uu.seUppsala University Publications
Change search
Refine search result
123 1 - 50 of 109
CiteExportLink to result list
Permanent link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf
Rows per page
  • 5
  • 10
  • 20
  • 50
  • 100
  • 250
Sort
  • Standard (Relevance)
  • Author A-Ö
  • Author Ö-A
  • Title A-Ö
  • Title Ö-A
  • Publication type A-Ö
  • Publication type Ö-A
  • Issued (Oldest first)
  • Issued (Newest first)
  • Created (Oldest first)
  • Created (Newest first)
  • Last updated (Oldest first)
  • Last updated (Newest first)
  • Disputation date (earliest first)
  • Disputation date (latest first)
  • Standard (Relevance)
  • Author A-Ö
  • Author Ö-A
  • Title A-Ö
  • Title Ö-A
  • Publication type A-Ö
  • Publication type Ö-A
  • Issued (Oldest first)
  • Issued (Newest first)
  • Created (Oldest first)
  • Created (Newest first)
  • Last updated (Oldest first)
  • Last updated (Newest first)
  • Disputation date (earliest first)
  • Disputation date (latest first)
Select
The maximal number of hits you can export is 250. When you want to export more records please use the Create feeds function.
  • 1.
    Ahlberg, Beth Maina
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, International Maternal and Child Health (IMCH).
    Njoroge, Kezia Muthoni
    School of Health, Community of Education Studies, Northumbria University, Newcastle upon Tyne, UK.
    'Not men enough to rule!': politicization of ethnicities and forcible circumcision of Luo men during the postelection violence in Kenya2013In: Ethnicity and Health, ISSN 1355-7858, E-ISSN 1465-3419, Vol. 18, no 5, p. 454-468Article in journal (Refereed)
    Abstract [en]

    Background

    As a contribution to ongoing research addressing sexual violence in war and conflict situations in the Democratic Republic of Congo, Kenya and Rwanda, this paper argues that the way sexual violence intersects with other markers of identity, including ethnicity and class, is not clearly articulated. Male circumcision has been popularized, as a public health strategy for prevention of HIV transmission, although evidence of its efficacy is disputable and insufficient attention has been given to the social and cultural implications of male circumcision.

    Methods

    This paper draws from media reporting and the material supporting the prosecutor at the International Criminal Court case against four Kenyans accused of crimes against humanity, to explore the postelection violence, especially forcible male circumcision.

    Results

    During the postelection violence in Kenya, women were, as in other conflict situations, raped. In addition, men largely from the Luo ethnic group were forcibly circumcised. Male circumcision among the Gikuyu people is a rite of passage, but when forced upon the Luo men, it was also associated with cases of castration and other forms of genital mutilation. The aim appears to have been to humiliate and terrorize not just the individual men, but their entire communities. The paper examines male circumcision and questions why a ritual that has marked a life-course transition for inculcating ethical analysis of the self and others, became a tool of violence against men from an ethnic group where male circumcision is not a cultural practice.

    Conclusion

    The paper then reviews the persistence and change in the ritual and more specifically, how male circumcision has become, not just a sexual health risk, but, contrary to the emerging health discourse and more significantly, a politicized ethnic tool and a status symbol among the Gikuyu elite. In the view of the way male circumcision was perpetrated in Kenya, we argue it should be considered as sexual violence, with far-reaching consequences for men's physical and mental health.

  • 2. Bell, Jessica
    et al.
    Ancillotti, Mirko
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Coathup, Victoria
    Coy, Sarah
    Rigter, Tessel
    Tatum, Travis
    Grewal, Jasjote
    Akcesme, Faruk Berat
    Brkić, Jovana
    Causevic-Ramosevac, Anida
    Milovanovic, Goran
    Nobile, Marianna
    Pavlidis, Cristiana
    Finlay, Teresa
    Kaye, Jane
    Challenges and opportunities for ELSI early career researchers2016In: BMC Medical Ethics, ISSN 1472-6939, E-ISSN 1472-6939, Vol. 17, article id 37Article in journal (Refereed)
    Abstract [en]

    BACKGROUND: Over the past 25 years, there has been growing recognition of the importance of studying the Ethical, Legal and Social Implications (ELSI) of genetic and genomic research. A large investment into ELSI research from the National Institutes of Health (NIH) Human Genomic Project budget in 1990 stimulated the growth of this emerging field; ELSI research has continued to develop and is starting to emerge as a field in its own right. The evolving subject matter of ELSI research continues to raise new research questions as well as prompt re-evaluation of earlier work and a growing number of scholars working in this area now identify themselves as ELSI scholars rather than with a particular discipline.

    MAIN TEXT: Due to the international and interdisciplinary nature of ELSI research, scholars can often find themselves isolated from disciplinary or regionally situated support structures. We conducted a workshop with Early Career Researchers (ECRs) in Oxford, UK, and this paper discusses some of the particular challenges that were highlighted. While ELSI ECRs may face many of the universal challenges faced by ECRs, we argue that a number of challenges are either unique or exacerbated in the case of ELSI ECRs and discuss some of the reasons as to why this may be the case. We identify some of the most pressing issues for ELSI ECRs as: interdisciplinary angst and expertise, isolation from traditional support structures, limited resources and funding opportunities, and uncertainty regarding how research contributions will be measured. We discuss the potential opportunity to use web 2.0 technologies to transform academic support structures and address some of the challenges faced by ELSI ECRs, by helping to facilitate mentoring and support, access to resources and new accreditation metrics.

    CONCLUSION: As our field develops it is crucial for the ELSI community to continue looking forward to identify how emerging digital solutions can be used to facilitate the international and interdisciplinary research we perform, and to offer support for those embarking on, progressing through, and transitioning into an ELSI research career.

  • 3.
    Bessani, Alysson
    et al.
    Univ Lisbon, Fac Ciencias, LaSIGE, Lisbon, Portugal..
    Brandt, Joergen
    Humboldt Univ, Berlin, Germany..
    Bux, Marc
    Humboldt Univ, Berlin, Germany..
    Cogo, Vinicius
    Univ Lisbon, Fac Ciencias, LaSIGE, Lisbon, Portugal..
    Dimitrova, Lora
    Charite, Berlin, Germany..
    Dowling, Jim
    KTH Royal Inst Technol, Stockholm, Sweden..
    Gholami, Ali
    KTH Royal Inst Technol, Stockholm, Sweden..
    Hakimzadeh, Kamal
    KTH Royal Inst Technol, Stockholm, Sweden..
    Hummel, Micheal
    Charite, Berlin, Germany..
    Ismail, Mahmoud
    KTH Royal Inst Technol, Stockholm, Sweden..
    Laure, Erwin
    KTH Royal Inst Technol, Stockholm, Sweden..
    Leser, Ulf
    Humboldt Univ, Berlin, Germany..
    Litton, Jan-Eric
    Karolinska Inst, Solna, Sweden..
    Martinez, Roxanna
    Karolinska Inst, Solna, Sweden..
    Niazi, Salman
    KTH Royal Inst Technol, Stockholm, 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.
    Zimmermann, Karin
    Charite, Berlin, Germany..
    BiobankCloud: A Platform for the Secure Storage, Sharing, and Processing of Large Biomedical Data Sets2016In: BIOMEDICAL DATA MANAGEMENT AND GRAPH ONLINE QUERYING, 2016, p. 89-105Conference paper (Refereed)
    Abstract [en]

    Biobanks store and catalog human biological material that is increasingly being digitized using next-generation sequencing (NGS). There is, however, a computational bottleneck, as existing software systems are not scalable and secure enough to store and process the incoming wave of genomic data from NGS machines. In the BiobankCloud project, we are building a Hadoop-based platform for the secure storage, sharing, and parallel processing of genomic data. We extended Hadoop to include support for multi-tenant studies, reduced storage requirements with erasure coding, and added support for extensible and consistent metadata. On top of Hadoop, we built a scalable scientific workflow engine featuring a proper workflow definition language focusing on simple integration and chaining of existing tools, adaptive scheduling on Apache Yarn, and support for iterative dataflows. Our platform also supports the secure sharing of data across different, distributed Hadoop clusters. The software is easily installed and comes with a user-friendly web interface for running, managing, and accessing data sets behind a secure 2-factor authentication. Initial tests have shown that the engine scales well to dozens of nodes. The entire system is open-source and includes pre-defined workflows for popular tasks in biomedical data analysis, such as variant identification, differential transcriptome analysis using RNA-Seq, and analysis of miRNA-Seq and ChIP-Seq data.

  • 4. Bjugn, Roger
    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.
    Hostmaelingen, Njal
    Simeon-Dubach, Daniel
    Petrini, Carlo
    What Are Some of the ELSI Challenges of International Collaborations Involving Biobanks, Global Sample Collection, and Genomic Data Sharing and How Should They Be Addressed?2015In: Biopreservation and Biobanking, ISSN 1947-5535, E-ISSN 1947-5543, Vol. 13, no 2, p. 70-71Article in journal (Refereed)
  • 5. Borry, Pascal
    et al.
    Cornel, Martina C
    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.
    Where are you going, where have you been: a recent history of the direct-to-consumer genetic testing market.2010In: Journal of community genetics, ISSN 1868-310X, Vol. 1, no 3, p. 101-106Article in journal (Refereed)
    Abstract [en]

    In recent years, various private companies have been marketing and offering genetic tests directly to consumers. This article reviews the recent history of this commercial phenomenon. In particular, we discuss and describe the following subjects: (1) the factors that allowed for the creation of the direct-to-consumer (DTC) genetic testing (GT) market; (2) information regarding the size and potential success or failure of the DTC GT market; (3) recent changes in the DTC GT market; and (4) the recent events that may have an impact on the regulatory oversight of DTC genetic testing and the future evolution of this market. This review of factors suggests that despite the possibility of a change of business model as well as increased regulation, the commercialization of genetic testing is here to stay. As such it is important to pay close attention not only to the science underlying these tests but also to the ethical, legal, and social issues.

