This book is a comprehensive and unique text and reference in medical ethics. By far the most inclusive set of primary documents and articles in the field ever published, it contains over 100 selections. Virtually all pieces appear in their entirety, and a significant number would be difficult to obtain elsewhere. The volume draws upon the literature of history, medicine, philosophical and religious ethics, economics, and sociology. A wide range of topics and issues are covered, such as (...) law and medicine, truth-telling by the physician, research, population policy, genetics, abortion, dying, and individual rights in medical care. The selections span the centuries, beginning with material from the works of Hippocrates, continuing through Thomas Percival, John Stuart Mill, and Claude Bernard, down to modern commentators like Henry K. Beecher, Walsh McDermott, David L. Bazelon, Paul Freund, H. L. A. Hart, John Rawls, Paul Ramsey, Richard McCormick, Rashi Fein, and Bernard Barber. The text has eight major divisions, beginning with sections on the ethical dimensions of the physician-patient relationship in history; the moral bases of medical ethics; and regulation, compulsion, and protection of the consumer in clinical medicine and public health. Each of these sections includes key essays that appear for the first time. All of the book's major divisions contain primary documents: codes such as the Hippocratic Oath, Medieval Law for the Regulation of Medicine, and the first as well as the most recent code of the American Medical Association; court decisions, including those on Karen Quinlan and on abortion in the United States and West Germany; government documents such as the statement of the National Commission on the Protection of Human Subjects, the Tuskegee Syphilis Report, the British Parliamentary debate on euthanasia, and the Council of Europe on rights of the sick and dying; and various published guidelines such as the Harvard Medical School brain death criteria, the American Hospital Association on patient's rights, and Pope Pius XII on the prolongation of life. Cases that illustrate moral dilemmas are provided for discussion purposes. Each section is preceded by a succinct editor's introduction. The documents and essays are of practical value for practitioners and students in medicine, law, ethics, and counselling, and for individual patients and groups concerned with medical care. Through encompassing divergent viewpoints, the essays and primary documents were selected to encourage humane practices and deepen understanding of the multiple traditions that shaped and do shape the development of medicine. (shrink)

In order to shorten queues to healthcare, the Swedish government has introduced a yearly “queue billion” that is paid out to the county councils in proportion to how successful they are in reducing queues. However, only the queues for first visits are covered. Evidence has accumulated that queues for return visits have become longer. This affects the chronically and severely ill. Swedish physicians, and the Swedish Medical Association, have strongly criticized the queue billion and have claimed that it (...) conflicts with medical ethics. Instead they demand that their professional judgments on priority setting and medical urgency be respected. This discussion provides an interesting illustration of some of the limitations of new public management and also more generally of the complicated relationships between medical ethics and public policy. (shrink)

The introduction of genomics and biobanking methodologies to the African research context has also introduced novel ways of doing science, based on values of sharing and reuse of data and samples. This shift raises ethical challenges that need to be considered when research is reviewed by ethics committees, relating for instance to broad consent, the feedback of individual genetic findings, and regulation of secondary sample access and use. Yet existing ethics guidelines and regulations in Africa do not successfully (...) regulate research based on sharing, causing confusion about what is allowed, where and when. In order to understand better the ethics regulatory landscape around genomic research and biobanking, we conducted a comprehensive analysis of existing ethics guidelines, policies and other similar sources. We sourced 30 ethics regulatory documents from 22 African countries. We used software that assists with qualitative data analysis to conduct a thematic analysis of these documents. Surprisingly considering how contentious broad consent is in Africa, we found that most countries allow the use of this consent model, with its use banned in only three of the countries we investigated. In a likely response to fears about exploitation, the export of samples outside of the continent is strictly regulated, sometimes in conjunction with regulations around international collaboration. We also found that whilst an essential and critical component of ensuring ethical best practice in genomics research relates to the governance framework that accompanies sample and data sharing, this was most sparingly covered in the guidelines. There is a need for ethics guidelines in African countries to be adapted to the changing science policy landscape, which increasingly supports principles of openness, storage, sharing and secondary use. Current guidelines are not pertinent to the ethical challenges that such a new orientation raises, and therefore fail to provide accurate guidance to ethics committees and researchers. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Morality in Flux: Medical Ethics Dilemmas in the People's Republic of ChinaRen-Zong Qiu (bio)IntroductionModern China is undergoing a fundamental change from a monolithic society to a rather pluralistic one. It is a long and winding road. Marxism is facing various challenges as the influence of Western culture increases. Confucianism is still deeply entrenched in the Chinese mind but various religions, including Buddhism, Islam, and Christianity are experiencing (...) a revival. Almost fifty minorities coexist in the country in addition to the majority Han people. Tension and conflict are inevitable as diverse—and sometimes incompatible—values come to the fore at this historic juncture. Many fields, including medicine, face new challenges, and in this environment the field of bioethics is flourishing.Like many countries, China is groping with the effects of new medical technology and skyrocketing health care costs. But in the context of the Chinese sociocultural environment, some unique—as well as more familiar—issues arise. None of the classic texts provide ready-made answers to these dilemmas; we must find the answers ourselves. The only reasonable way to resolve the conflicts between opposing values is through dialogue, consultation, and negotiation among the various social and cultural groups.The bioethical dilemmas receiving the most attention in China now relate to the two ends of life: birth and death. On one end are issues relating to reproductive technology, especially birth control and family planning; at the other end is euthanasia.Dilemmas Surrounding Reproductive TechnologyAccording to traditional Chinese belief, not having a child results from not having virtue. In fact, the most serious violation of the Confucian [End Page 16]principle of filial piety is to be without offspring. A Chinese man without a child experiences heavy psychological pressure, and the burden is especially onerous for women because infertility is always blamed on the wife. Wives who do not bear a child are stigmatized and mistreated—even abused—in families that stick to traditional values.In China today, this widely held belief is colliding with another reality: an apparent increase in infertility among newly-married couples. The rate may be about 5 percent. These couples turn to doctors for help.Artificial insemination by donor (AID) and by husband is now widely practiced. Eleven provinces have established sperm banks, and private doctors are performing AID for considerable fees. But procedures to address legal and ethical problems associated with the procedure have lagged behind. With the exception of a few centers in large cities, AID is undertaken without established procedures or policies relating to the selection of donors and recipients, records about those involved, or clarification of the status of the child. The legal status of the child remains unresolved.The status of the child within the community is also unresolved as traditional values clash with the application of modern technology to childbearing. The case of "The Child Who Did Not Belong" (see box), illustrates how an AID child is not accepted by the family that embraces traditional values because he is not the husband's biological child.In vitro fertilization (IVF) is another alternative. Two IVF centers are in operation, one in Beijing and the other in Changsha, and both have succeeded in producing live births. This technology has received considerable media attention and is generally accepted even among those with traditional views.But much of this medical technology is not widely accessible—especially in rural areas—and so some infertile couples resort to surrogate motherhood to ensure an heir. An infertile couple enters into a contract with a woman who has intercourse with the husband in order to bear a child for the couple. This practice is called "borrowing a wife." In some villages, the "borrowed wife" receives as much as 10,000 yuan (five times a professor's monthly salary or about $250) for a girl and double that for a boy.But the more common and thorny problems involved with the beginning of life relate to birth control, family planning, and the "one couple, one child" policy that the Chinese government instituted to curb overpopulation. The goal of that policy is to prevent China's population from exceeding 1.2 billion in the year 2000... (shrink)

