Shore D, Berg K, Wynne D, Folstein M F
Division of Clinical and Treatment Research, National Institute of Mental Health, Rockville, MD 20857.
Am J Med Genet. 1993 May 1;48(1):17-21. doi: 10.1002/ajmg.1320480106.
Genetic research may uncover the causes of severe mental disorders, and many projects have been undertaken to locate the genes responsible for schizophrenia, bipolar disorder, and Alzheimer disease. A number of sensitive legal and ethical issues have been raised, including 1) protection of confidential data concerning research subjects; 2) the assessment of types and degree of risk to subjects who participate in such studies; 3) the legal and ethical acceptability of substituted judgement on behalf of patients who may not be competent to provide informed consent; and 4) the separation of research and clinical roles in areas such as genetic counseling. Federal regulations and other guidelines are of limited value in dealing with such concerns, and many important human subjects issues will need to be dealt with by the investigator, subject to approval by a local Institutional Review Board. There does seem to be general agreement that informed consent must be obtained, potential risks of research need to be minimized, and confidentiality of sensitive data must be protected.
基因研究可能会揭示严重精神障碍的病因，并且已经开展了许多项目来定位与精神分裂症、双相情感障碍和阿尔茨海默病相关的基因。由此引发了一些敏感的法律和伦理问题，包括：1）保护有关研究对象的机密数据；2）评估参与此类研究的对象所面临的风险类型和程度；3）代表可能无能力提供知情同意的患者进行替代判断的法律和伦理可接受性；4）在遗传咨询等领域区分研究和临床角色。联邦法规和其他指导方针在处理此类问题方面价值有限，许多重要的人体研究对象问题将需要由研究者处理，并需获得当地机构审查委员会的批准。似乎普遍达成的共识是，必须获得知情同意，研究的潜在风险需要降至最低，并且敏感数据的保密性必须得到保护。
