Background: Retention of study participants is essential to advancing Alzheimer’s disease (AD) research and developing therapeutic interventions. However, recent multi-year AD studies have lost 25% to 39% of participants. Objective: We surveyed a random sample of 443 participants (Clinical Dementia Rating [CDR]≤1) at four Alzheimer Disease Research Centers to elucidate perceived facilitators and barriers to continued participation in longitudinal AD research. Methods: Reasons for participation were characterized with factor analysis. Effects of perceived fulfillment of one’s own goals and complaints on attendance and likelihood of dropout were estimated with logistic regression models. Open-ended responses suggesting study improvements were analyzed with a Latent Dirichlet Allocation topic model. Results: Factor analyses revealed two categories, personal benefit and altruism, as drivers of continued participation. Participants with cognitive impairment (CDR >  0) emphasized personal benefits more than societal benefits. Participants with higher trust in medical researchers were more likely to emphasize broader social benefits. A minority endorsed any complaints. Higher perceived fulfillment of one’s own goals and fewer complaints were related to higher attendance and lower likelihood of dropout. Facilitators included access to medical center support and/or future treatment, learning about AD and memory concerns, and enjoying time with staff. Participants’ suggestions emphasized more feedback about individual test results and AD research. Conclusion: The results confirmed previously identified facilitators and barriers. Two new areas, improved communication about individual test results and greater feedback about AD research, emerged as the primary factors to improve participation.

Background: Informed consent (IC) is critical to performing ethical research. Unfortunately, the IC process and supporting IC forms are frequently burdensome and do not necessarily meet the informational needs of participants. The intersecting legal and ethical challenges of obtaining IC from individuals with memory or cognitive deficits further exacerbate existing IC shortcomings. For this reason, study coordinators play a critical role in facilitating the IC process in Alzheimer's disease (AD) research. To identify opportunities to improve how IC is obtained in AD research, we examined the IC process from the perspectives of study coordinators at two Alzheimer's Disease Research Centers (ADRC). Methods: We performed semi-structured interviews with 15 study coordinators from two ADRC sites detailing their experience obtaining IC. Interviews were conducted in private, recorded, transcribed, and independently coded using the constant comparative method of grounded theory. Key themes were explored as they emerged. Results: Coordinators reported overall satisfaction with the IC process. However, many reported difficulties maintaining participant attention, explaining complex procedures, and addressing medical misinformation. Although the centers use site-specific consent forms, coordinators at both centers stressed that their IC is too long and the supporting IC forms are too complicated. Coordinators indicated modifying the IC process to the perceived needs of individual participants. Adaptations reported include altering the cadence and vocabulary they employ, using supplemental materials, varying the order of IC topics, and limiting the depth of information presented. Conclusion: A qualitative analysis of interviews with study coordinators reveals opportunities to improve how we obtain IC in AD research. These insights will be used to create an electronic informed consent (eConsent) designed to boost engagement, enhance trust, and improve understanding by supporting participants' direct agency in the IC process.

Background The informed consent (IC) process offers an opportunity for researchers to promote participant autonomy and facilitate decision making. However, the traditional IC experience is often tedious, requiring study coordinators to present information in long IC documents. Paper IC documents can be difficult to understand and do not necessarily meet the needs of participants or study coordinators. The COVID‐19 pandemic underscores the need to provide an alternative to the in‐person, paper‐based IC process to minimize person‐to‐person contact. We worked with IRBs to revise how we engage and consent people in Alzheimer’s Disease Research Centers at the University of Wisconsin‐Madison and Emory University. Method In an ongoing effort to improve the IC process for adults at risk of developing memory and cognitive deficit, our team has been building and testing an electronic IC experience. We interviewed a total of 63 participants with a median age of 72. Participants underwent both the eConsent prototype and the paper consent. Seventy (70) percent of those participants preferred the eConsent over the traditional paper copy. We adapted into REDCap the electronic IC experience (eConsent). We collected input on the project from IRBs and study coordinators, and measured participant’s understanding of key elements of the IC through questions distributed throughout the eConsent. Results Each interested study participant received a unique link to the eConsent in REDCap. We observed which participants selected to review the eConsent information on their own, and which ones preferred to be guided remotely with the Study coordinators. We evaluated level of engagement with the eConsent and scored comprehension. The insights provided by this informed consent approach were used to determine whether it would be well suited for at‐home self‐administration across a diverse population. Conclusion Study participants and study coordinators alike prefer an electronic consent process and participants retain information better as opposed to the typical paper consent form. While the REDCap consent survey is a temporary solution for our study team, it is a cost‐effective solution that facilitates a better experience for the participants. We believe that this REDCap eConsent could be a beneficial solution for the virtual recruitment and consent process at other ADRC sites.

Electronic platforms provide an opportunity to improve the informed consent (IC) process by permitting elements shown to increase research participant understanding and satisfaction, such as graphics, self-pacing, meaningful engagement, and access to additional information on demand. However, including these elements can pose operational and regulatory challenges for study teams and institutional review boards (IRBs) responsible for the ethical conduct and oversight of research. We examined the experience of two study teams at Alzheimer's Disease Research Centers who chose to move from a paper-based IC process to an electronic informed consent (eIC) process to highlight some of these complexities and explore how IRBs and study teams can navigate them. Here, we identify the key regulations that should be considered when developing and using an eIC process as well as some of the operational considerations eIC presents related to IRB review and how they can be addressed.

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