This is being provided in a rough-draft format. Communication Access Realtime Translation (CART) is provided in order to facilitate communication accessibility and may not be a totally verbatim record of the proceedings.
MAYA SABATELLO: Hi, my name is Maya Sabatello. Associate Professor at Columbia University. Long time disability rights advocate. Community member as well. My research focuses on health disparities with particular focus on inclusion of people with disabilities health research including the sort of new type of research on the block, which is medical research we'll explain more about that soon as well. This is my fabulous team here. I'll let them introduce themselves. I think it will be easier. Kate.
KATE PEGLOW: I'm Kate. I work with Maya. I received my Masters of Public Health at Columbia as well in May.
MIKA BAUGH: My name is Mika, I'm not at Columbia. I'm from Indiana University. I'm a Ph.D. candidate there. Sexual reproductive health. I'm also on this research team. it's really a great lens for me.
KREENJALA PYAKUREL: Hi, my name is Kreenjala. I'm also a part of the team. I joined in June with Kate. Recently graduated from Clark University in biology. Very excited. Good to see you all today.
ATTENDEE: Michael Bean, lawyer in San Francisco. Do a lot of work on behalf of incarcerated people with disabilities. And also working on other healthcare related issues, including challenge to physician-assisted suicide.
ATTENDEE: I'm Amanda. I'm with Disability Rights Section Department of Justice.
ATTENDEE: Hi, Jennifer, American Diabetes Association, attorney with advocacy program.
ATTENDEE: Angelica Williams, Community Outreach for the United States.
ATTENDEE: Hi, Cheryl. I am also trial attorney in the disability rights section of Department of Justice. I work with Amanda and Angela.
MAYA SABATELLO: Fabulous, so many of you guys here. We're going to craft the policy.
[ Laughter ]
People with disabilities are included in health research.
ATTENDEE: Let's do it.
MAYA SABATELLO: Exactly. I will admit I also am a lawyer in my past. So, I have done litigation in medical malpractice cases before moving to advocacy, so I think we can have great conversation.
So, we'll start with our presentation entitled "Impact of Ableism." This is based mostly on, research we're conducting at the Columbia University involves folks with disabilities as well as blind, low vision, deaf and hard of hearing individuals. And we'll share some of the findings that we learned trying to think about inclusion of people with disabilities in research in order to increase ultimately health equity.
So, Kate, can we go to the next slide? Just kind of, I got to have my announcements serving on review board all of us research program. National program for research. Everything we say smart or not, is in our personal capacities take it as such. We're sharing here information that we haven't published yet, larging of it broader audience. So keep it as confidential as possible. Some very general background which I'm sure that many of you know of course people with disabilities are pretty large group. Sorry, Mika. Go.
MIKA BAUGH: folks with disabilities are not little tiny group, we, I'm blind person. So, you know there's a lot of folks with disabilities in the United States. 26% of adults you can find different numbers for different reasons. We're here and here to stay. In that population we have disproportionately high prevalence of lots of things amongst marginalized communities, anybody in America or the US or world could be disabled.
But we do see a lot more folks with disabilities in those other marginalized communities for lots of reasons.
What that means low social determinants of health, I don't know, we call it social determinants of health. Like employment, low income, living in places that aren't walkable, having, low education, all of the things that are outside of your physical body that affect your health.
And when you have that, we have folks in marginalized communities all these other difficult things that happen that leads to limited access to routine care preventive care. Any sort of medical care. Then, because we don't have medical care that we need then we have high proportion of chronic diseases, that's really sad story I just painted for you all, that's where we're at. That's why we're doing this. Go to the next slide. Great.
One way to fix that or work on that through health research we can improve health knowledge and theory if we have better health knowledge we have better health outcomes. So, we need health research to like I said improve understanding of prevention and diagnosis and treatment for various diseases and conditions. Need to provide insights into drugs they were informing clinical decisions increase generalizable knowledge about causes of diseases and they were, that's important one to increase generalizable knowledge important for you to know your own personal health information also for communities and folks with disabilities other marginalized communities having that general community knowledge is important as well.
