariness.  And it really escalated to situations of mistrust and even aggression against scientists writ large, of course, with clinician investigators being high on that list of suspect.  Individuals.  So thinking about how the pandemic changed things  and how all of these procedural hurdles occurred, it does cause me, both of us, both myself and Dr. Turnbull to reflect on who was kind of left behind  by all those hurdles that I've just described. You know, the investigators in one of the articles included in their discussion comments that whereas their consent form used to take  for a non-COVID therapy used to take 15 minutes,  about 10 minutes to go through and then another five minutes of clerical work to get it scanned into the computer.  It took on average four hours  once the COVID pandemic began. And so if you think about that, you know, 16 time multiplier and you think about burden and you think about the people in particular  who were disproportionately impacted by that burden, where does that leave us in terms of fairness?  So one of the solutions that we heard brought up repeatedly involved email and Zoom connections and video chatting  to get consent processes done. And in some cases that happened and worked well.  None of my studies used that. So I was doing a number of large cohort studies of adult ICU patients when COVID-19 started and we paused, we thought about the best way  to continue to do this work and ultimately we didn't end up using anything that included broadband internet access.  You know, just since you're probably wondering what did you do? We did work with our IRB and eventually they agreed that we could just call people at home  because we were enrolling people who had survived their ICU stays.  We didn't have to do it in the hospital at all, it turned out and it actually became a much easier process. So whereas in the past,  we would have had to track down their attending doctor, get their permission, then find a time that they weren't off having a scan  or doing something else and then do an in-person process that often took half an hour by the time you'd signed everything and answered every question.  We ended up just calling people once they got home, talking to them over the phone and doing everything as oral consent. Obviously that's not gonna work  for a lot of research projects, but since we were mostly at least at enrollment, just asking survey questions, just patient reported outcomes,  it was great, I have to say.  And it made me really wonder why weren't we doing this before? Why were we making this so hard? And often, asking a lot of our patients right before they were being discharged  at a time when they didn't wanna talk about anything except how to get home. And they'd already been asked to sign a lot of forms and we were just another person.  Whereas when we called a day or two after they got home, they were often very excited to talk to somebody from the hospital because now they'd identified questions  and now they had problems that they needed help with and we could address those problems and answer those questions and then say, hey, there are a lot of other people like you  here are the questions we're trying to answer through research, would you be willing to participate in this study?  So all that long story to say, even though we thought about it, we didn't end up doing anything that included the internet.  One of the reasons when we thought about it was that we were worried it would influence who could participate. So less than two thirds of households  in the rural parts in rural America have access to a broadband internet connection. Yes, you can sometimes drive somewhere that you get that access,  but that again is a pretty big burden. And it's actually not that different in many disadvantaged neighborhoods in urban centers.  And as soon as you're talking about excluding people from disadvantaged neighborhoods or rural parts of the country, you end up enrolling a non-representative sample of patients.  So consent methods that required internet connectivity could alleviate or exacerbate disparities. We don't know. There is this kind of alternative hypothesis  that if you're requiring in-person consent, especially for patients who lack capacity, we know from previous empiric research that kind of the more advantages you have,  the higher the income of your zip code, et cetera, the more likely you are going to be to have a surrogate who can sit full time in your room  while you're critically ill. And so if you're requiring in-person, you may be limiting yourself to patients who have a lot of resources  and therefore have a family member or surrogate who can take time off and sit there and be there. That wasn't our case, right? We were mostly enrolling people who had capacity  shortly before going home, but it's still something to think about. We don't really know the impact of using consent methods  that require good internet access. You may be alleviating or exacerbating healthcare disparities in research participation. So it's something to think about.  We don't know the outcomes, but I do think it's worth considering putting a lot of thought into when you're deciding how to work around restrictions on clinical research consent.  The other issue is that access to broadband internet is connected to age. So you can see from this graph, this is looking at 2000 to 2019, I believe. Yeah, that's right.  That across all age groups, access to broadband internet is going up. And if you are doing a study that's looking at 20-somethings you can assume they all have pretty close,  depending on where they are. But most people have broadband internet access.  Or at least they say they use the internet. That's different from being able to download a form, scan it, upload it and send it back. But most people at least access the internet.  That bottom line there with the smallest proportion of people who say they use the internet is still people over age 65. So if you're requiring people to be pretty internet savvy,  you are still putting yourself in a position to potentially exclude your oldest patients. And that was something we thought about a bunch.  