The Ethics and Regulation of Research with Human Subjects, edited by Professors Carl Coleman of Seton Hall, Jerry Menikoff of the University of Kansas, Jesse Goldner of Saint Louis University, and Nancy Dubler of the Albert Einstein College of Medicine, is an up-to-date and authoritative collection of readings on ethical, legal, and policy issues in research with human subjects. The authors have modeled their text on the casebook style commonly used in law schools. At 746 pages, plus front (...) matter and an appendix, this book contains just about everything one needs to know for a thorough grasp on human subjects research, including federal and state regulations governing this research, interpretive guidance from federal agencies, international guidelines and codes, court decisions, historical documents and case studies, and selected readings from scholarly articles and books. The book includes written comments and questions to help students understand and interpret the readings. (shrink)

Health is a value-laden concept. The state of being that it designates is a fundamental human goal. As a value, the concept is normative, governing both clinical practice and the therapeutic treatment developed by medical research. Also, the promise of health plays a pivotal role in health-policy discourse. Almut Caspary considers philosophical and theological concepts of health in the context of its practical significance, both in the past and today. This conceptual analysis culminates in a preliminary sketch of (...) a concept of health; focusing on the stem-cell debate, it offers a discriminating approach to contemporary ethical problems in medicine. "Gesundheit" ist ein wertgeladener Begriff. Er bezeichnet einen grundsatzlich wunschenswerten Zustand menschlicher Existenz, der das arztliche Handeln im klinischen Alltag leitet. Daruber hinaus werden (gesundheits-)politische Debatten mit Verweis auf den Nutzen fur die Gesundheit entschieden. Vor diesem Hintergrund setzt sich Almut Caspary epochenubergreifend mit philosophischen und theologischen Uberlegungen zur Gesundheit auseinander. Die konzeptuelle Diskussion erlaubt die Skizzierung eines Gesundheitsverstandnisses, das - wie am Beispiel der Stammzelldebatte gezeigt wird - ein differenziertes Abwagen in medizinethischen Konfliktfallen zulasst. (shrink)

Summary Principles Timely support for patients and people close to them, and effective, sensitive communication are essential. Decisions must be based on the individual patient's circumstances and reviewed regularly. Sensitive advance discussion should always be encouraged, but not forced. Information about CPR and the chances of a successful outcome needs to be realistic. Practical matters Information about CPR policies should be displayed for patients and staff. Leaflets should be available for patients and people close to them explaining about CPR, how (...) decisions are made and their involvement in decisions. Decisions about attempting CPR must be communicated effectively to relevant health professionals. In emergencies If no advance decision has been made or is known, CPR should be attempted unless: the patient has refused CPR; the patient is clearly in the terminal phase of illness; or the burdens of the treatment outweigh the benefits. Advance decision making Competent patients should be involved in discussions about attempting CPR unless they indicate that they do not want to be. Where patients lack competence to participate, people close to them can be helpful in reflecting their views. Legal issues Patients' rights under the Human Rights Act must be taken into account in decision making. Neither patients nor relatives can demand treatment which the health care team judges to be inappropriate, but all efforts will be made to accommodate wishes and preferences. In England, Wales and Northern Ireland relatives and people close to the patient are not entitled in law to take health care decisions for the patient. In Scotland, adults may appoint a health care proxy to give consent to medical treatment. Health professionals need to be aware of the law in relation to decision making for children and young people.IntroductionWhy policies are neededCardiopulmonary resuscitation can be attempted on any person whose cardiac or respiratory functions cease. Failure of these functions is part of dying and thus …. (shrink)