One way that we're working on that research is through precision medical research.
This is new kid on the block. New sort of research aims to identify tailored approaches. So, this is based on you, your biology, environment lifestyle. In this way, we can learn based on people, what's going on, then tailor treatment and diagnosis and they were to that person as opposed to just Joe Schmo that might have this condition. Holistic data collection. Person centered, focusing on chronic health conditions not necessarily we see a lot of studies what's the cause of blindness how do we solve this, I use blindness because that's my disability, it's focused on chronic health conditions how do we help folks have higher quality of life whatever treatment they need based on themselves.
So, yeah, focused on return of individualized results. With this kind of research, you are getting information about yourselves and you are actually getting results returned to you huge component of this a lot of times I don't know if you all have gone to the doctor you get tests done you don't necessarily get the results you only get the call if there's something wrong. This is intentional return of results to the individual person.
Then also, this is something that's open to the general public. Not just studies as on say somebody who has cancer you are eligible to be in the study because you have cancer. Precision medicine research is open to healthy folks, less healthy folks all the folks we're trying to learn about everybody's individual body not just the one body that got cancer over here.
If we can do that, do this in a way that's person centered holistic, and sort of does research in the right way, then we're going to promote health equity people with disabilities and everyone else are going to have better overall health with that I'll pass it to Maya.
MAYA SABATELLO: One more thing about precision research really it aims to the beauty of it from disability perspective is that its a step away little bit constant focus on disability and really look at the other interactions that happen to individuals. In cancer treatment very much actually ( ) if you think about tailored drugs for cancer, actually targeting the cancerous cells rather than the person. So, that's one of the greatest areas of precision medicines research in terms of its ability to really reduce mortality and death, but also part of the return of results option is really to encourage individuals to understand their genetic risk and act on them to reduce, by changing environments, increasing physical activities taking other measures to reduce worse health out.
Plays out really inviting everyone to participate you can do many many studies with this data we're collecting. Can target specific diseases, I know you are working with die had diabetes community a lot of work to identify components that lead to folks have diabetes. Same thing with cancer and cardiac conditions kidney disease and so forth. It doesn't necessarily focus on the disability per se, being blind or deaf it could. Gene therapy for deafness has been part of the conversation.
Important thing is really when thinking about how we create, do health research important that we have diversity, there's some reason that was mentioned ill proving understanding of health and diseases and health outcomes, much better if we can have diverse people know findings specifically for large corporations not just for certain populations. Some studies, especially clinical trials focused for example only on men, which for them when you translate into clinical settings give same medication to women doesn't fly. Same thing sometimes you have with different folks with different genetic conditions, they might not respond the same way as others and if they were not included in studies of course they are not going to know what to do.
In terms of cost start with health disparities sicker we are costly by not including people we are not able to increase more labor and productivity and ensure people are healthier. Including again diverse population huge impact trying to create better health on population level not just individuals but targeting entire communities, there is whole area of presession, focuses on community level. There's issue of trust that is important for why we need to have diverse population. If people like me are not included in studies, there's question do the findings apply to me?
How do I know that the drug just developed is legitimate, how do we know recommendations suited for me? If people like me, however like me is, are not finally issue of, we're thinking about hell as outcome there's going outcome consideration or discussion around the fact it’s being part of, you'll have responsibility to act on your health risks but also have to play part of that process and in fact if you are excluded and it’s not personal choice to be, if you are excluded not by choice then taking away your health or biomedical citizenship I think research participation in many ways is part of being included in society judgment like everyone, everyone else can participate. If you choose to you should be able to.
