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

> **NIH NIH R01** · WASHINGTON UNIVERSITY · 2022 · $530,875

## Abstract

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.

## Key facts

- **NIH application ID:** 10394876
- **Project number:** 5R01AG058254-05
- **Recipient organization:** WASHINGTON UNIVERSITY
- **Principal Investigator:** James M Dubois
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $530,875
- **Award type:** 5
- **Project period:** 2018-08-15 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10394876

## Citation

> US National Institutes of Health, RePORTER application 10394876, Implementing Evidence-based Informed Consent Practices to Address the Risk of Alzheimer's Dementia and Cognitive Impairment in Clinical Trials (5R01AG058254-05). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10394876. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*