From opt-out to opt-in consent for secondary use of medical data and residual biomaterial: An evaluation using the RE-AIM framework

Abstract

Background Patient records, imaging, and residual biomaterial from clinical procedures are crucial resources for medical research. In the Netherlands, consent for secondary research has historically relied on opt-out consent. For ethical-legal experts who purport passive consent undermines patient autonomy, opt-in consent (wherein affirmative action is required) is seen as the preferred standard. To date, there is little empirical research exploring patient feasibility, organizational consequences, and the potential risks for research based on secondary data. Thus, we applied the RE-AIM framework to evaluate the impact of migrating from an opt-out to an opt-in consent process. Methods This evaluation was carried out in Radboud University Medical Center, a large tertiary hospital located in the southeast of the Netherlands. All non-acute, mentally competent patients ≥16 years of age registered between January 13, 2020 and June 30, 2023 were targeted (N = 101,437). In line with the RE-AIM framework, individual and organizational consequences were evaluated across five domains: reach, efficacy, adoption, implementation, and maintenance. Results 101,437 eligible patients were approached of whom 66,214 (65.3%) consented, 8,059 (7.9%) refused consent and 27,164 (26.8%) had no response. Of the 74,273 patients with a response, 89.1% consented to secondary use. The migration to an opt-in consent system was modestly successful; yet notably, differential response patterns by key sociodemographic characteristics were observed. Adaptions to the process flow improved its effectiveness and resulted in a reasonable response over time. Implementation was most affected by budgetary restraints, thus impeding the iterative approach which could have further improved domain outcomes. Conclusion This evaluation provides an overview of logistical and pragmatic issues encountered when migrating from opt-out to opt-in consent. Response bias remains a major concern. Though not always directly transferable, these lessons can be broadly used to inform other health care organizations of the potential advantages and pitfalls of an opt-in consent system.