Patient involvement in clinical trials is vital for the development of life-saving vaccines and treatments. But before anyone can decide to take part in a trial, they must be fully informed about the research and what taking part would involve. This is the purpose of the informed consent process. However we know that in reality it often fails to achieve this, perhaps due to informed consent documents typically being long and difficult to read. As a result, many people are discouraged from taking part, and evidence suggests that even those who do sign up, often have a limited understanding of the study1.
The i-Consent project, which is funded by the European Union’s Horizon 2020 Programme, is committed to promoting patient involvement in research by improving the informed consent process. To achieve this, the project aims to develop a new set of guidelines, which are more inclusive and consider gender, age and cultural perspectives. This will ensure that information is more effectively tailored to meet the needs of the patient by utilising both digital and non-digital tools.
While we have vaccines against some causes of meningitis, we still need new vaccines to be developed. These vaccines will need to be trialled and MRF are involved in this project to help improve participation in clinical trials.
Project objectives
1 - Identify gaps, barriers and challenges, and prioritise needs, requirements and areas for action in the informed consent process.
2 - Develop tailored strategies to inform the development of informed consent documents.
3 - Create and validate guidelines on how to develop comprehensive informed consent that improves participation in research, considering gender and vulnerable populations.
Our role in the project
Patient involvement in clinical research is crucial to the development of new vaccines to prevent deadly diseases such as meningitis and septicaemia. It is hoped that through the development of new guidelines, recruitment and retention for clinical trials can be improved, enabling important developments in the prevention of disease.
MRFs role in the project is to:
- Organise a workshop with European patient groups to gather their perspectives on the issues and challenges relating to informed consent for vaccine trials.
- Conduct a literature review into the reasons and possible solutions for the underrepresentation of women in clinical research.
- Conduct a review of popular online platforms to understand effective methods for communicating with women online on health topics.
Key findings from the workshop with European patient groups:
- Long, complicated informed consent documents which incorporate technical/legal language and medical jargon are barriers to a patients’ understanding of the trial.
- Informed consent documents should connect with potential participants, presenting a clear case for participation and offering a compelling story that is relevant and meaningful.
- The inclusion of excessive risk information was felt to contribute to the inability of documents to connect with patients, in that this information was perceived to be for the benefit of the sponsor (to reduce their legal liability) rather than the patient.
- Good communication and trust is vital in the relationship between researcher and patient. Both written and oral information should be trustworthy and clear.
- The order in which information is presented is also important in establishing patient trust. A statement about ethical approval should be included at the beginning of the IC document to show that the trial has been scrutinised by independent authorities.
All project reports will made publically available in due course, pending approval from the European Commission. Available reports can be accessed on the i-Consent website.
Key partners
There are seven partner organisations involved in the project, based across four European countries. They are a multi-disciplinary group, bringing together expertise from academia, medicine and public health, the pharmaceutical industry and commercial organisations.
In addition to MRF, the partner organisations are: