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Ethical and legal considerations regarding the ownership and commercial use of human biological materials and their derivatives

Authors Petrini C

Received 19 July 2012

Accepted for publication 23 August 2012

Published 7 September 2012 Volume 2012:3 Pages 87—96

DOI https://doi.org/10.2147/JBM.S36134

Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 6

Carlo Petrini

Italian National Institute of Health, Rome, Italy

Abstract: This article considers some of the ethical and legal issues relating to the ownership and use – including for commercial purposes – of biological material and products derived from humans. The discussion is divided into three parts: after first examining the general notion of ownership, it moves to the particular case of possible commercial use, and finally reflects on the case in point in the light of the preceding considerations. Units of cord blood donated altruistically for transplantation and which are found unsuitable for storage and transplantation, or which become unsuitable while stored in biobanks, are taken as an example. These cord-blood units can be discarded together with other biological waste, or they can be used for research or the development of blood-derived products such as platelet gel. Several ethical questions (eg, informed consent, property, distribution of profits, and others) arise from these circumstances. In this regard, some criteria and limits to use are proposed.

Keywords: bioethics, biological specimen banks, cord-blood stem cell transplantation, ethics, informed consent,
legislation

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