Informed Consent and Anonymous Tissue Samples: The Case of HIV Seroprevalence Studies
Kopelman, Loretta M.
Journal of Medicine and Philosophy. 1994 Dec; 19(6): 525-552.
Human Immunodeficiency Virus (HIV) seroprevalence studies use anonymous tissue samples obtained in hospitals and clinics without donor consent. This can be justified as a response to a public health emergency, but should not be seen as setting a precedent for waiving consent whenever samples are anonymous. The following recommendations grow out of this discussion: (1) Studies using anonymous tissue samples should not be automatically exempt from consent requirements, and consent should not be waived simply to avoid anticipated refusals, low participation rates or self selection bias. (2) The consensus on informed consent favors fulfilling as many of the elements of informed consent as reasonably possible, so studies should be assessed individually to determine if any or all elements of informed consent should be modified or omitted. (3) There is a need for greater regulation of the research use of tissue samples. (4) Investigators seeking approval to waive consent or modify elements of informed consent should document the sort of new findings that they believe would effect their calculations about the benefits and burdens to subjects who are enrolled in the study, and institutional review boards should indicate whether they agree with the investigators' analysis.
Aids; Aids Serodiagnosis; Anonymous Testing; Biomedical Research; Confidentiality; Consensus; Consent; DNA; DNA Data Banks; Data Banks; Discrimination; Epidemiology; Government; Government Regulation; Health; HIV Seropositivity; Hospitals; Informed Consent; Institutional Review Boards; Investigators; Newborns; Policy Analysis; Pregnant Women; Presumed Consent; Privacy; Professional Patient Relationship; Public Health; Public Policy; Regulation; Research; Review; Risks and Benefits; Social Discrimination; Stigmatization; Trust; Voluntary Programs;
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Clayton, Ellen Wright; Steinberg, Karen K.; Khoury, Muin J.; Thomson, Elizabeth; Andrews, Lori; Kahn, Mary Jo Ellis; Kopelman, Loretta M.; Weiss, Joan O. (1995-12-13)