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  • 1.
    Salles, Arleen
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Evers, Kathinka
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Farisco, Michele
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Anthropomorphism in AI2020In: AJOB Neuroscience, ISSN 2150-7740, E-ISSN 2150-7759, Vol. 11, no 2, p. 88-95Article in journal (Refereed)
    Abstract [en]

    AI research is growing rapidly raising various ethical issues related to safety, risks, and other effects widely discussed in the literature. We believe that in order to adequately address those issues and engage in a productive normative discussion it is necessary to examine key concepts and categories. One such category is anthropomorphism. It is a well-known fact that AI’s functionalities and innovations are often anthropomorphized (i.e., described and conceived as characterized by human traits). The general public’s anthropomorphic attitudes and some of their ethical consequences (particularly in the context of social robots and their interaction with humans) have been widely discussed in the literature. However, how anthropomorphism permeates AI research itself (i.e., in the very language of computer scientists, designers, and programmers), and what the epistemological and ethical consequences of this might be have received less attention. In this paper we explore this issue. We first set the methodological/theoretical stage, making a distinction between a normative and a conceptual approach to the issues. Next, after a brief analysis of anthropomorphism and its manifestations in the public, we explore its presence within AI research with a particular focus on brain-inspired AI. Finally, on the basis of our analysis, we identify some potential epistemological and ethical consequences of the use of anthropomorphic language and discourse within the AI research community, thus reinforcing the need of complementing the practical with a conceptual analysis.

  • 2.
    Pestoff, Rebecka
    et al.
    Linkoping Univ, Dept Clin Genet, Univ Hosp, S-58185 Linkoping, Sweden;Linkoping Univ, Dept Clin & Expt Med, Univ Hosp, S-58185 Linkoping, Sweden.
    Svensson, Karin
    Dept Clin Genet & Pathol, Div Lab Med, Off Med Serv, SE-22185 Lund, Sweden.
    Paneque, Milena
    Univ Porto, I3S Inst Invest & Inovacao Saude, Porto, Portugal;Univ Porto, IBMC Inst Mol & Cell Biol, Porto, Portugal;Univ Porto, Ctr Predict & Prevent Genet CGPP, Porto, Portugal.
    Ingvoldstad, Charlotta
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Karolinska Inst, Dept Clin Sci Intervent & Technol, Stockholm, Sweden; Karolinska Univ Hosp, Ctr Fetal Med, S-17176 Stockholm, Sweden.
    Developing a national certification pathway for genetic counselors in Sweden: a short report2020In: Journal of Community Genetics, ISSN 1868-310X, E-ISSN 1868-6001, Vol. 11, no 1, p. 113-117Article in journal (Refereed)
    Abstract [en]

    There is no Master's level education for genetic counseling in Sweden, meaning that genetic counselor professionals have very different backgrounds. Hence, there is a need to harmonize the quality of genetic counseling and introduce standards for practice. The Swedish Society for Genetic Counselors and the Swedish Society of Medical Genetics and Genomics collaborated to determine professional requirements and a career pathway, defining three vocational levels within the genetic counselor profession. We report here an individual educational pathway leading up to eligibility for certification as a genetic counselor in Sweden.

  • 3.
    Rejnö, Åsa
    et al.
    University West, Sweden;Skaraborg Hospital, Skövde, Sweden.
    Ternestedt, Britt-Marie
    Ersta Sköndal Bräcke University College, Sweden.
    Lennart, Nordenfelt
    Ersta Sköndal Bräcke University College, Sweden.
    Silfverberg, Gunilla
    Ersta Sköndal Bräcke University College, Sweden.
    Godskesen, Tove E.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Ersta Sköndal Bräcke University College, Sweden.
    Dignity at stake: Caring for persons with impaired autonomy2020In: Nursing Ethics, ISSN 0969-7330, E-ISSN 1477-0989, Vol. 27, no 1, p. 104-115Article in journal (Refereed)
    Abstract [en]

    Dignity, usually considered an essential ethical value in healthcare, is a relatively complex, multifaceted concept. However, healthcare professionals often have only a vague idea of what it means to respect dignity when providing care, especially for persons with impaired autonomy. This article focuses on two concepts of dignity, human dignity and dignity of identity, and aims to analyse how these concepts can be applied in the care for persons with impaired autonomy and in furthering the practice of respect and protection from harm. Three vignettes were designed to illustrate typical caring situations involving patients with mild to severely impaired autonomy, including patients with cognitive impairments. In situations like these, there is a risk of the patient’s dignity being disrespected and violated. The vignettes were then analysed with respect to the two concepts of dignity to find out whether this approach can illuminate what is at stake in these situations and to provide an understanding of which measures could safeguard the dignity of these patients. The analysis showed that there are profound ethical challenges in the daily care of persons with impaired autonomy. We suggest that these two concepts of human dignity could help guide healthcare professionals to develop practical skills in person-centred, ethically grounded care, where the patient’s wishes and needs are the starting point.

  • 4.
    Niemiec, Emilia
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Howard, Heidi Carmen
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    “Genethics” and Public Health Genomics2020In: Applied Genomics and Public Health / [ed] George P. Patrinos, San Diego: Elsevier Inc./Academic Press , 2020, 1, p. 243-257Chapter in book (Other academic)
  • 5.
    Niemiec, Emilia
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Howard, Heidi Carmen
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Germline Genome Editing Research: What Are Gamete Donors (Not) Informed About in Consent Forms?2020In: The CRISPR Journal, ISSN 2573-1599, Vol. 3, no 1, p. 52-63Article in journal (Refereed)
    Abstract [en]

    The potential for using germline genome editing (GGE) in humans has garnered a lot of attention, both for its scientific possibilities as well as for the ethical, legal, and social challenges it ignites. The ethical debate has focused primarily on the suggestions of using GGE to establish a pregnancy (i.e., to offer it in a clinical setting), which is, to date, illegal in many jurisdictions. The use of GGE in research (where a pregnancy would not be established) has received much less attention, despite the fact that it raises serious ethical and social issues as well. Herein, we report on the analysis of informed consent forms for egg and sperm donation used in a widely publicized study where genome editing was used to correct a disease-causing genetic mutation in human embryos. Importantly, embryos were created using eggs and sperm obtained specifically for these experiments. The analysis indicates deficiencies in how the forms addressed various issues, including limited and potentially misleading information about the sensitive nature of the study, the lack of an explicit mention of genomic sequencing, as well as the poor readability of the forms. Furthermore, the arguably high compensation of U.S.$5,000 for egg donors raises questions about undue inducement to participate in research. Moreover, since the procurement of eggs involves serious health risks, it may be questioned whether research requiring such a procedure should be pursued. If such experiments are continued, donors should be informed about all relevant aspects in order to make informed decisions about participating.

  • 6. Dal-Ré, Rafael
    et al.
    Solberg, Berge
    Fuhr, Uwe
    Eriksson, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Reporting the details of consent procedures in clinical trials2020In: Journal of Clinical Epidemiology, ISSN 0895-4356, E-ISSN 1878-5921, Vol. 117, p. 150-151Article in journal (Refereed)
  • 7.
    Falkenström, Erica
    et al.
    Institutet för framtidsstudier.
    Höglund, Anna T
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    "There is total silence here". Ethical competence and inter-organizational learning in healthcare governance2020In: Journal of Health Organisation & Management, ISSN 1477-7266, E-ISSN 1758-7247, Vol. 34, no 1, p. 53-70Article in journal (Refereed)
  • 8.
    Höglund, Anna T
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    What shall we eat? An ethical framework for well-grounded food choices2020In: Journal of Agricultural and Environmental Ethics, ISSN 1187-7863, E-ISSN 1573-322XArticle in journal (Refereed)
  • 9.
    Matar, Amal
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Hansson, Mats G.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Höglund, Anna T.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    "A perfect society": Swedish policymakers' ethical and social views on preconception expanded carrier screening2019In: Journal of Community Genetics, ISSN 1868-310X, E-ISSN 1868-6001, Vol. 10, no 2, p. 267-280Article in journal (Refereed)
    Abstract [en]

    To improve healthcare policymaking, commentators have recommended the use of evidence, health technology assessment, priority setting, and public engagement in the process of policymaking. Preconception expanded carrier screening, according to the World Health Organization’s definition, is a novel health technology and therefore warrants assessment, part of which involves evaluating ethical and social implications. We examined ten Swedish policymakers’ perspectives on ethical and social aspects of preconception expanded screening through in-depth expert interviewing, using a semi-structured questionnaire. Respondents were affiliated to governmental and non-governmental institutions that directly influence healthcare policymaking in Sweden. The interviews were recorded, transcribed verbatim, and analyzed via inductive thematic analysis method, which generated seven themes and several subthemes. Policymakers harbored concerns regarding the economics, Swedish and international political respects, implementation procedures, and societal effects, which included long-term ones. Moreover, participants detailed the role of public engagement, research, and responsibility in regard to preconception expanded carrier screening implementation. Since this is a qualitative study, with a small non-random sample, the results may not be generalizable to all policymakers in Sweden. However, the results give a profound insight into the process and interpretative knowledge of experts, in the Swedish milieu and the extent of readiness of Sweden to implement a preconception expanded carrier screening program.

  • 10.
    Fernow, Josepine
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Achieving impact: some arguments for designing a communications strategy2019In: RRI implementation in bioscience organisations / [ed] Declich, Andrea, Uppsala University, 2019, p. 177-180Chapter in book (Refereed)
    Abstract [en]

    Practicing RRI implies that we make an effort to communicate beyond our peers, opening up research organisations and extending our reach to public policy makers and researchers in other fields. To achieve impact, researchers need to find new ways of interacting with actors outside their own fields. Ideally also doing it well, without wasting time, while maintaining public trust, and without contributing to misconceptions about what science can deliver. This contribution to the STARBIOS2 guideline on RRI implementation in bioscience organisations contextualises the need for communications and dissemination strategy for research projects and provides guidance on how to build a strategy for communication and dissemination.

  • 11.
    Mascalzoni, Deborah
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Eurac Res, Inst Biomed, Via Galvani 31, I-39100 Bolzano, Italy;Eurac Res, Inst Biomed, Balzano, Italy.
    Bentzen, Heidi Beate
    Univ Oslo, Norwegian Res Ctr Comp & Law, Dept Private Law, Fac Law, POB 6706, N-0130 Oslo, Norway;Univ Oslo, Ctr Med Eth, Oslo, Norway.
    Budin-Ljosne, Isabelle
    Norwegian Inst Publ Hlth, POB 222, N-0213 Oslo, Norway.
    Bygrave, Lee Andrew
    Univ Oslo, Norwegian Res Ctr Comp & Law, Dept Private Law, Fac Law, POB 6706, N-0130 Oslo, Norway.
    Bell, Jessica
    Univ Oslo, Norwegian Res Ctr Comp & Law, Dept Private Law, Fac Law, POB 6706, N-0130 Oslo, Norway;Univ Oxford, Oxford, England;Univ Melbourne, Melbourne, Vic, Australia;Univ Melbourne, Melbourne Law Sch, 185 Pelham St, Melbourne, Vic 3010, Australia.
    Dove, Edward S.
    Univ Edinburgh, Sch Law, LG 12,Old Coll,South Bridge, Edinburgh EH8 9YL, Midlothian, Scotland.
    Fuchsberger, Christian
    Eurac Res, Inst Biomed, Via Galvani 31, I-39100 Bolzano, Italy.
    Hveem, Kristian
    Norwegian Univ Sci & Technol, HUNT Res Ctr, Levanger, Norway;Norwegian Univ Sci & Technol, KG Jebsen Ctr Genet Epidemiol, Levanger, Norway;HUNT Res Ctr, Forskningsvegen 2, N-7600 Levanger, Norway.
    Mayrhofer, Michaela Th.
    BBMRI ERIC, Neue Stiftingtalstr 2-B-6, A-8010 Graz, Austria.
    Meraviglia, Viviana
    Eurac Res, Inst Biomed, Via Galvani 31, I-39100 Bolzano, Italy.
    O'Brien, David R.
    Harvard Univ, Boston, MA 02115 USA;Harvard Univ, Berkman Klein Ctr Internet & Soc, 23 Everett St,2nd Floor, Cambridge, MA 02138 USA.
    Pattaro, Cristian
    Eurac Res, Inst Biomed, Via Galvani 31, I-39100 Bolzano, Italy.
    Pramstaller, Peter P.
    Eurac Res, Inst Biomed, Via Galvani 31, I-39100 Bolzano, Italy.
    Rakic, Vojin
    Univ Belgrade, Ctr Study Bioeth, Inst Social Sci, Kraljice Natalije 45,POB 605, Belgrade 11000, Serbia.
    Rossini, Alessandra
    Eurac Res, Inst Biomed, Via Galvani 31, I-39100 Bolzano, Italy.
    Shabani, Mahsa
    Katholieke Univ Leuven, Leuven, Belgium;Leuven Inst Human Genom & Soc, Leuven, Belgium;Univ Leuven, Ctr Biomed Eth & Law, Kapucijnenvoer 35, B-3000 Leuven, Belgium.
    Svantesson, Dan Jerker B.
    Bond Univ, Fac Law, Gold Coast, Qld 4229, Australia.
    Tomasi, Marta
    Univ Trento, Fac Law, Via Verdi 53, I-38100 Trento, Italy;Free Univ Bozen Bolzano, Bolzano, Italy.
    Ursin, Lars
    Norwegian Univ Sci & Technol, Trondheim, Norway;Norwegian Univ Sci & Technol, Dept Publ Hlth & Nursing, KG Jebsen Ctr Genet Epidemiol, Hakon Jarls Gate 11, N-7030 Trondheim, Norway.
    Wjst, Matthias
    Helmholtz Zentrum Munchen, Natl Res Ctr Environm Hlth, Inst Lung Biol & Dis, D-85764 Munich, Germany;Tech Univ Munich, Munich, Germany.
    Kaye, Jane
    Univ Oslo, Norwegian Res Ctr Comp & Law, Dept Private Law, Fac Law, POB 6706, N-0130 Oslo, Norway;Univ Oxford, Oxford, England;Univ Melbourne, Melbourne, Vic, Australia;Univ Oxford, Nuffield Dept Populat Hlth, HeLEX Ctr Hlth Law & Emerging Technol, Ewert House,Ewert Pl, Oxford OX2 7DD, England.
    Are Requirements to Deposit Data in Research Repositories Compatible With the European Union's General Data Protection Regulation?2019In: Annals of Internal Medicine, ISSN 0003-4819, E-ISSN 1539-3704, Vol. 170, no 5, p. 332-334Article in journal (Other academic)
  • 12.
    Middleton, Anna
    et al.
    Connecting Sci, Soc & Eth Res, Wellcome Genome Campus, Cambridge, England;Univ Cambridge, Fac Educ, Cambridge, England.
    Milne, Richard
    Thorogood, Adrian
    Kleiderman, Erika
    Niemiec, Emilia
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Prainsack, Barbara
    Farley, Lauren
    Bevan, Paul
    Steed, Claire
    Smith, James
    Vears, Danya
    Atutornu, Jerome
    Howard, Heidi Carmen
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Morley, Katherine I
    Connecting Sci, Soc & Eth Res, Wellcome Genome Campus, Cambridge, England;Kings Coll London, Inst Psychiat Psychol & Neurosci, London, England;Univ Melbourne, Ctr Epidemiol & Biostat, Melbourne Sch Global & Populat Hlth, Melbourne, Vic, Australia.
    Attitudes of publics who are unwilling to donate DNA data for research.2019In: European Journal of Medical Genetics, ISSN 1769-7212, E-ISSN 1878-0849, Vol. 62, no 5, p. 316-323Article in journal (Refereed)
    Abstract [en]

    With the use of genetic technology, researchers have the potential to inform medical diagnoses and treatment in actionable ways. Accurate variant interpretation is a necessary condition for the utility of genetic technology to unfold. This relies on the ability to access large genomic datasets so that comparisons can be made between variants of interest. This can only be successful if DNA and medical data are donated by large numbers of people to 'research', including clinical, non-profit and for-profit research initiatives, in order to be accessed by scientists and clinicians worldwide. The objective of the 'Your DNA, Your Say' global survey is to explore public attitudes, values and opinions towards willingness to donate and concerns regarding the donation of one's personal data for use by others. Using a representative sample of 8967 English-speaking publics from the UK, the USA, Canada and Australia, we explore the characteristics of people who are unwilling (n = 1426) to donate their DNA and medical information, together with an exploration of their reasons. Understanding this perspective is important for making sense of the interaction between science and society. It also helps to focus engagement initiatives on the issues of concern to some publics.