  • 6. Borry, Pascal
    et al.
    Henneman, Lidewij
    Lakeman, Phillis
    ten Kate, Leo P
    Cornel, Martina C
    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.
    Preconceptional genetic carrier testing and the commercial offer directly-to-consumers.2011In: Human Reproduction, ISSN 0268-1161, E-ISSN 1460-2350, Vol. 26, no 5, p. 972-7Article in journal (Refereed)
    Abstract [en]

    Recently, a number of commercial companies are offering preconceptional carrier tests directly-to-consumers. This offer raises a number of concerns and issues above and beyond those encountered with preconceptional tests offered within the traditional health care setting. In order to bring some of these issues to light and to initiate dialogue on this topic, this article discusses the following issues: the current offer of preconceptional carrier tests (until the end of 2010) through online commercial companies; the implications for the informed consent procedure and the need for good information; the need for medical supervision and follow-up; and the appropriate use of existing resources. The article concludes with some reflections about the potential sustainability of the offer of preconceptional carrier tests directly-to-consumers.

  • 7. Borry, Pascal
    et al.
    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.
    Sénécal, Karine
    Avard, Denise
    Health-related direct-to-consumer genetic testing: a review of companies' policies with regard to genetic testing in minors.2010In: Familial Cancer, ISSN 1389-9600, E-ISSN 1573-7292, Vol. 9, no 1, p. 51-9Article in journal (Refereed)
    Abstract [en]

    More and more companies are advertising and selling genetic tests directly to consumers. Considering the ethical, legal, and psychological concerns surrounding genetic testing in minors, a study of companies' websites was performed in order to describe and analyze their policies with respect to this issue. Of the 29 companies analyzed, 13 did not provide any information about this matter, eight companies allowed genetic testing upon parental request, four companies stated that their website is not directed to children under 18 years, and four companies suggested that in order to be tested, applicants should have reached the age of legal majority. If private companies offer genetic tests which are also offered in a clinical setting, can they be expected to adhere to the existing clinical guidelines with regard to these tests? If so, a certain ambiguity exists. Many companies are emphasizing in their disclaimers that their services are not medical services and should not be used as a basis for making medical decisions. Nonetheless, it remains debatable whether genetic testing in minors would be appropriate in this context. In line with the Advisory Committee on Genetic Testing, the Human Genetics Commission addressed the problem of non-consensual testing and recommended not to supply genetic testing services directly to those under the age of 16 or to those not able to make a competent decision regarding testing.

  • 8. Borry, Pascal
    et al.
    Rusu, Olivia
    Dondorp, Wybo
    De Wert, Guido
    Knoppers, Bartha Maria
    Howard, Heidi Carmen
    Anonymity 2.0: direct-to-consumer genetic testing and donor conception.2014In: Fertility and Sterility, ISSN 0015-0282, E-ISSN 1556-5653, Vol. 101, no 3, p. 630-2Article in journal (Refereed)
  • 9. Borry, Pascal
    et al.
    Rusu, Olivia
    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.
    Genetic testing: anonymity of sperm donors under threat.2013In: Nature, ISSN 0028-0836, E-ISSN 1476-4687, Vol. 496, no 7444, p. 169-Article in journal (Refereed)
  • 10. Borry, Pascal
    et al.
    van Hellemondt, Rachel E
    Sprumont, Dominique
    Jales, Camilla Fittipaldi Duarte
    Rial-Sebbag, Emmanuelle
    Spranger, Tade Matthias
    Curren, Liam
    Kaye, Jane
    Nys, Herman
    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.
    Legislation on direct-to-consumer genetic testing in seven European countries.2012In: European Journal of Human Genetics, ISSN 1018-4813, E-ISSN 1476-5438, Vol. 20, no 7, p. 715-21Article in journal (Refereed)
    Abstract [en]

    An increasing number of private companies are now offering direct-to-consumer (DTC) genetic testing services. Although a lot of attention has been devoted to the regulatory framework of DTC genetic testing services in the USA, only limited information about the regulatory framework in Europe is available. We will report on the situation with regard to the national legislation on DTC genetic testing in seven European countries (Belgium, the Netherlands, Switzerland, Portugal, France, Germany, the United Kingdom). The paper will address whether these countries have legislation that specifically address the issue of DTC genetic testing or have relevant laws that is pertinent to the regulatory control of these services in their countries. The findings show that France, Germany, Portugal and Switzerland have specific legislation that defines that genetic tests can only be carried out by a medical doctor after the provision of sufficient information concerning the nature, meaning and consequences of the genetic test and after the consent of the person concerned. In the Netherlands, some DTC genetic tests could fall under legislation that provides the Minister the right to refuse to provide a license to operate if a test is scientifically unsound, not in accordance with the professional medical practice standards or if the expected benefit is not in balance with the (potential) health risks. Belgium and the United Kingdom allow the provision of DTC genetic tests.

  • 11.
    Bradby, Hannah
    Uppsala University, Disciplinary Domain of Humanities and Social Sciences, Faculty of Social Sciences, Department of Sociology.
    (Imaginary) healthcare heroes – Ms Conscientious (#2 in an occasional series)2015Other (Other (popular science, discussion, etc.))
  • 12.
    Budin-Ljosne, Isabelle
    et al.
    Univ Oslo, Inst Hlth & Soc, Ctr Med Eth, POB 1130, NO-0318 Oslo, Norway.;Cancergen No, Norwegian Canc Genom Consortium, Oslo, Norway..
    Teare, Harriet J. A.
    Univ Oxford, Nuffield Dept Populat Hlth, Ctr Hlth Law & Emerging Technol HeLEX, Oxford, England..
    Kaye, Jane
    Univ Oxford, Nuffield Dept Populat Hlth, Ctr Hlth Law & Emerging Technol HeLEX, Oxford, England..
    Beck, Stephan
    UCL, UCL Canc Inst, London, England..
    Bentzen, Heidi Beate
    Univ Oslo, Inst Hlth & Soc, Ctr Med Eth, POB 1130, NO-0318 Oslo, Norway.;Cancergen No, Norwegian Canc Genom Consortium, Oslo, Norway.;Univ Oslo, Norwegian Res Ctr Comp & Law, Fac Law, Oslo, Norway..
    Caenazzo, Luciana
    Univ Padua, Padua, Italy..
    Collett, Clive
    Hlth Res Author, London, England..
    D'Abramo, Flavio
    Free Univ Berlin, Focus Area DynAge, Berlin, Germany..
    Felzmann, Heike
    NUI Galway, Ctr Bioeth Res & Anal, Galway, Ireland..
    Finlay, Teresa
    Univ Oxford, Nuffield Dept Populat Hlth, Ctr Hlth Law & Emerging Technol HeLEX, Oxford, England..
    Javaid, Muhammad Kassim
    Univ Oxford, Nuffield Dept Orthopaed Rheumatol & Musculoskelet, NIHR Musculoskeletal Biomed Res Unit, Oxford, England..
    Jones, Erica
    UCL, UCL Canc Inst, London, England..
    Katic, Visnja
    Univ Rijeka, Sch Med, Rijeka, Croatia..
    Simpson, Amy
    Genet Alliance UK, London, England..
    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, Ctr Biomed, Bolzano, Italy..
    Dynamic Consent: a potential solution to some of the challenges of modern biomedical research2017In: BMC Medical Ethics, ISSN 1472-6939, E-ISSN 1472-6939, Vol. 18, article id 4Article in journal (Refereed)
    Abstract [en]

    Background: Innovations in technology have contributed to rapid changes in the way that modern biomedical research is carried out. Researchers are increasingly required to endorse adaptive and flexible approaches to accommodate these innovations and comply with ethical, legal and regulatory requirements. This paper explores how Dynamic Consent may provide solutions to address challenges encountered when researchers invite individuals to participate in research and follow them up over time in a continuously changing environment. Methods: An interdisciplinary workshop jointly organised by the University of Oxford and the COST Action CHIP ME gathered clinicians, researchers, ethicists, lawyers, research participants and patient representatives to discuss experiences of using Dynamic Consent, and how such use may facilitate the conduct of specific research tasks. The data collected during the workshop were analysed using a content analysis approach. Results: Dynamic Consent can provide practical, sustainable and future-proof solutions to challenges related to participant recruitment, the attainment of informed consent, participant retention and consent management, and may bring economic efficiencies. Conclusions: Dynamic Consent offers opportunities for ongoing communication between researchers and research participants that can positively impact research. Dynamic Consent supports inter-sector, cross-border approaches and large scale data-sharing. Whilst it is relatively easy to set up and maintain, its implementation will require that researchers re-consider their relationship with research participants and adopt new procedures.

