Ethical considerations in informed consent
Lucía Arellano, Pau Alcubilla, Lina Leguízamo
Abstract
The process of informed consent, a fundamental aspect of clinical research, involves providing research participants with information about a study and obtaining their voluntary agreement to participate. Its purpose is to safeguard the rights and welfare of participants by ensuring they comprehend the nature, potential benefits, and potential risks of the research, and can make an autonomous and informed decision about whether to participate. The history of informed consent in clinical research is relatively recent, beginning with the Nuremberg Code in 1947 and evolving through subsequent codes and laws such as the Declaration of Helsinki, the Belmont Report, the CIOMS guidelines, and the US Common Rule. There is a general ethical agreement on the structure and information that should be included in informed consent in order to ensure that participants have all the necessary information to make an informed decision. This chapter aims to provide an overview of significant historical milestones in the development of informed consent, current consensus on its structural features, and examples of situations where obtaining informed consent may pose a challenge, such as cluster-randomized clinical trials or decentralized clinical trials.