Department of Clinical Neurosciences, University of Cambridge, Addenbrookes Hospital, Cambridge, UK.
J Psychopharmacol. 2011 Feb;25(2):205-10. doi: 10.1177/0269881109349838. Epub 2010 Jan 21.
Many subjects cannot give fully informed consent to take part in research by virtue of age or mental capacity. However, it is unacceptable to deny these patients involvement in research by virtue of a lack of capacity to consent to such research. Further, this would hinder the advancement of medical science and technologies that might ultimately benefit these patients. Conversely, it is as unacceptable to discriminate against these patients and their condition as it is to exploit them or expose them to undue risk. Neuroscientific research raises a number of specific ethical issues in this patient population, in particular issues of consent, potential benefits of research, management of incidental findings and the assignment of appropriate controls. This paper examines the dilemmas that surround such ethical issues, and demonstrates that various procedures including informed consent, deferred consent and consent by proxy can be used to consent patients in both the standard medical and research arenas. Researchers, clinicians and regulatory authorities must work together to understand the benefits, limitations, risks and obligations of any research study involving these patients in order to advance medical care.
许多受试者由于年龄或智力因素，无法完全知情同意参与研究。然而，由于缺乏同意参与此类研究的能力而拒绝这些患者参与研究是不可接受的。此外，这将阻碍医学科学和技术的进步，而这些进步最终可能使这些患者受益。相反，歧视这些患者及其病情，以及剥削或使他们面临不必要的风险，同样是不可接受的。神经科学研究在这一患者群体中引发了一些具体的伦理问题，特别是在同意、研究的潜在益处、偶然发现的管理以及适当对照的分配方面。本文探讨了这些伦理问题所带来的困境，并表明可以使用各种程序，包括知情同意、延期同意和代理同意，来同意标准医疗和研究领域的患者。研究人员、临床医生和监管机构必须共同努力，了解涉及这些患者的任何研究的益处、局限性、风险和义务，以便推进医疗保健。
