- Description of the recruitment procedure. It is recommended to use the European Commission’s Recruitment and Informed consent procedure template.
- Material used for identification or recruitment of study participants such as advertising text, video etc. This must be in Norwegian or other languages that potential study participants understand. REK KULMU will not assess patient cards, greetings cards, interview guides for study personnel or other information that is not related to identification or recruitment of study participants.
- It must be clearly stated in the recruitment procedure who conducts the interview with the participant and who is obtaining the consent. The person who provides information about the clinical trial should be a qualified person from the research group, while the person who is obtaining the consent should not be in a dependent relationship with the potential participant to secure the principle of voluntary participation. It is REKs view that such a dependent relationship exists between patient and the treating physician. This implies that another person that the participant’s treating physician must obtain the consent.
- In the recruitment procedure, it must be clearly stated if personnel with legal access to the patient records are to identify potentially eligible study participants for recruitment purposes, e.g. identifications of patients with a particular diagnose. REK KULMU may grant a dispensation from the duty of confidentiality for this purpose, cf. the Norwegian Health Personnel Act (helsepersonelloven), section 29.
- Indicate in the recruitment procedure if there will be electronical documentation of collection of consent. Note that obtaining consent electronically requires a secure solution such as BankID or another kind of two-factor authentication.
