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)

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)

Background Research ethics guidelines are essential for conducting medical research. Recently, numerous attempts have been made to establish national clinical research documents in the countries of the Middle East. This article analyzes these documents. Methods Thirteen Arab countries in the Middle East were explored for available national codes, regulations, and guidelines concerning research ethics, and 10 documents from eight countries were found. We studied these documents, considering the ethical principles stated in the Declaration of Helsinki, the Council for International Organizations (...) of Medical Sciences (CIOMS) guidelines, and the International Conference of Harmonization - Guidelines for Good Clinical Practice (ICH-GCP). Our paper comprises a complete list of protections, such as confidentiality, informed consent, ethics committees, and others. Results This study found different levels and kinds of research ethics regulations and guidelines in the countries examined. Two groups can be distinguished: the countries in the first group have one or more research ethics regulations or guidelines, while the countries in the second group have not yet established any. Most of the documents showed various degrees of deficiencies in regard to ethical protection. The majority of the documents that were examined refer to one or more international documents on biomedical research ethics. Conclusions Recently, a lot of efforts have been made in many countries in the Middle East. However, compared with international documents, most of the research ethics documents in use in this region demonstrate numerous deficiencies. As it relates to these documents, extensive differences could be observed in regard to development, structure, content, and reference to international guidelines. (shrink)

Little is known about research misconduct within industry and how it compares to universities, even though a lot of biomedical research is performed by–or in collaboration with–commercial entities. Therefore, we sent an e-mail invitation to participate in an anonymous computer-based survey to all university researchers having received a biomedical research grant or scholarship from one of the two national academic research funders of Belgium between 2010 and 2014, and to researchers working in large biomedical companies or spin-offs in Belgium. The (...) validated survey included questions about various types of research misconduct committed by respondents themselves and observed among their colleagues in the last three years. Prevalences of misconduct were compared between university and industry respondents using binary logistic regression models, with adjustments for relevant personal characteristics, and with significance being accepted for p < 0.01. The survey was sent to 1766 people within universities and an estimated 255 people from industry. Response rates were 43 and 48%, and usable information was available for 617 and 100 respondents, respectively. In general, research misconduct was less likely to be reported by industry respondents compared to university respondents. Significant differences were apparent for one admitted action and three observed actions, always with lower prevalences for industry compared to universities, except for plagiarism. This survey, based on anonymous self-report, shows that research misconduct occurs to a substantial degree among biomedical researchers from both industry and universities. (shrink)

The combination of the issue of return of individual genetic results/incidental findings and paediatric biobanks is not much discussed in ethical literature. The traditional arguments pro and con return of such findings focus on principles such as respect for persons, autonomy and solidarity. Two dimensions have been distilled from the discussion on return of individual results in a genetic research context: the respect for a participant’s autonomy and the duty of the researcher. Concepts such as autonomy and solidarity do not (...) fit easily in the discussion when paediatric biobanks are concerned. Although parents may be allowed to enrol children in minimal risk genetic research on stored tissue samples, they should not be given the option to opt out of receiving important health information. Also, children have a right to an open future: parents do not have the right to access any genetic data that a biobank holds on their children. In this respect, the guidelines on genetic testing of minors are applicable. With regard to the duty of the researcher the question of whether researchers have a more stringent duty to return important health information when their research subjects are children is more difficult to answer. A researcher’s primary duty is to perform useful research, a policy to return individual results must not hamper this task. The fact that vulnerable children are concerned, is an additional factor that should be considered when a policy of returning results is laid down for a specific collection or research project. (shrink)

The concept of benefit sharing has been a topical issue on the international stage for more than two decades, gaining prominence in international law, research ethics and political philosophy. In spite of this prominence, the concept of benefit sharing is not devoid of controversies related to its definition and justification. This article examines the discourses and justifications of benefit sharing concept.

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”, 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)

BackgroundResearchers currently are not obligated to share individual research results with participants. This non-disclosure policy has been challenged on the basis of participants’ rights to be aware and in control of their personal medical information. Here, we determined how patients view disclosure of research PET results of brain amyloid and why they believe it is advantageous or disadvantageous to disclose.MethodAs a part of a larger diagnostic trial, we conducted semi-structured interviews with patients with amnestic Mild Cognitive Impairment. Participants had the (...) option to receive their brain amyloid PET scan result. Interviews were conducted before they received their IRR.ResultsA total of 38 aMCI patients wanted to know their IRR. The two most frequently mentioned reasons for choosing IRR disclosure were to better understand their brain health status and to be better able to make informed decisions about future personal arrangements. Emotional risk was mentioned as the primary disadvantage of knowing one’s IRR. On the other hand, non-disclosure was considered to be emotionally difficult also, as patients would be uncertain about their future health condition.ConclusionsMany patients diagnosed clinically with aMCI want to know their brain amyloid test results, even though this knowledge may be disadvantageous to them. Knowing what is going on with their health and the ability to make informed decisions about their future were the two principal advantages mentioned for obtaining their amyloid PET results. Because of the overwhelming consensus of aMCI patients was to disclose their brain amyloid PET scan results, researchers should strongly consider releasing this information to research subjects. (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)

