Keys to improving the informed consent process in research: Highlights of the i-CONSENT project
Jaime Fons-Martinez, Cristina Ferrer-Albero, Javier Diez-Domingo
Health Expectations, 27 July 2022
The ethical and legal governance of all aspects of informed consent in research is becoming increasingly extensive and complex. Instead of a single directive, informed consent is governed by a series of international rules applied to biomedical research, clinical trials and biobanks, while various ethical guidelines for research have been published by different international bodies.
Informed consent is an essential part of any research involving humans, but the array of available guidelines can complicate the informed consent process for sponsors, researchers and participants. Sponsors, in particular, find it difficult to adapt the informed consent process to the characteristics of the participants. Moreover, because of the length and complexity of informed consents, some participants may misconstrue key points and agree to participate in a trial that they do not fully understand. In these cases, the decision on their participation is mainly based on discussions with the researcher, which lacks traceability…