Terms and rights when taking part in clinical studies
If you take part in a clinical study, you have the right to access information registered about you, to be informed about any changes to the study, and the right to withdraw.
Changes to the study
You will be informed about any changes to the study that may affect your participation or your decision to take part. You will then be asked again whether you wish to continue participating or not.
Information about injury or complications
Those responsible for the study are required to inform you of your rights if you are injured or experience complications as a result of taking part in the study. You will also be informed about your options for applying for compensation through the Norwegian System for Patient Injury Compensation (NPE).
If the study involves testing of medicines, the responsible party is required to take out insurance in accordance with the Product Liability Act (the Norwegian Medicines Insurance scheme).
Travel expenses
Patients who take part in clinical studies may have their travel expenses covered. The condition is that the study has been approved by the health trust. The clinical study is then considered part of your treatment, and travel expenses are covered in accordance with current regulations.
Right to withdraw
Participation in clinical studies is voluntary, and you may withdraw from the study at any time. You do not need to give a reason for withdrawing, but you must inform those responsible for the study.
Withdrawing from a study will not have any negative consequences for you or for your further treatment. However, you will no longer receive the experimental treatment and will instead be offered standard treatment or follow‑up.
Privacy, right of access and storage of material
As part of a clinical study, personal data about you will be stored. Those responsible for the study are also responsible for ensuring that your privacy is protected.
If you agree to take part in a study, you have the right to access information registered about you and to have any incorrect data corrected. How your personal data will be used must be described in the consent form.
If you withdraw from the study, no further data or material will be collected from you. You may also request that data and samples already collected be deleted, except in medicine studies approved by the Norwegian Medicines Agency. Information that has already been included in published analyses cannot be deleted.
When the clinical study has been completed, you have the right to be informed of the study results.
Consent and the right to opt out
As a general rule, you as a patient, and sometimes your next of kin, must be asked for consent to take part in clinical studies. However, legislation allows for exceptions in certain studies.
An external research ethics committee (the Regional Committees for Medical and Health Research Ethics – REK) may approve the use of medical record information without prior consent from you or your next of kin. This applies to studies where, for various reasons, the personal benefit to you or the societal benefit of the research is considered greater than the disadvantage of not obtaining consent in advance.
Opting out of the use of biological material for research
REK may also approve research on biological material (blood samples, tissue samples, etc.) that is routinely collected in health and care services without obtaining consent. This can only take place if the research is of significant importance to society and if your welfare and integrity are safeguarded.
You have the right to opt out of research using biological material by submitting a separate form available on the website of the Norwegian Institute of Public Health: