Centre for Research Ethics & Bioethics (CRB)

Publications from CRB


Roughly our research covers three main areas: research ethics, clinical ethics and bioethics. Most of our research is published in peer reviewed articles and books, but we also publish the occasional project report or popular science book.

You will find the most recent publications by researchers active at CRB with abstracts and links to journals below. Our staff pages also contains publication lists.

Resignation Syndrome: Catatonia? Culture-Bound?

Sallin K, Lagercrantz H, Evers K, Engström I, Hjern A, Petrovic P, Front. Behav. Neurosci., 29 January 2016

Karl SallinAbstract: Resignation syndrome (RS) designates a long-standing disorder predominately affecting psychologically traumatized children and adolescents in the midst of a strenuous and lengthy migration process. Typically a depressive onset is followed by gradual withdrawal progressing via stupor into a state that prompts tube feeding and is characterized by failure to respond even to painful stimuli. The patient is seemingly unconscious. Recovery ensues within months to years and Kathinka Eversis claimed to be dependent on the restoration of hope to the family. Descriptions of disorders resembling RS can be found in the literature and the condition is unlikely novel. Nevertheless, the magnitude and geographical distribution stand out. Several hundred cases have been reported exclusively in Sweden in the past decade prompting the Swedish National Board of Health and Welfare to recognize RS as a separate diagnostic entity. The currently prevailing stress hypothesis fails to account for the regional distribution and contributes little to treatment. Consequently, a re-evaluation of diagnostics and treatment is required. Psychogenic catatonia is proposed to supply the best fit with the clinical presentation. Treatment response, altered brain metabolism or preserved awareness would support this hypothesis. Epidemiological data suggests culture-bound beliefs and expectations to generate and direct symptom expression and we argue that culture-bound psychogenesis can accommodate the endemic distribution. Last, we review recent models of predictive coding indicating how expectation processes are crucially involved in the placebo and nocebo effect, delusions and conversion disorders. Building on this theoretical framework we propose a neurobiological model of RS in which the impact of overwhelming negative expectations are directly causative of the down-regulation of higher order and lower order behavioral systems in particularly vulnerable individuals.

Ethical Frameworks and Comparative Effectiveness Research

Farisco M & Petrini C, in Levy A & Sobolev B (eds), Comparative Effectiveness Research in Health Services, Springer, DOI: 10.1007/978-1-4899-7586-7_2-1

Michele FariscoAbstract: 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.

The Cooperative Health Research in South Tyrol (CHRIS) study: rationale, objectives, and preliminary results,

Pattaro C, Gögele M, Mascalzoni D, Melotti R, Schwienbacher C, De Grandi A, Foco L, D’Elia Y, Linder B, Fuchsberger C, Minelli C, Egger C, KofinkLs, Zanigni S, Schäfer T, Facheris MF, Smárason SV, Rossini A, Hicks AA, Weiss H & Pramstaller PP, Journal of Translational Medicine, 2015;13:348

Deborah MascalzoniAbstract: The Cooperative Health Research In South Tyrol (CHRIS) study is a population-based study with a longitudinal lookout to investigate the genetic and molecular basis of age-related common chronic conditions and their interaction with life style and environment in the general population. All adults of the middle and upper Vinschgau/Val Venosta are invited, while 10,000 participants are anticipated by mid-2017. Family participation is encouraged for complete pedigree reconstruction and disease inheritance mapping. After a pilot study on the compliance with a paperless assessment mode, computer-assisted interviews have been implemented to screen for conditions of the cardiovascular, endocrine, metabolic, genitourinary, nervous, behavioral, and cognitive system. Fat intake, cardiac health, and tremor are assessed instrumentally. Nutrient intake, physical activity, and life-course smoking are measured semi-quantitatively. Participants are phenotyped for 73 blood and urine parameters and 60 aliquots per participant are biobanked (cryo-preserved urine, DNA, and whole and fractionated blood). Through liquid-chromatography mass-spectrometry analysis, metabolite profiling of the mitochondrial function is assessed. Samples are genotyped on 1 million variants with the Illumina HumanOmniExpressExome array and the first data release including 4570 fully phenotyped and genotyped samples is now available for analysis. Participants’ follow-up is foreseen 6 years after the first visit. The target population is characterized by long-term social stability and homogeneous environment which should both favor the identification of enriched genetic variants. The CHRIS cohort is a valuable resource to assess the contribution of genomics, metabolomics, and environmental factors to human health and disease. It is awaited that this will result in the identification of novel molecular targets for disease prevention and treatment.

The communication aspects of the Ebola virus disease outbreak in Western Africa – do we need to counter one, two, or many epidemics?

Svalastog AL & Allgaier J, Croatian Medical Journal, 2015;56:496-499.

The Dictionary of Quality of Life and Health Outcomes Measurement

Ahmed S, Andrich D, Barclay R, Barbic S, Bartlett S, Bronstein D, Coon C, Dendukuri N, Fairclough D, Gross C, Kerr C, Kuspinar A, Moriello C, Patrick D, Pickard S, Reid J, Ring L, Rodriguez AM, Rosenzveig A, Samp JC, Sawatzky R, Scott S, Wiseman L, Xu J.(Ed Nancy E. Mayo) for Amazon. 2015

Towards Good Palliation for Children with Cancer: Recognizing the Family and the Value of Communication,

Jalmsell L, 2015, Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, doctoral dissertation, ISSN 1651-6206 ; 1123

Li JalmsellAbstract: Pediatric cancer imposes a threat on the child’s life and approximately every fifth child diagnosed with cancer will die due to his or her disease. The overall aim of this thesis was to explore palliative care of children with cancer and bereaved family members. The thesis includes data collected retrospectively from medical records, a nationwide questionnaire directed to bereaved parents, a nationwide questionnaire for bereaved siblings and individual interviews with children in cancer care.

Most children dying from cancer were recognized as being beyond cure at time of death; for some this recognition occurred close to death, leaving little time for potential personal preferences (Paper I). Bereaved parents and siblings noticed extensive suffering in the child close to death (Paper II, VI), with physical fatigue being the most commonly reported symptom irrespectively of age and diagnosis of the child (Paper II). Bereaved parents’ psychological well-being appears to be closely related to experiencing suffering in the dying child (Paper III) but also to high-intensity treatment (with bone marrow transplant as the example) of a child that still dies from his or her disease (Paper IV). Bereaved siblings experience a lack in information at the end of their brother’s or sister’s life and report feeling poorly prepared for the loss. An increased risk of anxiety was seen in siblings whom nobody talked to about what to expect at the time of death of their brother or sister (Paper VI). When caring for children with cancer it is vital to take the individual child’s awareness and preferences regarding information into consideration. Bereaved parents who have communicated with their child about death expressed that this often occurred at the child’s own initiative (Paper V) and simple means such as fairy tales could be used to facilitate communication. Ill children themselves expressed in interviews wanting honest, but still hopeful information regarding bad news (Paper VII).

The results of this thesis stress the importance of striving to achieve good communication and keeping a family perspective throughout care of children with cancer.

Synthetic Biology in the Press: Media Portrayal
in Sweden and Italy

Ancillotti M, Eriksson S, in: I K Hagen, M Engelhard & G Toepfer (eds.) Ambivalences of Creating Life, Dordrecht: Springer, 2016:141-56.

Mirko AncillottiAbstract: Synthetic biology is a rapidly evolving field which potentially can change how we live in and understand the world. Given its potential impact it is important to inform and involve the public so that it gains a proper understanding of synthetic biology and is in a position to assess its future applications and implications. This study investigates through qualitative content analysis the synthetic biology press coverage in Sweden and Italy between 2009 and 2013. The three Stefan Erikssonmajor newspapers of each country were considered a good example of what was offered to the public in a period which witnessed important scientific advancements of the field and consequent media resonance. The framing of the articles was analyzed in the light of the idea that mass media not only inform the public but also contribute to the shaping of ideas. Language was analysed and found to be generally adequate. The topics were presented in an overall positive and optimistic tone, which was reflected also in the benefits and risks envisioned. The two countries can be considered rather different in many social and cultural respects, yet besides a few differences (mainly quantitative), striking similarities were found, probably related to a marked dependence on the common sources of the articles and the lack of critical scrutiny on the behalf of the media.

Navigating knowledge landscapes: on health, science, communication, media, and society

Svalastog A-L, Allgaier J, Gajović S, CMJ 2015; 56: 321-3

Broad Consent for Research With Biological Samples: Workshop Conclusions,

Grady D, Eckstein L, Berkman B, Brock D, Cook-Deegan R, Fullerton SM, Greely H, Hansson MG, Hull S, Kima S, Lo B, Pentz R, Rodriguez R, Weil C, Wilfond BS & Wendler D, the American Journal of Bioethics 2015;15(9):34-42.

