Withdrawal of biological research consent
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In the Register of Withdrawal from Biological Research Consent, patients can withdraw consent for the use of biological samples taken during routine healthcare examinations in research.
About the register
Research involving human biological material is regulated by the Health Research Act. The Act requires that all research on human biological material must be approved in advance by the Regional Committees for Medical and Health Research Ethics (REK).
As a general rule, research projects that involve people, human biological material or health information may not start unless the participants have been informed and have given their consent.
The register was established at the Norwegian Institute of Public Health (NIPH) in 2009, following the introduction of the Health Research Act on 1 July 2009. The register was previously called the Opt-Out Register, but was renamed the Register of Withdrawal from Biological Research Consent on 17 February 2012.
Exemption from the consent requirement
In some cases, the Health Research Act allows REK to approve exemptions from the requirement for consent. REK may, for example, approve the use of biological material taken from patients during routine healthcare examinations for research purposes without obtaining consent from each individual patient.
Such approval may only be granted if REK considers the research project to be of substantial benefit to society, and if the welfare and integrity of the participants are adequately safeguarded.
Selection for research projects
The register, which is managed by the Norwegian Institute of Public Health (NIPH), contains information on all patients who have withdrawn consent for the use of their biological material collected through the healthcare services for research.
The institution (Health Trust) responsible for conducting the research project must compare the project’s study participant list with the register. Patients who have withdrawn consent must be removed from the study sample. The research project may only use the remaining participants.
Privacy and information security
The Register of Withdrawal from Biological Research Consent is subject to strict requirements for privacy protection and information security. Only authorised personnel may compare information from the register with participant lists from research projects.
How to withdraw consent
You can withdraw consent by completing a paper form and sending it to the Register of Withdrawal from Biological Research Consent.