Participant Information and Consent

Consent is the primary regulation rule when conducting research on human biological material and personal health information. Consent shall be informed, voluntary, explicit and documentable. Request for participation and consent declarations must be designed in accordance with the template for information material.

A specific consent is based on information about a specific research project.

A broad consent is based on information about a thematic research area. The research participants must give consent for using human biological material and health data for such broad research purposes. Participants who have given broad consent are entitled to regular information about projects using the material.

Read more about Confidentiality and Consent at the Regional Committees for Medical and Health Research Ethics (REK) webpage.

At Oslo University Hospital there are procedures for establishing general and specific research biobanks, and also templates for Participation Information and Consent. You can find it in the Quality System, eHåndboken.

REK has Templates for Participation Information and Consent, read more at REK webpage for application.

Amendments that affect the conditions for approval must be assessed by REK. The changes must be applied to REK and be considered if there is need for new consent due to the changes. Read more about Procedures for Project Amendments.

Dispensation from professional secrecy requirements is possible in some rare cases. Read more at the REK webpage about Form for Dispensation and Consent and professional secrecy requirements at Rules and Procedures.