Background Informed consent is one of the key principles of conducting research involving humans. When research participants give consent, they perform an act in which they utter, write or otherwise provide an authorisation to somebody to do something. This paper proposes a new understanding of the informed consent as a compositional act. This conceptualisation departs from a modular conceptualisation of informed consent procedures. Methods This paper is a conceptual analysis that explores what consent is and what it does or does (...) not do. It presents a framework that explores the basic elements of consent and breaks it down into its component parts. It analyses the consent act by first identifying its basic elements, namely: a) data subjects or legal representative that provides the authorisation of consent; b) a specific thing that is being consented to; and c) specific agent(s) to whom the consent is given. Results This paper presents a framework that explores the basic elements of consent and breaks it down into its component parts. It goes beyond only providing choices to potential research participants; it explains the rationale of those choices or consenting acts that are taking place when speaking or writing an authorisation to do something to somebody. Conclusions We argue that by clearly differentiating the goals, the procedures of implementation, and what is being done or undone when one consent, one can better face the challenges of contemporary data-intensive biomedical research, particularly regarding the retention and use of data. Conceptualising consent as a compositional act enhances more efficient communication and accountability and, therefore, could enable more trustworthy acts of consent in biomedical science. (shrink)

BackgroundWe assessed potential consent bias in a cohort of > 40,000 adult patients asked by mail after hospitalization to consent to the use of past, present and future clinical and biological data in an ongoing ‘general consent’ program at a large tertiary hospital in Switzerland.MethodsIn this retrospective cohort study, all adult patients hospitalized between April 2019 and March 2020 were invited to participate to the general consent program. Demographic and clinical characteristics were extracted from patients’ electronic health records (EHR). Data (...) of those who provided written consent (signatories) and non-responders were compared and analyzed with R studio.ResultsOf 44,819 patients approached, 10,299 (23%) signed the form. Signatories were older (median age 54 [IQR 38–72] vs. 44 years [IQR 32–60], p <.0001), more comorbid (2614/10,299 [25.4%] vs. 4912/28,676 [17.1%] with Charlson comorbidity index ≤ 4, p <.0001), and more often of Swiss nationality (6592/10,299 [64%] vs. 13,813/28,676 [48.2%], p <.0001).ConclusionsOur results suggest that actively seeking consent creates a bias and compromises the external validity of data obtained via ‘general consent’ programs. Other options, such as opt-out consent procedures, should be further assessed. (shrink)