David Bourget (Western Ontario)
David Chalmers (ANU, NYU)
Rafael De Clercq
Ezio Di Nucci
Jack Alan Reynolds
Learn more about PhilPapers
Liza Dawson, Alison S. Bateman-House, Dawn Mueller Agnew, Hilary Bok, Dan W. Brock, Aravinda Chakravarti, Mark Greene, Patricia King, Stephen J. O'Brien, David H. Sachs, Kathryn E. Schill, Andrew Siegel & Davor Solter
Fertility and Sterility 80 (5):1077-1085 (2003)
We report on the deliberations of an interdisciplinary group of experts in science, law, and philosophy who convened to discuss novel ethical and policy challenges in stem cell research. In this report we discuss the ethical and policy implications of safety concerns in the transition from basic laboratory research to clinical applications of cell-based therapies derived from stem cells. Although many features of this transition from lab to clinic are common to other therapies, three aspects of stem cell biology pose unique challenges. First, tension regarding the use of human embryos may complicate the scientific development of safe and effective cell lines. Second, because human stem cells were not developed in the laboratory until 1998, few safety questions relating to human applications have been addressed in animal research. Third, preclinical and clinical testing of biologic agents, particularly those as inherently complex as mammalian cells, present formidable challenges, such as the need to develop suitable standardized assays and the difficulty of selecting appropriate patient populations for early phase trials. We recommend that scientists, policy makers, and the public discuss these issues responsibly, and further, that a national advisory committee to oversee human trials of cell therapies be established. **NB we did not reccommend a NAC, we think it might be appropriate**.
|Keywords||bioethics stem cell safety|
|Categories||categorize this paper)|
Setup an account with your affiliations in order to access resources via your University's proxy server
Configure custom proxy (use this if your affiliation does not provide a proxy)
|Through your library|
References found in this work BETA
No references found.
Citations of this work BETA
Rebecca Dresser (2009). First-in-Human Trial Participants: Not a Vulnerable Population, but Vulnerable Nonetheless. Journal of Law, Medicine and Ethics 37 (1):38-50.
Rebecca Dresser (2009). First-in-Human Trial Participants: Not a Vulnerable Population, but Vulnerable Nonetheless. Journal of Law, Medicine & Ethics 37 (1):38-50.
Similar books and articles
David Magnus (2010). Translating Stem Cell Research: Challenges at the Research Frontier. Journal of Law, Medicine & Ethics 38 (2):267-276.
Insoo Hyun (2010). Allowing Innovative Stem Cell-Based Therapies Outside of Clinical Trials: Ethical and Policy Challenges. Journal of Law, Medicine & Ethics 38 (2):277-285.
Frederic Bretzner, Frederic Gilbert, Françoise Baylis & Robert M. Brownstone (2011). Target Populations for First-In-Human Embryonic Stem Cell Research in Spinal Cord Injury. Cell Stem Cell 8 (5):468-475.
Ronald K. F. Fung & Ian H. Kerridge (2013). Uncertain Translation, Uncertain Benefit and Uncertain Risk: Ethical Challenges Facing First-in-Human Trials of Induced Pluripotent Stem (Ips) Cells. Bioethics 27 (2):89-96.
Nikolaus Knoepffler (2004). Stem Cell Research: An Ethical Evaluation of Policy Options. Kennedy Institute of Ethics Journal 14 (1):55-74.
Mark T. Brown (2009). Moral Complicity in Induced Pluripotent Stem Cell Research. Kennedy Institute of Ethics Journal 19 (1):pp. 1-22.
Cynthia B. Cohen Peter J. Cohen (2010). International Stem Cell Tourism and the Need for Effective Regulation: Part II: Developing Sound Oversight Measures and Effective Patient Support. Kennedy Institute of Ethics Journal 20 (3):207-230.
Philip J. Nickel (2008). Ethical Issues in Human Embryonic Stem Cell Research. In Kristen Renwick Monroe, Ronald B. Miller & Jerome Tobis (eds.), Fundamentals of the Stem Cell Debate: The Scientific, Religious, Ethical & Political Issues. University of California Press
Bernard Dickens, International Society for Stem Cell Research (ISSCR) Guidelines for the Conduct of Human Embryonic Stem Cell Research (December 2006).
Tamra Lysaght & Alastair V. Campbell (2013). Broadening the Scope of Debates Around Stem Cell Research. Bioethics 27 (5):251-256.
Bernard Lo & Lindsay Parham (2010). Resolving Ethical Issues in Stem Cell Clinical Trials: The Example of Parkinson Disease. Journal of Law, Medicine & Ethics 38 (2):257-266.
Melinda B. Fagan (2011). Social Experiments in Stem Cell Biology. Perspectives on Science 19 (3):235-262.
William M. Sage (2010). Will Embryonic Stem Cells Change Health Policy? Journal of Law, Medicine & Ethics 38 (2):342-351.
S. Matthew Liao, P. J. Goldschmidt & J. Sugarman (2007). Ethical and Policy Issues Relating to Progenitor-Cell-Based Strategies for Prevention of Atherosclerosis. Journal of Medical Ethics 33 (11):643-646.
Added to index2011-10-24
Total downloads6 ( #453,572 of 1,792,080 )
Recent downloads (6 months)4 ( #207,127 of 1,792,080 )
How can I increase my downloads?