Testing Modified Approaches to Informed Consent

描述(由申请人提供)：临床研究的主导伦理范式要求，首先，机构审查委员会(IRB)建立研究的伦理可接受性。一旦IRB确定与预期利益相关的风险总体上是合理的，合资格的个人就可以通过知情同意程序来决定风险/利益平衡和具体程序对他们是否合理。从理论上讲，这种模式具有重大的道德价值。然而，在实践中，证据表明，许多研究对象并不了解他们注册的研究的主要目的或关键程序。此外，同意书是传递和记录研究信息所需的法律机制，通常是在高度复杂的水平上编写的，调查人员很少确定受试者实际理解了什么。已经测试了许多类型的干预措施，以修改知情同意和提高受试者的理解，结果喜忧参半。总体而言，缩短同意书和增加对话可以提高理解分数，进行知识测验、纠正错误答案和重复测验也是如此。然而，这些干预措施通常是在模拟研究环境中进行测试的，要求个人“假装”他们是被招募进行研究的，和/或样本非常少。调查人员承认这些方法的局限性，但描述了可行性挑战，包括寻找实际试验和调查人员愿意合作，因为担心合作将减少父母试验的收益和/或将对受试者和工作人员造成过重负担。这个R21探索性项目的目标是设计简单的知情同意干预措施，采用与大多数类型的试验相关的方法；然后确定在约翰霍普金斯大学正在进行的六项临床试验中测试这些干预措施的可行性。具体地说，通过这笔规划赠款，我们将a)开发干预(强调关键研究信息的更简单的同意书；以及与所有受试者一起使用的言语反馈工具，以识别和讨论误解)；b)开发同意理解评估工具，以试验性地评估受试者在暴露于标准同意方法与增强同意方法时的理解；c)在正在进行的COPD、肺动脉高压、艾滋病毒(2)和癌症(2)试验中，对干预、评估、随机和招募程序进行试点测试；以及d)改进程序，确定样本量估计，并与未来的合作者会面，以申请R01申请，在多项全国性正在进行的临床研究中进行标准同意程序与增强同意程序的随机试验。这个项目将a)开发简化的知情同意书和一种原创的言语反馈干预工具，以促进受试者对研究的理解；b)将确定在6项正在进行的临床研究(慢性阻塞性肺病、肺动脉高压、艾滋病毒(2)和癌症(2))中，将这些同意程序的改进与标准同意方法进行比较的可行性。这项探索性工作将被用作未来R01提交的背景材料，我们将计划在正在进行的临床研究中对标准与增强同意方法进行大规模的全国性临床试验。虽然许多知情同意的改进已被推荐，但没有一项在现场环境下在几个正在进行的大型临床研究的背景下进行测试。

DESCRIPTION (provided by applicant): The dominant ethics paradigm for clinical research requires, first, that an Institutional Review Board (IRB) establish the ethical acceptability of a study. Once the IRB determines, generally, that risks are reasonable in relation to anticipated benefits, eligible individuals, through the informed consent process, can decide whether the risk/benefit balance and specific procedures are reasonable to them. In theory, this paradigm has significant moral merit. In practice, however, evidence suggests many research subjects do not understand the primary purpose or key procedures of studies in which they enroll. Further, consent forms the legally required mechanism for delivering and documenting study information often are written at highly complex levels and investigators rarely, if ever, determine what subjects actually understand. Many types of interventions have been tested to modify informed consent and improve subjects' understanding, with mixed results. In general, shortening consent forms and increasing dialogue have improved understanding scores, as has giving a knowledge quiz, correcting incorrect answers, and repeating the quiz. These interventions, however, generally were tested in simulated research settings, asking individuals to "pretend" they were being recruited for research, and/or with very small samples. Investigators acknowledge these methodological limitations but describe feasibility challenges, including finding actual trials and investigators willing to collaborate, given fears that collaborations will decrease parent trial accrual and/or will be overly burdensome to subjects and staff. The goal of this R21 exploratory project is to design simple informed consent interventions with an approach relevant to most types of trials; and then determine the feasibility of testing them in the context of six ongoing clinical trials at Johns Hopkins. Specifically, through this planning grant we will a) develop the intervention (simpler consent forms that emphasize critical study information; and a verbalization-feedback tool to be used with all subjects to identify and discuss misunderstandings); b) develop a Consent Understanding Evaluation tool to assess experimentally subjects' understanding when exposed to standard vs. enhanced consent approaches; c) pilot testing the intervention, assessments, and randomization and recruitment procedures in ongoing COPD, pulmonary hypertension, HIV (2), and cancer (2) trials; and d) Refine procedures, determine sample size estimates, and meet with future collaborators for an R01 application for a randomized trial of standard vs. enhanced consent procedures in multiple, national, ongoing clinical studies. PUBLIC HEALTH RELEVANCE This project will a) develop simplified informed consent forms and an original Verbalization-Feedback intervention tool to promote subjects' understanding of research; and b) will determine the feasibility of comparing these consent process enhancements to standard consent approaches in six ongoing clinical research studies (in COPD, pulmonary hypertension, HIV (2), and cancer (2)). This exploratory work will be used as background material for a future R01 submission, whereby we will plan a large, national clinical trial of standard vs. enhanced consent approaches in ongoing clinical studies. While numerous informed consent improvements have been recommended, none has been tested in field settings in the context of several large ongoing clinical studies.