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)
How physician executives and clinicians perceive ethical issues in Saudi Arabian hospitals.
OBJECTIVES: To compare the perceptions of physician executives and clinicians regarding ethical issues in Saudi Arabian hospitals and the attributes that might lead to the existence of these ethical issues. DESIGN: Self-completion questionnaire administered from February to July 1997. SETTING: Different health regions in the Kingdom of Saudi Arabia. PARTICIPANTS: Random sample of 457 physicians (317 clinicians and 140 physician executives) from several hospitals in various regions across the kingdom. RESULTS: There were statistically significant differences in the perceptions of physician executives and clinicians regarding the existence of various ethical issues in their hospitals. The vast majority of physician executives did not perceive that seven of the eight issues addressed by the study were ethical concerns in their hospitals. However, the majority of the clinicians perceived that six of the same eight issues were ethical considerations in their hospitals. Statistically significant differences in the perceptions of physician executives and clinicians were observed in only three out of eight attributes that might possibly lead to the existence of ethical issues. The most significant attribute that was perceived to result in ethical issues was that of hospitals having a multinational staff. CONCLUSION: The study calls for the formulation of a code of ethics that will address specifically the physicians who work in the kingdom of Saudi Arabia. As a more immediate initiative, it is recommended that seminars and workshops be conducted to provide physicians with an opportunity to discuss the ethical dilemmas they face in their medical practice. (+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)
Does justice require genetic enhancements?
It is argued that justice in some cases provides a pro tanto reason genetically to enhance victims of the genetic lottery. Various arguments--both to the effect that justice provides no such reason and to the effect that while there may be such reasons, they are overridden by certain moral constraints--are considered and rejected. Finally, it is argued that justice provides stronger reasons to perform more traditional medical tasks (treatments), and that therefore genetic enhancements should not play an important role in a public health care system. (+info)
The relation between funding by the National Institutes of Health and the burden of disease.
BACKGROUND: The Institute of Medicine has proposed that the amount of disease-specific research funding provided by the National Institutes of Health (NIH) be systematically and consistently compared with the burden of disease for society. METHODS: We performed a cross-sectional study comparing estimates of disease-specific funding in 1996 with data on six measures of the burden of disease. The measures were total mortality, years of life lost, and number of hospital days in 1994 and incidence, prevalence, and disability-adjusted life-years (one disability-adjusted life-year is defined as the loss of one year of healthy life to disease) in 1990. With the use of these measures as explanatory variables in a regression analysis, predicted funding was calculated and compared with actual funding. RESULTS: There was no relation between the amount of NIH funding and the incidence, prevalence, or number of hospital days attributed to each condition or disease (P=0.82, P=0.23, and P=0.21, respectively). The numbers of deaths (r=0.40, P=0.03) and years of life lost (r=0.42, P=0.02) were weakly associated with funding, whereas the number of disability-adjusted life-years was strongly predictive of funding (r=0.62, P<0.001). When the latter three measures were used to predict expected funding, the conclusions about the appropriateness of funding for some diseases varied according to the measure used. However, the acquired immunodeficiency syndrome, breast cancer, diabetes mellitus, and dementia all received relatively generous funding, regardless of which measure was used as the basis for calculating support. Research on chronic obstructive pulmonary disease, perinatal conditions, and peptic ulcer was relatively underfunded. CONCLUSIONS: The amount of NIH funding for research on a disease is associated with the burden of the disease; however, different measures of the burden of disease may yield different conclusions about the appropriateness of disease-specific funding levels. (+info)
Equitable rationing of highly specialised health care services for children: a perspective from South Africa.
The principles of equality and equity, respectively in the Bill of Rights and the white paper on health, provide the moral and legal foundations for future health care for children in South Africa. However, given extreme health care need and scarce resources, the government faces formidable obstacles if it hopes to achieve a just allocation of public health care resources, especially among children in need of highly specialised health care. In this regard, there is a dearth of moral analysis which is practically useful in the South African situation. We offer a set of moral considerations to guide the macro-allocation of highly specialised public health care services among South Africa's children. We also mention moral considerations which should inform micro-allocation. (+info)
Research, ethics and conflicts of interest.
In this paper, I have tried to develop a critique of committee procedures and conflict of interest within research advisory committees and ethical review committees (ERCs). There are specific features of conflict of interest in medical research. Scientists, communities and the subjects of research all have legitimate stakeholdings. The interests of medical scientists are particularly complex, since they are justified by the moral and physical welfare of their research subjects, while the reputations and incomes of scientists depend on the success of their science. Tensions of this kind must at times produce conflict of interest. It is important to recognise that conflicts of interest may unwittingly lead to manipulation of research subjects and their lay representatives on research committees. It is equally important to recognise distinctions between the legal and moral aspects of conflict of interest. Some practical suggestions are made which may go some way towards resolving these difficulties. They indicate what might be needed to ensure the validity of ethical discourse, and to reduce the risks associated with conflict of interest. (+info)
Genetic medicine: an experiment in community-expert interaction.
This project tested a two-way model of communication between lay groups and experts about genetic medicine in Perth, Western Australia. Focus group discussion with community group participants was followed by a communication workshop between community group participants and experts. Four groups of concerns or themes emerged from discussion: clinical considerations; legislative concerns; research priorities, and ethical and wider considerations. Community group concerns are not always met by the actions of "experts". This is, in part, because of the differing life-worlds of each group. However, the communication workshop showed the potential of two-way communication for both lay and expert members in understanding the others' viewpoint. Further, the approach developed here offers one possible way for community groups to participate in a substantial way in policy formulation processes. (+info)