# Consent as a compositional act – a framework that provides clarity for the retention and use of data

## TL;DR

This paper introduces a new framework for understanding informed consent as a compositional act, aiming to improve clarity and trust in biomedical research data use.

## Contribution

The paper proposes a novel conceptualization of informed consent as a compositional act, moving beyond modular approaches.

## Key findings

- Consent can be broken down into three basic elements: the data subject, the specific action, and the agent receiving consent.
- Viewing consent as a compositional act improves communication and accountability in data-intensive research.
- This framework helps address challenges in the retention and use of biomedical data.

## Abstract

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.

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.

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.

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.