BackgroundTo prevent sexual boundary violations (SBV) in mental health care institutions overall governments require these institutions to report SBV incidents to a central registry and to develop institutional guidelines how to react. In Europe SBV policies are only recently developed or implemented, as is also the case in Flanders (Belgium). The implementation of a new institutional policy is always a challenge and can encounter resistance, especially when it concerns SBV, because they remain delicate and complex.MethodThis study evaluated the extent (...) to which mandatory policies on SBV have been implemented in mental health care institutions in Flanders, and possible factors for (non-)implementation of these policies. An online survey was sent to the executives of all mental health care institutions in Flanders (N = 162).ResultsIn total 56 executives of mental health care institutions filled out the survey (response rate 35%). Results showed that the implementation of an SBV policy in mental health care institutions is unfortunately inadequate and not all SBV incidents were reported to the central registry. Type of institution and opinions on the SBV policy were related to the (non-)implementation of the requirements.ConclusionsIt is recommended that governments regularly communicate with mental health care institutions to better understand the concerns and difficulties concerning implementation of the required SBV policy and to support/stimulate an organisational culture of more openness and safety on this topic. (shrink)

Background: Despite potential benefits of the return of research results to research participants, the TriCouncil Policy Statement , which reflects Canadian regulatory ethical requirements, does not require this. The policies of Canadian research ethics boards are unknown.Objectives: To examine the policies of Canadian university based REBs regarding returning results to research participants, and to ascertain if the presence/absence of a policy may be influenced by REB member composition.Design: Email survey of the coordinators of Canadian university based REBs (...) to determine the presence/absence of a policy on return of research results to research participants both during an ongoing study and at conclusion. REB coordinators were asked to return a copy of the policy or guidelines and to describe the member composition of their REB.Findings: Of 50 REBs that were contacted 34 responded and 22 met the inclusion criteria. Two had a policy that governed the return of research results while on a study, and seven following the completion of a study. Presence of an ethicist or a lawyer on the REB did not influence the presence/absence of such policies. No REBs had specific guidelines describing how participants should be informed of results.Conclusions: Most REBs did not require researchers to disclose study results to research participants either during or following a study. Thus this study identifies an ethical shortcoming in the conduct of human research in Canada. It has also demonstrated that there are no clear recommendations by REBs to facilitate the return of results to participants following research projects. (shrink)

The European Medical Information Framework project, funded through the IMI programme, has designed and implemented a federated platform to connect health data from a variety of sources across Europe, to facilitate large scale clinical and life sciences research. It enables approved users to analyse securely multiple, diverse, data via a single portal, thereby mediating research opportunities across a large quantity of research data. EMIF developed a code of practice to ensure the privacy protection of data subjects, protect the interests (...) of data sharing parties, comply with legislation and various organisational policies on data protection, uphold best practices in the protection of personal privacy and information governance, and eventually promote these best practices more widely. EMIF convened an Ethics Advisory Board, to provide feedback on its approach, platform, and the EcoP. The most important challenges the ECoP team faced were: how to define, control and monitor the purposes for which federated health data are used; the kinds of organisation that should be permitted to conduct permitted research; and how to monitor this. This manuscript explores those issues, offering the combined insights of the EAB and EMIF core ECoP team. For some issues, a consensus on how to approach them is proposed. For other issues, a singular approach may be premature but the challenges are summarised to help the community to debate the topic further. Arguably, the issues and their analyses have application beyond EMIF, to many research infrastructures connected to health data sources. (shrink)

BackgroundResearch has been an essential part of the COVID-19 pandemic response, including in Latin American (LA) countries. However, implementing research in emergency settings poses the challenge of producing valuable knowledge rapidly while upholding research ethical standards. Research ethics committees (RECs) therefore must conduct timely and rigorous ethics reviews and oversight of COVID-19 research. In the LA region, there is limited knowledge on how countries have responded to this need. To address this gap, the objective of our project is (...) to explore if LA countries developed policies to streamline ethics review and oversight of research in response to the pandemic while ensuring its adherence to ethical standards, and to analyze to what extent these governance frameworks are in accordance with international guidance.MethodsWe conducted a descriptive and exploratory study assessing the COVID-19 research ethics governance frameworks of 19 LA countries, considering 4 dimensions based on international COVID-19 ethics guidance documents: (i) ethics review organizational model adopted, (ii) measures to coordinate between RECs and other research stakeholders, (iii) operational guidance for RECs, and (iv) key ethical issues for review and oversight of COVID-19 research.Results10 out of 19 LA countries have some policy to streamline ethics review of COVID-19 research. Of these countries only 6 issued comprehensive documents following international guidance that contemplate strategies with recommendations for concrete actions for a timely and rigorous review.ConclusionLA countries adopted partial strategies and operational guidance that may demonstrate a lack of a comprehensive view of research ethics for the review and oversight of COVID-19 research. Continuing efforts should be directed to strengthen LA countries' research capacity to respond timely and ethically to future health emergencies. Past lessons and the ones from this pandemic should be the basis to develop international standards and operational guidelines for ethics review and oversight of any research for public health emergencies. (shrink)

