The i-CONSENT Project publishes its final product: «Guidelines for tailoring the informed consent process in clinical studies»

Fragment of the guidelines.

The i-CONSENT Guidelines are now ready and available for academia, clinical investigators, pharmaceutical industry, ethical advisory boards, policy makers and any body involved in the development of the informed consent process.

«Guidelines for tailoring the informed consent process in clinical studies» compiles a series of recommendations where a broader and more dynamic concept of informed consent process is presented. According to i-CONSENT, the informed consent processes should focus on the participants and/or potential participants and should be co-designed with them.

The idea is to have a more understandable, tailored and inclusive informed consent. for that purpose, the guidelines provide with a step-by-step description in order to put it in practice.

In words of J.J.M van Delden: «I encourage the whole research ethics community to not only follow these suggestions but also to set up empirical research that will show that following these suggestions from i-CONSENT actually has merit and leads to better understanding.»

If you arrived here, we encourage you to use and disseminate this document that we believe can make a difference and can help to move towards the future of informed consent.