Cherniack E Paul
Department of Geriatrics and Adult Development, Mount Sinai School of Medicine, New York, USA.
Exp Aging Res. 2002 Apr-Jun;28(2):183-98. doi: 10.1080/03610730252800193.
Much has been written about the possible lack of capacity of the elderly, especially certain vulnerable populations of older individuals, to give informed consent for medical research. Several small studies have shown a deficit for comprehension of consent material, by the elderly, especially those with less education, but this appears small in comparison to an overall deficit in the general population. A number of investigations have suggested that deficits in executive control functions (ECFs) may be related to lack of capacity to make clinical judgments, but these have yet to be applied to research. Many methods have been piloted to measure capacity and to improve comprehension, some of which may help, although none has been proved conclusively to do either. As the elderly experience significant morbidity and mortality from a vast array of illnesses, the use of the elderly as subjects of medical research is especially important. To prevent older individuals from being coerced into participating or potentially being harmed by scientific investigation, they must give informed consent to their involvement. However, there are many studies to suggest that they are not well informed. A discussion ensued in the 1970s and 1980s about whether or not the elderly deserved special protection as a class of individuals, based on their possible increased risk during medical experimentation, but it was ultimately decided that, because the majority of elderly are perceived to be cognitively intact, they need not receive additional safeguards (High & Doole, 1995, Behavioral Science and Law, 13, 319-335). The U.S. Department of Health and Human Services in 2000 (Federal Registrar Rules and Regulations, 46, 8366-8392) reviewed existing protections for subjects of human research and deemed they were inadequate, issuing new guidelines. This article reviews evidence that differences exist between the ability of young and old in their capacity to give consent. Alterations in methods of obtaining consent may help individuals to give a more informed consent, and even enable subjects who lack the capacity to consent, such as cognitively impaired individuals, to participate in research. However an ideal means of screening or altering the consent process has yet to be devised. Many of these methods are briefly considered.
关于老年人，尤其是某些弱势老年人群体，可能缺乏为医学研究提供知情同意的能力，已有诸多相关著述。多项小型研究表明，老年人，尤其是受教育程度较低者，在理解同意书内容方面存在不足，但与普通人群的总体不足相比，这一不足似乎较小。一些调查表明，执行控制功能（ECF）的缺陷可能与临床判断能力的缺乏有关，但这些尚未应用于研究。已经尝试了许多方法来衡量能力并提高理解能力，其中一些可能会有所帮助，尽管尚无定论证明其中任何一种方法能做到这两点。由于老年人会因各种各样的疾病而经历显著的发病率和死亡率，因此将老年人用作医学研究对象尤为重要。为防止老年人被胁迫参与或可能因科学研究而受到伤害，他们必须对参与研究给予知情同意。然而，有许多研究表明他们并未得到充分告知。在20世纪70年代和80年代，曾就是否应基于老年人在医学实验中可能增加的风险，将其作为一类个体给予特殊保护展开过讨论，但最终决定，由于大多数老年人被认为认知功能完好，他们无需额外的保障措施（海伊和杜尔，1995年，《行为科学与法律》，第13卷，第319 - 335页）。2000年，美国卫生与公众服务部（《联邦法规汇编规则与条例》，第46卷，第8366 - 8392页）审查了现有的人体研究对象保护措施，认为这些措施不充分，于是发布了新的指导方针。本文回顾了有关年轻人和老年人给予同意能力存在差异的证据。改变获取同意的方法可能有助于个人给出更知情的同意，甚至使缺乏同意能力的受试者，如认知受损个体，能够参与研究。然而，尚未设计出理想的筛选或改变同意过程的方法。本文将简要探讨其中的许多方法。