  • 13.
    Helgesson, Gert
    et al.
    Stockholm Centre for Healthcare Ethics, Karolinska institutet.
    Eriksson, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Authorship Order2019In: Learned Publishing, ISSN 0953-1513, E-ISSN 1741-4857, Vol. 32, no 2, p. 106-112Article in journal (Refereed)
    Abstract [en]

    Considering the fact that authorship order plays such a significant role as a basis for scientific merit, this paper looks into the practices of authorship order from a research ethical perspective. We conclude that there is a wide variety of practices and no common understanding of what the different authorship positions signify. Authorship guidelines do not provide much help. We recognize that, regardless of what system for valuing authorship positions is used, it will be misleading and unfair in most applications because relative contributions vary in ways that are not captured by fixed value assignments to authorship positions. In theory, assigning percentage figures reflecting the relative contributions of the authors would solve that problem, but we argue that such a scheme is not likely to work in practice. It can also be questioned whether relative, rather than absolute, contributions should be the basis for scientific merit. Contributorship is discussed as an alternative, but is recognized to be insufficient both in communicating absolute and relative contributions, as standardly used. However, there may be a way forward with contributorship, but then, the level of detail needs to increase considerably and its application be standardized.

  • 14.
    Northoff, Georg
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Hangzhou Normal Univ, Dept Psychol, Hangzhou 310013, Zhejiang, Peoples R China;Univ Ottawa, Inst Mental Hlth Res, Mind Brain Imaging & Neuroeth, Ottawa, ON, Canada.
    Tumati, Shankar
    Univ Ottawa, Inst Mental Hlth Res, Mind Brain Imaging & Neuroeth, Ottawa, ON, Canada.
    "Average is good, extremes are bad" - Non-linear inverted U-shaped relationship between neural mechanisms and functionality of mental features2019In: Neuroscience and Biobehavioral Reviews, ISSN 0149-7634, E-ISSN 1873-7528, Vol. 104, p. 11-25Article, review/survey (Refereed)
    Abstract [en]

    Traditionally, studies emphasize differences in neural measures between pathological and healthy groups, assuming a binary distinction between the groups, and a linear relationship between neural measures and symptoms. Here, we present four examples that show a continuous relation across the divide of normal and pathological states between neural measures and mental functions. This relation can be characterized by a nonlinear inverted-U shaped curve. Along this curve, mid-range or average expression of a neural measure is associated with optimal function of a mental feature (in healthy states), whereas extreme expression, either high or low, is associated with sub-optimal function, and occurs in different neural disorders. Neural expression between the optimal or intermediate and pathological or extreme values is associated with sub-optimal function and atrisk mental states. Thus, this model of neuro-mental relationship can be summarized as "average is good, extremes are bad". By focussing on neuro-mental relationships, this model can facilitate the transition of psychiatry from a categorical to a dimensional and individualized approach needed in the era of precision medicine.

  • 15.
    Stahl, Bernd Carsten
    et al.
    De Montfort Univ, Ctr Comp & Social Responsibil, Leicester, Leics, England.
    Akintoye, Simisola
    De Montfort Univ, Leicester De Montfort Law Sch, Leicester, Leics, England.
    Fothergill, Tyr
    De Montfort Univ, Ctr Comp & Social Responsibil, Leicester, Leics, England.
    Guerrero, Manuel
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Karolinska Inst, Dept Neurobiol Care Sci & Soc, Div Neurogeriat, Solna, Sweden; Univ Chile, Dept Bioeth & Med Humanities, Santiago, Chile.
    Knight, Will
    De Montfort Univ, Ctr Comp & Social Responsibil, Leicester, Leics, England.
    Ulnicane, Inga
    De Montfort Univ, Ctr Comp & Social Responsibil, Leicester, Leics, England.
    Beyond Research Ethics: Dialogues in Neuro-ICT Research2019In: Frontiers in Human Neuroscience, ISSN 1662-5161, E-ISSN 1662-5161, Vol. 13, article id 105Article, review/survey (Refereed)
    Abstract [en]

    The increasing use of information and communication technologies (ICTs) to help facilitate neuroscience adds a new level of complexity to the question of how ethical issues of such research can be identified and addressed. Current research ethics practice, based on ethics reviews by institutional review boards (IRB) and underpinned by ethical principlism, has been widely criticized. In this article, we develop an alternative way of approaching ethics in neuro-ICT research, based on discourse ethics, which implements Responsible Research and Innovation (RRI) through dialogues. We draw on our work in Ethics Support, using the Human Brain Project (HBP) as empirical evidence of the viability of this approach.

  • 16.
    Farisco, Michele
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Brain, consciousness and disorders of consciousness at the intersection of neuroscience and philosophy2019Doctoral thesis, comprehensive summary (Other academic)
    Abstract [en]

    The present dissertation starts from the general claim that neuroscience is not neutral, with regard to theoretical questions like the nature of consciousness, but it needs to be complemented with dedicated conceptual analysis. Specifically, the argument for this thesis is that the combination of empirical and conceptual work is a necessary step for assessing the significant questions raised by the most recent study of the brain. Results emerging from neuroscience are conceptually very relevant in themselves but, notwithstanding its theoretical sophistication, neuroscience is not sufficient to provide a complete interpretation or an appropriate understanding of their impact. Consequently, the present thesis starts from the need for an interdisciplinary and hybrid field of research, i.e. fundamental neuroethics.

    Within this framework, the thesis takes consciousness and related disorders (i.e. Vegetative State/Unresponsive Wakefulness Syndrome, Minimally Conscious State and Coma) and the addicted brain as illustrative cases of the potential fruitful collaboration between empirical and conceptual investigations.

    The general goal of the thesis is to contribute to the overall development of bridging the gap between empirical and conceptual understandings of consciousness. The first paper sets the theoretical framework, providing an empirically-based description of the brain with significant philosophical implications for an understanding of consciousness. The last three papers of the thesis try to apply the theoretical framework to illustrative cases. Papers II and III analyse the possible application of science and technology for an easier detection and clinical care of patients with disorders of consciousness, with particular attention to communication mediated by neurotechnology and the simulation of the conscious brain, respectively; paper IV provides a potentially new ethical analysis of addiction within the elaborated general conceptual framework.

    The conclusion of the thesis is that the impact of neuroscientific results needs that a dedicated conceptual approach reveals and investigates their conceptual meaning. This conceptual analysis is not exclusive but integrative and complementary to the empirical science. The case of consciousness, analysed from both an ethical and conceptual point of view, is highly illustrative in this respect. In the end, a conceptual/linguistic work of clarification is urgently needed.

    List of papers
    1. The Intrinsic Activity of the Brain and Its Relation to Levels and Disorders of Consciousness
    Open this publication in new window or tab >>The Intrinsic Activity of the Brain and Its Relation to Levels and Disorders of Consciousness
    2017 (English)In: Mind and Matter, ISSN 1611-8812, E-ISSN 2051-3003, Vol. 15, no 2, p. 197-219Article in journal (Refereed) Published
    Abstract [en]

    Science and philosophy still lack an overarching theory of consciousness. We suggest that a further step toward it requires going beyond the view of the brain as input-output machine and focusing on its intrinsic activity, which may express itself in two distinct modalities, i.e. aware and unaware. We specifically investigate the predisposition of the brain to evaluate and to model the world. These intrinsic activities of the brain retain a deep relation with consciousness. In fact the ability of the brain to evaluate and model the world can develop in two modalities, implicit or explicit, that correspond to what we usually refer to as the unconscious and consciousness, and both are multilevel configurations of the brain along a continuous and dynamic line. Starting from an empirical understanding of the brain as intrinsically active and plastic, we here distinguish between higher cognitive functions and basic phenomenal consciousness, suggesting that the latter might characterize the brain’s intrinsic activity as such, even if at a very basic level. We proceed to explore possible impacts of the notion of intrinsic cerebral phenomenality on our understanding of consciousness and its disorders, particularly on the diagnosis and management of patients with disorders of consciousness.

    Place, publisher, year, edition, pages
    Imprint Academic, 2017
    Keywords
    Brain, Consciousness, Neuroscience, Philosophy
    National Category
    Philosophy Ethics Neurology
    Research subject
    Philosophy; Neuroscience
    Identifiers
    urn:nbn:se:uu:diva-339292 (URN)
    Funder
    EU, Horizon 2020, 720270
    Available from: 2018-01-17 Created: 2018-01-17 Last updated: 2019-08-30Bibliographically approved
    2. Externalization of Consciousness: Scientific Possibilities and Clinical Implications
    Open this publication in new window or tab >>Externalization of Consciousness: Scientific Possibilities and Clinical Implications
    2015 (English)In: Ethical Issues in Behavioural Neuroscience / [ed] G. Lee-J. Illes-F Ohl, Springer Berlin/Heidelberg, 2015, p. 205-222Chapter in book (Refereed)
    Abstract [en]

    The paper starts by analyzing recent advancements in neurotechnological assessment of residual consciousness in patients with disorders of consciousness and in neurotechnology-mediated communication with them. Ethical issues arising from these developments are described, with particular focus on informed consent. Against this background, we argue for the necessity of further scientific efforts and ethical reflection in neurotechnological assessment of consciousness and ‘cerebral communication’ with verbally non-communicative patients.

    Place, publisher, year, edition, pages
    Springer Berlin/Heidelberg, 2015
    Series
    Current Topics in Behavioural Neuroscience, ISSN 1866-3370 ; 19
    Keywords
    Consciousness Disorders of consciousness Neurotechnology Informed consent
    National Category
    Neurology
    Research subject
    Neuroscience; Bioethics
    Identifiers
    urn:nbn:se:uu:diva-245265 (URN)10.1007/7854_2014_338 (DOI)978-3-662-44866-3 (ISBN)
    Projects
    Human Brain Project
    Funder
    EU, FP7, Seventh Framework Programme, 604102
    Available from: 2015-02-26 Created: 2015-02-26 Last updated: 2019-08-30
    3. Large-scale brain simulation and disorders of consciousness: Mapping technical and conceptual issues
    Open this publication in new window or tab >>Large-scale brain simulation and disorders of consciousness: Mapping technical and conceptual issues
    2018 (English)In: Frontiers in Psychology, ISSN 1664-1078, E-ISSN 1664-1078, Vol. 9, article id 585Article in journal (Refereed) Published
    Abstract [en]

    Modelling and simulations have gained a leading position in contemporary attempts to describe, explain, and quantitatively predict the human brain's operations. Computer models are highly sophisticated tools developed to achieve an integrated knowledge of the brain with the aim of overcoming the actual fragmentation resulting from different neuroscientific approaches. In this paper we investigate plausibility of simulation technologies for emulation of consciousness and the potential clinical impact of large-scale brain simulation on the assessment and care of disorders of consciousness (DOCs), e.g. Coma, Vegetative State/Unresponsive Wakefulness Syndrome, Minimally Conscious State.Notwithstanding their technical limitations, we suggest that simulation technologies may offer new solutions to old practical problems, particularly in clinical contexts. We take DOCs as an illustrative case, arguing that the simulation of neural correlates of consciousness is potentially useful for improving treatments of patients with DOCs.

    Keywords
    Consciousness, Consciousness Disorders, brain modeling, Neuroethics, brain simulation
    National Category
    Computer Systems Ethics Philosophy Neurology Bioinformatics and Systems Biology
    Research subject
    Neuroscience; Philosophy
    Identifiers
    urn:nbn:se:uu:diva-347782 (URN)10.3389/fpsyg.2018.00585 (DOI)000430833800001 ()29740372 (PubMedID)
    Projects
    The human brain project
    Funder
    EU, Horizon 2020, 720270
    Available from: 2018-04-06 Created: 2018-04-06 Last updated: 2019-08-30Bibliographically approved
    4. Drug addiction: from neuroscience to ethics
    Open this publication in new window or tab >>Drug addiction: from neuroscience to ethics
    2018 (English)In: Frontiers in Psychiatry, ISSN 1664-0640, E-ISSN 1664-0640, Vol. 9, article id 595Article in journal (Refereed) Published
    Abstract [en]

    In the present paper we suggest a potential new ethical analysis of addiction focusing on the relationship between aware and unaware processings in the brain, i.e. on what is consciously and what is non-consciously perceived by the individual. We take the case of the opioids epidemics to argue that a consideration of both aware and unaware processings provides a more comprehensive ethical framework to discuss the ethical issues raised by addiction.Finally, our hypothesis is that in addition to identified Central Nervous System’s neuronal/neurochemical factors contributing to addictive dynamics, the socio-economic status, i.e. the individual background, plays a causal role through epigenetic processes, originating the need for additional reward in the brain. This provides a strong base for a socio-political form of responsibility for preventing and managing addiction crisis.