Again, I think when looking into studies, if you can go to next one, looking at studies have been conducted with people with disabilities who have mutually excluded from health research, or general health research, they think about value of participation and research beyond their own benefit, right most people think about that. But people with disabilities in particular also think about that type of research participation, something that indicates that they are part of society. They are equal members of that society. This is quote from a study done with adults with intellectual disabilities, the quote is basically I think that's one of the participants, intellectual disability [ reading screen ] that sense of personal worth with ability to participate in research again if you choose to. And I think also in our stud study we keep hearing hey we just joined because it was about people like us who wanted to make sure we can contribute to the conversation.
I also say that it's not only diverse inclusion good for science best practice, legal requirement. If looking into diverse existing, for example, at the NIH Revitalization Act of 1993, focuses specifically on women minor, there are other policies focus specifically on inclusion across life span, that is children to adult, elderly there's expectation that diverse populations will be included in research in health research. That really has been predominantly applicable in context of gender, mostly sex, we haven't reached out gender yet, sex differences, racial groups, ethnic groups and again across the life span. With argument that specifically prohibiting exclusion without scientific justification because, or cost is not acceptable. Also requiring that those who conduct clinical research and health research actually, the court about gender racial ethnic diversity as well as age of participant.
2016, 21st Century Act was enacted that act expended same requirements of reporting inclusion to precision medicine research. If you've noticed, I just mentioned do not specify disability, clinical trials not actually requires to provide information about disabilities, same thing with any health research there's no national requirement by NIH to provide that information. Which means that they are often excluded. We've done studies we know they are excluded consistently based on perception about ability, perception that having disability means that you have confounding factor.
We do have disabilities, my argument is that looking into the kind of whole body that we have, Americans With Disabilities Act, asp forwardable care act, very specific requirements of ensuring accessibility, accommodations equal treatment in public services, which my argument is that whenever we have university, Medical Centers that receive federal funding for research, they should be required to include people with disabilities in those studies.
Affordable Care Act requires taking steps to ensure examination of equipment, data collection, really trying to increase overall quality of healthcare for this population. Again we've got to have those folks in. We know that from practical perspective they, there's no reporting requirements, again very limited.
More than that, we actually know specifically with regards to precision medicine research we actually know they are under, under included mostly excluded. This is study that we've done to look at blind low vision and deaf and hard of hearing individuals in research program. Largest national precision research program. We focused on participant who provided medical records, folks who provide really broadest type of information for learning about them, then learning about how to improve health outcomes, we compared with national, presentations in cohort research program versus representation on national level.
Kate, if you can advance to the next slide.
What we found quite significant across the board under representation blind and deaf people all of us program, both across populations we found most the people with disabilities on that cohort, elderly over 65 and over represented. But we also have under presentation of women, under representation of racial and ethnic minoritized groups. Even though cohort is highly racial and diverse. This is most diverse racial ethnically diverse cohort that exists in this country, it has more than 51% folks who identify as minoritized, but when it comes to folks with disabilities even there we have limitations.
We have disproportionate number of people highly educated with high income included but not those from poor, and of course intersectionality matters meaning those who are blind, Black and women are least represented. When we looked at those intersections Black, blind women are represented cohort only about 20% what they should have been, for practical matter any researcher take this cohort try to do anything they will not be able to study that population Indigenous not included.
So, what are barriers why that, why do we have underrepresentation? Obviously, hard to know for sure we haven't, we cannot ask those participants in that study. We do know there are access issues, likely as well as that per sick tiffs, issues, might be issues of trust. This is kind of where our study begins and I'll give Kate the stage.
KATE PEGLOW: Moving into study, trust precision medicine research, we have goal of identifying sources of trust and distrust and of trustworthiness in this type of research. We've conducted online focus groups with recruitment through partner organizations and participants also selected participation into focus groups by disability and self-reported race ethnicity as well as languages.
We had total of 21 focus groups seven of which were with mobility participants, seven were blind, low vision. And seven deaf or hard of hearing. Focus groups also racially diverse with one issue three Hispanic nine white focus groups. And out of the 21 focus groups, we had total of 122 participants throughout those. 45 were blind low vision. 39 deaf hard of hearing. And 38 had mobility disabilities.
