00;00;04;29 - 00;00;44;16 Session of the ELSI Dialogues. My name is Janet Delgado from the University of Granada’s Department of Philosophy One, and I am part of the work package two ethics and governance team for the TTV Guide Transplant Project. I will be moderating this discussion, which will be recorded and made available online. Today we are going to be exploring the most recent research developments, considerations, and effective approaches for integrating sex and gender into medical research. 00;00;44;18 - 00;01;27;23 Before we dive in, I want to let you know that this session is a collaborative effort between BBMRI-Eric's ELSI team and TTV Guide Transplant, a project funded by European Union Horizon 2020 Research and Innovation Programme. The goal of the TTV Guide Transplant is to establish a tool to guide immunosuppression by quantifying an activity of the Torque Teno virus , TTV, in kidney transplant recipients within a randomized controlled clinical trial, including hundreds of kidney transplant recipients from all over Europe. 00;01;27;26 - 00;02;01;19 TTV-guided dosing of immunosuppressive drugs is being tested. Once established in routine clinical care, the hope is the TTV guidance will reduce infections and kidney transplant rejection. Visit ttv-guide.eu that is t-t-v DASH g-u-i-d-e DOT e-u for more information. As part of the project, the work package two wants to promote best practices and inclusion inclusion of sex and gender in clinical research. 00;02;01;21 - 00;02;32;07 And that is why this collaboration with BBMRI ELSI team was established for organising this session of ELSI Dialogues. Now let's begin. The medical community is moving on a path towards more personalised and effective medical treatment therapies for everyone. In doing so, it is crucial to integrate sex and gender into research as it has the potential to fuel structural and systematic change. 00;02;32;10 - 00;03;14;25 For example, considering gender factors such as social, cultural and economic influences can help address health disparities and improve health outcomes for all individuals. Today, we will explore how providing the research community with the resources and information needed to include sex and gender factors into their work will result in more inclusive and impactful results. We will be examining this topic from the perspective of researchers and healthcare professionals, and we will discuss subject area, including artificial intelligence applications and for nephrology. Guiding our webinar on these topics. 00;03;14;28 - 00;03;23;27 On this topic, our expert from BBMRI-ERIC Melanie Goisauf is a senior scientist and a member of the ELSI team. 00;03;23;27 - 00;03;47;26 in several research projects and leads BBMRI’s Ethics of AI Lab. Her research focus is on ethical, social, and societal aspects of biobanking, in particular on governance and stakeholder engagement, as well as gender, knowledge production and artificial intelligence. 00;03;47;28 - 00;04;25;29 Mónica Cano Abadía holds various roles at BBMRI. In addition to being a senior scientist, Mónica is the deputy head of the ELSI Research Department, and she is the gender, equality, and diversity specialist. Her research focus is the analysis of ethical and societal aspects of AI in medicine, especially concerning matters of trustworthiness. Welcome to the webinar everyone, and thank you for giving your time and expertise on this important topic. 00;04;26;01 - 00;05;10;01 Please use the chat box to write your questions. I will read them on your behalf once discussion finishes. Mónica Cano Abadía is going to thank you everyone for coming here with us today. We are very happy to be presenting this webinar on the incorporation of sex and gender in medical research. Next slide, please. First, as Janet who kindly invited us for this webinar today in this collaboration said before, we work at the ELSI Services and Research Department, at BBMRI. 00;05;10;01 - 00;05;42;24 ERIC and we do research, we provide services and we also do training such as these webinars. So we use the knowledge that we gain in research projects to provide training and we are very happy to be here with this one today. And next slide, please. The contents, some of the contents, of this webinar today stem from another collaboration that we were lucky enough to have a few months ago with the Barcelona Supercomputing Centre. 00;05;42;26 - 00;06;09;26 And within the project EOSC-LIFE. We organized these train-the-trainer that was called Integrating the Sex and Gender Dimension in Life Sciences Research and through this collaboration we we produced a handbook which will be made available online very soon. We are still in the making, but very soon if you stay tuned, we will circulate a link with the handbook. 00;06;09;26 - 00;06;48;00 And this handbook provides tools and guidance on basically the didactics of how teaching how to integrate the sex and gender dimension in the life sciences research. So some of the contents that we will present here today, especially the beginning of this webinar, will also be available in this handbook. Next slide, please. So into the topic already when it comes to the definitions of sex and gender, health experts frequently use these terms sex and gender interchangeably. 00;06;48;03 - 00;07;17;03 For example, in one of the papers that we will present later that it's a literature review that aims at understanding the use of sex and gender in the field of transplant research. They state that the term sex and gender were applied interchangeably in more than half of the studies that they analysed. Nonetheless, academics and policymakers that support the inclusion of sex and or gender in health encourage people to draw distinctions between the two. 00;07;17;03 - 00;07;44;14 Because it is, there are analytical distinctions that are very important in the field when it comes to definition and gender. We can have a look at this definition that the Canadian Institutes of Health Research has issued, which I consider is pretty complete, although about gender you can write and in fact, there's a lot of research done on just the definition of gender. 