Reasons for Declining Consent in a Population-Based Cohort Study Conducted in a Rural South American Community

Abstract

There is limited information on participants’ adherence and reasons for declining consent in observational cohort studies conducted in remote rural communities. We aimed at sharing lessons learned during the Atahualpa Project, a population-based cohort study conducted in a rural Ecuadorian village. Atahualpa residents aged ≥40 years identified during door-to-door surveys who signed a consent form were enrolled. Annual surveys were conducted to assess the number of participants who moved out of the village, as well as those who died, declined consent, and newly entered the study. Reasons for declining consent were tabulated. Abstracted data included age, sex, education, disability, time between enrollment and declining consent, and reasons for withdrawal. We also counted participants who, despite expressing their willingness to continue in the study, refused specific procedures. After five years of follow-up, 54 (6.3%) of 863 enrolled individuals declined consent. Increasing age and disability had no impact on declining consent. In contrast, refusal was higher among relatives or neighbors of a given participant declining consent. Most people who declined consent did so after one or two years of enrollment. Less than 20% of enrolled individuals refused certain procedures. “Fear of the needle” was the most frequent reason for refusing blood tests, and common reasons for declining complimentary exams were lack of interest and time constraints. Cohort retention in the Atahualpa Project is high. Main reasons for this adherence include adequate selection of the village, detailed planning of procedures, assurance of sponsorship, and field personnel who continuously engage with study participants. This trial is registered with NCT01627600.