Resolving ethical issues in stem cell clinical trials: the example of Parkinson disease.
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.
Lo
Bernard
B
UCSF, USA.
Parham
Lindsay
L
D002986:Clinical Trials as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence; D026689:Ethical Analysis; D026724:Ethical Review / Q000331:legislation & jurisprudence; D035082:Federal Government; D033161:Government Regulation; D006801:Humans; D010300:Parkinson Disease / Q000628:therapy*; D010344:Patient Advocacy / Q000941:ethics* / Q000331:legislation & jurisprudence; D018579:Patient Selection / Q000941:ethics*; D010919:Placebos; D012107:Research Design; D012449:Safety; D033581:Stem Cell Transplantation / Q000941:ethics* / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration
D010919:Placebos