  • 13. Cambon-Thomsen, Anne
    et al.
    Bovenberg, Jasper
    Lavitrano, Marialuisa
    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.
    Mayrhofer, Michaela
    Litton, Jan-Eric
    Ethical, Legal and Societal Implications of Biobanking at European Level: A Common Service of the European Biobank and Biomolecular Research Infrastructure2015In: Tissue Antigens, ISSN 0001-2815, E-ISSN 1399-0039, Vol. 85, no 5, p. 372-372Article in journal (Refereed)
  • 14. Corradetti, Claudio
    et al.
    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.
    Patientcentricity2012In: Studies in Ethics, Law, and Technology, ISSN 1941-6008, E-ISSN 1941-6008, Vol. 6, no 1, p. 1-2Article in journal (Refereed)
  • 15. Daulaire, Nils
    et al.
    Bang, Abhay
    Tomson, Goran
    Kalyango, Joan N.
    Cars, Otto
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Medical Sciences, Infectious Diseases.
    Universal Access to Effective Antibiotics is Essential for Tackling Antibiotic Resistance2015In: Journal of Law, Medicine & Ethics, ISSN 1073-1105, E-ISSN 1748-720X, Vol. 43, no S3, p. 17-21Article in journal (Refereed)
    Abstract [en]

    Universal access to effective antimicrobials is essential to the realization of the right to health. At present, 5.7 million people die from treatable infections each year because they lack this access. Yet, community-based diagnosis and appropriate treatment for many of the leading causes of avoidable infectious deaths has been shown to be feasible and effective, demonstrating that strategies to reach the under-served need to receive high priority. This is a necessary part of a broad strategy to assure the long-term benefits of antimicrobials and to combat antimicrobial resistance, both because the lack of systematic and rigorous efforts to assure effective coverage increases the likelihood of antimicrobial resistance, and because global efforts aimed at antimicrobial stewardship and innovation cannot succeed without explicitly addressing the needs of the under-served. Elements of this strategy will include clear evidence-based treatment protocols, a robust international framework and locally tailored regulations, active engagement with communities and local health providers, strong attention to program management and cost considerations, a focus on the end user, and robust surveillance and response to emerging resistance patterns. Only by balancing the needs of universal access with stewardship and innovation, and assuring that they are mutually reinforcing can a global strategy hope to effectively address antimicrobial resistance.

  • 16. De Wert, G.
    et al.
    Heindryckx, B.
    Pennings, G.
    Clarke, A.
    Eichenlaub-Ritter, U.
    van El, Carla G.
    Forzano, F.
    Goddijn, M.
    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.
    Radojkovic, D.
    Rial-Sebbag, E.
    Dondorp, W.
    Tarlatzis, B. C.
    Cornel, M. C.
    Responsible innovation in human germline gene editing: Background document to the recommendations of ESHG and ESHRE2018In: European Journal of Human Genetics, ISSN 1018-4813, E-ISSN 1476-5438, Vol. 26, no 4, p. 450-470Article in journal (Refereed)
    Abstract [en]

    Technological developments in gene editing raise high expectations for clinical applications, including editing of the germline. The European Society of Human Reproduction and Embryology (ESHRE) and the European Society of Human Genetics (ESHG) together developed a Background document and Recommendations to inform and stimulate ongoing societal debates. This document provides the background to the Recommendations. Germline gene editing is currently not allowed in many countries. This makes clinical applications in these countries impossible now, even if germline gene editing would become safe and effective. What were the arguments behind this legislation, and are they still convincing? If a technique could help to avoid serious genetic disorders, in a safe and effective way, would this be a reason to reconsider earlier standpoints? This Background document summarizes the scientific developments and expectations regarding germline gene editing, legal regulations at the European level, and ethics for three different settings (basic research, preclinical research and clinical applications). In ethical terms, we argue that the deontological objections (e.g., gene editing goes against nature) do not seem convincing while consequentialist objections (e.g., safety for the children thus conceived and following generations) require research, not all of which is allowed in the current legal situation in European countries. Development of this Background document and Recommendations reflects the responsibility to help society understand and debate the full range of possible implications of the new technologies, and to contribute to regulations that are adapted to the dynamics of the field while taking account of ethical considerations and societal concerns.

  • 17.
    de Wert, Guido
    et al.
    Department of Health, Ethics and Society, Research Institutes GROW and CAPHRI, Fac. of Health, Medicine and the Life Sciences, Maastricht University, Maastricht, The Netherlands.
    Pennings, Guido
    Bioethics Institute Ghent, Department of Philosophy and Moral Science, Ghent University, Ghent, Belgium.
    Clarke, Angus
    School of Medicine, Cardiff University, Cardiff, UK.
    Eichenlaub-Ritter, Ursula
    Institute of Gene Technology/Microbiology, Faculty of Biology, University of Bielefeld, Bielefeld, Germany.
    van El, Carla G.
    Department of Clinical Genetics, Section Community Genetics, and Amsterdam Public Health research institute, VU University Medical Center, Amsterdam, The Netherlands.
    Forzano, Francesca
    Clinical Genetics Department, Guy’s Hospital, Guy’s and St Thomas’ NHS Foundation Trust, London, UK.
    Goddijn, Mariëtte
    Center for Reproductive Medicine, Department of Obstetrics and Gynecology, Academic Medical Center, Amsterdam-Zuidoost, The Netherlands.
    Heindryckx, Björn
    Ghent-Fertility and Stem cell Team (G-FaST), Department for Reproductive Medicine, Ghent University Hospital, Ghent, Belgium.
    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.
    Radojkovic, Dragica
    Laboratory for Molecular Biology, Institute of Molecular Genetics and Genetic Engineering, University of Belgrade, Belgrade, Serbia.
    Rial-Sebbag, Emmanuelle
    University Paul Sabatier Toulouse, Toulouse, France.
    Tarlatzis, Basil C.
    1st Department of Obstetrics & Gynecology, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.
    Cornel, Martina C.
    Department of Clinical Genetics, Section Community Genetics, and Amsterdam Public Health research institute, VU University Medical Center, Amsterdam, The Netherlands.
    Human germline gene editing: Recommendations of ESHG and ESHRE2018In: European Journal of Human Genetics, ISSN 1018-4813, E-ISSN 1476-5438, Vol. 26, no 4, p. 445-449Article in journal (Refereed)
    Abstract [en]

    Technological developments in gene editing raise high expectations for clinical applications, first of all for somatic gene editing but in theory also for germline gene editing (GLGE). GLGE is currently not allowed in many countries. This makes clinical applications in these countries impossible now, even if GLGE would become safe and effective. What were the arguments behind this legislation, and are they still convincing? If a technique can help to avoid serious genetic disorders, in a safe and effective way, would this be a reason to reconsider earlier standpoints? The European Society of Human Reproduction and Embryology (ESHRE) and the European Society of Human Genetics (ESHG) together developed a Background document and Recommendations to inform and stimulate ongoing societal debates. After consulting its membership and experts, this final version of the Recommendations was endorsed by the Executive Committee and the Board of the respective Societies in May 2017. Taking account of ethical arguments, we argue that both basic and pre-clinical research regarding GLGE can be justified, with conditions. Furthermore, while clinical GLGE would be totally premature, it might become a responsible intervention in the future, but only after adequate pre-clinical research. Safety of the child and future generations is a major concern. Future discussions must also address priorities among reproductive and potential non-reproductive alternatives, such as PGD and somatic editing, if that would be safe and successful. The prohibition of human germline modification, however, needs renewed discussion among relevant stakeholders, including the general public and legislators.

  • 18.
    Dondorp, Wybo
    et al.
    Maastricht Univ, Res Sch CAPHRI, Dept Hlth Eth & Soc, NL-6200 MD Maastricht, Netherlands.;Maastricht Univ, Res Sch GROW, Dept Hlth Eth & Soc, NL-6200 MD Maastricht, Netherlands..
    de Wert, Guido
    Maastricht Univ, Res Sch CAPHRI, Dept Hlth Eth & Soc, NL-6200 MD Maastricht, Netherlands.;Maastricht Univ, Res Sch GROW, Dept Hlth Eth & Soc, NL-6200 MD Maastricht, Netherlands..
    Bombard, Yvonne
    Univ Toronto, Fac Med, Li Ka Shing Knowledge Inst, St Michaels Hosp, Toronto, ON, Canada.;Univ Toronto, Fac Med, Inst Hlth Policy Management & Evaluat, Toronto, ON, Canada..
    Bianchi, Diana W.
    Tufts Univ, Sch Med, Dept Pediat Obstet & Gynecol, Boston, MA 02111 USA..
    Bergmann, Carsten
    Ctr Human Genet Biosci, Ingelheim, Germany.;Univ Freiburg, Med Ctr, Dept Med, D-79106 Freiburg, Germany..
    Borry, Pascal
    Leuven Univ, Ctr Biomed Eth & Law, Dept Publ Hlth & Primary Care, Louvain, Belgium..
    Chitty, Lyn S.
    Great Ormond St Hosp & UCLH NHS Fdn Trusts, UCL Inst Child Hlth, Clin & Mol Genet Unit, London, England..
    Fellmann, Florence
    Univ Lausanne Hosp, Serv Med Genet, Lausanne, Switzerland..
    Forzano, Francesca
    Osped Galliera, Med Genet Unit, Genoa, Italy..
    Hall, Alison
    PHG Fdn, Cambridge, England..
    Henneman, Lidewij
    Vrije Univ Amsterdam Med Ctr, Sect Community Genet, Dept Clin Genet, Amsterdam, Netherlands.;Vrije Univ Amsterdam Med Ctr, EMGO Inst Hlth & Care Res, Amsterdam, Netherlands..
    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.
    Lucassen, Anneke
    Univ Southampton, Dept Clin Eth & Law CELS, Southampton, Hants, England.;Wessex Clin Genet Serv, Southampton, Hants, England..
    Ormond, Kelly
    Stanford Univ, Sch Med, Dept Genet, Stanford, CA USA.;Stanford Univ, Sch Med, Stanford Ctr Biomed Eth, Stanford, CA USA..
    Peterlin, Borut
    Univ Ljubljana, Med Ctr, Clin Inst Med Genet, Ljubljana 61000, Slovenia..
    Radojkovic, Dragica
    Univ Belgrade, IMGGE, Lab Mol Biol, Belgrade, Serbia..
    Rogowski, Wolf
    Helmholtz Zentrum, Deutsch Forschungszentrum Gesundheit & Umwelt, Munich, Germany..
    Soller, Maria
    Lund Univ, Div Clin Genet, Lund, Sweden.;Univ Lund Hosp, Reg Labs Reg Skane, S-22185 Lund, Sweden..
    Tibben, Aad
    Leiden Univ, Med Ctr, Dept Clin Genet, Leiden, Netherlands..
    Tranebjaerg, Lisbeth
    Bispebjerg Hosp, Rigshosp, Dept Audiol, Copenhagen, Denmark.;Univ Copenhagen, Kennedy Ctr, Dept Clin Genet, Copenhagen, Denmark.;Univ Copenhagen, ICMM, Inst Cellular & Mol Med, Copenhagen, Denmark..
    van El, Carla G.
    Vrije Univ Amsterdam Med Ctr, Sect Community Genet, Dept Clin Genet, Amsterdam, Netherlands.;Vrije Univ Amsterdam Med Ctr, EMGO Inst Hlth & Care Res, Amsterdam, Netherlands..
    Cornel, Martina C.
    Vrije Univ Amsterdam Med Ctr, Sect Community Genet, Dept Clin Genet, Amsterdam, Netherlands.;Vrije Univ Amsterdam Med Ctr, EMGO Inst Hlth & Care Res, Amsterdam, Netherlands..
    Non-invasive prenatal testing for aneuploidy and beyond: challenges of responsible innovation in prenatal screening2015In: European Journal of Human Genetics, ISSN 1018-4813, E-ISSN 1476-5438, Vol. 23, no 11, p. 1438-1450Article in journal (Refereed)
    Abstract [en]

