Delorio Nicole M, McClure Katie B
Department of Emergency Medicine, Oregon Health & Science University, Portland, OR 97239, USA.
Acad Emerg Med. 2005 Nov;12(11):1056-9. doi: 10.1197/j.aem.2005.07.001.
Although subject protection is the cornerstone of medical ethics, when considered in the context of research using emergency exception from informed consent, its success is debatable. The participants of a breakout session at the 2005 Academic Emergency Medicine Consensus Conference discussed the issues surrounding subject protection and advanced the following recommendations. 1) There are no outcome measures that define "protection"; therefore, it is not currently known whether or not subjects are protected under the current rules. 2) Care must be taken to protect not only the individual from harm during research but also to protect society from unregulated research in other countries and an inability to appropriately advance medical knowledge. 3) Some surrogate markers/methods of protection whose efficacies are debatable include data safety monitoring board activity, the community consultation and public notification (CC/PN) process, and institutional review board approval. 4) Minimal-risk studies should be held to different standards of protection than those that involve more significant risk to the subject. 5) A handful of studies have been published regarding community consultation and notification, and the majority are case studies. Those that are specifically designed to discover the most successful methods are hindered by a lack of formal outcomes measures and tend to have negative results. 6) Follow-up data from the CC/PN process should be disclosed to the Food and Drug Administration and incorporated into study designs. 7) Focus groups and/or random-digit dialing have been suggested as promising methods for fulfilling the CC/PN requirements. 8) Studies need to be funded and performed that formally investigate the best means of CC/PN. 9) More funding for this research should be a priority in the emergency medicine and critical care communities. More data regarding terminated studies should be made available to the research community. 10) Quantifiable markers of success for CC/PN must be validated so that research may determine the most successful methods. 11) Data regarding subjects' and family members' experiences with exception from informed consent studies need to be obtained.
尽管受试者保护是医学伦理的基石，但在使用知情同意紧急例外情况进行研究的背景下考量时，其成效存在争议。在2005年学术急诊医学共识会议的一次分组讨论会上，与会者探讨了围绕受试者保护的问题，并提出了以下建议。1）不存在界定“保护”的结果指标；因此，目前尚不清楚受试者在现行规则下是否得到了保护。2）必须谨慎行事，不仅要保护个体在研究过程中免受伤害，还要保护社会免受其他国家未经规范的研究以及无法适当推进医学知识的影响。3）一些保护的替代指标/方法，其有效性存在争议，包括数据安全监测委员会的活动、社区咨询和公众通知（CC/PN）程序以及机构审查委员会的批准。4）低风险研究应遵循与那些给受试者带来更大风险的研究不同的保护标准。5）关于社区咨询和通知的研究已有少数发表，且大多数是案例研究。那些专门设计用于发现最成功方法的研究因缺乏正式的结果指标而受阻，且往往得出负面结果。6）CC/PN程序的后续数据应披露给食品药品监督管理局，并纳入研究设计。7）焦点小组和/或随机数字拨号已被建议作为满足CC/PN要求的有前景的方法。8）需要资助并开展正式调查CC/PN最佳方式的研究。9）急诊医学和重症监护领域应优先为这项研究提供更多资金。应向研究界提供更多关于终止研究的数据。10）CC/PN成功的可量化指标必须得到验证，以便研究能够确定最成功的方法。11）需要获取关于受试者及其家庭成员在知情同意例外研究中的经历的数据。
