Your rights as a research subject in a clinical trial in Norway

Participation in clinical trials is voluntary. As a research subject in a clinical trial, you have the right, among other things, to know what data is registered about you and who has access to such data. You will be updated about any new information and changes to the clinical trial. You also have the right to withdraw from the clinical trial.

Consenting to participate in a clinical trial

You generally need to consent before you can participate in a clinical trial. You will receive detailed written and verbal information about what the clinical trial entails. If you wish to participate, you will sign a consent form to confirm that you have received information about the clinical trial and that you would like to participate.

This consent is not legally binding. You may withdraw from the clinical trial at any time without providing a reason. Participation in clinical trials is voluntary.
The Regional Committees for Medical and Health Research Ethics (REC) (in Norwegian) must assess and approve all clinical trials before they can start. In some cases, REC may grant exemptions from the ordinary rules requiring research subjects to provide prior consent to participate

Personal data and biological materials

Personal data relating to research participants will be stored in connection with clinical trials. Those responsible for the clinical trial are also responsible for safeguarding privacy and personal data.

If you consent to participate in a clinical trial, you will be entitled to know what data has been registered about you. You also have the right to request correction of any incorrect data. How your personal data will be used and who has access to it will be described in the consent form.

In some clinical studies, samples will be taken from the participants, for example blood or tissue samples. Such samples are also called biological material. Analyzes of the samples will be included in the study data and the samples themselves will be stored in a research biobank. When you join a study, you will be informed about how long the samples will be kept. The samples cannot be used for purposes other than those for which they were collected without your approval.

You can withdraw at any time

Participation in clinical trials is voluntary and you may withdraw at any time. If you wish to exercise your right to withdraw from a clinical trial, you will need to notify those responsible for the clinical trial. You do not need to provide any explanation for no longer wishing to participate, but please remember that it may be useful for the researchers to understand why you wish to withdraw.

Withdrawing from a clinical trial does not have any negative consequences, but you will not gain any further benefit from the experimental treatment. Instead, you will be offered ordinary treatment or monitoring.

If you withdraw from a clinical trial, the researchers will no longer collect data or materials from you. In some cases, you may also request that the data and samples that have already been collected be deleted. This does not apply to drug clinical trials or data that has already been included in the analyses performed.

Travel expenses

You may be entitled to travel expenses when you participate in a clinical trial. Travel expenses will be covered in accordance with the current rules for travel for treatment within the hospital trust.

Changes to the clinical trial

You will be informed of any changes to the clinical trial or if anything arises that could affect your desire to participate, such as newly discovered side effects. In such cases, you will be asked again whether or not you would like to continue to participate in the clinical trial. If you would like to continue, you will need to sign a new consent form to confirm that you have received the information.

Results from the clinical trial

When the clinical trial has been completed, you have a right to know the results of the clinical trial. Please do not hesitate to ask clinical trial staff about when and how the results of the clinical trial will be available.

Information about injuries and similar

Those responsible for the clinical trial have a duty to inform you of your rights in the event that you develop injuries or complications as a result of the clinical trial. You will also receive information about your possibilities for applying for compensation from the Norwegian System of Compensation to Patients (npe.no), in Norwegian.

If the clinical trial involves drug clinical trials, those responsible for the clinical trial have a duty to take out insurance pursuant to the Product Liability Act.

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Content provided by The Norwegian Directorate of Health, Oslo University Hospital

The Norwegian Directorate of Health, Oslo University Hospital. Your rights as a research subject in a clinical trial in Norway. [Internet]. Oslo: The Norwegian Directorate of Health; updated Wednesday, March 15, 2023 [retrieved Sunday, March 3, 2024]. Available from: https://www.helsenorge.no/en/clinical-trials/clinical-trials-terms-and-participant-rights/

Last updated Wednesday, March 15, 2023