P3‐504: a Qualitative Analysis of Coordinator Perceptions of the Consent Process: Lessons Guiding the Development of an Electronic Consent Platform
Year: 2019
Type: article
Abstract: The informed consent process is vital to performing ethical human subject research. Typically, consent forms are too long, burdensome and do not necessarily meet the needs of participants from groups underrepresented in research. Study coordinators have a unique role in facilitating the consent process, and they report difficulties retaining participant attention and addressing misinformation. To prepare for the development of an electronic consent we examined the current paper consent from the perspective of research study coordinators at the University of Wisconsin-Madison and Emory University Alzheimer's Disease Research Centers (ADRC). Each institution enrolls healthy adults and those with mild cognitive impairment and Alzheimer's disease. Interviews were completed with ADRC study coordinators in a private setting, following an interview guide to allow a semi-structured approach that encouraged open conversation. Coordinators reviewed their respective consent document in order to elicit feedback on past experiences while consenting study participants. Interviews with twelve coordinators, two participant screeners and one outreach specialist were recorded, transcribed and coded. Key themes were detected upon the analysis of the coordinator interviews. Comments such as the following were positive, “For the most part, they all go well… people seem very receptive to everything I'm saying.” However, barriers and coordinator adaptations were also uncovered. Data shows that 93% of the coordinators were asked follow up questions about the biomarker procedures, 80% on study logistics and duration and 67% were asked about physical pain. Common barriers include participant inattention, study complexity and therapeutic misconceptions. Due to these obstacles coordinators adapt the process to the perceived needs of the participant. Adaptations may include cadence, vocabulary, use of supplemental materials, order of topics and amount of information presented. However well intentioned, coordinator adaptations may not address participant needs. Study coordinators report consent forms are too long, complex, and contain unnecessary medical terminology. These findings reflect the consent process is not taking into consideration the needs and literacy of the participants. In exploring an electronic approach, we hope to improve comprehension by allowing participants to have control over the order and level of detail of information presented to them.
Source: Alzheimer s & Dementia
Language: English
Topic: Ethics in Clinical Research
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W2980339362