Mats G. HanssonAbstract: 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.

Patients in Clinical Cancer Trials: Understanding, Motivation and Hope

Godskesen T, 2014, Digital Comprehensive Summaries of Uppsala Dissertations from the Faculty of Medicine, doctoral dissertation, ISSN 1651-6206;1112.

Tove GodskesenAbstract: The overall aim of this thesis was to study participants' understanding of clinical cancer trials, and their motivation for participation. Of particular interest was the question of whether the patients hoped for a cure resulting from the trial. The thesis was based on four studies and used three methods: interviews, a questionnaire, and empirical bioethics. The results of Study I indicated that the participants in phase 1 trials understood most of the information provided, but were unaware of both the very small potential for treatment benefit, and the risk of harm. Patients in phase 3 trials had a good understanding of the trial, except regarding side effects and their right to withdraw. Some found it hard to ask questions and felt they needed more information (Study III). The participants in phase 1 trials were strongly motivated by the generally unrealistic hope for therapeutic benefit (Study I). When the chances of a cure are minuscule, as for participants with end-stage cancer in phase 1 trials, hope can play an important, positive role and offer meaning to one’s remaining life. However, hope for an unrealistic outcome could also deprive patients of an opportunity to spend their remaining lives, as they would otherwise choose (Study II). The participants in phase 3 trials indicated that their motivation for participation was multifaceted; the most common motivations included hope of therapeutic benefit, altruism, access to extra clinical examinations or better care, and a wish to repay society for the help they had received (Study III). After stratifying and analysing the motivation data by gender, age, education and previous experience of trial participation, males and those aged ≥65 years were significantly more motivated to participate out of a desire to reciprocate the help they had received, either because of a sense of duty or because their families or friends considered that they should attend (Study IV). In conclusion, the informed consent process seems to work relatively well, with good results within most subgroups. However, patients with end-stage cancer who are participating in phase 1 trials are a vulnerable group as they have very little potential for treatment benefit coupled with a tangible risk of harm.

“Cerebral Communication” With Patients With Disorders of Consciousness: Clinical Feasibility and Implications

Farisco M, AJOB Neuroscience, 2015;6(2):44-46

Michele FariscoAbstract: Recent neuroscientific and neurotechnological developments give us the possibility of detecting covert awareness in patients behaviorally diagnosed as in vegetative state/unresponsive wakefulness syndrome (VS/UWS). Starting from this detection of conscious brain activity, a potential new tool for communicating with these patients is under investigation by the scientific community. Several conceptual and ethical issues urge specific attention.

Conceptions of decision-making capacity in psychiatry: interviews with Swedish psychiatrists

Sjöstrand M, Karlsson P, Sandman L, Helgesson G, Eriksson S & Juht N, BMC Medical Ethics, 2015;16(34)

Stefan ErikssonAbstract: Decision-making capacity is a key concept in contemporary healthcare ethics. Previous research has mainly focused on philosophical, conceptual issues or on evaluation of different tools for assessing patients’ capacity. The aim of the present study is to investigate how the concept and its normative role are understood in Swedish psychiatric care. Of special interest for present purposes are the relationships between decisional capacity and psychiatric disorders and between health law and practical ethics. Methods Eight in-depth interviews were conducted with Swedish psychiatrists. The interviews were analysed according to descriptive qualitative content analysis in which categories and sub-categories were distilled from the material. Results Decision-making capacity was seen as dependent on understanding, insight, evaluation, reasoning, and abilities related to making and communicating a choice. However, also the actual content of the decision was held as relevant. There was an ambivalence regarding the relationship between psychiatric disorders and capacity and a tendency to regard psychiatric patients who made unwise treatment decisions as decisionally incapable. However, in cases relating to patients with somatic illnesses, the assumption was rather that patients who made unwise decisions were imprudent but yet decisionally capable. Conclusions The respondents’ conceptions of decision-making capacity were mainly in line with standard theories. However, the idea that capacity also includes aspects relating to the content of the decision clearly deviates from the standard view. The tendency to regard imprudent choices by psychiatric patients as betokening lack of decision-making capacity differs from the view taken of such choices in somatic care. This difference merits further investigations.

International Charter of principles for sharing bio-specimens and data

Mascalzoni D, Dove ES, Rubinstein Y, Dawkins HJS, Kole A, McCormack P, Woods S, Reiss O, Schaefer F, Lochmüller H, Knoppers BM & Hansson MG,, European Journal of Human Genetics 2015;23:721-728

Deborah MascalzoniAbstract: There is a growing international agreement on the need to provide greater access to research data and bio-specimen collections to optimize their long-term value and exploit their potential for health discovery and validation. This is especially evident for rare disease research. Currently, the rising value of data and bio-specimen collections does not correspond with an equal increase in data/sample-sharing and data/sample access. Mats G. HanssonContradictory legal and ethical frameworks across national borders are obstacles to effective sharing: more specifically, the absence of an integrated model proves to be a major logistical obstruction. The Charter intends to amend the obstacle by providing both the ethical foundations on which data sharing should be based, as well as a general Material and Data Transfer Agreement (MTA/DTA). This Charter is the result of a careful negotiation of different stakeholders' interest and is built on earlier consensus documents and position statements, which provided the general international legal framework. Further to this, the Charter provides tools that may help accelerate sharing. The Charter has been formulated to serve as an enabling tool for effective and transparent data and bio-specimen sharing and the general MTA/DTA constitutes a mechanism to ensure uniformity of access across projects and countries, and may be regarded as a consistent basic agreement for addressing data and material sharing globally. The Charter is forward looking in terms of emerging issues from the perspective of a multi-stakeholder group, and where possible, provides strategies that may address these issues.

Differences in trial knowledge and motives for participation among cancer patients in phase 3 clinical trials

Godskesen TM, Kihlbom U, Nordin K, Silén M, Nygren P, European Journal of Cancer Care, Article first published online: 21 APR 2015, DOI: 10.1111/ecc.12319

Tove GodskesenAbstract: While participants in clinical oncology trials are essential for the advancement of cancer therapies, factors decisive for patient participation have been described but need further investigation, particularly in the case of phase 3 studies. The aim of this study was to investigate differences in trial knowledge and motives for participation in phase 3 clinical cancer trials in relation to gender, age, education levels Ulrik Kihlbomand former trial experience. The results of a questionnaire returned from 88 of 96 patients (92%) were analysed using the Mann–Whitney U-test. There were small, barely relevant differences in trial knowledge among patients when stratified by gender, age or education. Participants with former trial experience were less aware about the right to withdraw. Male participants and those aged ≥65 years were significantly more motivated by a feeling of duty, or by the opinions of Marit Silénclose ones. Men seem more motivated than women by external factors. With the awareness that elderly and single male participants might be a vulnerable group and participants with former trial experience are less likely to be sufficiently informed, the information consent process should focus more on these patients. We conclude that the informed consent process seems to work well, with good results within most subgroups.

Treacherous narratives & seductive theories.On methodological challenges in psychosocial academic work 

Svalastog AL,NZOJIS 2015;1(3) 

Anna Lydia SvalastogAbstract: In psychosocial work, the narratives of the individual are an important basis of knowledge.They are significant sources for the history of the individual and the complex contexts in which the individual‘s life is lived. This text elaborates on the following questions; What constitutes a good narrative? How is it framed by today‘s information technology, and how does our understanding of history and time shape ethical and critical analysis of the same? 

Freedom of Choice About Incidental Findings Can Frustrate Participants' True Preferences

Viberg J, Segerdahl P, Langenskiöld S, Hansson MG, Bioethics, Article first published online: 23 APR 2015 DOI: 10.1111/bioe.12160

Jennifer VibergAbstract: Ethicists, regulators and researchers have struggled with the question of whether incidental findings in genomics studies should be disclosed to participants. In the ethical debate, a general consensus is that disclosed information should benefit participants. However, there is no agreement that genetic information will benefit participants, rather it may cause problems such as anxiety. One could get past this disagreement about disclosure of incidental findings by letting participants express their preferences in the consent form. We argue that this freedom of choice is problematic.

Pär SegerdahlIn transferring the decision to participants, it is assumed that participants will understand what they decide about and that they will express what they truly want. However, psychological findings about people's reaction to probabilities and risk have been shown to involve both cognitive and emotional challenges. People change their attitude to risk depending on what is at stake. Their mood affects judgments and choices, and they over- and underestimate probabilities depending on whether they are low or high. Moreover, different framing of the options can steer people to a specific choice.

