i-CONSENT develops a route map for professionals involved in the design of informed consent process
After three days of intense work, i-CONSENT can finally say that the process of elaboration of the guidelines is coming to an end.
The project team flipped around the traditional concept of guidelines and turned them into a ready-to-use and easy-to-consume document. In short, they will serve as a route map for anyone involved in the design of informed consent process at the study level, including researchers and sponsors.
“This new guideline format puts in practice most of the recommendations included in the guidelines. Its layered approach facilitates its comprehension and quick read. This is to say, the guidelines allow the researchers delve on those aspects they’re more concerned about”, Jaime Fons-Martínez, i-CONSENT Technical Coordinator.
All in all, the guidelines are a product of the revision of the scientific literature, soft and hard law, and qualitative research. All this, conducted of course with different stakeholders and experts. For the first time, participants are at the centre of the investigations and have been involved in different stages of the project.