Protecting confidentiality is an essential value in all human relationships, no less in medical practice and research.1 Doctor‐patient and researcher‐participant relationships are built on trust and on the understanding those patients' secrets will not be disclosed.2 However, this confidentiality can be breached in some situations where it is necessary to meet a strong conflicting duty.3Confidentiality, in a general sense, has received much interest in Islamic resources including the Qur'an, Sunnah and juristic writings. However, medical and research confidentiality have not been (...) explored deeply. There are few fatwas about the issue, despite an increased effort by both individuals and Islamic medical organizations to use these institutional fatwas in their research.Infringements on confidentiality make up a significant portion of institutional fatwas, yet they have never been thoroughly investigated. Moreover, the efforts of organizations and authors in this regard still require further exploration, especially on the issue of research confidentiality.In this article, we explore medical and research confidentiality and potential conflicts with this practice as a result of fatwas released by international, regional, and national Islamic Sunni juristic councils. We discuss how these fatwas affect research and publication by Muslim doctors, researchers, and Islamic medical organizations.We argue that more specialized fatwas are needed to clarify Islamic juristic views about medical and research confidentiality, especially the circumstances in which infringements on this confidentiality are justified. (shrink)

Background Studying the contribution of individual countries to leading journals in a specific discipline can highlight which countries have the most impact on that discipline and whether a geographic bias exists. This article aims to examine the international distribution of publications in the field of bioethics. Methods Retrospective quantitative study of nine peer reviewed journals in the field of bioethics and medical ethics (Bioethics, Cambridge Quarterly of Healthcare Ethics, Hastings Center Report, Journal of Clinical Ethics, Journal of Medical Ethics, Kennedy (...) Institute of Ethics Journal, Nursing Ethics, Christian Bioethics, and Theoretical Medicine and Bioethics). Results In total, 4,029 articles published between 1990 and 2003 were retrieved from the nine bioethical journals under study. The United States (59.3%, n = 2390), the United Kingdom (13.5%, n = 544), Canada (4%, n = 160) and Australia (3.8%, n = 154) had the highest number of publications in terms of absolute number of publications. When normalized to population size, smaller affluent countries, such as New Zealand, Finland and Sweden were more productive than the United States. The number of studies originating from the USA was decreasing in the period between 1990 and 2003. Conclusion While a lot of peer reviewed journals in the field of bioethics profile themselves as international journals, they certainly do not live up to what one would expect from an "international" journal. The fact that English speaking countries, and to a larger extent American authors, dominate the international journals in the field of bioethics is a clear geographic bias towards the bioethical discussions that are going on in these journals. (shrink)

Responsible research practices are critical to maintaining integrity in research and the provision of institutional trainings is an important means of promoting research integrity. However, studies show contrasting results on the efficacy of institutional training and that these approaches may not be fully effective in promoting research integrity among individuals and improving the overall climate in research integrity. Therefore, a more comprehensive multi-dimensional learning strategy seems to be needed. This includes continuous and tailored training at different institutional levels, the incorporation (...) of training sessions focusing on the development of the moral character of researchers, and the use of different mentoring practices. With this comprehensive approach, research institutions can foster a culture of integrity in research, improve the overall research integrity climate and promote responsible research practices by individuals. (shrink)

No university or research institution is immune to research misconduct or the more widespread problem of questionable research practices. To strengthen integrity in research, universities worldwide have developed education in research integrity. However, little is known about education in research integrity for PhD students in European research-intensive universities. We conducted a content analysis of didactic materials of 11 of the 23 members of the League of European Research Universities (LERU) to map out the content, format, frequency, duration, timing, and compulsory (...) status of their training programmes and the characteristics of instructors of the onsite courses. Quantitative results revealed substantial variation in educational materials among the studied institutions. This variation might be because European research universities are free to design curricula without any requirements from the European, national, or institutional public funding channels. Given the challenges inherent to modern science and preventing misconduct, research institutions should empower future generations of researchers to engage in responsible research practices. To promote integrity in research among PhD students, we provide a set of recommendations for university-wide education in research integrity for doctoral trainees based on our investigation of educational resources. (shrink)

BackgroundScientific researchers are expected to follow the professional norms in their own domain. With a growing number of scientific publications retracted and research misconduct cases revealed in recent years, Chinese biomedical research integrity is questioned. As institutions educating and training future researchers, universities and the guidance they provide are important for the research quality and integrity of the country. Therefore, through a review of the guidance and policy documents on research integrity in Chinese universities, this work aims to investigate how (...) the professional norms are specified in these documents.MethodsAfter a stratified sampling, 53 universities were selected. Their guidance and policy documents on research integrity were collected via a web search of their official websites. The search was confirmed by these universities. Then the content of all the collected documents were analyzed using inductive content analysis.Results118 active university documents were collected and analyzed. Most of the Chinese universities we investigated had their own guidance or policy on research integrity. They listed principles or examples of desired and undesired academic practices, investigation procedures and punishments of academic misconduct, and put forward measures to promote research integrity. Differences on specific practices and principles were observed between university groups and with European university documents.ConclusionDespite the discrepancy they have, all these documents were designed to promote research integrity and cultivate a good research environment in Chinese biomedical domain. Nevertheless, there is still room for improvement, for example, through more consultation of international guidance. (shrink)