So, you know, we've talked a bit about how consent changed during the pandemic. And there are, I think, lots of lessons to be learned  around how to be creative when getting informed consent in a way that doesn't exclude disadvantaged populations.  But I also think that you should think beyond consent. So thinking about the ethical obligations in research, what is it that we are tasked to do? And how can you do it  besides a long informed consent process? So obviously we need to respect the rights and dignity of our patients and clinician judgments.  We should be trying to provide optimal care to each patient. And we should be trying to avoid imposing big burdens or risks on patients. And burdens and risks are not just  what the intervention itself might do. Try to think beyond just this drug, how might it affect this patient? How might it affect this patient?  But all the other things they would have to go through to participate in research. We should be thinking about health inequalities. And that includes inequalities around  who gets to participate in research. Remember that, you know, whether or not we kind of like to,  kind of, whether or not we normally think about it this way because a lot of us still have that mindset  that became the norm following the 1970s of research is dangerous. It can also be true for certain fields, I'm thinking especially about like big oncology trials,  that getting into a trial means you get very good care. You're followed very closely. There can even be help getting to the hospital here sometimes. So if you can't access research,  sometimes you're not able to access kind of the best care. And we're not used to thinking of research as a positive thing that we wanna make sure people have access to.  We tend to think of it as a dangerous thing that we need to protect patients from. But in different situations, it can work both ways. And then there's an argument that I think  is increasingly has validity, especially in the kind of learning healthcare system, pragmatic trials world, that we actually have an obligation to learn  from all of that care we provide on a day-to-day basis, to continually try to be improving the quality of care and to conduct continuous learning activities.  And then of course, contribute to the common purpose of improving the quality and value of care for all. So your obligation is not just to get a consent form signed  it's to come up with a process that does these seven things.  Dr. DiMartino, do you wanna talk about what happens now? Yeah, I think we're gonna turn it over to Matthew too to help moderate a discussion for the final few minutes.  I think some reflections, we'd love to hear reflections from the audience about their own experiences, potentially have trialists within our audience  who can share some of their own experiences and reflections of what has worked well and what hasn't worked well, threats to the safety and wellbeing of their patients  and their researchers, their research staff. So Matthew, I think we'll turn it over to you and you can moderate the discussion. Yes, thanks so much. And a great job, both of you.  It was really informative and I myself benefited from hearing that discussion and different layers to the consent process and their various implications behind it.  So remind the audience that if you do have any questions or comments for discussion, please use the chat box on the side panel. We do have one question from the audience.  It is the use of datasets that has been approved previously by ethics committees for secondary analysis should be qualified as a minimum risk and not informed consent.  Is that correct?  So I can talk a little bit about my experience, which is that at least my experience has been that when you collect a dataset or when you create a dataset,  you are often deciding at that time what it will be available for. So there are datasets out there that are publicly available. They've been de-identified  and they were collected with the understanding that they would be used for multiple studies going forward in the future.  Secondary analyses are usually fine if no additional data needs to be collected. There's kind of a second process that happens where often there will be a question  within a consent form that says, if we think of new research questions we want to try and answer, can we call you back  or can we recontact you? And if that is not collected at the time of consent or enrollment in a study, then you can't, you know, if you're trying to do a secondary data analysis  and you think of one more question you want to ask, you actually can't call that person back to ask that additional question. So one thing that researchers I think can do  when they are designing their studies, if they think that might be of interest in the future is to add that question into the consent form. Can we recontact you in the future  if we think of a secondary question we might, or a secondary analysis that we might want to do that might benefit from just asking like one more question?  So in general, can you use an existing data set? Usually yes, but you need to check with the person who owns that data set as to whether it's been approved  for that use and often get their permission.  Great, thank you. The next question I have from the audience is, what is the driving force behind long burdensome consent forms? For example, IRBs, hospital lawyers, status quo,  and how do we change it? Clearly shorter consent forms are less burdensome and better understood by patients.  Definitely true. I mean, I think part of it is an understanding of why they came to be so long and written with such a stance, a legal kind of procedural stance  toward protection of the human subject. And that is embedded in our dark history as a profession of experimentation on certain individuals  and particular individuals from vulnerable communities.  And so that we carry importantly, and justifiably carry that residue forward of our past acts and how we learned  and developed a lot of what we know about medicine through the ways in which research was performed in the past.  And so particularly in the 1970s when there was a renewed interest in this, and I would say that egregious research behaviors did not end in the 1970s, unfortunately.  