    This paper contains a joint ESHG/ASHG position document with recommendations regarding responsible innovation in prenatal screening with non-invasive prenatal testing (NIPT). By virtue of its greater accuracy and safety with respect to prenatal screening for common autosomal aneuploidies, NIPT has the potential of helping the practice better achieve its aim of facilitating autonomous reproductive choices, provided that balanced pretest information and non-directive counseling are available as part of the screening offer. Depending on the health-care setting, different scenarios for NIPT-based screening for common autosomal aneuploidies are possible. The trade-offs involved in these scenarios should be assessed in light of the aim of screening, the balance of benefits and burdens for pregnant women and their partners and considerations of cost-effectiveness and justice. With improving screening technologies and decreasing costs of sequencing and analysis, it will become possible in the near future to significantly expand the scope of prenatal screening beyond common autosomal aneuploidies. Commercial providers have already begun expanding their tests to include sex-chromosomal abnormalities and microdeletions. However, multiple false positives may undermine the main achievement of NIPT in the context of prenatal screening: the significant reduction of the invasive testing rate. This document argues for a cautious expansion of the scope of prenatal screening to serious congenital and childhood disorders, only following sound validation studies and a comprehensive evaluation of all relevant aspects. A further core message of this document is that in countries where prenatal screening is offered as a public health programme, governments and public health authorities should adopt an active role to ensure the responsible innovation of prenatal screening on the basis of ethical principles. Crucial elements are the quality of the screening process as a whole (including non-laboratory aspects such as information and counseling), education of professionals, systematic evaluation of all aspects of prenatal screening, development of better evaluation tools in the light of the aim of the practice, accountability to all stakeholders including children born from screened pregnancies and persons living with the conditions targeted in prenatal screening and promotion of equity of access.

  • 19.
    Dreborg, Sten
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, Pediatrics.
    Redovisat forskningsfusk bara toppen av isberget?2013In: Läkartidningen, ISSN 0023-7205, E-ISSN 1652-7518, Vol. 110, no 37, p. 1584-1585Article in journal (Other academic)
  • 20.
    Ekstrand, Maria
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, International Maternal and Child Health (IMCH). Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Caring Sciences.
    Tyden, Tanja
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Caring Sciences. Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, Obstetrics and Gynaecology.
    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.
    Larsson, Margareta
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, Obstetrics and Gynaecology.
    Swedish parents’ interest in preconception genetic carrier screening2016In: Upsala Journal of Medical Sciences, ISSN 0300-9734, E-ISSN 2000-1967, Vol. 121, no 4, p. 289-294Article in journal (Refereed)
    Abstract [en]

    Introduction: Genetic technologies advance rapidly. It is possible to undergo genetic carrier screening before pregnancy to examine genetic risks to future offspring. We aimed to investigate parents’ interest and motives towards preconception genetic carrier screening (PCS) as well as factors associated with interest in PCS.

    Material and methods: Our study sample consists of 777 parent couples within the longitudinal Swedish Pregnancy Planning study. Women responded to questionnaires at three occasions: in early pregnancy, late pregnancy, and one year after childbirth. Male partners responded to one questionnaire one year after childbirth.

    Results: One-third of the parents were positive (30% versus 34% of women and men, respectively), less than a third were negative (26% versus 28%), and 45% versus 38% were uncertain about whether to consider PCS before a future pregnancy. No differences in PCS interest were found between women and men (P = 0.091), but a higher proportion of women were concerned about negative consequences (53% versus 46%, P < 0.003) and were ‘opposed to such a way of child selection’ (31.8% versus 25.2%,P = 0.002). Factors associated with PCS interest were experiences of prenatal diagnostics and positive attitudes towards finding out or choosing sex of one’s child (women), and prenatal diagnostics, self-rated poor health, and pregnancy planning (men).

    Conclusion: Both women and men had relatively high uncertainty towards PCS, but women were more concerned about negative consequences. The future extent of the clinical utility of PCS is currently unknown, but parents’ interests and doubts are important aspects to consider.

  • 21.
    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.
    The contribution of neuroethics to international brain research initiatives2016In: Nature Reviews Neuroscience, ISSN 1471-003X, E-ISSN 1471-0048, Vol. 18, no 1, p. 1-2Article in journal (Refereed)
  • 22.
    Evers, Kathinka
    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.
    Changeux, Jean-Pierre
    CNRS, UMR 3571, Coll France, Paris, France.;CNRS, UMR 3571, Inst Pasteur, Paris, France..
    Proactive epigenesis and ethical innovation2016In: EMBO Reports, ISSN 1469-221X, E-ISSN 1469-3178, Vol. 17, no 10, p. 1361-1364Article in journal (Refereed)
  • 23.
    Evers, Kathinka
    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.
    Changeux, Jean-Pierre
    Inst Pasteur, Paris, France.;Coll France, Paris, France..
    Proactive epigenesis and ethics - Response2017In: EMBO Reports, ISSN 1469-221X, E-ISSN 1469-3178, Vol. 18, no 8, p. 1272-1272Article in journal (Other academic)
  • 24.
    Evers, Kathinka
    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.
    Giordano, James
    Departments of Neurology and Biochemistry, Neuroethics Studies Program-Pellegrino Center for Clinical Bioethics, Georgetown University Medical Center, Washington, DC, United States.
    The Utility- and Use–of Neurotechnology to Recover Consciousness: Technical and Neuroethical Considerations in Approaching the “Hard Question” of Neuroscience2017In: Frontiers in Human Neuroscience, ISSN 1662-5161, E-ISSN 1662-5161, Vol. 11, p. 1-3, article id 564Article in journal (Refereed)
  • 25.
    Evers, Kathinka
    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.
    Salles, Arleen
    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.
    Theoretical Framing of Neuroethics: The Need for a Conceptual Approach2017In: Debates About Neuroethics: Perspectives on Its Development, Focus, and Future / [ed] Eric Racine; John Aspler, Springer Publishing Company, 2017, 1, p. 89-107Chapter in book (Refereed)
    Abstract [en]

    There are different dominant perspectives, theories, and methodologies within neuroethics, each importantly shaping the identification, understanding, and discussion of the relevant ethical, social, philosophical and scientific issues. In this chapter, we first provide a brief overview of current neuroethical approaches calling attention to a common tendency to underestimate the role and value of conceptual analysis. Against that background, we present and develop the theoretical framework of fundamental neuroethics. Next, we suggest that neuroethics should be built on the sound scientific and philosophical foundations of informed materialism. Finally, we apply the proposed theoretical framework to the neuroethical discussion of brain simulation.

  • 26.
    Evers, Kathinka
    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.
    Stjernschantz Forsberg, Joanna
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Eliason, James F.
    What are your views on commercialization of tissues for research?2012In: Biopreservation and Biobanking, ISSN 1947-5535, E-ISSN 1947-5543, Vol. 10, no 6, p. 476-478Article in journal (Refereed)
  • 27.
    Evers, Kathinka
    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.
    Stjernschantz Forsberg, Joanna
    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
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics.
    Commercialization of Biobanks2012In: Biopreservation and Biobanking, ISSN 1947-5535, E-ISSN 1947-5543, Vol. 10, no 1, p. 45-47Article in journal (Refereed)
    Abstract [en]

    Biobank policy and regulations profoundly vary between different societies. One area with profound differences in culture and tradition concerns commercialization, and the possibility of using the human body as a capital resource. In the United States there is acceptance of this possibility, whereas European law is based on principles that categorically prohibit selling parts of the human body. We suggest that questions of commercialization in the area of biobanking must be considered in relation to different ethical values, notably the principle of best possible use of collected biobank materials for the benefit of vital patient interests.