This table showing percentages out of total number of participant out of that total 122. And you can see here that white, Black and Hispanics are main populations we had in our focus groups. And in terms of racial ethnic diversity we had 51% of participants white and 34% Black African American and 15% Hispanic.
And blind low vision focus groups all the way to left there were the most racial and ethnically diverse focus group. With 14% of the participants being white, 16% Black. 6% Hispanic, 4% Asian.
Then looking at the gender and education demographics of participant population you can see that we had more female representation than male. 60% female. Then majority participant are also college educated if not more. So, again highly educated population.
Then today as Maya shared in the beginning, we'll share some of our preliminary findings. Outset clear that our participant expressed high support and precision medicines research through, though they also indicated some concerns we'll get into as well. Particularly, their concerns were related to their experiences in healthcare settings. Specifically with regards to support for precision medicine research participant across focus groups all highlighted key benefits from this type of researching that included they believe it will be great resource to healthcare diseases individual level as well as improved health outcomes on community level.
And then generally expressed interest in wanting to participate in precision medicines research. Highlighted importance of inclusion of people with disabilities in precision medicine research and contribute to larger effort of increasing scientific knowledge for society at large.
We see here in this quote on the screen, blind low vision participant high highlighting potential individual benefit of participating in prevision medicines research state more re can take information and match it as closely as possible with particulars of each person I guess the better that's going to be for the treatment that makes it easier for the provider and patient.
And then we also see with this participant who had mobility disability highlighting benefit of prevision research benefit for families, they state I think definitely getting individualized genetic results is benefit allows you to alter lifestyle, also if you have others in your familiar alert them to things that may be early warning sign gives them clue of something they can look out to. And maybe avoid because they are predisposed to something.
We also had deaf participant highlighting community he benefit and they state, I think the deaf community need this research. There's huge need for medical research for deaf community. We don't speak out medical community does not know what we need we need to have that voice. And then lastly, hard of hearing participant highlighted societal benefit gained through participation of precision medicine research. I can help them gain more knowledge for others going through the same thing I feel that's bigger pick of participating in that. Researchers actual go doing the work and have science behind it.
So, then moving into clinical settings are participant in the focus groups strongly expressed this connection between trust or distrust and negative experiences in interactions they had with doctors and clinical staff. And our participant highlighted when talking about clinical settings feelings of not being listened to or heard as well as facing miss assumptions or presumptions about their disability and about their competency and depends. Then just over all lack of disability knowledge and lack of understanding about disability that doctors and clinical staff had.
Then parent indicated that these experiences of negative interactions with clinical staff or with doctors are occurring intertwined with one another, so, one example from blind, low vision participant who was white and male they state medical folks in general when they see a blind person they want to fix us, like a problem you know. And so they see everything manifest itself into how they view other issues you may have. They want to communicate with the other person always that, mistrust.
Another example negative experiences clinical settings, our participants expressed how doctors and in general just healthcare system lack of knowledge. And degree of skepticism about patients with disability. And this hard of hearing participant white and female stated in hearing world, even to this day as add difficult happens often because I speak well and clearly you tell somebody you are hard of hearing or don't hear well this happens especially in doctor's office for some reason tends to be degree of skepticism that you are making it up.
Our participants also express location of clinics and institutions accessibility within those locations contributed to how they're contributing to general distrust in healthcare. Expressed and shared accessibility in medical settings and procedures, due to just lack of accessible technology as well as information, facilities and communication participant expressed importance of locations of clinics. Impacts thereof for trusting clinical care that they receive.
This white female participant with mobility disabilities states challenge for me is really that doctors that treat rare diseases in big cities not small communities. I felt hesitation moving to college going to new doctors, and this made me feel like new. I think locality does have a way in trust there's no way to get to know your doctor sometimes in the city versus rural community.