But there has been a sharpened focus and a real wraparound stance of IRBs,  Institutional Review Boards of protecting the subject or protecting the patient that has become the culture.  Although I know that IRBs are also interested in potentially increased agility and changing the way consent processes happen because there is a recognition  that those 20 page legalese forms are burdensome and confusing. And most importantly, maybe just don't convey the important information about what all is involved  in consenting to research participation. So it might convey the things that we as clinicians believe are most important in terms of, strictly thinking about the risks and benefits  of the pharmacology of the agent to which they would be exposed, but maybe is completely tone deaf to the other aspects of their participation.  I'm thinking again of trial participation for different antineoplastic agents where there might be quite a bit of burden on patients to return to a clinical setting  far more often than they otherwise would have. And potentially to even have follow-up testing, blood work or imaging that wouldn't have ordinarily  been necessitated by standard of care therapies. Some of which actually falls to the patient to pay. And so there's a lot that's kind of underappreciated  about what research participation means even by the principal investigators at times.  Yeah, I would add that like those long consent forms, they're protecting the hospital. They're not protecting the patient. And I don't know what the answer is.  I am not part of an IRB.  I don't know what those discussions sound like. I do think that one thing that kind of pushes on IRBs  is just kind of where the field is. So when investigators say, here are five other studies that have been done that have used this kind of consent on this kind of population  and they're published in great journals, why can't I do it? That can become very hard for an IRB to say no to, right?  If you can say, this is the standard in my field, here's how the consent has been done, that helps. So kind of the first person to do it successfully  and respectfully and not have it blow up and not have angry patients. If you can do it in a way that works,  that can quickly move the field, I think.  Right.  The next question is, what adaptations or changes to research practice made during the pandemic should carry forward?  I mean, I told you my story. I will never agree to do this in person again for just basic survey research for adults with capacity.  It doesn't make any sense. And not only was it burdensome to the patients, but it meant my research staff had to run around the hospital and track down doctors  and half the time they were in ORs and I was spending a lot of time that was money, frankly, for a budget, for a small research budget. So I think it's hard.  I guess I'm hoping that it will be hard to go back to demanding pens and papers and in-persons when there isn't a good reason.  Obviously, there are times when it has to be in-person,  but I'm hoping that we can, we remember what we've learned, that researchers for whom it did help, it allowed us to be creative and experimental  and to really think about what's really necessary,  to just point and say, hey, we've been doing it since 2020, it's worked fine. I don't understand how you can ask us to go back. It's also not a good use of resources  and more burdensome to my patients, no.  But I'm sure other people have other stories. And I realized that for many people, it was not something they ever wanna return to.  Yeah, that's great. I hope people populate the chat too if they have other examples, because I'd love to hear them.  Yeah, and for our audience members, one of the questions that the presenters were wondering was, what kind of adaptations did you have to make  and regarding the impact in efficiency recruitment and were any of the changes positive or worth continuing?  And while you guys contemplate that, just to follow up for our presenters, do you think any of the changes jeopardize patient safety  or perhaps the integrity or ethic standards of research?  You know, that's a good question that I've thought about this. And to my knowledge, I'm not aware of changes that were made that jeopardize patient safety.  I think there were probably changes that were made that jeopardize the legal procedural  kind of liability concerns of institutions and researchers, but on the patient side,  you know, it's hard for me to know, but I'm not aware of any. What do you think, Dr. Turnbull? I think my greatest concerns have to do with visitor restrictions  and, you know, being asked to consent to something in a clinical setting when you're sick, it's hard, you know, there's just an inherent power differential there.  As long as one person is sick and one is well, one is standing up and one is lying down. Like you just, you can't get past that. And as much as we try, it can be coercive.  And so I tend to think that if you have a healthy family member at your side, you're just a little less likely to feel like  you can't say no or you can't say yes or whatever it is. Then if you feel like I've got somebody in my corner who I totally trust and will stand up for me  if this gets ugly or somebody doesn't like my answer. So I think my only reservations are around the visitor restrictions, not around the consent processes themselves.  Right.  All right. Well, again, thank you so much, Dr. DiMartino, Dr. Turnbull. This will conclude our question and answer session. And I'd like to thank everyone in the audience  for joining us today on the wonderful presentation on the changes to the consent process. And again, thank you so much, Dr. DiMartino, Dr. Turnbull  for your time and expertise in this presentation.  Thanks for having us. Thanks for having us. And this webcast will be recorded and will be available within five to seven business days. And you can log into mysccm.org,  navigate to the My Learning tab to access the recording. Please join us for the next webcast, Conducting Post-Hoc Analyses Using Clinical Trial Data  on Thursday, October 20th at 1 p.m. Central Time. And that concludes our presentation today.

