Informed consent stands as one of the core principles when carrying out research with human subjects. Upon giving consent, research participants engage in an action in which they verbally state, document in writing, or otherwise provide an authorization allowing another party to undertake a specific action. This paper offers a novel interpretation of informed consent, viewing it as a compositional act. Such an approach diverges significantly from the traditional modular view of informed consent processes. This paper conducts a conceptual examination to probe the essence of consent and to determine its actual effects or limitations. It introduces a structured framework for scrutinizing the essential components of consent, dissecting them into their constituent parts. The analysis of the consent act begins by pinpointing its primary elements, which include: a) data subjects or their legal representative who supply the authorization through consent; b) a particular item or activity that receives the consent; and c) specific agent(s) who are the recipients of the consent.
This paper presents a framework that examines the fundamental elements of consent and dissects them into distinct parts. Rather than merely presenting options to prospective research participants, it clarifies the underlying reasons for those options or for the consenting actions that occur when individuals verbally or in writing authorize someone to act. We contend that clearly separating the objectives, the methods of application, and the specific actions performed or reversed through consent enables a more effective response to the difficulties arising in modern data-heavy biomedical research, especially concerning data storage and utilization. Framing consent as a compositional act promotes clearer communication and greater accountability, which, in turn, may facilitate more reliable consent processes within biomedical science.