00;07;44;14 - 00;08;15;15 But we can have a look at this one right now. So gender refers to the socially constructed roles, behaviors, expressions and identities of girls, women, boys, men, and gender diverse people. It influences how people perceive themselves and each other, how they act and interact, and the distribution of power and resources in society. Gender identity is not confined to a binary girl woman on the one hand and boy man on the other hand 00;08;15;17 - 00;08;48;00 nor it is static. It exists along a continuum and can change over time. There is a considerable diversity in how individuals and groups understand, experience and express gender through the roles they take on. So gender underpins social roles in the home, in the workplace, in political and religious arenas. And it is thus multidimensional and complex and may include women, men and non-binary people. 00;08;48;02 - 00;09;31;27 Next slide please. When it comes to sex, we can have a look at the definition by this, by the same institution which states that sex refers to a set of biological attributes in humans and animals, it is primarily associated with physical and physiological features, including chromosomes, gene expression, hormone levels and function and reproductive slash sexual anatomy. Sex is usually categorized as female or male, but there is a variation, as we will see later in the biological attributes that comprise sex and how these attributes are expressed. 00;09;31;29 - 00;09;42;09 So it is also something that, as we see, is quite complex and quite multidimensional. Next slide, please. 00;09;42;11 - 00;10;17;13 So why do these definitions matter? Here we have an example of an institution that that has aimed at integrating a more complex definition of sex and gender. And they stated in 2018 in their policies to affirm that the medical spectrum of sex and gender and they state sex and gender are more complex than previously assumed, it is essential to acknowledge that an individual's gender identity may not align with the sex assigned to them at birth. 00;10;17;20 - 00;10;57;12 For example, women does not necessarily align with female attributes and man does not necessarily align with male attributes. And narrow limits of the definition of sex would have public health consequences for the transgender population and individuals born with differences in sex, in sexual differentiation, also known as intersex traits. Most of the European Commission has announced in 2020, in late 2020, that their research grant recipients need to incorporate analysis that include sex and gender dimensions in their study design. 00;10;57;12 - 00;11;30;22 Unknown It is compulsory from 2020, and these can include disaggregating data by sex when examining, for example, cells or also considering how a technology might perpetuate gender stereotypes. Another example is, for example, the one of the leading medical journals, The Lancet, also has updated their author guidelines very recently, encouraging the enrolment of women and ethnic groups into clinical trials and to analyse the data accordingly. 00;11;30;25 - 00;12;12;06 Considering the influences and associations of sex and gender. So there is also an institutional, institutional atmosphere that is fostering this integration of sex and gender in research, in medical research. Next slide. The complexity of sex and gender is one of the aspects that complicates the integration of sex and gender in medicine. Usually the category of sex that refers to anatomical features has been presented within a binary understanding of sex. 00;12;12;12 - 00;13;22;23 Nonetheless, there is also individuals that that prove that these sex binary is an oversimplification of integrate biological and physiological variation that are observed in human beings. There exists a possibility of intersex individuals who possess diverse anatomical features or exhibit chromosomal variations. So the these binary classifications often fail to accommodate the vast spectrum of gender identities. And there's an aim to integrate a broad and diverse consideration of the category of sex in medical research. In this sense, we have we invite you to watch our webinar that we organized last year on the complexity of sex determination with Amanda Montañez, who created this amazing infographic on the complexity of sex determination. 00;13;22;25 - 00;13;58;20 Next slide, which is very big, very complex and very informative, and she explains in the webinar the process of generation of this of research and generation of this infographic and how complex she realized that sex determination was, I invite everyone to look it up. It's called Beyond XX and XY, and it is really interesting to spend some time reading the details. 00;13;58;20 - 00;14;24;25 It's very small written here, so you probably cannot read anything. So I invite everyone to spend some time with it because it's really informative and it's really eye opening. How the biological science behind sex usually is presented to us in a very yeah, in a very clear way. There's this category and there’s that category, but it can be way more complicated than that. 00;14;24;27 - 00;15;01;23 Next slide, please, to complicate it a little bit more, then sex and gender interact with each other and they also interact with other factors such as other biological factors and other sociocultural factors in very complex ways. So in practice, in practice, sex and gender are not static categories, but very dynamic categories that are in constant dialog with one another and with other categories that or even anatomical features. 00;15;01;25 - 00;15;35;06 So it is quite complicated there as well. One fascinating example is the experience of reporting pain in Western cultures and is a good example of how sex and gender interact. But my colleague Melanie will dig up and dig a little bit more into that. So the understanding of how sex and gender interact with each other and intersect with other biological and sociocultural factors can enhance the quality of science, health and medicine in several ways. 00;15;35;08 - 00;16;21;23 For example, it can help researchers identify and address health disparities that affect different populations. It can develop more effective treatments and interventions that take into account sex and gender differences. It can improve the accuracy and generalised ability of research findings. And it can help health care providers to deliver a more personalised and more patient centred approach to care, which takes into consideration the unique needs and experiences of different individuals based on their different attributes. 