The PICASO Ethical Board was established as an advisory entity soon after the project started. The PICASO Ethical Board consists of the project’s Ethical Manager (Chair), a legal expert, the two trial owners (internal members) and three external expert members.
The PICASO Ethical Board had its first meeting on 25 May 2016 where the ethical issues relevant to the project and the two trials were discussed, the PICASO Ethical Guidelines and Principles were defined, and the board’s Terms of Reference were agreed upon.
Three annual Ethical Board meetings have been held during the project’s lifetime. The board meetings have been used to discuss the ethical concerns/challenges either foreseen or encountered and advise on the best resolution. The meetings were actually held prior to active involvement of patients in the trials and thus represented a good opportunity for ensuring that any ethical and/legal issues were resolved before the trials started.
In addition, one online meeting was held in February 2019; the main purpose here was to give a final update on the project’s trials and their results as the trials were in their last phase.
The external board members have been very engaged in the project and their comments, observations and suggestions have been helpful and are truly valued by the project. See D3.3 PICASO Ethical Guidelines for more information about the Ethical Board.