Testing Modified Approaches to Informed Consent

描述（由申请人提供）：临床研究的主要伦理范式要求，首先，机构审查委员会（IRB）建立研究的伦理可接受性。一般来说，一旦IRB确定风险相对于预期收益是合理的，合格的个人可以通过知情同意程序决定风险/收益平衡和具体程序对他们是否合理。理论上，这种范式具有重大的道德价值。然而，在实践中，有证据表明，许多研究对象并不了解他们参加研究的主要目的或关键程序。此外，同意书（法律要求的传递和记录研究信息的机制）往往写得非常复杂，研究者很少（如果有的话）确定受试者真正理解了什么。已经测试了许多类型的干预措施，以修改知情同意并提高受试者的理解，结果好坏参半。总的来说，缩短同意表格和增加对话可以提高理解分数，就像进行知识测试、纠正错误答案和重复测试一样。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”他们被招募参加研究，和/或使用非常小的样本。研究人员承认这些方法上的局限性，但也描述了可行性挑战，包括寻找实际的试验和愿意合作的研究人员，因为担心合作会减少父母试验的累积和/或会给受试者和工作人员带来过度的负担。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；然后在约翰霍普金斯大学正在进行的六项临床试验中确定测试它们的可行性。具体来说，通过这项计划拨款，我们将a)制定干预措施（更简单的同意书，强调重要的研究信息；以及一个用于所有受试者的语言反馈工具，以识别和讨论误解）；b)开发一个同意理解评估工具，以评估实验对象在暴露于标准和增强同意方法时的理解；c)在正在进行的COPD、肺动脉高压、HIV(2)和癌症(2)试验中对干预、评估、随机化和招募程序进行试点测试；d)完善程序，确定样本量估计，并与未来的合作者会面，以便在多个国家正在进行的临床研究中进行标准与增强同意程序的随机试验的R01申请。该项目将a)制定简化的知情同意表和原始的语言反馈干预工具，以促进受试者对研究的理解；b)将确定在六项正在进行的临床研究(COPD、肺动脉高压、HIV（2)和癌症(2)）中将这些增强的同意流程与标准同意方法进行比较的可行性。这项探索性工作将作为未来R01提交的背景材料，据此，我们将计划在正在进行的临床研究中进行标准与增强同意方法的大型全国性临床试验。虽然有许多改进知情同意的建议，但在几项正在进行的大型临床研究中，没有一项在现场环境中进行过测试。

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.