Ethical , Legal And Social Aspects Research Articles

Abstract A050: MicroRNA as biomarkers in early detection and personalized treatment in ovarian cancer: Development of a personalized prevention consortium

Abstract Epithelial ovarian cancer (EOC) has poor survival given no effective early detection strategies and non-specific early disease symptoms. We have formed a consortium with European and American partners to provide the necessary validation of a microRNA (miRNA) panel for earlier detection of EOC using serum samples and data from prospective cohorts, paired with clinical data and biospecimens. Our objectives are to validate a serologic miRNA panel that, together with CA125, would have sufficient diagnostic discrimination to be used as a tool that, complementary to imaging, would allow early identification and direction of patients with suspected malignancy to personalized gyn-oncological care. We will validate serum miRNA profiles as biomarkers for early detection in samples collected from cases ⇐3 years prior to EOC diagnosis and matched controls and characterize sources of variation in miRNA profiles and their impact on discrimination. Evaluate miRNA profiles in the clinical setting and the discrimination between EOC cases and women with (i) benign ovarian tumors in blood samples collected prior to diagnostic surgery and (ii) underlying comorbidities (including other cancer types). Further, we will evaluate serum miRNA profiles as predictors of recurrence and will compare tumor tissue and serum miRNA profiles. Develop and optimize protocols for data integration and methods for algorithm development. Direct in silico validation, including miRNA and CA125 levels, and clinical and epidemiologic data. Address Ethical, Legal and Social Aspects (ELSA), including activities in key stakeholder groups. Challenges in health data privacy and sharing, including for development of an artificial intelligence model, will be addressed, as will the definition of a “healthy” population with respect to miRNA profiles for EOC. The consortium was launched in 2023, with the first findings expected in 2024. Beyond the initial direct aims of the consortium, expanded aims on further promising markers are envisaged. Citation Format: Renée Turzanski Fortner, Hilde Langseth. MicroRNA as biomarkers in early detection and personalized treatment in ovarian cancer: Development of a personalized prevention consortium [abstract]. In: Proceedings of the AACR Special Conference on Ovarian Cancer; 2023 Oct 5-7; Boston, Massachusetts. Philadelphia (PA): AACR; Cancer Res 2024;84(5 Suppl_2):Abstract nr A050.

Of looping kinds and unruly objects: the conceptual making of organoids

Although the traditional approach within ELSA (Ethical, Legal and Social Aspects) initiatives is to have certain kinds of objects “set” or ready to be governed within bioethics, I will claim that the established regime of bioethics and bio law act as governance while influencing the conceptualization of the entities at play, in this example, the organoids. As a small contrast case to making organoids, I will use the regulation and categorization of embryonic research as a more “natural kind” entity research compared to conceptually synthetic research, where the objects to be regulated are shaped by existing practices of language and material alike. While analyzing the conceptual making of the organoids, I will follow the general methodological framework of Ian Hacking in Social Construction of What? (1999) from philosophy of science, particularly his understanding of “looping kinds”. And since Hacking’s understanding of looping kinds is in a relatively vague formulation, I will supply with different structures within co – productionist account of science and technology studies, most notably of works of Jasonoff (2015) of co-productionist accounts and Bensaude – Vincent’s concept of “buzzword coalitions” (2014) in the making of conceptual coalition around organoids. I will use the structure of scientific objects to assign different uses of parts of concepts in the making.

Stop re-inventing the wheel: or how ELSA and RRI can align

ABSTRACT Ethical, Legal and Social Aspects (ELSA) originated in the 4th European Research Framework Programme (1994) and responsible research and innovation (RRI) from the EC research agenda in 2010. ELSA has received renewed attention in European funding schemes and research. This raises the question of how these two approaches to social responsibility relate to one another and if there is the possibility to align. There is a need to evaluate the relationship/overlap between ELSA and RRI because there is a possibility that new ELSA research will reinvent the wheel if it does not engage with the body of literature already present in RRI research. This provides unneeded extra bureaucracy, reformulations of research agendas, extra investment, and an overabundance of frameworks to implement, and ELSA research does not take advantage of the body of research developed in RRI. This paper evaluates how ELSA and RRI diverge, are complementary, and can be aligned.