Recent empirical evidence has demonstrated that research misconduct occurs to a substantial degree in biomedical research. It has been suggested that scientific integrity is also of concern in China, but this seems to be based largely on anecdotal evidence. We, therefore, sought to explore the Chinese situation, by making a systematic review of published empirical studies on biomedical research integrity in China. One of our purposes was also to summarize the existing body of research published in Chinese. We searched the (...) China National Knowledge Infrastructure, Wanfang Data, PubMed and Web of Science for potentially relevant studies, and included studies meeting our inclusion criteria, i.e. mainly those presenting empirically obtained data about the practice of research in China. All the data was extracted and synthesized using an inductive approach. Twenty-one studies were included for review. Two studies used qualitative methods and nineteen studies used quantitative methods. Studies involved mainly medical postgraduates and nurses and they investigated awareness, attitudes, perceptions and experiences of research integrity and misconduct. Most of the participants in these 21 studies reported that research integrity is of great importance and that they obey academic norms during their research. Nevertheless, the occurrence of research misbehaviors, such as fabrication, falsification, plagiarism, improper authorship and duplicate submission was also reported. Strengthening research integrity training, developing the governance system and improving the scientific evaluation system were areas of particular attention in several studies. Our review demonstrates that a substantial number of articles have been devoted to research integrity in China, but only a few studies provide empirical evidence. With more safeguard measures of research integrity being taken in China, it would be crucial to conduct more research to explore researchers’ in-depth perceptions and evaluate the changes. (shrink)

The reflexive, anticipatory, and deliberative approach proposed by Ankeny, Munsie, and Leach to iBlastoids, while worthwhile, requires an anchor to ensure that each process of its appr...

Assessing the risk-benefit ratio has always been considered key in designing clinical trials. These benefits can be diverse and may include social value and psychological benefits. When it comes to...

BackgroundEven though research integrity (RI) training programs have been developed in the last decades, it is argued that current training practices are not always able to increase RI-related awareness within the scientific community. Defining and understanding the capacities and lacunas of existing RI training are becoming extremely important for developing up-to-date educational practices to tackle present-day challenges. Recommendations on how to implement RI education have been primarily made by selected people with specific RI-related expertise. Those recommendations were developed mainly without (...) consulting a broader audience with no specific RI expertise. Moreover, the academic literature lacks qualitative studies on RI training practices. For these reasons, performing in-depth focus groups with non-RI expert stakeholders are of a primary necessity to understand and outline how RI education should be implemented.MethodsIn this qualitative analysis, different focus groups were conducted to examine stakeholders’ perspectives on RI training practices. Five stakeholders' groups, namely publishers and peer reviewers, researchers on RI, RI trainers, PhDs and postdoctoral researchers, and research administrators working within academia, have been identified to have a broader overview of state of the art.ResultsA total of 39 participants participated in five focus group sessions. Eight training-related themes were highlighted during the focus group discussions. The training goals, timing and frequency, customisation, format and teaching approach, mentoring, compulsoriness, certification and evaluation, and RI-related responsibilities were discussed. Although confirming what was already proposed by research integrity experts in terms of timing, frequency, duration, and target audience in organising RI education, participants proposed other possible implementations strategies concerning the teaching approach, researchers' obligations, and development an evaluation-certification system.ConclusionsThis research aims to be a starting point for a better understanding of necessary, definitive, and consistent ways of structuring RI education. The research gives an overview of what has to be considered needed in planning RI training sessions regarding objectives, organisation, and teaching approach. (shrink)

BackgroundPlagiarism is considered as serious research misconduct, together with data fabrication and falsification. However, little is known about biomedical researchers’ views on plagiarism. Moreover, it has been argued – based on limited empirical evidence – that perceptions of plagiarism depend on cultural and other determinants. The authors explored, by means of an online survey among 46 reputable universities in Europe and China, how plagiarism is perceived by biomedical researchers in both regions.MethodsWe collected work e-mail addresses of biomedical researchers identified through (...) the websites of 13 reputable universities in Europe and 33 reputable universities in China and invited them to participate in an online anonymous survey. Our questionnaire was designed to assess respondents’ views about plagiarism by asking whether they considered specific practices as plagiarism. We analyzed if respondents in China and Europe responded differently, using logistic regression analysis with adjustments for demographic and other relevant factors.ResultsThe authors obtained valid responses from 204 researchers based in China (response rate 2.1%) and 826 researchers based in Europe (response rate 5.6%). Copying text from someone else’s publication without crediting the source, using idea(s) from someone else’s publication without crediting the source and republishing one’s own work in another language without crediting the source were considered as plagiarism by 98, 67 and 64%, respectively. About one-third of the respondents reported to have been unsure whether they had been plagiarizing.Overall, the pattern of responses was similar among respondents based in Europe and China. Nevertheless, for some items significant differences did occur in disadvantage of Chinese respondents.ConclusionsFindings indicate that nearly all biomedical researchers understand (and disapprove of) the most obvious forms of plagiarism, but uncertainties and doubts were apparent for many aspects. And the minority of researchers who did not recognize some types of plagiarism as plagiarism was larger among China-based respondents than among Europe-based respondents. The authors conclude that biomedical researchers need clearer working definitions of plagiarism in order to deal with grey zones. (shrink)

