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

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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.