The use of genome-wide association studies in medical research and the increased ability to share data give a new twist to some of the perennial ethical issues associated with genomic research. GWAS create particular challenges because they produce fine, detailed, genotype information at high resolution, and the results of more focused studies can potentially be used to determine genetic variation for a wide range of conditions and traits. The information from a GWA scan is derived from DNA that is (...) a powerful personal identifier, and can provide information not just on the individual, but also on the individual's relatives, related groups, and populations. Furthermore, it creates large amounts of individual-specific digital information that is easy to share across international borders. This paper provides an overview of some of the key ethical issues around GWAS: consent, feedback of results, privacy, and the governance of research. Many of the questions that lie ahead of us in terms of the next generation sequencing methods will have been foreshadowed by GWAS and the debates around ethical and policy issues that these have created. (shrink)

This open access book presents an ethical approach to utilizing personal medical data. It features essays that combine academic argument with practical application of ethical principles. The contributors are experts in ethics and law. They address the challenges in the re-use of medical data of the deceased on a voluntary basis. This pioneering study looks at the many factors involved when individuals and organizations wish to share information for research, policy-making, and humanitarian purposes. -/- Today, it (...) is easy to donate blood or even organs, but it is virtually impossible to donate one’s own medical data. This is seen as ethically unacceptable. Yet, data donation can greatly benefit the welfare of our societies. This collection provides timely interdisciplinary research on biomedical big data. Topics include the ethics of data donation, the legal and regulatory challenges, and the current and future collaborations. -/- Readers will learn about the ethical and regulatory challenges associated with medical data donations. They will also better understand the special nature of using deceased data for research purposes with regard to ethical principles of autonomy, beneficence, and justice. In addition, the contributors identify the key governance issues of such a scheme. The essays also look at what we can learn in terms of best practice from existing medical data schemes. (shrink)

The geographically inequitable distribution of physicians has long posed a serious social problem in Japan. The government tackled this problem by establishing and managing Jichi Medical University (JMU) and regional quotas (RQs) for medical schools. JMU/RQs recruit local students who hope to work as physicians in rural areas, educate them for 6 years without tuition (JMU) or with scholarship (RQs), and after graduation, assign them to their home prefectures for 9 years, including 4–6 years of rural service. (...) JMU/RQs entrants now occupy 11.6% of all medical school entrants. While JMU/RQs have been shown to be highly effective in securing physicians for rural areas, ethical issues related to these policies have been raised, such as whether the government truly needs to implement these policies using tax money, and whether it is acceptable to limit the personal freedoms of the physicians. In this paper, we discuss these issues from the perspectives of social justice, utilitarianism, luck egalitarianism, liberty, medical professionalism and consistency with national health insurance and the Japanese Constitution. We conclude that JMU/RQs are necessary and ethically valid policies, and also propose some institutional improvements to better secure the integrity and maturity of these systems. (shrink)

This open access book presents an ethical approach to utilizing personal medical data. It features essays that combine academic argument with practical application of ethical principles. The contributors are experts in ethics and law. They address the challenges in the re-use of medical data of the deceased on a voluntary basis. This pioneering study looks at the many factors involved when individuals and organizations wish to share information for research, policy-making, and humanitarian purposes. Today, it is (...) easy to donate blood or even organs, but it is virtually impossible to donate one’s own medical data. This is seen as ethically unacceptable. Yet, data donation can greatly benefit the welfare of our societies. This collection provides timely interdisciplinary research on biomedical big data. Topics include the ethics of data donation, the legal and regulatory challenges, and the current and future collaborations. Readers will learn about the ethical and regulatory challenges associated with medical data donations. They will also better understand the special nature of using deceased data for research purposes with regard to ethical principles of autonomy, beneficence, and justice. In addition, the contributors identify the key governance issues of such a scheme. The essays also look at what we can learn in terms of best practice from existing medical data schemes. (shrink)

This book offers a synthesis of investigations on the ethics, governance and policies affecting the design, development and deployment of artificial intelligence. Each chapter can be read independently, but the overall structure of the book provides a complementary and detailed understanding of some of the most pressing issues brought about by AI and digital innovation. Given its modular nature, it is a text suitable for readers who wish to gain a reliable orientation about the ethics of AI and (...) for experts who wish to know more about specific areas of the current debate. (shrink)

One of the core goals of Digital Health Technologies (DHT) is to transform healthcare services and delivery by shifting primary care from hospitals into the community. However, achieving this goal will rely on the collection, use and storage of large datasets. Some of these datasets will be linked to multiple sources, and may include highly sensitive health information that needs to be transferred across institutional and jurisdictional boundaries. The growth of DHT has outpaced the establishment of clear legal pathways to (...) facilitate the collection, use and transfer of potentially sensitive health data. Our study aimed to address this gap with an ethical code to guide researchers developing DHT with international collaborative partners in Singapore. We generated this code using a modified Policy Delphi process designed to engage stakeholders in the deliberation of health data ethics and governance. This paper reports the outcomes of this process along with the key components of the code and identifies areas for future research. (shrink)