00;16;21;26 - 00;17;05;15 So ultimately, integrating sex and gender into scientific research can contribute to better health outcomes and improve quality of life for all individuals. Next slide, please. Why is it important to integrate the dimensions of sex and gender into medical research. It is different, it is important in order to identify differences in health outcomes and treatment responses between diverse sexes, which in different fields of medicine can be varying. 00;17;05;18 - 00;17;33;16 It is helpful to avoid generalising research findings from males to females and non-binary people, which is a tendency that has been happening and Melanie will delve into that later. It is helpful also to understand how sex and gender impact disease manifestation and progression and to develop more personalised and effective treatments for everyone, men, women, trans and non-binary people. 00;17;33;18 - 00;18;09;13 Additionally, it is important to promote health equity by providing tailored health care that is based on sex and gender differences when it is relevant and to improve the overall quality of research by accounting for the impact of sex and gender on health outcomes. Additionally, it is important to integrate that diverse and broad understanding of sex and gender, as I said earlier, so that it fosters the inclusion of everyone and contributes to an accurate representation of human diversity. 00;18;09;15 - 00;18;48;21 This would help addressing health disparities and promoting ethical research practices while advancing social progress and above all, enhance scientific rigor. Because human diversity should also be represented in in medical research. So this is a matter of the integration of sex and gender and furthermore, a diverse and broad understanding of the categories of sex and gender is a matter of the accuracy of data and is a matter of the quality of data and the research outcomes of medical research. 00;18;48;24 - 00;19;18;16 And for now, I will hand over to my colleague Melanie, which will continue with the next section. Okay. Thank you, Monica, for this introduction and bringing us to the topic of sex and gender and the importance in medicine and the way, the complex way, we are thinking about sex and gender and how sex and gender intersect. So they especially also in medicine, this is, of course, nothing new. The way 00;19;18;16 - 00;20;09;09 we also arrived to that point how we understand it today. So it's already a key part of the history of medicine. But that's one where women in particular were absent. So historically women have been excluded from medical trials and research studies, which has had significant implications for the understanding and treatment of health conditions. And this happened in a way that biological, biomedical research was long done on male animal models and cells and medical trials were conducted with a so to say, standard human that is middle aged white men in most cases, and that built a basis for what we called evidence based medical knowledge. 00;20;09;12 - 00;20;39;22 So differences, for instance, between and within sex and gender and we heard that that is a really complex matter, were left out in the interest of homogeneity or were simply not analysed. So and this exclusion has been driven by a number of factors, including concerns about potential harms to women of childbearing age, as well as lack of recognition of the unique ways that women's bodies may respond to medical treatments. 00;20;39;24 - 00;21;20;17 However, this exclusion has also meant that many medical treatments and interventions have been developed and tested primarily on men with limited understanding of how they may affect women differently. So sex classification does not seem to be solely a matter of biology and sex categories have changed throughout the history of science and what we also see then in the history of medicine, so to say, is that the anatomical knowledge of the sex body was largely informed by cultural understandings about gender differences. 00;21;20;19 - 00;21;53;28 Next slide, please. And I want to give you some examples about this last point, about this cultural understanding has been inscribed in medical knowledge and with these examples also within the images, anatomical images that were also used at that time. And there were supposedly universal representations of the human body in the 18th and 19th century, and especially in these illustrations. 00;21;54;01 - 00;22;31;12 But in fact, they were loaded with a lot of cultural values and cultural understandings. So what you see on the left hand side is an image by John Barclay, who also gave this representation. And there was clearly also an emphasis on how this was represented. So it's also a matter of style, so to say, we would say nowadays, and also in the comparison to animal skeletons, which would then highlight the distinctive features of the male skeleton on the left hand side and the female one on the right hand side. 00;22;31;12 - 00;23;06;00 And here you can see a little bit, I hope you can see it, that the male skeleton was compared to a horse because of its strength and the female one to an ostrich because it represents somehow the large pelvis and long narrow neck. And what you can also see in comparison of these two skeletons is for example the skulls, so the female head is very small compared to the male one and also the shoulders and this is different. 00;23;06;00 - 00;23;45;27 So these are really different representations about like the skeletons would look like the right hand side. On the top you see a picture that is mentioned in this book I or we I would say Monica would agree would highly recommend to read from Thomas Laqueur Making Sex. So kind of the history of how the sex was, how to say, invented throughout also the histories and what you can see in this picture is actually female female body parts. 