Research Kristien Hens

Abstract

The overall aim of the REALM project is to create a collaborative framework for regulatory authorities, application developers, healthcare professionals and policy officers to co-create and evaluate software for medical and healthcare use. We propose to create an inclusive platform leading to a transparent ecosystem for evaluation and certification of software in healthcare where both the developers and the regulatory (and Health Technology Assessment) bodies have access to a standardized set of technology stack and data. This will be achieved by first mapping and analyzing regulations, legislative efforts and guidelines from EU, national bodies and around the world on software in healthcare practice. These will guide the roadmap towards building an inclusive, fair and multistakeholder ecosystem. The scaffold for an integrated architecture will be developed in collaboration with DARWIN, based on standardized data models and optimized data driven methodologies for the effective use of real-world data (RWD) in healthcare regulatory practice. The architecture will consist of four components: two technological infrastructures, a living lab and a post-marketing surveillance module. i) a federated cloud-based data resources catalog will be established, to bring together currently available RWD data and synthetic data to facilitate the data needs of the platform. ii) Regulatory Toolbox will be established to bring together standardized tools to train, test, evaluate and monitor medical/healthcare software. iii) Living lab environment for piloting medical/healthcare software technology assessment taking into account human-software interactions as part of the system. iv) Post-marketing surveillance with RWD for ensuring quality standards of the certified software in practice. Finally, building on the proposed architecture, five real Medical Device Software (MDSW) projects are going to be implemented across 3 countries (Netherlands, Belgium and Greece).

Researcher(s)

• Promoter: Hens Kristien

Research team(s)

• Center for Ethics

Project type(s)

• Research Project

Abstract

High chronic illness rates and the increased prevalence of comorbidities put the current curative and evidence-based medical model under considerable pressure. In this context, precision medicine (PM) emerges as a novel data-driven approach to medical research and clinical practice. This new paradigm in medicine introduces distinct bio-ethical and (social) epistemological issues. In this proposal I present standpoint epistemology (SPE) as an innovative, potentially fruitful way to explore PM. SPE states that social position plays a role in establishing knowledge, which is therefore partial. SPE is also committed to the epistemic advantage thesis, which states that historically underrepresented perspectives have a distinct advantage in identifying knowledge gaps. In this project, I explore potentially fruitful applications of SPE in PM on three distinct levels, using both empirical (interviews) and theoretical methodologies. First, SPE offers a moral and epistemological incentive to include the perspectives of historically underrepresented groups in PM research (methodological level). Secondly, it motivates us to expand bioethical inquiry and attend to empirically informed bioethics in PM (bioethical level). And finally, based on the situated knowledge thesis, SPE can help us identify moral-epistemological issues in PM (moral-epistemological level). This project intends to further the bioethical debate on PM and PM practice by investigating the usefulness of an SPE approach.

Researcher(s)

• Promoter: Hens Kristien
• Fellow: Kenis Daan

Research team(s)

• Center for Ethics

Project type(s)

• Research Project

Abstract

Individuals with mental health (MH) conditions and their families, especially those with highly prevalent neurodevelopmental diversity (NDDs), are exposed to high levels of discrimination and stigma, which significantly affects their physical and mental well-being. Our world-leading collaborative group at the forefront of research in NDDs will launch a new project - ?Risk, Resilience and Developmental Diversity in Mental Health? (R2D2-MH). We propose a double paradigm shift to improve the wellbeing of people with MH conditions and their families. We will move (i) from risk-focused studies towards understanding and promoting resilience, and (ii) from a diagnosis based approach to a developmental diversity approach that will define wellbeing and functioning across the human lifespan. R2D2- MH aims to identify genetic and environmental protective/resilience factors and how they influence developmental diversity and MH. We will investigate at multiple levels two highly prevalent early risks for MH conditions: prematurity and genetic liability for NDDs. Our project has four main ambitions 1. Provide the largest European multi-scale dataset on early human brain development and MH outcomes; 2 Identify biological mechanisms of resilience to the adverse effects of NDD; 3. Co-develop, with the stakeholders, new digital tools to increase participatory research/medicine and reduce stigma; 4. Establish predictive models to guide personalised interventions. R2D2-MH integratesinterdisciplinary and complementary expertise across Europe, Israel, and Australia that covers ethics, epidemiology, sociology, genetics, cell biology, neuroscience, computational modelling, Information Technology, psychology, and psychiatry. Our research is highly engaged: it embeds participant and patient involvement in research to ensure that our expected outcomes are truly translational, and will help to reduce stigma and burden for individuals with MH conditions.

