Your Rights as a Trial Participant

Here you can learn about your rights as a trial subject.

For trials reported to the MREC

Your rights as a research participant in clinical trials on medicinal products

Your rights as a research participant in clinical investigations of medical devices

Your rights as a participant in trials with in vitro diagnostic devices

For trials reported to the NVK or the RVK

Your rights as a participant in other trials involving humans, tissue, cells or trials with medicinal products approved under the directive (reported to The Regional Scientific Ethics Committees)

Voluntariness and consent

Participation in a health science trial is always completely voluntary. Therefore, your doctor cannot tell you whether you should participate or not - it is your own decision.

Before you decide whether you want to participate in a trial, you must receive both verbal and written information about the trial. The oral information is given by the person or persons responsible for the trial, and it is important that you take the opportunity to ask questions if you are unsure. You have the right to have an advisor (relative, friend or acquaintance) present at the discussion about the trial, so that two of you can ask questions and talk about your possible participation afterwards. You also have the right to a reflection period before you decide - usually at least 24 hours.

If you choose to become a trial participant, you must sign a consent form stating that you want to participate and that you have received both verbal and written information about the trial. However, even if you have signed the consent form, you can always withdraw from the study. If you withdraw from the trial, researchers often want to know why for the sake of the reliability of the results, but you are not obliged to tell them. If you participate as a patient and withdraw from the trial, you will still receive the treatment you would have received if you had not participated in the trial. In other words, you do not lose any rights as a patient by participating in a trial.

You must be informed in writing

  • That you are being asked to participate in a health science trial and that you will receive non-standard care
  • The purpose of the trial and how it will be conducted
  • In the case of drug trials: which approved and unapproved drugs are used
  • Possible random allocation between several different treatments, one of which may be treatment with an inactive drug (placebo) if there is no standard treatment
  • Risks, side effects and disadvantages of participating in the trial
  • The benefits of the trial
  • If the trial involves the collection of biological material (e.g. blood or tissue) that will be stored
  • If you participate as a patient: What the standard treatment is, whether there are other possible treatment methods and what treatment you will receive if you choose not to participate in the trial. You must also be informed if information from your medical records is used
  • That information from your medical records, purely private matters and other confidential information may be disclosed to and processed by persons who must carry out a statutory quality control of the trial
  • Under which circumstances you can be excluded from the trial
  • Under what circumstances the trial may be discontinued
  • Name, address and telephone number of the trial contact person
  • Any financial support the researcher receives from private companies and foundations
  • Any remuneration for participation and information about taxation of this

Remuneration and compensation

In certain situations, remuneration is paid to trial participants. This could be lost earnings, transportation allowance, inconvenience allowance or other. The participant information will state whether remuneration is given in connection with participation in the trial and whether it is taxable. Read more about the guidelines for remuneration or other benefits to trial participants: Appendiks 1

Complaints and compensation options

If you, as a trial participant, are subjected to unsatisfactory treatment or are injured, there are various complaint and compensation options. When approving the trial, the scientific ethics committee ensures that there is an insurance and compensation scheme for the trial subjects. If you wish to seek compensation for an injury in connection with a healthcare trial, you must report the injury to the Patient Compensation Association.

The scheme also covers pharmaceutical injuries. Healthy trial subjects are also covered by the rules on occupational injury insurance.

If the trial is outside the area covered by the Patient Compensation Association, a separate insurance policy must be taken out. Such professional liability insurance policies normally provide coverage according to the general rules of tort law. You can obtain further information from the person responsible for the trial. In case of doubt, you can contact the secretariat of the scientific ethics committee for your region.

You have the opportunity to complain about the healthcare treatment in the trial. You can send your complaint to the Danish Patient Complaints Board.

Last updated 06-03-2024

Please note that the text on this page has been translated with the help of AI. If you find any errors in the text or something is unclear, please contact us for clarification.

Before you decide

If you are considering becoming a research subject, it is recommended that you read the brochure Before You Decide before you make a final decision. It describes the general aspects of a research project that you should be aware of.

The brochure does not apply to trials reported to the MREC.

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