ObjectiveTo present the ethical issues, moral arguments, and reasons found in the ethical literature on organoid models.DesignIn this systematic review of reasons in ethical literature, we selected sources based on predefined criteria: The publication mentions moral reasons or arguments directly relating to the creation and/or use of organoid models in biomedical research; These moral reasons and arguments are significantly addressed, not as mere passing mentions, or comprise a large portion of the body of work; The publication is peer-reviewed and published (...) in an academic article, book, national-level report, working paper, or Ph.D. thesis; The publications collected are in English.AnalysisEach article was read in-depth for identifiable moral reasons, arguments, and concerns. These were then inductively classified and synthesized to create broader categories of reasons, and eventually an overarching conceptual scheme was created.ResultsA total of twenty-three sources were included and analyzed out of an initial 266 collected sources. Five themes of ethical issues and arguments were found: Animal Experimentation; Clinical Applications and Experiments; Commercialization and Consent; Organoid Ontology and Moral Status; and Research Ethics and Research Integrity. These themes are then further broken down into sub-themes and topics. Given the extensive nature of the topics found, we will focus on describing the topics that comprised of more in-depth reasons and arguments rather than few, passing mentions or concerns.ConclusionsThe ethics of organoids requires further deliberation in multiple areas, as much of the discussions are not presented as in-depth arguments. Such sentiments are also echoed throughout the organoid ethics literature. (shrink)

BackgroundResearch with cerebral organoids is beginning to make significant progress in understanding the etiology of autism spectrum disorder (ASD). Brain organoid models can be grown from the cells of donors with ASD. Researchers can explore the genetic, developmental, and other factors that may give rise to the varieties of autism. Researchers could study all of these factors together with brain organoids grown from cells originating from ASD individuals. This makes brain organoids unique from other forms of ASD research. They are (...) like a multi-tool, one with significant versatility for the scope of ASD research and clinical applications. There is hope that brain organoids could one day be used for precision medicine, like developing tailored ASD drug treatments.Main bodyBrain organoid researchers often incorporate the medical model of disability when researching the origins of ASD, especially when the research has the specific aim of potentially finding tailored clinical treatments for ASD individuals. The neurodiversity movement—a developmental disability movement and paradigm that understands autism as a form of natural human diversity—will potentially disagree with approaches or aims of cerebral organoid research on ASD. Neurodiversity advocates incorporate a social model of disability into their movement, which focuses more on the social, attitudinal, and environmental barriers rather than biophysical or psychological deficits. Therefore, a potential conflict may arise between these perspectives on how to proceed with cerebral organoid research regarding neurodevelopmental conditions, especially ASD.ConclusionsHere, we present these perspectives and give at least three initial recommendations to achieve a more holistic and inclusive approach to cerebral organoid research on ASD. These three initial starting points can build bridges between researchers and the neurodiversity movement. First, neurodiverse individuals should be included as co-creators in both the scientific process and research communication. Second, clinicians and neurodiverse communities should have open and respectful communication. Finally, we suggest a continual reconceptualization of illness, impairment, disability, behavior, and person. (shrink)

Since its origin, bioethics has attracted the collaboration of few social scientists, and social scientific methods of gathering empirical data have remained unfamiliar to ethicists. Recently, however, the clouded relations between the empirical and normative perspectives on bioethics appear to be changing. Three reasons explain why there was no easy and consistent input of empirical evidence into bioethics. Firstly, interdisciplinary dialogue runs the risk of communication problems and divergent objectives. Secondly, the social sciences were absent partners since the beginning of (...) bioethics. Thirdly, the meta‐ethical distinction between ‘is’ and ‘ought’ created a ‘natural’ border between the disciplines. Now, bioethics tends to accommodate more empirical research. Three hypotheses explain this emergence. Firstly, dissatisfaction with a foundationalist interpretation of applied ethics created a stimulus to incorporate empirical research in bioethics. Secondly, clinical ethicists became engaged in empirical research due to their strong integration in the medical setting. Thirdly, the rise of the evidence‐based paradigm had an influence on the practice of bioethics. However, a problematic relationship cannot simply and easily evolve into a perfect interaction. A new and positive climate for empirical approaches has arisen, but the original difficulties have not disappeared. (shrink)