Researcher(s)

• Promoter: Hens Kristien

Research team(s)

• Center for Ethics

Project type(s)

• Research Project

Abstract

Raising autistic children is not self-evident. Parents of young children with autism are often confronted with daily challenges, resulting in uncertainties regarding their roles and responsibilities in parenthood. By a timely diagnosis and intervention, clinicians may provide some initial guidance: sharing knowledge on autism and adapted parenting practices is key to early intervention. However, lived experience of other parents and insights from neurodiversity theory may give rise to the question of whether such early intervention from professional experts is doing full justice to the many layers of autism as a phenomenon and the diversity of roles and responsibilities of parents in particular. Therefore, this project's central question is how clinicians can support parents of a young child with autism in their multiple roles and responsibilities in an empowering way. First, we aim to gain a layered insight into the roles and responsibilities of parents of young autistic children from different perspectives. Using qualitative methods, we will analyze perspectives from (a) the academic literature on early interventions, (b) parents with lived experience, and (c) neurodiversity scholars. Building on this layered insight, we aim to co-create and test a group-based intervention for parents of young autistic children in collaboration with an advisory group consisting of parents, clinicians and neurodiversity scholars.

Researcher(s)

• Promoter: Hens Kristien

Research team(s)

• Center for Ethics

Project type(s)

• Research Project

Abstract

The way we practice medicine now and in the near future will be different. One the one hand we have the ever decreasing costs of revolutionary technologies such as genomics, proteomics, wearables and miniaturization of laboratory tests such as ELISAs and PCR-based biomarker detection (among many other inventions). On the other hand, there is the trend to apply these technologies on a larger scale and transform medicine in a data-rich science, where high-quality data from large cohorts will be used to gain new insights into diseases. This will lead to better and earlier diagnostics. The ultimate goal is preventing diseases, by taking preventive measures before the onset of a disease. This revolution in data gathering and also poses new ethical questions: First of all, pose these new technologies privacy risk for participants in the study? Second, how do we manage this sometimes sensitive data and who does actually owns it? How do we ask for consent in large cohorts with many different data types? What about incidental findings? The pilot study "I am Frontier" puts us in a good spot to provide answers and recommendations for these questions since we will have will many different data types (from genomics and proteomics to clinical and lifestyle data) of all participants and we can also chart their expectations and experiences. Especially for proteomics, we want to chart the privacy risks of this data type since, for now, it is considered non-personal data.

Researcher(s)

• Promoter: Hens Kristien
• Co-promoter: Boonen Kurt

Research team(s)

• Center for Ethics

Project type(s)

• Research Project

Abstract

With this project, we want to investigate the hypothesis that reflecting on the challenges and questions raised by epigenetics can shed some light on the current discussions on environmental ethics issues. Specifically, we will focus on whether technological solutions are an adequate response to environmental crises and whether environmental responsibility should be understood as primary an individual or a collective endeavor, or that we have to abandon dualistic thinking about the concept of responsibility itself. As we believe that ethical reflection on responsibility concepts also entails investigation of intuitions regarding responsibility, the project also entails an empirical part. We investigate values and intuitions regarding responsibility of researchers and research participants in two projects about pollution and epigenetics. Hence, our research question is: How does a dynamic concept of human biology influence concepts of moral responsibility towards environmental pollution?

Researcher(s)

• Promoter: Hens Kristien
• Fellow: Vulliermet François-Lucien

Research team(s)

• Center for Ethics

Project type(s)

• Research Project

Abstract

The transition to preventive medicine based on precision data raises several interesting philosophical and ethical questions. First, there is the question of the implications for responsibility. Preventive medicine has the potential to transform the concept of 'being a patient': as more and more risk factors are discovered in genomic and other data, more and more people gain actionable information about their health status. They all become potential patients. This transformation has relevance for how we conceive of responsibility for health. To which extent does more information also imply more individual responsibility for health? To which extent is there a collective responsibility to enable people to take care of their health? Can nudging techniques be employed? Is preventive medicine an individual or collective endeavour? Second, this ties in into the question of the value-ladenness of concepts of health and disease. Existing discussions of personalized medicine often take for granted that the question of what is 'good' or 'healthy' is fixed. Hence, 'personalized' refers to how health can be achieved but does not investigate how the meaning of 'health' is also linked to personal choices and contexts. If the aim of preventive medicine is to allow as many people to live good lives, it may need to include personal choices and contexts into the equation. Third, such a truly personalized approach may help the empowerment of patients. On the one hand, understanding and taking action on one's own health risks may empower people to take up responsibility for their own wellbeing. On the other hand, some people will not take up specific recommendations or consider the idea of preventive medicine an infringement of their autonomy. In this exploratory project, we will make an inventory of existing thoughts and opinions on responsibility, concepts of health and disease and empowerment in the context of precision medicine. This will be done through a study of the existing literature, but also in close engagement with the WeAre-partnership – composed of VITO, Vlaams Patiëntenplatform, Domus Medica, Zorgnet-Icuro and the Koning Boudewijnstichting – which is actively involved in building up an innovation ecosystem for personalized and preventive healthcare solutions, and by means of interviews with relevant stakeholders.