Limits of decentered governance in science-society policies

ABSTRACTThis article addresses the practices of implementing science policies that involve science-society relations, such as funding policies on ethical, legal, and social aspects (ELSA) and Responsible Research and Innovation (RRI). I examine how R&D actors translate such science governance. In particular, the paper focuses on possible tensions when scientists juggle competing policy demands. The paper draws mainly on interviews with scientists within biotechnology and nanotechnology in Norway. It shows that scientists try to accommodate rather than enact ELSA and RRI. They employ coping strategies of ‘following rules’, ‘dismissing’, and ‘contesting through talking the talk’. Thus, science-society policies fail to enter as a counter-logic to the hegemonic public management governing regime. The main argument is that RRI does not take hold because of a failure of meta-governance. Successful science-society policies should not focus only on encouraging scientists to adopt responsible behaviors, but on creating possible conditions for new practices.

M5 - The Use of Genomic Information In Medical Practice: A Survey on People’s Knowledge, Expectations, And Fears

Background Integrating novel medical technologies, like genomic high throughput research, into daily clinical practice very often involves considering various ethical, legal and social aspects (ELSA). Here, we aim to survey the attitudes towards the use of genomic high thoughput technologies and compare the views of different groups of participants, e.g. geneticists, physicians, patients, and the general population. To get an idea of the current perspectives, we developed a questionnaire that investigates on the one hand the current state of knowledge about the field of genetics (e.g. legal aspects) and on the other hand surveys the attitudes, fears, and expectations toward genome sequencing approaches. Methods We developed a questionnaire to assess people’s knowledge about genetics, professional experiences in the genetic context as well as their personal attitudes, fears and expectations towards the disclosure of findings from genomic high throughput approaches. The recruitment started in May 2016 and so far the sample includes data of 151 individuals that we studied in a preliminary analysis. Results 63 % of the participants would get their genome sequenced if they had the possibility in a clinical or in a research context. The wish to receive information about a finding heavily depended on the specifics of the finding in question. In case of a finding about a somatic genetic disease, 70.8 % wanted to be informed, in case of a psychiatric disorder, only 54.5 % wanted to receive information. Interestingly 83.4 % of participants who had a psychiatric disorder themselves wished to learn findings concerning psychiatric disorders, whereas only 48.6% of participants who had no psychiatric disorders wanted to be informed about those findings. When asked about potential consequences after disclosure, a majority of participants found that such knowledge might cause them to experience distress, even to the point of developing a depression. With regard to the disclosure of a clinically relevant finding, the majority of respondents (77.3%) were strongly interested in receiving counseling sessions. Regarding participants´ assumptions about legal regulations, we find that 52.3 % believe that there is a legal duty to disclose an incidental finding in the research context. Discussion Our data show that, in general, there is a positive and open attitude toward the implementation of genomic high throughput approaches. However, there comes a point where participants do not want to be informed anymore. The willingness to receive information on one’s own genetic conditions based on genomic data is critically influences by the characteristics of the potential finding. Of particular note, people are much more open toward learning about a risk of a somatic genetic disease than they are about receiving information related to a psychiatric disorder. This finding is relevant to the field of psychiatric genetics as it indicates that there still might be subliminal tendencies of stigmatization. Further analysis will show to what extent the stakeholders’ attitudes will differ and if knowledge and expertise in the field has an impact on attitudes.

Ethics Literacy and “Ethics University”: Two Intertwined Models for Public Involvement and Empowerment in Bioethics

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.

