How to achieve integration?

In this chapter, the ethical, legal, and social aspects (ELSA) under the view of personalized medicine (PM) research and implementation in the healthcare context are illustrated.Nowadays, there is a multidisciplinary open debate on the current state of research on the ethical, legal, and social implications of PM. This chapter will be of interest to researchers and healthcare professionals to start their knowledge on PM, focusing on ELSA basic concepts related to the opportunity of sharing genomic and health-related data, ensuring continued progress in our knowledge of human health and well-being.In a general framework, the citizens’ data sharing and risk to privacy, informed consent, unsolicited or “incidental” findings, General Data Protection Regulation (GDPR), and some other general aspects related to data regulation are illustrated for providing basic knowledge and starting point to understand ELSA and gradually becoming more adept in performing these aspects under PM research and implementation. It is also briefly described the aspect of intellectual property and health technology assessment. Last but not least, one short section is dedicated to work and genetic discrimination. Also, briefly, the concept of equity and PM is described.This chapter closes with a discussion about the sometimes confusing concept of ELSA research versus ELSA on PM research.KeywordsEthical, legal, and social aspects (ELSA)Data sharingPatient recruitmentFAIRInformed consentGenetic discriminationEqual accessEquityPersonalized medicine

Human Brain Project: Ethics Management or Proceduralization of Reflexivity? Everywhere, the reflexivity and responsibility of research and innovation is called for – the neurosciences being no exception. Undesirable side effects of scientific‐technical developments should be recognized early on and opportunities for participation by non‐scientific actors should be made available. In addition to the well‐known reflective programs such as Technology Assessment, Public Understanding of Science, Ethical Legal and Social Implications (ELSI) of Science, Science Communication and Citizen Science, a new program is emerging: Responsible Research and Innovation (RRI). With the dimensions of anticipation, reflexivity, inclusiveness and responsiveness advocated here, social accountability of research has just been expanded again: factually (applying to the scientific practice of all domains), temporally (becoming more and more permanent) and socially (involving more and more actors). The following study will first reconstruct the current prominence of RRI as the dynamics of a changing relationship between science and society, then explore into the claim and reality of RRI as documented in publicly available material. The observation: While RRI at the level of its program aims at legitimacy through democratization of knowledge production, the organization of RRI demonstrates highly orchestrated bureaucratic arrangements and procedures. In the case of the Human Brain Project, it thus becomes clear that and how RRI is being put to the service of supporting neuroinformatic big science through targeted reductions: it is mainly framed as ‘ethics management’ and hardly integrated into research practice or even public discourse.

Informing lay citizens about complex health-related issues and their related ethical, legal, and social aspects (ELSA) is one important component of democratic health care/research governance. Public information activities may be especially valuable when they are used in multi-staged processes that also include elements of information and deliberation. This paper presents a new model for a public involvement activity on ELSA (Ethics University) and evaluation data for a pilot event. The Ethics University is structurally based on the "patient university," an already established institution in some German medical schools, and the newly developed concept of "ethics literacy." The concept of "ethics literacy" consists of three levels: information, interaction, and reflection. The pilot project consisted of two series of events (lasting 4 days each). The thematic focus of the Ethics University pilot was ELSA of regenerative medicine. In this pilot, the concept of "ethics literacy" could be validated as its components were clearly visible in discussions with participants at the end of the event. The participants reacted favorably to the Ethics University by stating that they felt more educated with regard to the ELSA of regenerative medicine and with regard to their own abilities in normative reasoning on this topic. The Ethics University is an innovative model for public involvement and empowerment activities on ELSA theoretically underpinned by a concept for "ethics literacy." This model deserves further refinement, testing in other ELSA topics and evaluation in outcome research.

