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Negotiating Commercial Interests in Biospecimens.

Jessica L Roberts1

  • 1Jessica L. Roberts, J.D., is George Butler Research Professor and the Director of the Health Law & Policy Institute at the University of Houston Law Center in Houston, TX. She holds a J.D. from the Yale Law School in New Haven, CT and a B.A. from the University of Southern California in Los Angeles, CA. Professor Roberts is a 2018 Greenwall Faculty Scholar in Bioethics.

The Journal of Law, Medicine & Ethics : a Journal of the American Society of Law, Medicine & Ethics
|June 30, 2017
PubMed
Summary

Proposed Common Rule changes mandate disclosure of commercial interests in biospecimen research. This informs participants about potential tissue value and may enable negotiation of commercial rights.

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Area of Science:

  • Biomedical Ethics
  • Health Law
  • Research Policy

Background:

  • Publicly funded research often utilizes human biospecimens.
  • Current regulations may not adequately inform participants about commercial interests in their biospecimens.
  • Participants may be unaware of the potential commercial value of their donated tissue.

Purpose of the Study:

  • To analyze proposed changes to the Common Rule regarding biospecimen commercialization.
  • To examine the implications of mandatory disclosure of commercial interests for research participants.
  • To assess the potential impact on participants' ability to negotiate rights for their biospecimens.

Main Methods:

  • Review of proposed amendments to the Common Rule.
  • Analysis of ethical considerations in human biospecimen research.
  • Examination of legal precedents concerning ownership of excised human tissue.

Main Results:

  • Proposed changes require disclosure of potential commercial profit from biospecimens.
  • Disclosure aims to inform participants of the commercial value of their tissue.
  • This may create opportunities for participants to negotiate commercial rights.

Conclusions:

  • Mandatory disclosure of commercial interests can enhance transparency in biospecimen research.
  • Informed consent processes may be strengthened by revealing potential financial benefits.
  • Proposed rules could challenge existing legal frameworks regarding biospecimen ownership.