    Keywords
    Addiction, Ethics of addiction, Unaware processing, Opioids Epidemics, Drugs addiction
    National Category
    Psychiatry Ethics
    Identifiers
    urn:nbn:se:uu:diva-364429 (URN)10.3389/fpsyt.2018.00595 (DOI)000450456300001 ()30524319 (PubMedID)
    Projects
    Human Brain Project
    Funder
    EU, Horizon 2020, 785907
    Available from: 2018-10-26 Created: 2018-10-26 Last updated: 2019-08-30Bibliographically approved
  • 17.
    Molema, Claudia
    et al.
    Tilburg Univ, Dept Tranzo, Sci Ctr Care & Welf, Tilburg, Netherlands;Natl Inst Publ Hlth & Environm, Ctr Nutr Prevent & Hlth Serv, Bilthoven, Netherlands.
    Veldwijk, Jorien
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Natl Inst Publ Hlth & Environm, Ctr Nutr Prevent & Hlth Serv, Bilthoven, Netherlands.
    Wendel-Vos, Wanda
    Natl Inst Publ Hlth & Environm, Ctr Nutr Prevent & Hlth Serv, Bilthoven, Netherlands.
    de Wit, Ardine
    Natl Inst Publ Hlth & Environm, Ctr Nutr Prevent & Hlth Serv, Bilthoven, Netherlands;Univ Med Ctr Utrecht, Julius Ctr Hlth Sci & Primary Care, Utrecht, Netherlands.
    van de Goor, Ien
    Tilburg Univ, Dept Tranzo, Sci Ctr Care & Welf, Tilburg, Netherlands.
    Schuit, Jantine
    Natl Inst Publ Hlth & Environm, Ctr Nutr Prevent & Hlth Serv, Bilthoven, Netherlands;Vrije Univ Amsterdam, Dept Hlth Sci, Amsterdam, Netherlands;EMGO Inst Hlth & Care Res, Amsterdam, Netherlands.
    Chronically ill patients' preferences for a financial incentive in a lifestyle intervention. Results of a discrete choice experiment2019In: PLoS ONE, ISSN 1932-6203, E-ISSN 1932-6203, Vol. 14, no 7, article id e0219112Article in journal (Refereed)
    Abstract [en]

    Background The preferences of diabetes type 2 patients and cardiovascular disease patients for a financial incentive added to a specified combined lifestyle intervention were investigated. Methods A discrete choice experiment questionnaire was filled out by 290 diabetes type 2 patients (response rate 29.9%). Panel-mixed-logit models were used to estimate the preferences for a financial incentive. Potential uptake rates of different financial incentives and relative importance scores of the included attributes were estimated. Included attributes and levels were: form of the incentive (cash money and different types of vouchers), value of the incentive (ranging from 15 to 100 euros), moment the incentive is received (start, halfway, after finishing the intervention) and prerequisite for receiving the incentive (registration, attendance or results at group or individual level). Results Prerequisites for receiving the financial incentive were the most important attribute, according to the respondents. Potential uptake rates for different financial incentives ranged between 37.9% and 58.8%. The latter uptake rate was associated with a financial incentive consisting of cash money with a value of (sic)100 that is handed out after completing the lifestyle program with the prerequisite that the participant attended at least 75% of the scheduled meetings. Conclusions The potential uptake of the different financial incentives varied between 37.9% and 58.8%. The value of the incentive does not significantly influence the potential uptake. However, the potential uptake and associated potential effect of the financial incentive is influenced by the type of financial incentive. The preferred type of incentive is (sic)100 in cash money, awarded after completing the lifestyle program if the participant attended at least 75% of the scheduled meetings.

  • 18.
    Matar, Amal
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Considering a Baby? Responsible Screening for the Future: Ethical and social implications for implementation and use of preconception expanded carrier screening in Sweden2019Doctoral thesis, comprehensive summary (Other academic)
    Abstract [en]

    Preconception expanded carrier screening is a novel technology that involves the offer of a screening test for many recessive diseases (via an expanded screening panel) to prospective parents, with no priori risk. Test positive couples have a number of reproductive choices; prenatal diagnosis and aborting affected fetus, IVF and preimplantation genetic diagnosis, sperm or ovum donation or simply accept the risk. The test had been piloted in studies and can potentially be implemented in Europe. Therefore, it seemed pertinent to evaluate stakeholders’ perspectives on ethical and social implications of implementing and using preconception ECS in Sweden.

    Two main stakeholders were examined; healthcare professionals and health policymaking experts, via a mix of qualitative methods for data collection and data analysis. In Study I, we employed in-depth interviews to collect data and content analysis to analyze it. In Studies III and IV, expert interviews were used to gather data while thematic analysis was utilized to interpret it. Furthermore, in Study II, an ethical concept namely; reproductive autonomy, was critically discussed within a setting that expects a couple to make a conjoint reproductive decision about preconception ECS, while each partner still upholds his or her individual autonomy.

    The main findings of the empirical studies (Studies I, III and IV) echo to a great extent the prevailing ethical and social debates associated with the novel technology. Respondents expressed concerns with reproductive autonomy, medicalization, prioritization of health resources, discrimination and long term societal changes. Furthermore, respondents emphasized the importance to observe Swedish values, such as human dignity, equality and solidarity, when assessing a preconception ECS program. In addition, they described practicalities of implementation and political considerations that are pertinent to the Swedish context. Finally, some respondents recognized the advantages of reduced suffering and decrease in fetal anomalies and abortion as a consequence of preconception ECS.

    Study II, proposed a notion of couple autonomy, where certain demands if met, a couple’s reproductive decision can be accepted by healthcare staff as autonomous.

    The findings, in this thesis, steer towards non implementation of preconception ECS in its current status within the publicly-funded healthcare system in Sweden. This is because healthcare providers and experts were of the opinion that it would not solve a medical need, threaten Swedish values and use up resources extensively.

    List of papers
    1. Swedish healthcare providers' perceptions of preconception expanded carrier screening (ECS)—a qualitative study
    Open this publication in new window or tab >>Swedish healthcare providers' perceptions of preconception expanded carrier screening (ECS)—a qualitative study
    2016 (English)In: Journal of Community Genetics, ISSN 1868-6001, Vol. 7, no 3, p. 203-214Article in journal (Refereed) Published
    Abstract [en]

    Reproductive autonomy, medicalization, and discrimination against disabled and parental responsibility are the main ongoing ethical debates concerning reproductive genetic screening. To examine Swedish healthcare professionals’ views on preconception expanded carrier screening (ECS), a qualitative study involving academic and clinical institutions in Sweden was conducted in September 2014 to February 2015. Eleven healthcare professionals including clinicians, geneticists, a midwife, and a genetic counselor were interviewed in depth using a semi-structured interview guide. The questionnaire was constructed after reviewing the main literature and meetings with relevant healthcare providers. The interviews were recorded, transcribed verbatim, and content analyzed for categories and subcategories. Participants nurtured many ethical and non-ethical concerns regarding preconception ECS. Among the ethical concerns were the potential for discrimination, medicalization, concerns with prioritization of healthcare resources, and effects on reproductive freedom. The effects of implementation of preconception ECS, its stakeholders, regulations, and motivation are some of non-ethical concerns. These concerns, if not addressed, may affect the uptake and usage of carrier screening within Swedish healthcare system. As this is a qualitative study with a small non-random sample size, the findings cannot be generalized. The participants had little to no working experience with expanded screening panels. Moreover, the interviews were conducted in English, a second language for the participants, which might have limited the expression of their views. However, the authors claim that the findings may be pertinent to similar settings in other Scandinavian countries.

    Place, publisher, year, edition, pages
    Springer, 2016
    Keywords
    reproductiion, autonomy, expanded carrier screening
    National Category
    Obstetrics, Gynecology and Reproductive Medicine Public Health, Global Health, Social Medicine and Epidemiology
    Identifiers
    urn:nbn:se:uu:diva-294966 (URN)10.1007/s12687-016-0268-2 (DOI)000386778700004 ()27225888 (PubMedID)
    Available from: 2016-05-31 Created: 2016-05-31 Last updated: 2019-01-11Bibliographically approved
    2. Couple autonomy in preconception expanded carrier screening
    Open this publication in new window or tab >>Couple autonomy in preconception expanded carrier screening
    (English)Manuscript (preprint) (Other academic)
    Abstract [en]

    Background: Preconception Expanded Carrier Screening (ECS) is a genetic test offered to a general population or to couples who have no known risk of recessive and X-linked genetic diseases and are interested in becoming parents. A test may screen for carrier status of several autosomal recessive diseases at one go. Such a program has been piloted in the Netherlands and may become a reality in more European countries in the future. The ethical rationale for such tests is that they would enhance reproductive autonomy. The dominant conception of autonomy is individual-based. However, at the clinic, people deciding on preconception ECS will be counselled together and are expected to make a joint decision, as a couple. The aim of the present study was to develop an understanding of autonomous decisions made by couples in the context of reproductive technologies in general and of preconception ECS in particular. A further aim was to shed light on what occurs in reproductive clinics and to suggest concrete implications for the approach of healthcare professionals in those clinics. Discussion: Based on the shift in emphasis from individual autonomy to relational autonomy, a notion of couple autonomy was suggested and some features of this concept were outlined. First, that both partners are individually autonomous and that the decision is reached through a communicative process. In this process each partner should feel free to express his or her concerns and preferences, so no one partner dominates the discussion. Further, there should be adequate time for the couple to negotiate possible differences and conclude that the decision is right for them. The final decision should be reached through consensus of both partners without coercion, manipulation or miscommunication. Through concrete examples, the suggested notion of couple autonomy was applied to diverse clinical situations. Conclusions: A notion of couple autonomy can be fruitful for healthcare professionals by facilitating the ways in which close ones are vital for the decision-making concerning preconception ECS. A normative implication for healthcare staff is to allow the necessary time for decision-making and to promote a dialogue that can increase the power of the weaker part in a relationship.

    National Category
    Other Medical Biotechnology
    Identifiers
    urn:nbn:se:uu:diva-366363 (URN)
    Available from: 2018-11-20 Created: 2018-11-20 Last updated: 2019-01-11Bibliographically approved
    3. "A perfect society": Swedish policymakers' ethical and social views on preconception expanded carrier screening
    Open this publication in new window or tab >>"A perfect society": Swedish policymakers' ethical and social views on preconception expanded carrier screening
    2019 (English)In: Journal of Community Genetics, ISSN 1868-310X, E-ISSN 1868-6001, Vol. 10, no 2, p. 267-280Article in journal (Refereed) Published
    Abstract [en]

    To improve healthcare policymaking, commentators have recommended the use of evidence, health technology assessment, priority setting, and public engagement in the process of policymaking. Preconception expanded carrier screening, according to the World Health Organization’s definition, is a novel health technology and therefore warrants assessment, part of which involves evaluating ethical and social implications. We examined ten Swedish policymakers’ perspectives on ethical and social aspects of preconception expanded screening through in-depth expert interviewing, using a semi-structured questionnaire. Respondents were affiliated to governmental and non-governmental institutions that directly influence healthcare policymaking in Sweden. The interviews were recorded, transcribed verbatim, and analyzed via inductive thematic analysis method, which generated seven themes and several subthemes. Policymakers harbored concerns regarding the economics, Swedish and international political respects, implementation procedures, and societal effects, which included long-term ones. Moreover, participants detailed the role of public engagement, research, and responsibility in regard to preconception expanded carrier screening implementation. Since this is a qualitative study, with a small non-random sample, the results may not be generalizable to all policymakers in Sweden. However, the results give a profound insight into the process and interpretative knowledge of experts, in the Swedish milieu and the extent of readiness of Sweden to implement a preconception expanded carrier screening program.

    Keywords
    Preconception, Expanded carrier screening, Genetic, Policymakers, Reproductive decision-making, Ethics, Social effects
    National Category
    Other Medical Biotechnology Other Health Sciences Medical Ethics
    Identifiers
    urn:nbn:se:uu:diva-362390 (URN)10.1007/s12687-018-0389-x (DOI)000463053900011 ()30259298 (PubMedID)
    Available from: 2018-10-04 Created: 2018-10-04 Last updated: 2019-04-25Bibliographically approved
    4. Values and value conflicts in implementation and use of preconception expanded carrier screening: an expert interview study
    Open this publication in new window or tab >>Values and value conflicts in implementation and use of preconception expanded carrier screening: an expert interview study
    2019 (English)In: BMC Medical Ethics, ISSN 1472-6939, E-ISSN 1472-6939, Vol. 20, article id 25Article in journal (Refereed) Published
    Abstract [en]

    Background: Endeavors have been made to found and incorporate ethical values in most aspects of healthcare, including health technology assessment. Health technologies and their assessment are value-laden and could trigger problems with dissemination if they contradict societal norms. Per WHO definition, preconception expanded carrier screening is a new health technology that warrants assessment. It is a genetic test offered to couples who have no known risk of recessive genetic diseases and are interested pregnancy. A test may screen for carrier status of several autosomal recessive diseases and X-linked at one go. The technique has been piloted in the Netherlands and is discussed in other countries. The aim of the study was to examine values and value conflicts that healthcare experts recounted in relation to the discussion of implementation and use of preconception ECS in Sweden.

    Methods: We interviewed ten experts, who were associated with influencing health policymaking in Sweden. We employed systematizing expert interviews, which endeavor to access experts' specialist knowledge. There were four female and six male informants, of which four were physicians, three bioethicists, one a legal expert, one a theologian and one a political party representative in the parliament. The participants functioned as members of two non-governmental bodies and three governmental organizations. We employed thematic analysis to identify themes, categories and subcategories.

    Results: Two main themes surfaced: values and value conflicts. The main categories of Respect for persons, Solidarity, Human dignity, Do no harm, Health and Love formed the first theme, while values conflicting with autonomy and integrity respectively, constituted the second theme. Concepts relating to respect for persons were the most commonly mentioned among the participants, followed by notions alluding to solidarity. Furthermore, respondents discussed values conflicting with Swedish healthcare ones such as equality and solidarity.

    Conclusions: The experts highlighted values and concepts that are distinctive of welfare states such as Sweden and delineated how preconception ECS could challenge such values. Moreover, the analysis revealed that certain values were deemed more substantive than others, judging by the extent and detail of inference; for example, respect for persons and solidarity were on top of the list.