Researcher(s)

• Promoter: Hens Kristien

Research team(s)

• Center for Ethics

Project type(s)

• Research Project

Abstract

Synthetic biology is a new discipline that allows designing and creating novel, completely man-made biological systems such as metabolic pathways. The innovative technology is a game-changer for the sustainable production of pharmaceuticals, biofuels, enzymes, aroma compounds and bioplastics. The synthetic systems are often implemented in E. coli or yeast cells because the biotechnological toolbox for these organisms is readily available. However, these microbes are often not optimally suited for industrial or medical applications. This project therefore aims to develop a novel toolbox that allows the ethical exploitation of superior non-standard microbes. The project will not only yield an important breakthrough for the efficiency and possibilities of synthetic biology, but also constitutes a research consortium of a team of young and ambitious scientists that will serve as a strategic hub for the further development of synthetic biology in Flanders, thereby helping to maintain its leading position in biotech.

Researcher(s)

• Promoter: Lebeer Sarah
• Co-promoter: Hens Kristien

Research team(s)

• Environmental Ecology & Applied Microbiology (ENdEMIC)

Project type(s)

• Research Project

Abstract

B2-InF promotes Responsible Research and Innovation (RRI) and public participation in the field of Assisted Reproduction Technologies (ART), in order to align its scientific exercise and dissemination with the knowledge, concerns and expectations of populations (18-30 year-old) in Belgium, Switzerland, Italy, Spain, Macedonia, Albania, Slovenia and Kosovo. How? 1) By collecting, analyzing and transferring social scientific knowledge, expectations, and concerns about ART to clinics and policymakers and 2) by improving the scientific information offered by ART clinics to society from sociocultural, legal and gender perspectives through recommendation guidelines. B2-InF's target population is young people aged 18 to 30 who are childless and have not yet considered having offspring or experienced the need for ART, and therefore are not yet conscious of their fertility needs. Members of this population are referred to as "not patients" or "young population." B2-InF defines ART to include every procedure that involves manipulation of gametes to achieve pregnancy in the treatment of infertility. B2-InF also follows World Health Organization's definition of infertility: "lack of conception following one year of unprotected sexual intercourse."

Researcher(s)

• Promoter: Hens Kristien

Research team(s)

• Center for Ethics

Project type(s)

• Research Project

Abstract

Video games are sometimes thought to cause aggression, isolation or mental illness, despite the lack of conclusive evidence. The depiction of people with mental illness in video games is also often problematic, as the stereotype of the psychopathic character and of the mental institution as a setting for horror. However, more and more, artists use video games as a way to express their experiences with psychiatric diagnoses. Also, more and more games feature realistic and nuanced characters with a psychiatric diagnosis. With this project we want to investigate, using methodologies from disability studies and empirical philosophy, what we can learn from video games regarding the experience of a psychiatric diagnosis, especially autism, psychosis and depression.

Researcher(s)

• Promoter: Hens Kristien
• Co-promoter: Van Goidsenhoven Leni
• Fellow: Meinen Lisanne

Research team(s)

• Center for Ethics

Project type(s)

• Research Project

Abstract

In folk psychology and in bioethical discussions, the central dogma of genetics is often taken for granted: humans are seen as defined in a genetic blueprint. The conceptualization of psychiatric conditions as innate or acquired, biological or psychosocial, genetic or environmental, influences the ascription of both capacity responsibility (the capacity to adapt or adjust one's own behavior) and normative responsibility of individuals or the society towards those diagnosed. But findings in the field of epigenetics indicate that the social and physical environment influence how genes are expressed. Indeed, epigenetics may shed a new light on distinctions such as innate/acquired, genetic/ environmental, biological/psychosocial: a far more complex view on neurodevelopmental disorders may emerge, with ethical implications. However, the implications of epigenetics for discussions on the scope and extent of normative responsibility have not been adequately addressed. NEUROEPIGENETHICS aims to investigate the ethical implications of epigenetics for neurodevelopmental disorders. We will use theoretical and empirical methods to investigate how certain concepts (innate/biological/ genetic) affect the ways in which professionals and stakeholders (persons with a neurodevelopmental disorder and their families) conceive of responsibility. We will evaluate how the emerging field of epigenetics alters the ascription of capacity responsibility and normative responsibility. We will research how individuals with Autism Spectrum Disorder (ASD), Tourette Syndrome (TS) and Attention Deficit Hyperactivity Disorder (ADHD)and their families experience the interaction between their condition and their biological and social environment. Finally, we will define moral responsibility in light of the emerging field of epigenetics in the area of neurodevelopmental dis