Human dignity has long been used as a foundational principle in policy documents and ethical guidelines intended to govern various forms of biomedical research. Despite the vast amount of literature concerning human dignity and embryonic tissues, the majority of biomedical research uses non-embryonic human tissue. Therefore, this contribution addresses a notable lacuna in the literature: the relationship, if any, between human dignity and human tissue. This paper first elaborates a multidimensional understanding of human dignity that overcomes many of the shortcomings (...) associated with the use of human dignity in other ethical debates. Second, it discusses the relationship between such an understanding of human dignity and ‘non-embryonic’ human tissue. Finally, it considers the implications of this relationship for biomedical research and practice involving human tissue. The contribution demonstrates that while human tissue cannot be said to have human dignity, human dignity is nevertheless implicated by human tissue, making what is done with human tissue and how it is done worthy of moral consideration. (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 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)

Background: Today, many healthcare or dementia organizations, clinicians, and companies emphasize the importance of detection of Alzheimer’s disease in an early phase. This idea has gained considerable momentum due to the development of biomarkers, the recent FDA and EMA approval of three amyloid tracers, and the failure of a number of recent therapeutic trials conducted in the early dementia phase. On the one hand, an early etiological diagnosis can lead to early and more efficacious intervention. On the other hand, it (...) is questioned how early an etiological diagnosis is beneficial to the patient. Here we consider ethical issues related to the process of biomarker testing and the impact on the diagnostic disclosure to patients with mild cognitive impairment due to prodromal Alzheimer’s disease. Methods: A systematic review of the theoretical bioethics literature was performed by using electronic databases. The review was limited to articles published in English between 2003 and 2016. Results: A total of twenty articles were included in our effort to make an analysis of the ethical challenges. One of the biggest challenges was the uncertainty and the predictive value of the biomarker-based diagnosis where patients can be amyloid positive without full certainty whether or when they will develop symptomatic decline due to Alzheimer’s disease. Another challenge was the tension between the right to know versus the wish not to know, the limited efficacy of currently available treatment options, and the opportunities and consequences after receiving such an early diagnosis. Conclusion: Based on the results and the additional comments in the discussion, several unanswered questions emerged. Therefore, careful consideration of all these ethical issues is required before the disclosure of a biomarker-based diagnosis to the patient with mild cognitive impairment due to Alzheimer’s disease. (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)

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)

Since the mid-1990s most EU Member States have established a national forensic DNA database. These mass repositories of DNA profiles enable the police to identify DNA stains which are found at crime scenes and are invaluable in criminal investigation. Governments have always brushed aside privacy objections by stressing that the stored DNA profiles do not contain sensitive genetic information on the included individuals and that they reside under the statutory privacy protection regulations. However, it has been generally overlooked that the (...) police also store the DNA samples from which the DNA profiles are derived. Although these DNA samples are actually a potential source of genetic information, they have so far scarcely been the subject of discussion. In this article we will show that both European and national regulations offer inadequate protection to completely prevent function creep, that is, the use of these forensic DNA samples for purposes beyond those envisaged at the time of collection. (shrink)

Ex-vivo tissue engineering is an emerging medical technology. Its aim is to regenerate tissues and organs and to restore them to full physiological activity. Some clinical trials with human tissue engineered products have been conducted and others will follow. These trials not only have to confirm the therapeutic value of the HTEP, they also have to provide insight in its regenerative activity, its safety and long-term effects. The development of these trials is aggravated by the complexity of the tissue engineering (...) process and product. This paper investigates how this complexity influences the ethical conduct of clinical trials with HTEPs. We focus on the value and validity of the trial, the risk-benefit ratio and the protection of the trial participant. We argue that trials with HTEPs need a robust methodology. The risk-benefit ratio of a new HTEP must be determined and compared with available efficacious therapies. This requires the identification and minimisation of risks associated with tissue engineering. Finally a process as complex as tissue engineering presents serious challenges for the informed consent process, and for the protection of the trial participant during and after the trial. (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)

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)

CITATION: Ewuoso, C., Hall, S. & Dierickx, K. 2017. How do healthcare professionals manage ethical challenges regarding information in healthcare professional/patient clinical interactions? a review of concept- or argument-based articles and case analyses. South African Journal of Bioethics and Law, 10:75-82, doi:10.7196/SAJBL.2017.v10i2.610.

