Selecting subjects for participation in clinical research: one sphere of justice.
Recent guidelines from the US National Institutes of Health (NIH) mandate the inclusion of adequate numbers of women in clinical trials. Ought such standards to apply internationally? Walzer's theory of justice is brought to bear on the problem, the first use of the theory in research ethics, and it argues for broad application of the principle of adequate representation. A number of practical conclusions for research ethics committees (RECs) are outlined. Eligibility criteria in clinical trials ought to be justified by trial designers. Research ethics committees ought to question criteria that seem to exclude unnecessarily women from research participation. The issue of adequate representation should be construed broadly, so as to include consideration of the representation of the elderly, persons with HIV, mental illness and substance abuse disorders in clinical research. (+info)
Confidentiality and HIV status in Kwazulu-Natal, South Africa: implications, resistances and challenges.
This article provides a contextualized comparison and analysis of the former Kwazulu and the new Kwazulu-Natal policy documents on HIV confidentiality, the differing practices within the region, and their implications for support and gender. It is based on interviews with key players in the regional NACOSA (National AIDS Convention of South Africa), and participation in meetings between August and November 1995. The main division is between those influenced by other rural African models, especially the Zambian concept of "shared confidentiality' as a way of ensuring support, and who have gone on to develop more community-based practices to destigmatize the disease, in contrast with the stronger emphasis in the new document on individual rights, assuming a more urban constituency, and where "shared confidentiality' is much more circumscribed. One of the difficulties of the new policy in which "confidentiality' is interpreted as "secrecy', is that it would seem to foreclose and neutralize lay and community support, as distinct from the earlier and unacknowledged policy of former Kwazulu. It also seeks to provide an enhanced role for professional counsellors. This psychologizing of the infection and the distancing from "community', and from women's groups, is surprising in a country in whose townships "community' remains a powerful motivating symbol, and where NGOs and peer groups have been identified everywhere as central to effective HIV/AIDS related prevention, care and support for behavior change. (+info)
Health outcomes and managed care: discussing the hidden issues.
Too often the debate over health outcomes and managed care has glossed over a series of complex social, political, and ethical issues. Exciting advances in outcomes research have raised hopes for logical medical reform. However, science alone will not optimize our patients' health, since value judgements are necessary and integral parts of attempts to improve health outcomes within managed care organizations. Therefore, to form healthcare policy that is both fair and efficient, we must examine the fundamental values and ethical concerns that are imbedded in our efforts to shape care. We must openly discuss the hidden issues including: (1) trade-offs between standardization of care and provider-patient autonomy; (2) effects of financial incentives on physicians' professionalism; (3) opportunity costs inherent in the design of insurance plans; (4) responsibilities of managed care plans for the health of the public; (5) judicious and valid uses of data systems; and (6) the politics of uncertainty. (+info)
Indigenous peoples and the morality of the Human Genome Diversity Project.
In addition to the aim of mapping and sequencing one human's genome, the Human Genome Project also intends to characterise the genetic diversity of the world's peoples. The Human Genome Diversity Project raises political, economic and ethical issues. These intersect clearly when the genomes under study are those of indigenous peoples who are already subject to serious economic, legal and/or social disadvantage and discrimination. The fact that some individuals associated with the project have made dismissive comments about indigenous peoples has confused rather than illuminated the deeper issues involved, as well as causing much antagonism among indigenous peoples. There are more serious ethical issues raised by the project for all geneticists, including those who are sympathetic to the problems of indigenous peoples. With particular attention to the history and attitudes of Australian indigenous peoples, we argue that the Human Genome Diversity Project can only proceed if those who further its objectives simultaneously: respect the cultural beliefs of indigenous peoples; publicly support the efforts of indigenous peoples to achieve respect and equality; express respect by a rigorous understanding of the meaning of equitable negotiation of consent, and ensure that both immediate and long term economic benefits from the research flow back to the groups taking part. (+info)
Impact of therapeutic research on informed consent and the ethics of clinical trials: a medical oncology perspective.
