Diese Abhandlung untersucht die Frage, ob internationale Richtlinien für die Gentechnologie, insbesondere im Hinblick auf "genetische Verbesserungen" , wünschenswert und machbar erscheinen. Es wird die Auffassung vertreten, daß die Forderung nach solchen internationalen Richtlinien sich unüberwindlichen praktischen Hindernissen gegenübersieht. Den Hintergrund für diese Auffassung bilden die Ambivalenz des Richtlinienkonzepts, das Fehlen einer Autorität, die solche Richtlinien in Kraft setzen könnte, mangelnder Konsens über zentrale Normen oder Werte, die in die Richtlinien einbezogen werden könnten, der Widerstand sowohl von Seiten der Wissenschaft (...) als auch der privaten Wirtschaft gegen solche Richtlinien und schließlich die öffentliche Forderung nach der Einführung von Methoden "genetischer Verbesserung". Die Forschung über Methoden "genetischer Verbesserung" hat schon begonnen und wird sich ohne Zweifel fortsetzen. Es wird daher in diesem Beitrag vorgeschlagen, daß öffentliche Mittel zur Unterstützung der Forschung über "genetische Verbesserung" zur Verfügung gestellt werden, um sicher zu stellen, daß Forschung dieser Art angemessene vorhergehende Begutachtung und andauernde Überwachung erfährt. Öffentlichkeit, Vorausschau und Kritik können uns helfen, vom Mißbrauch des Menschen als Forschungsobjekt und rücksichtslosem Forscherdrang weg und hin zu akzeptablen Formen der "genetischen Verbesserung" zu kommen. This essay explores whether international guidelines in genetics, specifically regarding genetic enhancement, are desirable and feasible. It is argued that the quest for international guidelines faces insuperable practical obstacles. These include the ambiguity of the concept of guidelines, no authoritative body to issue guidelines, lack of consensus about substantive norms or values to be incorporated into guidelines, resistance from the scientific as well as the private business sector to guidelines, and public demand for genetic enhancement. Genetic enhancement research has already begun and will no doubt continue. It is proposed that public funding for genetic enhancement research be provided to ensure that such research receives adequate prior review and continual monitoring. Publicity, oversight, and critique can help steer us away from abuses of human research subjects and reckless science toward acceptable forms of genetic enhancement. (shrink)

Thirty-three physicians, bioethicists, and medical economists from ten different countries met at Lawrence University, Appleton, Wisconsin, to create The Appleton Consensus: International Guidelines for Decisions to Forego Medical Treatment. The guidelines deal with four specific decision-making circumstances: 1. Five guidelines were created for decisions involving competent patients or patients who have executed an advance directive before becoming incompetent, and those guidelines fell into three categories. 2. Thirteen guidelines were created for decisions involving patients who (...) were once competent, but are not now competent, who have not executed an advance directive. 3. Seven guidelines were created for decisions involving patients who are not now and never have been competent, for whom 'no substituted judgement' can be rendered. 4. Eleven guidelines were created for decisions involving the scarcity of medical resources, which exists in all communities. Five concepts were identified as being critical in the establishment of priorities, given the reality of scarce health resources (1). The term 'physician' is used in the American sense, synonymous with 'medical practitioner'. (shrink)

In an era of unrivalled sequencing, computation and networking capability, international sharing of genomic samples and data is becoming a modus operandi for modern medical research. Researchers are collaborating to establish large collections with global scale. Having never before set foot outside the cell, the molecules that shape us are being digitized and launched across the globe. Protecting individual privacy interests in this information is a central challenge of the genomic research era. This article reviews international privacy norms (...) governing human genomic biobanks and databases. It will not directly consider biobanks established for other health-related purposes, such as screening or therapy. A genomic biobank is “a hybrid infrastructure,” an organized collection of human biological material combined with associated health information: physical measurements, outcome data in medical records, and epidemiological information, as well as genomic data derived from the samples. (shrink)