00;23;45;27 - 00;24;14;20 So the uterus and vagina of women, women were seen as isomorphic to the penis. So that should actually represent female body parts. But it's exactly kind of the opposite to what we've seen for for men. So also kind of the cultural understanding or a whole world view that makes this look like this represents how the thinking was back then. 00;24;14;20 - 00;25;11;16 And we are talking here about the Renaissance, so the illustrators back then learned also how to depict the female genitalia from other pictures and not from nature alone. But it was not like the procedure in that time. So they took other pictures to reproduce that kind of picture. And that's, in fact, an interesting procedure. Also, when we reflect on our practices today, which I will talk about a little bit later, I just also included also on there on the right hand side, a different kind of source to explore this further, because it's not only that people directly involved in medical or science thought a lot about about sex and differences in male and female sex. 00;25;11;16 - 00;25;41;29 And this is very nicely and very entertaining, represented in Liv Strömquist’s graphic novel where she showed, where there were actually a lot of men that have been too interested in in in in that in these differences and how they shaped also understandings about how the differences are made which happened also really real world effects on women how this was seen. 00;25;41;29 - 00;26;11;17 So also a recommendation for this book. So next slide please. So so much about history. So what about today? So we see that my classifications of course have evolved. Historically is not the way that we think the same way about sex differences as we did in the Renaissance. They have an impact on how modern biomedical research practice is shaped and conducted. 00;26;11;17 - 00;26;50;14 So we are not free of all of these cultural understandings. They are still, to a certain extent, inscribed in how we understand these differences. So gender can influence the therapies that are offered to patients, and sex is directly linked to certain bodily functions that have to do with health, as it refers to the biological attributes that distinct male, female and or intersex according to the function that derive from the from chromosomes, reproductive organs, specific hormones, or environmental factors. 00;26;50;16 - 00;27;25;00 And also, in a way what Monica described, how they interact in in that is that sex bias can lead to a gendered perspective of diseases. Some very prominent example in that is heart disease, which has for a long time been primarily understood or seen as the male disease. And standards have been created based on kind of male on males and, and the outcomes of studies also on that. 00;27;25;02 - 00;27;57;03 So women and gender diversity individuals are often mis- or underdiagnosed. I think this is also very known that heart attacks and so on and the symptoms which are shown differently when were not seen in the same way also and this led and could lead also to health disparities and inequalities in health care. Next slide, please. And this is the example Monica mentioned before about pain. 00;27;57;07 - 00;28;29;28 And we want to make you aware of this website. On the right hand side, this is a QR code queue, so just follow the dinosaur. So it is really interesting project where you can find a couple of really interesting examples about how this happened and what has happened and also what steps can be taken. So when it comes to pain and especially chronic pain, sex and gender interact and affect all parts of the pain pathway. 00;28;30;00 - 00;29;01;28 So from signalling to perception to expression and treatment. And this has also to do, of course, with gender so understood as the more social, societal, social component here is that men and women are also raised to express pain differently and which may also modify that biological response to pain and their willingness to report it, and also how to how they report it. 00;29;02;00 - 00;29;37;18 And also when it comes to biology, there have been differences found also in testosterone, for instance, and estrogens that are connected to that. And while in both cases the result is increased sensitivity to pain, there are still differences. So the pathways are different. And this could mean that this could have an implication for drug discovery of drug development. 00;29;37;20 - 00;30;18;16 So further research is also needed here. Next slide, please. So what is suggested on the website for this case study in how to gender these innovations is that studying the underlying biological mechanisms of pain in females typical bodies and male typical bodies may also promote sex specific treatments. So also a closer look into that would be necessary and how this influence all of that, as mentioned, maybe to design sex tailored pain treatments. 00;30;18;18 - 00;30;55;03 The second innovation, the first is that studying how sex and gender interact and how sex and sex interact is also would also be necessary to consider, as I said, because men, women, boys, girls are socialised also differently when it comes to pain. And this also impacts the sensitivity to pain and the reporting of pain and also then all the reporting also when it comes to the study of studying pain. 00;30;55;03 - 00;31;33;23 And the third innovation mentioned is the understanding how gender impacts the reporting and treatment of pain, especially when it comes to these gender stereotypes and also when it comes to the health care professionals in in in dealing that how they kind of see pain differently or the reporting of pain differently in men and women. For instance, the second dinosaur that appeared on the slide is leads to a very interesting webinar we have previously, which is on gendered innovations. 00;31;33;23 - 00;32;13;25 So on this project and also highly recommended to look into that also for more examples in the in that direction. Next slide, please. So today also sex and gender differences are documented for major diseases such as heart disease, cancer, stroke, Alzheimer's, COVID 19, as well as the efficiency and side effect of drugs. And what you can see here is an overview of recent research in women's health and sex related differences in disease, which can be found on the nature website. 00;32;13;25 - 00;32;49;19 So this is a nature collection where you can find many studies that show how how differences actually make a difference in a way that this difference needs to be considered to have a better outcomes and to do better, stronger research that considers all that. So that's also highly recommended to visit this website and to see what or to see that there's actually already a lot of things going on in in in diseases and in considering change of sex and gender. 