Mats G. HanssonAlthough it seems attractive to let participants express their preferences to incidental findings in the consent form, it is uncertain if this choice enables people to express what they truly prefer. In order to better understand the participants' preferences, we argue that future empirical work needs to confront the participant with the complexity of the uncertainty and the trade-offs that are connected with the uncertain predictive value of genetic risk information.

Epigenetics, society and bio-objects

Svalastog AL, Damjanovicova M, Croat Med J 2015;56:166-8, DOI: 10.3325/cmj.2015.56.166

Anna Lydia SvalastogAbstract: The molecular account of the environmental that epigenetics offers bestow it with paramount importance for biomedical perspective of health and disease and for social sciences perspective on human interactions and well-being. It offers new prospects for interventions to shape the health of both individuals and populations, and invokes its own ethical, legal, and social implications. We here propose treatment of the relation between epigenetics and society through the framework of bio-objectification. After discussing how epigenetic information becomes part of particular bio-identification and bio-objectification processes, we then propose the bio-objectification framework as a fruitful conceptual framework for the analysis of dynamic research and responsive regulatory landscape of this biotechnology

Whole-genome sequencing in newborn screening? A statement on the continued importance of targeted approaches in newborn screening programmes

Howard HC, Knoppers BM, Cornel MC, Wright Clayton E, Sénécal K, Borry P, European Journal of Human Genetics, 2015 online pre-publication, doi: 10.1038/ejhg.2014.289

Heidi C. HowardAbstract: The advent and refinement of sequencing technologies has resulted in a decrease in both the cost and time needed to generate data on the entire sequence of the human genome. This has increased the accessibility of using whole-genome sequencing and whole-exome sequencing approaches for analysis in both the research and clinical contexts. The expectation is that more services based on these and other high-throughput technologies will become available to patients and the wider population. Some authors predict that sequencing will be performed once in a lifetime, namely, shortly after birth. The Public and Professional Policy Committee of the European Society of Human Genetics, the Human Genome Organisation Committee on Ethics, Law and Society, the PHG Foundation and the P3G International Paediatric Platform address herein the important issues and challenges surrounding the potential use of sequencing technologies in publicly funded newborn screening (NBS) programmes. This statement presents the relevant issues and culminates in a set of recommendations to help inform and guide scientists and clinicians, as well as policy makers regarding the necessary considerations for the use of genome sequencing technologies and approaches in NBS programmes. The primary objective of NBS should be the targeted analysis and identification of gene variants conferring a high risk of preventable or treatable conditions, for which treatment has to start in the newborn period or in early childhood.

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?

Bjugn R, Farisco M, Høstmælingen N, Simeon-Dubach D, Petrini C, Biopreservation and Biobanking 2015;13(2):70-71

Michele FariscoAbstract: Many medical research studies require the transfer of human biological material and associated data between biobanks across the world. Ensuring compliance with various national ethical and legal frameworks may be a challenging task. First of all this requires engagement with national experts. In addition, efforts are needed to provide more detailed information about the various requirements globally for the collection, storage, distribution, and use in each country to facilitate multi-national research and global specimen and data sharing.

Keeping the human: neuroethics and the conciliation of dissonant values in the 21st century

Gini A, Larrivee D, Farisco M, Sironi VA, Neuroscience and Neuroeconomics 2015;4:1-10

Michele FariscoAbstract: 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.

The rhetoric and prose of the human/animal contrast

Segerdahl P, Language & Communication 2015;42: 36-49.

Pär SegerdahlAbstract: The opposition in philosophy between humans as thinkers and animals as non-thinkers is often considered to stem from anthropocentrism. In this paper I try to demonstrate that philosophers don't really place “us” at the centre, but rather their own thinking and the philosophical language they develop as thinkers. The human/animal contrast functions rhetorically to communicate that philosophical self-centredness to an audience that recognises itself as “human.” I try to dismantle the contrast between humans and animals by exposing what I see as its true core: forgetfulness of how philosophical language (and thinking in that language) is generated by idealisation and sublimation of the reflexive uses of language.

Being Humans When We Are Animals

Segerdahl P, Nordic Wittgenstein Review, 2014;3 (No.2); 125-149

Pär SegerdahlAbstract: This paper investigates forms of metaphysical vertigo that can appear when contrasts between humans and animals are challenged. Distinguishing three forms of vertigo and four ways of differentiating humans and animals, the paper attempts to achieve a perspicuous representation of what could be termed “the difficulty of being humans when we are animals”; or alternatively, “the difficulty of being animals when we are humans”.

Nothing about us without us? A comparison of adolescent and adult health-state values for the child health utility-9D using profile case best-worst scaling

Ratcliffe J, Huynh E, Stevens K, Brazier J, Sawyer M, Flynn T, Health Economics, 2015, online first 16 February 2015.

Terry FlynnAbstract: The main objective of this study was to compare and contrast adolescent and adult values for the Child Health Utility-9D (CHU9D), a new generic preference-based measure of health-related quality of life designed for application in the economic evaluation of treatment and preventive programmes for children and adolescents. Previous studies have indicated that there may be systematic differences in adolescent and adult values for identical health states. An online survey including a series of best–worst scaling discrete choice experiment questions for health states defined by the CHU9D was administered to two general population samples comprising adults and adolescents, respectively. The results highlight potentially important age-related differences in the values attached to CHU9D dimensions. Adults, in general, placed less weight upon impairments in mental health (worried, sad, annoyed) and more weight upon moderate to severe levels of pain relative to adolescents. The source of values (adults or adolescents) has important implications for economic evaluation and may impact significantly upon healthcare policy. Copyright © 2015 John Wiley & Sons, Ltd.

Ethics, Law and Governance of Biobanking

Reichel J, & Lind A-S, The New General Data Protection Regulation – where are we are and where might we be heading?, in: Mascalzoni D (Ed.), Springer, National, European and International Profiles, Dordrecht, the Netherlands, 2015

Jane ReichelAbstract: The current EU Directive on Data Protection, has been described as the most far reaching Data Protection regime in the world. Still, the ongoing work within the EU to enact a new General Data Protection Regulation seems to be heading towards an even stricter regime. Medical researchers in bio Anna-Sara Lindbanking and epidemiology have had quite a fright on behalf of the proposal, especially the amendments suggested by rapporteur Albrecht of the European Parliament’s LIBE Committee in December 2012, that to a large extent were accepted by the Committee in a October 2013 and the European Parliament in its first reading of the proposal in March 2014. This short overview discusses the status of the legislative procedures and comments on the consequences of changing the legal form from a directive to a regulation. A brief description of the content of the General Data Protection Regulation relevant to research on health data is also given.

Ethics, Law and Governance of Biobanking

Mascalzoni D (ed), Springer, National, European and International Approaches Series: The International Library of Ethics, Law and Technology, Vol. 14 2015, VI, 277 p.

Deborah MascalzoniAbout the book: Biobank research and genomic information are changing the way we look at health and medicine. Genomics challenges our values and has always been controversial and difficult to regulate. In the future lies the promise of tailored medical treatments and pharmacogenomics but the  borders between medical research and clinical practice are becoming blurred. We see sequencing platforms for research that can have diagnostic value for patients. Clinical applications and research have been kept separate, but the blurring lines challenges existing regulations and ethical frameworks. Then how do we regulate it?

Ethics, law and governance of biobaking, Springer 2015This book contains an overview of the existing regulatory landscape for biobank research in the Western world and some critical chapters to show how regulations and ethical frameworks are developed and work. How should international sharing work? How design an ethical informed consent?

There is an underlying critique: the regulatory systems are becoming increasingly complex and opaque. The international community is building systems that should respond to that. According to the authors in fact, it is time to turn the ship around. Biobank researchers have a moral responsibility to look at and assess their work in relation to the bigger picture: the shared norms and values of current society. Research ethics shouldn’t only be a matter of bioethicists writing guidelines that professionals have to follow. Ethics should be practiced through discourse and regulatory frameworks need to be part of that public discourse. Ethics review should be then not merely application of bureaucracy and a burden for researchers but an arena where researchers discuss their projects, receive advice and practice their ethics skills.

