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Ethical issues in HIV research in poor countries.

PURPOSE: To increase awareness of the potential for conducting unethical research in poor nations in the name of scientific inquiry, and to enumerate ethical questions in HIV/AIDS research. ORGANIZING CONSTRUCT: Principles of ethics and ethical analysis in clinical research. SOURCES AND METHODS: Review of literature on ethical principles of research in developing nations. FINDINGS: People who participate in clinical trials in poor countries often do so because that may be the only way to gain access to health care. However, access to tested drugs beyond clinical trials is not guaranteed. Participants often do not understand the consequences of being research subjects. CONCLUSIONS: Conducting research in poor nations requires recognition of ethical issues and maintenance of ethical standards, regardless of material wealth of the countries. Ethical standards also indicate including people from the target population in decisions relating to designing and conducting clinical trials.

Clinical Protocols↗

Using explicit decision rules to manage issues of justice, risk, and ethics in decision analysis: when is it not rational to maximize expected utility?

Concepts of justice, risk, and ethics can be merged with decision analysis by requiring the analyst to specify explicity a decision rule or sequence of rules. Decision rules are categorized by whether they consider: 1) aspects of outcome distributions beyond central tendencies; 2) probabilities as well as utilities of outcomes; and 3) means as well as ends. This formulation suggests that distribution-based decision rules could address both risk (for an individual) and justice (for the population). Rational choice under risk if choices are one-time only (vs. repeated events) or if one branch contains unlikely but disastrous outcomes might ignore probability information. Incorporating risk attitude into decision rules rather than utilities could facilitate use of multiattribute approaches to measuring outcomes. Certain ethical concerns could be addressed by prior specification of rules for allowing particular branches. Examples, including selection of polio vaccine strategies, are discussed, and theoretical and practical implications of a decision rule approach noted.

Beneficence↗

Advanced training in biomedical ethics: a curriculum in clinical specialty programmes.

Medical ethics play an essential role in the practice of medicine, in the care of individual patients, in the allocation of health care resources, and in the formulation of health care policy. A specific body of knowledge, 'biomedical ethics', has developed which applies ethical theory to biomedical practice. This has provided doctors with tools systematically to integrate rational ethical analysis into clinical decision-making. Training in the discipline of biomedical ethics is now required for all doctors in Canada. The goals, content areas, learning objectives, and learning methods considered appropriate for advanced training in this field for medical specialists are provided in this paper. Six topic areas are discussed: introduction to ethical theory, clinical ethics, professional ethics, ethics of human experimentation, ethics of health policy, and independent study. Ways this curriculum could be organized and evaluated are also offered.

Curriculum↗

Critical care in the Philippines: the "Robin Hood Principle" vs. Kagandahang loob.

Practical medical decisions are closely integrated with ethical and religious beliefs in the Philippines. This is shown in a survey of Filipino physicians' attitudes towards severely compromised neonates. This is also the reason why the ethical analysis of critical care practices must be situated within the context of local culture. Kagandahang loob and kusang loob are indigenous Filipino ethical concepts that provide a framework for the analysis of several critical care practices. The practice of taking-from-the-rich-to-give-to-the-poor in public hospitals is not compatible with these concepts. The legislated definition of death and other aspects of the Philippine Law on Organ Transplants also fail to be compatible with these concepts. Many ethical issues that arise in a critical care setting have their roots outside the seemingly isolated clinical setting. Critical care need not apply only to individuals in a serious clinical condition. Vulnerable populations require critical attention because potent threats to their lives exist in the water that they drink and the air that they breathe. We cannot ignore these threats even as we move inevitably towards a technologically dependent, highly commercialized approach to health management.

Bioethical Issues↗

How physicians face ethical difficulties: a qualitative analysis.