    Keywords
    Moral values; intrinsic and extrinsic values; preconception expanded carrier screening; respect for persons; Solidarity; human dignity.
    National Category
    Other Medical Biotechnology
    Identifiers
    urn:nbn:se:uu:diva-366366 (URN)10.1186/s12910-019-0362-1 (DOI)000465408300001 ()31014326 (PubMedID)
    Available from: 2018-11-20 Created: 2018-11-20 Last updated: 2019-05-10Bibliographically approved
  • 19.
    Goisauf, Melanie
    et al.
    ERIC, BBMRI, Graz, Austria.
    Martin, Gillian
    ERIC, BBMRI, Graz, Austria;Univ Malta, Dept Sociol, Msida, Malta.
    Bentzen, Heidi Beate
    Univ Oslo, Norwegian Res Ctr Comp & Law, Fac Law, Oslo, Norway;Univ Oslo, Ctr Med Eth, Fac Med, Oslo, Norway.
    Budin-Ljösne, Isabelle
    Norwegian Inst Publ Hlth, Oslo, Norway.
    Ursin, Lars
    Norwegian Univ Sci & Technol, Dept Publ Hlth & Nursing, Trondheim, Norway.
    Durnova, Anna
    ERIC, BBMRI, Graz, Austria;Inst Adv Studies, Vienna, Austria.
    Leitsalu, Liis
    ERIC, BBMRI, Graz, Austria;Univ Tartu, Inst Genom, Estonian Genome Ctr, Tartu, Estonia.
    Smith, Katharine
    Imperial Coll London, Inst Global Hlth Innovat, Ctr Hlth Policy, London, England.
    Casati, Sara
    Univ Milano Bicocca, Dept Med & Surg, Milan, Italy.
    Lavitrano, Marialuisa
    Univ Milano Bicocca, Dept Med & Surg, Milan, Italy.
    Mascalzoni, Deborah
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. EURAC Res, Inst Biomed, Bolzano, Italy.
    Boeckhout, Martin
    Univ Med Ctr Utrecht, Dept Med Humanities, Julius Ctr Hlth Sci & Primary Care, Utrecht, Netherlands.
    Mayrhofer, Michaela Th.
    ERIC, BBMRI, Graz, Austria.
    Data in question: A survey of European biobank professionals on ethical, legal and societal challenges of biobank research2019In: PLoS ONE, ISSN 1932-6203, E-ISSN 1932-6203, Vol. 14, no 9, article id e0221496Article in journal (Refereed)
    Abstract [en]

    Biobanks have evolved, and their governance procedures have undergone important transformations. Our paper examines this issue by focusing on the perspective of the professionals working in management or scientific roles in research-based biobanks, who have an important impact on shaping these transformations. In particular, it highlights that recent advances in molecular medicine and genomic research have raised a range of ethical, legal and societal implications (ELSI) related to biobank-based research, impacting directly on regulations and local practices of informed consent (IC), private-public partnerships (PPPs), and engagement of participants. In our study, we investigate the ways that these concerns influence biobanking practices and assess the level of satisfaction of the cross-national biobanking research communities with the ELSI related procedures that are currently in place. We conducted an online survey among biobankers and researchers to investigate secondary use of data, informing and/or re-contacting participants, sharing of data with third parties from industry, participant engagement, and collaboration with industrial partners. Findings highlight the need for a more inclusive and transparent biobanking practice where biobanks are seen in a more active role in providing information and communicating with participants; the need to improve the current IC procedures and the role of biobanks in sharing of samples and data with industry partners and different countries, and the need for practical, tangible and hands-on ethical and legal guidance.

  • 20.
    van Overbeeke, Eline
    et al.
    Clinical Pharmacology and Pharmacotherapy, KU Leuven, Leuven, Belgium.
    Janssens, Rosanne
    Clinical Pharmacology and Pharmacotherapy, KU Leuven, Leuven, Belgium.
    Whichello, Chiara
    School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, Netherlands.
    Schölin Bywall, Karin
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Sharpe, Jenny
    Muscular Dystrophy UK, London, United Kingdom.
    Nikolenko, Nikoletta
    John Walton Muscular Dystrophy Research Centre, Newcastle University, Newcastle, United Kingdom.
    Philips, Berkeley S.
    Pfizer, Tadworth, United Kingdom.
    Guiddi, Paolo
    Applied Research Division for Cognitive and Psychological Science, European Institute of Oncology, Milan, Italy.
    Pravettoni, Gabriella
    Applied Research Division for Cognitive and Psychological Science, European Institute of Oncology, Milan, Italy; Department of Oncology and Hematology Oncology, Faculty of Medicine and Surgery, University of Milan, Milan, Italy.
    Vergani, Laura
    Applied Research Division for Cognitive and Psychological Science, European Institute of Oncology, Milan, Italy; Department of Oncology and Hematology Oncology, Faculty of Medicine and Surgery, University of Milan, Milan, Italy.
    Marton, Giulia
    Applied Research Division for Cognitive and Psychological Science, European Institute of Oncology, Milan, Italy; Department of Oncology and Hematology Oncology, Faculty of Medicine and Surgery, University of Milan, Milan, Italy.
    Cleemput, Irina
    Belgian Health Care Knowledge Centre, Brussels, Belgium.
    Simoens, Steven
    Clinical Pharmacology and Pharmacotherapy, KU Leuven, Leuven, Belgium.
    Kübler, Jürgen
    Quantitative Scientific Consulting, Marburg, Germany.
    Juhaeri, Juhaeri
    Sanofi, Bridgewater, NJ, United States.
    Levitan, Bennet
    Janssen Research & Development, Titusville, NJ, United States.
    de Bekker-Grob, Esther W.
    School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, Netherlands.
    Veldwijk, Jorien
    School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, Netherlands.
    Huys, Isabelle
    Clinical Pharmacology and Pharmacotherapy, KU Leuven, Leuven, Belgium.
    Design, Conduct, and Use of Patient Preference Studies in the Medical Product Life Cycle: A Multi-Method Study2019In: Frontiers in Pharmacology, ISSN 1663-9812, E-ISSN 1663-9812, Vol. 10, no 1395Article in journal (Refereed)
    Abstract [en]

    Objectives: To investigate stakeholder perspectives on how patient preference studies (PPS) should be designed and conducted to allow for inclusion of patient preferences in decision-making along the medical product life cycle (MPLC), and how patient preferences can be used in such decision-making.

    Methods: Two literature reviews and semi-structured interviews (n = 143) with healthcare stakeholders in Europe and the US were conducted; results of these informed the design of focus group guides. Eight focus groups were conducted with European patients, industry representatives and regulators, and with US regulators and European/Canadian health technology assessment (HTA) representatives. Focus groups were analyzed thematically using NVivo.

    Results: Stakeholder perspectives on how PPS should be designed and conducted were as follows: 1) study design should be informed by the research questions and patient population; 2) preferred treatment attributes and levels, as well as trade-offs among attributes and levels should be investigated; 3) the patient sample and method should match the MPLC phase; 4) different stakeholders should collaborate; and 5) results from PPS should be shared with relevant stakeholders. The value of patient preferences in decision-making was found to increase with the level of patient preference sensitivity of decisions on medical products. Stakeholders mentioned that patient preferences are hardly used in current decision-making. Potential applications for patient preferences across industry, regulatory and HTA processes were identified. Four applications seemed most promising for systematic integration of patient preferences: 1) benefit-risk assessment by industry and regulators at the marketing-authorization phase; 2) assessment of major contribution to patient care by European regulators; 3) cost-effectiveness analysis; and 4) multi criteria decision analysis in HTA.

    Conclusions: The value of patient preferences for decision-making depends on the level of collaboration across stakeholders; the match between the research question, MPLC phase, sample, and preference method used in PPS; and the sensitivity of the decision regarding a medical product to patient preferences. Promising applications for patient preferences should be further explored with stakeholders to optimize their inclusion in decision-making.

  • 21.
    Slokenberga, Santa
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Lund Univ, Fac Law, Lund, Sweden.
    Reichel, Jane
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Stockholm Univ, Fac Law, Stockholm, Sweden.
    Niringiye, Rachel
    Aegis Advocates, Kampala, Uganda.
    Croxton, Talishiea
    Univ Maryland, Baltimore, MD 21201 USA.
    Swanepoel, Carmen
    Stellenbosch Univ, Fac Med & Hlth Sci, Natl Hlth Lab Serv, Div Heamatol,Dept Pathol, Stellenbosch, South Africa.
    Okal, June
    Univ Nairobi, Nairobi, Kenya.
    EU data transfer rules and African legal realities: is data exchange for biobank research realistic?2019In: International Data Privacy Law, ISSN 2044-3994, E-ISSN 2044-4001, Vol. 9, no 1, p. 30-48Article in journal (Refereed)
    Abstract [en]

    Key Points

    • To effectively collaborate in biobanking and build capacity in low and middle-income countries, data transfer from European Union (EU) Member States to states in Africa is crucial.

    • Although under the General Data Protection Regulation (GDPR) avenues for data transfer exist, the ones feasible for transcontinental data exchange for biobank research rely on EU enforcement which in essence means limited oversight possibilities and, consequently, considerable risks to the EU data subject’s privacy.

    • To ensure effective data protection for data subjects in biobanking, raising the data protection bar in data recipient countries is crucial. Although Kenya, Nigeria, South Africa, and Uganda have taken considerable steps towards developing data protection frameworks, only that of South Africa and Nigeria’s Protection of Personal Information Bill seem to be such to meet the protection level set out by the GDPR. The legislative initiatives in Kenya and Uganda require revisions to ensure that protection of privacy is not undermined when data are being sent to these countries.

    • Currently, considerable responsibility is placed in the hands of the legislatures in the countries of concern—and notably in Kenya, and Uganda—to set foundations for ending research and research integrity-harming practices. In Nigeria, these foundations are defined in the Protection of Personal Information Bill, but not adopted yet. South Africa, however, has taken a big step towards building routes for genuine biobank capacity-building in the country and collaboration in that regard.

  • 22.
    Fellmann, Florence
    et al.
    Univ Lausanne, ColLab, Lausanne, Switzerland.
    van El, Carla G.
    Vrije Univ Amsterdam, Amsterdam UMC, Dept Clin Genet, Sect Community Genet, Amsterdam, Netherlands;Vrije Univ Amsterdam, Amsterdam UMC, Amsterdam Publ Hlth Res Inst, Amsterdam, Netherlands.
    Charron, Philippe
    Sorbonne Univ, Hop Pitie Salpetriere, AP HP, Referral Ctr Inherited Cardiac Dis,ICAN,INSERM,UM, Paris, France;European Reference Network Rare & Low Prevalence, Amsterdam, Netherlands.
    Michaud, Katarzyna
    Lausanne Univ Hosp, Univ Ctr Legal Med Lausanne Geneva, Lausanne, Switzerland;Univ Lausanne, Lausanne, Switzerland.
    Howard, Heidi C.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Boers, Sarah N.
    Univ Med Ctr Utrecht, Dept Med Humanities, Julius Ctr Hlth Sci & Primary Care, Utrecht, Netherlands.
    Clarke, Angus J.
    Cardiff Univ, Inst Med Genet, Sch Med, Div Canc & Genet, Cardiff, S Glam, Wales.
    Duguet, Anne-Marie
    Univ Paul Sabatier Toulouse III, INSERM, UMR 1027, Toulouse, France.
    Forzano, Francesca
    Guys & St Thomas NHS Fdn Trust, Dept Clin Genet, London, England.
    Kauferstein, Silke
    Goethe Univ Frankfurt, Inst Legal Med, Frankfurt, Germany.
    Kayserili, Hulya
    Koc Univ, Sch Med KUSoM, Dept Med Genet, Istanbul, Turkey.
    Lucassen, Anneke
    Univ Southampton, Fac Med, Clin Eth & Law, Southampton, Hants, England;Univ Hosp Southampton NHS Fdn Trust, Clin Genet Serv, Southampton, Hants, England.
    Mendes, Alvaro
    Univ Porto, I3S, IBMC Inst Mol & Cell Biol, UnIGENe, Porto, Portugal;Univ Porto, I3S, IBMC Inst Mol & Cell Biol, CGPP Ctr Predict & Prevent Genet, Porto, Portugal.
    Patch, Christine
    Kings Coll London, Florence Nightingale Fac, Nursing & Midwifery Palliat Care, London, England;Queen Mary Univ London, Genom England, London, England.
    Radojkovic, Dragica
    Univ Belgrade, IMGGE, Belgrade, Serbia.
    Rial-Sebbag, Emmanuelle
    Univ Paul Sabatier Toulouse III, INSERM, UMR 1027, Toulouse, France.
    Sheppard, Mary N.
    European Reference Network Rare & Low Prevalence, Amsterdam, Netherlands;St Georges Med Sch, Cardiovasc Pathol Mol & Clin Sci Res Inst, London, England.
    Tasse, Anne-Marie
    McGill Univ, Publ Populat Project Genom & Soc P3G, Montreal, PQ, Canada;Genome Quebec Innovat Ctr, Montreal, PQ, Canada.
    Temel, Sehime G.
    Bursa Uludag Univ, Dept Med Genet, Fac Med, Bursa, Turkey;Bursa Uludag Univ, Dept Histol & Embryol, Fac Med, Bursa, Turkey.
    Sajantila, Antti
    Univ Helsinki, Dept Forens Med, Helsinki, Finland.
    Basso, Cristina
    European Reference Network Rare & Low Prevalence, Amsterdam, Netherlands;Univ Padua, Dept Cardiac Thorac & Vasc Sci, Cardiovasc Pathol Unit, Padua, Italy.
    Wilde, Arthur A. M.
    European Reference Network Rare & Low Prevalence, Amsterdam, Netherlands;Univ Amsterdam, Amsterdam UMC, Heart Ctr, Amsterdam, Netherlands;Univ Amsterdam, Dept Clin & Expt Cardiol, Amsterdam Cardiovasc Sci, Amsterdam, Netherlands.
    Cornel, Martina C.
    Vrije Univ Amsterdam, Amsterdam UMC, Dept Clin Genet, Sect Community Genet, Amsterdam, Netherlands;Vrije Univ Amsterdam, Amsterdam UMC, Amsterdam Publ Hlth Res Inst, Amsterdam, Netherlands.
    Benjamin, Caroline
    Borry, Pascal
    Clarke, Angus
    Cordier, Christophe
    Cornel, Martina
    van El, Carla
    Howard, Heidi
    Melegh, Bela
    Perola, Markus
    Peterlin, Borut
    Rogowski, Wolf
    Soller, Maria
    Stefansdottir, Vigdis
    de Wert, Guido
    European recommendations integrating genetic testing into multidisciplinary management of sudden cardiac death2019In: European Journal of Human Genetics, ISSN 1018-4813, E-ISSN 1476-5438, Vol. 27, no 12, p. 1763-1773Article in journal (Refereed)
    Abstract [en]

    Sudden cardiac death (SCD) accounts for 10-20% of total mortality, i.e., one in five individuals will eventually die suddenly. Given the substantial genetic component of SCD in younger cases, postmortem genetic testing may be particularly useful in elucidating etiological factors in the cause of death in this subset. The identification of genes responsible for inherited cardiac diseases have led to the organization of cardiogenetic consultations in many countries worldwide. Expert recommendations are available, emphasizing the importance of genetic testing and appropriate information provision of affected individuals, as well as their relatives. However, the context of postmortem genetic testing raises some particular ethical, legal, and practical (including economic or financial) challenges. The Public and Professional Policy Committee of the European Society of Human Genetics (ESHG), together with international experts, developed recommendations on management of SCD after a workshop sponsored by the Brocher Foundation and ESHG in November 2016. These recommendations have been endorsed by the ESHG Board, the European Council of Legal Medicine, the European Society of Cardiology working group on myocardial and pericardial diseases, the ERN GUARD-HEART, and the Association for European Cardiovascular Pathology. They emphasize the importance of increasing the proportion of both medical and medicolegal autopsies and educating the professionals. Multidisciplinary collaboration is of utmost importance. Public funding should be allocated to reach these goals and allow public health evaluation.

