Journal
JOURNAL OF LAW MEDICINE & ETHICS
Volume 38, Issue 2, Pages 257-+Publisher
WILEY-BLACKWELL PUBLISHING, INC
DOI: 10.1111/j.1748-720X.2010.00486.x
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Funding
- National Institutes of Health (NIH), National Center for Research Resources (NCRR) [1 UL1 RR024131-01]
- National Institutes of Health [MH062246]
- NIH Roadmap for Medical Research
- Greenwall Foundation
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Clinical trials of stem cell transplantation raise ethical issues that are intertwined with scientific and design issues, including choice of control group and intervention, background interventions, endpoints, and selection of subjects. We recommend that the review and IRB oversight of stem cell clinical trials should be strengthened. Scientific and ethics review should be integrated in order to better assess risks and potential benefits. Informed consent should be enhanced by assuring that participants comprehend key aspects of the trial. For the trial to yield generalizable knowledge, negative findings and serious adverse events must be reported.
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