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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.
Hello. We are pleased to have two guests from the MRCT Center associated with Brigham and Women's Hospital and Harvard University drives ethical, actionable, and practical solutions for global clinical trials. They are an independent convener, bringing together multidisciplinary teams of expert stakeholders from industry, academia, advocacy organizations, regulatory agencies, and clinical sites to address critical challenges in the conduct and oversight of clinical research. The MRCT Center produces guidance to help sponsors design better trials, reduce regulatory risk, strengthen transparency and participant protections, and bring safe and effective treatments to representative populations. Our guests today are Willyanne Decormier Plosky and Blythe Chen. Dr. Dacormier Plosky is a program director at the MRCT Center and focuses primarily upon initiatives within the representation and research portfolio and has more than twenty years of experience in health systems and programming, monitoring and evaluation, and capacity building. Previously, has worked at Avenir Health, the World Bank, UNICEF, and Management Sciences for Health. We are also happy to have Blithe Chen with us. Blithe joined the MRCT Center as a research assistant last year.
Catherine Batsford:She supports the Reimagining Informed Consent Project, the Reproductive Health Project, and the Representation and Research Portfolio. Today, we're going to explore privacy in IRBs, informed consent, and the creation of a new toolkit by MRCT Center to help navigate these challenges. Once again, thank you for being here. And first, we do like to ask all of our guests to share a little bit about their career path. Can you each take a moment to tell us how you found yourself in this field?
Blythe Chen:Sure. I can go first. So thank you for having us both. As you said earlier, my name is Blythe Chen, and I'm a research assistant at the MRCT Center. I actually got into the field sideways.
Blythe Chen:I graduated in COVID and joined a translational research lab in Cambridge, Massachusetts as an administrative support member. And I got really interested in the public health aspect of the work and had a very supportive boss that allowed me to be very hands on. I volunteered at vaccine clinics. I supported a biostatistics workshop in South Africa and rounded in the hospital and realized that health services was a passion and interest of mine. I then went on to get my Miles per hour at Brown and specialize in health services.
Blythe Chen:And there, I supported a research group focused on collating data from nursing homes and assisted living centers with CMS claims data. So that really got me interested in the data side of this work. And the MRCT Center is a very natural continuation of my interests, and I'm just really happy to be working with Willianne.
Catherine Batsford:Oh my gosh, that sounds exciting. A fun career path.
Willyanne Decormier Plosky:Thank you, Catherine. It's so lovely to be here. I am Willyanne Decormier Plosky. And as you mentioned, I am a program director at the Multiregional Clinical Trial Center, which is the MRCT Center in Long Form of Brigham and Women's Hospital in Harvard. I would say that my career path, like many, has not been a straightforward path.
Willyanne Decormier Plosky:I started out knowing, even since I was a kid, that I really wanted to work in international health in some way. But when I went to my undergrad, I dropped out of pre med to do anthropology and history, completely thrilling my parents who were I was a first generation college student, so they were like, Oh my God, no pre med. And then when I got out, it's bewildering to try and find a job when you're coming out a major like anthropology and trying to sort that out. And I ended up working at Management Sciences for Health, which is a big international health organization. From there, I went back to graduate school to Yale to do my master's in global health.
Willyanne Decormier Plosky:And then I started working at the World Bank and very quickly was thrown into some very high level international work. The country level, hundreds of millions of dollars for budgets and really extensive programs, really, and also working the beginning of the launch of antiretroviral therapy in Africa and kind of really getting to work with some interesting things. At which point, my husband got his residency in Connecticut. So we were like shifts passing because I just had left Connecticut. So I had to leave my job to go kind of continue my marriage and I was also pregnant at the time.
Willyanne Decormier Plosky:So I ended up working at Avanir Health, which is in Connecticut, also international health, but more on the modeling side, which I'd never done before. So basically, they develop models for countries to predict their population curves, their epidemics, their reproductive health strategies, and it really helps them think through all of their different planning aspects, which really was helpful to me to understand what underpinned a lot of the global health decisions we're making at the higher level at the World Bank. After I concluded my time there, after, well, I'd say about ten years in, I went back to school mid career to Colombia to do my doctorate in global health with two young children and a three month old infant.