Governments are increasingly using randomized controlled trials (RCTs) to evaluate policy interventions. RCTs are often understood to provide the highest quality evidence regarding the causal efficacy of an intervention. While randomization plays an essential epistemic role in the context of policy RCTs however, it also plays an important distributive role. By randomly assigning participants to either the intervention or control arm of an RCT, people are subject to different policies and so, often, to different types and levels of (...) benefits. In this paper, I identify one necessary condition as well as a set of sufficient conditions for the permissible use of random assignment by government agencies. I argue first that random assignment is permissible only if it is consistent with governments’ duty to realize morally important outcomes. I argue second that random assignment is permissible in cases where investigators are in a state of genuine equipoise regarding all arms of the experiment and the policy to which people have a claim of justice. Finally, I defend a set of conditions under which random assignment is permissible in cases where one or more arms of a policy RCT are reasonably expected to be either superior or inferior to this policy. (shrink)

"[T]his is much more than a conventional reference guide. . . . An essential item in any collection that deals with the subject of ethics and public policy." Choice.

In this important collection of essays Dennis Thompson argues for a more robust conception of responsibility in public life than prevails in contemporary democracies. He suggests that we should stop thinking so much about public ethics in terms of individual vices and start thinking about it more in terms of institutional vices. Combining theory and practice with many concrete examples and proposals for reform, these essays could be used in courses in applied ethics or political theory and will (...) be read by professionals and graduate students in schools of political science, public policy, law, public health, journalism and business. (shrink)

: This paper argues that three salient corrupt practices that mark contemporary Chinese health care, namely the over-prescription of indicated drugs, the prescription of more expensive forms of medication and more expensive diagnostic work-ups than needed, and illegal cash payments to physicians—i.e., red packages—result not from the introduction of the market to China, but from two clusters of circumstances. First, there has been a loss of the Confucian appreciation of the proper role of financial reward for good health care. Second, (...) misguided governmental policies have distorted the behavior of physicians and hospitals. The distorting policies include (1) setting very low salaries for physicians, (2) providing bonuses to physicians and profits to hospitals from the excessive prescription of drugs and the use of more expensive drugs and unnecessary expensive diagnostic procedures, and (3) prohibiting payments by patients to physicians for higher quality care. The latter problem is complicated by policies that do not allow the use of governmental insurance and funds from medical savings accounts in private hospitals as well as other policies that fail to create a level playing field for both private and government hospitals. The corrupt practices currently characterizing Chinese health care will require not only abolishing the distorting governmental policies but also drawing on Confucian moral resources to establish a rightly directed appreciation of the proper place of financial reward in the practice of medicine. (shrink)

Health-worker migration, commonly called "medical brain drain", refers to the mass migration of trained and skilled health professionals from low-income to high-income countries. This is currently leaving a significant number of poor countries, particularly in sub-Saharan Africa, with critical staff shortages in the healthcare sector. A broad consensus exists that, where medical brain drain exacerbates such shortages, it is unethical, and this review presents the main arguments underpinning this view. Notwithstanding the general agreement, which policies are justifiable on (...) ethical grounds to tackle brain drain and how best to go about implementing them remains controversial. The review offers a discussion of the specific ethical issues that have to be taken into account when deciding which policy measures to prioritise and suggests a strategy of policy implementation to address medical brain drain as a matter of urgency. (shrink)

Background The ethical governance of Artificial Intelligence (AI) in health care and public health continues to be an urgent issue for attention in policy, research, and practice. In this paper we report on central themes related to challenges and strategies for promoting ethics in research involving AI in global health, arising from the Global Forum on Bioethics in Research (GFBR), held in Cape Town, South Africa in November 2022. Methods The GFBR is an annual meeting organized by the (...) World Health Organization and supported by the Wellcome Trust, the US National Institutes of Health, the UK Medical Research Council (MRC) and the South African MRC. The forum aims to bring together ethicists, researchers, policymakers, research ethics committee members and other actors to engage with challenges and opportunities specifically related to research ethics. In 2022 the focus of the GFBR was “Ethics of AI in Global Health Research”. The forum consisted of 6 case study presentations, 16 governance presentations, and a series of small group and large group discussions. A total of 87 participants attended the forum from 31 countries around the world, representing disciplines of bioethics, AI, health policy, health professional practice, research funding, and bioinformatics. In this paper, we highlight central insights arising from GFBR 2022. Results We describe the significance of four thematic insights arising from the forum: (1) Appropriateness of building AI, (2) Transferability of AI systems, (3) Accountability for AI decision-making and outcomes, and (4) Individual consent. We then describe eight recommendations for governance leaders to enhance the ethical governance of AI in global health research, addressing issues such as AI impact assessments, environmental values, and fair partnerships. Conclusions The 2022 Global Forum on Bioethics in Research illustrated several innovations in ethical governance of AI for global health research, as well as several areas in need of urgent attention internationally. This summary is intended to inform international and domestic efforts to strengthen research ethics and support the evolution of governance leadership to meet the demands of AI in global health research. (shrink)