BACKGROUND: Physicians face ethical difficulties daily, yet they seek ethics consultation infrequently. To date, no systematic data have been collected on the strategies they use to resolve such difficulties when they do so without the help of ethics consultation. Thus, our understanding of ethical decision making in day to day medical practice is poor. We report findings from the qualitative analysis of 310 ethically difficult situations described to us by physicians who encountered them in their practice. When facing such situations, the physicians sought to avoid conflict, obtain assistance, and protect the integrity of their conscience and reputation, as well as the integrity of the group of people who participated in the decisions. These goals could conflict with each other, or with ethical goals, in problematic ways. Being aware of these potentially conflicting goals may help physicians to resolve ethical difficulties more effectively. This awareness should also contribute to informing the practice of ethics consultation. OBJECTIVE: To identify strategies used by physicians in dealing with ethical difficulties in their practice. DESIGN, SETTING, AND PARTICIPANTS: National survey of internists, oncologists, and intensive care specialists by computer assisted telephone interviews (n = 344, response rate = 64%). As part of this survey, we asked physicians to tell us about a recent ethical dilemma they had encountered in their medical practice. Transcripts of their open-ended responses were analysed using coding and analytical elements of the grounded theory approach. MAIN MEASUREMENTS: Strategies and approaches reported by respondents as part of their account of a recent ethical difficulty they had encountered in their practice. RESULTS: When faced with ethical difficulties, the physicians avoided conflict and looked for assistance, which contributed to protecting, or attempting to protect, the integrity of their conscience and reputation, as well as the integrity of the group of people who participated in the decisions. These efforts sometimes reinforced ethical goals, such as following patients' wishes or their best interests, but they sometimes competed with them. The goals of avoiding conflict, obtaining assistance, and protecting the respondent's integrity and that of the group of decision makers could also compete with each other. CONCLUSION: In resolving ethical difficulties in medical practice, internists entertained competing goals that they did not always successfully achieve. Additionally, the means employed were not always the most likely to achieve those aims. Understanding these aspects of ethical decision making in medical practice is important both for physicians themselves as they struggle with ethical difficulties and for the ethics consultants who wish to help them in this process.

Adult↗

[In the search of a language for medical ethics].

After World War II, the interest in medical ethics increased and several international codes defending patients rights appeared. Four pragmatic, non ideological and non religious principles were defined to analyze clinical ethical problems. Autonomy, the capacity of self management and to reach our own informed decisions; the informed consent is the way to accomplish this principle. Beneficence, the basic principle of medical acts, with the risk of being transformed in an extreme paternalism. A reinterpretation of beneficence equilibrates the rights of patients physicians. Non wickedness, first of all not to harm, a Hippocratic idea to prevent iatrogenesis and Justice, to maintain personal, social and political equity. These principles are a language, an ethical analysis methodology and give clues for our relationship with patients. They are a guide for personal analysis, reflection and change and show a collective and individual path to incorporate ethics to our daily work.

Ethics, Medical↗

Ethics, politics, and human embryo stem cell research.

Three reports on ethical aspects of research involving human embryonic stem cells were issued in the final months of 1999. Two were from governmental agencies or commissions: the National Institutes of Health and the National Bioethics Advisory Commission. The third report was issued by the American Association for the Advancement of Science and the Institute for Civil Society. All three reports endorse the use of federal funds for embryonic stem cell research, but other differences distinguish these reports. This article describes the differences and provides an ethical analysis of the main arguments.

Embryo, Mammalian↗

Ethics and public health: forging a strong relationship.

The field of bioethics arose in the late 1960s in response to the emerging ethical dilemmas of that era. The field for many years focused in general on the dilemmas generated by high-technology medicine rather than on issues of population health and the ethical problems of public health programs and regulations. The time has come to more fully integrate the ethical problems of public health into the field of public health and, at the same time, into the field of bioethics. Public health raises a number of moral problems that extend beyond the earlier boundaries of bioethics and require their own form of ethical analysis.

Bioethics↗

Evidence-based ethics for neurology and psychiatry research.