  • 28.
    Falkenström, Erica
    et al.
    Stockholm Univ, S-10691 Stockholm, Sweden..
    Ohlsson, Jon
    Stockholm Univ, S-10691 Stockholm, Sweden..
    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.
    Developing ethical competence in healthcare management2016In: Journal of Workplace Learning, ISSN 1366-5626, E-ISSN 1758-7859, Vol. 28, no 1, p. 17-32Article in journal (Refereed)
    Abstract [en]

    Purpose - The purpose of this paper was to explore what kind of ethical competence healthcare managers need in handling conflicts of interest (COI). The aim is also to highlight essential learning processes to develop healthcare managers' ethical competence. Design/methodology/approach - A qualitative study was performed. Semi-structured interviews with ten Swedish healthcare managers from different care providers were carried out twice and analysed through step-wise categorisation. Findings - Four categories of COI were revealed and two ways (passive and active) in which COI were handled. Ethical guidelines did not help the healthcare managers to handle the COI, and none of the managers made use of any sort of systematic ethical analysis. However, certain ethical competence was of great importance to identify and handle COI, consisting of contextual understanding, rational emotions, some theoretical knowledge and a suitable language. Organising work so that ethical analysis can be carried out is of great importance, and top management needs to clearly express the importance of ethical competence and allocate resources to allow adequate learning processes. Originality/value - This paper highlights the management level and focuses on how work-integrated learning-processes can enable ethical competence. Ethical competence at the management level is essential both to comply with the constitution and legal requirements regarding healthcare, and so that managers are able to analyse COI and justify their decisions.

  • 29.
    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.
    “Cerebral Communication” With Patients With Disorders of Consciousness.: Clinical Feasibility and Implications2015In: AJOB Neuroscience, ISSN 2150-7740, E-ISSN 2150-7759, Vol. 6, no 2, p. 44-46Article in journal (Refereed)
  • 30.
    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.
    Neurotechnology–mediated communication: a new tool for personal rights of patients with disorders of consciousness?2016In: Mind, brain and education at Erice: ten years / [ed] Antonio M. Battro, Kurt W. Fischer & María Lourdes Majdalani, Erice: Ettore Majorana Foundation , 2016, p. 149-152Chapter in book (Other academic)
    Abstract [en]

    In the inspiring and friendly environment of the ninth International Summer School on Mind, Brain and Education, titled Body, Brain and Personal Identity: Historical and Contemporary Perspectives, and directed by Antonio M. Battro, Kurt W. Fischer and Fernando Vidal, I presented the provisional results of my investigation of the impact of neurotechnology on the speechless subjects’ ability to communicate. In particular, I focused on the possible use of neurotechnology to communicate with comatose patients. 

  • 31.
    Farisco, Michele
    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.
    Alleva, Enrico
    Italian National Institute of Health.
    Chiarotti, Flavia
    Italian National Institute of Health.
    Macrì, Simone
    Italian National Institute of Health.
    Petrini, Carlo
    Italian National Institute of Health.
    Clinicians’ attitudes towards patients with disorders of consciousness: a survey2014In: Neuroethics, ISSN 1874-5490, E-ISSN 1874-5504, Vol. 7, no 1, p. 93-104Article in journal (Refereed)
    Abstract [en]

    Notwithstanding fundamental methodological advancements, scientific information about disorders of consciousness (DOCs)—e.g. Vegetative State/Unresponsive Wakefulness Syndrome (VS/UWS) and Minimally Conscious State (MCS)—is incomplete. The possibility to discriminate between different levels of consciousness in DOC states entails treatment strategies and ethical concerns. Here we attempted to investigate Italian clinicians’ and basic scientists’ opinions regarding some issues emerging from the care and the research on patients with DOCs. From our survey emerged that Italian physicians working with patients with DOCs give a central role to ethics. Current Italian regulation regarding basic research conducted in patients with DOCs apparently risks to be inadequate to support scientific advancement, and would deserve a different assessment compared to ordinary treatments. We think the results of our survey deserve attention from an international audience because they exemplify the difficulty to define a shared approach to the issues related to patients with DOCs and the necessity to better assess both the ordinary and experimental treatment of patients with DOCs at the ethical and legal level.

  • 32.
    Farisco, Michele
    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.
    Petrini, Carlo
    Biomedical research involving patients with disorders of consciousness: ethical and legal dimensions2014In: Annali dell'Istituto Superiore di Sanità, ISSN 0021-2571, Vol. 50, no 3, p. 221-228Article in journal (Refereed)
    Abstract [en]

    The directive 2001/20/UE and the research involving patients with docs. Researchinvolving patients with disorders of consciousness (DOCs) deserves special ethical andlegal attention because of its Janus-faced nature. On the one hand, it raises concernsabout the risk to expose the involved subjects to disproportionate risks not respectingtheir individual dignity, particularly their right to be cared for; on the other hand, researchis an essential tool in order to improve the clinical condition of patients withDOCs. The present paper concerns the ethical and legal dimensions of biomedical researchinvolving patients with disorders of consciousness. In particular, it focuses oninformed consent to experimental treatments, which is a challenging issue both from anethical and legal point of view. The first part reads the Directive 2001/20/EU in the lightof the experimentation of patients with DOCs, and suggests a revision in order to betterassess the issue of informed consent.The particular case of informed consent for observational studies of non-communicativepatients. The second part presents an informed consent form for studies throughvideo-recording of patients unable to communicate their own consent. This form hasbeen elaborated by the bioethics unit of the project “Review of the nosography of vegetativestates: application of methods of behavioral analysis to individuals in coma orvegetative state” developed at the Italian National Institute of Health.Relevance of the suggested form. The paper describes the conceptual framework ofthe form for informed consent to studies through video-recoding, which is a relevantexample of what issues should be included in an informed consent for any type of studiesthrough video-recording of patients unable to express their own consent. The article hasbeen sent on November the 7th 2013, before the adoption of the Regulation (EU) no.536/2014 (and consequent abrogation of the Directive 2001/20/EU) and the release ofthe new edition of the Italian Code of Medical Ethics.

  • 33.
    Farisco, Michele
    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.
    Salles, Arleen
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Centre for Research Ethics and Bioethics. Centro de Investigaciones Filosoficas.
    Big Science, Brain Simulation and Neuroethics2016In: AJOB Neuroscience, ISSN 2150-7740, E-ISSN 2150-7759, Vol. 7, no 1, p. 28-30Article in journal (Refereed)
    Abstract [en]

    We believe that it is valuable to investigate conceptual understandings of the brain andof simulation in order to better grasp the ethical implicationsof simulation technology in particular. Such conceptualexamination is offered by fundamental neuroethics. Inthis commentary we propose a reading of simulationwithin the framework of fundamental neuroethics.

  • 34.
    Farisco, Michele
    et al.
    Biogem – Istituto di ricerche genetiche, Ariano Irpino, Avellino.
    Ferrigno, Luigina
    Petrini, Carlo
    Rosmini, Francesco
    Codici, linee guida e commentari di etica della ricerca: la questione della qualità2014In: Epidemiologia & Prevenzione, ISSN 1120-9763, Vol. 38, no 3-4, p. 268-272Article in journal (Refereed)
    Abstract [en]

    After an overview of the evolution of ethics laws for medical activities, we suggest a possible classification of documents regarding the ethical conduct of scientific research with human beings. The authors outline the necessity to define formal criteria for the development and the implementation of ethics standards.

  • 35.
    Farisco, Michele
    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.
    Petrini, Carlo
    Italian National Institute of Health.
    Ethical Frameworks and Comparative Effectiveness Research2015In: Comparative Effectiveness Research in Health Services / [ed] Levy A & Sobolev B, New York: Springer Science+Business Media B.V., 2015, p. 1-37Chapter in book (Refereed)
    Abstract [en]

    The issue of comparative effectiveness research (CER) is assessed from an ethical point of view by comparison with the main ethical frameworks and by analysis of some of the relevant institutional documents. Two main conclusions emerge from the study: no ethical framework seems able to objectively and definitively assess CER; no institutional document, neither national nor international, has specifically assessed the ethical implications of CER. Nevertheless, this vacuum regarding CER raises relevant ethical concerns, thus revealing the necessity and urgency of an ethical evaluation of CER.

  • 36.
    Farisco, Michele
    et al.
    Department of Philosophy, Pontifical Faculty of Theology of Southern Italy S. Thomas, Naples, Italy .
    Petrini, Carlo
    Italian National Institute of Health.
    Medical Responsibility and Clinical Guidelines: A Few Remarks from Two Italian Juridical Cases2012In: Medicine Studies, ISSN SSN: 1876-4533 (print version) ISSN: 1876-4541 (electronic version), Vol. 3, no 3, p. 157-169Article in journal (Refereed)
    Abstract [en]

    Purpose

    The aim of this paper is to assess the complex issue of responsibility in clinical practice. The paper focuses mainly on the relationship between personal- and medical-professional responsibility of practitioners and clinical guidelines.

    Methods

    After a theoretical review of the different definitions of responsibility in selected bioethical and biojuridical literature, two recent juridical proceedings concerning medical responsibility from Italian Courts are discussed. Subsequently, a theoretical analysis of the definition of clinical practice guidelines is proposed in order to show their feasibility to assess personal- and medical-professional responsibility.

    Results

    The definitions of responsibility and the two Italian cases show the theoretical and practical difficulties of shared assessments of both personal-professional and medical-professional responsibility in clinical practice. Clinical practice guidelines cannot be assumed as an objective code of action stating exactly a rule of conduct in all situations, but as a tool suggesting how to decide what to do in different conditions.

    Conclusions

    Responsibility in clinical practice is such a complex issue to deserve a special ethical assessment. The clinician’s personal-professional responsibility cannot be replaced or reduced by clinical practice guidelines, because medicine is as such a relationship focused on the expertize of practitioners. Nonetheless, a shared approach to different clinical conditions is needed in order to avoid a relativist outcome and protect patients’ and even clinicians’ rights. Formal guidelines (that describe not exactly what to do but how to decide what to do) are proposed as potential useful tool to achieve this aim.

