E. Information research subjects
To inform potential subjects, all study-specific information must be submitted. This includes, but is not limited to, information sheets with consent forms, advertising and recruitment texts, study brochures, patient diaries and questionnaires. General information not specifically drawn up for the study need not be submitted for review. This concerns, for example, brochures with information about standard treatment, general instructions for use of an app or device, privacy policy of a website, travel organisation or other parties, claim forms, welcome or thank you notes, et cetera.
Language Subject Information Sheet
The reviewing committee (MREC or CCMO) only assesses the Dutch information sheet and consent form. However, every test subject must be able to make well-informed decisions about participating in a study. If a person not sufficiently proficient in Dutch, is asked to participate in a study, the subject information sheet must be available in a language that the person is proficient in. As a standard, the study's sponsor is responsible for a good translation. The review committee does not require the translated subject information sheet; however the corresponding translation certificate must be submitted. If a person who is not proficient in Dutch, is asked to participate in research unexpectedly and incidentally, a translation certificate is not required. In addition to providing adequate written information, the investigator must also ensure that oralinformation is provided (before and during the study) in a language that the subject is sufficiently proficient in.