And so touching little bit on accessibility, we had all of all types of accessibility come up within the focus groups and they were scruffed in all settings throughout themes participants brought up those types of accessibility included technology, communication, information and but there were differences we saw by disability subgroup. When looking at the number just of excerpts for different types of accessibility. And so, for the blind and low vision participants we saw them discussing information accessibility most frequently. While mobility disability participant mentioned physical accessibility, deaf hard of hearing, communication accessibility the most then we saw with tech accessibility and accommodations those were discussed almost equally among each disability type.
>> We've seen, expressed distrust in the healthcare system because of negative experiences in these settings. And importantly participants also highlighted you how these negative experiences in healthcare settings directly tied with and spill into their thoughts and concerns about precision medicines research. So, this one quote from Black, blind, low vision participant where she explained experience with doctor that caused her to lose trust. And as a result of that, she expressed concerns about privacy of her health information in precision medicines research.
She says my primary doctor took it upon himself to diagnose me with something that I don't even have. I tried to apply for life insurance and I got denied. So for me that trust was broken. I was just giving you access and you abused it. Now when you talk about pre -- precision research I hope when people have access to see what's going on that they respect people's privacy.
And many participants expressed fear of exploitation or being used as guinea pig in precision medicines research. Often relating fear to previous experiences of exploitation in clinical settings, and research this example participant with mobility disability explained their concerns about potential exploitation in precision medicines research describing that they feel this way because of their experience in healthcare in which they feel that they are offering more value to the doctor than the doctor is providing for them.
He said I spend a lot of time teaching my primary care physician about things like he takes more notes about what I'm saying and things that are working for they than he is giving me sometimes you know. So, I almost feel like, again, that this research piece, there's always balance between offering, you know, value, providing value also being used as guinea pig.
And odd experiences in healthcare that spilled into views on precision medicines research disrespect and misunderstanding. As Black, blind, low vision participant explained clinicians don't really listen to us, they talk at us and not to us, to means they are not listen anything, that means they don't understand. So, I think researchers should say hey what are your concerns, needs, wants. That for me would build up the trust.
So, here the participant draws on her experiences of being not listened to and misunderstood by clinicians to how she thinks about researchers and therefore t with suggestion of what researchers have to do in order of prevision medicines research to be inclusive of people with disability.
Our studies has strong focus on intersectionality. Highlighting idea that individuals with disability may have other groups of belonging that are overlapping, thing may result be compounding marginalization due to systems of power and privilege that are in place. We focus on the intersection of disability and race ethnicity for our study. Indeed heard from participants how their belonging to multiple marginalized groups, translate to experiences of compounded disparities in clinical settings, daily life activities and research.
And here, for example, Hispanic participant with mobility disability explained that Latinos with disability experience compounded disparities.
And they cannot separate racial identity and culture from their disability identity. These identities are interconnected have therefore large impact on their life experiences and health. As she stated there's all of these things that we as Latinos and we as people with disabilities are facing, and as disabled Latinos specifically faced with ( ) I think there's harm in prevision medicines research ultimately ending up in the sale place that we are now we come together based on genetic ruts.
How do we together with healthcare providers work towards better outcomes without getting stuck again in broken systems in ableism in terms of doctors wanting to fix us. And there's so much potential harms because I think harms that currently exist might get amplified.
And another theme that came up when looking at intersectionality was idea identities. So that is some participant share this hierarchy of their identities and expressed that discrimination they faced was often based on one identity and not the other. So, this issue is illustrated in first quote on the top of the slide from Black blind low vision participant. For me, the first issue that comes to mind is the fact of being Black. The second being blind. Those of us that are blind know that we are discriminated against in different ways. I think we, I think just we have those two issues being Black and blind and I'm not saying that everybody is that type that way but they are out there.
