AN ADAPTED STAGED CONSENT MODEL FOR RECRUITMENT AND INFORMED CONSENT IN READINESS COHORTS: THE PERSPECTIVE OF THE EUROPEAN PREVENTION OF ALZHEIMER’S DEMENTIA CONSORTIUM (EPAD)

Abstract

To facilitate screening and recruitment of research participants and to reduce time and costs associated with traditional trials in Alzheimer's disease, researchers are setting up ‘readiness cohorts’. These cohorts are well-characterized populations of potential participants for recruitment into prevention or early treatment trials. In setting up such cohorts, researchers must make ethically challenging design decisions. Therefore, within the interdisciplinary Ethical, Legal and Social implications (ELSI) work package of the European Prevention of Alzheimer's Dementia (EPAD) project, we developed ethics guidelines for responsible development of a readiness cohort (the EPAD longitudinal cohort study), including guidance on recruitment and informed consent. We used a mixed methods approach. First, we performed a literature review. Second, we held several meetings in person and by teleconference during 2015/2016 to discuss associated ethical dilemmas. Third, we organized multi-disciplinary group discussions within EPAD to create concrete broad-based ethics guidance for recruitment and informed consent. The longitudinal and transitional nature of a readiness cohort creates the risk of the cohort and its concatenated trials becoming a ‘fish trap’ for its participants. With every step further into such a research project, it becomes more difficult for a participant to go back or retract from participation. Therefore, we recommend an adapted staged-consent model for concatenated projects like EPAD, which are extended over time and multi-staged, and in which participants and data move from one stage to the next. This consent model feeds relevant information, bit by bit, along research participants’ journey, and asks informed consent at every moment in which important decisions need to be made by participants. Although informed consent is always given for a specific stage of the research project, information about the ‘totality of the project’ must always and explicitly be part of the informed consent process. It is critical to the success of readiness cohorts to carefully align ethical guidance for recruitment and informed consent. The ELSI work package of EPAD recommends an adapted staged-consent model. This model may also be of value to other research collaborations in the process of developing and using readiness cohorts in Alzheimer's disease research.