00;32;49;19 - 00;33;26;01 And when it comes to disease. Next slide, please. So what is also, of course, a topic for today's knowledge production and especially also medical biomedical knowledge production, it was it's described more in a social science perspective at the datafication of health and the ways how we categorize sex and gender and how we use that also in research. So this is a picture of that of a chapter from the book Data Feminism. 00;33;26;03 - 00;33;56;08 And I think the headline here is telling a lot already what gets counted counts. So what with the kind of categories or classifications that we made, this is then all that we see and then we count and include and also in research. So categorisations and classifications, I used that interchangeably for also today, take a central role in and database knowledge production. 00;33;56;10 - 00;34;23;25 So in speaking of what gets counted counts means here that data must be classified to be processed, processed and it must, it must be put in some kind of category. By the time that information becomes data or is translated into data, it's already then being classified. And this raises the question, who is counted, who gets in, who is involved, who benefits? 00;34;23;25 - 00;35;01;03 Then by the end from a technology and who is maybe overlooked. So what's what's the missing data then? In all that, I also want to point to two other books, since this is a training, I guess further things might be of interest to you. So one is by Bowker and Star Sorting Things Out. And in these books a book, the author explores authors explore how classification systems shape our understanding of the world and how they can have unintended consequences. 00;35;01;05 - 00;35;38;08 And they also illustrate how classification system can reinforce existing power structures and marginalize certain groups and categories like gender, race, sexuality, class - we focusing today on sex and gender, but of course, there are other categories - have become key classifications for the study of society and in understanding the reproduction also of social order within society, but also how we how we see all that through through this lens of categorisation or classification, for instance, the ICD. 00;35;38;08 - 00;36;28;15 So the International Classification of Diseases, a statistical is a statistical classification and diseases that are statistically relevant are included here. And in this book they show in a really good way how this changed also over time with every new version, how we changed our classifications or understandings of disease. And as you can see here on this slide is from Epstein called Inclusion The Politics of Differences in Medical Research and here the author looks into how medical research has historically excluded certain groups, particularly women and people of colour from clinical trials and other studies. 00;36;28;15 - 00;37;15;01 And the author argues that this exclusion has led to a lack of understanding about how different groups experience disease and respond to treatments. And all these categories I've mentioned have also taken kind of a new importance, so to say, within modern medicine especially, we datafied biomedical and health research so all together. The takeaway from from these three books would be what gets counted, classified or categorised counts get included or not transformed and produced in biomedical research and development. 00;37;15;01 - 00;38;00;28 So we always need also to reflect in how we measure thing and define things and how we classify them. And next slide, please. To give you an example about that, I want to point you here to a paper coming from from our team and which you can find on the right hand side, going Moving back to the future of big data driven research: reflecting on the social in genomics, why we then ask on the example of this a large scale genome wide association studies on same sex sexual behaviour, how the social is inscribed, reproduced, included also. 00;38;00;28 - 00;38;44;21 So there and also in doing research. And this illustrates and also how science and society are co-produced in research and how underlying social classifications and categorisations can be incorporated into knowledge production. So that was not only a practice, so to say back then, it's also happening also in today's research. And what's interesting also here to point out is that and this is all mentioned also in the in the study that the authors have made a couple of reductive assumptions which is mentioned in the in the limitations of these studies. 00;38;44;23 - 00;39;37;19 But for instance, what you can see here later, they acknowledge that the research is based on a binary sex system with exclusions of noncompliant groups. As the authors report that they have been dropping individuals from the studies, both biological sex and self-identified sex gender did not match so both categorising sexual orientations is also mainly down here, so to say, in practice rather than attraction or desire, and in building it on normative assumptions about sexuality, which means in that case gender binary and heteronormativity, which could also be problematic as sexual behaviour, is diverse and does not necessarily correspond with such assumptions. 00;39;37;19 - 00;40;16;22 And I wanted to use these examples to show that although there is research on the on the on the biology so to say or that the genetics of of that are going on, but that it is still also a social practice in a way that decisions are made in how certain groups get in or excluded. And I think in that example it's really interesting that in the research about sexuality groups that are outside, so to say or exclude seen excluded from the gender binary are excluded to learn about the complexity of sexuality. 00;40;16;25 - 00;40;51;17 So that was really short about this study. So next slide, please. So let's look a little bit to tomorrow. But I mean, in that way tomorrow, it's happening today already and so a big data and artificial intelligence in medicine. So with this increasing datafication of health, big amounts of digital data are generated inside and outside the medical context. 