PURPOSE: To create a more meaningful understanding of the informed consent process as it has come to be practiced and regulated in clinical trials, this discussion uses the experience gained from the conduct of therapeutic research that involves cancer patients. DESIGN: After an introduction of the ethical tenets of the consent process in clinical research that involves potentially vulnerable patients as research subjects, background that details the use of written consent documents and of the term "informed consent" is provided. Studies from the cancer setting that examine the inadequacies of written consent documents, and the outcome of the consent process itself, are reviewed. Two ethically challenging areas of cancer clinical research, the phase I trial and the randomized controlled trial, are discussed briefly as a means of highlighting many dilemmas present in clinical trials. Before concluding, areas for future research are discussed. RESULTS: Through an exclusive cancer research perspective, many current deficiencies in the informed consent process for therapeutic clinical trials can be critically examined. Also, new directions for improvements and areas of further research can be outlined and discussed objectively. The goals of such improvements and research should be prevention of further misguided or ineffective efforts to regulate the informed consent process. CONCLUSION: To ignore this rich and interesting perspective potentially contributes to continued misunderstanding and apathy toward fulfilling the regulatory and ethically obligatory requirements involved in an essential communication process between a clinician-investigator and a potentially vulnerable patient who is considering clinical trial participation. (+info)
Protective truthfulness: the Chinese way of safeguarding patients in informed treatment decisions.
The first part of this paper examines the practice of informed treatment decisions in the protective medical system in China today. The second part examines how health care professionals in China perceive and carry out their responsibilities when relaying information to vulnerable patients, based on the findings of an empirical study that I had undertaken to examine the moral experience of nurses in practice situations. In the Chinese medical ethics tradition, refinement [jing] in skills and sincerity [cheng] in relating to patients are two cardinal virtues that health care professionals are required to possess. This notion of absolute sincerity carries a strong sense of parental protectiveness. The empirical findings reveal that most nurses are ambivalent about telling the truth to patients. Truth-telling would become an insincere act if a patient were to lose hope and confidence in life after learning of his or her disease. In this system of protective medical care, it is arguable as to whose interests are being protected: the patient, the family or the hospital. I would suggest that the interests of the hospital and the family members who legitimately represent the patient's interests are being honoured, but at the expense of the patient's right to know. (+info)
Ancient Chinese medical ethics and the four principles of biomedical ethics.
The four principles approach to biomedical ethics (4PBE) has, since the 1970s, been increasingly developed as a universal bioethics method. Despite its wide acceptance and popularity, the 4PBE has received many challenges to its cross-cultural plausibility. This paper first specifies the principles and characteristics of ancient Chinese medical ethics (ACME), then makes a comparison between ACME and the 4PBE with a view to testing out the 4PBE's cross-cultural plausibility when applied to one particular but very extensive and prominent cultural context. The result shows that the concepts of respect for autonomy, non-maleficence, beneficence and justice are clearly identifiable in ACME. Yet, being influenced by certain socio-cultural factors, those applying the 4PBE in Chinese society may tend to adopt a "beneficence-oriented", rather than an "autonomy-oriented" approach, which, in general, is dissimilar to the practice of contemporary Western bioethics, where "autonomy often triumphs". (+info)
Human rights is a US problem, too: the case of women and HIV.
Overall, US AIDS incidence and mortality have shown significant declines since 1996, probably because of new antiviral therapies. For women, however, these benefits have been much less pronounced than for men. At the heart of women's HIV risk is gender-based discrimination, which keeps women, and especially women of color, poor and dependent. Although human rights issues are often linked with AIDS issues abroad, in the US they receive insufficient attention in our response to women's HIV risk. Advocacy from public health professionals is needed to overcome the longstanding paternalistic attitudes of federal agencies toward women and to change the paradigm of women's HIV/AIDS prevention and care. Examples of unjust and punitive social policies that may affect women's HIV risk include the 1996 welfare policy legislation, drug treatment policies for women, and women's access to medical research and technology. The overriding public health response to AIDS consists of behavioral interventions aimed at the individual. But this approach will not successfully address the issues of women with AIDS until efforts are made to eliminate society's unjust and unhealthy laws, policies, and practicles. (+info)