Records the papers and commentaries, with an edited discussion, presented at an international consultation convened by the Council for International Organizations of Medical Sciences (CIOMS) to guide revision of the CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects. The Guidelines, first issued in 1982 and then revised in 1993, are being updated and expanded to address a number of new and especially challenging ethical issues. These include issues raised by international collaborative trials (...) of drugs in developing countries, especially expensive drugs, and the use of placebo controls in randomized clinical trials. Others arise from the complexity of research in human genetics, including stem-cell research, and in reproductive biology. Throughout, particular attention is given to the difficult questions that arose during the heated debate over trials in developing countries, of short-duration zidovudine (AZT) therapy to reduce perinatal transmission of HIV. The International Ethical Guidelines for Biomedical Research Involving Human Subjects set out a code of research ethics that is widely used by ethical review committees and other bodies responsible for reviewing and overseeing the ethical design of studies and conduct of research. The revision of the Guidelines is being coordinated by CIOMS, in collaboration with WHO. The consultation centered on seven specially commissioned papers, authored by international experts that explore some of the more difficult issues in depth. Each is followed by an invited commentary, often expressing opposing views, and a summary of the issues or conclusions that emerged during the subsequent debate. The first paper, on justice in international research, deals with the question of whether proposals for research to be conducted in a developing country should make provision for future access of the population involved to the interventions under investigation. Also considered are questions that arise when research uses populations in developing countries to investigate interventions that will be of exclusive benefit to the industrialized world. Case studies of recent drug trials and their research protocols are discussed to illustrate circumstances in which use of populations in developing countries is justified or constitutes exploitation. Ethical challenges of the randomized controlled trial are considered in the second paper, which includes a discussion on the equitable distribution of benefits and risks, the use of placebo for controls, and the obligation to ensure that the participation of controls does not compromise their medical care or endanger their health. A paper on informed consent in international health research considers how cultural factors influence communication and language in the informed-consent process and respect for privacy and confidentiality in the research. Subsequent papers address issues in genetics research and reproductive biology, including the moral status of fetuses and the use of embryos in research, and examine the contribution which international human rights instruments can make in the application of the general principles of ethics to research involving human subjects. The final paper gives an overview of capacity building and the role of communities in international biomedical research. (shrink)

ABSTRACTSuicide attempt rates are on the rise in predominantly Islamic Republic of Pakistan. However, there exists an indigenous academic apathy toward exploring media-suicide relationships. This study, using content analysis and interviews, examines the lack of compliance with international ethical guidelines for suicide reporting by Pakistani newspapers. In 553 reported suicide cases, 2,355 guideline violations were detected. The overall tone of suicide news stories remained overwhelmingly irresponsible, and analysis indicates that both Urdu and English language newspapers made similar violations. (...) Largely ignorant of international standards, Pakistani journalists report attempted suicide cases just like any other crime. This study suggests a prompt action on the part of appropriate bodies to amend relevant codes of ethics and eventually educate relevant journalist fraternities to report suicides in a socially responsible way. (shrink)

ZusammenfassungWährend die juristische und medizinethische Rechtfertigung des Verzichts auf Wiederbelebung in Deutschland akademisch hinreichend geklärt ist, zeigen sich doch erhebliche Unterschiede und zahlreiche Probleme bei der praktischen Umsetzung in der Klinik. Innerhalb des interdisziplinären Behandlungsteams gehören Kommunikationsdefizite und die Intransparenz der ethischen Entscheidungsprozesse zu den häufigsten Schwierigkeiten, die in der Medizinischen Klinik für Nephrologie und Hypertensiologie am Klinikum Nürnberg mit der Implementierung einer hausinternen Leitlinie, der Anordnung zum Verzicht auf Wiederbelebung, behoben werden sollten.Die Evaluationsstudie, die 118 VaW-Anordnungen bei 4718 Behandlungsfällen (...) im Zeitraum von November 2004 bis Juli 2005 einschloss, verfolgte einen dualen Forschungsansatz. Eine quantitative Dokumentationsanalyse aller VaW-Protokolle wurde mit der leitfadengestützten Befragung von 16 Ärzten und Pflegekräften kombiniert.Teambesprechungen waren in 62,4 %, Entscheidungsgründe in 74,6 % aller VaW-Protokolle dokumentiert. Die Interviews ergaben eine positive, aber berufsgruppendifferente Bewertung der Kommunikation, wobei die Pflegenden kritischer eingestellt waren als ihre medizinischen Kollegen. Die VaW-Dokumentation bewirkte nach Auffassung aller Befragten eine hohe Nachvollziehbarkeit und Transparenz. Die VaW-Anordnung wurde darüber hinaus als gut anwendbar und praxistauglich betrachtet. Nahezu alle Befragten sprachen sich für eine Beibehaltung des VaWVerfahrens in der Klinik aus.Die Implementierung der VaW-Anordnung als hausinterne Leitlinie und Dokumentationsstandard hat zu einer Förderung des interdisziplinären Dialogs und zu einer erheblichen Verbesserung der Transparenz der ethischen Entscheidungsprozesse im Rahmen des Verzichts auf Wiederbelebung geführt. Hilfreich und praxistauglich erfreut sich die VaW-Anordnung einer hohen Akzeptanz bei Pflegenden und Medizinern und wird seit drei Jahren in der Nephrologie am Klinikum Nürnberg konsequent angewendet. (shrink)

