In the first five of these articles I have questioned the justice, and effectiveness, of total dependence in clinical research on willing volunteers. I have explored ways that might better and more equitably spread the burden of participating in clinical research as subjects of it. Here I consider this question: if consent is the barrier, must we regard consent as indispensable?

With the rapid advancements made in biotechnology, bioethical discourse has become increasingly important. Bioethics is a multidisciplinary and interdisciplinary field that goes beyond the realm of natural sciences, and has involved fields in the domain of the social sciences. One of the important areas in bioethical discourse is religion. In a country like Malaysia, where Muslims make up the majority of the population, Islam plays a crucial role in providing the essential guidelines on the permissibility and acceptability of biotechnological applications (...) in various fields such as medicine, agriculture, and food processing. This article looks at the framework of a complementary model of bioethics derived from the perspective of Islam. The framework is based on ‘maqasid al-shariah’ (purposes or objectives of Islamic law) which aims to protect and preserve mankind’s faith, life, intellect, progeny, and property. It is proposed that ‘maqasid al-shariah’ be used as a pragmatic checklist that can be utilized in tackling bioethical issues and dilemmas. (shrink)

A review of medical ethics literature relating to the importance of the participation of patients in decision-making introduces the role of rights-based mediation as a voluntary process now being developed innovatively in America. This is discussed in relation to the theory of communicative ethics and moral personhood. References are then made to the work of medical ethics committees and the role of mediation within these. Finally it is suggested that mediation is part of an eirenic ethic already being used informally (...) in good patient care, and that there is a case for developing it further. (shrink)

: Genetic interventions raise a host of moral issues and, of its various species, germ-line genetic enhancement is the most morally contentious. This paper surveys various arguments against germ-line enhancement and attempts to demonstrate their inadequacies. A positive argument is advanced in favor of certain forms of germ-line enhancements, which holds that they are morally permissible if and only if they augment Rawlsian primary goods, either directly or by facilitating their acquisition.

A discussion of ethical decision-making literature is overdue. In this article, we summarize the current literature of ethical decision-making models used in mental health professions. Of 1,520 articles published between 2001 and 2020 that met initial search criteria, 38 articles were included. We report on the status of empirical evidence for the use of these models along with comparisons, limitations, and considerations. Ethical decision-making models were synthesized into eight core procedural components and presented based on the composition of steps present (...) in each model. This taxonomy provides practitioners, trainers, students, and supervisors relevant information regarding ethical decision-making models. (shrink)

The aim of this paper is to analyze an Intensive Care Unit case that required ethics consultation at a University Hospital in Northern Italy. After the case was resolved, a retrospective ethical analysis was performed by four clinical ethicists who work in different healthcare contexts. Each ethicist used a different method to analyze the case; the four general approaches provide insight into how these ethicists conduct ethics consultations at their respective hospitals. Concluding remarks examine the similarities and differences among the (...) various approaches and offer a reflection concerning the possibility of a shared resolution to the case. The authors’ efforts to come to a tentative consensus may serve as an example for professionals working in medical contexts that reflect an increasing pluralism of values. This article aims to respond to some of these concerns by illustrating how different methods in clinical ethics would be used when considering a real case. The goal is not to establish the best model on a theoretical level, but to learn from actual practice in order to see if there are common elements in the different methods, and to validate their pertinence to clinical ethics consultation. (shrink)

This article presents the case of an HIV-positive client who reported having sexual relations with an unknowing partner. The issue raised is whether the therapist was required to warn the unknowing partner, similar to the Tarasoff mandate that is imposed on therapists. The case is analyzed from an ethical framework similar to that presented by Beauchamp and Childress. Two opinions are presented, each leading to different conclusions about whether the therapist should inform the unknowing partner. It is concluded that although (...) such analysis is valuable in aiding the therapist in his or her decision-making process, no clear professional standard for the management of the problem is evident. (shrink)

The new field of neuroethics has recently emerged following unprecedented developments in the neurosciences. Neuroimaging and cognitive enhancement in particular are demanding ethical debate. For example, neuroscientists are able to measure, with increasing accuracy, intimate personal biases and thoughts as they occur in the brain. Smart drugs are now available that can effectively and safely enhance mental functioning in both healthy and clinical populations. This article describes the scientific principles behind these technologies, and urges the development of ethical principles based (...) on a clear understanding of them. Europe should take the United States’ lead in devoting resources specifically intended to examine neuroethical concerns within European healthcare and legal frameworks. (shrink)

A patient with AIDS dementia was confronted and compulsorily prevented from flying out of the country before being admitted against his will to hospital. While finding this on balance justified in the circumstances the commentators raise moral questions about the levels of care in general practice and within the couple's own relationships.