The field of bioethics is increasingly coming into contact with empirical research findings. In this article, we ask what role empirical research can play in the process of ethical clarification and decision-making. Ethical reflection almost always proceeds in three steps: the description of the moral question,the assessment of the moral question and the evaluation of the decision-making. Empirical research can contribute to each step of this process. In the description of the moral object, first of all, empirical research has a (...) role to play in the description of morally relevant facts. It plays a role in answering the “reality-revealing questions” (what, why,how, who, where and when), in assessing the consequences and in proposing alternative courses of action. Secondly, empirical research plays a role in assessing the moral question. It must be acknowledged that research possesses “the normative power of the factual,” which can also become normative by suppressing other norms. However, inductive normativity should always be balanced out by a deductive form of normativity. Thirdly, empirical research also has a role to play in evaluating the decision-making process. It can rule out certain moral choices by pointing out the occurrence of certain unexpected consequences or effects. It can also be useful, however, as a sociology of bioethics in which the discipline of bioethics itself becomes an object of research. (shrink)

BackgroundExisting research on perceptions of plagiarism and cultural influences mainly focuses on comparisons between the Western World and the Eastern World. However, possible differences within the Western World have hardly been assessed, especially among biomedical academics. The authors compared perceptions of plagiarism among European biomedical researchers who participated in an online survey.MethodsThe present work is based on the data collected in a previous online survey done in 2018 among biomedical researchers working in leading European and Chinese universities. Respondents based in (...) Europe were grouped into three geographical regions and their responses were analyzed using logistic regression analysis with adjustments for demographic factors.ResultsData were available from 810 respondents. In addition to their generally similar responses, different perceptions of plagiarism were observed among respondents in the three European regions. In summary, among the three European regions, Nordic respondents identified the most types of practices as plagiarism. Compared to the southern respondents, Nordic and northwestern respondents were more likely to consider less evident practices as plagiarism, such as Rephrasing another person’s work without crediting the source [aORN|S 1.99, aORS|NW 0.50 ] and With permission from the original author, using another’s text without crediting the source [aORN|S 3.16, aORS|NW 0.26 ]. In contrast, the southern respondents were the most inclined to recognize recycling of one’s previously rejected research proposal as plagiarism.ConclusionsIn spite of a generally similar response pattern, the present study indicates different perceptions of plagiarism among European biomedical researchers. These intra-European differences should be considered when addressing plagiarism. (shrink)

BackgroundPrevention of mother to child transmission of HIV remains a key public health priority in most developing countries. The provider Initiated Opt – Out Prenatal HIV Screening Approach, recommended by the World Health Organization lately has been adopted and translated into policy in most Sub – Saharan African countries. To better ascertain the ethical reasons for or against the use of this approach, we carried out a literature review of the ethics literature.MethodsPapers published in English and French Languages between 1990 (...) and 2015 from the following data bases were searched: Pubmed, Cochrane literature, Embase, Cinhal, Web of Science and Google Scholar. After screening from 302 identified relevant articles, 21 articles were retained for the critical review.DiscussionMost authors considered this approach ethically justifiable due to its potential benefits to the mother, foetus and society. The breaching of respect for autonomy was considered acceptable on the grounds of libertarian paternalism. Most authors considered the Opt - Out approach to be less stigmatizing than the Opt - In. The main arguments against the Opt - Out approach were: non respect of patient autonomy, informed consent becoming a meaningless concept and the HIV test becoming compulsory, risk of losing trust in health care providers, neglect of social and psychological implications of doing an HIV test, risk of aggravation of stigma if all tested patients are not properly cared for and neglect of sociocultural peculiarities.ConclusionsThe Opt – Out approach could be counterproductive in case gender sensitive issues within the various sociocultural representations are neglected, and actions to offer holistic care to all women who shall potentially test positive for HIV were not effectively ascertained. The Provider Initiated Opt – Out Prenatal HIV Screening option remains ethically acceptable, but deserves caution, active monitoring and evaluation within the translation of this approach into to practice. (shrink)

Ethical deliberations are unfolding for potentially controversial organoid‐entities such as brain organoids and embryoids. Much of the ethical deliberation centers on the questionable moral status of such organoid‐entities. However, while such work is important and appropriate, ethical deliberations may become too exclusively rooted in moral status and potentially overshadow other relevant moral dilemmas. The ethical discussion on organoid models can benefit from insights brought forth by both Judith Jarvis Thomson and Don Marquis in how they attempted to advance the abortion (...) debate. To discuss other abortion ethical issues more fully, both Thomson and Marquis assumed differing moral status positions of the conceptus and followed lines of reasoning based on these moral status assumptions. We suggest a similar approach with controversial organoid‐entities like brain organoids and embryoids. To avoid overshadowing or overlooking other relevant ethical issues, ethicists ought to first assume an organoid‐entity moral status position (such as a high moral status or no moral status) and explore any possible arguments that may result from such a position. While we ought not to copy the content of Thomson and Marquis' arguments exactly for organoid‐entities, it is worthwhile to translate their arguments' overarching structures. This paper explores the relevant insights of Thomson and Marquis, how they can be translated into the organoid ethics debate, and what possible lines of inquiry may be worth exploring based on particular moral status assumptions. (shrink)