  • 37.
    Farisco, Michele
    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.
    Petrini, Carlo
    Misdiagnosis as an ethical and scientific challenge2014In: Annali dell'Istituto Superiore di Sanità, ISSN 0021-2571, Vol. 50, no 3, p. 229-233Article in journal (Refereed)
    Abstract [en]

    Difficulties of behavioral assessment of consciousness. An astonishingly high rateof misdiagnosis between vegetative state/unresponsive wakefulness syndrome and minimallyconscious state has been detected. This raises the issue of the adequacy of theconsciousness’ assessment in patients with disorders of consciousness. The behavioralassessment of consciousness could be not able to detect covert awareness, which is increasinglyidentified by the instrumental assessment.Ancillary methods. Neurotechnology, particularly neuroimaging, provides relevant dataconcerning the neurological underlying condition of patients with DOCs, but the instrumentalapproach has still to assess some technical issues.Ethical considerations. A correct diagnosis of a DOC is not only an instrumental issue,but also an ethically relevant demand to the scientific community. Finally, an integrationbetween behavioral and instrumental assessments seems to be the most adequate strategyin order to decrease the rate of misdiagnosis.

  • 38.
    Farisco, Michele
    et al.
    Biogem, Genetic Reseach Centre, Ariano Irpino (AV) Italy.
    Petrini, Carlo
    The Impact of Contemporary Neurotechnology on Diagnosing and Treating Patients with Disorders of Consciousness: A Review2013In: International Journal of Clinical Therapeutics and Diagnosis, ISSN 2332-2926, Vol. 1, no 2, p. 12-19Article in journal (Refereed)
    Abstract [en]

    Disorders of consciousness, especially Vegetative State, are assessed from a theoretical (historical and ethical) and empirical (neuroscientific) points of view, through a review of the most relevant recent literature. Both the potentiality of neuroscientific investigation and the limitations of its clinical (diagnostic and prognostic) application are underlined, showing the urgency of a collaboration between science, law and ethics in order to define the most appropriate nosography and to ensure the best therapy to patients with disorders of consciousness.

  • 39.
    Gainotti, Sabina
    et al.
    Ist Super Sanita, Natl Ctr Rare Dis, Vle Regina Elena 299, I-00162 Rome, Italy.
    Turner, Cathy
    Newcastle Univ, Inst Med Genet, Int Ctr Life, Newcastle Upon Tyne, Tyne & Wear, England.
    Woods, Simon
    Newcastle Univ, PEALS Policy Eth & Life Sci Res Ctr, Newcastle Upon Tyne, Tyne & Wear, England.
    Kole, Anna
    Rare Dis Europe, EURORDIS, Paris, France.
    McCormack, Pauline
    Newcastle Univ, PEALS Policy Eth & Life Sci Res Ctr, Newcastle Upon Tyne, Tyne & Wear, England.
    Lochmüller, Hanns
    Newcastle Univ, Inst Med Genet, Int Ctr Life, Newcastle Upon Tyne, Tyne & Wear, England.
    Riess, Olaf
    Univ Tubingen, Inst Human Genet & Appl Genom, Tubingen, Germany.
    Straub, Volker
    Newcastle Univ, Inst Med Genet, Int Ctr Life, Newcastle Upon Tyne, Tyne & Wear, England.
    Posada, Manuel
    SpainRDR, Inst Rare Dis Res, Madrid, Spain; ISCIII, CIBERER, Madrid, Spain.
    Taruscio, Domenica
    Ist Super Sanita, Natl Ctr Rare Dis, Vle Regina Elena 299, I-00162 Rome, 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, Ctr Biomed, Bolzano, Italy.
    Improving the informed consent process in international collaborative rare disease research: effective consent for effective research2016In: European Journal of Human Genetics, ISSN 1018-4813, E-ISSN 1476-5438, Vol. 24, no 9, p. 1248-1254Article in journal (Refereed)
    Abstract [en]

    The increased international sharing of data in research consortia and the introduction of new technologies for sequencing challenge the informed consent (IC) process, adding complexities that require coordination between research centres worldwide. Rare disease consortia present special challenges since available data and samples may be very limited. Thus, it is especially relevant to ensure the best use of available resources but at the same time protect patients' right to integrity. To achieve this aim, there is an ethical duty to plan in advance the best possible consent procedure in order to address possible ethical and legal hurdles that could hamper research in the future. Therefore, it is especially important to identify key core elements (CEs) to be addressed in the IC documents for international collaborative research in two different situations: (1) new research collections (biobanks and registries) for which information documents can be created according to current guidelines and (2) established collections obtained without IC or with a previous consent that does not cover all CEs. We propose here a strategy to deal with consent in these situations. The principles have been applied and are in current practice within the RD-Connect consortia - a global research infrastructure funded by the European Commission Seventh Framework program but forward looking in terms of issues addressed. However, the principles established, the lessons learned and the implications for future research are of direct relevance to all internationally collaborative rare-disease projects.

  • 40. Gini, Adriana
    et al.
    Larrivee, Denis
    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.
    Sironi, Vittorio
    Keeping the human: neuroethics and the conciliation of dissonant values in the 21st century2015In: Neuroscience and neuroeconomics, ISSN 2230-3561, Vol. 4, p. 1-10Article in journal (Refereed)
    Abstract [en]

    Studied since antiquity, the human brain has recently been the inspiration for an international neuroscientific entrepreneurship, the Human Brain Project in Europe and the Brain Research through Advancing Innovative Neurotechnologies initiative in the USA. Different in their approach, both regard the human brain as one of the greatest challenges of 21st century science and the organ that makes us “human”. However, it is mainly the necessity of developing new therapies that affect up to a billion people worldwide, which has propelled the search for extensive expertise and investment in neuroscience research. The debate on ethical and social policy issues as well as the research and medical strategies of such gigantic efforts has involved participants as diverse as neuroscientists, philosophers, scholars in ethics and law, politicians, and the general public, rendering modern neuroscience an interdisciplinary and conflictual endeavor. In fact, the brain is described as the biological underpinning of our thoughts, emotions, perceptions, free willed actions, and memories, features unique to our humanity. In this review, three neuroscientists and a philosopher from the neuroethics community provide their perspectives for an up-to-date survey of salient neuroethical issues, ie, modulation of free will and neuropharmaceuticals and neurotechnologies that enhance cognitive capacities, as well as an introduction of the reader to the controversial new discipline of neuroethics. Written for nonexperts in the field, it is intended to reflect on and to impart information helpful in understanding the challenges and the perils of modern neuroscience, whose tools are so powerful as to jeopardize what is uniquely “human” through willful mind manipulation. We conclude that, for any future effort to “recreate” the mind and, at the same time, keep what is uniquely ours, it will be necessary to reflect ethically and review carefully man's past best efforts at self-understanding.

  • 41.
    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.
    God vård innebär att sällsynta sjukdomar ges resurser.2018In: Dagens MedicinArticle in journal (Other (popular science, discussion, etc.))
    Abstract [sv]

    Sverige behöver ta ett nationellt ansvar så att människor med sällsynta diagnoser också kan få ta del av forskning och nya läkemedel.

  • 42.
    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 University College.
    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.
    "I have a lot of pills in my bag, you know": Institutional Norms in the Provision of Hope in Phase 1 Clinical Cancer Trials2017In: Journal of Oncology Pharmacy Practice, ISSN 1078-1552, E-ISSN 1477-092X, Vol. 13, no 10, p. 679-682Article in journal (Refereed)
    Abstract [en]

    Hope of a miracle cure is often an important motive for participating in phase 1 clinical cancer trials. Communication of hope may stimulate patients to participate and may enhance their quality of life; however, it may also deprive them of an opportunity to spend the remainder of their lives as they wish. Much depends on the kind of hope involved. This article outlines three forms of hope entertained by trial participants that, in various ways, are triggered, enhanced or modified by institutional norms within health care. This has normative as well as clinical implications; the information threshold for informed consent to enter phase 1 trials should be higher than that for consenting to medical treatment or entering randomised, controlled, phase 3 trials, clarifying the demarcation between clinical treatment and research. A simultaneous care model that integrates both trial participation and palliative care could and should also be offered; this is in line with the recommendations of the WHO, which state that palliative care should be applicable early in the course of illness. 

  • 43.
    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.
    Petri, Suzanne
    Rigshospitalet, Copenhagen University Hospital, Denmark.
    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.
    Halkoaho, Arja
    Tampere University of Applied Sciences, Finland.
    Mangset, Margrete
    Oslo universitetssykehus, Oslo University Hospital, Norway.
    Pirinen, Merja
    University of Eastern Finland, Kuopio, Finland.
    Engelbak Nielsen, Zandra
    Rigshospitalet, Copenhagen University Hospital, Denmark.
    When Nursing Care and Clinical Trials Coincide: A Qualitative Study of the Views of Nordic Oncology and Hematology Nurses on Ethical Work Challenges2018In: Journal of Empirical Research on Human Research Ethics, ISSN 1556-2646, E-ISSN 1556-2654Article in journal (Refereed)
    Abstract [en]

    This study investigated the kinds of ethical challenges experienced by nurses in oncology and hematology when nursing care and research overlap in clinical trials, and how the nurses handle such challenges. Individual interviews with 39 nurses from Sweden, Denmark, and Finland indicated that all nurses were positive about research, considering it essential for developing the best care. Ethical challenges exist, however; the most difficult were associated with the end-of-life patients, no longer responsive to standard therapy, who eagerly volunteer for cutting-edge drug trials in the hope of gaining therapeutic benefit. Many nurses lacked systematic strategies for addressing such challenges but found support from their nursing colleagues and relied on the research protocols to guide them.