Despite the extensive consideration the notion of informed consent has heralded in recent decades, the unique considerations pertaining to the giving of informed consent by and on behalf of Indigenous Australians have not been comprehensively explored; to the contrary, these issues have been scarcely considered in the literature to date. This deficit is concerning, given that a fundamental premise of the doctrine of informed consent is that of individual autonomy, which, while privileged as a core value of non-Indigenous Australian culture, (...) is displaced in Indigenous cultures by the honouring of the family unit and community group, rather than the individual, as being at the core of important decision-making processes relating to the person. To address the hiatus in the bioethical literature on issues relating to informed consent for Aboriginal peoples, the following article provides findings from a two-year research project, funded by Australia’s National Health and Medical Research Council (NHMRC), conducted in the Northern Territory. The findings, situated in the context of the literature on cultural safety, highlight the difference between the Aboriginal and biomedical perspectives on informed consent. (shrink)

In clinical research – whether pharmaceutical, genetic or biomarker research – it is important to protect research participants’ autonomy and to ensure or strengthen their control over health-related decisions. Empirical–ethical studies have argued that both the ethical concept and the current legalistic practice of informed consent should be adapted to the complexity of the clinical environment. For this, a better understanding of recruitment, for which also the physician–patient relationship plays an important role, is needed.Our aim is to ethically reflect communication (...) processes by identifying patterns used by physicians to motivate patients’ participation in clinical research and to assess whether patients also use these patterns in formulating their own research motivation. We conducted a secondary analysis with empirical data from a research project involving physicians and patients in a clinical research setting of a biomarker study for rectal cancer treatment. Our empirical data included observations of physician–patient consultations ( n = 54) and semi-structured interviews with patients ( n = 40). Overall, we collected 93 interviews.We found two dominant communication patterns, which physicians applied for motivating patients to take part in this research study. Some forms of these patterns tend to mislead patients’ understanding, while others could justifiably be applied in this consultation setting without undermining patients’ autonomy. This insight that the physician–patient communication has a strong influence on patients increases the importance to strengthen physicians’ ethically acceptable communication patterns regarding research participation.We further suggest that there is a need for a critical reflection of the ethics committee’s requirements for information regarding research participation. (shrink)

The increased competition for a share of the market of insured patients, which arose in the wake of failed comprehensive health care reform, has provoked questions about what, if any, standards will govern new “competitive” health care organizations. Managed care arrangements, which typically shift to providers and patients some or all of the financial risk for patient care, are of special concern because they can create incentives to withhold beneficial care from patients. Of course, fee-for-service medical practice creates incentives to (...) provide unnecessary services, and managed care can avoid that type of harm. Still, as Edmund Pellegrino has noted, “managed care, by its nature, places the good of the patient into conflict with … the good of all the other patients served by the plan; the good of the plan and the organization, themselves…; and the self-interest of the physician. (shrink)

Two key themes structure the work of French philosopher of science Gilbert Simondon: the processes of individuation and the nature of technical objects. Moreover, these two themes are also at the heart of contemporary debates within Ethics and Bioethics. Indeed, the question of the individual is a key concern in both Virtue Ethics and Feminist Ethics of Care, while the hyper-technical reality of the present stage of medical technology is a key reason for both the urgency for and the success (...) of the field of Bioethics. And yet, despite its potential for thinking about these issues, Simondon’s philosophy remains largely unknown. Rather than exploring Simondon’s complex ontology for itself, the aim of this paper is to establish what contribution his work can make in Ethics and Bioethics on two essential questions: the relational structure of the self and the nature of the human-technology relation. I argue that Simondon’s re-conceptualization of the individual harmonizes with perspectives in Feminist Bioethics (particularly the Ethics of Care) and points toward what I call an “open” Virtue Ethics that takes relations to be essential. In order to establish this connection, I explore at length the relational approach to Feminist Bioethics offered by Susan Sherwin’s work. I argue that a Simondonian account of technology and of the individual furthers the relational understanding of the self, offers a characterization of Virtue Ethics that is in harmony with the Ethics of Care, and clarifies a notion of responsibility that is implicated in the complex reality of the modern technological milieu. (shrink)

In one study funded by the United States Department of Agriculture, people from North Dakota were interviewed to discover which moral principles they use in evaluating the morality of transgenic organisms and their introduction into markets. It was found that although the moral codes the human subjects employed were very similar, their views on transgenics were vastly different. In this paper, the codes that were used by the respondents are developed, compared to that of the academically composed Belmont Report, and (...) then modified to create the more practical Common Moral Code. At the end, it is shown that the Common Moral Code has inherent inconsistency flaws that might be resolvable, but would require extensive work on the definition of terms and principles. However, the effort is worthwhile, especially if it results in a common moral code that all those involved in the debate are willing to use in negotiating a resolution to their differences. (shrink)

The prevailing case study approach to teaching biomedical ethics is compared with a new methodology using short written exercises designed to develop decision making skills. Course content of this new approach and its adaptability to computer assisted instruction with student-faculty interactive software are outlined.