Die ethischen Aspekte der Verwendung von Placebos in klinischen Versuchsreihen wurden im letzten Jahrzehnt ausführlich und kontrovers diskutiert. Es fehlt dennoch eine gründliche vergleichende Analyse der verschiedenen internationalen Richtlinien, ihrer Terminologien und ihrer auf Placebo bezogenen Prinzipien. Das zentrale Problem ist die Rechtfertigung von Placebo bei einer nachgewiesen wirksamen Therapie. Alle aktuellen Versionen der untersuchten Richtlinien schlagen solche Rechtfertigungen vor, unterscheiden sich hierbei jedoch beträchtlich. Zunächst werden wir ein formales allgemeines Prinzip herausarbeiten. Dann werden wir drei verschiedene Kategorien von Kriterien (...) darstellen: das Schadensrisiko oder die Belastung, zwingende wissenschaftliche Gründe und die Erhältlichkeit einer nachgewiesen wirksamen Therapie. Die Analyse zeigt bedeutende normative Abweichungen und Widersprüche innerhalb und zwischen den einzelnen Richtlinien. Besonders frappierend ist es, dassmancheRichtlinien es erlauben, Versuchsteilnehmer dem Risiko eines schweren Schadens auszusetzen, während andere gerade dies untersagen. Abschließend versuchen wir zu zeigen, wie sich die normativen Unterschiede bei der Entscheidungsfindung von Forschern und Ethikkommissionen auswirken können. (shrink)

There is currently no international consensus around post-trial obligations toward research participants, community members, and host countries. This literature review investigates arguments and attitudes toward post-trial access. The literature review found that academic discussions focused on the rights of research participants, but offered few practical recommendations for addressing or improving current practices. Similarly, there are few regulations or legislation pertaining to post-trial access. If regulatory changes are necessary, we need to understand the current arguments, legislation, and attitudes towards post-trial (...) access and participants and community members. Given that clinical trials conducted in low-income countries will likely continue, there is an urgent need for consideration of post-trial benefits for participants, communities, and citizens of host countries. While this issue may not be as pressing in countries where participants have access to healthcare and medicines through public schemes, it is particularly important in regions where this may not be available. (shrink)

The increase in the scope of international collaborative medical research involving human subjects is raising the problem of whether and how to maintain Western ethical standards when research is conducted in countries with very different social and ethical values. Existing international ethical guidelines for research largely reflect Western concepts of human rights, focusing on the bioethical principles of respect for persons, beneficence, and justice. However, in countries and societies where these values are understood differently or are not (...) expressed in local cultures and institutions, it may be impossible or of no practical value to insert them into the research setting.In the United States, individual informed consent is considered ethically imperative for research involving human subjects. However, this imperative may be difficult to instill in societies that define persons by their relations to others, and important decisions are commonly made by heads of households or group leaders rather than by individuals. The baseline economic and health care conditions in foreign communities may also create ethical conflicts. (shrink)