American bioethics, historically arising out of theology and philosophy, has been dominated by the method of normative analysis. Ethics as policy, however, requires in addition a solid evidence base. This paper discusses the background conditions that make neurotherapeutics research particularly challenging. Three key ethical issues are discussed within an evidence-based ethics framework: the ethical challenges arising from changes in the financial incentive structures for academic researchers and their institutions, the challenges of risk-benefit analysis for neurotherapeutics protocols testing innovative interventions, and the evolving issues surrounding impaired decision-making capacity and surrogate consent for research. For each of these issues, selected empirical data are reviewed, areas for further inquiry are noted, and the need for development of novel methods for bioethics policy research is discussed.

Bioethical Issues↗

The contribution of Kantian moral theory to contemporary medical ethics: a critical analysis.

Kantian deontology is one of three classic moral theories, among virtue ethics and consequentialism. Issues in medical ethics are frequently addressed within a Kantian paradigm, at least --although not exclusively--in European medical ethics. At the same time, critical voices have pointed to deficits of Kantian moral philosophy which must be examined and discussed. It is argued that taking concrete situations and complex relationships into account is of paramount importance in medical ethics. Encounters between medical or nursing staff and patients are rarely symmetrical relationships between autonomous and rational agents. Kantian ethics, the criticism reads, builds on the lofty ideal of such a relationship. In addition to the charge of an individualist and rationalist focus on autonomy, Kantian ethics has been accused of excluding those not actually in possession of these properties or of its rigorism. It is said to be focussed on laws and imperatives to an extent that it cannot appreciate the complex nuances of real conflicts. As a more detailed analysis will show, these charges are inadequate in at least some regards. This will be demonstrated by drawing on the Kantian notion of autonomy, the role of maxims and judgment and the conception of duties, as well as the role of emotions. Nevertheless the objections brought forward against Kantian moral theory can help determine, with greater precision, its strengths and shortcomings as an approach to current problems in medical ethics.

Emotions↗

When consent is unbearable: an alternative case analysis.

Dr Agich takes up a previous difficult case related by Dr Kottow in an earlier issue of the Journal. He analyses the three ethical problems as presented in the case and offers his own opinion of it as well as his own conclusions with regard to the medical ethical aspects of it. Unlike Dr Kottow, Dr Agich's reading of the case indicates that the application of the principle of informed consent does not rule out ethical decisions for the physician, but emphasizes the relevance of ethical analysis beyond the issue of informed consent.

Adenocarcinoma↗

[Research ethics: the case with the tule (kuna), Urabbá, Colombia].

An ethical analysis was performed during the development of a research project titled "Culture, nourishment and malaria in the Kuna aboriginals of Urabá, Colombia." This project had 2 objectives; (1) to investigate the prevalence of malaria and its relationship with hypovitaminosis A and nutritional status, and (2) to understand the community's conceptions and practices towards malaria. The current paper summarizes reflections concerning the application of ethical principles and moral values during the course of the malaria research project. Two intercultural relationships were clearly defined: the culture of the Tule (Kuna) Indians, with a traditional medical system, and the culture of the research group, focused on the biomedical model. The rationale and the discussion proposed during the writing of the project proposal was presented as well as the dilemmas that developed during the project within the communities. These problems required rapid decision-making in situations for which the scientists had not been adequately prepared. A need was indicated for application of ethical principles to permeate the analysis throughout the research process in a horizontal manner, such that the human dignity of the participants and the ethnicity of the community are preserved above the purposes of the project. In the research process, mediation between the ethics of conviction and the ethics of consequences must take precedence, with both outcomes tied to an informed consent in place during the process. The establishment of national and local research ethics committees was indicated as necessary to preserve the lifestyle and culture of the ethnic groups. These values were seen as endangered given the trading pressures and health policies in a globalized world.

Colombia↗

Ethical issues for bioscientists in the new millennium.

