Testing Modified Approaches to Informed Consent

测试知情同意的修改方法

• 批准号: 7599647
• 负责人: NANCY E KASS
• 金额: $ 20.5万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-04-01 至 2011-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7599647
• 关键词: Authorization documentation; Benefits and Risks; Chronic Obstructive Airway Disease; Clinic; Clinical; Clinical Research; Clinical Trials; Collaborations; Complex; Comprehension; Computers; Consent; Consent Forms; Data; Data Collection; Enrollment; Ensure; Environment; Equilibrium; Ethics; Evaluation; Exploratory/Developmental Grant; Feedback; Fright; Funding; Future; Goals; Grant; HIV; Hearing; Human; Individual; Informed Consent; Institution; Internet; Intervention; Intervention Studies; Knowledge; Learning; Malignant Neoplasms; Masks; Measures; Medical; Morals; Multimedia; Parents; Participant; Pilot Projects; Procedures; Process; Pulmonary Hypertension; Randomized; Randomized Controlled Clinical Trials; Readability; Reading; Recruitment Activity; Research; Research Ethics Committees; Research Infrastructure; Research Personnel; Research Subjects; Research Training; Risk; Sample Size; Sampling; Secure; Self Determination; Simulate; Site; Source; Staff Attitudes; Testing; Time; Work; Writing; compare effectiveness; design; improved; innovation; instrument; leukemia; malignant breast neoplasm; meetings; preference; prevent; public health relevance; research study; response; theories; tool; trial comparing

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.

描述（由申请人提供）：临床研究的主要伦理规范要求，首先，机构审查委员会（IRB）确定研究的伦理可接受性。通常，一旦IRB确定风险相对于预期获益是合理的，合格的个人可以通过知情同意程序决定风险/获益平衡和特定程序对其是否合理。从理论上讲，这种范式具有重大的道德价值。然而，在实践中，有证据表明，许多研究受试者并不了解他们参加的研究的主要目的或关键程序。此外，同意书 提供和记录研究信息的法定机制 通常是写在高度复杂的水平和调查人员很少，如果有的话，确定什么科目实际上理解。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，结果好坏参半。一般来说，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可以提高理解分数。然而，这些干预措施通常在模拟研究环境中进行测试，要求个人“假装”他们被招募参加研究，和/或样本非常小。研究者承认这些方法学限制，但描述了可行性挑战，包括寻找实际试验和愿意合作的研究者，因为担心合作会减少母试验的累积和/或对受试者和工作人员造成过度负担。 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，其方法与大多数类型的试验相关;然后确定在约翰霍普金斯正在进行的六项临床试验的背景下测试它们的可行性。具体而言，通过这项规划补助金，我们将a）制定干预措施，（更简单的同意书，强调关键的研究信息;和一个言语反馈工具，用于所有受试者，以识别和讨论误解）; B）开发一个同意理解评估工具，以实验方式评估受试者在暴露于标准与增强的同意方法时的理解; 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;和d）完善程序，确定样本量估计数，并与未来的合作者会面，以申请R 01，在多个国家正在进行的临床研究中进行标准与增强知情同意程序的随机试验。 公共卫生相关性本项目将a）开发简化的知情同意书和原始的言语反馈干预工具，以促进受试者对研究的理解;和B）将确定在6项正在进行的临床研究（COPD、肺动脉高压、HIV（2）和癌症（2））中将这些知情同意过程增强与标准知情同意方法进行比较的可行性。这项探索性工作将用作未来R 01提交的背景材料，我们将计划在正在进行的临床研究中进行一项关于标准与增强知情同意方法的大型国家临床试验。虽然已经建议了许多知情同意的改进，但在几项正在进行的大型临床研究的背景下，没有一项在现场环境中进行过测试。