Experience of non-breastfeeding mothers: Norms and ethically responsible risk communication

Nihén Fahlquist J, Nursing Ethics, online December 22, 2014, doi:10.1177/0969733014561913

Jessica Nihlén FahlquistAbstract: Breastfeeding is currently strongly recommended by midwives and paediatricians, and the recommendations are based on documents provided by the World Health Organization and public health authorities worldwide. The underlying question is how non-breastfeeding mothers are affected emotionally when informed that breastfeeding is the safest and healthiest option. The method used is an anonymous web-based qualitative survey exploring the narratives of non-breastfeeding mothers, published on Thesistools.com. The aim is to achieve qualitative knowledge about the emotions of non-breastfeeding mothers. Participants were based in Sweden, the United Kingdom and the Netherlands and were selected through a purposeful sample. The online survey anonymizes responses automatically, and all respondents had to tick a box agreeing to be quoted anonymously in scientific articles. The study conforms to research ethics guidelines. Respondents describe how they were affected, and the following themes emerged in studying their descriptions: depression, anxiety and pain, feeling failed as a mother and woman, loss of freedom/feeling trapped, relief and guilt. The themes are discussed against the background of the ethics of care and a theory of ethically responsible risk communication. Three conclusions are made. First, the message should become more empathetic. Second, information should be given in an attentive dialogue. Third, information providers should evaluate effects in a more inclusive way.

Children's Views on Long-Term Screening for Type 1 Diabetes

Swartling U, Helgesson G, Ludvigsson J & Hansson MG, Journal of Empirical Research on Human Research Ethics, 2014;9(4):1-9.

Mats G. HanssonAbstract: There are an increasing number of medical research studies involving children, including many long-term birth cohort studies. Involving children raises many issues, and little is known about children’s own views. This study explored children’s views (N = 5,851) on participation in a long-term screening study for type 1 diabetes. The results show that children 10 to 13 years of age have in general a positive attitude to pediatric research and emphasized trust in researchers. The children stressed the importance to receive information and to be involved in decisions. The children also reported feeling concerned about blood sampling and disease risk. Researchers involved in long-term pediatric research need to address these issues to promote involvement and decrease worry.

Ethical Review Boards are poor advocates for patient perspectives

Masterton M, Renberg T, Hansson MG, Kälvemark Sporrong S, Research Ethics, 2014;10(3):169-181.

Malin MastertonAbstract: In medical research, patients are increasingly recognized with ‘lay knowledge’ but their views are poorly researched. The study objective was to investigate patients’ attitudes to medical research. This is in comparison to lay and expert members Tobias Renbergon ethical review boards (ERB), as their task is to evaluate the risk−benefits of research, which are ultimately grounded in attitudes and values. From focus-group interviews with patients suffering from chronic inflammatory diseases, a postal questionnaire was Mats G. Hanssondeveloped and sent to patient members of the Swedish Rheumatism Association (n = 1195) and to all ERB board members in Sweden (N = 583). Response rates were 65 percent and the surveys were conducted in Jan−May 2011. Agreement across the groups Sofia Kälvemarkincluded priority for medical research on diagnostic and early detection of disease. A key difference was expert and lay ERB members giving higher priority to basic research/research on lifestyle and prevention (primarily benefiting future patients), whereas patients prioritized research on daily function. On this significant point, lay members did not share the opinion of this patient group, indicating that they may be poor representatives for patients’ views. These results call for further research: how can patient perspectives be included in ERB discussions and in what way should patients’ values influence the research agenda

RD-Connect: An Integrated Platform Connecting Databases, Registries, Biobanks and Clinical Bioinformatics for Rare Disease Research

Thompson R, Johnson L, Taruscio D, Monaco L, Gut IG, Hansson MG, 't Hoen P-BA, Patrinos GP, Dawkins H, Ensini M, Zatloukal K, Koubi D, Heslop E, Paschall JE, Posada M, Robinson PN, Bushby K, Lochmueller H,, Journal of general internal medicine, 2014;29(S3):780-787.

Mats G. HanssonAbstract: Research into rare diseases is typically fragmented by data type and disease. Individual efforts often have poor interoperability and do not systematically connect data across clinical phenotype, genomic data, biomaterial availability, and research/trial data sets. Such data must be linked at both an individual-patient and whole-cohort level to enable researchers to gain a complete view of their disease and patient population of interest. Data access and authorization procedures are required to allow researchers in multiple institutions to securely compare results and gain new insights. Funded by the European Union’s Seventh Framework Programme under the International Rare Diseases Research Consortium (IRDiRC), RD-Connect is a global infrastructure project initiated in November 2012 that links genomic data with registries, biobanks, and clinical bioinformatics tools to produce a central research resource for rare diseases.

Current trends in biobanking for rare diseases: a review

Graham CE, Molster C, Baynam GS, Bushby K, Hansson M, Kole A, Mora M, Monaco L, Bellgard M, Carpentieri D, Posada M, Riess O, Rubinstein YR, Schaefer F, Taruscio D, Terry SF, Zatloukal K, Knoppers B, Lochmüller H, Dawkins HJS, Journal of Biorepository Science for Applied Medicine 2014;2:49-61

Mats G. HanssonAbstract:Rare diseases (RD) refer to a collection of approximately 5,000–8,000 individual diseases that have a low prevalence and are often genetic in origin. While RD can manifest throughout life, they frequently affect children and newborns. Common characteristics include being severe, disabling, life-threatening, degenerative and affecting different organ systems. The burden of RD is often exacerbated by a lack of specific treatments. Whilst there is etiological heterogeneity, there is overlap in cellular and molecular pathways. Amongst specialists, there is legitimate hope that based on genetic knowledge and pathway definition, a new medical classification system, currently called “precision medicine”, will be developed, which may change our view on how to apply shared therapeutic targets. Thus, collection of clinical and genetic data and biospecimens (in biobanks) will play an increasing role in diagnoses and development of therapies for RD. Biobanks are maintained collaboratively by researchers or their institutions, and involve a delicate balance between health policy objectives, academic research, public good outcomes, and community trust. Due to the nature of RD, international cooperation is critical for sharing limited numbers of RD samples and achieving a critical mass. Here we review the current and future direction of RD biobanks and discuss research and development stemming from the use of biospecimens to improve management of RD.

Doing gender in the context of telenursing: Analyses of authentic calls to a telenursing site in Sweden

Hakimnia R, Clarsson M, Höglund AT, Holmström IK, Clinical Nursing Studies 2015;3(2):24-30.

Abstract: Aim: The aim of the present study was to Anna T. Höglundanalyze authentic health calls to a telenursing site in Sweden regarding reasons for calling and outcome of the calls with focus on a gender perspective. Background: Telephone advice nursing is an expanding service in many Western countries. In Sweden, all regions are now connected to a national telenursing service. Healthcare in Sweden is stipulated by law to be equitable. This includes the teleursing service, which is a new actor in Swedish healthcare system, and which often is a citizen's first contact with healthcare.

Methods: The study had a descriptive and comparative design. 800 authentic calls to SHD were analysed regarding reasons for calling, and outcome of the calls.

Results: The results showed that men, and especially fathers, received more referrals to general practitioners than women. The most common caller was a woman fluent in Swedish (64%), and the least likely caller was a man non-fluent in Swedish (3%). All in all, 70% of the callers were women. When the calls concerned children, 78% of the callers were female. In total, 9% of the calls were made by a man calling for another person. Callers were predominately young (mean age 29 years for women and 33 for men).

Conclusions: It is important that telenursing does not become a "feminine" activity, only suitable for young callers fluent in Swedish. Given the telenurses' gatekeeping role, there is a risk that differences on this first level of health care can be reproduced throughout the whole healthcare system. In striving for more equitable telenursing services, future research might investigate if campaigns encouraging men to call, and more frequent use of translators could enhance access to telenursing services

Privacy Threat Modeling for Emerging BiobankClouds

Gholami A, Lind A-S, Reichel J, Litton J-E, Edlund A, Laure E, Journal
of Procedia Computer Science, 2014;37:489–496

Anna-Sara LindAbstract: There is an increased amount of data produced by next generation sequencing (NGS) machines which demand scalable storage and analysis of genomic data. In order to cope with this huge amount of information, many biobanks are interested in cloud computing capabilities such as on-demand elasticity of computing power and storage capacity. There Jane Reichelare several security and privacy requirements mandated by personal data protection legislation which hinder biobanks from migrating big data generated by the NGS machines. This paper describes the privacy requirements of platform-as-service BiobankClouds according to the European Data Protection Directive (DPD). It identifies several key privacy threats which leave BiobankClouds vulnerable to an attack. This study benefits health-care application designers in the requirement elicitation cycle when building privacy-preserving BiobankCloud platforms.