ABSTRACTThe relation between technology assessment (TA) and responsible research and innovation (RRI) is a very topical (and controversial) issue, as TA is clearly enveloped in broader science, technology and innovation (STI) processes, such as the EU-wide shift towards RRI. In this short response to van Lente et al.’s [Van Lente, Harro, Tsjalling Swierstra, and Pierre-Benoît Joly. 2017. “Responsible Innovation as a Critique of Technology Assessment.” Journal of Responsible Innovation] essay, I first stress that this contribution has several merits; for example, it points to pervasive challenges for TA communities, such as the issue of including normative concerns when assessing innovations, it opens these challenges to debate, without shying away from engaging TA communities. However, I disagree with the authors’ claim that RRI would be ‘a next step of TA’ or even a ‘form of TA’. In my essay, I explain why I believe RRI is different from TA and why, rather than a critique of TA, RRI could instead lead to a travesty of TA, threatening the vitality and the uniqueness of TA institutions in the long-term. Under the spell of RRI, TA risks being reduced to a role of mere provider of ex-ante impact assessments. I conclude that following the money attached to RRI has a price that TA institutions should carefully, critically and reflexively consider before they pay.

Two scientific domains that are crucial in “Biomedical Big Data”, computing and statistics, do not typically require “training in the responsible conduct of research” or research ethics. While “responsible conduct of research” (RCR) comprises interactions with subjects (human and non-human), it also involves interactions with other scientists, the scientific community, the public, and in some contexts, research funders. Historically, the development or emergence of disciplines and professions tend to involve a semi-simultaneous emergence of professional norms and/or codes of conduct. However, Biomedical Big Data is not emerging as a single discipline or profession, and engages practitioners from many diverse backgrounds. Moreover, the place of the data analyst or the computer scientist developing analytic algorithms seems to be too granular to be considered specifically within the activities that comprise “responsible research and innovation” (RRI). Current legal and policy-level considerations of Biomedical Big Data and RRI are implicitly assuming that scientists carrying out the research and achieving the innovations are exercising their scientific freedom – i.e., conducting research – responsibly. The assumption is that all scientists are trained to conduct research responsibly. In the United States, federal agencies funding research require that training in RCR be included – some of the time. Because the vast majority of research that was federally funded has not included Biomedical Big Data, RCR training paradigms have emerged over the past 20 years in US institutions that are not particularly relevant for Big Data. While it would be efficient to utilize such established, well-known, easily-documented RCR training programs, this chapter discusses how and why this is less likely to support the development of professional norms that are relevant for Biomedical Big Data. This chapter will describe an alternative approach that can support ongoing reflection on professional obligations, which can be used in a wide range of ethical, legal, and social implications (ELSI), including those that have not yet been identified. This may be the greatest strength of this alternative approach for preparing practitioners for Biomedical Big Data, because the ability to apply prior learning in ethics to previously unseen problems is especially critical in the current era of dynamic and massive data accumulation. To support the development of normative ethical practices among practitioners in Biomedical Big Data, this chapter reviews the guidelines for professional practice from three statistical associations (American Statistical Association; Royal Statistics Society; International Statistics Institute) and from the Association of Computing Machinery. These can be leveraged to ensure that, in their work with Biomedical Big Data, participants know and understand the ethical, legal, and social implications of that work. Formal integration of these (or other relevant) guidelines into the preparation for practice with data (big and small) can help in dealing with ethical challenges currently arising with Big Data in biomedical research; moreover, this integration can also help deal with challenges that have not yet arisen. These outcomes, which are consistent with recent calls for the institutionalization of reflection and reasoning around ELSI across scientific disciplines, in Europe, are only possible as long as the integration effort does not follow a currently-dominant paradigm for training in RCR. Preparing scientists to engage competently in conversations around ethical issues in Biomedical Big Data requires purposeful, discipline-relevant, and developmental training that can come from, and support, a culture of ethical biomedical research and practice with Big Data.