00;40;51;19 - 00;41;29;29 Unknown For example, health records, variable datas from smartwatches and so on, and also cohort data and so on. And this data is of course being also reused and this is in terms of large amount of data, it's estimated that up to 30% of the entire world stored data is health related data. So really a large amount and this is of course often used secondarily used in this research and then treated, so to say, often as raw data. 00;41;29;29 - 00;42;14;07 And yeah, yeah, for social scientists this is it doesn't exist in that way. So raw data is an oxymoron is one of the kind of famous quotes here also meaning that a data is never produced free of theoretical framings, methodological decisions and technological conditions. So building on that data is never a kind of built on this raw data, especially in further uses or reuses of data, because this data have been collected in a certain way and is then merged also in big database research with other sources of data which require harmonisation. 00;42;14;13 - 00;42;44;29 And here we are again with how decisions are made, what's how it how data gets harmonised. And we see also here different developments or transformation going on while we see a strong tendency also to open up and to consider more diversity and to include more groups in these practices of data, reuse and harmonisation, of course, you have to work then with the kind of data you have. 00;42;44;29 - 00;43;10;11 So we see then also that we are going back to the to the usual categories in in that way. And how this data is also used is also then linked to technological advancements in the medical field, in particular artificial intelligence applications, which means here that of course to build a AI, it needs to be trained with certain data on it. 00;43;10;11 - 00;43;51;06 So if you feed AI with these data and the categorisations and assumptions we are using on that, of course AI is then working with it. And so I used also an image here, I think, which shouldn't be the future in doctors focusing more and more on data and not so much on the patient but also using an image again to remind you on what was said earlier about how how things got reused hundreds of years ago by producing new images based on other images. 00;43;51;08 - 00;44;21;10 And I think we should reflect also in how we produce data, health data on knowledge, building, on other kinds of data, and how this is how this is often used and which kind of decisions are made and that are then ultimately also used to train artificial intelligence. So the message here would be that with the emergence of these big datasets, algorithms, medical AI, these imaginaries or 00;44;21;17 - 00;44;49;27 understanding of standards or standardised bodies and the categories that are used or ignored become even more important. Also here. And the next slide, please, to give you also an idea that, of course there is research and awareness on on bias, also gender bias, but then it's still complex and this topic’s bias is not the same as bias in most of the cases. 00;44;49;27 - 00;45;22;08 So what we want to have in for artificial intelligence is understanding differences better. You know, kind of strive for more personalised medicine. And to consider that, as I've mentioned, for the development of treatments and diagnosis and health care in general for the well-being of the patients. But what we should avoid is, of course, this stigma, discrimination, underrepresentation of certain societal groups. 00;45;22;08 - 00;45;58;20 So there needs to be a good balance in practice to produce also better outcomes. And with that, I hand over back to Monica. Thank you, Melanie. Next slide, please. Now I'm going to to show a few papers also for further reading. All of them have their associated QR code with Dinosaur to so that you can have a look at them and read them more thoroughly. 00;45;58;20 - 00;46;38;10 But I will give some insights on the integration of sex and gender that has already been done in the field of nephrology and transplant research. This particular paper that tries to integrate the gender perspective into nephrology starts by stating that the field of nephrology has largely ignored this in their prospective approach and that there's not many studies that have been investigating and scientific evidence in this regard. 00;46;38;12 - 00;47;10;10 Nonetheless, there is, they referred to a recent study that has been conducted in Spain, where they show that chronic kidney disease shows differences between genders in both prevalence and rate of progression. Additionally, also in treatment and health outcomes. So understanding the differences that gender brings into the field is relevant because there are reported differences already as they state chronic, 00;47;10;10 - 00;47;49;24 Chronic kidney disease shows differences in prevalence according to gender because there is high higher prevalence in women and in evolution because there is a faster progression in men than in women and prognosis. Young women on dialysis increased their non cardiovascular mortality and lose the survival advantage over men in general population. These greater prevalence of chronic kidney disease in women may be due to the longer life expectancy of women they achieve. 00;47;49;24 - 00;48;29;24 Thus the risk age of chronic kidney disease. Or it could be also due to the inaccuracy of the formulas that estimate certain measures, certain indicators that measure how well the kidneys are functioning, such as glomerular filtration rate. So if there is inaccuracy of the formulas applied to women, that could be a source of bias that is introduced there and that could account for these greater prevalence of chronic kidney disease in women. 00;48;29;26 - 00;49;10;19 They also stated in this study that the application of a gender perspective improves the scientific rigor and the reproducibility of clinical trials by identifying and addressing gender biases that can exist in the design and the conduct and analysis of clinical trials. So integrating this perspective of a particular the case of the they talk about they use the term gender can lead to a more accurate and reliable result when it comes to understanding the different populations based on gender. 00;49;10;21 - 00;49;49;16 So this perspective may provide clues that could lead or so they state, to new pharmacological targets and treatment strategies by identifying differences that could be gender specific and that could be important to identify when it comes to disease mechanisms, risk factors and treatment responses. So they conduct here a study trying to to invite people to integrate these prospective in a field that they identify is lacking this perspective. 