To Simulate or not to Simulate: What are the questions?,

Dudai Y, Evers K, Neuron, 2014;84(2):254-261

Kathinka EversAbstract: Simulation is a powerful method in science and engineering. However, simulation is an umbrella term, and its meaning and goals differ among disciplines. Rapid advances in neuroscience and computing draw increasing attention to large-scale brain simulations. What is the meaning of simulation, and what should the method expect to achieve? We discuss the concept of simulation from an integrated scientific and philosophical vantage point and pinpoint selected issues that are specific to brain simulation.

Changes on the horizon for consumer genomics in the EU

Kalokairinou L, Howard HC, Borry P, Science, 346(6207); 296-298

Heidi C. HowardAbstract: Although the direct-to-consumer (DTC) genetic testing market has been developing for over a decade, effective oversight has been challenging, with regulations remaining complex and often unclear. Recent developments indicate that important changes in the regulatory landscape may be imminent. In November 2013, the U.S. Food and Drug Administration (FDA) halted the DTC genetic testing company 23andMe from marketing its “Personal Genome Service” without marketing clearance or approval, which highlighted concerns over potential adverse health consequences of the genome-wide testing offered (1). The company has no timeline for when it will offer health-related genetic testing again in the United States (2). Meanwhile, in the European Union (EU), a proposed regulation could limit availability of such test results directly to consumers. We describe this ongoing revision of the EU in vitro diagnostic (IVD) medical device directive and how this may drastically affect market authorization of genetic tests.

Civil Society Participation in the Management of the Common Good: A Case of Ethics in Biological Resource Centres

Calvo P, Eriksson S, in Common goods: New forms of participation of civil society in democracy and the economy / Daniel Pallarés Domínguez & Stefan Eriksson (eds). Recerca no 15 (2014), pp. 7-19.

Stefan ErikssonAbstract: The management of commons is now at the centre of researchers' attention in many branches of science, particularly those related to the human or social sciences. This paper seeks to demonstrate how civil society participation in common goods or resources is not only possible but is also desirable for society because of the medium and long-term benefits it offers involved and/or affected parties. To this end, we examine the falsity of the discourse underlying the supposed incompetence of civil society to cooperate interpersonally in the pursuit of common objectives, and also analyse a specific example of the necessary and possible participation of civil society in managing common goods through biobanks.

On the Child's Own Initiative: Parents Communicate With Their Dying Child About Death

Jalmsell L, Kontio T, Stein M, Henter JI, Kreicbergs U, Death Stud. 2014 Aug 25. DOI: 10.1080/07481187.2014.913086 [Epub ahead of print]

Li JalmsellAbstract: Open and honest communication has been identified as an important factor in providing good palliative care. However, there is no easy solution to if, when and how parents and a dying child should communicate about death. This paper reports how bereaved parents communicated about death with their child, dying from a malignancy. Communication was often initiated by the child and included communication through narratives such as fairy-tales and movies and talking more directly about death itself. Parents also reported that their child prepared for death by giving instructions about his or her grave or funeral and giving away toys.

Misdiagnosis as an ethical and scientific challenge

Farisco M, Petrini C, Ann Ist Super Sanità, 2014;50(3):229-233

Michele FariscoAbstract: Difficulties of behavioral assessment of consciousness. An astonishingly high rate of misdiagnosis between vegetative state/unresponsive wakefulness syndrome and minimally conscious state has been detected. This raises the issue of the adequacy of the consciousness' assessment in patients with disorders of consciousness. The behavioral assessment of consciousness could be not able to detect covert awareness, which is increasingly identified by the instrumental assessment. Ancillary methods. Neurotechnology, particularly neuroimaging, provides relevant data concerning the neurological underlying condition of patients with DOCs, but the instrumental approach 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 integration between behavioral and instrumental assessments seems to be the most adequate strategy in order to decrease the rate of misdiagnosis.

Biomedical research involving patients with disorders of consciousness: ethical and legal dimensions

Farisco M, Evers K and Petrini C, Ann Ist Super Sanità, 2014;50(3):221-228

Michele FariscoAbstract: The directive 2001/20/UE and the research involving patients with docs. Research involving patients with disorders of consciousness (DOCs) deserves special ethical and legal attention because of its Janus-faced nature. On the one hand, it raises concerns about the risk to expose the involved subjects to Kathinka Eversdisproportionate risks not respecting their individual dignity, particularly their right to be cared for; on the other hand, research is an essential tool in order to improve the clinical condition of patients with DOCs. The present paper concerns the ethical and legal dimensions of biomedical research involving patients with disorders of consciousness. In particular, it focuses on informed consent to experimental treatments, which is a challenging issue both from an ethical and legal point of view. The first part reads the Directive 2001/20/EU in the light of the experimentation of patients with DOCs, and suggests a revision in order to better assess the issue of informed consent. The particular case of informed consent for observational studies of non-communicative patients. The second part presents an informed consent form for studies through video-recording of patients unable to communicate their own consent. This form has been elaborated by the bioethics unit of the project "Review of the nosography of vegetative states: application of methods of behavioral analysis to individuals in coma or vegetative state" developed at the Italian National Institute of Heal th. Relevance of the suggested form. The paper describes the conceptual framework of the form for informed consent to studies through video-recoding, which is a relevant example of what issues should be included in an informed consent for any type of studies through video-recording of patients unable to express their own consent. The article has been sent on November the 7 th 2013, before the adoption of the Regulation (EU) no. 536/2014 (and consequent abrogation of the Directive 2001/20/EU) and the release of the new edition of the Italian Code of Medical Ethics.

Nuclear energy, responsible risk communication and moral emotions: a three level framework

Nihén Fahlquist J, Roeser S, Journal of Risk Research, 2014, online DOI: 10.1080/13669877.2014.940594

Jessica Nihlén FahlquistAbstract: Communication about nuclear risks is treacherous territory, especially after Fukushima, requiring not only considerations about effectiveness, but also about ethical legitimacy. In this paper, a three-level framework of morally responsible risk communication is developed, focusing on the procedure, the message and the effects of risk communication. This gives rise to three conditions of ethically responsible risk communication: it requires a legitimate procedure, an ethically justified risk message and concern for and evaluation of the effects of the message and procedure. The role of emotions, such as sympathy, empathy and feelings or responsibility, is emphasized as a key to addressing and explicating moral values at these three levels. Emotions point out moral aspects of risks such as justice, fairness and autonomy. This framework can shed important new light on morally responsible communication about nuclear risks. The first condition of this framework requires that the procedure of communication is participatory, in order to include the relevant moral emotions and values concerning nuclear energy of all stakeholders. A legitimate procedure does not guarantee an ethically justified message concerning nuclear risks. For this reason, the second condition requires an ethical deliberation of the message and the values and emotions entailed in it. Finally, the third condition requires a moral evaluation of the effects of risk communication concerning nuclear energy. A successful risk communication effort triggers reflection, compassion and a willingness to take responsibility for energy-related issues. Problematic effects of risk communication can be a lack of trust or a sense of hopelessness and passivity. Evaluating all three levels from a moral point of view should be done in an iterative way, allowing possible revisions and improvements. Considering the high stakes and current stalemates in the nuclear debate, the suggested model provides a promising, constructive and morally legitimate way forward.

Where families and healthcare meet

Verkerk MA, Lindemann H, McLaughlin J, Leach Scully J, Kihlbom U, Nelson J, Chin J, Journal of Medical Ethics, 2014, doi:10.1136/medethics-2013-101783

Ulrik KihlbomAbstract: Recent developments in professional healthcare pose moral problems that standard bioethics cannot even identify as problems, but that are fully visible when redefined as problems in the ethics of families. Here, we add to the growing body of work that began in the 1990s by demonstrating the need for a distinctive ethics of families. First, we discuss what ‘family’ means and why families can matter so deeply to the lives of those within them. Then, we briefly sketch how, according to an ethics of families, responsibilities must be negotiated against the backdrop of family relationships, treatment decisions must be made in the light of these negotiated responsibilities and justice must be served, both between families and society more generally and within families themselves.

