McCarthy D B, Shatin D, Drinkard C R, Kleinman J H, Gardner J S
Center for Health Care Policy and Evaluation, United HealthCare, Minneapolis, MN 55440-1459, USA.
Health Serv Res. 1999 Apr;34(1 Pt 2):417-25.
To determine the effects of state legislation requiring patient informed consent prior to medical record abstraction by external researchers for a specific study.
DATA SOURCES/STUDY SETTING: Informed consent responses obtained from November 1997 through April 1998 from members of a Minnesota-based IPA model health plan.
Descriptive case study of consent to gain access to medical records for a pharmaco-epidemiologic study of seizures associated with use of a pain medication that was conducted as part of the FDA's post-marketing safety surveillance program to evaluate adverse events associated with approved drugs.
The informed consent process approved by an institutional review board consisted of three phases: (1) a letter from the health plan's medical director requesting participation, (2) a second mailing to nonrespondents, and (3) a follow-up telephone call to nonrespondents.
Of 140 Minnesota health plan members asked to participate in the medical records study, 52 percent (73) responded and 19 percent (26) returned a signed consent form authorizing access to their records for the study. For 132 study subjects enrolled in five other health plans in states where study-specific consent was not required, health care providers granted access to patient medical records for 93 percent (123) of the members.
Legislation requiring patient informed consent to gain access to medical records for a specific research study was associated with low participation and increased time to complete that observational study. Efforts to protect patient privacy may come into conflict with the ability to produce timely and valid research to safeguard and improve public health.
确定一项州立法的影响，该立法要求外部研究人员在进行特定研究抽取医疗记录之前获得患者的知情同意。
数据来源/研究背景：1997年11月至1998年4月从明尼苏达州一家基于独立执业协会（IPA）模式的健康计划成员处获得的知情同意回复。
关于同意获取医疗记录以进行一项药物流行病学研究的描述性案例研究，该研究是关于与一种止痛药使用相关的癫痫发作，作为美国食品药品监督管理局（FDA）上市后安全监测计划的一部分，以评估与已批准药物相关的不良事件。
由机构审查委员会批准的知情同意过程包括三个阶段：（1）健康计划医疗主任发出的邀请参与的信件，（2）给未回复者的第二次邮件，以及（3）给未回复者的跟进电话。
在被邀请参与医疗记录研究的140名明尼苏达州健康计划成员中，52%（73人）做出了回复，19%（26人）返回了签署的同意书，授权为该研究获取他们的记录。对于在其他五个州的健康计划中登记的132名研究对象，在这些州不需要针对该研究的特定同意，医疗服务提供者为93%（123人）的成员提供了患者医疗记录的访问权限。
要求患者知情同意以获取特定研究的医疗记录的立法与低参与率以及完成该观察性研究的时间增加相关。保护患者隐私的努力可能与及时开展有效研究以保障和改善公众健康的能力产生冲突。
