– supporting material involved in the proposed project.
The approved version of the protocol must have copies of informed consent forms (ICF), both in English and the local language in which they are going to be administered. However translations may be carried out after the English language ICF(s) have been approved by the ERC. If the research involves more than one group of individuals, for example healthcare users and healthcare providers, a separate specifically tailored informed consent form must be included for each group. This ensures that each group of participants will get the information they need to make an informed decision. For the same reason, each new intervention also requires a separate informed consent form. For guidance on how to write an informed consent form,