“Same same but different”? On the questionable but crucial differentiation between ethical and social aspects in health technology assessment

Technological surveillance for the sake of safeguarding public safety (e.g., cameras, sensors, mobile phones, OSINT) pervades the lives of individuals on many levels. In this article, we advance the idea that the addition of AI changes the way surveillance ecologies function and thus deserves to spawn its own concept: the surveillance AI-cology. Surveillance AI-cologies are made up of interconnected collections of disparate actors (technological, human, more-than-human, organisational, etc.), all implicated in AI-aided surveillance tasks. They contain not only the usual complexities of any technological ecosystem but also the added complexity of AI, with emergent characteristics, both technically and socially. We argue for the utility of multi-faceted perspectives in doing work within AI-cologies, and we describe (anthropologically inspired) methodology for understanding and unpacking AI surveillance ecosystems. The development of democratically controlled AI surveillance requires the systematic consideration of ethical, legal, and social aspects (ELSA) within the quintuple helix (public, private, civil society, academia, nature). We stress the relevance of clearly defining which perspectives of the quintuple helix are considered in AI surveillance, and which not, to achieve a transparent set of (ELSA) values that guide AI surveillance development and implementation. We provide an example of the way we have developed and applied (some of) these methodologies in the context of a test-site for the development and application of smart city technology, a so-called “Living Lab.” Here we take the stance of active involvement of academics as “critical friends” into complex innovation and assessment processes. Together with our conversation partners in the field, we tease out and reflect upon the (public safety) values embedded in the setup of the Living Lab we explore. We end with a call to understand surveillance AI-cologies not as a problem to be solved, but as a continuing process to be discussed among highly diverse stakeholders.

Metaphors in ELSA research: Bridging the gap between the laboratory and the life-world Key features and critique of ELSA researchSince the inception of the Human Genome Project, interdisciplinary discussions between the natural and social sciences have often been conceptualized as ELSI (in the United States) or ELSA (in Europe).The acronym ELSA/I refers to the ethical, legal, and social aspects or implications of research in the life sciences [1] and has been extended to other fields of technological development, such as AI research [2].Situated at the boundary of science and society, ELSA research has since then been designed and funded primarily to improve the acceptability of biomedical and biotechnological innovations and to strengthen the overall trustworthiness of science [3].The integration of ELSA programs into scientific research funding has led to the emergence of a distinct and influential branch of research in bioethics and medical ethics, which encompasses additional initiatives such as "responsible research and innovation" (RRI) and "integrated research" [4][5][6].Hub Zwart and Annemiek Nelis have identified four features that are characteristic of ELSA research, namely: "embeddedness in scientific programmes; early anticipation of issues, publics and those responsible for dealing with these issues; interactivity, to encourage stakeholders and publics to assume a more active role in co-designing research agendas; and interdisciplinarity, to bridge the boundaries between research communities such as bioethics and STS" [1, p. 543]. 1 The close interconnection of science policy funding with the bio-industry has, however, raised concerns about the independence of ELSA research [7].Problems related to joint project funding and the pursuit of economic interests, the emphasis on merely legitimizing science, and the reduction of ethical reflection to a box-ticking exercise -among other potential and actual limitations and biases -were already articulated and criticized in the early stages of ELSA's development [8].This critique culminates in the suspicion that ELSA research serves merely as a fig leaf for other research interests [9][10][11].Ethical research accompanying biotechnological and biomedical innovations faces several challenges.First, it depends on a general willingness to cooperate across disciplines as well as on third-party funding within ELSA programs.

This scoping review aims to summarize the importance of community return on investment in the All of Us Research Program, particularly for enhancing the representation of underrepresented communities. It explores previous studies on social determinants of health (SDoH) and discusses the ethical, legal, and social implications (ELSI) associated with past implementations of the program. Furthermore, it discusses encountered challenges and explores strategies. We conducted a scoping review of relevant literature to examine the intersection of SDoH and ELSI within the All of Us Program. A systematic search of the literature was performed in March 2025, on PubMed/MEDLINE, EMBASE, Web of Science, Cochrane Library, and Google Scholar. We identified 17 studies that focused on the intersection of the SDoH domains and ELSI. Studies showcased the importance of addressing economic, educational, and environmental factors alongside ethical considerations to enhance health equity. Despite challenges such as data completeness and participant diversity, the program’s approach to engaging with diverse communities and prioritizing ethical standards exemplifies a forward-thinking strategy in research. Understanding the intersection of SDoH and ELSI is crucial for the success of the All of Us Program. Integrating these factors may enhance the program’s ability to address the needs of underrepresented communities, ultimately increasing community return on investment. By continuing to address the challenges of inclusivity and data comprehensiveness, the program stands to contribute substantially to the reduction of health disparities and the advancement of healthcare for all.