Catherine Batsford:Oh my gosh.
Willyanne Decormier Plosky:You asked me about the ten years after that, I have pretty much zero recollection.
Dan McLean:So it sounds like you got a doctorate in multitasking as well.
Willyanne Decormier Plosky:Yeah. Yeah. With a surgeon husband and three young children, it's no joke to do a PhD program and just advice to anyone out there. The best advice I ever got was just get through it. Do your dissertation on whatever you can do and just get it done.
Willyanne Decormier Plosky:But then a friend had sent me this job posting from the MRCT Center. And at first, I wasn't even going to apply because I had no background in clinical research. I'd done kind of the opposite end when medications are developed, how to get them into health systems, how to set up a behavior change program so people might want to adopt to those therapies and things like that. So it's been a real interesting learning curve and just it's always every single day is incredibly interesting. And I'm thrilled to work with such thoughtful people, whether at the MRCT Center or across pharma, across academic institutions.
Willyanne Decormier Plosky:It's really just been a wonderful kind of, if you're a good nerd like I am, you're like a kid in a candy store with all of the different interesting questions.
Catherine Batsford:So how did you get interested in the privacy protections portion of the work that you do?
Willyanne Decormier Plosky:Well, I'll just start by saying, this is Willy Ann, that this has been percolating at the MRCT Center for a while. Our faculty director, who is incredible, Doctor. Barbara Beer, she is in a leadership position for Smart IRB and has always been talking with IRB leadership around kind of potential issues that they're challenged by. At the same time, so that's been happening over the last, I'd say, at least three to five years pre Dobbs decision. At the same time, we've also had a pretty large and evolving representation of research portfolio, which even predated accelerated during COVID.
Willyanne Decormier Plosky:We had launched in 2020 a large guidance document. It's about 400 pages on representation of research that address kind of populations in general that are underserved. And since that time, we've been focusing on specific populations and what maybe their specific needs are. So we've looked at, for example, LGBTQIA plus inclusion, people with disabilities, and we've been thinking about pregnant lactating populations. This has been coming together.
Willyanne Decormier Plosky:And I'll just say at the same time, we had a wonderful intern who'd been working with us since she was in high school. Her name is Eva Glazier. And she had been working, starting the work with Barbara to start feeling out what some of these issues around privacy might be and especially privacy protections in pregnancy. And she has worked for a long time at the MRCT Center, but has since taken a new job in the last, I'd say, year. But she's been an integral part of the work as well.
Catherine Batsford:So, Bly, what are some of the privacy questions that have come up as you've started delving into this protections for people who become pregnant during a trial?
Blythe Chen:That's a great question and something that, as Willianne said, Eva was starting to dive into. I would point you to the paper that the center recently published at the end of February of this year called Disclosure of Pregnancy Related Privacy Risks in Clinical Research Post Ops. Some of the sources that we talk about in this paper note that there is about a two percent rate of participants of reproductive potential that get pregnant even when following contraceptive guidelines in clinical trials. So it's still an important thing to note that despite adherence, this can still happen. Some issues that might come up in clinical trials have to do with uneven legislation across The United States.
Blythe Chen:After the Dobbs decision came down in 2022. There is now an uneven patchwork of laws regulating reproductive health across The United States, which means that participants in the same trial might be subject to different laws across states. So if I'm participating in a clinical trial and I'm in Rhode Island, someone with my exact same makeup might be subject to different rules if they are participating in another state in The United States. So this could open data up to different risks. Part of the challenge, just to say, is that, as Blaythe mentioned, about one percent
Willyanne Decormier Plosky:to two percent of participants of reproductive potential who have the potential to become pregnant do become pregnant during a trial. So it's not a huge number, but it's not a zero. And for that reason, and because in clinical trials, you're testing sometimes products that could be harmful to either the person who's pregnant as their body changes during pregnancy or to the developing baby or fetus. So clinical trials want to be very careful to make sure that they're protecting the safety and well-being to the greatest extent possible. So to do that, in clinical trials, in most study protocols, you'll see that there is a contraceptive section in the eligibility criteria that they put in there that study participants must be using usually one, sometimes two forms of contraception.