While the debate on values in science focuses on normative questions on the level of the individual (e.g. should researchers try to make their work as value free as possible?), comparatively little attention has been paid to the institutional and professional norms that researchers are expected to follow. To address this knowledge gap, we conduct a content analysis of leading national codes of conduct for research integrity of European countries, and structure our analysis around the question: do these documents allow (...) for researchers to be influenced by “non-epistemic” (moral, cultural, commercial, political, etc.) values or do they prohibit such influence in compliance with the value-free ideal (VFI) of science? Our results return a complex picture. On the one hand, codes of conduct consider many non-epistemic values to be a legitimate influence on the decision-making of researchers. On the other, most of these documents include what we call _VFI-like positions_: passages claiming that researchers should be free and independent from any external influence. This shows that while many research integrity documents do not fully endorse the VFI, they do not reject it and continue to be implicitly influenced by it. This results in internal tensions and underdetermined guidance on non-epistemic values that may limit some of the uses of research integrity codes, especially for purposes of ethical self-regulation. While codes of conduct cannot be expected to decide how researchers should act in every instance, we do suggest that they acknowledge the challenges of how to integrate non-epistemic values in research in a more explicit fashion. (shrink)

Scientific malpractice is not just due to researchers having bad intentions, but also due to a lack of education concerning research integrity practices. Besides the importance of institutionalised trainings on research integrity, research supervisors play an important role in translating what doctoral students learn during research integrity formal sessions. Supervision practices and role modelling influence directly and indirectly supervisees’ attitudes and behaviour toward responsible research. Research supervisors can not be left alone in this effort. Research institutions are responsible for supporting (...) supervisors in being more aware of their RI function, and in supporting responsible supervision practices to have a positive cascading effect on supervisees’ research practices. We interviewed 22 European research supervisors to investigate how they perceive their role as research integrity trainers and their real-life supervision practices. Moreover, we investigated their points of view concerning the role of research institutions in supporting supervision practices. Although there are different commonalities in supervisors’ perception of their research integrity-related role, differences are emphasised depending on the supervisors’ characteristics such as academic domain, seniority, working country and gender. In addition, supervisors’ way of mentoring depend also on supervisees’ learning curve. Overall, all supervisors agreed on institutions playing an important role in support their supervision effort and practices. This study aims to be a starting point for better understanding research integrity supervision practices and the role of institutions in supporting them. Moreover, it puts the basis to further investigate differences in supervision practices depending on supervisors’ characteristics. (shrink)

Cerebral organoid models in-of-themselves are considered as an alternative to research animal models. But their developmental and biological limitations currently inhibit the probability that organoids can fully replace animal models. Furthermore, these organoid limitations have, somewhat ironically, brought researchers back to the animal model via xenotransplantation, thus creating hybrids and chimeras. In addition to attempting to study and overcome cerebral organoid limitations, transplanting cerebral organoids into animal models brings an opportunity to observe behavioral changes in the animal itself. Traditional animal (...) ethics frameworks, such as the well-known three Rs (reduce, refine, and replace), have previously addressed chimeras and xenotransplantation of tissue. But these frameworks have yet to completely assess the neural-chimeric possibilities. And while the three Rs framework was a historical landmark in animal ethics, there are identifiable gaps in the framework that require attention. The authors propose to utilize an expanded three Rs framework initially developed by David DeGrazia and Tom L. Beauchamp, known as the Six Principles (6Ps). This framework aims to expand upon the three Rs, fill in the gaps, and be a practical means for assessing animal ethical issues like that of neural-chimeras and cerebral organoid xenotransplantation. The scope of this 6Ps application will focus on two separate but recent studies, which were published in 2019 and 2020. First, they consider a study wherein cerebral organoids were grown from donors with Down syndrome and from neurotypical donors. After these organoids were grown and studied, they were then surgically implanted into mouse models to observe the physiological effects and any behavioral change in the chimera. Second, they consider a separate study wherein neurotypical human embryonic stem cell-derived cerebral organoids were grown and transplanted into mouse and macaque models. The aim was to observe if such a transplantation method would contribute to therapies for brain injury or stroke. The authors place both studies under the lens of the 6Ps framework, assess the relevant contexts of each case, and provide relevant normative conclusions. In this way, they demonstrate how the 6Ps could be applied in future cases of neural-chimeras and cerebral organoid xenotransplantation. (shrink)

The field of bioethics is increasingly coming into contact with empirical research findings. In this article, we ask what role empirical research can play in the process of ethical clarification and decision-making. Ethical reflection almost always proceeds in three steps: the description of the moral question,the assessment of the moral question and the evaluation of the decision-making. Empirical research can contribute to each step of this process. In the description of the moral object, first of all, empirical research has a (...) role to play in the description of morally relevant facts. It plays a role in answering the “reality-revealing questions” (what, why,how, who, where and when), in assessing the consequences and in proposing alternative courses of action. Secondly, empirical research plays a role in assessing the moral question. It must be acknowledged that research possesses “the normative power of the factual,” which can also become normative by suppressing other norms. However, inductive normativity should always be balanced out by a deductive form of normativity. Thirdly, empirical research also has a role to play in evaluating the decision-making process. It can rule out certain moral choices by pointing out the occurrence of certain unexpected consequences or effects. It can also be useful, however, as a sociology of bioethics in which the discipline of bioethics itself becomes an object of research. (shrink)