  • 23.
    Grauman, Åsa
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Hansson, Mats G.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    James, Stefan K
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology.
    Veldwijk, Jorien
    Erasmus Univ, Erasmus Choice Modelling Ctr, Rotterdam, Netherlands.
    Höglund, Anna T
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Exploring research participants' perceptions of cardiovascular risk information-Room for improvement and empowerment2019In: Patient Education and Counseling, ISSN 0738-3991, E-ISSN 1873-5134, Vol. 102, no 8, p. 1528-1534Article in journal (Refereed)
    Abstract [en]

    OBJECTIVE: The objective of this study was to explore research participants' (adults, age 50-65) perceptions of receiving cardiovascular risk information.

    METHODS: Five focus group interviews (N = 31) were performed with research participants aged 50-65 who participated in the Swedish CArdioPulmonary BioImage Study (SCAPIS). The interviews were analyzed using qualitative content analysis.

    RESULTS: The categories; the complexity of cardiovascular risk; insufficient presentation of test result; emotional responses; and health examinations provides confirmation, emerged. The test results were written in medical terms and lacked recommendations for further action which made it difficult for lay people to understand and use, and for some, also caused unnecessary worry.

    CONCLUSION: There was inadequate guidance concerning the implications of the test results, especially for participants without clinical findings. In order to allow research participants to obtain better cognitive and behavioral control, improvements are needed with regard to how personal risk information is communicated in research projects connected to health services.

    PRACTICAL IMPLICATIONS: The participants largely relied on physical signs when assessing their own cardiovascular risk. Health examinations are crucial for helping to add nuance to individuals' risk perceptions. For personal health information to have any real value for individuals, it must be designed from a user perspective.

  • 24.
    Witt, Stefanie
    et al.
    Univ Med Ctr Hamburg Eppendorf, Ctr Psychosocial Med, Dept Med Psychol, Hamburg, Germany.
    Escherich, Gabriele
    Univ Med Ctr Hamburg Eppendorf, Ctr Obstet & Pediat, Dept Pediat Hematol & Oncol, Hamburg, Germany.
    Rutkowski, Stefan
    Univ Med Ctr Hamburg Eppendorf, Ctr Obstet & Pediat, Dept Pediat Hematol & Oncol, Hamburg, Germany.
    Kappelhoff, Gerhard
    Univ Med Ctr Hamburg Eppendorf, Ctr Obstet & Pediat, Dept Pediat Hematol & Oncol, Hamburg, Germany.
    Frygner Holm, Sara
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Russ, Sandra
    Case Western Reserve Univ, Dept Psychol Sci, Cleveland, OH 44106 USA.
    Bullinger, Monika
    Univ Med Ctr Hamburg Eppendorf, Ctr Psychosocial Med, Dept Med Psychol, Hamburg, Germany.
    Quitmann, Julia
    Univ Med Ctr Hamburg Eppendorf, Ctr Psychosocial Med, Dept Med Psychol, Hamburg, Germany.
    Exploring the Potential of a Pretend Play Intervention in Young Patients With Leukemia2019In: Journal of Pediatric Nursing: Nursing Care of Children and Families, ISSN 0882-5963, E-ISSN 1532-8449, Vol. 44, p. E98-E106Article in journal (Refereed)
    Abstract [en]

    Purpose: The aims of the study are 1) to gain knowledge of parents' and professionals' perceptions about cancer stricken children's resources, burdens, and ability to pretend play, and 2) to prepare the initiation of a pretend play intervention based on children's needs and included parents' and professionals' feedback.

    Design and Methods: Qualitative design using semi-structured interviews with 13 parents of children diagnosed with leukemia and 15 professionals in the field of pediatric oncology. Themes were derived with content analysis via deductive and inductive coding.

    Results: Analysis resulted in five topics. (1) Ability to play in the context of leukemia (2) ways of coping with leukemia (3) difficulty in transition to normality (4) parental quality of life and parents' needs (5) perceptions of the potential of pretend play.

    Conclusion: Study results indicate the potential of pretend play interventions for young cancer patients and the need for additional professional support of parents.

    Practice Implications: Pretend play is a tool children carry with them regardless of their circumstances. If we can enhance their ability to play, doing so should give them an advantage in creative problem solving and creative expression as they deal with a life threatening disease. 

  • 25.
    Whichello, Chiara
    et al.
    Erasmus School of Health Policy & Management and Erasmus Choice Modelling Centre, Erasmus University, Rotterdam, Netherlands.
    van Overbeeke, Eline
    Department of Pharmaceutical and Pharmacological Sciences, University of Leuven, Leuven, Belgium.
    Janssens, Rosanne
    Department of Pharmaceutical and Pharmacological Sciences, University of Leuven, Leuven, Belgium.
    Schölin Bywall, Karin
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Russo, Selena
    4Applied Research Division for Cognitive and Psychological Science, IEO European Institute of Oncology IRCCS, Milan, Italy.
    Weldwijk, Jorien
    Erasmus School of Health Policy & Management and Erasmus Choice Modelling Centre, Erasmus University, Rotterdam, Netherlands.
    Cleemput, Irina
    Belgian Health Care Knowledge Centre, Brussels, Belgium.
    Juhaeri, Juhaeri
    Sanofi, Bridgewater, NJ, United States.
    Levitan, Bennet
    Global R&D Epidemiology, Janssen Research & Development, Titusville, United States.
    Kübler, Jürgen
    Quantitative Scientific Consulting, Marburg, Germany.
    Smith, Meredith
    Global Patient Safety and Labeling, Amgen Inc., Thousand Oaks, CA, United States.
    Hermann, Richard
    Astra Zeneca, Gaithersburg, MD, United States.
    Engelbrecht, Matthias
    Department of Internal Medicine 3 – Rheumatology and Immunology, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) and Universitätsklinikum Erlangen, Erlangen, Germany.
    Heuber, Alex J.
    Department of Internal Medicine 3 – Rheumatology and Immunology, Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) and Universitätsklinikum Erlangen, Erlangen, Germany.
    Comanescu, Alina
    Community Health Association, Bucharest, Romania.
    Harding, Sarah
    Global Patient Safety, Takeda, London, United Kingdom.
    Simoens, Steven
    Department of Pharmaceutical and Pharmacological Sciences, University of Leuven, Leuven, Belgium.
    Huys, Isabelle
    Department of Pharmaceutical and Pharmacological Sciences, University of Leuven, Leuven, Belgium.
    de Bekker-Grob, Esther
    Erasmus School of Health Policy & Management and Erasmus Choice Modelling Centre, Erasmus University, Rotterdam, Netherlands.
    Factors and Situations Affecting the Value of Patient Preference Studies: Semi-Structured Interviews in Europe and the US2019In: Frontiers in Pharmacology, ISSN 1663-9812, E-ISSN 1663-9812, Vol. 10, article id 1009Article in journal (Refereed)
    Abstract [en]

    Objectives: Patient preference information (PPI) is gaining recognition among the pharmaceutical industry, regulatory authorities, and health technology assessment (HTA) bodies/payers for use in assessments and decision-making along the medical product lifecycle (MPLC). This study aimed to identify factors and situations that influence the value of patient preference studies (PPS) in decision-making along the MPLC according to different stakeholders.

    Methods: Semi-structured interviews (n = 143) were conducted with six different stakeholder groups (physicians, academics, industry representatives, regulators, HTA/payer representatives, and a combined group of patients, caregivers, and patient representatives) from seven European countries (the United Kingdom, Sweden, Italy, Romania, Germany, France, and the Netherlands) and the United States. Framework analysis was performed using NVivo 11 software.

    Results: Fifteen factors affecting the value of PPS in the MPLC were identified. These are related to: study organization (expertise, financial resources, study duration, ethics and good practices, patient centeredness), study design (examining patient and/or other preferences, ensuring representativeness, matching method to research question, matching method to MPLC stage, validity and reliability, cognitive burden, patient education, attribute development), and study conduct (patients’ ability/willingness to participate and preference heterogeneity). Three types of situations affecting the use of PPS results were identified (stakeholder acceptance, market situations, and clinical situations).

    Conclusion: The factors and situation types affecting the value of PPS, as identified in this study, need to be considered when designing and conducting PPS in order to promote the integration of PPI into decision-making along the MPLC.

  • 26.
    Veldwijk, Jorien
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Erasmus Univ, Erasmus Sch Hlth Policy & Management, POB 1738, NL-3000 DR Rotterdam, Netherlands;Natl Inst Publ Hlth & Environm, Ctr Nutr Prevent & Hlth Serv, Bilthoven, Netherlands.
    Groothuis-Oudshoorn, Catharina G. M.
    Univ Twente, Hlth Technol & Serv Res, Enschede, Netherlands.
    Kihlbom, Ulrik
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Health Economics. Karolinska Inst, Dept Learning Informat Management & Eth, Stockholm, Sweden.
    Langenskiöld, Sophie
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Health Economics. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Karolinska Inst, Dept Learning Informat Management & Eth, Stockholm, Sweden.
    Dekker, Evelien
    Acad Med Ctr, Dept Gastroenterol & Hepatol, Amsterdam, Netherlands.
    Kallenberg, Frank G. J.
    Acad Med Ctr, Dept Gastroenterol & Hepatol, Amsterdam, Netherlands.
    de Wit, G. Ardine
    Natl Inst Publ Hlth & Environm, Ctr Nutr Prevent & Hlth Serv, Bilthoven, Netherlands;Univ Med Ctr Utrecht, Julius Ctr Hlth Sci & Primary Care, Utrecht, Netherlands.
    Lambooij, Mattijs S.
    Natl Inst Publ Hlth & Environm, Ctr Nutr Prevent & Hlth Serv, Bilthoven, Netherlands.
    How psychological distance of a study sample in discrete choice experiments affects preference measurement: a colorectal cancer screening case study2019In: Patient Preference and Adherence, ISSN 1177-889X, E-ISSN 1177-889X, Vol. 13, p. 273-282Article in journal (Refereed)
    Abstract [en]

    Purpose: The purpose of this study was to investigate to what extent the outcomes of a discrete choice experiment (DCE) differ based on respondents' psychological distance to the decision at hand. Methods: A DCE questionnaire regarding individuals' preferences for genetic screening for colorectal cancer (CRC) within the Dutch national CRC screening program was created. The DCE contained nine D-efficient designed choice tasks and was distributed among two populations that differ in their psychological distance to the decision at hand: 1) a representative sample of the Dutch general population aged 55-65 years, and 2) a sample of Dutch individuals who attended an information appointment regarding colonoscopies following the detection of blood in their stool sample in the CRC screening program. The DCE consisted of four attributes related to the decision whether to participate in genetic screening for CRC: 1) risk of being genetically predisposed, 2) risk of developing CRC, 3) frequency of follow-up colonoscopies, and 4) survival. Direct attribute ranking, dominant decision-making behavior, and relative importance scores (based on panel MIXL) were compared between the two populations. Attribute level estimates were compared with the Swait and Louviere test. Results: The proportion of respondents who both ranked survival as the most important attribute, and showed dominant decision-making behavior for this attribute, was significantly higher in the screened population compared to the general population. The relative importance scores of the attributes significantly differed between populations. Finally, the Swait and Louviere test also revealed significant differences in attribute level estimates in both the populations. Conclusion: The study outcomes differed between populations depending on their psychological distance to the decision. This study shows the importance of adequate sample selection; therefore, it is advocated to increase attention to study sample selection and reporting in DCE studies.

  • 27.
    Niemiec, Emilia
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Howard, Heidi Carmen
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Include egg donors in CRISPR gene-editing debate2019In: Nature, ISSN 0028-0836, E-ISSN 1476-4687, Vol. 575, no 7781, p. 51-51Article in journal (Other academic)
  • 28.
    Pennartz, Cyriel M. A.
    et al.
    Department of Cognitive and Systems Neuroscience, Swammerdam Institute for Life Sciences, University of Amsterdam, Amsterdam, Netherlands ; Research Priority Area, Brain and Cognition, University of Amsterdam, Amsterdam, Netherlands.
    Farisco, Michele
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Biogem, Biology and Molecular Genetics Institute, Ariano Irpino, Italy.
    Evers, Kathinka
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Indicators and Criteria of Consciousness in Animals and Intelligent Machines: An Inside-Out Approach2019In: Frontiers in Systems Neuroscience, ISSN 1662-5137, E-ISSN 1662-5137, Vol. 13, article id 25Article, review/survey (Refereed)
    Abstract [en]

    In today’s society, it becomes increasingly important to assess which non-human and non-verbal beings possess consciousness. This review article aims to delineate criteria for consciousness especially in animals, while also taking into account intelligent artifacts. First, we circumscribe what we mean with “consciousness” and describe key features of subjective experience: qualitative richness, situatedness, intentionality and interpretation, integration and the combination of dynamic and stabilizing properties. We argue that consciousness has a biological function, which is to present the subject with a multimodal, situational survey of the surrounding world and body, subserving complex decision-making and goal-directed behavior. This survey reflects the brain’s capacity for internal modeling of external events underlying changes in sensory state. Next, we follow an inside-out approach: how can the features of conscious experience, correlating to mechanisms inside the brain, be logically coupled to externally observable (“outside”) properties? Instead of proposing criteria that would each define a “hard” threshold for consciousness, we outline six indicators: (i) goal-directed behavior and model-based learning; (ii) anatomic and physiological substrates for generating integrative multimodal representations; (iii) psychometrics and meta-cognition; (iv) episodic memory; (v) susceptibility to illusions and multistable perception; and (vi) specific visuospatial behaviors. Rather than emphasizing a particular indicator as being decisive, we propose that the consistency amongst these indicators can serve to assess consciousness in particular species. The integration of scores on the various indicators yields an overall, graded criterion for consciousness, somewhat comparable to the Glasgow Coma Scale for unresponsive patients. When considering theoretically derived measures of consciousness, it is argued that their validity should not be assessed on the basis of a single quantifiable measure, but requires cross-examination across multiple pieces of evidence, including the indicators proposed here. Current intelligent machines, including deep learning neural networks (DLNNs) and agile robots, are not indicated to be conscious yet. Instead of assessing machine consciousness by a brief Turing-type of test, evidence for it may gradually accumulate when we study machines ethologically and across time, considering multiple behaviors that require flexibility, improvisation, spontaneous problem-solving and the situational conspectus typically associated with conscious experience.

