These are the most recent publications by researchers active at CRB.
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
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.
Stjernschantz Forsberg J, Soini S, Nature Reviews Genetics, doi:10.1038/nrg3646. Published online 10 December 2013
Abstract: Human tissue samples and their associated data have become increasingly important in biomedical research. This development has led to a debate about the appropriate ethical and legal standards for their use, which has focused largely on the issue of informed consent. The traditional consent requirements of clinical research demand that individuals are informed about the specific details of every study, which presents substantial challenges for biobank research. A key question has therefore been how to weigh the interests of the individuals whose samples are used against the interests of research.
Sjöstrand M, Eriksson S, Juth N, Helgesson G, Journal of Medicine and Philosophy, first published online 24 October 2013; doi: 10.1093/jmp/jht049.
Abstract: Different ideas of the normative relevance of autonomy can give rise to profoundly different action-guiding principles in healthcare. If autonomy is seen as a value rather than as a right, it can be argued that patients’ decisions should sometimes be overruled in order to protect or promote their own autonomy. We refer to this as paternalism in the name of autonomy. In this paper, we discuss different elements of autonomy (decision-making capacity, efficiency, and authenticity) and arguments in favor of paternalism for the sake of autonomy that have been proposed in the bioethical debate. We argue that if autonomy is valuable, then paternalism for the sake of autonomy may be justified. However, policies allowing paternalism in the name of autonomy may be self-defeating.
Abstract: Incidental findings (IFs) are acknowledged to be among the most important ethical issues to consider in biobank research. Genome-wide association studies and disease-specific genetic research might reveal information about individual participants that are not related to the research purpose, but may be relevant to those participants' future health. In this article, we provide a synopsis of arguments for and against the disclosure of IFs in biobank research. We argue that arguments that do not distinguish between communications about pathogenic conditions and complex genetic risk for diseases fail, as preferences and decisions may be far more complex in the latter case. The principle of beneficence, for example, often supports the communication of incidentally discovered diseases, but if communication of risk is different, the beneficence of such communication is not equally evident. By conflating the latter form of communication with the former, the application of ethical principles to IFs in biobank research sometimes becomes too easy and frictionless. Current empirical surveys of people's desire to be informed about IFs do not provide sufficient guidance because they rely on the same notion of risk communication as a form of communication about actual health and disease. Differently designed empirical research and more reflection on biobank research and genetic risk information is required before ethical principles can be applied to support the adoption of a reasonable and comprehensive policy for handling IFs.European
The European Reform of the Data Protection Rules (RoDPR) and the Amendments proposed by the Committee on Civil Liberties, Justice and Home Affairs (LIBE)1, which are currently under discussion in the European Union (EU) Parliament, have alarmed the scientific community. The declared focus of RoDPR is to strengthen privacy protection and personal control over data in general. However, by trying to apply to research the same set of rules developed for regulating commerce or the Internet, the RoDPR could be seriously detrimental to health research. Research based on biobanks and registries is effective only if access to sufficient data is granted and if the use of data is maximized through data sharing2. This is particularly important for rare disease research.
Hansson MG, van Ommen GJ, Chadwick R & Dillner J, Lancet Oncology online pre publication March 21, 2013
Abstract: The regulatory framework for protection of human subjects seems not to keep pace with the developments in biomedical research. A recent example of this is the proposal by the European Committee on Civil Liberties, Justice and Home Affairs that processing of data for scientific reasons should not be exempt from strict requirements of specific consent by the data subject. Such a policy will have serious consequences for the use of registries and previously collected biobanks in medical research. With two concrete examples from cancer research we argue here for an approach to ethical review that seeks to optimize benefits and minimize risks to patients, by using more simplified procedures when risks are low.
Svalastog AL, New Genetics and Society, online pre-publication 15 March 2013 DOI:10.1080/14636778.2012.760265
Abstract: Despite more than 50 years of genetic research on Sámi people in Sweden, there has been very little engagement with the ethical issues related to this research. My aim is to investigate the ethical challenges in biobank research on Sámi people, to identify ethical challenges that have been overlooked and to find ethical solutions. In my historical research inquiry of published material and interviews with people that have participated in this research, my research questions have been: How are blood samples from Sámi people collected, codified, governed and analyzed? What ethical strategies have been utilized? My main findings are: Sweden acquired biobank collections from Sámi people that are not registered or cannot be traced through the biobank register at the Swedish National Board of Health and Welfare. These collections entail ethical challenges concerning how the donors are identified, how the material is categorized, the regional ethical committees, governance and Sámi representation. My suggestions focus on transparency and traceability, competence and native peoples' rights and representation in biobank-related activities.
Kuhlau F, Doctoral dissertation, Acta Universitatis Upsaliensis, 2013
Abstract: Life scientists have increasingly been asked to incorporate a dual use responsibility in their research conduct. In this thesis, different aspects of what constitutes a reasonable responsibility in terms of avoiding harmful misuse of research for biological weapon purposes have been explored.
