The Health Research Act regulates research on human biological material. The law requires that all research on human biological material must be pre-approved by the Regional Committees for Medical and Health Research Ethics (REK). Any human research studies involving health information or biological material requires informed consent. However, there are noted exemptions from consent requirements.
Exemption from consent requirement
The Health Research Act allows REK to approve exemptions from the consent requirement. REK can allow biological material from patients taken during routine examinations in healthcare services to be used in research without having to obtain consent from the patient. REK can only grant such approval if the research study is considered to be of great social significance and that the welfare and confidentiality of participants is protected.
Patients, however, can withhold consent for research on their biological material collected by healthcare services. All patients who submit biological samples for diagnostic procedures and treatment need to receive information about how to withhold consent for use of their biological materials in research.
Information from healthcare personnel
In order for patients to be informed of their right to withhold consent, information should be provided by healthcare professionals when biological samples are taken.
Selection for research projects
The registry includes identifiers of all patients who do not want their biological material used for research purposes. The institution (Health Trust) conducting the research is required to compare their study participant list with the registry of patients who have withdrawn consent in order to remove those who have withdrawn their consent.
Privacy and information security
The Register of Withdrawal from Biological Research Consent is subject to strict information and privacy requirements. Only authorised personnel at the institution conducting the research can compare the registry list with the research study list.
Work is ongoing to develop an electronic solution for the registry. The online solution will be available on this website. Until then, the downloadable form must be used.