3D Bioprinting: A Deliberate Business

Genetic Engineering & Biotechnology NewsVol. 35, No. 1 Features3D Bioprinting: A Deliberate BusinessLaura HockadayLaura HockadayLaura Hockaday, Ph.D. (E-mail Address: laura.hockaday@tufts.edu), is a postdoctoral scholar at Tufts University, Biomedical Engineering Department, Catherine Kuo Laboratory.Search for more papers by this authorPublished Online:29 Dec 2014https://doi.org/10.1089/gen.35.01.09AboutSectionsView articleView Full TextPDF/EPUB ToolsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail View articleFiguresReferencesRelatedDetailsCited byInnovation in Additive Manufacturing Using Polymers: A Survey on the Technological and Material Developments26 March 2022 | Polymers, Vol. 14, No. 7Biodegradable Polymers for Biomedical Additive ManufacturingApplied Materials Today, Vol. 20A comparative study in the printability of a bioink and 3D models across two bioprinting platformsMaterials Letters, Vol. 264Bioresorbable polymers for bioprinting applications3-dimensional bioprinting for tissue engineering applications25 April 2016 | Biomaterials Research, Vol. 20, No. 13D bioprinting – An Ethical, Legal and Social Aspects (ELSA) frameworkBioprinting, Vol. 1-2 Volume 35Issue 1Jan 2015 Information© 2015 by GEN PublishingTo cite this article:Laura Hockaday.3D Bioprinting: A Deliberate Business.Genetic Engineering & Biotechnology News.Jan 2015.14-17.http://doi.org/10.1089/gen.35.01.09Published in Volume: 35 Issue 1: December 29, 2014PDF download

The role of philosophy of science in Responsible Research and Innovation (RRI): the case of nanomedicine

Research on ethical, legal and social aspects (ELSA) of life sciences and new technologies has mainly been focused on impacts and consequences, while the emerging framework of Responsible Research and Innovation (RRI) focuses rather on increased involvement and reflexivity in research processes to foster science and technology that better answers the needs of society. I argue that philosophy of science should be a central feature of RRI and demonstrate how the philosophy of science can contribute in this sense. I show how investigating basic assumptions in research, here exemplified by reductive assumptions in causal modeling, can have important ethical and societal implications.

The role of future-oriented technology analysis in the governance of emerging technologies: The example of nanotechnology

This paper analyzes the role that different types of future-oriented technology analysis (FTA) have played in the development of nanotechnology governance. In the US, FTA has been used to create visionary concepts and to promote cooperation between and among agencies, departments of the federal government, academia, and stakeholders. In Germany FTA has mainly been used to shape and define research and innovation agendas of established science–industry networks. The aim of the paper is to show what problems/challenges with regard to the innovation system have been addressed and what main actors have been involved, from the first monitoring and forecasting studies on nanotechnology to the establishment of national nanotechnology programs and continuing on until today. The paper offers a comparative analysis of the use and role of FTA where the focus is not on individual activities, but rather on the longer-term interplay between the organizational settings in both countries and the future-oriented nanotechnology analysis.In countries such as the US and Germany, where FTA on nanotechnology were already underway in the late 1980s, the early stages of FTA relied on expert-based methods such as technology intelligence and technology forecasting to define the field and to explore what could happen in general. Participatory formats such as dialogues on ethical, legal and social aspects (ELSA) became more important only later on. Especially the inter-organizational setting can be considered a crucial condition for maximizing the impact that participatory FTA can have in the future governance of nanotechnology.

Embracing complexity and uncertainty: An analysis of three orders of ELSA research on biobanks

During the past decades, research on ethical, legal, and social aspects (ELSA) of biobanks suggested and analysed various ethically and socially justifiable frameworks for collecting, storing, and distributing human biological material and bioinformation. In this article, we identify three patterns of argument that differ in terms of shared core assumptions and similar conceptual as well as normative orientations. These discursive 'orders', which are related to specific macropolitical contexts, have significantly shaped contexts for biobank policymaking. The first order was characterised by high expectations of genomics and biobanking. Second order discourse partly took over the problems located in the first order, but reintroduced them into a justificatory framework that identified biobanks as public goods per se. The third order of ELSA expertise maintained a supportive attitude towards biobanking. However, regulation based on deductive reasoning became progressively complemented by ideals of participatory mechanisms and different methodologies of studying public perceptions. We conclude that this emphasis on learning processes and deliberation helps biobank communities to develop new concepts, methods and insights that will prove helpful in order to adapt to essentially undetermined futures of transnational innovation societies.