This essay has two purposes. The first is to argue that our moral duties towards human embryos should be assessed in light of the Golden Rule by asking the normative question, “how would I want to be treated if I were an embryo?” Some reject the proposition “I was an embryo” on the basis that embryos should not be recognized as persons. This essay replies to five common arguments denying the personhood of human embryos: (1) that early human embryos lack (...) ontological individuation; (2) that they are members of the species Homo sapiens but not yet human persons; (3) that the argument for personhood commits the “heap argument” fallacy; (4) that since human procreation in nature is inefficient, human embryos cannot be persons; and (5) the “burning building” scenario proves that all arguments for personhood are irrational or inconsistent. The second purpose is to set forth and criticize in light of the normative judgement defended in part one the present legal situation of cryo-preserved embryos in the U.S. The essay ends by proposing legislative reforms to protect ex utero human embryos. (shrink)

In these articles I have so far explored the set of duties that call upon patients to participate in clinical research as subjects of it. Here I consider whether they acquire a set of rights in consequence of participation, and what these rights may be.

There is a “revolving door” between federal agencies and the industries regulated by them. Often, at the end of their industry tenure, key industry personnel seek employment in government regulatory entities and vice versa. The flow of workers between the two sectors could bring about good. Industry veterans might have specialized knowledge that could be useful to regulatory bodies and former government employees could help businesses become and remain compliant with regulations. But the “revolving door” also poses at least three (...) ethical and policy challenges that have to do with public trust and fair representation. First, the presence of former key industry personnel on review boards could adversely impact the public’s confidence in regulatory decisions about new technology products, including agrifood biotechnologies. Second, the ‘‘revolving door’’ may result in policy decisions about technologies that are biased in favor of industry interests. And third, the ‘‘revolving door’’ virtually guarantees industry a voice in the policy-making process, even though other stakeholders have no assurance that their concerns will be addressed by regulatory agencies. We believe these three problems indicate a failure of regulatory review for new technologies. The review process lacks credibility because, at the very least, it is procedurally biased in favor of industry interests. We argue that prohibiting the flow of personnel between regulatory agencies and industry would not be a satisfactory solution to the three problems of public trust and just representation. To address them, regulatory entities must reject the traditional notion of objectivity. Instead they should adopt the conception of objectivity developed by Sandra Harding and re-configure their regulatory review on the basis of it. That will ensure that a heterogeneous group of stakeholders is at the decision-making table. The fair representation of interests of different constituencies in the review process could do much to inspire warranted public confidence in regulatory protocols and decisions. (shrink)

This paper reports the responses of 251 mental health care practitioners to a mail survey examining their views concerning ethical conflicts and practices within their work environments. Besides identifying the sources and types of conflicts they experience, respondents were asked how ethical standards have changed over the last 10 years as well as the factors influencing these changes. Conclusions and implications are outlined and future research needs are described.

U.S. approaches to oversight of research and technological products have developed over time in an effort to ensure safety to humans, animals, and the environment and to control use in a social context. In modern times, regulatory and oversight tools have evolved to include diverse approaches such as performance standards, tradable allowances, consultations between government and industry, and pre-market safety and efficacy reviews. The decision whether to impose an oversight system, the oversight elements, the level of oversight, the choice of (...) approach, and its execution can profoundly affect technological development, individual and collective interests, and public confidence in technological products. Oversight is conducted by a range of institutions with various capabilities, cultures, and motives. Avenues for disputing oversight decisions are also important, and some argue that the U.S. operates in an adversarial regulatory culture in which Congress, the media, and stakeholders regularly contest the decisions of federal agencies. (shrink)

Die Behandlung von einwilligungsunfähigen psychisch kranken Menschen mit neuen Therapiemethoden ist insbesondere im Kontext des „individuellen Heilversuchs“, der als Anwendung wenig erprobter Therapieansätze im Rahmen von „ultima ratio“-Entscheidungen charakterisiert ist, mit ethischen Abwägungsproblemen verbunden. Diese bestehen aufgrund von Einschränkungen in der Handlungs- und Entscheidungsautonomie der betroffenen Patienten und, aufgrund eigen- oder fremdgefährdender Symptome der psychischen Krankheit selbst, insbesondere in der praktischen Umsetzung ethisch akzeptierter Modelle stellvertretender Entscheidung sowie in der Wahl des Bezugspunkts der Nutzen-Risiko-Analyse des intendierten Therapieverfahrens. Der Artikel untersucht (...) den ethischen Konflikt zwischen gerechtfertigter Hilfeleistung und Instrumentalisierungsrisiko psychisch kranker Menschen zu Fremdzwecken am historischen Beispiel der „Rindenexcisionen“ des Psychiaters Gottlieb Burckhardt (1836–1907). Als Lösungsmöglichkeit dieses ethischen Konflikts wird das „Konzept des kontrollierten individuellen Heilversuchs“ diskutiert. (shrink)