The scientific understanding of biological processes is developing extremely fast, providing opportunities for changing people's lives in many ways-through health care, food and the environment. The speed with which these changes are occurring means that even bioscientists can only keep up with their own narrow field of science. It is not surprising that members of the public are frightened about the rapidity and impact of the changes arising from the biological revolution. These concerns are often expressed in ethical terms. Decision making about the direction of research and its application is becoming more transparent. This means that bioscientists will have to engage in the debate about their work with members of the public, including those who are opposed to it, in order to create acceptance of their work and its products. At the moment, bioscientists are often ill equipped to enter this debate because of their lack of training in ethics and lack of understanding of the impact of ethics on their work. A better understanding of bioethics will be necessary for entering this debate with vigour. A comprehensive ethical analysis is outside the scope of this text. Some of the principal arguments about the ethics of two aspects of bioscience research-genetically modified crops and the use of experimental animals-will be discussed to illustrate a few of the issues that derive from ethical analyses. I hope that this will encourage toxicologists to take a greater interest in bioethics.

Animal Welfare↗

Issues in genetic testing of children.

Commentary about the ethical issues involved in the genetic testing in children (GTIC) has centered around beliefs that early testing of children when no medical benefits are anticipated should be discouraged. This article discusses the types of GTIC and the contexts of possible testing scenarios, and provides a review of the current research into the effects of such testing on children and their families. As data cannot support either substantive benefits or harms accrued after GTIC, it is recommended that the traditional ethical analysis based on principled theory be augmented by theories that reflect a family-centered ethic.

Child↗

Community health and ethical theory: implications for holistic nursing.

A conceptual shift from Enlightenment philosophies to communitarian virtues is discussed. Epidemics and preventing disease spread are used as a basis for discussing the major bioethical concepts beneficence, justice, respect for autonomy, and Moskop's principle of restrictive measures. The addition of the concept of community and communitarian virtues to the ethical analysis is discussed. Holistic nurses are challenged to develop and employ morally sound rationale for ethical decisions.

Beneficence↗

Who has the right to know the genetic constitution of a particular person?

Having conquered computer science, linguistics and aesthetics, the 'informational paradigm' has finally reached bioscience. In terms of information theory a human being's personal identity is defined by his/her unique combination of genetic information ('genetic fingerprint'). Any ethical analysis of the accessibility of individual genetic data must therefore be considered both from a medical ethics and from an information ethics point of view. As far as medical ethics is concerned it is obvious that certain medical activities relating to the physical and psychological integrity of human beings require informed consent. Since all activity involved in revealing a person's genetic constitution fulfils the requirements of informed consent, it goes without saying that only the person concerned has the right to determine who should have access to his/her genetic information. From an information ethics point of view, however, there is by definition no such thing as the natural right to private ownership of any kind of information. Information is in principle rather defined as a publicly shared good. We could therefore conclude from this that in principle everyone has the right to know everyone else's genetic constitution. The paper discusses some of the resulting problems by analysing different sets of arguments and confronting them with higher-order principles of modern ethics.

Confidentiality↗

Issues in biomedical ethics.

Bioethics is the discipline of ethics dealing with moral problems arising in the practice of medicine and the pursuit of biomedical research. Physicians may confront ethical dilemmas regularly in their individual relationships with patients and in institutional and societal decisions on health care policy. Ethical problem solving requires the application of certain ethical rules and principles to specific situations. Although ethical theories differ, certain ethical rules and principles appear consistently. These include nonmaleficence, beneficence, respect for individual autonomy, confidentiality, and justice. This article discusses some of the ethical issues that arise in clinical practice, including informed consent, do-not-resuscitate orders, noninitiation and termination of medical therapy, genetic intervention, allocation of scarce health resources, and infection with the human immunodeficiency virus (HIV). Some of these problems require ethical analysis at the bedside; others require physician involvement on a broader level. Perspectives on the different ethical issues are presented; however, absolute answers to these ethical dilemmas are not provided. Interpretation of the ethical principles and the application of these principles to each clinical situation demands the thoughtful attention of the practitioner.

Acquired Immunodeficiency Syndrome↗