Researcher(s)

• Promoter: Hens Kristien
• Fellow: Hens Kristien

Research team(s)

• Center for Ethics

Project type(s)

• Research Project

Abstract

In folk psychology and in bioethical discussions, the central dogma of genetics is often taken for granted: humans are seen as defined in a genetic blueprint. The conceptualization of psychiatric conditions as innate or acquired, biological or psychosocial, genetic or environmental, influences the ascription of both capacity responsibility (the capacity to adapt or adjust one's own behavior) and normative responsibility of individuals or the society towards those diagnosed. But findings in the field of epigenetics indicate that the social and physical environment influence how genes are expressed. Indeed, epigenetics may shed a new light on distinctions such as innate/acquired, genetic/ environmental, biological/psychosocial: a far more complex view on neurodevelopmental disorders may emerge, with ethical implications. However, the implications of epigenetics for discussions on the scope and extent of normative responsibility have not been adequately addressed. NEUROEPIGENETHICS aims to investigate the ethical implications of epigenetics for neurodevelopmental disorders. We will use theoretical and empirical methods to investigate how certain concepts (innate/biological/ genetic) affect the ways in which professionals and stakeholders (persons with a neurodevelopmental disorder and their families) conceive of responsibility. We will evaluate how the emerging field of epigenetics alters the ascription of capacity responsibility and normative responsibility. We will research how individuals with Autism Spectrum Disorder (ASD), Tourette Syndrome (TS) and Attention Deficit Hyperactivity Disorder (ADHD)and their families experience the interaction between their condition and their biological and social environment. Finally, we will define moral responsibility in light of the emerging field of epigenetics in the area of neurodevelopmental disorders and child psychiatric practice.

Researcher(s)

• Promoter: Hens Kristien

Research team(s)

• Center for Ethics

Project type(s)

• Research Project

Abstract

The lived experience of what it means to have a diagnosis of autism has not gained sufficient attention. In this project, I will interview 12 adolescents (14-18 years old) who have received a recent diagnosis of autism. I will query how they experience having a diagnosis, and how they experience 'autism' and 'being different'.

Researcher(s)

• Promoter: Hens Kristien

Research team(s)

• Center for Ethics

Project type(s)

• Research Project

Abstract

Although it is reasonable to accept that those parents who are not genetically linked to their children have equal parental status and rights and obligations as those who share their genes with their children, the meaning of the genetic contribution for the resulting children is less straightforward. A practice in which the importance of the genetic link for offspring has been much discussed in the media recently is that of artificial reproduction, through artificial insemination or IVF, with donor gametes or embryos. However, a systematic study of values and opinions of donor conceived children is missing. The aim of this study is to investigate how do persons conceived through artificial reproduction techniques (ART) using donor gametes think about parenthood and the importance of genes, by means of focus groups. An evaluation of the role and significance of genetics and biology in relation to parenthood has important consequences for the way we conceive parenthood in philosophy and law, as it may, by reevaluating what makes one a parent, put into question the often deployed distinction between 'biological' and 'social' parenthood. With this study we want to add to the ongoing debate on parenthood, genetics and biology by interviewing those who are acutely confronted with such questions in their lives, the children that have been conceived through artificial reproduction with donor gametes. We aim to map opinions and lived experiences of donor conceived adults, as a first effort to elucidate on a more conceptual level the meaning of genetics and biology in the context of parenthood and kinship. On the basis of this mapping, a philosophical analysis of ethical and legal implications of anonymous vs. non-anonymous sperm donation could be fruitfully developed.

Researcher(s)

• Promoter: Hens Kristien

Research team(s)

• Center for Ethics

Project type(s)

• Research Project

Abstract

This project deals with the question of responsibility of pregnant women towards their child. As such, there is a need to investigate also the perspective of women themselves, a perspective that is sometimes overlooked in philosophical discussions on this theme. I will explicitly also investigate the ideas and theories of feminist philosophers and their viewpoints on responsibility, pregnancy and difference, and investigate the viewpoints of women in the qualitative part of the research to avoid gender bias.

Researcher(s)

• Promoter: Lemmens Willem
• Fellow: Hens Kristien

Research team(s)

• Center for Ethics

Project type(s)

• Research Project