Purpose: A study was made of attitudes of clinical geneticists regarding the age at which minors should be allowed to undergo a carrier test and the reasons they provide to explain their answer. Methods: European clinical institutions where genetic counselling is offered to patients were contacted. 177 (63%) of the 287 eligible respondents answered a questionnaire. Results: Clinical geneticists were significantly more in favour of providing a carrier test to a younger person if the request was made together with the (...) parents than if the adolescent requested the test personally. Although a large fraction of respondents (16%–30%) were “neither unwilling nor willing” to provide a carrier test to a 16-year-old adolescent who requested the test personally, for most disorders slightly more clinical geneticists were “very willing” or “willing”. Conclusion: Age is not the only decisive element when considering the participation of adolescents in decisions affecting their health. The clinical geneticists referred to cognitive, emotional and sexual maturity and the support of parents as crucial elements in their comments regarding when to tell children about their genetic risk or to allow adolescents to request a carrier test. (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)

In this brief report, the authors argue that while a lot of concerns about forensic DNA databases have been raised using arguments from biomedical ethics, these databases are used in a complete different context from other biomedical tools. Because they are used in the struggle against crime, the decision to create or store a genetic profile cannot be left to the individual. Instead, this decision is made by officials of a society. These decisions have to be based on a policy (...) that is the concretisation of some of society's most fundamental ideas about its own nature and function. Individuals wanting to influence these decisions have to try to influence this policy, within the bounds of a state's own self-concept. This article is an attempt to reorient the discussion about forensic DNA databases from a biomedical debate to a more political–philosophical one. (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)

While ethical and empirical interest in so-called secondary variants and incidental findings in clinical genetics contexts is growing, critical reflection on the ethical foundations of the various recommendations proposed is thus far largely lacking. We examine and critique the ethical justifications of the three most prominent disclosure positions: briefly, the clinical geneticist decides, a joint decision, and the patient decides. Subsequently, instead of immediately developing a new disclosure option, we explore relevant foundational ethical values and norms, drawing on the normative (...) and empirical ethical literature. Four ethical signposts are thereby developed to help guide disclosure discussions. These are: respectful sharing of the clinician’s expertise; transparent communication; epistemic modesty; and respect for the embedded nature of the patient. We conclude by considering the most common current disclosure positions in the light of the four ethical signposts. (shrink)

For a significant number of patients, there exists no, or only little, interest in developing a treatment for their disease or condition. Especially with regard to rare diseases, the lack of commercial interest in drug development is a burning issue. Several interventions have been made in the regulatory field in order to address the commercial disinterest in these conditions. However, existing regulations mainly focus on the provision of incentives to the sponsors of clinical trials of orphan drugs, and leave unanswered (...) the overarching question about the rightful place of orphan drugs in resource allocation systems. In this article, we analyse the ethical aspects of funding research and development in the field of rare diseases. We then propose an ethical framework that can help health policy makers move forward in the difficult matter of fairly allocating resources for the prevention, diagnosis and treatment of rare diseases. (shrink)

Biobanking policy needs to take into account the concept of human dignity, because this concept is enshrined in both international and South African law. The accepted understanding of informed consent, which is also required by law, is inadequate for biobanking because it is often not possible to inform people of possible uses of their stored tissue. If human dignity is understood as a multidimensional concept that corresponds to the multidimensionality of the human person, then human dignity can be said to (...) be both (i) something that all people already have, as an inviolable worth that inheres in their potential to live meaningful lives; and (ii) something that people seek to realize through morally good behavior in historically-situated relationships. This understanding of human dignity can be used as both an interpretive lens and a normative vision. It is interpretive because it reveals how various attitudes to biobanking and the various proposed consent regimes--presumed, broad, and specific--might all be underpinned by appeals to human dignity. It is a normative vision because, given that all of these positions can be underpinned as morally meaningful with respect to human dignity, provision should be made for all of the possible consent regimes in law and in biobanking practice. Nonetheless, where compromise cannot be avoided, then, at the very least, human dignity understood as the human potential to live a meaningful moral life must be protected. (shrink)

This article presents an overview ofregulations, guidelines and societal debates ineight member states of the EC about a)embryonic and fetal tissue transplantation(EFTT), and b) the use of human embryonic stemcells (hES cells) for research into celltherapy, including `therapeutic' cloning. Thereappears to be a broad acceptance of EFTT inthese countries. In most countries guidance hasbeen developed. There is a `strong' consensusabout some of the central conditions for `goodclinical practice' regarding EFTT.International differences concern, amongstothers, some of the informed consent issuesinvolved, and the (...) questions whether anintermediary organisation is necessary, whetherthe methods of abortion may be influenced bythe possible use of EFT, and whether EFTTshould only be used for the experimentaltreatment of rare disorders. The potential useof hES cells for research into cell therapy hasgiven a new impetus to the debate about (human)embryo research. The therapeutic prospects withregard to the retrieval and research use of hEScells appear to function as a catalyst for theintroduction of less restrictive regulationsconcerning research with spare embryos, atleast in some European countries. It remains tobe seen whether the prospect of treatingpatients suffering from serious disorders withtransplants produced by therapeutic cloningwill decrease the societal and moral resistanceto allowing the generation of embryos for`instrumental' use. (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)

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...

BackgroundResearch with cerebral organoids is beginning to make significant progress in understanding the etiology of autism spectrum disorder. 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)

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)