Willyanne Decormier Plosky:Sometimes they specify that it must be like a long acting method. There's different kinds of specification depending on the trial. Or that they will be abstinent or some form so that it lowers the risk of them becoming pregnant during the trial. That said, some participants do become pregnant during trials. And so on top of the contraceptive requirements, there's also often pregnancy testing requirements, sometimes at various stages during the trial.
Willyanne Decormier Plosky:So sometimes it's before at screening, which is basically before the trial even starts, before the person even signs on to be part of the trial. They are out there, goes through something called screening, which is when you're kind of determined if you're eligible. At screening, sometimes there's a pregnancy test given. Then there's also sometimes a pregnancy test, what we call day zero, right before the trial starts, then sometimes at different points during the trial. These pregnancy tests can sometimes be done at home.
Willyanne Decormier Plosky:The person can do a home test or take a test on their own. Sometimes they're done in a lab. But regardless, there's often a contraceptive requirement and a pregnancy testing requirement for people who can become pregnant during clinical trials. So once the Dobbs decision came into effect and we have these varying state laws, now we have a situation where you're collecting pregnancy data on participants, storing that somehow. And then usually you want to be communicating after screening and when someone's about to sign up for a trial, they go through another process called informed consent.
Willyanne Decormier Plosky:So this is when I'm talking, I'm sure, to the Premier crowd, they probably know what informed consent is. But if there's some students out there who are interested in clinical research, informed consent process, it's meant to be a process where the research team and the potential participant discuss documentation called an informed consent form. And it's also just opportunity to ask questions. And in that form, the research team is supposed to go over the risks and benefit of the trial and things like the trial schedule, but they're also supposed to talk about any kind of privacy issues. So what we were concerned about is, do these informed consent forms actually contain any language about potential privacy risks for pregnant participants in the light of this Dobbs decision, where some states may be scrutinizing people who have pregnancy, whether it's pregnancy to term or pregnancy loss, kind of having that that process under a little bit more potential attention.
Dan McLean:As you've talked about, the Dobbs decision, just to to put it out there, this is not news anymore. This is a 2022, as people know, the supreme court overturned Roe v Wade, and that changed the laws across the country, and that has been evolving ever since. And I was trying to remind myself where we were in that state of play now because it does constantly change. So Encyclopedia Britannica has an update, and they said as of March 26 so March 2026, so just last month, 13 states have enacted a total ban on abortion with few exceptions. They also go on the state.
Dan McLean:The landscape of abortion rights is in flux with each new election cycle, state legislative session, and the court decisions and round of court decisions. So that's the world that we're living in with a whole evolving set of laws. So then you're facing a challenge with the human subjects research trials that are national in scale in some, but not all cases, I imagine. So I that's the question I have is, you know, we have a big country. So in some ways, is it tempting for researchers and IRBs to say, you know what?
Dan McLean:Let's not run this in right now this list of states, and what is the downside risk to the trial if you did that? So I don't know how researchers and IRBs are managing this challenge, and I think in part what you all are trying to resolve.
Willyanne Decormier Plosky:Well, I would say that I can't really speculate on what researchers are planning that way or what's entering even into their calculus. But I will say that in the paper that we published led by Eva Glazier and the New England Journal, Kathryn, you mentioned the questions that are coming up. And there's a table of questions within that paper. And the first question is really asking, what are the laws in your state? And as you just said, Daniel, that is in flux, I think, continuously.