The increase in the scope of international collaborative medical research involving human subjects is raising the problem of whether and how to maintain Western ethical standards when research is conducted in countries with very different social and ethical values. Existing international ethical guidelines for research largely reflect Western concepts of human rights, focusing on the bioethical principles of respect for persons, beneficence, and justice. However, in countries and societies where these values are understood differently or are not (...) expressed in local cultures and institutions, it may be impossible or of no practical value to insert them into the research setting.In the United States, individual informed consent is considered ethically imperative for research involving human subjects. However, this imperative may be difficult to instill in societies that define persons by their relations to others, and important decisions are commonly made by heads of households or group leaders rather than by individuals. The baseline economic and health care conditions in foreign communities may also create ethical conflicts. (shrink)

This article critically looks at the challenges that are incumbent in the deployment of married soldiers who work for the South African National Defence Force. The SANDF previously deployed soldiers outside the borders of South Africa for a period of 6 months or less. But currently, the SANDF has a deployment period of 12 months. This period is twice that of the earlier period, which means that soldiers and their families have to spend 12 months apart from one another. This (...) has an adverse effect on the marriages of soldiers and makes the SANDF appear as an uncaring institute because its military operations tend to impact family lives. Using a qualitative research approach, this article explores the emic experiences of married soldiers who were deployed, and concludes by suggesting some pastoral guidelines that may prove useful for a multi-professional team handling the issues of deployment. (shrink)

BackgroundIn research ethics, the most basic question would always be, “which is an ethical issue, which is not?” Interestingly, depending on which ethics guideline we consult, we may have various answers to this question. Though we already have several international ethics guidelines for biomedical research involving human participants, ironically, we do not have a harmonized document which tells us what these various guidelines say and shows us the areas of consensus. In this manuscript, we attempted to do (...) just that.MethodsWe extracted the imperatives from five internationally-known ethics guidelines and took note where the imperatives came from. In doing so, we gathered data on how many guidelines support a specific imperative.ResultsWe found that there is no consensus on the majority of the imperatives and that in only 8.2 % of the imperatives were there at least moderate consensus. Of the 12 clusters, Informed Consent has the highest level of consensus and Research Collaboration and Regulatory Sanctions have the least.ConclusionThere was a lack of consensus in the majority of imperatives from the five internationally-known ethics guidelines. This may be partly explained by the differences among the guidelines in terms of their levels of specification as well as conceptual/ideological differences. (shrink)

The theme of the 10th Annual Research Ethics Conference organized by the Uganda National Council for Science and Technology (2018) was “Evolution of Research Ethics in Uganda and the Region: Past, Present and Future”. We were asked to address the topic: “The History of CIOMS and the recent changes in the international ethics guidelines: implications for local research”. The thrust of the conference was to track progress in ensuring ethical conduct of research, highlight challenges encountered, and to propose (...) strategies for effective and meaningful implementation of international ethical guidelines in local contexts. Consequently, the purpose of this paper is to comment on the implications of the history of CIOMS ethical guidelines and suggest strategies for their effective and meaningful implementation in the East African region, and perhaps the whole of Sub‐Saharan Africa. Inferring from the ‘evolutionary’, ‘flexible’, and ‘general’ nature of the CIOMS guidelines, we proposed a six‐point strategy for ensuring their effective and meaningful implementation in local contexts. This strategy is in the form of obligations for local research regulators and researchers, the fulfillment of which will go a long way towards their smooth and meaningful implementation in local contexts. These obligations are: ensuring evidence‐based adaptation of each individual guideline; ensuring sufficiently judicious and motivated RECs membership; acting proactively to ensure harmony between bioethics and local legal regimes; cultivating a ‘bioethics culture’ among the public; moving towards regional bioethics governance; and playing an active and meaningful role in future revisions of these guidelines. (shrink)

