Multimedia Aided Consent for Alzheimer’s Disease Research

Abstract

Given the ethical primacy of informed consent and issues of justice for impaired populations who might be harmed by an absence of research-based treatment advances, continued search for ways to more meaningfully engage people with AD in the consent or assent process is warranted.

Informed consent, therapeutic misconception, and clinical trials for Alzheimer's disease

“…43 Although this enhanced consent procedure did not show significant benefit with respect to comprehension and decisional capacity, this procedure highlights a creative, person-centered approach to informed consent for people with Alzheimer's disease. 43 Other approaches to minimize a therapeutic misconception include paying participants who volunteer for a trial to make a clearer distinction between research participation and regular medical care, in which patients are not routinely paid. 6 Paying participants raises concern for coercion, however, particularly given the potential for diminished decisional capacity for people with Alzheimer's disease, but the idea here is that enrollment procedures can be modified to highlight the research focus of the trial.…”

“…In focusing on the participants and proxies, attention should be paid to minimizing therapeutic misconception for both as the decision to enroll in a trial is usually a shared process, and a therapeutic misconception could then theoretically influence participants and/or proxies in the decision‐making process . A number of approaches have been advanced to further optimize decision making for clinical trial enrollment for people with Alzheimer's disease with a goal of maximizing autonomy as well as protection from harm . For example in a group of participants with mild to moderate dementia due to Alzheimer's disease, an enhanced consent procedure was trialed using a multimedia approach with video clips as well as corrective feedback .…”

“…43 For example in a group of participants with mild to moderate dementia due to Alzheimer's disease, an enhanced consent procedure was trialed using a multimedia approach with video clips as well as corrective feedback. 43 Although this enhanced consent procedure did not show significant benefit with respect to comprehension and decisional capacity, this procedure highlights a creative, person-centered approach to informed consent for people with Alzheimer's disease. 43 Other approaches to minimize a therapeutic misconception include paying participants who volunteer for a trial to make a clearer distinction between research participation and regular medical care, in which patients are not routinely paid.…”

“…A number of approaches have been advanced to further optimize decision making for clinical trial enrollment for people with Alzheimer's disease with a goal of maximizing autonomy as well as protection from harm . For example in a group of participants with mild to moderate dementia due to Alzheimer's disease, an enhanced consent procedure was trialed using a multimedia approach with video clips as well as corrective feedback . Although this enhanced consent procedure did not show significant benefit with respect to comprehension and decisional capacity, this procedure highlights a creative, person‐centered approach to informed consent for people with Alzheimer's disease …”

Introductory to Issue 41(1): Navigating Thorny Aspects of Dementia Care: Sex, Money, Cars and More

“…Palmer and colleagues (Palmer et al, 2017) describe their considerable efforts with a sample of adults with Alzheimer's disease and normal controls (N = 248) to enhance the research consent procedure with multimedia and corrective feedback for individuals with mild to moderate Alzheimer's disease. This study is important for at least two reasons-first, of course, is the need to include adults with dementia in a wide range of studies in a manner that maximizes their opportunities to provide capable and ethical consent.…”