iPS Cells: Mapping the Policy Issues. Cell 133:1032-1039, 2009

Scritto da Matteo Lulli - Phoenix Scientific Staff

Sabato 19 Dicembre 2009 11:11

Flash Report su una rassegna pubblicata nel numero 139 di Cell, uscito l'11 dicembre

Nel numero 139 di Cell uscito l'11 dicembre, è stata pubblicata una rassegna che è di grande interesse per chi si occupi non solo dello studio delle cellule staminali pluripotenti (iPS) in vista di una loro possibile applicazione terapeutica ma anche dei problemi etici, legali e sociali che sottendono questo campo della ricerca scientifica traslazionale. Tali problemi sono parte integrante degli scopi di Phoenix ONLUS.
Si riporta qui di seguito la prima pagina dell'articolo, rimandando all'articolo originale per una sua lettura completa (Matteo Lulli)

iPS Cells: Mapping the Policy Issues

Authors: Amy Zarzeczny,¹ Christopher Scott,³ Insoo Hyun,⁴ Jami Bennett,⁵ Jennifer Chandler,⁶ Sophie Chargé,⁷ Heather Heine,⁸ Rosario Isasi,⁹ Kazuto Kato,¹⁰ Robin Lovell-Badge,¹¹ Kelly McNagny,⁵ Duanqing Pei,¹² Janet Rossant,¹³ Azim Surani,¹⁴ Patrick L. Taylor,¹⁵ Ubaka Ogbogu,¹⁶ and Timothy Caulfield²,*

Affiliations.

1. Health Law Institute

2. Faculty of Law and School of Public Health, Health Law Institute University of Alberta, Edmonton, Alberta T6G 2H5, Canada

3. Center for Biomedical Ethics, Stanford University, Stanford, CA 94305, USA

4. Department of Bioethics, School of Medicine, Case Western Reserve University, Cleveland, OH 44106, USA

5. The Biomedical Research Centre, University of British Columbia, Vancouver, British Columbia V6T 1Z3, Canada

6. Faculty of Law, University of Ottawa, Ottawa, Ontario K1N 6N5, Canada

7. Stem Cell Network, Ottawa, Ontario K1H 8L6, Canada

8. University of British Columbia, Vancouver, British Columbia V6T 1Z3, Canada

9. Centre of Genomics and Policy, McGill University, Montréal, Québec H3A 1A4, Canada

10. Institute for Research in Humanities, Graduate School of Biostudies, Institute for Integrated Cell-Material Sciences, Kyoto University, Kyoto 606-8501, Japan

11. National Institute for Medical Research, London NW7 1AA, UK

12. Guangzhou Institutes of Biomedicine and Health, Guangzhou, Guangdong 510663, China

13. Hospital for Sick Children, Toronto, Ontario M5G 2L3, Canada

14. Gurdon Institute, University of Cambridge, Cambridge CB2 1QN, UK

15. Harvard Stem Cell Institute, Children’s Hospital Boston, MA 02138, USA

16. Faculty of Law, University of Toronto, Toronto, Ontario M5S 2C5, Canada

*Correspondence: Questo indirizzo e-mail è protetto dallo spam bot. Abilita Javascript per vederlo.

Journal: Cell 139, December 11, 1032-1039, 2009

Abstract: Given the explosion of research on induced pluripotent stem (iPS) cells, it is timely to consider the various ethical, legal, and social issues engaged by this fast-moving field. Here, we review issues associated with the procurement, basic research, and clinical translation of iPS cells.

First Page: Since the 2007 announcement that adult human skin cells can be reprogrammed to act like human embryonic stem cells (hESCs) (Takahashi et al., 2007), stem cell research has experienced renewed attention and enthusiasm from scientists, the public, patient groups, and policy makers. These new cells, called induced pluripotent stem (iPS) cells have been hailed as an ethical victory (Aalto-Setala et al., 2009) because they represent a way of producing valuable hESC-like pluripotent stem cells without involving the destruction of human embryos. The development of iPS cells has also opened up stem cell research, in part due to the fact that the technology is more accessible, less expensive, and less resource constrained (i.e., does not require the use of embryos or scarce human oocytes) than that required for hESC research.

The rapid advances in iPS cell research and the significant expectations placed upon this field make it both timely and imperative to consider the ethical, legal, and social issues (ELSI) associated with it and their impact on the iPS cell policy landscape. This was the goal of an international workshop held in association with the 2009 annual meeting of the International Society for Stem Cell Research (http://www.isscr.org), which brought together an international team of stem cell scientists, bioethicists, and ELSI scholars. In this article, which emerged from the workshop, we consider various ethical, legal, social, and policy issues associated with aspects of iPS cell procurement and basic research including privacy, consent, intellectual property, and potential uses. Next, we address features of clinical translation including safety, regulation, and oversight.

Finally, we conclude by reflecting on the theme of exceptionalism and the overarching context of commercial pressure. Our intent is not to provide a comprehensive analysis of these complex issues or a list of recommendations but rather to highlight key areas that require both further reflection and research.

Privacy

One of the most significant issues associated with iPS cell procurement and research relates to the privacy interests of cell donors. As is true in other areas of human tissue research, iPS cell lines result from a living individual and, as such, carry that individual’s DNA “fingerprint,” which contains an immeasurable amount of information about the donor including genetic predisposition to disease. Inappropriate disclosure of this information could violate that individual’s privacy and result in social, economic, or other risks (Sugarman, 2008). Related concerns regarding genetic privacy have been addressed in considerable depth in the context of genetics research (Lowrance and Collins, 2007). The Genetic Information Nondiscrimination Act of 2008 in the US is an example of a legislative response to some of these concerns (http://www.gpo.gov/fdsys/pkg/PLAW-110publ233/html/PLAW-110publ233.htm).

Even if the original cells used to derive iPS cells were isolated from a donor who is no longer alive (and stored as a clinical sample or in a cord blood stem cell bank, for example), the iPS cell DNA still contains information about close relatives of the donor and thereby engages their privacy interests.

One way for researchers to address these concerns is to de-identify or anonymize the data at the time of donation. How…. (it continues on the original article: Cell 139, December 11, 2009 ©2009 Elsevier Inc.).

Ultimo aggiornamento Martedì 22 Dicembre 2009 17:08