New guidelines for tailoring the informed consent process in clinical studies are now available, and compile a series of recommendations where a broader and more dynamic concept of informed consent is presented.
The i-CONSENT project
has drawn attention to the fact that the need to comply with strict, yet vital ethical and legal regulations, has resulted in informed consent documents being seen as an off-putting ‘contract’ between the sponsor, researcher and participant rather than the informative document it should be.
Linda Glennie, Director of Research Evidence & Policy at Meningitis Research Foundation, and i-CONSENT consortium member says: “Patient involvement in clinical trials is essential to the development of new vaccines to prevent deadly diseases such as meningitis. Yet to participate in a clinical trial, individuals must be able to understand research. Currently, the overly technical and legalistic approach to obtaining informed consent can hamper this process and is difficult for patients to understand.”
Dr Javier Díez-Domingo, Scientific Co-ordinator of I-consent said: “i-CONSENT highlights the need for change, proposing that informed consent should instead be considered a process, rather than a document to be signed, and that researchers should seek to establish a positive, patient-centred approach. The newly developed guidelines
include theoretical recommendations as well as practical guidance on how to make these processes more inclusive.”
“Informed consent is the cornerstone for ensuring the autonomy of a potential participant in a study, from the first contact and decision-making until their participation has concluded. Ensuring that the informed consent process is understandable and meets the needs of potential participants is essential. Knowing the target population and co-creating the information materials allows for the development of more understandable materials that are better adapted to the needs of participants,” explains the technical coordinator of i-CONSENT, Jaime Fons-Martínez.
It is hoped that this reformed approach will lead to great improvements in the informed consent process; which in turn should help facilitate participation in vital medical research.
The i-CONSENT consortium includes the following partners: FISABIO Foundatin (FISABIO), GlaxoSmithKline Spain (GSK), The Bambino Gesu` Children's Hospital (Ospedale Pediatrico Bambino Gesu`, OPBG), Meningitis Research Foundation (MRF), Libera Università degli Studi Maria Ss. Assunta di Roma (LUMSA), UNESCO Chair in Bioethics and Human Rights (UNESCOBOCHAIR), AND-Consulting Group (AND-GC). i-CONSENT has received funding from the Horizon 2020 program of the European Commission (No. 741856).