  • 29.
    Northoff, Georg
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Mental Health Center, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China ; Mind, Brain Imaging and Neuroethics, Institute of Mental Health Research, University of Ottawa, Ottawa, Canada.
    Wainio-Theberge, Soren
    Mind, Brain Imaging and Neuroethics, Institute of Mental Health Research, University of Ottawa, Ottawa, Canada.
    Evers, Kathinka
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Is temporo-spatial dynamics the “common currency” of brain and mind?: In Quest of “Spatiotemporal Neuroscience”2019In: Physics of Life Reviews, ISSN 1571-0645, E-ISSN 1873-1457Article, review/survey (Refereed)
    Abstract [en]

    Neuroscience has made considerable progress in unraveling the neural correlates of mental phenomena like self, consciousness, and perception. However, the “common currency” shared between neuronal and mental activity, brain and mind, remains yet unclear. In this article, we propose that the dynamics of time and space provides a “common currency” that connects neuronal and mental features. Time and space are here understood in a dynamic context (as in contemporary physics): that is, in terms of the way the brain's spontaneous activity constructs its spatial and temporal relationships, for instance in terms of functional connectivity and different frequencies of fluctuations. Recruiting recent empirical evidence, we show that the different ways in which the spontaneous activity constructs its “inner time and space” are manifested in distinct mental features. Specifically, we demonstrate how spatiotemporal mechanisms like spatiotemporal repertoire, integration, and speed yield mental features like consciousness, self, and time speed perception. The focus on the brain's spatiotemporal mechanisms entails what we describe as “Spatiotemporal Neuroscience”. Spatiotemporal Neuroscience conceives neuronal activity in terms of its temporo-spatial dynamics rather than its various functions (e.g., cognitive, affective, social, etc.) as in other branches of neuroscience (as distinguished from Cognitive, Affective, Cultural, Social, etc. Neuroscience). That allows Spatiotemporal Neuroscience to take into view the so-called ‘spatio-temporality’ of mental features including their non-causal, intrinsic and transformative relationship with neuronal features. In conclusion, Spatiotemporal Neuroscience opens the door to investigate and ultimately reveal the brain's own temporo-spatial dynamics as the hitherto missing “common currency” of neuronal and mental features.

  • 30. Dal-Ré, Rafael
    et al.
    Avendaño-Solà, Cristina
    Bloechl-Daum, Brigitte
    de Boer, Anthonius
    Eriksson, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Fuhr, Uwe
    Holm, Søren
    James, Stefan K
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Medicinska och farmaceutiska vetenskapsområdet, centrumbildningar mm, UCR-Uppsala Clinical Research Center.
    Mentz, Robert J
    Perucca, Emilio
    Rosendaal, Frits R
    Treweek, Shaun
    Low risk pragmatic trials do not always require participants' informed consent2019In: BMJ. British Medical Journal, E-ISSN 1756-1833, Vol. 364, article id l1092Article in journal (Other academic)
  • 31. Middleton, Anna
    et al.
    Milne, Richard
    Howard, Heidi
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Niemiec, Emilia
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Robarts, Lauren
    Critchley, Christine
    Nicol, Dianne
    Prainsack, Barbara
    Atutornu, Jerome
    Vears, Danya F
    Smith, James
    Steed, Claire
    Bevan, Paul
    Scott, Erick R
    Bobe, Jason
    Goodhand, Peter
    Kleiderman, Erika
    Thorogood, Adrian
    Morley, Katherine I
    Members of the public in the USA, UK, Canada and Australia expressing genetic exceptionalism say they are more willing to donate genomic data2019In: European Journal of Human Genetics, ISSN 1018-4813, E-ISSN 1476-5438Article in journal (Refereed)
    Abstract [en]

    Public acceptance is critical for sharing of genomic data at scale. This paper examines how acceptance of data sharing pertains to the perceived similarities and differences between DNA and other forms of personal data. It explores the perceptions of representative publics from the USA, Canada, the UK and Australia (n = 8967) towards the donation of DNA and health data. Fifty-two percent of this public held 'exceptionalist' views about genetics (i.e., believed DNA is different or 'special' compared to other types of medical information). This group was more likely to be familiar with or have had personal experience with genomics and to perceive DNA information as having personal as well as clinical and scientific value. Those with personal experience with genetics and genetic exceptionalist views were nearly six times more likely to be willing to donate their anonymous DNA and medical information for research than other respondents. Perceived harms from re-identification did not appear to dissuade publics from being willing to participate in research. The interplay between exceptionalist views about genetics and the personal, scientific and clinical value attributed to data would be a valuable focus for future research.

  • 32.
    Motta, Benedetta M.
    et al.
    Univ Lubeck, Eurac Res, Inst Biomed, I-39100 Bolzano, Italy.
    Grander, Christoph
    Med Univ Innsbruck, Dept Internal Med Gastroenterol Hepatol Endocrino, Innsbruck, Austria.
    Gogele, Martin
    Univ Lubeck, Eurac Res, Inst Biomed, I-39100 Bolzano, Italy.
    Foco, Luisa
    Univ Lubeck, Eurac Res, Inst Biomed, I-39100 Bolzano, Italy.
    Vukovic, Vladimir
    Univ Lubeck, Eurac Res, Inst Biomed, I-39100 Bolzano, Italy.
    Melotti, Roberto
    Univ Lubeck, Eurac Res, Inst Biomed, I-39100 Bolzano, Italy.
    Fuchsberger, Christian
    Univ Lubeck, Eurac Res, Inst Biomed, I-39100 Bolzano, Italy.
    De Grandi, Alessandro
    Univ Lubeck, Eurac Res, Inst Biomed, I-39100 Bolzano, Italy.
    Cantaloni, Chiara
    Univ Lubeck, Eurac Res, Inst Biomed, I-39100 Bolzano, Italy.
    Picard, Anne
    Univ Lubeck, Eurac Res, Inst Biomed, I-39100 Bolzano, Italy.
    Mascalzoni, Deborah
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Univ Lubeck, Eurac Res, Inst Biomed, I-39100 Bolzano, Italy.
    Rossini, Alessandra
    Univ Lubeck, Eurac Res, Inst Biomed, I-39100 Bolzano, Italy.
    Pattaro, Cristian
    Univ Lubeck, Eurac Res, Inst Biomed, I-39100 Bolzano, Italy.
    Tilg, Herbert
    Med Univ Innsbruck, Dept Internal Med Gastroenterol Hepatol Endocrino, Innsbruck, Austria.
    Pramstaller, Peter P.
    Univ Lubeck, Eurac Res, Inst Biomed, I-39100 Bolzano, Italy.
    Microbiota, type 2 diabetes and non-alcoholic fatty liver disease: protocol of an observational study2019In: Journal of Translational Medicine, ISSN 1479-5876, E-ISSN 1479-5876, Vol. 17, no 1, article id 408Article in journal (Refereed)
    Abstract [en]

    Background: Non-alcoholic fatty liver disease (NAFLD) is characterized by triglyceride accumulation in the hepatocytes in the absence of alcohol overconsumption, commonly associated with insulin resistance and obesity. Both NAFLD and type 2 diabetes (T2D) are characterized by an altered microbiota composition, however the role of the microbiota in NAFLD and T2D is not well understood. To assess the relationship between alteration in the microbiota and NAFLD while dissecting the role of T2D, we established a nested study on T2D and non-T2D individuals within the Cooperative Health Research In South Tyrol (CHRIS) study, called the CHRIS-NAFLD study. Here, we present the study protocol along with baseline and follow-up characteristics of study participants. Methods: Among the first 4979 CHRIS study participants, 227 individuals with T2D were identified and recalled, along with 227 age- and sex-matched non-T2D individuals. Participants underwent ultrasound and transient elastography examination to evaluate the presence of hepatic steatosis and liver stiffness. Additionally, sampling of saliva and faeces, biochemical measurements and clinical interviews were carried out. Results: We recruited 173 T2D and 183 non-T2D participants (78% overall response rate). Hepatic steatosis was more common in T2D (63.7%) than non-T2D (36.3%) participants. T2D participants also had higher levels of liver stiffness (median 4.8 kPa, interquartile range (IQR) 3.7, 5.9) than non-T2D participants (median 3.9 kPa, IQR 3.3, 5.1). The non-invasive scoring systems like the NAFLD fibrosis score (NFS) suggests an increased liver fibrosis in T2D (mean - 0.55, standard deviation, SD, 1.30) than non-T2D participants (mean - 1.30, SD, 1.17). Discussion: Given the comprehensive biochemical and clinical characterization of study participants, once the bio-informatics classification of the microbiota will be completed, the CHRIS-NAFLD study will become a useful resource to further our understanding of the relationship between microbiota, T2D and NAFLD.

  • 33.
    Hansson, Mats G.
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Holm, Anna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Segerdahl, Pär
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    MIND THE RISK · DEN GENETISKA RISKINFORMATIONENS ETIK FÖR INDIVID OCH SAMHÄLLE: SLUTRAPPORT FRÅN ETT FORSKNINGSPROGRAM2019Book (Other (popular science, discussion, etc.))
    Abstract [sv]

    Forskningsprogrammet "Mind the risk: Den genetiska riskinformationens etik för individ och samhälle" tilldelades anslag från Stiftelsen Riksbankens Jubileumsfond 2013. Målet var att analysera etiska aspekter av genetisk riskinformation inom vården: ett fält som på senare år utvecklats i rasande takt. I dag kan både enskilda och sjukvården ta reda på genetiska risker och förutsättningar. Forskare från flera länder har inom programmet analyserat debatten och hur patienter, sjukvårdspersonal och anhöriga ser på etiska dilemman inom den nya genetiska medicinen. Detta är programmets slutrapport. 

  • 34.
    Cornel, Martina C.
    et al.
    Vrije Univ Amsterdam, Amsterdam UMC, Clin Genet & Amsterdam Publ Hlth Res Inst, Sect Community Genet, Boelelaan 1117, Amsterdam, Netherlands.
    Howard, Heidi Carmen
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Lim, Daniel
    Kirkland & Ellis Int LLP, London, England.
    Bonham, Vence L.
    NHGRI, Social & Behav Res Branch, NIH, Bethesda, MD 20892 USA.
    Wartiovaara, Kirmo
    Univ Helsinki, Helsinki Univ Hosp, Clin Genet, Meilahdentie 2, Helsinki 00290, Finland.
    Moving towards a cure in genetics: what is needed to bring somatic gene therapy to the clinic?2019In: European Journal of Human Genetics, ISSN 1018-4813, E-ISSN 1476-5438, Vol. 27, no 3, p. 484-487Article in journal (Refereed)
    Abstract [en]

    Clinical trials using somatic gene editing (e.g., CRISPR-Cas9) have started in Europe and the United States and may provide safe and effective treatment and cure, not only for cancers but also for some monogenic conditions. In a workshop at the 2018 European Human Genetics Conference, the challenges of bringing somatic gene editing therapies to the clinic were discussed. The regulatory process needs to be considered early in the clinical development pathway to produce the data necessary to support the approval by the European Medicines Agency. The roles and responsibilities for geneticists may include counselling to explain the treatment possibilities and safety interpretation.

  • 35.
    Salles, Arleen
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Programa de Neuroetica, Centro de Investigaciones Filosoficas, Buenos Aires, Argentina.
    Evers, Kathinka
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Farisco, Michele
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Biogem Genetic Research Centre, Ariano Irpino, Italy.
    Neuroethics and Philosophy in Responsible Research and Innovation: The Case of the Human Brain Project2019In: Neuroethics, ISSN 1874-5490, E-ISSN 1874-5504, Vol. 12, no 2, p. 201-211Article in journal (Refereed)
    Abstract [en]

    Responsible Research and Innovation (RRI) is an important ethical, legal, and political theme for the European Commission. Although variously defined, it is generally understood as an interactive process that engages social actors, researchers, and innovators who must be mutually responsive and work towards the ethical permissibility of the relevant research and its products. The framework of RRI calls for contextually addressing not just research and innovation impact but also the background research process, specially the societal visions underlying it and the norms and priorities that shape scientific agendas. This requires the integration of anticipatory, inclusive, and responsive dimensions, and the nurturing of a certain type of reflexivity among a variety of stakeholders, from scientists to funders. In this paper, we do not address potential limitations but focus on the potential contribution of philosophical reflection to RRI in the context of the Ethics and Society subproject of the Human Brain Project (HBP). We show how the type of conceptual analysis provided by philosophically oriented approaches theoretically and ethically broadens research and innovation within the HBP. We further suggest that overt inclusion of philosophical reflection can promote the aims and objectives of RRI.

  • 36.
    Schölin Bywall, Karin
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Veldwijk, Jorien
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Erasmus School of Health Policy & Management (ESHPM) and Erasmus Choice Modelling Centre (ECMC), Erasmus University Rotterdam, Rotterdam, The Netherlands.
    Hansson, Mats G.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Kihlbom, Ulrik
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Patient Perspectives on the Value of Patient Preference Information in Regulatory Decision Making: A Qualitative Study in Swedish Patients with Rheumatoid Arthritis2019In: Patient, ISSN 1178-1653, E-ISSN 1178-1661, Vol. 12, no 3, p. 297-305Article in journal (Refereed)
    Abstract [en]

    Background

    There is increasing interest in involving patient preferences for benefits and risks in regulatory decision making. Therefore, it is essential to identify patient perspectives regarding the value of patient preference information (PPI).