The growing number of papers on Responsible Innovation (RI) and Responsible Research and Innovation (RRI) have shaped the popularity and usefulness of RI and RRI as a technology governance concept. This study reviews and assesses the development of RRI research through a bibliometric analysis of 702 RRI-focused papers and 26,471 secondary references published in the Web of Science Core Collection database between 2006 and 2020. Firstly, the paper provides a broad outline of the field based on annual growth trends, journal distribution, and disciplinary distribution for RRI publications. Secondly, this study reveals the current state of RRI research by identifying influential literature, journals, authors, countries, and institutions. Thirdly, a phased keyword analysis is conducted to determine the stage characteristics of the RRI field. Finally, based on the bibliometric analyses, this study summarises the evolutionary trajectory of RRI and makes recommendations for future research directions. As a complement to the previous qualitative literature review, the paper provides a systematic and dynamic understanding of RRI research.

The ethical, legal, and social implications (ELSI) of emerging neurobiobanks and data resources are unclear in an African scientific landscape with unique cultural, linguistic, and belief systems. The overarching goal of the African Neurobiobank for Precision Stroke Medicine—ELSI Project is to identify, examine, and develop novel approaches to address ELSI issues of biobanking and stroke genomic research in sub-Saharan Africa (SSA). To accomplish the goal we will (1) explore knowledge, attitude, perceptions, barriers, and facilitators influencing ELSI issues related to biobanking and stroke genomic research; (2) use information obtained to craft a community intervention program focused on ELSI issues; and (3) build capacity and careers related to genomics and biobanking for effective client/community engagement while enhancing regulatory, governance, and implementation competences in biobanking science in SSA. A community-based participatory research and mixed-methodological approach, focused on various levels of the social ecological model, will be used to identify and examine relevant ELSI issues. Contextual intervention tools, platforms, and practices will be developed to enhance community understanding and participation in stroke biobanking and genomics research activities while facilitating enduring trust, and equitable and fair utilization of biobanking resources for genetic and trans-omics research. A concurrent capacity building program related to genetic counseling and biobanking will be implemented for early career researchers. The huge potential for neurobiobanking and genomics research in Africa to advance precision medicine applicable to stroke and other neurological disorders requires addressing ELSI challenges while building sustainable research, career, and regulatory capacities in trans-omics and biobanking science.

The emergence and rapid development of ICT-centred research methodologies, and data-driven research and innovation in particular, fundamentally challenge ethical values, human rights and security in the EU and beyond. This is especially—though not exclusively—the result of fragmented legal, ethical and terminological frameworks; a mismatch between rules and how they are applied or disregarded in practice; the privatisation of research data and methods; the fact that these challenges are spread over multiple actors and disciplines and issues raised by data opportunism. These challenges keep Responsible Research and Innovation (RRI) largely hypothetical in many contexts and may lead to social rejection and distorted legislation of emerging research methodologies as well as the huge socio-economic potential they hold. This contribution advances the first blueprint for an innovative approach aimed at overcoming the challenges obstructing the full realisation of RRI. The Designing-by-Debate (DbD) approach provides a systematic model and method for inclusive dialogue through smart stewardship, enabling researchers and the broader stakeholder community to develop, fine-tune and operationalise the framework for RRI to their situation. It is an iterative process based on different forms of participatory debate, aimed at formulating RRI protocols and policies with maximal participation from all stakeholders. The method relies on sharing protocols and guidelines so that they can be used and improved simultaneously through new RRI applications. The DbD approach has different well-defined layers and components, that are aimed at making RRI work in the field. Notwithstanding its greater ambitions, the scope of this contribution is confined to DbD in the context of data-driven research and innovation (and how to align it with ethical, normative, and societal values that are central to the EU identity). DbD, we argue, provides the prerequisites for a holistic yet concrete approach to key legal, ethical and social challenges emerging from ubiquitous use of technology and ‘data’ to do research and innovation.

