Informed Consent is the document that allows patients to voluntarily decide their participation in a clinical research. However, most of the time, the information is not properly displayed and does not consider patient characteristics such as age, gender, etnic qroup, etc.
Therefore, researchers and other profesionals in the sector have decided to turn the Informed Consent into a process where citizens become literate in health. The idea is to have the essential information clearly presented and personalised by using innovative tools to allow different ways of communication among stakeholders participating in the research.
A new perspective
i-CONSENT is a research project funded by the European Union H2020 programme aiming to create personalised and innovative Informed Consent guidelines. This new perspective will facilitate and improve patient’s autonomy in decision making.
The main objective of I-Consent is to develop guidelines on how to present Informed Consent to patients, so that the guidelines are comprehensive, facilitate participation in research and guarantee autonomy.
To obtain this, 6 specific steps will be persued:
Assess all stakeholder’s needs in relation to Informed Consent
Identify gaps, barriers and challenges in the process of Informed Consent
Analyse the risks and opportunities of using digital technologies
Develop tailored strategies for the development of Informed Consent
Analyse the legal aspect of Informed Consent in relation to social media use
Create and validate guidelines
Organise workshops in order to interact with all potential stakeholders and assess their needs
Develop new resources to facilitate the understanding of Informed Consent using digital and non-digital tools
Develop, validate and publish comprehensive guidelines to improve the Informed Consent process
I-Consent Concept & Approach
i-CONSENT understands Informed Consent as a process. It's starting point is the first contact between researcher and the potential patient but will continue until the end of the study.
After the subject has showed his interest on the research, the second step is the discussion. Researchers will explain what the study involves backed by innovative tolos (such as videos, comics or apps, among others) to provide the patient the sufficient level of understanding in order to move to the next stage and make a decision on his/her participation.
It will ensure that the gender and age perspectives are included and that the vulnerable population is taken into account in order to improve the information that the patient usually receives during clinical research.
After the patient's enrollment comes the interventon. During all this process there will be a follow-up to monitor the process and resolve any doubts that may come up.
When the research is over, feedback will be collected and analyzed from patients and research team to assess the process, provide improvements and generate a new starting point for future research.
The validation of guidelines will be related to 3 target groups in 3 case studies:
- Meningitis vaccines in adults
- Respiratory syncytial virus (RSV) in pregnant woman
- Human papilloma virus (HPV) in preadolescents and adolescents.