    Objectives

    The aim of this study was to explore how patients with rheumatoid arthritis (RA) value the use of PPI in regulatory decision making regarding medical products.

    Methods

    Regulators and patients with RA were interviewed to gather initial insights into opinions on the use of PPI in regulatory decisions regarding medical products. The interviews were used to draft and validate the interview guide for focus groups with patients with RA. Participants were purposively sampled in collaboration with the Swedish Rheumatism Association in Stockholm and Uppsala. Each focus group consisted of three to six patients (18 in total). All interviews were audio-recorded, transcribed verbatim, and analysed using content analysis.

    Results

    According to the participants, PPI could lead to regulators considering patients’ needs, lifestyles and well-being when making decisions. PPI was important in all stages of the medical product lifecycle. Participants reported that, when participating in a preference study, it is important to be well-informed about the use of the study and the development, components, administration, and risks related to the medical products.

    Conclusions

    Patients thought PPI could be valuable to consider in regulatory decisions. It is essential for patients to be well-informed when asked for their preferences. Research on information materials to inform patients in preference studies is needed to increase the value of PPI in regulatory decision making.

  • 37.
    Janssens, Rosanne
    et al.
    Department of Pharmaceutical and Pharmacological Sciences,KU Leuven, Leuven, Belgium.
    Russo, Selena
    Applied Research Division for Cognitive and Psychological ScienceIEO European Institute of Oncology, Milan, Italy; Faculty of Medicine, School of Women’s and Children’s HealthUniversity of New South Wales, Kensington, Australia; Behavioural Sciences Unit, Kids Cancer CentreSydney Children’s Hospital, Randwick, Australia.
    van Overbeeke, Eline
    Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
    Whichello, Chiara
    Erasmus School of Health Policy & Management (ESHPM) and Erasmus Choice Modelling Centre (ECMC), Erasmus University Rotterdam, Rotterdam, The Netherlands.
    Harding, Sarah
    Takeda International, London, UK.
    Kübler, Jürgen
    QSciCon, Marburg, Germany.
    Juhaeri, Juhaeri
    Sanofi, Bridgewater, USA.
    Schölin Bywall, Karin
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Comanescu, Alina
    Community Health Association Romania, Bucharest, Romania.
    Heuber, Alex
    Department of Internal Medicine 3, Rheumatology and ImmunologyFriedrich-Alexander-Universität Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.
    Englbrecht, Matthias
    Department of Internal Medicine 3, Rheumatology and ImmunologyFriedrich-Alexander-Universität Erlangen-Nürnberg and Universitätsklinikum Erlangen, Erlangen, Germany.
    Nikolenko, Nikoletta
    John Walton Muscular Dystrophy Research Centre, Institute of Genetic Medicine, Newcastle University, Newcastle Upon Tyne, UK.
    Pravettoni, Gabriella
    Applied Research Division for Cognitive and Psychological ScienceIEO European Institute of Oncology, Milan, Italy.
    Simoens, Steven
    Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
    Stevens, Hilde
    Institute for Interdisciplinary Innovation in Healthcare (I3h), Université libre de Bruxelles, Brussels, Belgium.
    Hermann, Richard
    AstraZeneca, Gaithersburg, USA.
    Levitan, Bennett
    Global R&D Epidemiology, Janssen Research & Development, Titusville, USA.
    Cleemput, Irina
    Belgian Health Care Knowledge Centre (KCE), Brussels, Belgium.
    de Bekker-Grob, Esther
    Erasmus School of Health Policy & Management (ESHPM) and Erasmus Choice Modelling Centre (ECMC), Erasmus University Rotterdam, Rotterdam, The Netherlands.
    Veldwijk, Jorien
    Erasmus School of Health Policy & Management (ESHPM) and Erasmus Choice Modelling Centre (ECMC), Erasmus University Rotterdam, Rotterdam, The Netherlands.
    Huys, Isabelle
    Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, Leuven, Belgium.
    Patient Preferences in the Medical Product Life Cycle: What do Stakeholders Think? Semi-Structured Qualitative Interviews in Europe and the USA2019In: Patient, ISSN 1178-1653, E-ISSN 1178-1661, Vol. 12, no 5, p. 513-526Article in journal (Refereed)
    Abstract [en]

    Background

    Patient preferences (PP), which are investigated in PP studies using qualitative or quantitative methods, are a growing area of interest to the following stakeholders involved in the medical product lifecycle: academics, health technology assessment bodies, payers, industry, patients, physicians, and regulators. However, the use of PP in decisions along the medical product lifecycle remains limited. As the adoption of PP heavily relies on these stakeholders, knowledge of their perceptions of PP is critical.

    Objective

    This study aimed to characterize stakeholders’ attitudes, needs, and concerns with respect to PP in decision making along the medical product lifecycle.

    Methods

    Semi-structured interviews (n = 143) were conducted with academics (n = 24), health technology assessment/payer representatives (n = 24), industry representatives (n = 24), patients, caregivers and patient representatives (n = 24), physicians (n = 24), and regulators (n = 23) from seven European countries and the USA. Interviews were conducted between April and August 2017. The framework method was used to organize the data and identify themes and key findings in each interviewed stakeholder group.

    Results

    Interviewees reported being unfamiliar (43%), moderately familiar (42%), or very familiar (15%) with preference methods and studies. Interviewees across stakeholder groups generally supported the idea of using PP in the medical product lifecycle but expressed mixed opinions about the feasibility and impact of using PP in decision making. Interviewees from all stakeholder groups stressed the importance of increasing stakeholders’ understanding of the concept of PP and preference methods and ensuring patients’ understanding of the questions asked in PP studies. Key concerns and needs in each interviewed stakeholder group were as follows: (1) academics: investigating the validity, reliability, reproducibility, and generalizability of preference methods; (2) health technology assessment/payer representatives: developing quality criteria for evaluating PP studies and gaining insights into how to weigh them in reimbursement/payer decision making; (3) industry representatives: obtaining guidance on PP studies and recognition on the importance of PP from decision makers; (4) patients, caregivers, and patient representatives: providing an incentive and adequate information towards patients when participating in PP studies; (5) physicians: avoiding bias as a result of commercial agendas in PP studies and clarifying how to deal with subjective and emotional elements when measuring PP; and (6) regulators: avoiding the misuse of PP study results to overrule the traditional efficacy and safety criteria used for marketing authorization and obtaining robust PP study results.

    Conclusions

    Despite the interest all interviewed stakeholder groups reported in PP, the effective use of PP in decision making across the medical product lifecycle is currently hampered by a lack of standardization and consensus on how to both measure and use PP.

  • 38. Whichello, Chiara
    et al.
    Levitan, Bennett
    Juaheri, Juaheri
    Kihlbom, Ulrik
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    de Bekker-Grob, Esther
    PATIENT PREFERENCES IN THE MEDICAL PRODUCT LIFECYCLE: INITIAL RESULTS FROM THE IMI PREFER PUBLIC-PRIVATE PROJECT2019In: Value in Health, ISSN 1098-3015, E-ISSN 1524-4733Article in journal (Refereed)
  • 39.
    Frygner-Holm, Sara
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Neuroscience, Åsenlöf: Physiotheraphy.
    Russ, Sandra
    Case Western Reserve University, Cleveland, OH, USA.
    Quitmann, Julia
    University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
    Ring, Lena
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, Research group (Dept. of women´s and children´s health), Clinical Psychology in Healthcare.
    Zyga, Olena
    Case Western Reserve University, Cleveland, OH, USA.
    Hansson, Mats G.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Ljungman, Gustaf
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, Research group (Dept. of women´s and children´s health), Neuropediatrics/Paediatric oncology.
    Höglund, Anna T.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Pretend Play as an Intervention for Children With Cancer: A Feasibility Study2019In: Journal of Pediatric Oncology Nursing, ISSN 1043-4542, E-ISSN 1532-8457, Vol. 37, no 1, p. 65-75Article in journal (Refereed)
    Abstract [en]

    Children with cancer suffer from symptoms and burdensome treatments that often cause distress to children and their families. Mortality is one aspect of cancer diagnosis, while another is the quality of life and well-being during and after the treatment. By supporting children's communication, self-efficacy and coping ability in the care situation, children are given the possibilities for increased independence and participation and are allowed to develop an influence over their care. The aim of this study was to develop and evaluate the feasibility and acceptability of an adult-facilitated pretend play intervention for children with cancer. Five children with ongoing treatment for cancer were invited to a play intervention that consisted of six to eight sessions of structured pretend play aimed at increasing participation, independence, and well-being. A mixed method design was used to evaluate the feasibility and acceptability of the play intervention. Measures were collected before and after interventions, and in conjunction with every play session. Results suggest that the children enjoyed the play intervention. Findings indicate small improvements regarding self-efficacy in care situations and equal or increased quality of life for participants. A main finding was that no adverse events or increased worrying was reported in conjunction with play sessions. Therefore, the intervention is regarded as safe, feasible, and acceptable as reported by participants and their primary caregivers and a possible means of increasing participation and independence in children with a cancer diagnosis.

  • 40.
    Guerrero, Manuel
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Deparment of Bioethics and Medical Humanities, Faculty of Medicine, University of Chile.
    Del Villar, María Soledad
    Theology Department, Boston College, Chesnut Hill, USA.
    Hau, Boris
    Transitional Justice Observatory, Human Rights Centre, Universidad Diego Portales, Santiago, Chile.
    Johansson, María Teresa
    Department of Language and Literature, Universidad Alberto Hurtado, Santiago, Chile.
    Professions and Profiles:: Epistemic Communities and the Registration of Human Rights Violations2019In: Resistance to Political Violence in Latin America: Documenting Atrocity / [ed] Palgrave Macmillan, Cham: Palgrave Macmillan, 2019, p. 79-115Chapter in book (Refereed)
    Abstract [en]

    This chapter focuses on the critical service provided by lawyers and social workers of the Comité and Vicaría’s Legal Department in their work with relatives and direct victims of political repression. Based on archival documentation, secondary literature, and interviews with former staff members, it explores how these professions and their respective epistemes supported those persecuted by the regime. It argues that an interdisciplinary style of working emerged, and was sustained over a nineteen-year period, by a professional community that gave practical form to the Catholic Church’s desire to protect and foster human dignity. The chapter demonstrates that this work was sustained by a combination of professional acumen; a substantial degree of professional innovation in the face of an urgent and uncertain situation; an amount of political, community, and trades union organisational skill and experience, and the adoption of a humanitarian ethos that drew no distinctions of class, origin, or political affiliation.

  • 41.
    Nihlén Fahlquist, Jessica
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Public Health and the Virtues of Responsibility, Compassion and Humility2019In: Public Health Ethics, ISSN 1754-9973, E-ISSN 1754-9981, Vol. 12, no 3, p. 213-224Article in journal (Refereed)
    Abstract [en]

    In contrast to medical care, which is focused on the individual patient, public health is focused on collective health. This article argues that, in order to better protect the individual, discussions of public health would benefit from incorporating the insights of virtue ethics. There are three reasons to for this. First, the collective focus may cause neglect of the effects of public health policy on the interests and rights of individuals and minorities. Second, whereas the one-on-one encounters in medical care facilitate a compassionate and caring attitude, public health involves a distance between professionals and the public. Therefore, public health professionals must use imagination and care to evaluate the effects of policies on individuals. Third, the relationship between public health professionals and the people who are affected by the policies they design is characterized by power asymmetry, demanding a high level of responsibility from those who wield them. Against this background, it is argued that public health professionals should develop the virtues of responsibility, compassion and humility. The examples provided, i.e. breastfeeding information and vaccination policy, illustrate the importance of these virtues, which needed for normative as well as instrumental reasons, i.e. as a way to restore trust.

  • 42. Larrivee, Denis
    et al.
    Farisco, Michele
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Science and Society Unit, Biology and Molecular Genetics Institute, Ariano Irpino, Italy.
    Realigning the Neural Paradigm for Death2019In: Journal of Bioethical Inquiry, ISSN 1176-7529, E-ISSN 1872-4353, Vol. 16, no 2, p. 259-277Article in journal (Refereed)
    Abstract [en]

    Whole brain failure constitutes the diagnostic criterion for death determination in most clinical settings across the globe. Yet the conceptual foundation for its adoption was slow to emerge, has evoked extensive scientific debate since inception, underwent policy revision, and remains contentious in praxis even today. Complications result from the need to relate a unitary construal of the death event with an adequate account of organismal integration and that of the human organism in particular. Advances in the neuroscience of higher human faculties, such as the self, personal identity, and consciousness, and dynamical philosophy of science accounts, however, are yielding a portrait of higher order global integration shared between body and brain. Such conceptual models of integration challenge a praxis relying exclusively on a neurological criterion for death.

  • 43.
    Soulier, Alexandra
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Reconsidering Dynamic Consent in Biobanking Ethical and Political Consequences of Transforming Research Participants into ICT Users2019In: IEEE technology & society magazine, ISSN 0278-0097, E-ISSN 1937-416X, Vol. 38, no 2, p. 62-70Article in journal (Refereed)
    Abstract [en]

    Biobanks are not new. However, the scope of their application is growing, especially in genomics. Biobanks are also currently being reorganized to enable more genomic samples to be made available for different types of studies. Some future uses of the biobanks cannot be anticipated.

    These developments conflict with requirements for provision of informed consent at the moment of recruitment for studies. A procedure known as Dynamic Consent (DC) has thus been proposed that, based on information and communication technologies (ICT), should allow participants to consent in real time to projects in which their samples and data may be of interest.

    In addition, DC would empower participants through ongoing access to information and communication and direct consultation. As such, DC aligns itself with other ICT projects in claiming to be a democratic tool. We critique these claims and highlight their adverse impacts in order to examine the ethical and political consequences of transforming research participants into ICT users.