However, not all participants from minoritized racial ethnic groups felt this way. One example is the quote at the bottom of slide from Asian, blind, low vision participant stating that the Asian part of me, it doesn't seem to really affect how healthcare professionals interact with me it's the blind part that often creates barriers more often than not honestly cannot be taken down so that as an individual seeking high quality medical care, I end up changing healthcare providers.
So, participants expressed how they're intersecting identities impacted experiences in clinical settings, healthcare system as well as interest in participating in precision medicine research especially with deaf hard of hearing community issues surrounded lack of access to health information and education with participant expressing hope that prevision medicine research could provide remedies. As Black deaf participant stated Black community itself is very removed from the concept of going to see the doctor or carrying for physical health. When we're looking at the scope of Black deaf individuals, there is greater struggle with that because Black deaf community does not have education that founds that we need. I want to see that change. So, I thought I was a, so I thought if I was a part of this I could be a part of the solution.
MIKA BAUGH: What does all this mean? What we found is that it, we have these existing laws that encourage inclusion I really like Maya's legal argument, I don't know how you feel about those things, we have laws that encourage this inclusion, what we don't have translates into actual participation, right. So, the laws is there great foundation but here we still are without this participation. What we found is that people's interaction with care providers going to doctor, dentist every day, this really affects how they feel about research. And we wouldn't necessarily think that those two would have to be related if I go to the doctor and have all these negative experiences and then some researcher wants to come after me researching questions about medicine, like, that might not compute for me.
That might not be institution or something that I trust. Even though, like these participants said they can see benefit to themselves and families and to the disability community all of these ways. It's still that some of that harm that's happening in clinical care translating into research as we know if we don't have right inputs going into the black box not AI person, we don't have right in puts we can't have right outputs right. That's what we're working on.
What do we do we need to create studies as researchers that are worth thee of trust for this population. We need to acknowledge that there isn't the trust that. There's sources of distrust and where those come from, we need to make studies and do things that address that. So, some of the things we can do to increase trustworthiness or shift in that direction for folks with disabilities, there's changes on all levels, right. If you look at the individual interactions or individual person interaction with clinical care providers, their community, systems we have to make changes everywhere we can't just look at the disabled person hey you need to feel better about this there's a lot of benefits that could happen if you get in this research. I love this bullet point it's my favorite, duh, we should be respectful to people as researchers as providers as you know as folks that are dealing with disabled folks be respectful. Have direct communication. Be a good person.
I'm sort of playing it up little bit really is true that a lot of participants said that relationship is so important and when people don't talk to you, or they don't talk to you in commensurate with your education or your other identities it really, it causes problems. So, I feel like that should be easiest thing to do. But you know we should focus on that and do that thing. Then, we should also work on people's miss assumptions and disability knowledge and this his, also with researchers, too, there's astounding research done by folks that carry miss assumptions about disability and don't have disability knowledge.
Research, in my opinion, that they create are produced is flawed because they don't have the right bases or knowledge. They don't have that knowledge because I'm going to jump to bullet point 35 he didn't do outreach with disability community. If they are going do good research really anything having that outreach and engagement and leadership and guidance and such from the disability community, that's what's going to help trust, some of our participant talked about how there is community field so if I have strong relationship or affiliation with disability organization, inequity, NFB is part nine research study or project, that's going to make me feel better I know some of my buddies went and vetted that research doesn't have to be NFB but he know gaging with community designing studies in ways people can participate. If you tell me I can participate and the screen reader doesn't work on its survey, okay, that's really great you thought I could participate clearly, you know your money wasn't where your mouth was.
So, that said, those are what we should, what we need to do to build trustworthiness. Of course research will hopefully lead us to better health outcomes for people. But before we officially end I do want to say thank you first to the research participants who offered their time and expertise and insight. We had a lot of community partners who we want to thank funders. NFB, NAD I can give you whole list of acronyms, alphabet soup, it is important NIH is funding researching. Some research collaborators, shoutout to Lou Ann Blake. I will quickly before we hopefully have time for questions and discussion I will put in a plug for we would love more research. We are trying to study trustworthiness -- we have study it will take hour to complete. Accessible study.