The first study investigated the claim that scientists have a dual use responsibility, and also outlined some of its possible content. Criteria for what may constitute preventable harm were used to analyze some proposed obligations in the field, and it was concluded that reasonable obligations include: e.g. considering the potential negative implications of one's research and reporting activities of concern. In the second study, the conditions for a Precautionary Principle (PP) were explored and applied to the dual use research context. The study found that the main conditions of the PP frequently appear in present discussions and formulations of life scientists' responsibility. It was also concluded that the PP is applicable to the dual use field and that it is meaningful and useful as a normatively guiding principle. The third study suggested an ethics of dissemination, based on the assumption that scientists have a responsibility to occasionally constrain the dispersion of their research findings. Three core aspects were proposed for an ethics of dual use dissemination. Additionally, to help scientists understand when constraints may be justified, three corresponding conditions for their application were suggested. In the fourth study, the concept of ethical competence was introduced and explored within a dual use context. It was concluded that competence-building is important in the nurturing of individual responsibility and, subsequently, in achieving a culture of dual use responsibility in the life sciences.
Finally, the discussion on ethical competence was included in a proposed ethic of deliberation, in which various stakeholders in the dual use debate are conceived to participate in communicative processes. It was argued that spaces for deliberative activities should be institutionalized by the scientific community to ensure structural opportunities for individuals to both assume responsibility and share it. Moreover, it was argued that deliberation can constitute a cornerstone of responsible dual use governance.
Eriksson S & Helgesson G, Studentlitteratur, 2013
Abstract: Vetenskapliga publikationer har fått en allt mer central roll i forskarvärlden. Publikationen förmedlar och tillgängliggör forskningsresultat samtidigt som den utgör en måttstock på forskargruppens och den enskilde forskarens vetenskapliga insats. Exempelvis fördelas i allt högre utsträckning fakultetsmedel utifrån institutionernas vetenskapliga produktion och vetenskaplig kompetens bedöms ofta i termer av längden på publikationslistan. Den hårda konkurrensen om forskningsmedel och tjänster kan locka forskare att ta genvägar till ytterligare publikationer. Risken är att vetenskapen då undergrävs och att forskare blir orättvist bedömda.
Johnsson L, Doctoral thesis, Acta Universitatis Upsaliensis, 2013
Abstract: What role should trust have in biobank research? Is it a scarce resource to be cultivated, or does its moral significance lie elsewhere? How does it relate to the researcher's individual responsibility?
In this thesis I draw four general conclusions. First, trust is still very much present in at least some biobanking settings, notably in Sweden, but possibly also internationally. Second, a morally relevant conception of trust entails that to be trustworthy, researchers must consider the normative expectations that people have of them, and renegotiate expectations that are mistaken. Third, this conception differs from "public trust" assessed through surveys. The main use of the latter is to legitimate policy, not to identify moral duties. Fourth, in spite of ethics review, guidelines and informed consent procedures, ethical issues will always arise during the course of a research project. Researchers can therefore never avoid their individual moral responsibility. Ensuring that one is adequately trusted is one step towards conducting morally acceptable research.
Study I indicates that few Swedes refuse storage of samples in healthcare-associated biobanks and their use in research. Study II suggests that people are somewhat more willing to donate samples than surveys indicate, especially when approached face-to-face by health care personnel. Relationships of trust might thus be important in people's decision-making. Study III investigates trust as a moral concept. The trustee is often in a unique position to determine what the other's trust amounts to. When it is mistaken, the trustee has an obligation to counteract it, compensate for it, or renegotiate the expectations that cannot be met. In Study IV, I critique the feasibility of guaranteeing the trustworthiness of the research apparatus through formal measures such as ethics review and guidelines. Not only are there limitations of such measures to consider. They also risk blinding researchers to ethical issues that are not covered by the rules, fostering moral complacency, and alienating researchers to ethics.
Abstract: Our starting point in this article is the debate between John Harris and Iain Brassington on whether or not there is a duty to take part in scientific research. We consider the arguments that have been put forward based on fairness and a duty to rescue, and suggest an alternative justification grounded in a hypothetical agreement: that is, because effective healthcare cannot be taken for granted, but requires continuous medical research, and nobody knows what kind of healthcare they will need, participating in research should be viewed from the perspective of a social contract, based on our mutual need for medical advances.
Eriksson S, Sundström E, Läkartidningen 2013;5(110):220-222.
Abstract: Artikeln ger en översikt över etiska problem och frågeställningar som aktualiseras vid klinisk observationell forskning. Syftet är att medvetandegöra forskare i Sverige om de etiska aspekter som kan läggas på deras forskning.
Studier av observationell karaktär, från journalgranskning till registerstudier, delar etiska problem med annan forskning på människor, exempelvis kliniska läkemedelsprövningar. Det kan röra sig om fusk, intressekonflikter och mycket annat. Här gäller också mer generella principer, som att det kan vara oetiskt att viktig forskning inte utförs eller försvåras av olika anledningar. Likaså är det ett etiskt problem om forskning är av så låg kvalitet att den leder till felaktiga slutsatser. Men det finns etiska aspekter som är mer speciella för epidemiologisk forskning, vilka diskuteras i artikeln, såsom att hantera data, dela data och att skapa samlingar av data. De etiska aspekterna på sådan forskning rör framför allt personlig integritet och datasäkerhet och artikeln lyfter fram att även med etiktillstånd att utan samtycke använda data kräver personuppgiftslagen att forskningspersonerna informeras om sina rättigheter i samband med att deras personuppgifter behandlas.