Willyanne Decormier Plosky:And so it's something that was one of our strongest recommendations is that when you start the process of developing your study, that you discuss this with legal counsel to understand what really are the current laws at the state level, what are even the organizational policies at your own organization? But really trying to understand what also is this a multi site trial as Blythe said, that's particularly important. Is there really understanding the privacy aspects there if there's data sharing sites, states with medical records. So just really trying to understand your sort of ecosystem there around what is the legal landscape and what is your data landscape look like?
Blythe Chen:So a lot of this legislation varies. We also noted that data can be in multiple states at the same time if it's part of one trial. And some of this legislation is more punitive towards clinicians or places that are providing care. So it's really important for not only participants to understand the risk that they might have entering into a trial with data. But it's also important for researchers to think at the outset and to really dig into what is the most current legislation in their geographic area, what are maybe their institutional rules that have been set out as a response to some of this new legislation, what is the IRB requiring they address, and some of the tools, not to jump the gun, but the tools that our center is putting out really guide researchers through the process of thinking from both sides.
Blythe Chen:What do we want to present to the participant about their level of risk in entering a trial, but also what do we need to address with the IRB in terms of what's acceptable for our data and how we're storing it and how it's collected and when it's collected. As Lillianne said, pregnancy is monitored at screening, but also throughout a trial.
Catherine Batsford:We would love to hear more about the toolkit so the participants can learn more and then the IRBs can learn more. So if you'd like to dive into that, we'd love to hear more.
Willyanne Decormier Plosky:Yeah, I can talk a little bit about that. But first, I'd just like to say one thing that I didn't mention was when we were at the beginning when we were talking about how we sort of got interested in this and some of the progression, recently, there's been more attention towards inclusion of pregnant lactating participants in trials because the recognition has come, thankfully, that we really need to protect women and people who could become pregnant through research, not from research. There's an estimated ninety percent of people who are pregnant take over the counter medications during their pregnancy. I don't know the statistics on prescribed medications, but me myself, I give this example, but when I was pregnant, I had severe asthma. And the doctor said, well, I said, should I take my medication?
Willyanne Decormier Plosky:These are really strong steroids. And they said, well, we don't know, but we do know that you need to breathe. So you're left in a quandary when you're pregnant. Do I take this? Do I not take it?
Willyanne Decormier Plosky:There's no information. And isn't it much better to be understanding the risk and the efficacy in a controlled environment like a trial where you have access to your doctors, the risks and benefits have been really thought very carefully about by the physician, then just taking that out in the real world and just hoping for the best. So there's been recently the International Council on Harmonization of Technical Requirements for Pharmaceuticals, the ICH standards, put out draft guidance on inclusion of pregnant participants in clinical trials that the FDA posted for public comment. And we also commented on those as well. But just to say that, so there's a push for inclusion, rightly so, of pregnant lactating participants.
Willyanne Decormier Plosky:But then there's also these challenges that are coming up with in the legal sphere. We've been developing a toolkit, the Pregnancy Privacy Protections for Participants Toolkit, P4 for short. It's going to be a series of tools. We have in draft three of the tools. What it's intended for?
Willyanne Decormier Plosky:The primary audience is for researchers and IRBs. So the first two tools, and hopefully we can circle back to this first one in a few minutes, is called recommended language for informed consent forms. So we talked about ICF forms, and this is guidance for researchers on pregnancy privacy protections. And what it is is it proposes a very short form or longer form example language that you could put into informed consent forms. Then we have a local context form to really support researchers and IRBs in thinking about the local context.
Willyanne Decormier Plosky:There's often a local context form that they fill out, but this adds the layer of really thinking about what are, Danielle, as you've been really getting back to, what are these laws and what impacts do they have? Do we have to mandatory report on pregnancy? What is that conception? And then the last one is privacy protections considerations for pregnant participants. So this is to hand out to pregnant participants.
Willyanne Decormier Plosky:It's not meant to be the tool is supposed to go to researchers and IRBs for them to adapt to their own local context. They can take the text, adapt it, put it in their own formatting, and then give it to participants. It's not meant to be given wholesale because you really do need to understand what your local context is, but it gives some guideposts. And really, that goes through things like, why should I report a pregnancy? Can the study medication potentially harm my baby?
