Informed Consent in Two Alzheimer’s Disease Research Centers: Insights From Research Coordinators

Abstract

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.

From paper to screen: regulatory and operational considerations for modernizing the informed consent process

“…Interviews with study coordinators from the two ADRC teams about their paper-based IC process identified key challenges: difficulties maintaining participant attention, explaining complex procedures, and modifying the IC process to support the needs of individual participants [19]. Often, such challenges are not specifically considered as part of IRB review.…”

“…We produced a participant-centric, interactive eIC experience that incorporates IC best practices such as using simplified language, graphics, comprehension questions with corrective feedback [16][17][18], and tiered information (i.e., allowing participants to access supplemental information about specific concepts). This eIC approach addressed some of the barriers to an effective IC process that ADRC study coordinators previously identified, including making it easier to customize the order in which information is presented to research participants [19]. The eIC experience was piloted with study coordinators and participants who provided input on which features of eIC were most relevant and meaningful to them (manuscript in preparation).…”

Participation in and withdrawal from cancer clinical trials: A survey of clinical research coordinators

“… 7 CRCs perform tasks, such as screening study subjects, patient education and acquisition of informed consent, scheduling clinical visits and contacting study subjects, completing case report forms, observing adverse events, and liaising with researchers and sponsors. 9 , 10 , 11 As CRC nurses work on the front lines from the beginning to the end of clinical trials, 12 they can best identify the main reasons for participation and withdrawal from clinical trials and suggest potential remedial measures. Many studies have assessed motivations for or barriers to clinical trial participation as well as the reasons for study withdrawal by surveying the participants or physicians.…”