  • 44.
    Gottvall, Maria
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Caring Sciences.
    Introduction of School-Based HPV Vaccination in Sweden: Knowledge and Attitudes among Youth, Parents, and Staff2014Doctoral thesis, comprehensive summary (Other academic)
    Abstract [en]

    The overall aim of this thesis is to provide a better understanding of knowledge, attitudes, consent, and decision-making regarding Human papillomavirus (HPV) vaccination, seen from the perspectives of concerned parties – high school students, school nurses, and parents.

    Two quantitative studies were performed: one descriptive cross-sectional study and one quasi-experimental intervention study. Qualitative studies using focus group interviews and individual interviews were also performed.

    High school students’ knowledge about HPV and HPV prevention was low but their attitudes toward HPV vaccination were positive. An educational intervention significantly increased the students’ knowledge regarding HPV and HPV prevention. Their already positive attitudes toward condom use and HPV vaccination remained unchanged. The students wanted to receive more information about HPV from school nurses. The school nurses were also positive to HPV vaccination but identified many challenges concerning e.g. priorities, obtaining informed consent, culture, and gender. They saw an ethical dilemma in conflicting values such as the child’s right to self-determination, the parents’ right to make autonomous choices on behalf of their children, and the nurse’s obligation to promote health. They were also unsure of how, what, and to whom information about HPV should be given. Parents, who had consented to vaccination of their young daughters, reasoned as follows: A vaccine recommended by the authorities is likely to be safe and effective, and the parents were willing to do what they could to decrease the risk of a serious disease for their daughter. Fear of unknown adverse events was overweighed by the benefits of vaccination. Parents also saw the school nurse as an important source of HPV information.

    Conclusions: Positive attitudes toward HPV vaccination despite limited knowledge about HPV, are overarching themes in this thesis. School nurses have a crucial role to inform about HPV prevention. It is important that the concerned parties are adequately informed about HPV and its preventive methods, so that they can make an informed decision about vaccination. A short school-based intervention can increase knowledge about HPV among students. From a public health perspective, high vaccination coverage is important as it can lead to a reduced number of HPV-related disease cases. 

    List of papers
    1. High HPV vaccine acceptance despite low awareness among Swedish upper secondary school students
    Open this publication in new window or tab >>High HPV vaccine acceptance despite low awareness among Swedish upper secondary school students
    2009 (English)In: European journal of contraception & reproductive health care, ISSN 1362-5187, E-ISSN 1473-0782, Vol. 14, no 6, p. 399-405Article in journal (Refereed) Published
    Abstract [en]

    OBJECTIVE: To investigate knowledge of human papillomavirus (HPV) and attitudes to HPV vaccination and condom use among Swedish first year upper secondary school students. METHODS: Classroom questionnaire filled in by 608 students from a strategic sample of seven upper secondary schools in Sweden. RESULTS: Only 13.5% (n = 82) of the students had heard about HPV and 6% (n = 35) were aware of HPV vaccination. As many as 84% (n = 508) would like to be vaccinated against HPV. The high cost of vaccination was the greatest obstacle (total group 37%, n = 227); among girls the second major hindrance was the fear of needles (19%, n = 65). Before considering an HPV vaccination 73% (n = 443) wanted more information and 36% (n = 220) would like to receive such information from the school nurse. The students considered it less likely that they would use a condom when having intercourse with a new partner if they were vaccinated than if they were not (p < 0.001). CONCLUSION: Despite intensive marketing directed at potential vaccine consumers, knowledge of HPV and of HPV vaccines was very low among first year upper secondary school students. Their attitude towards vaccination was positive but most of them wanted more information before considering vaccination.

    National Category
    Medical and Health Sciences
    Identifiers
    urn:nbn:se:uu:diva-111802 (URN)10.3109/13625180903229605 (DOI)000277147900004 ()19929642 (PubMedID)
    Available from: 2009-12-22 Created: 2009-12-22 Last updated: 2017-12-12Bibliographically approved
    2. Knowledge of human papillomavirus among high school students can be increased by an educational intervention
    Open this publication in new window or tab >>Knowledge of human papillomavirus among high school students can be increased by an educational intervention
    2010 (English)In: International Journal of STD and AIDS (London), ISSN 0956-4624, E-ISSN 1758-1052, Vol. 21, no 8, p. 558-562Article in journal (Refereed) Published
    Abstract [en]

    The aim of this study was to evaluate the effect of an educational intervention concerning human papillomavirus (HPV) directed at Swedish first year high school students. The intervention consisted of a class room lesson, a website and a folder. Outcome variables were knowledge of HPV and attitudes to preventive methods such as HPV vaccination, condom use and Pap smear testing. An intervention group (n = 92) was matched with two comparison groups (n = 184). At baseline, the median score for HPV knowledge was one out of 10 in both groups. At follow-up, the median knowledge score had increased to six in the intervention group, but was still one in the comparison group (P < 0.001). Attitudes to HPV vaccination, condom use and Pap smear testing remained the same (P > 0.05). In conclusion, a short school-based intervention can greatly increase the students' knowledge about HPV, but attitudes and behaviours are less easy to influence.

    Keywords
    hpv, knowledge, adolescent, intervention, HPV vaccine, prevention, condom
    National Category
    Dermatology and Venereal Diseases
    Research subject
    Caring Sciences
    Identifiers
    urn:nbn:se:uu:diva-132897 (URN)10.1258/ijsa.2010.010063 (DOI)000284445200006 ()20975088 (PubMedID)
    Projects
    HPV projekt
    Available from: 2010-10-28 Created: 2010-10-28 Last updated: 2017-12-12Bibliographically approved
    3. Challenges and opportunities of a new HPV immunization program: Perceptions among swedish school nurses
    Open this publication in new window or tab >>Challenges and opportunities of a new HPV immunization program: Perceptions among swedish school nurses
    Show others...
    2011 (English)In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 29, p. 4576-4583Article in journal (Refereed) Published
    Abstract [en]

    Aim To investigate school nurses’ perceptions of HPV immunization, and their task of administering the vaccine in a planned school-based program in Sweden. Method: Data were collected through five focus group interviews with school nurses (n = 30). The interviews were recorded, transcribed verbatim and analyzed using content analysis.

    Findings The theme Positive attitude to HPV immunization despite many identified problems and challenges summarizes the results. The school nurses saw the program as a benefit in that the free school-based HPV immunization program could balance out social inequalities. However, they questioned whether this new immunization program should be given priority given their already tight schedule. Some also expressed doubts regarding the effect of the vaccine. It was seen as challenging to obtain informed consent as well as to provide information regarding the vaccine. The nurses were unsure of whether boys and their parents should also be informed about the immunization.

    Conclusion Although some positive aspects of the new HPV immunization program were mentioned, the school nurses primarily identified problems and challenges; e.g. regarding priority setting, informed consent, culture and gender. In order to achieve a good work environment for the school nurses, and obtain a high coverage rate for the HPV immunization, these issues need to be taken seriously, be discussed and acted upon.

    Keywords
    HPV, Vaccination, School nurses, Focus groups, Dilemmas, Gender
    National Category
    Medical and Health Sciences
    Identifiers
    urn:nbn:se:uu:diva-153525 (URN)10.1016/j.vaccine.2011.04.054 (DOI)000292471700006 ()
    Available from: 2011-05-14 Created: 2011-05-14 Last updated: 2018-05-16Bibliographically approved
    4. Informed Consent for HPV Vaccination: A Relational Approach
    Open this publication in new window or tab >>Informed Consent for HPV Vaccination: A Relational Approach
    Show others...
    2015 (English)In: Health Care Analysis, ISSN 1065-3058, E-ISSN 1573-3394, Vol. 23, no 1, p. 50-62Article in journal (Refereed) Published
    Abstract [en]

    The aim of this study was to explore the relational aspects of the consent process for HPV vaccination as experienced by school nurses, based on the assumption that individuals have interests related to persons close to them, which is not necessarily to be apprehended as a restriction of autonomy; rather as a voluntary and emotionally preferred involvement of their close ones. Thirty Swedish school nurses were interviewed in five focus groups, before the school based vaccination program had started in Sweden. The empirical results were discussed in light of theories on relational autonomy. The school nurses were convinced that parental consent was needed for HPV vaccination of 11-year-old girls, but problems identified were the difficulty to judge when a young person is to be regarded as autonomous and what to do when children and parents do not agree on the decision. A solution suggested was that obtaining informed consent in school nursing is to be seen as a deliberative process, including the child, the parents and the nurse. The nurses described how they were willing strive for a dialogue with the parents and negotiate with them in the consent process. Seeing autonomy as relational might allow for a more dialogical approach towards how consent is obtained in school based vaccination programs. Through such an approach, conflicts of interests can be made visible and become possible to deal with in a negotiating dialogue. If the school nurses do not focus exclusively on accepting the individual parent's choice, but strive to engage in a process of communication and deliberation, the autonomy of the child might increase and power inequalities might be reduced.