In this paper, the author attempts to explore some of the problems connected with the formulation and application of international biomedical ethical guidelines, with particular reference to Africa. Recent attempts at revising and updating some international medical ethical guidelines have been bedevilled by intractable controversies and wrangling regarding both the content and formulation. From the vantage position of relative familiarity with both African and Western contexts, and the privilege of having been involved in the revision and (...) updating of one of the international ethical guidelines, the author reflects broadly on these issues and attempts prescribing an approach from both the theoretical and practical angles liable to mitigate, if not completely eliminate, some of the problems and difficulties. (shrink)

This article provides a critical comparative analysis of the substantive and procedural values and ethical concepts articulated in guidelines for allocating scarce resources in the COVID-19 pandemic. We identified 21 local and national guidelines written in English, Spanish, German and French; applicable to specific and identifiable jurisdictions; and providing guidance to clinicians for decision making when allocating critical care resources during the COVID-19 pandemic. US guidelines were not included, as these had recently been reviewed elsewhere. Information was (...) extracted from each guideline on: 1) the development process; 2) the presence and nature of ethical, medical and social criteria for allocating critical care resources; and 3) the membership of and decision-making procedure of any triage committees. Results of our analysis show the majority appealed primarily to consequentialist reasoning in making allocation decisions, tempered by a largely pluralistic approach to other substantive and procedural values and ethical concepts. Medical and social criteria included medical need, co-morbidities, prognosis, age, disability and other factors, with a focus on seemingly objective medical criteria. There was little or no guidance on how to reconcile competing criteria, and little attention to internal contradictions within individual guidelines. Our analysis reveals the challenges in developing sound ethical guidance for allocating scarce medical resources, highlighting problems in operationalising ethical concepts and principles, divergence between guidelines, unresolved contradictions within the same guideline, and use of naïve objectivism in employing widely used medical criteria for allocating ICU resources. (shrink)

In light of the coronavirus pandemic, an international study (N = 1066) was conducted to explore the new bioterrorism conspiracy, faith in government, and compliance with public health guidelines related to COVID-19. Hierarchical regressions showed that while general belief in conspiracies decreased faith in government during COVID-19, it increased belief in bioterrorism regarding the coronavirus. Critical thinking was associated with decreased endorsement of biowarfare conspiracy. Higher levels of belief in bioterrorism, faith in government, and perceived risk positively facilitated (...) compliance behavior in public internationally. Interestingly, while people reported ‘worrying about others’ as their motivation to follow guidelines, ‘worrying about self’ was most strongly associated with compliance. The implications of these findings are discussed in the light of enhancing compliance with public health guidelines and effective ways of conveying them to an increasingly polarized society. (shrink)

Refugees and asylum seekers may experience challenges related to pre-arrival experiences, structural disadvantage after migration and during resettlement requiring the need for special protection when participating in research. The aim was to review if and how people with refugee and asylum seeker backgrounds have had their need for special protection addressed in national and international research ethics guidelines. A systematic search of grey literature was undertaken. The search yielded 2187 documents of which fourteen met the inclusion criteria. Few (...) guidelines addressed specific ethical considerations for vulnerable groups much less people with refugee and asylum seeker backgrounds. One guideline explicitly addressed vulnerability for refugees and asylums seekers. To ensure members of ethics committees and researchers consider the potential challenges of conducting research with these groups, guidelines may need to be supplemented with a refugee and asylum seeker specific research ethics framework. Such a framework may be necessary to optimally protect people with refugee and asylum seeker backgrounds in research. (shrink)

The International Society for Stem Cell Research (ISSCR) has recently released the 2021 update of its guidelines. The update includes detailed new recommendations on human–animal chimera research. This paper argues that the ISSCR recommendations fail to address the core ethical concerns raised by neurological chimeras—namely, concerns about moral status. In minimising moral status concerns, the ISSCR both breaks rank with other major reports on human–animal chimera research and rely on controversial claims about the grounds of moral status that (...) many people will rightly reject. A more robust framework for regulating human–animal chimera research still needs to be developed. (shrink)

International travel for medical care, or medical tourism, creates ethical and safety concerns for patients. Guidelines could be developed and distributed to help address these concerns, but they may at the same time appear to endorse this practice.