The transdisciplinary Assisted Living project conducts research within (ICT), health science, social science and ethics. The overall aim of the project is to advance responsible research and innovation (RRI) in the field of welfare technology. By adapting an RRI framework, the project aims to: (a) map how stakeholders and experts perceive the state-of-the-art of responsible welfare technologies, focusing on assisted living technologies (ALT), in Norway and internationally; (b) develop ALT solutions for users with mild cognitive impairment and dementia (MCI/D), through an RRI approach; (c) judge by an integrated HTA approach whether technologies introduced through an RRI process score better than currently implemented technologies; and d) create a wider dialogue on responsible welfare technologies for the future, reflecting on alternatives and options. In the project RRI is operationalized as involving four dimensions: (i) A specific focus on addressing significant societal needs and challenges, (ii) A research and development process that actively engages and responds to a range of stakeholders, (iii) A concerted effort to anticipate potential problems, identify alternatives, and reflect on underlying values, and (iv) A willingness from relevant actors to act and adapt according to 1–3. These dimensions are built into the project's design in different ways. The project, funded by the Research Council of Norway, started December 2015 and we have by now had substantial experience with working with these dimensions in practice. This paper will describe the experiences with including needs assessment, engagement, anticipation, reflection and responsiveness in the project, after 1.5 years operation. The paper will highlight several challenges that have appeared in the project when doing RRI in practice, related to transdisciplinarity, communication, project planning and control, and quality. We believe that the challenges experienced in our project are typical of RRI projects, so it is important to create open discussions about the pros and cons of RRI projects in the community of RRI practitioners.

ELSI (Ethical, Legal and Social Implications) initiatives are frequently attached to major science programmes. The expectation is that ELSI research will produce a practical advanced assessment of the impacts of technological development. Williams' overview of the field demonstrates that this encourages a mechanistic understanding of technological development leading to compressed foresight, i.e. the notion that the future is imminent in the present. The development of the ELSI domain in Canada has been characterised by an affinity between the types of knowledge valorised by the field and modes of legal reasoning, suggesting a legal variant of compressed foresight. The concept of juridification and an analysis of two related modes of legal reasoning (analogy and reflective equilibrium) shed light on the connection between legal reasoning and the ELSI field in Canada. The deployment of the aforementioned modes of legal reasoning enables law to define and operationalise difficult questions by drawing on currently existing principles and precedents. Thus, when legal modes of reasoning are brought to bear on ELSI questions, the future is made a calculable and manageable extension of the present, dovetailing with the ELSI field's requirement of pragmatic, advanced assessment.

Responsible research and innovation (RRI) has recently emerged as a policy framework to align technological innovation with broader social values. It helps regions focus on their strengths and boost their innovation, growth, and prosperity through partnerships between business, public entities, and knowledge institutions. However, the study of RRI dynamics including whether and how attitudes, drivers, and behaviours at the individual, organizational, and network levels affect the impact of RRI, is in its infancy. Based on a survey of societal actors from three regional innovation ecosystems in Norway, Austria, and Spain, we examine the role of RRI in responsible regional planning. Our study advances our knowledge about regional innovation policies by providing evidence of how different stakeholders and policymakers engage in RRI when designing responsible regional planning. We identify the extent to which they incorporate RRI activities into their work practices, the extent to which their organizations and network support their practices and outcomes, and the effects they have observed. Our study also considers the factors that promote or impede RRI activities. The results are particularly relevant for policy makers interested in strengthening regional innovation policies and boosting regional growth via RRI.