PEER REVIEWED PUBLICATIONS
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.
Mascalzoni D (ed), , Springer, National, European and International Approaches Series: The International Library of Ethics, Law and Technology, Vol. 14 2015, VI, 277 p.
About 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?
This 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.
Nihén Fahlquist J, Nursing Ethics, online December 22, 2014, doi:10.1177/0969733014561913
Abstract: 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.
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
Abstract: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
Abstract: Aim: The aim of the present study was to analyze 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
Abstract: 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 are 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.
Dudai Y, Evers K, Neuron, 2014;84(2):254-261
Abstract: 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.
Kalokairinou L, Howard HC, Borry P, Science, 2014:346(6207); 296-298
Abstract: 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.
Abstract: 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.
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]
Abstract: 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.
Farisco M, Petrini C, Ann Ist Super Sanità, 2014;50(3):229-233
Abstract: 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
Abstract: 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 disproportionate 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.
Nihén Fahlquist J, Roeser S, Journal of Risk Research, 2014, online DOI: 10.1080/13669877.2014.940594
Abstract: 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.
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
Abstract: 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.
Abstract: The paper starts by analyzing recent advancements in neurotechnological assessment of residual consciousness in patients with disorders of consciousness and in neurotechnology-mediated communication with them. Ethical issues arising from these developments are described, with particular focus on informed consent. Against this background, we argue for the necessity of further scientific efforts and ethical reflection in neurotechnological assessment of consciousness and ‘cerebral communication’ with verbally non-communicative patients.
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)
About: 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.
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
Abstract: 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.
Abstract: 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.
Reichel J, German Law Journal, 2014;15:883-906
Abstract: 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
Lind 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
Helgesson G & Eriksson S, Medicine, Health Care and Philosophy, 2014, online pre-publication, doi: 10.1007/s11019-014-9583-8
Abstract: 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.
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 PeopleSvalastog 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.
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.
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.
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.
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.
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.
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.
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
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.
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.