Clinical trials – Terms and participant rights in Norway
If you participate in a clinical trial in Norway, you have the right to withdraw, to have access to the information recorded about you, and to be informed of any changes in the trial.
You can withdraw at any time
It is voluntary to participate in clinical trials, and you can withdraw at any time. You do not need to give any explanation as to why you want to withdraw, but you must make sure to notify those responsible for the trial.
Withdrawing from a trial will not result in any negative consequences for you or your further treatment. You will not, however, receive more of the treatment being tested, and will be offered regular treatment or follow-up instead.
Changes in the trial
You will be informed of any changes in the trial or if anything occurs that may affect your desire to participate in the trial. You will then be asked again if you still want to participate or not.
Information about injury etc.
Those responsible for the trial are obliged to inform you of your rights if you are injured or suffer complications as a result of your participation in the trial. You will also receive information about your opportunities of applying for compensation via the Norwegian System of Patient Injury Compensation (NPE).
If the trial involves testing of drugs, the persons responsible for the trial are obliged to take out insurance under the Product Liability Act (Drug insurance – in Norwegian).
Patients participating in clinical trials may receive cover for travel expenses. This only applies to clinical trials that have been approved by the hospital. In such a case, the clinical trial is considered as treatment, and travel expenses are covered according to applicable rules.
Privacy, right of access, and storage of materials
When you take part in a clinical trial, your personal data will be stored. Those in charge of the clinical trial are also responsible for safeguarding your privacy.
If you, as a patient, agree to participate in a trial, you have the right to access the data recorded about you. You also have the right to have any errors in the data corrected. The declaration of consent shall stipulate how your personal data is to be used.
If you withdraw from the trial, no further personal data or material will be collected. If you withdraw, you can also demand that your personal data and samples already collected are erased, except in pharmaceutical trials approved by the Norwegian Medicines Agency.
Once the clinical trial has ended, you have the right to know the result of the trial.
Consent and reservation rights
The main rule is that you as a patient and, if applicable, your relatives, shall be asked for consent to participate in clinical trials. For some trials, however, the law does allow the trial to proceed without obtaining consent.
An external research ethics committee (Regional Committee for Medical and Health Research Ethics – REK) may authorise the use of data from medical journals without you as the patient or your relatives being asked in advance. This applies to trials where, for various reasons, it is believed that the benefit of the trial to you as a person or to society is greater than the disadvantage of not asking for consent in advance.
Reservation against the use of biological material for research
The REK may also approve research using biological materials (blood tests, tissue samples, etc.) that are routinely collected in healthcare services without asking for your consent. This is only possible if the research is of significant interest to society, and when your welfare and integrity are safeguarded during the trial.
You have the right to make reservations against research on biological material by submitting a specific form. If you wish to make such a reservation, you can download and fill in the Form for reservation against the use of biological materials (in Norwegian).