Despite the ever increasing collaboration between industry and universities, the previous empirical studies on research integrity and misconduct excluded participants of biomedical industry. Hence, there is a lack of empirical data on how research managers and biomedical researchers active in industry perceive the issues of research integrity and misconduct, and whether or not their perspectives differ from those of researchers and research managers active in universities. If various standards concerning research integrity and misconduct are upheld between industry and universities, this (...) might undermine research collaborations. Therefore we performed a qualitative study by conducting 22 semi-structured interviews in order to investigate and compare the perspectives and attitudes concerning the issues of research integrity and misconduct of research managers and biomedical researchers active in industry and universities. Our study showed clear discrepancies between both groups. Diverse strategies in order to manage research misconduct and to stimulate research integrity were observed. Different definitions of research misconduct were given, indicating that similar actions are judged heterogeneously. There were also differences at an individual level, whether the interviewees were active in industry or universities. Overall, the management of research integrity proves to be a difficult exercise, due to many diverse perspectives on several essential elements connected to research integrity and misconduct. A management policy that is not in line with the vision of the biomedical researchers and research managers is at risk of being inefficient. (shrink)

-/- It is commonly believed that the etiology of autism is at least partly explained through genetics. Given the complexity of autism and the variability of the autistic phenotype, genetic research and counseling in this field are also complex and associated with specific ethical questions. Although the ethics of autism genetics, especially with regard to reproductive choices, has been widely discussed on the public fora, an in depth philosophical or bioethical reflection on all aspects of the theme seems to be (...) missing. With this literature review we wanted to map the basic questions and answers that exist in the bioethical literature on autism genetics, research, counseling and reproduction, and provide suggestions as to how the discussion can proceed. We found 19 papers that fitted the description of “bioethics literature focusing on autism genetics,” and analyzed their content to distill arguments and themes. We concluded that because of the complexity of autism, and the uncertainty with regard to its status, more ethical reflection is needed before definite conclusions and recommendations can be drawn. Moreover, there is a dearth of bioethical empirical studies querying the opinions of all parties, including people with autism themselves. Such empirical bioethical studies should be urgently done before bioethical conclusions regarding the aims and desirability of research into autism genes can be done. Also, fundamental philosophical reflection on concepts of disease should accompany research into the etiology of autism. © 2016 Wiley Periodicals, Inc. (shrink)

Aim This study is a systematic review that aims to assess how healthcare professionals manage ethical challenges regarding information within the clinical context.Method and Materials We carried out searches in PubMed, Google Scholar and Embase, using two search strings; searches generated 665 hits. After screening, 47 articles relevant to the study aim were selected for review. Seven articles were identified through snowballing, and 18 others were included following a system update in PubMed, bringing the total number of articles reviewed to (...) 72. We used a Q-sort technique for the analysis of identified articles.Findings This study reveals that healthcare professionals around the world generally employ (to varying degrees) four broad strategies to manage different types of challenges regarding information, which can be categorized as challenges related to confidentiality, communication, professional duty, and decision-making. The strategies employed for managing these challenges include resolution, consultation, stalling, and disclosure/concealment.Conclusion There are a variety of strategies which health professionals can adopt to address challenges regarding information management within the clinical context. This insight complements current efforts aimed at enhancing health professional-patient communication. Very few studies have researched the results of employing these various strategies. Future empirical studies are required to address this. (shrink)

ABSTRACT Publications are primarily a means of communicating scientific information to colleagues, but they are much more than that. Publications in peer reviewed journals are proof of academic competence, are used as a crucial component in evaluation criteria for academic promotion and fundraising and increase the prestige of research centres and universities. The urgent need for publications has also led to abuses in authorship. In the past the single‐author article was the rule, but over the past decades, the average number (...) of authors on scientific manuscripts has drastically increased. In the field of bioethics, however, no research has been undertaken to study whether the percentage of single‐author articles is decreasing, the proportion of multi‐author articles is increasing or the average number of authors per article is increasing. The objective of this research is to analyze these trends in authorship for the period 1990–2003 in peer reviewed journals in the field of bioethics. In the nine peer reviewed journals from the field of bioethics we studied, we observed a significant increase of the multi‐author article and of the average number of authors. This is mainly due to the increase in the number of publications with an empirical design. This growing trend is a challenge for the editors of journals in the field of bioethics to enhance awareness about the value and definition of authorship. (shrink)