Professional statements guide neonatal resuscitation thresholds at the border of viability. A 2015 systematic review of international guidelines by Guillen et al. found considerable variability between statements’ clinical recommendations for infants at 23–24 weeks gestational age (GA). The authors concluded that differences in the type of data included were one potential source for differing resuscitation thresholds within this “ethical gray zone.” How statements present ethical considerations that support their recommendations, and how this may account for variability, has not (...) been as rigorously explored. We performed a mixed-methods exploratory analysis of 25 current international guidelines for neonatal resuscitation at 22+0−25+0 weeks GA. Qualitative analysis using a modified grounded theory yielded 34 distinct codes, eight categories, and four overarching themes. Three themes, consequentialism, principlism, and rights-based, consisted of concepts central to these ethical frameworks. The fourth theme, clinical reasoning, described counseling practices, medical management, outcomes data, and prognostic uncertainty, without any ethical context. The theme of clinical reasoning appeared in 22 of 25 guidelines. Ten guidelines lacked any ethical theme. Guidelines with an identified ethical theme were more likely to recommend comfort care than guidelines without an identified ethical theme, and recommended it at a higher average GA (22.7 weeks vs. 22.0 weeks, p = 0.03). Thus, how ethical concepts are incorporated into guidelines potentially impacts resuscitation thresholds. We argue that inclusion of explicit discussion of ethical considerations surrounding resuscitation in the “gray zone” would clarify values that inform recommendations and facilitate discussions about how neonatology ought to approach periviability as outcomes continue to evolve. (shrink)

Human embryo models formed from stem cells—known as embryoids—allow scientists to study the elusive first stages of human development without having to experiment on actual human embryos. But clear ethical guidelines for research involving embryoids are still lacking. Previously, a handful of researchers put forward new recommendations for embryoids, which they hope will be included in the next set of International Society for Stem Cell Research guidelines. Although these recommendations are an improvement over the default approach, they (...) are nonetheless unworkable, because they rely on a poorly conceived notion of an embryoid’s ‘potential’ to trigger stringent research regulations. (shrink)

The paper develops value based management guidelines from the famous Indian treatise on management, Kautilya's Arthashastra. Guidelines are given for individual components of a total framework in detail, which include guidelines for organizational philosophy, value based leadership, internal corporate culture, accomplishment of corporate purpose and feedback from stakeholders.

The intent of ethics is to establish a set of standards that will provide a framework to modify, regulate, and possibly enhance moral behaviour. Eleven focus groups were conducted with physicians from six culturally distinct countries to explore their perception of formalized, written ethical guidelines (i.e., codes of ethics, credos, value and mission statements) that attempt to direct their ethical practice. Six themes emerged from the data: lack of awareness, no impact, marginal impact, other codes or value statements supersede, (...) personal codes or values dictate, and ethical guidelines are useful. Overall, codes were valued only when they were congruent with existing personal morality. The findings suggest the need to re-evaluate the purpose, content, and delivery of codes for them to improve their function in promoting ethical conduct. (shrink)

The aim of this article is to articulate and critically discuss different answers to the following question: How should decision-makers deal with conflicts that arise when the values usually entailed in ethical guidelines – such as accuracy, privacy, non-discrimination and transparency – for the use of Artificial Intelligence clash with one another? To begin with, I focus on clarifying some of the general advantages of using such guidelines in an ethical analysis of the use of AI. Some disadvantages (...) will also be presented and critically discussed. Second, I will show that we need to distinguish between three kinds of conflict that can exist for ethical guidelines used in the moral assessment of AI. This section will be followed by a critical discussion of different answers to the question of how to handle what we shall call internal and external values conflicts. Finally, I will wrap up with a critical discussion of three different strategies to resolve what is called a ‘genuine value conflict’. These strategies are: the ‘accepting the existence of irresolvable conflict’ view, the ranking view, and value monism. This article defends the ‘accepting the existence of irresolvable conflict’ view. It also argues that even though the ranking view and value monism, from a merely theoretical point of view, are better equipped to solve genuine value conflicts among values in ethical guidelines for artificial intelligence, this is not the case in real-life decision-making. Keywords: AI; ethical guidelines; algorithm-based sentencing; value conflicts. (shrink)