00;49;49;18 - 00;50;30;15 Next slide, please. This second study that I would like to to present, it's called The Underrepresentation of Women in recent Landmark Kidney Trials: The Gender Gap Prevails. So the title is already telling us a result of their of this study that is underrepresentation of women and they focus also on on the analysis of how certain medications are have shown significant benefits for kidney disease patients. 00;50;30;22 - 00;51;19;11 But their concerns about potential sex differences when it comes to the effects of these agents and these potential differences are have not been sufficiently studied. So this stems, as they stated this in this study from the underrepresentation of women in clinical trials, including cardiovascular and nephrology trials. So these and the representation of women in the clinical trials leads to insufficient data when it comes to assessing the potential sex disparate effects of pharmacological agents that treat kidney or kidney patients, kidney disease patients. 00;51;19;13 - 00;52;19;15 They also say that there are some differences when it comes to gender because women may perceive more harm from trial participation and are generally they state more risk adverse under stress and have been shown to be more reluctant than men to participate in clinical trials. Additionally, there is some exclusion criteria and different ones than Melanie was stating, but in in this case they talk about people of childbearing age may be excluded from the study design due to the potential for pregnancy and or breastfeeding, and they state how it is necessary to develop a gender sensitive recruitment toolbox for including patient investigators that can engage in engagement and communication strategies that are gendered. 00;52;19;18 - 00;52;53;04 So they consider that they need to introduce somehow this undesirable bias when it comes to fostering more inclusion of women in clinical trials and they develop some strategies to bolster the recruitment of women in clinical trials and to ensure the adequate representation of women in clinical trials and to identify potential gender differences in treatment, efficacy and safety. 00;52;53;07 - 00;53;43;12 And here we have some the the figure that appears in their paper that shows some of the strategies that they are fostering. For example, I will highlight some. They talk about how it is important to produce recruitment strategies that are targeting women and gender diverse individuals. They say the need of including more women and gender diverse investigators and or coordinators on study team, they highlight the importance of incorporating input from previous women and gender diverse individuals involved in or declining involvement in clinical trials. 00;53;43;15 - 00;54;19;13 And they think that it would be beneficial to also ensure flexible clinical appointments, schedules for on site visits to facilitate people with caring obligations. The participation of people with caring obligations. And they also have some some recommendations for regulatory bodies that I find quite interesting. The first one says that they would invite regulatory bodies to require reporting of results based on or stratified by sex and gender in subgroup analyses. 00;54;19;13 - 00;55;03;13 And this relates to what Melanie was saying before that what gets counted counts. So it is important also that from regulatory bodies there is this this push towards investigators to also have to report the results in a sex or gender stratified way because what gets counted counts and what does get counted doesn't count. So this is important. Also, they also talk about the importance of standardising the collection of biologic and sex and gender identity reporting, which is not standardised. 00;55;03;13 - 00;55;39;18 And it is creating a lot of confusion in there when it comes to building that. The basis, for example, before we're talking about the datatification of of of health it it is complicated to to use or to analyse also how certain databases are balanced or imbalanced when it comes to sex and gender because way of reporting, sex and gender is not standardised and the definitions of sex and gender are a bit fluctuating. 00;55;39;23 - 00;56;19;10 So then it would be beneficial to standardise this collection of sex and gender when it comes to when it comes to reporting. And they used to consider that it would be important to increase the representation of women and minorities in leadership and decision making bodies for regulatory agencies and pharmaceutical companies. Next slide, please. The third study that I would like to present is a review that tried to well that that analysed the use of sex and gender consideration in transplant research. 00;56;19;10 - 00;56;59;12 They conducted a broad review, literature review, analysing the use of the concepts of sex and gender in the field of transplant research. This is the study that I mentioned at the beginning that stated that more than half of the of the papers that they reviewed were using the concepts of sex and gender interchangeably. So there is already a terminal, logically, the terminological confusion in the field of transplant research when it comes to using sex and gender, it's completely interchangeable. 00;56;59;14 - 00;57;40;06 57.5% of the studies were just using both in an interchangeable way. They are worried by this outcome because they know that in the context of solid organ tissue and cell transplantation, the sex of donors and transplant candidates and recipients has been shown to influence, to influence health outcomes. But if then we don't have the appropriate data to analyse these, if it is worrying, because then the studies that are talking about sex are confounding sex and gender constantly. 00;57;40;06 - 00;58;30;00 So it is worrying that this there is this lack of analytical accuracy. They also say that there is gender differences that can be observed in organ donation patterns, in access to the waiting list, in access of trans access to transplantation and patient participation. And they also state how sometimes both sex and gender can be relevant. For example, they consider that it is both sex and gender are relevant when it comes to interpreting the observation that female kidney transplant recipients experience a higher risk of allograft failure than males. 