There's lots of ways to complete it. You can do it online. Over Zoom. Do it in alternative format. Do it with one of us, there's lots of ways. There's compensation for that study. If you are eligible, so if you are person who is blind or low vision, deaf hard of hearing mobility disability that makes you eligible and we're happy to talk with anyone who is interested in doing the study after we finish here today. That's what I have.
MAYA SABATELLO: One of the things that keeps coming back to me, really the not just about researcher. Has researcher trying to do inclusive studies I can share some bigger challenges that we face one with NIH. Although they are not increasing, open to having conversations about folks with disabilities in general including precision medicine research. Institutional level. Amount of challenges that we have to build to recruit people with disabilities because everyone immediately assumes they are vulnerable population requires special protection. Need to bring study into high risk even when just asking views. Very difficult issue across studies when saying, when I'm, hey, make sure we have accommodations, we have budgets for that. Like oh, that's too costly. Entire networks issue falls over the question of we don't want to ask whether they have a disability because we do not want to offer accommodations don't ask don't tell, therefore we are out of it, right R let them know against ADA, against federal funding, they'll say okay we might want to do something we don't have funding, it's that type of conversation.
Then I'll just say also with review boards, there's so much, so many challenges to do recruitment involve folks with disabilities and studies it is remark. Again, beyond assumption of competency that comes across, across disability groups, and without assessment they assume people cannot do it. Just for this project now, we have with us some copies of the invitation letter in braille, for example. Seems like such a straightforward thing. Invitation letter approved by review board, we're not changing it. Just doing it in braille, we had to submit three different modifications to get that document approved.
When I'm saying in general statement in the, we're going provide accommodations they require me to report on every accommodation and get permission before we do it. Which means, I have participants they say I need to do it X, Y, Z, wait we have to get approval takes another three weeks, we've lost participant in that moment, right. That's the thing. Folks with disability who want to participate should be able to do it first time, or immediately communicate. Not go through the additional barriers that other participants do not have.
If you have suggestions as to what we can do to change those systems, change those structures, or if we missed anything in terms of experiences of folks with disabilities, we should be thinking about ensure we are passing along to NIH other research.
ATTENDEE: I don't have a suggestion. This is Cheryl Ross with civil rights division at DOJ. I'm a white woman. One of the things you said early on, how people with disabilities have traditionally been excluded from research disability is confounding factor. And I was curious like, what the counter argument is to that? Or like what.
MAYA SABATELLO: If you actually want to create medications good for real people, then that's what you have to do. It's almost artificial to say okay we're just going to take student pot top ideal prototype and test drugs on them. Most people are in different --
MIKA BAUGH: Hair color, height, someone decided it's disability I guess that's my thing why, who gets to decide that that is the confounder.
MAYA SABATELLO: Few things-- do you want to say something?
MIKA BAUGH: I'm sorry, a lot of research funded by private marketed and they want their, to pay least amount of money for research to get most effect of the drug. So if they, so, my wife had two cancers same time, she was excluded from all studies because no they only want to study one cancer, it's going to confuse the results.
MAYA SABATELLO: Correct, that's cancer, question if blind person without medication, is that confounder?
ATTENDEE: Well, I'm just saying same argument, they'll say, I don't think there's any basis for it in either case. You should be studying human beings, human beings are complicated.
MAYA SABATELLO: I think where there's concern about counter impact of the drugs that's one thing. It's very difficult when general exclusion criteria that are not climate we've done study, and other folks done it on folks with intellectual disabilities and there's another group that's done on other folks with disabilities, looking at NIH funded clinical trials. What we found in about 50% of cases, people with disabilities are excluded because of subjective decision making of researcher. What does that mean. We don't have any criteria, they can put in protocol, researcher can exclude based on their decision that the person ineligible. There's no criteria. So, is it because you think they are not able to understand? Is it because you think they cannot follow procedures, because actual risks these are all up in the air.
