Selling Clinical Biospecimens: Guidance for Researchers and Private Industry

Abstract

AbstractThe 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.