Externalization of Consciousness. Scientific Possibilities and Clinical Implications

Farisco M, Laureys S, Evers K, in: Geyer M, Ellenbroek B, Marsden C (eds), Current Topics in Behavioural Neurosciences, 2014, doi: 10.1007/7854_2014_338

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

Culture, science and bioethics: Interdisciplinary understandings of and practices in science, culture and ethics

Chenhall R, Martinelli L, McLaughlin J, Smestad Paulsen B, Senior K, Svalastog AL, Tunon H and Werdelin L, New Zealand Online Journal of Interdisciplinary Studies, 2014;1(2)

Anna Lydia SvalastogAbout: This paper presents insights from four years of interdisciplinary discussions and analysis focusing on the complex and multidimensional character of the relationship between culture and ethics. Our approach to culture is one which seeks to understand how values we know as cultural – that is embedded in and emergent from particular locations and groupings of people who develop shared understandings over time – are part of how groups are recognised (or denied), how knowledge is produced and understood, how people understand their position in the world and how history and change influence the boundaries between cultures and the differential valuing of cultures. Our overall claim is that cultural dynamics are embedded in all areas of cultural analysis and bioethical or ethical debate. What the paper produces is a case for seeing culture as a vital component to how we debate science and ethics and indicates several ways this can be done analytically and methodologically. The value of the interdisciplinary analyses captured in the domains we discuss is that they draw out the interrelated nature of the practices associated with "culture", "ethics" and "science". Drawing out such interrelationships is an important stage in thinking through the questions of justice, rights and power, that each of us in our different fields see as vital to our research practice. We share a conviction of the need for inter-/trans-disciplinary evaluations of our own disciplines, in order to make visible the culture of Dominant research that resist forms of analysis that question how things are done and why. We also recognise the need to constantly question our own cultural positionings within our disciplines and our society and how we are located within power relations from which we may receive benefit.

Practical Barriers and Ethical Challenges in Genetic Data Sharing

Simpson CL, Goldenberg AJ, Culverhouse R, Daley D, Igo RP, Jarvik GP, Mandal DM, Mascalzoni D, Gray Montgomery C, Pierce B, Plaetke R, Shete S, Goddard KAB, Stein CM, International Journal of Environmental Research and Public Health, 2014;11(8):8383-8398

Deborah MascalzoniAbstract: The underlying ethos of dbGaP is that access to these data by secondary data analysts facilitates advancement of science. NIH has required that genome-wide association study data be deposited in the Database of Genotypes and Phenotypes (dbGaP) since 2003. In 2013, a proposed updated policy extended this requirement to next-generation sequencing data. However, recent literature and anecdotal reports suggest lingering logistical and ethical concerns about subject identifiability, informed consent, publication embargo enforcement, and difficulty in accessing dbGaP data. We surveyed the International Genetic Epidemiology Society (IGES) membership about their experiences. One hundred and seventy five (175) individuals completed the survey, a response rate of 27%. Of respondents who received data from dbGaP (43%), only 32% perceived the application process as easy but most (75%) received data within five months. Remaining challenges include difficulty in identifying an institutional signing official and an overlong application process. Only 24% of respondents had contributed data to dbGaP. Of these, 31% reported local IRB restrictions on data release; an additional 15% had to reconsent study participants before depositing data. The majority of respondents (56%) disagreed that the publication embargo period was sufficient. In response, we recommend longer embargo periods and use of varied data-sharing models rather than a one-size-fits-all approach.

Exploring the communication between telenurse and caller - A critical discourse analysis

Hakimnia R, Holmström IK, Carlsson M, Höglund AT, International Journal of Qualitiative Studies on Health and Well-being, 2014;9:24255

Anna T. HöglundAbstract: Background: Telenursing is an expanding service in most Western societies. Sweden is a front-line country, with all of its 21 counties connected to Swedish Healthcare Direct (SHD) 1177. The intention of the service is twofold: to make health care more efficient, while also making it more accessible and safe for patients. Previous research has shown, however, that the service is not used equitably. Gender, age, socio-economic, and ethnicity differences have been reported as determining factors for the use of the service and the advice given. Aim: The aim of the study was to explore the communication between telenurses and callers in authentic calls to SHD 1177. Methodology: A qualitative method, using critical discourse analysis (CDA), was chosen. The approach was deductive, that is, the analysis was made in view of a predetermined framework of theory. Twenty calls were strategically chosen and included in the study. Results: The CDA resulted in five types of calls, namely a gatekeeping call, a gendered call, a call marked by impersonal traits, a call with voices of the life world, and finally a counter discourse call. The dominating patterns in the calls were of gatekeeping and biomedical character. Patterns of the societal gender order were found, in that representations of the reluctant male caller and the ideal female caller were identified, but also a call representing a counter discourse. The service seemed difficult to use for patients with low language proficiency. Conclusion: Telenursing could potentially challenge inequalities in health care. However, the discourse of telenursing is dialectically related to neoliberal ideology and the ideology of medicine. It is also situated in a gendered context of ideal femininity and hegemonic masculinity. Through better awareness of gender biases and the callers’ different resources for making themselves heard, the communication between telenurse and caller might become more equal and thereby better suitable for all callers.

Communicating with the European Composite Administration

Reichel J, German Law Journal, 2014;15:883-906

Jane ReichelAbstract: One of the reasons for introducing a “Union” citizenship in the 1993 Maastricht Treaty was to provide a direct channel between the citizens of the Member States and the EU. In contrast to many other international organizations, the role of the individual has been central to the European project already since its inception. In its famous 1962 judgment given in Van Gend en Loos, the Court of Justice of the European Union (CJEU) underscored the importance of the “vigilance of individuals concerned” seeking to protect their European rights in the new legal order through judicial control. The right to directly vote on the representatives of the European Parliament had already been introduced in the 1970s. The citizens of the Member States were thus equipped with two classic forms of participation even prior to the introduction of Union citizenship: law making and the legal adjudication of individual cases. A further third form was introduced in the Lisbon Treaty; participatory democracy. The question put forward in the article is how these channels for participation functions vis-à-vis the developing administrative cooperation between European and national authorities, the European composite administration. Does the current legal framework on citizen involvement merely provide an ad hoc approach, diluting any possibility of effective democratic or judicial control over the administration, or whether it enables a flexible and pragmatic form of control via Union citizen participation in the multi-faceted legal and political reality of the EU.

The Right to Health in Sweden

Anna-Sara LindLind A-S, in: Flood, C. & Gross, A. (Eds.) The Right to Health at the Public/Private Divide - A Global Comparative Study, Cambridge University Press, 2014:51-78


Plagiarism in research

Helgesson G & Eriksson S, Medicine, Health Care and Philosophy, 2014, online pre-publication, doi: 10.1007/s11019-014-9583-8

Stefan ErikssonAbstract: Plagiarism is a major problem for research. There are, however, divergent views on how to define plagiarism and on what makes plagiarism reprehensible. In this paper we explicate the concept of “plagiarism” and discuss plagiarism normatively in relation to research. We suggest that plagiarism should be understood as “someone using someone else’s intellectual product (such as texts, ideas, or results), thereby implying that it is their own” and argue that this is an adequate and fruitful definition. We discuss a number of circumstances that make plagiarism more or less grave and the plagiariser more or less blameworthy. As a result of our normative analysis, we suggest that what makes plagiarism reprehensible as such is that it distorts scientific credit. In addition, intentional plagiarism involves dishonesty. There are, furthermore, a number of potentially negative consequences of plagiarism.

On the Stand. Another Episode of Neuroscience and Law Discussion From Italy

Farisco M & Petrini C, Neuroethics 2014;7(2):243-245

Abstract: After three proceedings in which neuroscience was a relevant factor for the final verdict in Italian courts, for the first time a recent case puts in question the legal relevance of neuroscientific evidence. This decision deserves international attention in its underlining that the uncertainty still affecting neuroscientific knowledge can have a significant impact on the law. It urges the consideration of such uncertainty and the development of a shared management of it.

On Teachers’ Education in Sweden, school curriculums, and the Sámi People

Svalastog AL, in Gärdebo J, Öhman M-B, Maruyama H (eds.) Re:Mindings. Co-Constituting Indigenous/Academic/Artistic Knowledges, Uppsala University: Uppsala Multiethnic Papers 55 / The Hugo Valentin Centre, Uppsala 2014, pp.153-171

Striving for good nursing care: Nurses' experiences of do not resuscitate orders within oncology and hematology care

Pettersson M, Hedström M and Höglund AT, Nursing Ethics published online 9 June 2014, DOI: 10.1177/0969733014533238

Abstract: Background: Within oncology and hematology care, patients are sometimes considered to have such a poor prognosis that they can receive a do not resuscitate order from the physician responsible, stipulating that neither basic nor advanced coronary pulmonary rescue be performed in the event of a cardiac arrest. Studies on do not resuscitate decisions within oncology and hematology units, focusing on the specific role of the nurse in relation to these decisions, are scarce.

Objective: The aim of this study was to investigate hematology and oncology nurses' experiences and perceptions of do not resuscitate orders, in order to achieve a deeper understanding of the nurses' specific role in these decisions.

Research design: A qualitative, descriptive methodology with individual semi-structured interviews was used.
Participants and research context:
A total of 15 nurses from eight hematology/oncology wards in four hospitals in Sweden were interviewed individually.

