Mazanec Susan, Daly Barbara, Meropol Neal J, Step Mary
School of Nursing, Case Western Reserve University, 10900 Euclid Avenue, Cleveland, OH44106-4904, USA. susan.
J Empir Res Hum Res Ethics. 2012 Dec;7(5):71-5. doi: 10.1525/jer.2012.7.5.71.
Research registries are increasingly important in medical research and are essential to the mission of cancer centers. However, designing enrollment and data collection procedures that are consistent with ethical norms and regulatory requirements yet are efficient and cost effective is a major challenge. Current standard consent forms can be a barrier to enrollment because of their length, multiple components, and technical language. We pilot tested an IRB-approved registry booklet and simplified one-page, tiered consent form, allowing for choice of extent of participation. The booklet was mailed to patients with breast cancer as part of their routine information packet prior to the first clinic appointment. A research nurse met with 27 patients at initial treatment to review the booklet, answer questions, obtain informed consent, and collect quality of life data. The consent rate was 78% with 21 patients enrolling in the study. Twelve of the 21 patients (57%) did not read the booklet prior to the visit. The 9 patients (43%) who had read the booklet prior to arrival found it easy to understand. The multi-stage, simplified consent process and data collection were acceptable to these patients and readily integrated into clinical operations. An easy-to-read registry booklet may be an effective guide for discussion, but in-person consent procedures and further testing of the approach are required.
研究注册在医学研究中日益重要，对癌症中心的使命至关重要。然而，设计出既符合伦理规范和监管要求又高效且具成本效益的入组和数据收集程序是一项重大挑战。当前的标准同意书因其篇幅、多个组成部分和专业术语可能成为入组的障碍。我们对一份经机构审查委员会（IRB）批准的注册手册和简化的单页分层同意书进行了试点测试，允许患者选择参与程度。该手册在首次门诊预约前作为常规信息包的一部分邮寄给乳腺癌患者。一名研究护士在初始治疗时与27名患者会面，审查手册、回答问题、获取知情同意并收集生活质量数据。同意率为78%，有21名患者参与研究。21名患者中有12名（57%）在就诊前未阅读手册。9名（43%）在到达前阅读了手册的患者觉得它易于理解。这种多阶段、简化的同意程序和数据收集对这些患者来说是可以接受的，并且很容易融入临床操作。一本易于阅读的注册手册可能是进行讨论的有效指南，但仍需要亲自进行同意程序并对该方法进行进一步测试。