    National Category
    Medical Ethics
    Research subject
    Medical Science
    Identifiers
    urn:nbn:se:uu:diva-212366 (URN)10.1007/s10728-012-0237-9 (DOI)000348414900004 ()23275146 (PubMedID)
    Available from: 2013-12-16 Created: 2013-12-09 Last updated: 2017-12-06Bibliographically approved
    5. Trust versus concerns: how parents reason when they accept HPV vaccination for their young daughter
    Open this publication in new window or tab >>Trust versus concerns: how parents reason when they accept HPV vaccination for their young daughter
    Show others...
    2013 (English)In: Upsala Journal of Medical Sciences, ISSN 0300-9734, E-ISSN 2000-1967, Vol. 118, no 4, p. 263-270Article in journal (Refereed) Published
    Abstract [en]

    Background. From spring of 2012, human papillomavirus (HPV) vaccine against cervical cancer is offered free of charge to all girls aged 10-12 years through a school-based vaccination programme in Sweden. The aim of this study was to explore how parents reason when they accept HPV vaccination for their young daughter and also their views on HPV-related information. Methods. Individual interviews with parents (n = 27) of 11-12-year-old girls. The interviews were recorded, transcribed verbatim, and analysed using thematic content analysis. Results. Three themes emerged through the analysis: Trust versus concern, Responsibility to protect against severe disease, and Information about HPV and HPV vaccination is important. The parents expressed trust in recommendations from authorities and thought it was convenient with school-based vaccination. They believed that cervical cancer was a severe disease and felt a responsibility to protect their daughter from it. Some had certain concerns regarding side effects and vaccine safety, and wished for a dialogue with the school nurse to bridge the information gaps. Conclusions. Trust in the recommendations from authorities and a wish to protect their daughter from a severe disease outweighed concerns about side effects. A school-based vaccination programme is convenient for parents, and the school nurse has an important role in bridging information gaps. The findings from this qualitative study cannot be generalized; however, it can provide a better understanding of how parents might reason when they accept the HPV vaccination for their daughter.

    Keywords
    Decision-making, HPV vaccination, parents, school-based vaccination, school nurses
    National Category
    Medical and Health Sciences
    Identifiers
    urn:nbn:se:uu:diva-210566 (URN)10.3109/03009734.2013.809039 (DOI)000325527300009 ()23777602 (PubMedID)
    Note

    De två första författarna delar förstaförfattarskapet.

    Available from: 2013-11-13 Created: 2013-11-11 Last updated: 2017-12-06Bibliographically approved
  • 45.
    Gottvall, Maria
    et al.
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Caring Sciences.
    Tydén, Tanja
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Caring Sciences.
    Larsson, Margareta
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Women's and Children's Health, Obstetrics and Gynaecology.
    Stenhammar, Christina
    Uppsala University, Disciplinary Domain of Medicine and Pharmacy, Faculty of Medicine, Department of Public Health and Caring Sciences, Caring Sciences.
    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.
    Informed Consent for HPV Vaccination: A Relational Approach2015In: Health Care Analysis, ISSN 1065-3058, E-ISSN 1573-3394, Vol. 23, no 1, p. 50-62Article in journal (Refereed)
    Abstract [en]

    The aim of this study was to explore the relational aspects of the consent process for HPV vaccination as experienced by school nurses, based on the assumption that individuals have interests related to persons close to them, which is not necessarily to be apprehended as a restriction of autonomy; rather as a voluntary and emotionally preferred involvement of their close ones. Thirty Swedish school nurses were interviewed in five focus groups, before the school based vaccination program had started in Sweden. The empirical results were discussed in light of theories on relational autonomy. The school nurses were convinced that parental consent was needed for HPV vaccination of 11-year-old girls, but problems identified were the difficulty to judge when a young person is to be regarded as autonomous and what to do when children and parents do not agree on the decision. A solution suggested was that obtaining informed consent in school nursing is to be seen as a deliberative process, including the child, the parents and the nurse. The nurses described how they were willing strive for a dialogue with the parents and negotiate with them in the consent process. Seeing autonomy as relational might allow for a more dialogical approach towards how consent is obtained in school based vaccination programs. Through such an approach, conflicts of interests can be made visible and become possible to deal with in a negotiating dialogue. If the school nurses do not focus exclusively on accepting the individual parent's choice, but strive to engage in a process of communication and deliberation, the autonomy of the child might increase and power inequalities might be reduced.

  • 46.
    Grady, Christine
    et al.
    NIH, Ctr Clin, Dept Bioeth, Bethesda, MD 20892 USA..
    Eckstein, Lisa
    Univ Tasmania, Fac Law, Hobart, Tas 7001, Australia..
    Berkman, Ben
    NHGRI, Bethesda, MD USA..
    Brock, Dan
    Harvard Univ, Sch Med, Dept Social Med, Div Med Eth, Cambridge, MA 02138 USA..
    Cook-Deegan, Robert
    Duke Inst Genome Sci & Policy, Durham, NC USA..
    Fullerton, Stephanie M.
    Univ Washington, Sch Med, Genome Eth Law & Policy, Seattle, WA 98195 USA..
    Greely, Hank
    Stanford Law Sch, Crown Quadrangle, Stanford, CA 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.
    Hull, Sara
    NIH, Ctr Clin, Dept Bioeth, Bethesda, MD 20892 USA.;NHGRI, Bioeth Core, Bethesda, MD USA..
    Kim, Scott
    NIH, Ctr Clin, Dept Bioeth, Bethesda, MD 20892 USA..
    Lo, Bernie
    Greenwall Fdn, New York, NY USA..
    Pentz, Rebecca
    Emory Univ, Ctr Eth, Winship Canc Inst, Atlanta, GA 30322 USA..
    Rodriguez, Laura
    NHGRI, Div Policy Commun & Educ, Bethesda, MD USA..
    Weil, Carol
    NCI, Canc Diag Program, Bethesda, MD 20892 USA..
    Wilfond, Benjamin S.
    Seattle Childrens Hosp, Seattle, WA USA..
    Wendler, David
    NIH, Ctr Clin, Dept Bioeth, Bethesda, MD 20892 USA..
    Broad Consent for Research With Biological Samples: Workshop Conclusions2015In: American Journal of Bioethics, ISSN 1526-5161, E-ISSN 1536-0075, Vol. 15, no 9, p. 34-42Article in journal (Refereed)
    Abstract [en]

    Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health (NIH) Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and timely topic.

  • 47.
    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.
    Genomics for policy makers and for researchers. Review of: Genomics and society-Ethical, Legal, Cultural and Socioeconomic Implication. Edited by: Dhavendra Kumar and Ruth Chadwick. 2016In: European Journal of Human Genetics, ISSN 1018-4813, E-ISSN 1476-5438, Vol. 24, no 12, p. 1835-1835Article, book review (Other academic)
  • 48.
    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. ..
    Bouder, Frederic
    Dept Technol & Soc Studies, Maastricht.
    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.
    Genetics and risk - an exploration of conceptual approaches to genetic risk2018In: Journal of Risk Research, ISSN 1366-9877, E-ISSN 1466-4461, Vol. 21, no 2, p. 101-108Article in journal (Other academic)
  • 49.
    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.
    Lochmuller, Hanns
    Newcastle Univ, Inst Med Genet, John Walton Muscular Dystrophy Res Ctr, Newcastle Upon Tyne, Tyne & Wear, England..
    Riess, Olaf
    Univ Tubingen, Rare Dis Ctr, Inst Med Genet & Appl Genom, Tubingen, Germany..
    Schaefer, Franz
    Heidelberg Univ, Ctr Pediat & Adolescent Med, Div Pediat Nephrol, Heidelberg, Germany..
    Orth, Michael
    Ulm Univ Hosp, Dept Neurol, Ulm, Germany..
    Rubinstein, Yaffa
    NIH, ORDR, Natl Ctr Adv Translat Sci, Bldg 10, Bethesda, MD 20892 USA..
    Molster, Caron
    Dept Hlth Govt Western Australia, Off Populat Hlth Genom, Publ Hlth & Clin Serv Div, Perth, WA, Australia..
    Dawkins, Hugh
    Dept Hlth Govt Western Australia, Off Populat Hlth Genom, Publ Hlth & Clin Serv Div, Perth, WA, Australia.;Murdoch Univ, Ctr Comparat Genom, Murdoch, WA, Australia.;Curtin Univ Technol, Ctr Populat Hlth Res, Bentley, WA, Australia.;Univ Western Australia, Sch Pathol & Lab Med, Nedlands, WA, Australia..
    Taruscio, Domenica
    Ist Super Sanita, Natl Ctr Rare Dis, Rome, Italy..
    Posada, Manuel
    SpainRDR, ISCIII, Inst rare Dis Res, Madrid, Spain.;CIBERER, Madrid, Spain..
    Woods, Simon
    Newcastle Univ, Policy Eth & Life Sci Res Ctr, Newcastle Upon Tyne, Tyne & Wear, England..
    The risk of re-identification versus the need to identify individuals in rare disease research2016In: European Journal of Human Genetics, ISSN 1018-4813, E-ISSN 1476-5438, Vol. 24, no 11, p. 1553-1558Article in journal (Refereed)
    Abstract [en]

    There is a growing concern in the ethics literature and among policy makers that de-identification or coding of personal data and biospecimens is not sufficient for protecting research subjects from privacy invasions and possible breaches of confidentiality due to the possibility of unauthorized re-identification. At the same time, there is a need in medical science to be able to identify individual patients. In particular for rare disease research there is a special and well-documented need for research collaboration so that data and biosamples from multiple independent studies can be shared across borders. In this article, we identify the needs and arguments related to de-identification and re-identification of patients and research subjects and suggest how the different needs may be balanced within a framework of using unique encrypted identifiers.

  • 50.
    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.
    van Ommen, Gert Jan
    Chadwick, Ruth
    Dillner, Joakim
    Patients would benefit from simplified ethical review and consent procedure2013In: The Lancet Oncology, ISSN 1470-2045, E-ISSN 1474-5488, Vol. 14, no 6, p. 451-453Article in journal (Refereed)
123 1 - 50 of 109
CiteExportLink to result list
Permanent link
Cite
Citation style
  • apa
  • ieee
  • modern-language-association
  • vancouver
  • Other style
More styles
Language
  • de-DE
  • en-GB
  • en-US
  • fi-FI
  • nn-NO
  • nn-NB
  • sv-SE
  • Other locale
More languages
Output format
  • html
  • text
  • asciidoc
  • rtf