  • 44.
    Carrieri, Daniele
    et al.
    Univ Exeter, Egenis, England.
    Howard, Heidi Carmen
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Benjamin, Caroline
    Univ Cent Lancashire UCLan, Sch Community Hlth & Midwifery, Preston, Lancs, England;Liverpool Womens NHS Hosp Trust, Merseyside & Cheshire Clin Genet Serv, Liverpool, Merseyside, England.
    Clarke, Angus J.
    Cardiff Univ, Sch Med, Cardiff, S Glam, Wales.
    Dheensa, Sandi
    Univ Southampton, Fac Med, Clin Eth & Law, Southampton, Hants, England.
    Doheny, Shane
    Cardiff Univ, Sch Med, Cardiff, S Glam, Wales.
    Hawkins, Naomi
    Univ Exeter, Law Sch, Exeter, Devon, England.
    Halbersma-Konings, Tanya F.
    Univ Groningen, Univ Med Ctr Groningen, Dept Genet, Groningen, Netherlands.
    Jackson, Leigh
    Univ Exeter, Sch Med, Egenis, England.
    Kayserili, Hulya
    Koc Univ KUSoM, Sch Med, Med Genet Dept, Istanbul, Turkey.
    Kelly, Susan E.
    Univ Exeter, Egenis, England.
    Lucassen, Anneke M.
    Univ Southampton, Fac Med, Clin Eth & Law, Southampton, Hants, England;Univ Hosp Southampton NHS Fdn Trust, Wessex Clin Genet Serv, Southampton, Hants, England.
    Mendes, Alvaro
    Univ Porto, I3S, IBMC Inst Mol & Cell Biol, UnIGENe, Porto, Portugal;Univ Porto, I3S, IBMC Inst Mol & Cell Biol, CGPP Ctr Predict & Prevent Genet, Porto, Portugal.
    Rial-Sebbag, Emmanuelle
    Univ Paul Sabatier Toulouse III, INSERM, UMR 1027, Toulouse, France.
    Stefansdottir, Vigdis
    Natl Univ Hosp Iceland, Dept Genet & Mol Med, Landspitali, Reykjavik, Iceland.
    Turnpenny, Peter D.
    Royal Devon & Exeter NHS Fdn Trust, Clin Genet, Exeter, Devon, England.
    van El, Carla G.
    Vrije Univ, Amsterdam UMC, Sect Community Genet, Dept Clin Genet, Amsterdam, Netherlands;Vrije Univ, Amsterdam UMC, Amsterdam Publ Hlth Res Inst, Amsterdam, Netherlands.
    van Langen, Irene M.
    Univ Groningen, Univ Med Ctr Groningen, Dept Genet, Groningen, Netherlands.
    Cornel, Martina C.
    Vrije Univ, Amsterdam UMC, Sect Community Genet, Dept Clin Genet, Amsterdam, Netherlands;Vrije Univ, Amsterdam UMC, Amsterdam Publ Hlth Res Inst, Amsterdam, Netherlands.
    Forzano, Francesca
    Guys & St Thomas NHS Fdn Trust, Clin Genet Dept, London, ON, Canada.
    Recontacting patients in clinical genetics services: recommendations of the European Society of Human Genetics2019In: European Journal of Human Genetics, ISSN 1018-4813, E-ISSN 1476-5438, Vol. 27, no 2, p. 169-182Article in journal (Refereed)
    Abstract [en]

    Technological advances have increased the availability of genomic data in research and the clinic. If, over time, interpretation of the significance of the data changes, or new information becomes available, the question arises as to whether recontacting the patient and/or family is indicated. The Public and Professional Policy Committee of the European Society of Human Genetics (ESHG), together with research groups from the UK and the Netherlands, developed recommendations on recontacting which, after public consultation, have been endorsed by ESHG Board. In clinical genetics, recontacting for updating patients with new, clinically significant information related to their diagnosis or previous genetic testing may be justifiable and, where possible, desirable. Consensus about the type of information that should trigger recontacting converges around its clinical and personal utility. The organization of recontacting procedures and policies in current health care systems is challenging. It should be sustainable, commensurate with previously obtained consent, and a shared responsibility between healthcare providers, laboratories, patients, and other stakeholders. Optimal use of the limited clinical resources currently available is needed. Allocation of dedicated resources for recontacting should be considered. Finally, there is a need for more evidence, including economic and utility of information for people, to inform which strategies provide the most cost-effective use of healthcare resources for recontacting.

  • 45.
    Carrieri, Daniele
    et al.
    Univ Exeter, Egenis, Exeter, Devon, England.
    Howard, Heidi Carmen
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Wellcome Genome Campus, Soc & Eth Res, Connecting Sci, Cambridge, England.
    Clarke, Angus J.
    Cardiff Univ, Sch Med, Cardiff, S Glam, Wales.
    Stefansdottir, Vigdis
    Landspitali Natl Univ Hosp Iceland, Dept Genet & Mol Med, Reykjavik, Iceland.
    Cornel, Martina C.
    Vrije Univ Amsterdam, Amsterdam Publ Hlth Res Inst, Sect Community Genet, Amsterdam UMC,Dept Clin Genet, Amsterdam, Netherlands.
    van El, Carla G.
    Vrije Univ Amsterdam, Amsterdam Publ Hlth Res Inst, Sect Community Genet, Amsterdam UMC,Dept Clin Genet, Amsterdam, Netherlands.
    Forzano, Francesca
    Guys & St Thomas NHS Fdn Trust, Clin Genet Dept, London, England.
    Reply to Bombard and Mighton2019In: European Journal of Human Genetics, ISSN 1018-4813, E-ISSN 1476-5438, Vol. 27, no 4, p. 507-508Article in journal (Other academic)
  • 46.
    Ballantyne, Angela
    et al.
    University of Otago Wellington, Bioeth, Wellington, New Zealand.
    Eriksson, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Research ethics revised: The new CIOMS guidelines and the World Medical Association Declaration of Helsinki in context2019In: Bioethics, ISSN 0269-9702, E-ISSN 1467-8519, Vol. 33, no 3, p. 310-311Article in journal (Other academic)
  • 47.
    Viberg, Jennifer
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Langenskiöld, Sophie
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Cardiology. Karolinska Inst, Med Management Ctr, Dept Learning Informat Management & Eth, Stockholm, Sweden.
    Segerdahl, Pär
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Hansson, Mats G.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Hösterey, Ulrika Ugander
    Sahlgrens Univ Hosp, Dept Clin Pathol & Genet, Gothenburg, Sweden.
    Gummesson, Anders
    Sahlgrens Univ Hosp, Dept Clin Pathol & Genet, Gothenburg, Sweden.
    Veldwijk, Jorien
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Erasmus Univ, Erasmus Sch Hlth Policy & Management, Rotterdam, Netherlands; Erasmus Univ, Erasmus Choice Modelling Ctr, Rotterdam, Netherlands.
    Research participants' preferences for receiving genetic risk information: a discrete choice experiment2019In: Genetics in Medicine, ISSN 1098-3600, E-ISSN 1530-0366, Vol. 21, no 10, p. 2381-2389Article in journal (Refereed)
    Abstract [en]

    Purpose: This study aims to determine research participants’ preferences for receiving genetic risk information when participating in a scientific study that uses genome sequencing.

    Methods: A discrete choice experiment questionnaire was sent to 650 research participants (response rate 60.5%). Four attributes were selected for the questionnaire: type of disease, disease penetrance probability, preventive opportunity, and effectiveness of the preventive measure. Panel mixed logit models were used to determine attribute level estimates and the heterogeneity in preferences. Relative importance of the attribute and the predicted uptake for different information scenarios were calculated from the estimates. In addition, this study estimates predicted uptake for receiving genetic risk information in different scenarios.

    Results: All characteristics influenced research participants’ willingness to receive genetic risk information. The most important characteristic was the effectiveness of the preventive opportunity. Predicted uptake ranged between 28% and 98% depending on what preventive opportunities and levels of effectiveness were presented.

    Conclusion: Information about an effective preventive measure was most important for participants. They valued that attribute twice as much as the other attributes. Therefore, when there is an effective preventive measure, risk communication can be less concerned with the magnitude of the probability of developing disease.

     

  • 48.
    Declich, Andrea
    Department of Biology, University of Rome Tor Vergata, Rome, Italy.
    Colizzi, Vittorio (Contributor)
    Department of Biology, University of Rome Tor Vergata, Rome, Italy.
    Montesano, Carla (Contributor)
    Department of Biology, University of Rome Tor Vergata, Rome, Italy.
    Minutolo, Antonella (Contributor)
    Department of Biology, University of Rome Tor Vergata, Rome, Italy.
    Potestà, Marina (Contributor)
    Department of Biology, University of Rome Tor Vergata, Rome, Italy.
    Caiati, Giovanni (Contributor)
    Laboratorio di Scienze della Cittadinanza, Rome, Italy.
    Colonnello, Claudia (Contributor)
    Laboratorio di Scienze della Cittadinanza, Rome, Italy.
    d'Andrea, Luciano (Contributor)
    Laboratorio di Scienze della Cittadinanza, Rome, Italy.
    Marta, Federico L. (Contributor)
    Laboratorio di Scienze della Cittadinanza, Rome, Italy.
    Alcantara, Luiz C Jr. (Contributor)
    Fundacao Oswaldo Cruz, Rio de Janeiro, Brazil.
    Buchan, Alistair (Contributor)
    Radcliffe Department of Medicine, University of Oxford, Oxford, United Kingdom.
    Buzan, Elena (Contributor)
    Department of Biodiversity, University of Primorska, Koper, Slovenia.
    Dam, Rinita (Contributor)
    Radcliffe Medical Department, University of Oxford, United Kingdom.
    Djilianov, Dimitar (Contributor)
    Agrobioinstitute, Agricultural Academy, Sofia, Bulgaria.
    Elster, Doris (Contributor)
    Faculty of Biology & Chemistry, University of Bremen, Bremen, Germany.
    Fernow, Josepine (Contributor)
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Giovanetti, Marta (Contributor)
    Fundacao Oswaldo Cruz, Rio de Janeiro, Brazil.
    Henderson, Lorna R (Contributor)
    Oxford University Hospitals National Health Service Foundation Trust, Oxford, United Kingdom.
    Kalpazidou Schmidt, Evanthia (Contributor)
    Danish Centre for Studies in Research and Research Policy, University of Aarhus, Aarhus, Denmark.
    Khouri, Fernanda (Contributor)
    Fundacao Oswaldo Cruz, Rio de Janeiro, Brazil.
    Kiparoglou, Vasiliki (Contributor)
    Oxford University Hospitals National Health Service Foundation Trust, Oxford, United Kingdom.
    Moyankova, Daniela (Contributor)
    Agrobioinstitute, Agricultural Academy, Sofia, Bulgaria.
    Ovseiko, Pavel (Contributor)
    Radcliffe Medical Department, University of Oxford, United Kingdom.
    Salvato, Maria (Contributor)
    University System of Maryland, Baltimore, MD, United States.
    Shah, Sarwar (Contributor)
    NHR Oxford Biomedical Research Centre, Oxford University, United Kingdom.
    Wium, Martha (Contributor)
    International Centre for Genetic Engineering and Biotechnology, Cape Town, South Africa.
    Zerbini, Luiz (Contributor)
    International Centre for Genetic Engineering and Biotechnology, Cape Town, South Africa.
    Bielwski, Krzysztof P (Contributor)
    Intercollegiate Faculty of Biotechnology, University of Gdańsk and Medical University of Gdańsk, Gdańsk, Poland.
    Raszczyk, Izabela (Contributor)
    Intercollegiate Faculty of Biotechnology, University of Gdańsk and Medical University of Gdańsk, Gdańsk, Poland.
    Barendziak, Tanja (Contributor)
    Faculty of Biology & Chemistry, University of Bremen, Bremen, Germany.
    Brikholz, Julia (Contributor)
    Faculty of Biology & Chemistry, University of Bremen, Bremen, Germany.
    Dziedzic, Marta (Contributor)
    Intercollegiate Faculty of Biotechnology, University of Gdańsk and Medical University of Gdańsk, Gdańsk, Poland.
    RRI implementation in bioscience organisations: Guidelines from the STARBIOS2 project2019Collection (editor) (Refereed)
    Abstract [en]

    The Guidelines are a tool to promote, within biosciences research organisations, a structural change (i.e., a durable transformation of a research organisation) that facilitates the practice of Responsible Research and Innovation (RRI). They are one of the outputs of the STARBIOS2 project.

    The Guidelines arise from the practical experience of implementing Action Plans carried by the research organisations involved in the STARBIOS2 project, from the mutual learning activity among the STARBIOS2 partners, also supported by a study and update of RRI issues.

    The Guidelines aim to help readers to formalize and trigger structural change aimed at introducing RRI-related practices that are appropriate to their own organisations. The  Guidelines are not a series of prescriptions, but an itinerary of reflection and self-interpretation that is addressed to different actors within the Biosciences, such as: researchers, research organisations managers and technical staff members, professionals within research-funding organisations, students and others. Although these Guidelines are not designed for their specific needs, they could be useful to science policymakers as well. In very general terms, the Guidelines’ readers are people who intend to promote RRI or to emphasize responsibility within the research activities in which they are engaged, or who are trying to collect resources for designing and implementing activities with this end.

    To support this itinerary of reflection and self-interpretation, the document provides:

    • A description of a general RRI Model for research organisations within the biosciences, that is a set of ideas, premises and “principles of action” that define the practice of RRI in Bioscience research organisations
    • Some practical guidance for designing interventions to promote RRI in research organisations in the Biosciences, putting into practice the RRI Model
    • A set of useful practices in implementing the structural change process.

    Information on particular STARBIOS2 cases and experiences, as well as materials, tools and sources, are also provided in the Appendix and in the Annex.

  • 49.
    Godskesen, Tove
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Ersta Sköndal Bräcke högskola.
    Eriksson, Stefan
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Theology, Department of Theology.
    Selektiv rapportering av kliniska prövningar2019In: Dagens Medicin, no 15/5Article in journal (Other (popular science, discussion, etc.))
  • 50.
    Fernow, Josepine
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    de Miguel Beriain, Inigo
    Universidad del País Vasco.
    Brey, Philip
    University of Twente .
    Stahl, Berndt
    De Montfort University .
    Setting future ethical standards for ICT, Big Data, AI and robotics: The contribution of three European projects2019In: Orbit Journal, ISSN 2515-8562, Vol. 2019, no 1Article in journal (Other academic)
    Abstract [en]

    Policymakers struggle to assess the ethical, legal and human rights impacts of IT systems in research, industry, and at home. At the same time, research needs to be useful for industry, academia, and society to have impact on policy. Right now, three European projects: PANELFIT, SHERPA and SIENNA, are working together with stakeholders to improve ethical, human rights and legal frameworks for information and communication technologies (ICT), big data analytics, artificial intelligence (AI) and robotics. Stakeholder involvement is key, and the outputs will support the European Union’s vision of Responsible Research and Innovation (RRI), as a means to foster the design of inclusive research and innovation. Here, we provide a short introduction to the projects and outline plans for collaboration with the aim to maximise our joint policy impact.

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