Willyanne Decormier Plosky:What kind of data do they collect from me? Should I stay in the trial or not? Depending on what the risk level is, will that be discussed with the team, and some questions for participants to ask the researchers. So these three tools are in development and hopefully will be launched within the next month to be public. And then we'll be continuing to work on additional tools as we talk more with our whole ecosystem that we talk with about what would be most valuable in terms of the tools that we develop in the future.
Blythe Chen:I think you brought up some interesting points. And I just want to add that our toolkit sits at the convergence of the recognition that pregnant participants should be better included in clinical trials research And also the legislative context in The United States is evolving sometimes very quickly. And so our goal is to provide resources for clinical trial teams and also IRBs to meet the challenges of the present day field.
Willyanne Decormier Plosky:Just to say, we're not lawyers, we're not giving legal
Catherine Batsford:guidance. Just really kind of
Willyanne Decormier Plosky:thinking prompts to really stimulate kind of this thinking about this issue and how you might navigate this, you know, within your own context.
Dan McLean:To that end, with the staying abreast of your own state laws, so does the toolkit have the updated versions for states a, b, and c, or is it just is it more of a guideline of contact legal counsel at your institution to ask them to do their due diligence? Is that the way it's set up? It's just helping you find the path to get the most accurate and reliable information. You're not setting yourselves up as the hub of legal advice and guidance here.
Willyanne Decormier Plosky:Yeah. That's correct. Yeah, we just we do I think we do. I don't I'm not entirely sure if we still have this in the toolkit, but I think we do reference a map by I believe it's the Guttmacher Institute, where they have a map of kind of current legislation where folks can go to look at that. But other than that, and that's just really mentioned as a reference.
Willyanne Decormier Plosky:It doesn't supplant the need to really have these kind of in-depth discussions with your team, with your organization, with your legal advisor. And really, the toolkit is more, as I said, it's really just a prompt thinking about these issues, really thinking about what are the issues in informed consent. We have a number of questions that really came up as we were thinking about the informed consent process. So questions like, Okay, this is a relatively small population, one to 2%. The informed consent forms are usually quite long and dense already.
Willyanne Decormier Plosky:Some are 40 pages, 60 pages. When you add additional text to that, it makes it even more complicated. So how much additional text do we want to add for a population that might be small? Is it necessary to do a lengthy for something that's only going to be needed by a smaller population of people? So that question around the density of length, the other questions are around, when do you provide this guidance?
Willyanne Decormier Plosky:As I said, some of the pregnancy testing is before the informed consent, sometimes in some trials. So when do you provide this? Do you provide it at any time someone is tested? Before they're tested? At any point during the trial, do you provide this information?
Willyanne Decormier Plosky:There's other questions about format. We all struggle with this in informed consent right now because they're so long and they're What kind of formats are you doing? Are you thinking about this in terms of just the paper format, the discussion? Are we moving into an app format? And how is Once that you move into sort of breaking down the informed consent into kind of modular formats, where would this really fit?
Willyanne Decormier Plosky:Would it disappear when you start bringing things up into a really high level? So there's a lot of just trying to really think about the nuance of really making sure that people are understanding.
Catherine Batsford:Yeah. How to do this best. For a researcher, an IRB member listening right now, what is the single most important thing that they should be doing differently today to protect these participants?
Blythe Chen:Have a plan to communicate with participants. The reason that I think we've been talking about this, and WilliAnn, feel free to chime in, is because we recognize that there is a gap in current practice regarding informed consent and what people might be aware of when they decide to join a clinical trial. I think that this toolkit really strikes a good balance between addressing risk and helping people develop a plan as they think about how to run a study. The fact that we have information for participants that's really rooted in plain language, which is something that MRCT Center also focuses on. We have a clinical research glossary that helps participants understand at their level what might be really important.
