The FISABIO team sat together with experts in the field and discussed the guidelines’ content using the RAND/UCLA methodology

In addition to the validation of the materials elaborated following the i-CONSENT guidelines, it has deemed necessary to evaluate the appropriateness of the project recommendations by experts. The event, which took place today, counted with participants representing the different project stakeholders: Patient representatives; Pharma Industry; Investigators; Ethical Committees; Regulators.

The methodology selected for the evaluation is the RAND/UCLA Appropriateness Method. According to several authors (Masdeu Ávila, 2015), this method is the best one for developing guidelines and recommendations . Even so, the has adapted the approach to current COVID-19 pandemic in content and shape. As the introductory meeting can’t be held face-to-face, it was held virtually. The participants, who had previously completed a survey and sent a report with some suggestions, debated the main conclusions today.

This new study will increase the quality of the recommendations. It will provide the final guidelines with a very valuable input. This quality check will also translate the guidelines into a more feasible, realistic and ready-to-use text for clinical researchers. 

A report of this study will be included in the deliverable D3.2.

The picture corresponds to the project expert meeting on February 2019.