de Melo-Martín Inmaculada, Hellmers Natalie, Henchcliffe Claire
Division of Medical Ethics, Department of Medicine, Weill Cornell Medical College, 402 East 67th Street, New York, NY 10065, USA.
Weill Cornell Parkinson's Disease and Movement Disorders Institute, Department of Neurology, Weill Cornell Medical College, 428 East 72nd Street, Suite 400, New York, NY 10021, USA.
Parkinsonism Relat Disord. 2015 Aug;21(8):829-32. doi: 10.1016/j.parkreldis.2015.05.011. Epub 2015 May 19.
First-in-human clinical trials of innovative medical procedures, such as cell transplantation for Parkinson's disease, present a variety of ethical challenges. In an era of rapidly developing stem cell technologies likely to be translated into clinical trials over the next few years, it is critical that ethical concerns be fully considered. One important undertaking is ensuring that research participants give free and truly informed consent. This will necessitate adequate disclosure of risks and benefits at a time when these are incompletely defined; ensuring understanding of a complex research protocol when there is significant possibility of therapeutic misconception; and careful determination of capacity for informed consent in patients with a neurodegenerative disorder that is known to affect cognition. Here we call attention to the ethical issues that researchers conducting these types of trials will face when trying to obtain a genuinely informed consent, and we suggest possible solutions.
创新性医疗程序的首次人体临床试验，如针对帕金森病的细胞移植，带来了各种伦理挑战。在未来几年干细胞技术可能迅速发展并转化为临床试验的时代，充分考虑伦理问题至关重要。一项重要工作是确保研究参与者给予自由且真正知情的同意。这将需要在风险和益处尚未完全明确时充分披露相关信息；在存在治疗误解的重大可能性时确保对复杂研究方案的理解；以及仔细确定已知会影响认知的神经退行性疾病患者的知情同意能力。在此，我们提请注意进行这类试验的研究人员在试图获得真正知情同意时将面临的伦理问题，并提出可能的解决方案。