A Knowledge Base for Teaching Biology Situated in the Context of Genetic Testing

Recent developments in the field of genomics will impact the daily practice of biology teachers who teach genetics in secondary education. This study reports on the first results of a research project aimed at enhancing biology teacher knowledge for teaching genetics in the context of genetic testing. The increasing body of scientific knowledge concerning genetic testing and the related consequences for decision-making indicate the societal relevance of such a situated learning approach. What content knowledge do biology teachers need for teaching genetics in the personal health context of genetic testing? This study describes the required content knowledge by exploring the educational practice and clinical genetic practices. Nine experienced teachers and 12 respondents representing the clinical genetic practices (clients, medical professionals, and medical ethicists) were interviewed about the biological concepts and ethical, legal, and social aspects (ELSA) of testing they considered relevant to empowering students as future health care clients. The ELSA suggested by the respondents were complemented by suggestions found in the literature on genetic counselling. The findings revealed that the required teacher knowledge consists of multiple layers that are embedded in specific genetic test situations: on the one hand, the knowledge of concepts represented by the curricular framework and some additional concepts (e.g. multifactorial and polygenic disorder) and, on the other hand, more knowledge of ELSA and generic characteristics of genetic test practice (uncertainty, complexity, probability, and morality). Suggestions regarding how to translate these characteristics, concepts, and ELSA into context-based genetics education are discussed.

The Ethics of Synthetic Biology

Synthetic Biology (SB) is the new kid on the block among emerging technosciences that are said to have a revolutionary impact and the potential to pose major ethical chal-lenges. SB aims at designing biological sys-tems for numerous useful purposes, ideally starting from scratch and creating new life forms. The new EU-funded project SYNTH-ETHICS will address a variety of ethical, legal and social aspects (ELSA) of these ongoing and anticipated developments. In the follow-ing, we will sketch the contours of the emerging discourse on the ethics of SB and our approach to its analysis. 1 Synthetic Biology

What is ELSA genomics?

The name Elsa might arouse various literary associations, from the female lead in Richard Wagner's (1813–1883) Lohengrin , to the wealthy socialite, Countess Elsa Schrader, in the musical The Sound of Music . This article, however, discusses a rather more recent personification of the name, ELSA as an acronym, which describes a particular field, or rather, a particular style of research that has emerged during the past two decades. > Some see ELSA as an ‘artefact’ of contemporary research funding strategies; a neologism coined for strategic reasons, but in need of a clear definition Research into the ethical, legal and social aspects (ELSA) or issues (ELSI) of genetics, and later genomics, was originally developed in the context of the Human Genome Project (HGP) in the USA, from where it subsequently spread to Canada and Europe—it is important to emphasize the genealogy of ELSA genomics as a ‘by‐product’ of the HGP. It was James Watson himself who, as the first Director of the HGP, decided that some of the project's budget should be devoted to studying the societal issues related to genetics research and its applications. At the press conference to announce his appointment as director, Watson suddenly and unexpectedly declared that the ethical and social implications of genome research warranted a special effort and should be funded directly by the US National Institutes of Health (Bethesda, MD, USA), which financed the larger part of the human genome sequencing effort (Cook‐Deegan, 1994/1995). Watson argued that, in the face of unprecedented challenges presented by modern biological research, the ‘contract’ between science and society was bound to be revisited by the large‐scale application of genomics research. Thus, in addition to discovering the structure of DNA together with Francis Crick, Watson can also be credited with ‘inventing’ ELSA and providing the impetus for what came …

Ethical, Legal and Social Aspects of Brain-Implants Using Nano-Scale Materials and Techniques

Nanotechnology is an important platform technology which will add new features like improved biocompatibility, smaller size, and more sophisticated electronics to neuro-implants improving their therapeutic potential. Especially in view of possible advantages for patients, research and development of nanotechnologically improved neuro implants is a moral obligation. However, the development of brain implants by itself touches many ethical, social and legal issues, which also apply in a specific way to devices enabled or improved by nanotechnology. For researchers developing nanotechnology such issues are rather distant from their daily work in the lab, but as soon as they use their materials or devices in medical applications such as therapy of brain diseases they have to be aware of and deal with them. This paper is intended to raise sensitivity for the ethical, legal and social aspects (ELSA) involved in applying nanotechnology in brain implants or other devices by highlighting the short term problems of testing and clinical trials within the existing regulatory frameworks (A), the short and medium-term questions of risks in the application of the devices (B) and the long-term perspectives related to problems of enhancement (C). To identify and address such issues properly nanotechnologists should involve ethical, legal and social experts and regulatory bodies in their research as early as possible. This will help to remove pressure from regulatory bodies, to settle public concern and to prevent non-acceptable developments for the benefit of the patients.