Max Weber's century old thesis on christian ethics and the spirit of capitalism, has been the object of an endless discussion. This has much to do with the interest of the author: Weber was neither intrigued by the fact of a connection between protestantism and capitalism, nor by the influence of Calvinism on the development of the modern capitalism. His interest, however, was exclusively focused on the question 'how can the relation between protestant ethic and capitalism be conceived and reconstructed'. (...) We try to explain many misconceptions by recovering what Weber really has said. Therefore the concepts of 'spirit of capitalism' and 'protestant ethic' are clarified and discussed. First, the spirit of capitalism is not an economic system, but an ethos. The definition of it in respect with the content, the motivation, the aim, and morality is elaborated in a comparison with the commercial ethos of the Middle Ages and the Renaissance. This makes clear that Weber's first concern was an analysis of the origin of the modern spirit, not as an intellectual construction, but as an expression of behavior. Second, we investigate what is meant by the terms 'protestantism' and 'ethics' and what the religious roots of the new spirit are: innerworldly ascetism, the notion of calling, and the concepts of wealth and poverty. It is no wonder that there was a lot of criticism because Weber's writings on the above topic were situated on the crossroads of sociology, theology, history and economy. We present and comment on the main criticisms: protestantism rejects capitalism; the spirit of capitalism is much older than the Reformation; there is no monocausal relation between the protestant ethic and the spirit of capitalism; the role of catholicism in this development was as/more important in the rise of capitalism. Most of these criticisms result from a superficial presentation of Weber's writings and explanations in his own Anticritics, and don't do justice to Weber's 'idealtypische' and 'verstehende' approach. This approach was not intended to give a complete and exhaustive 'last' explanation of the essence of a social phenomenon. (shrink)

In classical speculation on medical matters health is conceived of as a bodily statewhich is in accordance with Nature. It is a state of natural balance in the mixture (complexio) of the primary qualities of the human body. Although few of the details in theancient natural philosophy and the Galenic philosophy of health have survived, it is important to note that two of the ancient ideas still influence the thoughts: the idea ofa balance between opposing elements or forces, and, in (...) particular, the idea of a natural or normal state of the living organism. In the actual reflection there is a forceful attempt to formulate a conception of health and disease in terms of biological norms where the interpretation is unambiguous. According to this conception the biological norms are related to certain natural goals (e.g. survival). These goals are not attributed to the body for the outside, but belong to the internal constitution of the body. In this paper the author wants to present the essential tenets and main merits of such a theory, more precisely the bio-statistical theory of the American philosopher Christopher Boorse. In a second phase he points out a critical assessment of this perspective, mainly focussing on the claims of a value-free scientific approach and of neutrality. (shrink)

The participation of minors in clinical trials is essential to provide safe and effective medical care to children. Because few drugs have been tested in children, pediatricians are forced to prescribe medications off-label with uncertain efficacy and safety. In this article, we analyze how the enrollment of minors in clinical trials is negotiated within relationships of mutual trust between clinicians, minors, and their parents. After a brief description of the problems associated with involving minors in clinical research, we consider how (...) existing “relationships of trust” can be used as a place where the concerns of research subjects can be more fully discussed and addressed. Building on the tacit recognition of trust found in The European Clinical Trials Directive we make policy recommendations that allow for clearer, more ethically informed guidelines for enrolling minors in clinical research. (shrink)

In this article we first clarify the technological possibilities in an Age of Biological Control. Secondly we offer a short overview of some major international statements on reproductive cloning. Since a careful use of terminology will help public policy, we opt for a clarification of the means and purposes of human cloning in a third paragraph. Fourthly, we summarize the main arguments against human reproductive cloning from a bio-ethical point of view. The main objective is however the analysis of the (...) influence of two different theological interpretations of Imago Dei in the cloning debate: stewardship and created co-createdness. We evaluated the dynamic approach from a creational perspective to be the most apt for coping with new biotechnological developments. The authors conclude, however, that also this more dynamic theological approach leads to a radical rejection of reproductive cloning. (shrink)

In the past decade, policy-makers in science have been concerned with harmonizing research integrity standards across Europe. These standards are encapsulated in the European Code of Conduct for Research Integrity. Yet, almost every European country today has its own national-level code of conduct for research integrity. In this study we document in detail how national-level codes diverge on almost all aspects concerning research integrity – except for what constitutes egregious misconduct. Besides allowing for potentially unfair responses to joint misconduct by (...) international collaborations, we argue that the divergences raise questions about the envisaged self-regulatory function of the codes of conduct. (shrink)

Protecting confidentiality is an essential value in all human relationships, no less in medical practice and research.1 Doctor-patient and researcher-participant relationships are built on trust and on the understanding those patients' secrets will not be disclosed.2 However, this confidentiality can be breached in some situations where it is necessary to meet a strong conflicting duty.3Confidentiality, in a general sense, has received much interest in Islamic resources including the Qur'an, Sunnah and juristic writings. However, medical and research confidentiality have not been (...) explored deeply. There are few fatwas about the issue, despite an increased effort by both individuals and Islamic medical organizations to use these institutional fatwas in their research.Infringements on confidentiality make up a significant portion of institutional fatwas, yet they have never been thoroughly investigated. Moreover, the efforts of organizations and authors in this regard still require further exploration, especially on the issue of research confidentiality.In this article, we explore medical and research confidentiality and potential conflicts with this practice as a result of fatwas released by international, regional, and national Islamic Sunni juristic councils. We discuss how these fatwas affect research and publication by Muslim doctors, researchers, and Islamic medical organizations.We argue that more specialized fatwas are needed to clarify Islamic juristic views about medical and research confidentiality, especially the circumstances in which infringements on this confidentiality are justified. (shrink)