Ethical considerations: In accordance with national regulations, an ethical review was not required for this study. The research followed international guidelines for empirical research, as outlined in the Helsinki Declaration.

Findings: The nurses strived for good nursing care through balancing harms and goods and observing integrity and quality of life as important values. Experienced hindrances for good care were unclear and poorly documented decisions, uninformed patients and relatives, and disagreements among the caregivers and family. The nurses expressed a need for an ongoing discussion on do not resuscitate decisions, including all concerned parties.

Conclusion: In order to provide good nursing care, nurses need clear and well-documented do not resus- citate orders, and patients and relatives need to be well informed and included in the decisions. To increase the understanding for each other's opinions within the medical team, regular ethical discussions are required.

Fuzzy logic and preconceptional genetic carrier screening

Inthorn J, APHSC, 2014;1

Abstract: Medical screening programs have been established based on the idea of early treatment and prevention. The selection of tests as well as the diseases tested for that are included in a screening need to be ethically justified. This article looks at criteria for screening such as severity of a disease and efficiency of a test and their applicability for newly developed preconceptional genetic carrier screening. Preconceptional genetic carrier screening can be used by couples planning a pregnancy in order to learn it they are both carriers of a recessive inherited diseases und thus have an increased risk of having an affected child. It is argued that introducing fuzzy logic helps to overcome a binary logic of ethical decisions and to discuss ethical problems connected to the selection of diseases for preconceptional genetic carrier screening in a more nuanced way. With ongoing research about the relationship between genotype and phenotype as well as current development of new genetic screening methods the selection of tests and diseases will have to deal with knowledge deficits which fuzzy logic can help to handle.

Rare Disease Research: Breaking the Privacy Barrier

Mascalzoni D, Paradiso A, Hansson M, Applied & Translational Genomics, Available online 18 April 2014

Abstract: Due to the few patients affected, rare disease research has to count on international registries to exist in order to produce significant research outputs. Data sharing of registries is therefore a unique resource to allow rare disease research to flourish and any lost data will jeopardize the quality of an already extremely difficult research. The rules usually applied to research such as the right to withdraw or the need for specific consent for every use of data can be detrimental in order to get effective results. Privacy rights regulated through traditional informed consent mechanisms have been regarded as a major barrier in order to effectively share data worldwide. Some authors argue that this barrier hampers results that could be beneficial to the patients so that another right will be overstated: the right to quality healthcare. We argue in this paper that privacy has been often interpreted just one-sided as the right to secrecy but it can entail another meaning: the right to manage one’s own private sphere. Managing it pertains, not only to the right to deny access, but also to the right to grant access. At the same time research on patient participation and transparency shows that new forms of IT-based informed consent can provide a good balance between the right of individuals to be in control of their data and the opportunity for science to pursue international research.

Perspectives on open science and scientific data sharing: an interdisciplinary workshop

Destro Bisol G, Anagnostou P, Capocasa M, Bencivelli S, Cerroni A, Contreras J, Enke N, Fantini B, Greco P, Heeney C, Luzi C, Manghi P, Mascalzoni D, Molloy J, Parenti F,  Wicherts JM & Boulton G, Journal of Anthropological Science, 2014;92:1-22

Summary: The process of making scientific knowledge and data open to the whole scientific community and the public is vigorously underway owing to the combined efforts of researchers and stakeholders. A workshop designed to foster dialogue about open science and open data between scholars from different scientific domains, and entitled “Scientific data sharing: an interdisciplinary workshop”, was held in Anagni, Italy, 2-4 September 2013. We here report summaries of the presentations and discussions at the meeting. They deal with four sets of issues: (i) setting a common framework, a general discussion of open data principles, values and opportunities; (ii) insights into scientific practices, a view of the way in which the open data movement is developing in a variety of scientific domains (biology, psychology, epidemiology and archaeology); (iii) a case study of human genomics, which was a trail-blazer in data sharing, and which encapsulates the tension that can occur between large-scale data sharing and one of the boundaries of openness, the protection of individual data; (iv) open science and the public, based on a round table discussion about the public communication of science and the societal implications of open science. There were three proposals for the planning of further interdisciplinary initiatives on open science. Firstly, there is a need to integrate top-down initiatives by governments, institutions and journals with bottom-up approaches from the scientific community. Secondly, more should be done to popularize the societal benefits of open science, not only in providing the evidence needed by citizens to draw their own conclusions on scientific issues that are of concern to them, but also explaining the direct benefits of data sharing in areas such as the control of infectious disease. Finally, introducing arguments from social sciences and humanities in the educational dissemination of open data may help students become more profoundly engaged with Open Science and look at science from a broader perspective.

Developing an interactive mobile phone self-report system for self-management of hypertension. Part 2: Content validity and usability

Bengtsson U, Kjellgren K, Höfer S, Taft C, Ring L, Blood Press 2014 May 1 [Epub ahead of print]

Abstract: Self-management support tools using technology may improve adherence to hypertension treatment. There is a need for user-friendly tools facilitating patients' understanding of the interconnections between blood pressure, wellbeing and lifestyle. This study aimed to examine comprehension, comprehensiveness and relevance of items, and further to evaluate the usability and reliability of an interactive hypertension-specific mobile phone self-report system. Areas important in supporting self-management and candidate items were derived from five focus group interviews with patients and healthcare professionals (n = 27), supplemented by a literature review. Items and response formats were drafted to meet specifications for mobile phone administration and were integrated into a mobile phone data-capture system. Content validity and usability were assessed iteratively in four rounds of cognitive interviews with patients (n = 21) and healthcare professionals (n = 4). Reliability was examined using a test-retest. Focus group analyses yielded six areas covered by 16 items. The cognitive interviews showed satisfactory item comprehension, relevance and coverage; however, one item was added. The mobile phone self-report system was reliable and perceived easy to use. The mobile phone self-report system appears efficiently to capture information relevant in patients' self-management of hypertension. Future studies need to evaluate the effectiveness of this tool in improving self-management of hypertension in clinical practice.

The value of bio-objects and policy discourses in Europe

Svalastog AL, Croat Med J. 2014;55:167-70

Abstract: In a series of texts (primarily published in the Croatian Medical Journal ) new entities, identified and/or produced by new technology, have been analytically defined as bio-objects. Bio-objects derive from innovative knowledge, they are generated through a "bio-objectification" process, and continuously negotiat ed in the intersection of science, politics, and society. Identification and construction of bio-objects are conducted in a variety of practices and discourses inside and outside of scientific laboratories, and configured in science, policy, and media. Information-over-loaded knowledge landscapes (KL) are in turn characterized by open-source distribution, and are both depoliticizing and (re-)politicizing the content and function of bio-objects. In this article, the focus is on the value of bio-objects, and includes an inquiry into the history of the changeable value of bio-objects as a scientific and economic project in Europe.

The organization and governance of research played an important role in the fundamental reorganization of science after World War II (WWII). Costs for research and treatment based on new technology were inevitable to achieve new knowledge, diagnostics, and treatments. Outcomes of the investments were uncertain, at the same time as priorities in the health care system became a more and more pressing issue to handle, for government as well as for individual hospitals, patient groups, and the European public. In this article, the relation between value production and society is emphasized, in particular the relative value of bio-objects, its close relation to the process of reorganizing science in post-war Europe, and the present situation of relative value generated by priority challenges.

Developing an interactive mobile phone self-report system for self-management of hypertension. Part 1: Patient and professional perspectives

Bengtsson U, Kasperowski D, Ring L, Kjellgren K, Blood Press 2014 Feb 24 [Epub ahead of print]

Abstract: Low adherence remains a struggle in hypertension management, despite improvement efforts. Presuming that increased patient participation is a possible approach, we collaborated with patients and healthcare professionals to design a self-report system to support self-management. The study aimed to explore and describe relevant aspects of hypertension and hypertension treatment, for use in the development of an interactive mobile phone self-report system. It further aimed to suggest which clinical measures, lifestyle measures, symptoms and side-effects of treatment would be meaningful to include in such a system. Five focus group interviews were performed with 15 patients and 12 healthcare professionals, and data was analysed using thematic analysis. Patients suggested trust, a good relationship with caregivers, and well-being as important aspects of hypertension self-management. Furthermore, they regarded blood pressure, dizziness, stress, headache and tiredness as important outcomes to include. Patients sought to understand interconnections between symptoms and variations in blood pressure, whilst healthcare professionals doubted patients' ability to do so. Healthcare professionals emphasized accessibility, clear and consistent counselling, complication prevention and educational efforts. The study presents aspects of importance for follow-up to understand the interplay between blood pressure and daily life experiences for patients with hypertension.

