Breaking the stalemate: a prospective regulatory framework for unforseen research uses of human tissue samples and health information.
The legal and ethical issues raised by new research uses of previously collected human tissues and health information are increasingly important to genetics research. This Article discusses and criticizes current positions on such uses, including the recent report of the National Bioethics Advisory Commission, Research Involving Human Biological Materials. It then proposes a new regulatory framework for tissue and information collected in the future that would better protect the interests of the people who provide them. It ends by suggesting a resolution for the problems of previously collected tissue and information.
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D026683:Advisory Committees; D030561:Databases, Nucleic Acid / Q000592:standards; D033002:Duty to Recontact; D028744:Ethics Committees, Research; D030661:Genetic Privacy; D036281:Genetic Research / Q000331:legislation & jurisprudence*; D033161:Government Regulation; D006805:Human Experimentation / Q000331:legislation & jurisprudence; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D008499:Medical Records; D014019:Tissue Donors / Q000331:legislation & jurisprudence*; D014481:United States