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.

项目总结

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