Video Summary

The webcast discussed the changing models of consent for medical research, particularly in the context of the COVID-19 pandemic. Traditionally, the ethics of consent in research and clinical care have been treated differently, with research having more stringent requirements to protect patients. However, the emergence of the learning healthcare system has blurred the lines between research and clinical practice, leading to the need for a new ethical framework. The webcast discussed the challenges of obtaining informed consent during the pandemic, including limited access to patients, the use of video chat for consent discussions, and the impact of changing attitudes towards science. The speakers also highlighted the importance of considering the rights and dignity of patients, providing optimal care, minimizing burdens and risks, addressing healthcare inequalities, and contributing to the common purpose of improving healthcare. The webcast concluded with a discussion of the adaptations made during the pandemic and the potential for these changes to continue in the future. Overall, the webcast emphasized the need for a patient-centered approach to consent in medical research.

Asset Subtitle

Professional Development and Education, Research, 2022

Asset Caption

The highly contagious nature of COVID-19 necessitated the use of isolation for infected patients and those under investigation. Because of limited in-person interactions with next of kin and those with medical power of attorney, researchers had to find alternative methods for obtaining consent to conduct research among this highly vulnerable population in a time of rapid, intensive investigation of unproven treatments. This webcast explores alternative methods of obtaining informed consent using modern technology and legal and ethical considerations. Topics include:

Hybrid consent using both written and electronic materials
Electronic consent through web-based research tools
Opt-out consent

Meta Tag

Content Type Webcast

Knowledge Area Professional Development and Education

Knowledge Area Research

Knowledge Level Intermediate

Knowledge Level Advanced

Membership Level Professional

Membership Level Select

Tag Professional Development

Tag Clinical Research Design

Year 2022

Keywords

changing models of consent

medical research

COVID-19 pandemic

ethics of consent

research and clinical care

learning healthcare system

informed consent

video chat for consent

changing attitudes towards science

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