New EU project works on improving guidelines for Informed Consent, including vulnerable populations, under a gender perspective

New EU project works on improving guidelines for Informed Consent, including vulnerable populations, under a gender perspective

20 June 2017

The informed consent (IC) process allows an individual; to voluntarily decide whether or not to participate in research.

Autonomy of the patient in the decision of having a medical procedure or participating in clinical research is of major importance. Here’s why:

Generally, ICs are difficult to read documents that do not include all stakeholders’ perceptions. Therefore, informative IC should be a process that includes needed information under a gender and age perspective, more importantly if these are vulnerable populations.

Therefore, the main objective of I-Consent is to develop guidelines on how to present IC to citizens, so that they are comprehensive and facilitate participation of citizens in research.

Linda Glennie, Head of Research, Evidence and Policy at Meningitis Research Foundation (MRF) said, ‘Patient involvement in clinical trials is absolutely crucial to the development of new vaccines to prevent deadly diseases such as meningitis. To participate in any clinical trial, individuals must be able to understand the research. However this is currently hindered by cumbersome IC processes. We are therefore delighted to be involved in this project which will see the development of better IC guidelines. We hope this will lead to better patient involvement and scientific innovation.’

In particular, MRF will work with patient groups from across Europe to gather feedback and perspectives on existing issues and challenges relating to informed consent for vaccine trials in adults, adolescents and pregnant women against serious diseases including meningitis. Ultimately we hope to reach consensus on how issues should be prioritized in terms of their importance and difficulty, in addition to further exploring potential solutions to identified challenges.

Specific objectives of I-Consent: 
  1. Identify gaps, barriers and challenges, and prioritize needs, requirements and areas for action in the process of IC
  2. Develop tailored strategies to inform the development of informed consent
  3. Create and validate guidelines to develop comprehensive IC that improve citizens’ participation in research.
The I-Consent project, worth approximately 3 million euros, was granted within the Horizon 2020 Program of the European Union after a competitive one stage selection process. The project started with a kick-off meeting in Valencia (Spain) on the 11th & 12th of May 2017 and will be funded for three years. 



The I-Consent consortium members include public health experts (Fundacion para el fomento de la investigacion sanitaria y biomedica de la Comunitat Valenciana - FISABIO, Spain), the academic community (LUMSA University and UNESCO Chair in Bioethics and Human Rights) , clinical experts in child health (Bambino Gesù Pediatric Hospital), the pharmaceutical industry (GlaxoSmithKline, Spain) and commercial companies (Sparks & Co., France, and Synectika Research and Consulting, UK) as well as Meningitis Research Foundation as a patient group.

 This project has received funding from the European Union’s
Horizon 2020 research and innovation programme under Grant Agreement N° 741856. 

Sam Williams
Media Relations Manager

Hi, I’m Sam and I’m MRF's PR Manager.

If you want to know more about this story call me on 0333 405 626251, out of office hours on 07875 498047 or email me

samanthaw@meningitis.org