He explains the current project developments and the methodology used to meet its objectives

Jaime holds a Degree in Sociology and Business Management and Administration, Master’s Degree in Sociology and Anthropology. Moreover, He has been working as sociologist investigating and developing Strategies for Health Care Providers. Fons Martínez, has also been professor in the Valencian School for Health Studies (EVES) and in the University of Valencia.

Most importantly, Jaime serves as project Technical Coordinator and is responsible of the Informed Consent guidelines development (WP3). In this sense, he is also in charge of the development of new strategies for improving health literacy and other project Tasks. During the interview, he will talk us through the current project developments and the methodology used to meet its objectives.

From where do the i-CONSENT recommendations come from?

The project is elaborating the recommendations in various phases. The first one coincided with the first year of the project. It consisted of a systematic and narrative review of the literature, hard law and soft law. The subjects investigated where the folowing:

  • Strategies to improve the Informed Consent Process (ICP),
  • Gender and age-related issues,
  • Ethical and legal issues concerning ICP,
  • And socio-cultural and psychological perspectives towards Informed Consent.

Simultaneously, we organised a Patient’s Nominal group in order to assess their needs and set a starting point to our investigations.

Along with Patient Organisations, other project stakeholders are being consulted since the beginning of the project, what role do they play?

Excatly. The recommendations are based on what we call the ‘i-CONSENT Methodology’. This approach places the main stakeholders at the centre of the action. Certainly, we want to involve all the interested parties not only in the projects outcomes but also in the research process. Their opinion, their needs and their feedback is essential to us, this is the differentiating element of i-CONSENT.

What where the next steps to complete the guidelines?

After the literature revision and first meeting with Patients, we organised a series of encounters with the rest of the project’s stakeholders.

The workshops where organised both with each stakeholder independently and with groups of mixed stakeholders representatives, so we could confront their points of view.

After these workshops, we wanted to meet up with the three target groups chosen for the validation of the guidelines: children, pregnant women, and adults. Finally, without forgetting the specifications of people from different cultural backgrounds, we brought together some volunteers and ask for their feedback as well.

The recommendations are based on what we call the ‘i-CONSENT Methodology’ which places the main stakeholders at the centre of the action.

Jaime Fons-Martínez, i-CONSENT Technical Coordinator

As you can see, we tried to include any person that could be affected by the informed consent processes and misconduct in their conduction.

Currently, nearly finalising the second year of project, can we say the recommendations are nearly finished?

We are planning to release the first guideline draft at the end of this year and we are discussing the most suitable formats. For the moment we can only say that we will have two versions. The first one will be a long version with specific information on the origin of the recommendations and on how to implement them. The second one will be a schematic short summary with the main ideas.

Finally, once the draft is finished, the project will carry out three different Informed Consent Processes (for VRS, Meningitis and HPV vaccines) based on the i-CONSENT guidelines that will be tested in 3 European countries.