Authoritarian governments are characterised by political systems with concentrated and centralised power. Healthcare is a critical component of any state. Given the powers of an authoritarian regime, we consider the opportunities they possess to derive good health outcomes. The 2019 Varsity Medical Ethics Debate convened on the motion: ‘This house believes authoritarian government is the route to good health outcomes’ with Oxford as the Proposition and Cambridge as the Opposition. This article summarises and extends key arguments made (...) during the 11th annual debate between medical students from the Universities of Oxford and Cambridge. By contrasting the principles underlying authoritarianism and democracy, it enables a discussion into how they translate into healthcare provision and the outcomes derived. Based on the foundation of said principles, an exploration of select cases represents examples of applications and the results. We analyse the past, present and future implications on the basis of fundamental patient-centred care. (shrink)

Scant consideration has been given to the ethical implications of the policy of closing down psychiatric hospitals in favour of community care. The recent adherents of this policy in government have been enthusiastic in encouraging its implementation. This paper has three sections: a brief resumé of the history and principles of community care for the mentally ill; a discussion on the merits and de-merits of psychiatric care in the hospital and in the community; and an outline of (...) some preliminary categories for ethical analysis. (shrink)

This manual is a compendium of various health care policies, guidelines, protocols, and programs that concern clinical issues with ethical implications. The collection of policies, guidelines, and procedures are helpful in drafting and reviewing institutional procedures and helping policymakers develop useful mechanisms for assuring ethical treatment of patients and staff.

BackgroundIn the pandemic time, many low- and middle-income countries are experiencing restricted access to COVID-19 vaccines. Access to imported vaccines or ways to produce them locally became the principal source of hope for these countries. But developing a strategy for success in obtaining and allocating vaccines was not easy task. The governments in those countries have faced the difficult decision whether to accept or reject offers of vaccine diplomacy, weighing the price and availability of COVID-19 vaccines against the concerns over (...) their efficacy and safety. We aimed to analyze public opinion regarding the governmental strategies to obtain COVID-19 vaccines in three Central Asian countries, focusing particularly on possible ethical issues.MethodsWe searched for opinions expressed either in Russian or in the respective national languages. We provided data on the debate within three countries, drawn from social media postings and other sources. The opinion data was not restricted by source and time. This allowed collecting a wide range of possible opinions that could be expressed regarding COVID-19 vaccine supply and human participation in the vaccine trial. We recognized ethical issues and possible questions concerning different ethical frameworks. We also considered scientific data and other information, in the process of reasoning.ResultsAs a result, public views on their respective government policies on COVID-19 vaccine supply ranged from strongly negative to slightly positive. We extracted the most important issues from public debates, for our analysis. The first issue involved trade-offs between quantity, speed, price, freedom, efficacy, and safety in the vaccines. The second set of issues arose in connection with the request to site a randomized trial in one of the countries (Uzbekistan). After considering additional evidence, we weighed individual and public risks against the benefits to make specific judgements concerning every issue.ConclusionsWe believe that our analysis would be a helpful example of solving ethical issues that can arise concerning COVID-19 vaccine supply around the world. The public view can be highly critical, helping to spot such issues. An ignoring this view can lead to major problems, which in turn, can become a serious obstacle for the vaccine coverage and epidemics’ control in the countries and regions. (shrink)

Non-therapeutic genetic testing in childhood presents a “myriad of ethical questions”; questions which are discussed and resolved in professional policy and position statements. In this paper we consider an underdiscussed but strongly influential feature of policy-making, the role of selective case and exemplar in the production of general recommendations. Our analysis, in the tradition of rhetoric and argumentation, examines the predominate use of three particular disease exemplar to argue for or against particular genetic tests. We discuss the influence (...) these choices have on the type and strength of subsequent recommendations. We argue that there are lessons to be drawn about how genetic diseases are conceptualised and we caution against the geneticisation of medical policy making. (shrink)

Objective To obtain information about the similarities and differences in regulating different types of medical research in the European Union .Methods Web searches were performed from September 2009 to January 2011. Notes on pre-determined topics were systematically taken down from the web pages. The analysis relied only on documents and reports available on the web, reflecting the situation at the end of 2010.Results In several countries, regulatory legislation applied only to clinical trials on drugs and medical devices, in (...) other states various types of research were also regulated but by laws different from those concerning trials, and in many countries, some research areas were not controlled by legislation at all. In very few countries was all medical research handled similarly from a legal point of view. The number of research ethics committees in a single country varied from one to 264. Their areas of responsibility, working principles and length of time to grant research permission varied as well as the rules for obtaining informed consent from vulnerable groups. In 10 EU countries, there was no appeal mechanism after a negative decision by an REC. The RECs were not accountable to any organisation in five EU countries.Conclusions There is a need for a fundamental debate regarding whether and which kinds of changes are needed for the further harmonisation of medical research governance in the EU and how cross-country medical research could be facilitated in the future. (shrink)

I. Glenn Cohen’s Patients with Passports: Medical Tourism, Law, and Ethics offers a thorough examination of the growing practice of medical tourism, the legal regulations governing it, and the many ethical issues it raises for policy-makers, health care providers, and prospective medical tourists. Demonstrating mastery of the relevant literatures in the social sciences, law, ethics, and political philosophy, Cohen provides a comprehensive overview of the current practice of medical tourism, and offers well-argued, sensible (...) policy advice to guide its reform. Cohen’s book is a significant achievement of interdisciplinary scholarship and is essential reading for scholars and policy-makers. Medical... (shrink)

We examined the ethical justification for a national policy governing public funding for the induced pluripotent stem cell stock project in Japan and argue that the initiation of the iPSC stock project in 2012, when no clinical trial using iPSC-derived products had yet succeeded, was premature and unethical. Our analysis considers a generally accepted justice criterion and shows it fails to justify public funding of the iPSC stock project. We also raise concerns related to the massive amounts of public (...) funding at stake and the absence of evidence supporting claimed success rates. We conclude that the iPSC stock project should be re-considered and deferred until a substantial number of clinical trials using iPSC-derived products are deemed successful. This analysis should benefit others worldwide as they consider their own public funding policies. (shrink)

Details goverment, private, and international response to the policy recommendations of the National Bioethics Advisory Commission.

Mit Beitragen von: Wolfgang U. Eckart, Christian Bonah, Wolfgang U. Eckart / Andreas Reuland, Alexander Neumann, Peter Steinkamp, Volker Roelcke, Anne ...

Business and Society Review, Volume 127, Issue S1, Page 343-367, Spring 2022.

Every healthcare organisation enacts a multitude of policies, but there has been no discussion as to what procedural and substantive requirements a policy writing process should meet in order to achieve good outcomes and to possess sufficient authority for those who are asked to follow it.Using, as an example, the controversy about patient’s refusal of blood transfusions, I argue that a hospital wide policy is preferable to individual decision making, because it ensures autonomy, quality, fairness, and efficiency.Policy (...) writing for morally controversial medical practices needs additional justification compared to policies on standard medical practices and secures legitimate authority for HCO members by meeting five requirements: all parties directed by the policy are represented; the deliberative process encompasses all of the HCO’s obligations; the rationales for the policy are made available; there is a mechanism for criticising, and for evaluating the policy. (shrink)

Introduction -- Historical perspectives of medical ethics -- The medical ethics Renaissance: a brief assessment -- Risk disclosure/'informed consent' -- Consent, control and minors: Gillick and beyond -- Sterilisation/best interests: legislation intervenes -- The end of life: total abrogation -- Medical ethics in government-commissioned reports -- Conclusion.

Physicians in Islamic countries might be requested to participate in the Islamic legal code of qiṣāṣ, in which the victim or family has the right to an eye-for-an-eye retaliation. Qiṣāṣ is only used as a punishment in the case of murder or intentional physical injury. In situations such as throwing acid, the national legal system of some Islamic countries asks for assistance from physicians, because the punishment should be identical to the crime. The perpetrator could not be punished without a (...) physician’s participation, because there is no way to guarantee that the sentence would be carried out without inflicting more injury than the initial victim had suffered. By examining two cases of acid throwing, this paper discusses issues related to physicians’ participation in qiṣāṣ from the perspective of medical ethics and Islamic Shari’a law. From the standpoint of medical ethics, physicians’ participation in qiṣāṣ is not appropriate. First, qiṣāṣ is in sharp contrast to the Hippocratic Oath and other codes of medical ethics. Second, by physicians’ participation in qiṣāṣ, medical practices are being used improperly to carry out government mandates. Third, physician participation in activities that cause intentional harm to people destroys the trust between patients and physicians and may adversely affect the patient–physician relationship more generally. From the standpoint of Shari’a, there is no consensus among Muslim scholars whether qiṣāṣ should be performed on every occasion. We argue that disallowing physician involvement in qiṣāṣ is necessary from the perspectives of both medical ethics and Shari’a law. (shrink)

Informed by a search of the literature about the usage of genetic testing information (GTI) by insurance companies, this paper presents a practical ethical analysis of several distinct public policy options that might be used to govern or constrain GTI usage by insurance providers. As medical research advances and the extension to the Human Genome Project (2016, https://en.wikipedia.org/wiki/human_genome_project_-_write) moves to its fullness over the next decade, such research efforts will allow the full synthesis of human DNA to be (...) connected to predictive health dispositions. As testing costs fall, there will be ever more pressure for citizens to disclose GTI. Genetic testing information is integral to future medical care because it can be used to better assess individually tailored medical therapies as well as to allow a more informed risk analysis by the insurance industry, which in some countries such as the USA underwrites a majority of citizen medical expenses. As discussed in this examination, the revelation of people’s uniquely personal GTI to insurers has enormous societal implications. The major contribution of the paper is to offer policy makers and concerned citizens a nuanced articulation of the basic options to regulate GTI, with a special consideration for ethical fairness and equity. As genetic-based medicine blossoms and pressures to reduce healthcare costs increase, there will be an ever greater impetus for countries to revisit their genetic testing policies. Organizations and policy makers striving to create GTI oversights perceived to be both “fair and effective” need to be aware of the ethical perspectives discussed in this paper. (shrink)

Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device. This article addresses the difficult policy challenge of promoting the welfare and (...) interests of research participants, as well as the public, in the absence of regulatory requirements and without discouraging independent, innovative scientific inquiry. The article recommends a series of measures, including education, consultation, transparency, self-governance, and regulation to strike the appropriate balance. (shrink)