Detection of Alzheimer’s disease in an early stage is receiving increasing attention for a number of reasons, such as the failure of drug trials in more advanced disease stages, the demographic evolution, the financial impact of AD, and the approval of amyloid tracers for clinical use. Five focus group interviews with stakeholders were conducted.. The verbatim transcripts were analysed via the Nvivo 11 software. Most stakeholder groups wanted to know their own amyloid PET scan result. However, differences occurred between FGs: (...) two groups wanted to know, whilst in the three other groups FG members opted not to know or were still in doubt about their decision. Stakeholders provided insight into their reasons for wanting to know their amyloid PET scan result, for not wanting to know their result, or why they were in doubt about their decision. Several advantages and disadvantages were mentioned as part of knowing their amyloid PET scan result. Certain considerations were clustered in a grey zone, in between advantage and disadvantage, such as the emotional consequences. Clinicians, researchers, and policymakers ought to be aware of the diversity of reasons for wanting to know their result and how possible benefits and risks can be viewed differently. The current findings are of importance for future early diagnosis and disclosure of results in the research setting. (shrink)

Ex-vivo tissue engineering is a quickly developing medical technology aiming to regenerate tissue through the introduction of an ex-vivo created tissue construct instead of restoring the damaged tissue to some level of functionality. Tissue engineering is considered by some as a new medical paradigm. We analyse this claim and identify tissue engineering’s fundamental characteristics, focusing on the aim of the intervention and on the complexity and continuity of the process. We inquire how these features have an impact not only on (...) the scientific research itself but also on the ethical evaluation of this research. We suggest that viewing tissue engineering as a new medical paradigm allows us to develop a wider perspective for successful investigation instead of focusing on isolated steps of the tissue engineering process in an anecdotal way, which may lead to an inadequate ethical evaluation. We argue that the concept of tissue engineering as a paradigm may benefit the way we address the ethical challenges presented by tissue engineering. (shrink)

The concept of benefit sharing pertains to the act of giving something in return to the participants, communities, and the country that have participated in global health research or bioprospecting activities. One of the key concerns of benefit sharing is the ethical justifications or reasons to support the practice of the concept in global health research and bioprospecting. This article evaluates one of such ethical justifications and its meaning to benefit sharing, namely justice. We conducted a systematic review to map (...) the various principles of justice that are linked to benefit sharing and analysed their meaning to the concept of benefit sharing. Five principles of justice have been shown to be relevant in the nuances of benefit sharing in both global health research and bioprospecting. The review findings indicate that each of these principles of justice provides a different perspective for a different benefit sharing rationale. For example, commutative justice provides a benefit sharing rationale that is focused on fair exchange of benefits between research sponsors and communities. Distributive justice produces a benefit sharing rationale that is focused on improving the health needs of the vulnerable research communities. We have suggested that a good benefit sharing framework particularly in global health research would be more beneficial if it combines all the principles of justice in its formulation. Nonetheless, there is a need for empirical studies to examine the various principles of justice and their nuances in benefit sharing among stakeholders in global health research. (shrink)

Universities and other research institutions are increasingly providing additional training in research integrity to improve the quality and reliability of research. Various training courses have been developed, with diverse learning goals and content. Despite the importance of training that focuses on moral character and professional virtues, there remains a lack of training that adopts a virtue ethics approach. To address this, we, a European Commission-funded consortium, have designed a train-the-trainer programme for research integrity. The programme is based on (1) virtue (...) ethics, (2) the ethos of science, (3) learning by doing and (4) learner-centred teaching. The blended learning programme combines e-learning modules with participatory group sessions. Trainers are taught how to guide researchers through a series of structured exercises for fostering reflection on scientific virtues, and how to promote understanding and application of the European Code of Conduct for Research Integrity. Trainers are provided with adaptable tools and resources that can be used and combined in different ways. The programme implementation began in Spring 2020 and 470 trainers have participated to date. When trainers were asked to grade – between 0 (very bad) and 10 (excellent) – the e-learning modules and the participatory exercises, 60% scored a grade 8 or higher (median = 8, IQR = 2) for the e-learning modules, whereas 80% scored a grade 8 or higher (median = 9, IQR = 1) for the participatory exercises. A majority felt that the training helped them as a trainer to learn about ways to organise and teach a research integrity course (82%) and would recommend the interactive exercises to others (92%). Trainers have educated over 3300 researchers in Europe using our virtue-based approach. The VIRT2UE train-the-trainer programme fosters research integrity by providing trainers with exercises and tools which enable them to stimulate the development of good researchers across Europe. (shrink)