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Selling Clinical Biospecimens: Guidance for Researchers and Private Industry

Published online by Cambridge University Press:  01 September 2023

Peter H. Schwartz Open the ORCID record for Peter H. Schwartz [Opens in a new window]  and
Jane A. Hartsock
Peter H. Schwartz
Affiliation:
INDIANA UNIVERSITY, INDIANAPOLIS, IN, USA
Jane A. Hartsock
Affiliation:
INDIANA UNIVERSITY, INDIANAPOLIS, IN, USA
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Abstract

The recently revised Common Rule requires that donors of biospecimens for research be informed if their specimens might be used for commercial profit. The Common Rule, however, does not apply to sharing or selling de-identified biospecimens that are “leftover” from clinical uses. As a result, many medical researchers remain uncertain of their legal and ethical obligations when a commercial entity expresses interest in these specimens.

Keywords

BiospecimensCommercial UseResearch
Type
Independent Articles
Information
Journal of Law, Medicine & Ethics , Volume 51 , Issue 2: International Collaborations: The Future of Health Care , Summer 2023 , pp. 429 - 436
Copyright
© 2023 The Author(s)

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