Chen Donna T, Meschia James F, Brott Thomas G, Brown Robert D, Worrall Bradford B
Department of Neurology, Center for Biomedical Ethics and Humanities, University of Virginia, Charlottesville, VA 22908, USA.
Stroke. 2008 Oct;39(10):2732-5. doi: 10.1161/STROKEAHA.108.515130. Epub 2008 Jul 24.
In stroke and other brain disorders, severely affected phenotypes often impair decision-making capacity. Severity is in part under genomic control. Therefore, scientifically valid research into genetic risk may require inclusion of such impaired individuals. U.S. Federal regulations do not detail rules governing enrollment of adults with impaired decision-making capacity into genetic research. Rather, policy and practice are locally determined. This study was conducted to obtain data on how investigators and IRBs handle surrogate authorization to enroll probands into a genetic study where some may lack capacity because of ischemic stroke.
Sequential surveys of sites from an ongoing North American study investigating genetic risks for ischemic stroke (2003: 49 sites, response rate=100%; 2007: 53 sites; response rate=91%) assessed whether and how investigators enroll adults with impaired decision-making capacity and determined frequency of IRB approval for enrollment by surrogate authorization.
Approximately 40% of sites report that their IRBs do not approve surrogate authorization to enroll stroke patients-43% (21/49) in 2003 and 35% (17/48) in 2007. Thirty-three percent of sites report evaluating eligible adults who lacked capacity to provide their own informed consent; 18% (9/49) in 2003 and 15% (7/48) in 2007 have enrolled these individuals. Surrogate enrollment is the most common method used. Most sites have not enrolled any individual lacking capacity to give his or her own consent.
Our study suggests that enrollment by surrogate authorization into stroke genetic research is often not approved by IRBs, and even when allowed is frequently not used. For disorders like stroke, this situation has significant implications for scientific validity.
在中风及其他脑部疾病中，严重受影响的表型往往会损害决策能力。严重程度部分受基因组控制。因此，对遗传风险进行科学有效的研究可能需要纳入这类受损个体。美国联邦法规并未详细规定有关将决策能力受损的成年人纳入基因研究的规则。相反，政策和实践由地方自行决定。本研究旨在获取关于研究人员和机构审查委员会（IRB）如何处理代孕授权以将先证者纳入基因研究的数据，在该研究中，一些人可能因缺血性中风而缺乏行为能力。
对一项正在进行的北美研究中的研究点进行连续调查，该研究调查缺血性中风的遗传风险（2003年：49个研究点，回复率 = 100%；2007年：53个研究点；回复率 = 91%），评估研究人员是否以及如何纳入决策能力受损的成年人，并确定IRB对通过代孕授权进行纳入的批准频率。
约40%的研究点报告称其IRB不批准代孕授权以纳入中风患者——2003年为43%（21/49），2007年为35%（17/48）。33%的研究点报告称评估了缺乏提供自身知情同意能力的合格成年人；2003年有18%（9/49），2007年有15%（7/48）纳入了这些个体。代孕纳入是最常用的方法。大多数研究点尚未纳入任何缺乏给予自身同意能力的个体。
我们的研究表明，通过代孕授权纳入中风基因研究通常未得到IRB的批准，即使允许，也常常未被采用。对于中风这类疾病，这种情况对科学有效性具有重大影响。
