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)
International developments in abortion law from 1988 to 1998.
OBJECTIVES: In 2 successive decades since 1967, legal accommodation of abortion has grown in many countries. The objective of this study was to assess whether liberalizing trends have been maintained in the last decade and whether increased protection of women's human rights has influenced legal reform. METHODS: A worldwide review was conducted of legislation and judicial rulings affecting abortion, and legal reforms were measured against governmental commitments made under international human rights treaties and at United Nations conferences. RESULTS: Since 1987, 26 jurisdictions have extended grounds for lawful abortion, and 4 countries have restricted grounds. Additional limits on access to legal abortion services include restrictions on funding of services, mandatory counseling and reflection delay requirements, third-party authorizations, and blockades of abortion clinics. CONCLUSIONS: Progressive liberalization has moved abortion laws from a focus on punishment toward concern with women's health and welfare and with their human rights. However, widespread maternal mortality and morbidity show that reform must be accompanied by accessible abortion services and improved contraceptive care and information. (+info)
Preimplantation genetic diagnosis and the 'new' eugenics.
Preimplantation genetic diagnosis (PID) is often seen as an improvement upon prenatal testing. I argue that PID may exacerbate the eugenic features of prenatal testing and make possible an expanded form of free-market eugenics. The current practice of prenatal testing is eugenic in that its aim is to reduce the numbers of people with genetic disorders. Due to social pressures and eugenic attitudes held by clinical geneticists in most countries, it results in eugenic outcomes even though no state coercion is involved. I argue that technological advances may soon make PID widely accessible. Because abortion is not involved, and multiple embryos are available, PID is radically more effective as a tool of genetic selection. It will also make possible selection on the basis of non-pathological characteristics, leading, potentially, to a full-blown free-market eugenics. For these reasons, I argue that PID should be strictly regulated. (+info)
Can we learn from eugenics?
Eugenics casts a long shadow over contemporary genetics. Any measure, whether in clinical genetics or biotechnology, which is suspected of eugenic intent is likely to be opposed on that ground. Yet there is little consensus on what this word signifies, and often only a remote connection to the very complex set of social movements which took that name. After a brief historical summary of eugenics, this essay attempts to locate any wrongs inherent in eugenic doctrines. Four candidates are examined and rejected. The moral challenge posed by eugenics for genetics in our own time, I argue, is to achieve social justice. (+info)
Genetic screening with the DNA chip: a new Pandora's box?
The ethically controversial option of genetic population screening used to be restricted to a small number of rather rare diseases by methodological limitations which are now about to be overcome. With the new technology of DNA microarrays ("DNA chip"), emerging from the synthesis of microelectronics and molecular biology, methods are now at hand for the development of mass screening programmes for a wide spectrum of genetic traits. Thus, the DNA chip may be the key technology for a refined preventive medicine as well as a new dimension of eugenics. The forthcoming introduction of the DNA chip technology into medical practice urgently requires an internationally consistent framework of ethical standards and legal limitations if we do not want it to become a new Pandora's box. (+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)
Most deaths related to abortion occur in the developing world.(7/1337)
Performance of research ethics committees in Spain. A prospective study of 100 applications for clinical trial protocols on medicines.
OBJECTIVES: To review the characteristics and performance of research ethics committees in Spain in the evaluation of multicentre clinical trial drug protocols. DESIGN: A prospective study of 100 applications. SETTING: Forty-one committees reviewing clinical trial protocols, involving 50 hospitals in 25 cities. MAIN MEASURES: Protocol-related features, characteristics of research ethics committees and evaluation dynamics. RESULTS: The 100 applications involved 15 protocols (of which 12 were multinational) with 12 drugs. Committees met monthly (except one). They had a mean number of 12 members, requested a mean of six complete dossiers and nine additional copies of the protocol with a mean deadline of 14 days before the meeting. All applications were approved except three (two of the three were open-label long-term safety trials rejected by the same committee), which were approved by the other committees involved. The mean time from submission to approval was 64 days. The mean time from submission to arrival of the approval document at our offices was 85 days. Twenty-five committees raised queries for 38 of the 97 finally approved applications. Impact of evaluation fee, number of members, queries raised and experience of committees on timings were not statistically significant. CONCLUSION: Obtaining ethical approval is time-consuming. There is much diversity in the research ethics committees' performance. A remarkable delay (> 20 days) exists between the decision and the arrival of the written approval, suggesting administrative or organisational problems. (+info)