Expanding the Ethical Analysis of Biobanks

Author:

Rothstein Mark A.

Abstract

Biobanks are repositories of human biological materials collected for biomedical research. There are over 300 million stored specimens in the United States, and the number grows by 20 million per year. In the post-genome world of high throughput gene sequencing and computational biology, biobanks hold the promise of facilitating large-scale research studies. New organizational and operational models of research repositories also raise complex issues of big science, big business, and big ethical concerns.

Publisher

Cambridge University Press (CUP)

Subject

Health Policy,General Medicine,Issues, ethics and legal aspects

Reference71 articles.

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2. 27. 45 C.F.R. Parts 160, 164.

3. 31. It is easy to imagine a situation in which a cancer patient consents to donate his or her surgically excised tumor to a biobank on the express condition that neither the biobank nor any researcher associated with the biobank will ever contact the individual again. Because current HIPAA rules would require additional authorizations for each research protocol, the biobank would have to violate the individual's express wishes or discard the sample.

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5. 2. De Code Genetics, using a database of donated samples, has announced preliminary advances in discovering the genetics of cardiovascular disease, schizophrenia, osteoporosis, and other disorders. See (last accessed February 1, 2005).

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