00;58;30;03 - 00;59;09;28 So why is this that it can happen? So there's both reasons, biological reasons, and also behavioural reasons that can be attributed to some gender stereotypes. So they say that members of the female sex may be at higher risk of experiencing immune mediated graft injuries as a result of immune sensitisation than those of the male sex because of possible pregnancies or a stronger immune reactivity or different biological phenomena. 00;59;10;04 - 01;00;00;17 And on the other hand, and gender is also important because as they state, women could be more caring about the healing process. And also they appear more to immune suppression. They are more constant when it comes to taking their medication. So then these are factors that are also affecting their risk of complications. So they consider that it is important the careful consideration of sex and gender in allotransplantation and donation research that can help outline personalised strategy use and to aid decisions on organ allocation and to improve transplant outcomes. 01;00;00;19 - 01;00;41;25 This considerations can also highlight disparities in care and optimise patient experience and inform policy changes that can that can benefit patients ultimately. Next slide, please. So after these many consideration that we have presented you today, what can be done? So we refer again to this project, Gendered Innovations, which is quite it is very interesting. It is quite useful when it comes to providing with with useful information. 01;00;41;27 - 01;01;22;10 And we invite you to go to their website and to have a look. They have a part that go that I think it's called Rethinking Concepts and they invite to precisely this to rethink, to, to assess critically the concepts that we are using in, in medical research so that we can be more accurate when we are using certain terms and also to assess when certain terms can need to be used, because not always the category of sex will have will be useful to to know. 01;01;22;10 - 01;02;05;14 It depends on the field of medicine that we are understanding. Sometimes it might not be important. For example, they put the example I like this one very much of the knee replacement that they some company was marketing a knee prothesis for women and a knee prothesis for men. And they are they were wondering if sex here is a factor, maybe a sex was being used as a proxy for other things such as height, weight, etc. Maybe they got the categories of weight and height would be more useful to know which prosthesis a person needs. 01;02;05;14 - 01;02;27;01 Then the category of sex. Sex is just some kind of like mega classification that we can use to mean okay shorter people that weigh less. But what you need is actually the actual height and the actual weight of the person, not the sex. So this is just one example where we we may we may not meet the category of sex. 01;02;27;01 - 01;03;05;25 So it is also important to assess in which moment it is necessary. That's why also we like to talk about situated knowledge because the the categories that we use need to be situated in particular practices. So here this is an invitation to think and rethink the concepts, the background assumptions about sex and gender that we are using. And we can just try to ask ourselves certain questions to assess if we are using certain background. 01;03;06;11 - 01;03;41;14 assumptions, for example, like do researchers in our team assume certain gender roles? Are there certain gender roles in in our lab, on our research team? Are we as researchers aware of possible gender biases in our field? Are we do we know which kind of gender biases are present in our field of expertise? Do we, as researchers assume here in this particular study that gender and sex are binary, or are we open to trying to analyse it in a different way? 01;03;41;18 - 01;04;13;23 Do we have the data to analyse it in a different way? That's another question that that is worth being asked. Do we, as researchers take into consideration here the interactions between sex and gender and how how they might affect certain health outcomes? So these can be questions to ask ourselves so that we can try to integrate critically all the categories of sex and gender into into research. 01;04;13;26 - 01;04;51;05 And with that next slide. Thank you very much. And yeah, thank you. We are done with it. Thank you very much, both of you throughout this webinar, we all have learned about the real complexity of the integration of sex and gender into medical research. I mean, it's not just okay, I'm going to conduct research. I'm going to include male and female. 01;04;51;09 - 01;05;20;00 Then I'm gonna provide descriptive analyses and that’s it. I have that. No, it’s so much complex than that, is really important to be aware of this because we all and all the scientists and researchers want to do it the better. So it's really important to, as you have heard, first of all, just seeing and stating what is really relevant for my particular research. 01;05;20;03 - 01;06;11;24 Before starting the research project. What should I include? Sex, gender, both, intersex. What is relevant for my topic for the topic that I want to analyse or research and then also as you stated too, somehow think about that in each phase of their research progression, not only at the beginning, not only at the end, to do it kind of accurate all along the process and how necessary is to prepare before the design of their research to avoid sex or gender biases, but also all along the research and all of these of course, to conduct better, more reliable and more accurate research. 01;06;11;27 - 01;06;47;21 And that's the our goal, the goal of all the scientists and all the researchers. So BBMRI-Eric regularly share content and updates on the importance of sex and gender in medical research from their ELSI experts and via their BBMRI newsletter. You can sign up on the website www.bbmri-eric.eu . You will also find the ELSI knowledge base and helpdesk on that website. 01;06;47;24 - 01;07;16;28 If you enjoy this recording, do share it with interested friends and colleagues and leave us a review or comment on whichever platform you tuned in via. It helps to reach new audiences. Watch out for our next ELSI episode via our BBMRI-ERIC socials on Twitter and LinkedIn. Thank you for joining us. I will now open the floor up for questions and 01;07;17;01 - 01;07;25;11 comments. If you have any questions, please write in the chat and I will read for you.