Blythe Chen:That is also integrated into this work. We have amazing informational designers who have helped us take text and information that we developed and also present it to participants in a way that's easy to understand, and also to present to researchers developing a protocol for an IRB, and it helps sort of guide them through the work. I think it's an under discussed topic currently, and my number one advice is have a plan.
Willyanne Decormier Plosky:I think, Blythe, I really loved when you said recognizing that there's a gap. I think that's step one is recognizing that this really hasn't been thoroughly thought about yet and discussed. When we were developing the toolkit and we were doing some research with some interviewees at IRBs and they would say, Gosh, we really haven't thought about this before. Or they thought about it, but hadn't really thought about some of the nuanced issues within that. So I'd say kind of recognizing that there's a gap, having a communications plan and also really thinking about what your data plan is.
Willyanne Decormier Plosky:Because when we're talking about data and really mapping your data, so that includes really thinking about what sources, what tools you're using to collect data, to transfer data, to store data, to analyze data, who's using those tools within the infrastructure? So not maybe just the participant, but the research team, the labs, the insurance. What is sort of this map of your data use? And then really also thinking about what are the security provisions within those? What really is the secure?
Willyanne Decormier Plosky:Are those secure up to hospital standards? Do they have cookies? Do they sell data to third parties or fourth parties? So really trying to think about, this is rapidly evolving, right? I'm not go into or presuppose what different programs have or don't have or anything like that, but just to say, to really think about what is within this, when it's probably starting to look like, do you know when you're on those meetings and they have those nodes and they go off the word maps or word clouds?
Willyanne Decormier Plosky:This is probably what the data structures are starting to look like. And really thinking about where you might have, I would say, that potentially are privacy gaps that users might not really know about from the outset. So you want to be as clear as you can be with participants to the best of your knowledge, I think.
Catherine Batsford:And that in the end protects everyone when we know where the data is and how it's being used. You're protecting the most vulnerable first, but I participants would benefit from it.
Willyanne Decormier Plosky:Absolutely. So
Dan McLean:I made a couple notes as you were going along. It seems like that if you're trying to encourage people to participate in a trial, they have whatever concerns they have regardless of what type of human subjects research trial it may be. And I take the communications point. I think that's dead on, and that's something that we've heard as a recurring theme throughout a lot of these conversations we've had on the podcast is speaking with people about the research in an understandable way, and that helps build trust as you go. So I think that makes total sense.
Dan McLean:For some of these where then you're you're asking participants to take pregnancy tests, that's another layer, and then it immediately makes you wonder what's gonna happen to that data. And then if you happen to be in a state where that data may cause potential legal ramifications, I can see how some people may say, you know what? I don't I'm good. I don't wanna participate. So I I'm just wondering how you can help get people over that hurdle and say, we we are protecting your privacy.
Dan McLean:We are trying to encourage a broad group of people participating. And I don't know what the answer is. I don't know if the toolkit provides a path for IRBs and researchers to help navigate some of that. I don't know if certificates of confidentiality are effective in any way or if that is something that MRCT has considered. But I just throw that out there is how do you both communicate and also not scare everyone off?
Blythe Chen:Well, a core tenet of informed consent is that it's freely given and can be revoked at any time. So ultimately, it always comes down to the participant as to whether or not they want to continue on in a study. But making sure that they have the most information available to them is, in my opinion, it's empowering. I that don't more information would necessarily dissuade participants.
Willyanne Decormier Plosky:There's so many different things in clinical trials beyond pregnancy testing. There's many aspects of clinical trials that may be concerning to a potential participant, many things that may be enticing to a potential participant. And that's why think this, why we started this conversation on the toolkit about informed consent, because it is so important to have we do the best we can, right, to communicate what is happening in the study and what are the risks and the benefits. And in terms of data collection, there are privacy sections that do state that the team does the best of their ability to, in plain language, we would say not encrypted, would say something like that you get a code number or something that you're not identifiable and different kinds of ways to really say clearly in an easily understandable way that there are potential privacy risks but that the team does do the best that they can to protect your data. And there's even discussion now, I'll just say, around secondary use of data.