Possibilities and limits of mind-reading: A neurophilosophical perspective

Evers K & Sigman M, Consciousness and Cognition, 2014;22:887–897

Abstract: Access to other minds once presupposed other individuals' expressions and narrations. Today, several methods have been developed which can measure brain states relevant for assessments of mental states without 1st person overt external behavior or speech. Functional magnetic resonance imaging and trace conditioning are used clinically to identify patterns of activity in the brain that suggest the presence of consciousness in people suffering from severe consciousness disorders and methods to communicate cerebrally with patients who are motorically unable to communicate. The techniques are also used non-clinically to access subjective awareness in adults and infants. In this article we inspect technical and theoretical limits on brain–machine interface access to other minds. We argue that these techniques hold promises of important medical breakthroughs, open up new vistas of communication, and of understanding the infant mind. Yet they also give rise to ethical concerns, notably misuse as a consequence of hypes and misinterpretations.

In Need of Meta-Scientific Experts?

Farisco M, AJOB Neuroscience 2014, 5(2):20-52

Abstract: A recent Italian case shows that the interpretation of neuroscientific evidence is often uncertain and debated. Judges and courts have to deal with this uncertainty. We suggest as a strategy to assess it the involvement of meta-scientific experts who can help lay people (as judges and juries presumably are, in science) to understand the formal and conceptual limitation of neuroscience.

Making researchers moral: Why trustworthiness requires more than ethics guidelines and review

Johnsson L, Eriksson S, Helgesson G & Hansson MG, Research Ethics 2014;10(1):29-46

Abstract: Research ethics, once a platform for declaring intent, discussing moral issues and providing advice and guidance to researchers, has developed over time into an extra-legal regulatory system, complete with steering documents (ethics guidelines), overseeing bodies (research ethics committees) and formal procedures (informed consent). The process of institutionalizing distrust is usually motivated by reference to past atrocities committed in the name of research and the need to secure the trustworthiness of the research system. This article examines some limitations of this approach. First, past atrocities cannot provide the necessary justification unless institutionalized distrust is a necessary or efficient means to prevent future ones – and there are several reasons to doubt this. Second, the efficacy of ethics review in safeguarding morally acceptable research depends on the moral competence and integrity of individual researchers – the very qualities that institutionalized distrust calls into question. Third, ethics guidelines cannot, as is sometimes assumed, educate or guide researchers in moral behaviour unless they already possess considerable capacity for moral judgment. Fourth, institutionalized distrust is a potential threat to the moral competence and integrity of researchers by encouraging a blinkered view of ethical issues, inducing moral heteronomy through incentives, and alienating them to research ethics. We conclude that the moral problem posed by inappropriate short-term behaviour on behalf of researchers is dwarfed by the potential long-term consequences if their moral competence is allowed to deteriorate. Measures must therefore be taken to ensure that researchers are equipped to take their individual responsibility and are not obstructed from so doing.

Distortion, confusion, and impasses: could a public dialogue within Knowledge Landscapes contribute to better communication and understanding of innovative knowledge?

Svalastog AL, Allgaier J, Martinelli L, Gajovic S:, Croat Med J. 2014;55:54-60, doi: 10.3325/cmj.2014.55.54

Summary: Researchers and scientists need to communicate new knowledge to society. Previously, the discussion on this communication process has focused on dialoge between scientists on the one hand, and policy makers and the public on the other. The authors suggest that today, researchers, PR consultants, interest groups, policy makers and lay people interact on the Internet, creating "knowledge landscapes" where knowledge is interrelated, framed and shaped. The focus of this article is on "bio objects" (such as stem cells and chimeras) and science communicaiton in relation to citizenship and personalized medicine.

Hope for a cure and altruism are the main motives behind participation in phase 3 clinical cancer trials

Godskesen T, Hansson MG, Nygren P, Nordin K, Kilhlbom U, European Journal of Cancer Care, 2014; doi: 10.1111/ecc.12184. Published  2 January 2014.

Abstract: It is necessary to carry out randomised clinical cancer trials (RCTs) in order to evaluate new, potentially useful treatments for future cancer patients. Participation in clinical trials plays an important role in determining whether a new treatment is the best therapy or not. Therefore, it is important to understand on what basis patients decide to participate in clinical trials and to investigate the implications of this understanding for optimising the information process related to study participation. The aims of this study were to (1) describe motives associated with participation in RCTs, (2) assess if patients comprehend the information related to trial enrolment, and (3) describe patient experiences of trial participation. Questionnaires were sent to 96 cancer patients participating in one of nine ongoing clinical phase 3 trials at the Department of Oncology, Uppsala University Hospital in Sweden. Eighty-eight patients completed the questionnaire (response rate92%); 95% of these were patients in adjuvant therapy and 5% participated in clinical trials on palliative care. Two main reasons for participation were identified: personal hope for a cure and altruism. Patients showadequate understanding of the information provided to them in the consent process and participation entails high patient satisfaction.

Enhancing Research Ethics Capacity in the Middle East: Experience and Challenges of a Fogarty-Sponsored Training

Siverman H, Edwards H, Shamoo A & Matar A, Journal of Empirical Research on Human Research Ethics: An International Journal, 2013;8(5):40-51

Abstract: We describe the research ethics capacity needs of the countries from the Middle East region. Against this background, we relate the experience of an international training program focused on providing long-term training in research ethics to individuals from low- and middle-income countries in the Middle East area. We describe our pedagogical approach to training, program changes to address challenges faced, and accomplishments of trainees. Many former trainees developed research ethics curricula in their home institutions, established or enhanced their institutions' research ethics committees, provided leadership to national research ethics systems, and conducted research in research ethics. Based on our analysis, we make recommendations for how trainees can further address current regional research ethics needs in the Middle East and conduct future research. This paper is part of a collection of papers analyzing the Fogarty International Center's International Research Ethics Education and Curriculum Development program.

ERIC - A new governance tool for Biobanking

Reichel J, Lind A-S, Hansson MG, Litton, J-E, European Journal of Human Genetics advance online publication 5 February 2014; doi: 10.1038/ejhg.2014.6

Abstract: In 2009, the EU introduced a new governance tool for research, the European Research Infrastructure Consortium, commonly referred to as ERIC. On 22nd November 2013, an ERIC within biobanking research was established, the BBMRI-ERIC, with its seat in Graz, Austria. This article analyses what use the ERIC can be to researchers in biobanking, focusing on legal and ethical perspectives. Our conclusion is that the main advantages with the ERIC are its functions as a platform, creating opportunities for long-term cooperation between the Member States involved and their researchers. Within the platform, research groups can develop functional standards for technical, legal and ethical purposes, set up criteria for biobanks, and so on. The ERIC also creates a platform for the involved researchers to communicate with policymakers in the EU and the Member States. However, when it comes to addressing the diverse regulatory framework for biobanking in the EU, one of the more important hurdles today, the ERIC does not provide for any substantial tools.

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Reports and from CRB

Regulating biobank research: new book

[2015-01-13] Biobank research and genomic information are changing the way we look at health and medicine. So how can we regulate it? A recent book published by Springer shows us how the regulatory systems work and raises a critical voice.

Deborah MascalzoniDeborah Mascalzoni is Senior Researcher at CRB and the editor of Ethics, Law and Governance of Biobanking that was recently published by Springer. According to her, we can't keep clinical applications and research separate anymore.

New book thinks about ethics

[2014-12-16] Why would a cancer patient agree to test a drug that might not be effective on their own disease? And are researchers responsible if their research can be used to develop biological weapons? A new book provides some food for thought.

Pär SegerdahlJust the other day, Pär Segerdahl published a book called Thinking about ethics with a collection of texts and reflections from the Ethics Blog. The texts might not provide the answers to all the questions posed above, but they should at least give you some ideas.

Ethical rounds in psychiatric care

[2014-12-01] Is there a way to use ethical rounds to improve the ethical climate in health care? Two outpatient psychiatry clinics in Uppsala have been part of a study to find out if it is possible.

Marit SilénIt turns out that the staff appreciated participating in the ethical rounds and saw them as an important forum for discussing ethical questions. According to Marit Silén, who did the intervention as part of her postdoc at CRB, there weren’t any measurable differences in how staff perceive that ethical issue are handled in the workplace - the ethical climate -  before and after the intervention. Read more

Download report (in Swedish) or a short flyer about the results (also in Swedish).

Biobank and registry ethics

Biobank and registry ethics publications from CRB with abstracts

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Nursing ethics

Nursing ethics publications from CRB with abstracts

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