Terms and rights in clinical trials

Consent to participate in clinical trials

As a general rule, you must give your consent before you can participate in a clinical trial. You will receive thorough written and oral information about what the trial involves. If you wish to participate, you sign a consent form to confirm that you have received information about the trial and wish to take part.

Consent is not legally binding. You can withdraw from the trial at any time without giving a reason. Participation in a trial is voluntary.

Regional Committees for Medical and Health Research Ethics (REK)must review and approve all clinical trials before they can begin. In certain cases, REK may grant an exemption from the usual rules requiring study participants to give prior consent to participation.

Personal data and biological material

Personal data about participants will be stored in connection with a clinical trial. Those responsible for the clinical trial are also responsible for safeguarding privacy.

If you agree to participate in a trial, you have the right to access the information recorded about you. You also have the right to have any errors in the information corrected. How your personal data will be used and who will have access to it must be described in the consent form.

In some clinical trials, samples will be taken from participants, such as blood or tissue samples. These samples are also called biological material. Analyses 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 trial, you will be informed how long the samples will be stored. The samples may not 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 can withdraw at any time. If you do, you must notify those responsible for the trial. You do not have to explain why you no longer wish to participate, but bear in mind that it may be useful for the researchers to know why you wish to withdraw.

Withdrawing from a trial will not have any negative consequences, but you will no longer receive the trial treatment. Instead, you will be offered standard treatment or follow-up.

If you withdraw from the trial, the researchers will not collect any more information or material from you. In some cases, you may also request that information and samples already collected be deleted. This does not apply to drug trials or information already included in completed analyses.

Travel expenses

When you participate in a clinical treatment trial, your travel expenses may be reimbursed. Travel expenses are covered according to the applicable rules for travel to treatment at the health trust.

Changes to the trial

You will be informed of any changes to the trial or if anything arises that could affect your wish to participate, such as newly discovered side effects. You will then be asked again whether you still wish to participate. If you wish to continue, you sign a new consent form to confirm that you have been informed.

Results of the trial

When the clinical trial has ended, you have the right to know the results. Ask the study staff when and how the results will be made available.

Information about injury and similar matters

Those responsible for the trial are required to inform you of your rights if you are injured or experience complications as a result of the trial. You will also receive information about your options forapplying for compensation through the Norwegian System of Patient Injury Compensation (npe.no).

If the trial involves testing medicinal products, those responsible for the trial are required to take out insurance in accordance with the Product Liability Act.