Willyanne Decormier Plosky:This is becoming discussion point as well for further use of data. How do you inform people about that? When do you inform people about that? So in a way, this discussion is mirroring some of the discussions on other topics within clinical research. And it's just to say that really trying to be thoughtful about what participants may experience during the trial, what they may be concerned about during the trial, and what you want to be able to communicate to them in advance is helpful.
Willyanne Decormier Plosky:And to have tools that not just the informed consent, but to come back to say that this informed consent isn't just a piece of paper. It's a process. You might need supplementary materials. You might need further discussion. And one of the things I've also been focusing on a lot because we work closely with inclusion of people with disabilities is that you're always just trying to make sure that you're inclusive of accessibility and making sure that the communication is done in a way that anyone would be able to access that kind of communication.
Dan McLean:On the toolkit, did I hear you say that there's four components and three are just about done and you're in the process of completing the fourth. Can you share a little bit more about that timeline and what comes next and how people may be able to access it?
Willyanne Decormier Plosky:Yeah. Well, we'll have I think, Danielle, in our initial discussions, we said we were going to have four for initial So initially, we were going to have the informed consent, the local context, and then two patient facing materials. We decided to combine the two patient facing materials into one. So that's why three are coming into launch. So we have three starting out.
Willyanne Decormier Plosky:We have some initial ideas on, I would say, a few more, like two to three. But they're in a very early stage. And we're still really trying to scope out what would be most useful to research teams and to IRBs. I think some of that discussion, it'll be interesting to see actually how that discussion evolves now that the paper came out in the New England Journal. We're actually working on several other publications that are related.
Willyanne Decormier Plosky:And then the launch of the toolkit, when there's a bit more awareness around this gap, the questions that we're going to get from our colleagues that are in IRBs and even questions that may come from participants or folks that are at academic research organizations. So we don't want to kind of set in stone right now what those next few are going to be, but we should I would say the timeframe for that would be maybe within another year or so from the first three initial launch, but it's going to depend on the questions we get and how challenging they are, how naughty they are to really kind of work through a little bit.
Dan McLean:Is there a spot on your webpage where people can get updates if they wanted to follow along?
Willyanne Decormier Plosky:I would say the best way actually people can get updates is to sign up for our newsletter. So the MRCT Center has a regular newsletter that we put out once a month.
Dan McLean:Great.
Willyanne Decormier Plosky:So you can see in there, we post not only things that have come out, but sometimes things that are in the pipeline to let people know. And usually, pro tip that sometimes before the launch of materials, start hosting webinars on these kinds of topics to kind of gather information and discuss among colleagues. So when you start to see things like that popping up, sometimes there will be materials forthcoming depending on the priority for all of our colleagues, what they say the priority is for the topic. But yeah, there's the newsletter, and then we have on our website, we post when we have new materials on there. So for example, the comments that we submitted on the ICH E21 proposed guidelines are on there, and the paper that we did publish is on there.
Willyanne Decormier Plosky:And then you're free to explore there's so much more on the website. Blayde mentioned, the Clinical Research Glossary, and then there's a whole section on health literacy. If you're interested in trying to do anything involving plain language or there's just so many sections, there's a whole other section on pediatrics. So there's a new project on AI, which everybody's interested in. So,
Catherine Batsford:yeah. Well, thank you so much for joining us. Dan, did you have any follow-up questions?
Dan McLean:No, I didn't. It's really, really interesting and it's an important topic and I'm glad that MRCT is helping come up with a way to help people navigate this. So thank you for being here and helping share this and highlight some of these issues.
Catherine Batsford:Yeah, absolutely. And we hope that women keep participating because like you said, it's so important for research that we're part of it. So thank you so much.
Willyanne Decormier Plosky:Thank you for the opportunity to be here.
Blythe Chen:Thank you.