BackgroundBiobanks have recently been established in several low- and middle-income countries in the Arab region of the Middle East. We aimed to explore the views of biobank managers regarding the challenges, ethical issues, and governance arrangements of their biobanks.MethodsIn-depth semi-structured qualitative interviews were conducted with a purposive sample of eight biobank managers from Egypt, Jordan, and Sudan. Interviews were performed either face-to-face, by phone, or via Zoom and lasted approximately 45–75 min. After verbal consent, interviews were recorded and then transcribed. (...) The authors performed a thematic analysis of the transcripts independently and then integrated the themes via a consensus process.ResultsBiobank managers discussed the main challenges in establishing their biobanks. These included the staff’s lack of experience and training, limited funds, deficit awareness of biobanks, obtaining funding from different sources. Only four reported they were active in distributing biospecimens and health data to researchers. Six biobanks used a broad consent model, one used tiered consent, and another allowed participants to opt-out of being recontacted. Five managers avoided partnerships with pharmaceutical companies due to concerns with unfavorable reactions from the community. Five managers did not have clear policies for returning research results to the donors. Five expressed challenges with sample and data sharing with international collaborators; all five used material transfer agreements. The biobank managers revealed variable governance arrangements and activities with community involving awareness and educational efforts rather than active engagement. Several expressed the importance of transparency with the operations of their biobanks and gaining the trust of their stakeholders.ConclusionManagers of biobanks in LMICs in the Arab Middle East encounter financial, operational, and social challenges toward their sustainability efforts. Discussions with key stakeholders are warranted to manage ethical issues involving informed consent, privacy, data sharing, and the return of results. We recommend that biobank managers in the Arab Middle East form collaborative networks within the region and internationally, develop trusting governance relationships with their stakeholders, and pursue engagement activities with their communities to enhance trust. (shrink)

Zemyarska MS. Is it ethical to provide IVF add-ons when there is no evidence of a benefit if the patient requests it? J Med Ethics 2019;45:346–50. doi: 10.1136/medethics-2018-104983. The Acknowledgements section of ….

Developments in medical big data analytics may bring societal benefits but are also challenging privacy and other ethical values. At the same time, an overly restrictive data protection regime can form a serious threat to valuable observational studies. Discussions about whether data privacy or data solidarity should be the foundational value of research policies, have remained unresolved. We add to this debate with an empirically informed ethical analysis. First, experiences with the implementation of the General Data Protection Regulation (GDPR) (...) within a European research consortium demonstrate a gap between the aims of the regulation and its effects in practice. Namely, strictly formalised data protection requirements may cause routinisation among researchers instead of substantive ethical reflection, and may crowd out trust between actors in the health data research ecosystem; while harmonisation across Europe and data sharing between countries is hampered by different interpretations of the law, which partly stem from different views about ethical values. Then, building on these observations, we use theory to argue that the concept of trust provides an escape from the privacy-solidarity debate. Lastly, the paper details three aspects of trust that can help to create a responsible research environment and to mitigate the encountered challenges: trust as multi-agent concept; trust as a rational and democratic value; and trust as method for priority setting. Mutual cooperation in research—among researchers and with data subjects—is grounded in trust, which should be more explicitly recognised in the governance of health data research. (shrink)

This "cutting edge" anthology of recent articles explores important contemporary ethical issues that arise in the health care professions. Argument-based in style and tone, it features unique first-person interviews with prominent practitioners in biomedicine, case studies from both the administrative and "front-line" perspectives, and a worldview methodology for linking theory to action. Explores such areas as the Hippocratic Oath; Paternalism and Autonomy; Privacy and Confidentiality; Informed Consent; Gender Issues; Genetic Engineering; Euthanasia; Abortion; and Healthcare Policy in the United States (...) (with regard to the "right" to healthcare and to the allocation of transplants). For anyone in the biomedical professions, including biomedical or laboratory administrators, managers, or supervisors, as well as practitioners such as physicians, nurses, or other health care professionals who deal directly with patients. (shrink)

Non-Invasive Prenatal Testing is a technology which provides information about fetal genetic characteristics very early in pregnancy by examining fetal DNA obtained from a sample of maternal blood. NIPT is a morally complex technology that has advanced quickly to market with a strong push from industry developers, leaving many areas of uncertainty still to be resolved, and creating a strong need for health policy that reflects women’s social and ethical values. We approach the need for ethical policy-making by (...) studying the use of NIPT and emerging policy in the province of Ontario, Canada. Using an adapted version of constructivist grounded theory, we conducted interviews with 38 women who have had personal experiences with NIPT. We used an iterative process of data collection and analysis and a staged coding strategy to conduct a descriptive analysis of ethics issues identified implicitly and explicitly by women who have been affected by this technology. The findings of this paper focus on current ethical issues for women seeking NIPT, including place in the prenatal pathway, health care provider counselling about the test, industry influence on the diffusion of NIPT, consequences of availability of test results. Other issues gain relevance in the context of future policy decisions regarding NIPT, including funding of NIPT and principles that may govern the expansion of the scope of NIPT. These findings are not an exhaustive list of all the potential ethical issues related to NIPT, but rather a representation of the issues which concern women who have personal experience with this test. Women who have had personal experience with NIPT have concerns and priorities which sometimes contrast dramatically with the theoretical ethics literature. These findings suggest the importance of engaging patients in ethical deliberation about morally complex technologies, and point to the need for more deliberative patient engagement work in this area. (shrink)