Slutligen pekar författarna på att forskningen kan effektiviseras genom att data delas och används i ny forskning, och att användning av vårdens kvalitetsregister i forskning bör underlättas genom bättre infrastruktur och öppenhet från registren mot externa forskare.
Abstract: Today, certain rule-violating behaviours, such as doping, are considered to be an issue of concern for the sport community. This paper underlines and examines the affective dimensions involved in moral responses to, and attitudes towards, rule-violating behaviours in sport. The key role played by affective processes underlying individual-level moral judgement has already been implicated by recent developments in moral psychological theories, and by neurophysiological studies. However, we propose and discuss the possibility of affective processes operating on a social level which may influence athletes' individual-level attitudes. We conclude that one-sided focus on individual rule-violating behaviour and individual sanctions may prove to be ineffective in coming to terms with the issue. In this regard we recommend a twofold approach by addressing underlying social dimensions, along with preventive measures through affect-oriented education.
Abstract: Commercialization in the context of biobank research is controversial both regarding the possible right of individuals to receive monetary compensation for (the use of) their tissue samples and of biobanks to sell the material. In this article we comment on two views; that commercialization of human material is intrinsically wrong, and that selling tissue samples is wrong due to its consequences. We argue that the first perspective is unconvincing, but suggest that the principle of putting samples to the “best possible use” is fundamental for vital patient needs, and seems to exclude paying individuals for their samples as well as direct marketing of materials stored in biobanks
Abstract: Life scientists have with increasing intensity been requested to recognize and take responsibility for the potential dual use implications of their work. To assist in meeting these demands, a number of educational modules have been produced to raise awareness of relevant dual use and biosecurity issues. A main purpose of such efforts has been to nurture an active culture of dual use responsibility in the life sciences. Despite the inherent ethical nature of the dual use dilemma, it has traditionally been conceptualized within a security framework and has largely been neglected in the bioethics discourse. This article introduces the concept of ethical competence in dual use and argues that a culture of responsibility cannot be realized unless awareness is accompanied by the capacities to reflect and act in dual use situations. Ethical competence may play a valuable part in developing a culture of dual use responsibility despite the unpredictable and openended nature of bioethical processes. However, such a competence is neither self-sustained nor self-sufficient. Organizational support and leadership are important to provide opportunities for building and sustaining dual use ethical competence (e.g., through education or mentoring). Moreover, other actors and their additional competences may occasionally be required to sufficiently safeguard dual use research.
All rights reserved. Posted with permission from the American Biological Safety Association (ABSA), Mundelein, IL. Originally published in Applied Biosafety: Journal of the American Biological Safety Association, 17(3), p. 120. Copyright © 2012.
Silén M, Kjellström S, Sidenvall B, Christensson L, Svantesson M, Nursing Ethics, 2012;19(4):501-512.
Abstract: Few qualitative studies explore the phenomenon of positive ethical climate and what actions are perceived as promoting it. Therefore, the aimof this study was to explore and describe actions that acute care ward nurses perceive as promoting a positive ethical climate. The critical incident technique was used. Interviews were conducted with 20 nurses at wards where the ethical climate was considered positive, according to a previous study. Meeting the needs of patients and next of kin in a considerate way, as well as receiving and giving support and information within the work group, promoted a positive ethical climate. Likewise, working as a team with a standard for behaviour within the work group promoted a positive ethical climate. Future research should investigate other conditions that might also promote a positive ethical climate.
Stjernschantz Forsberg, J, doctoral thesis, Acta Universitatis Upsaliensis, 2012
Abstract: The aim of this thesis is to investigate the relationship between individuals and society in the context of healthcare and medical research, more specifically concerning the rights and duties of individuals in regard to biobank-based research. My starting point is that we all have a strong vested interest in improved healthcare, and therefore the possibilities to conduct important research should be optimized. In the first article, I investigate whether individual results from research using samples in large-scale biobanks should be returned. I conclude that there is good reason not to implement such policies, and instead to allocate available resources to pursuing medical advances. In the second article, I compare consent for using stored samples in research with consent for organ donation, whereby many countries have adopted opt-out strategies in order to increase the number of organs available. I claim that the default position should be changed in biobank research as well, i.e. it should be presumed that individuals want to contribute rather than that they do not. In the third article, I argue that safeguarding autonomy by requiring informed consent for using samples in research not only defeats the interests of society but also runs counter to the interests of the individuals the policy purports to protect. Finally, in the fourth article I suggest that it is reasonable to view participation in medical research from the perspective of a social contract, built on our mutual need for medical advances, and that this implies that there is a moral duty to adhere to the contract by allowing one's samples to be used in research. A central conclusion in this thesis is that biobank research should be viewed as a natural part of healthcare, like quality control, method development and teaching, and that as such, it ought to be endorsed and facilitated.