Implementing Evidence-based Informed Consent Practices to Address the Risk of Alzheimer's Dementia and Cognitive Impairment in Clinical Trials

实施循证知情同意实践，以解决临床试验中阿尔茨海默氏症痴呆和认知障碍的风险

• 批准号: 10394876
• 负责人: James M Dubois
• 金额: $ 53.09万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-08-15 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10394876
• 关键词: Address; Adopted; Adoption; Alzheimer' s Disease; Alzheimer' s disease risk; Assessment tool; Attitude; Budgets; Clinical Research; Clinical Trials; Conduct Clinical Trials; Consent; Consent Forms; Consolidated Framework for Implementation Research; Control Groups; Data; Development; E-learning; Elements; Enrollment; Ethics; Facebook; Family member; Fostering; Grant; Guidelines; Happiness; Impaired cognition; Individual; Informed Consent; Institutional Review Boards; Intervention; Interview; Language; LinkedIn; Measures; Methods; Online Systems; Outcome; Participant; Patients; Persons; Policies; Policy Maker; Positioning Attribute; Principal Investigator; Process; Publications; Randomized; Research; Research Ethics; Research Support; Resources; Surveys; Testing; Twitter; United States; United States National Institutes of Health; Work; Workload; behavior change; clinical practice; design; effectiveness testing; evidence base; experience; formative assessment; impaired capacity; implementation science; implementation trial; innovation; interest; member; outcome prediction; primary outcome; research in practice; satisfaction; social media; social stigma; surrogate decision maker; trait

Project Summary Informed consent is a cornerstone of the ethical conduct of research. This poses a challenge for research involving participants with Alzheimer's disease or cognitive impairments. On the one hand, cognitive impairment can interfere with the capacity to understand, appreciate, and reason with information, potentially compromising the quality of consent. On the other hand, research holds the key to treatment advances for those with Alzheimer's dementia and cognitive impairment. Excluding individuals from research can impede progress. Its is also often unnecessary, because following best practices for informed consent can often enable individuals or their surrogates to provide consent while adequately protecting participants. Level 1 evidence indicates benefits of each of the following best practices in research involving patients with Alzheimer's disease: (a) Use plain language and figures in consent forms or consent aids; (b) assess participants' understanding of consent information using a validated measure; (c) discuss consent information that individuals misunderstood during assessment; and (d) assess ability to appoint a surrogate decision- maker or study partner. Our preliminary research indicates that these best practices are not routinely followed, and some studies find persistent problems with the consent process in clinical trials. Accordingly, the proposed project aims to implement consent best practices among clinical research coordinators (CRCs) and principal investigators (PIs) in the United States. This project will use surveys and interviews of CRCs, PIs, Alzheimer's Disease family members, and IRB members or staff to identify current practices and barriers to implementing consent best practices. Informed by survey and interview data, we will test the effectiveness of a web-based toolkit with resources that explain and facilitate the use of consent best practices. We will push the toolkit to CRCs/PIs in the implementation group (n=600) using social media platforms such as Twitter, Facebook, and LinkedIn and will examine whether implementation group outcomes (e.g., attitudes, intent to adopt, and adoption of best practices) are superior to those of the control group (n=300). By increasing use of consent best practices, this innovative study will have a significant impact on the ethical conduct of clinical trials with participants with Alzheimer's disease or cognitive impairments, and will reduce barriers to enrolling participants with Alzheimer's disease. It will also advance our understanding of how to implement best practices in research ethics, which is important because current approaches are ineffective.

项目摘要 知情同意是研究道德行为的基石。这对研究提出了挑战 参与者患有阿尔茨海默病或认知障碍。一方面，认知 损伤可能会干扰理解、欣赏和推理信息的能力， 影响同意的质量。另一方面，研究是治疗进展的关键， 老年痴呆症和认知障碍患者。将个人排除在研究之外可能会阻碍 中求进工作总它也往往是不必要的，因为遵循知情同意的最佳做法往往可以使 个人或其代理人提供同意，同时充分保护参与者。 1级证据表明，在涉及以下患者的研究中，以下每种最佳实践均具有益处： 阿尔茨海默病：（a）在同意书或同意辅助工具中使用简单的语言和数字;（B）评估 参与者使用经验证的措施了解同意信息;（c）讨论同意信息 （d）评估委任替代决定的能力─ 制造商或学习伙伴。 我们的初步研究表明，这些最佳做法并没有得到例行遵循，一些研究表明， 发现临床试验中同意过程中持续存在的问题。因此，拟议项目旨在 在临床研究协调员（CRC）和主要研究者中实施知情同意最佳实践 (PIs)在美国 本项目将使用调查和访谈的CRC，PI，阿尔茨海默氏症的家庭成员，和IRB 成员或工作人员，以确定当前的做法和障碍，以实施同意的最佳做法。知情 通过调查和访谈数据，我们将测试基于网络的工具包的有效性， 并促进同意最佳做法的使用。我们将在实施过程中向CRCs/PI推广该工具包 使用Twitter、Facebook和LinkedIn等社交媒体平台的一组（n=600），并将检查 实施小组的成果（例如，态度、采用意图和采用最佳做法） 上级优于对照组（n=300）。 通过增加使用同意最佳实践，这项创新研究将对 对患有阿尔茨海默病或认知障碍的参与者进行临床试验的道德行为，并将 减少阿尔茨海默病参与者的入组障碍。它也将促进我们对 如何实施研究伦理的最佳实践，这很重要，因为目前的方法是 无效。

项目成果

Perceived barriers to assessing understanding and appreciation of informed consent in clinical trials: A mixed-method study.

• DOI: 10.1017/cts.2021.807
• 发表时间: 2021
• 期刊: Journal of clinical and translational science
• 影响因子: 2.6
• 作者: Solomon ED;Mozersky J;Baldwin K;Wroblewski MP;Parsons MV;Goodman M;DuBois JM
• 通讯作者: DuBois JM

Houston We Have a Problem: Ground Zero for the US Coronavirus Outbreak.

休斯顿，我们有一个问题：美国冠状病毒爆发的归零地。

• DOI: 10.1353/nib.2021.0014
• 发表时间: 2021
• 期刊: Narrative inquiry in bioethics
• 作者: Tu,Yuan-Po

How are US institutions implementing the new key information requirement?

美国机构如何实施新的关键信息要求？

• DOI: 10.1017/cts.2020.1
• 发表时间: 2020-01-10
• 期刊: Journal of clinical and translational science
• 影响因子: 2.6
• 作者: Mozersky J;Wroblewski MP;Solomon ED;DuBois JM
• 通讯作者: DuBois JM

Personal Narrative About COVID-19 Research.

关于 COVID-19 研究的个人叙述。

• DOI: 10.1353/nib.2021.0002
• 发表时间: 2021
• 期刊: Narrative inquiry in bioethics
• 作者: Schiller,Gary

Therapeutic Misconception, Misestimation and COVID-19 Research.

• DOI: 10.1353/nib.2021.0022
• 发表时间: 2021-01-01
• 期刊: Narrative inquiry in bioethics
• 作者: Dehority, Walter