Very rarely measurements to assess competency, abilities, let alone getting accommodation, I think we had two hundred-something studies from 2018 to 2022 one offered accommodation and accommodation was just help with reading. So it wasn't even something big. So, I'm saying you know creating, so I think that's one of the things you know. One exclusion might be justified not saying it's not if you have increased risk if there's counter, these are all legitimate concerns. But ( ) at the moment it's the role.
ATTENDEE: That's helpful. Someone making legal argument what would be, probably be scientists other end of the table saying exactly that confounding factor what is scientific argument that we as lawyers --.
MAYA SABATELLO: We need to have due process. Due process for exclusion, right. What criterias, what grounds have you measured those criteria.
ATTENDEE: Can you articulate, if you were doing study on site maybe site would be exclusionary, wouldn't be for anyone else's, seems like basic common sense, so easy to exclude people worried about taking advantage of them that, there hasn't been constituent wait a second.
MAYA SABATELLO: Touching very correct point, fact with people with disabilities historically been abused in research protection ( ) that's misinterpretation. Also private companies, you know, they still have to report. Right to get FDA approval for drugs they still have to report who was included in the study. I'm saying let expand reporting requirements that will give us better sense who is in and who is out.
ATTENDEE: Go ahead, I'm sorry.
ATTENDEE: I came late. If you talked about this earlier, tell me. In thinking about what would make a potential participant be more willing to trust the research going on, it does seem to be one of the things might be does that person see someone like him or her as researcher not just as other people, so, have you looked at or thought about either as coresearcher, for example, with people with intellectual, if you have people there as part of the group, maybe that gives some comfort level to the person who is participating.
KATHERINE PEGLOW: We heard that a lot throughout the focus group conversations brought up through what we see as affinity cultural couldn't grew went not only share disability, race, culture, just being similar along those lines and 100% people are saying this would help me trust this would make me feel like you thought of me from if the onset with beginning research, especially having someone on research team like my maybe something I've gone through personally experience this person has thought about when making research at the onset definitely come up we've seen that throughout, yeah.
MAYA SABATELLO: Came up clearly idea if we have researchers with disability on board we can design studies different ways. One of the concerns we kept hearing researchers do a bunch of studies, but they forget to ask end users whether or accessible. This project, this assignment that we're doing which is activity we contracted a company that per discussion they declared they are all accessible federal regulations, blah, blah, blah, blah, blah.
[ Laughter ]
I said did you check it. Yes, we've checked it. Did you test it with it right people. We've tested it all good and well and done, of course first time we tried doesn't work.
[ Laughter ]
It just doesn't work. So, again, we're offering alternative formats. Retracted contract. Like, sorry, not accessible, just missed our population. But that's the thing people don't even understand that. So, having members with diverse abilities who can check, we've done it with all studies with generally not this assignment, but in general when we work with deaf folks ASL they are the ones leading focus groups not us. We've done same thing with other focus groups. Importance of having that, that diversity on the time also absolutely important. I think we have to expend again NIH's approach to what is diversity in research. The research workforce.
Because there are a lot of programs around inclusion and diversity. But accessibility and disability are not there yet. They are just starting to end I think there's like thinking five years ago versus what we see now world of difference. I will say also that again precision medicines research program on national level is first program in the country to actually collect disability data from participants. Of course they started three years after the program started. Half participants do not have that yet. We need to increase reporting, data collection requirements. Thinking about what we heard about AI and medical records. If we do not have medical records information about disability status and accommodations, we cannot know who are the patients populations we are looking at, we do, what are along rims we are, these are issues data collection reporting that should be so easy to fix as the beginning of the fixing.
ATTENDEE: Thank you so much.
[ Applause ]