What relationship between investigators and subjects of clinical research would best meet the needs and wants of both – and of society, which has an interest not only in clinical research being done but also in its being done well? This series of articles argues that investigators and subjects should work together in a partnership based in shared aims. Other relationships are possible, however, and here I examine two.

If patients are to be partners rather than subjects, contributing effectively to clinical research in which they have an interest, both they and investigators must change their ways. The case is argued here that the conduct of clinical research fulfils an essential need of society and that, therefore, in the interests of society, there is a moral imperative that it be done. Further essays will develop this theme, questioning along the way whether consent is a redundant concept.

To better understand the available publications addressing ethical issues in rural health care we sought to identify the ethics literature that specifically focuses on rural America. We wanted to determine the extent to which the rural ethics literature was distributed between general commentaries, descriptive summaries of research, and original research publications. We identified 55 publications that specifically and substantively addressed rural health care ethics, published between 1966 and 2004. Only 7 (13%) of these publications were original research articles while (12) (...) 22% were descriptive summaries of research and 36 (65%) were general commentaries. The majority of publications examined (55%) were clinically focused while 27% addressed organizational ethics and 18% addressed ethical ramifications of rural health care policy at a national or community level. Our findings indicate that there are a limited number of publications focusing on rural health care ethics, suggesting a need for scholars and researchers to more rigorously address rural ethics issues. (shrink)

Most contributions to the current debate about the consideration and application of empirical information in ethics scholarship deal with epistemological issues such as the role and the meaning of empirical research in ethical reasoning. Despite the increased publication of empirical data in ethics literature we still lack systematic analyses and conceptual frameworks that would help us to understand the rarely discussed methodological and practical problems in appraising empirical research. This paper demonstrates the need for critical appraisal and its crucial methodological (...) role in the application of empirical information in ethical reasoning. Furthermore, it systematically examines the criteria and the appropriate appraisal of empirical research and the associated challenges by highlighting current problems in empirical ethics literature. These problems reveal the following challenges for a critical and responsible consideration of empirical information in ethical reasoning: (i) training in the basic skills of locating and communicating empirical data from the relevant studies; (ii) training in basic knowledge of how to critically appraise empirical (qualitative and quantitative) research and its results; (iii) determination of quality standards for empirical ethics research; (iv) adequate reporting of the methodology and results of empirical ethics research in scientific journals. (shrink)

This series of articles argues for a different relationship between investigators and subjects of clinical research based on partnership in shared aims and recognition, by each, of their duties within this partnership. This second essay describes how those duties arise and explores the basis on which, and by and to whom, they are owed. The conclusion that patients have duties in research raises a number of moral issues which, ultimately, question the concept of consent. Discussion of these will be continued (...) in future articles. (shrink)

Risk analysis and regulatory systems are usually evaluated according to utilitarian frameworks, as they are viewed to operate “objectively” by considering the health, environmental, and economic impacts of technological applications. Yet, the estimation of impacts during risk analysis and the decisions in regulatory review are affected by value choices of actors and stakeholders; attention to principles such as autonomy, justice, and integrity; and power relationships. In this article, case studies of biotechnology are used to illustrate how non-utilitarian principles are prominent (...) in risk analysis and regulatory review and to argue that these relationships should be carefully considered as we consider nanotechnology oversight systems for its products. We argue that there are not distinct separations between “science-based” review systems, in which evaluations of the consequences of technological products are primarily considered, and principles of integrity, justice, non-maleficence, and autonomy. It should further be expected that, given research into fair treatment during decision-making processes, attention to ethics will affect how citizens assess emerging technologies. Finally, a more holistic approach for evaluating oversight systems for the products of nanotechnology is suggested, one which does not draw a sharp distinction between risk analysis, regulation, and respect for non-utilitarian values. (shrink)

In a series of articles, I argue for a different relationship between investigators and subjects of clinical research – one that is based on partnership in shared aims. This would require significant behavioural change since any relationship of this nature requires each partner to recognise their duties within it. This third essay examines the duties that would fall on patients in this partnership.