Tissue banking, patient rights, and confidentiality: tensions in law and policy.
The collection, storage and analysis of tissue samples, including genetic data, has become an increasingly common part of biomedical research. Though there are many scientific justifications for the creation of tissue and DNA databanks, the storage and use of human tissue continues to create legal dilemmas. In this paper, the impact and relevance of existing common law principles are reviewed. It is noted that the Canadian common law rules covering consent and confidentiality may create challenges for the research community. Emerging health information legislation does, however, create a somewhat more lenient research environment, largely because these laws allow, in some circumstances, research on identifiable health information without consent. Nevertheless, conflicts between existing common law, research ethics policy and new health information legislation illustrate profound policy dilemmas created by research involving storage and use of tissue and genetic material.
Caulfield
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Canada Research Chair in Health Law and Policy, Health Law Institute, University of Alberta, Edmonton, Alberta, Canada.
D035843:Biomedical Research / Q000941:ethics / Q000331:legislation & jurisprudence; D002170:Canada; D003219:Confidentiality / Q000331:legislation & jurisprudence*; D006801:Humans; D033181:Information Dissemination / Q000331:legislation & jurisprudence; D007258:Informed Consent / Q000331:legislation & jurisprudence; D010067:Ownership / Q000331:legislation & jurisprudence; D028701:Patient Rights / Q000331:legislation & jurisprudence*; D011640:Public Policy; D014015:Tissue Banks / Q000331:legislation & jurisprudence*