Abstract
The Convention on Human Rights and Biomedicine developed by the Council of Europe, now undergoing ratification, is the first international treaty focused on bioethics. This article describes the background of the Convention's development and its general provisions and provides a comparison of its requirements with those of federal regulations governing research with human subjects. Although most provisions are comparable, there are significant differences in scope and applicability, for example, in the areas of compensation for injury, research participation by persons with limited capacity to consent, assisted reproduction, organ transplantation, and research in emergency situations. The Convention represents a milestone in international bioethics and protection of human rights that will probably be referred to with increasing frequency.
MeSH terms
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Adolescent
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Adult
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Bioethical Issues*
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Bioethics*
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Compensation and Redress
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Economics
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Embryo Research
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Embryo, Mammalian
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Emergency Medical Services
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Ethical Review
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Ethics
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Ethics Committees
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Ethics Committees, Research
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Europe
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Federal Government
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Fertilization in Vitro
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Financial Support
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Genetic Predisposition to Disease
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Genetic Testing
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Genetic Therapy
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Government
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Government Regulation*
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Guidelines as Topic*
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Human Experimentation
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Human Genome Project
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Human Rights*
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Humans
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Informed Consent
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International Cooperation*
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Internationality*
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Mental Competency
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Minors
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Nontherapeutic Human Experimentation
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Patients
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Persons
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Prejudice
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Prisoners
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Reproductive Techniques, Assisted
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Research
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Research Embryo Creation
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Research Subjects
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Risk
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Risk Assessment
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Social Control, Formal*
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Therapeutic Human Experimentation
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Third-Party Consent
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Tissue Donors
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Tissue and Organ Procurement
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United States
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United States Dept. of Health and Human Services
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United States Food and Drug Administration
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Vulnerable Populations
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Wounds and Injuries