Your Rights as a Trial Participant in Trials with In Vitro Diagnostic Equipment

If you are participating in a clinical trial of in vitro diagnostic equipment, it is important to be aware of your rights. You can read about them on this page.

As a participant, your participation in a clinical trial is voluntary.

  1. You are entitled to both oral and written information and must sign a consent form before you can participate.
  2. You have the right to bring a family member or another person to the information session.
  3. You are entitled to a reflection period before signing the consent form.
  4. You can withdraw from the trial at any time without giving a reason. In this case, you will not lose your right to patient treatment or other rights.
  5. Information about you, your health or your blood samples etc. must be processed in accordance with data protection legislation.[1] The data controller for the trial must ensure that you are informed of these rules.
  6. Your consent to the trial means that the data controller and the sponsor may obtain information about your health in the medical record systems when necessary for quality control and monitoring of the trial.
  7. If the information about your health collected during the trial is later used by the trial sponsor for research or statistical purposes, you cannot object to the processing and sharing of this information.
  8. You have the right to refuse to learn about new health information that may be obtained about you during the trial, but which is not directly related to the trial.
  9. If the trial is conducted under public auspices, you have the right of access to documents concerning the organization of the trial, except for those parts that contain trade secrets or confidential information about other persons.
  10. If you are injured during the trial, you can file a complaint in accordance with the rules in the Danish Act on Complaints and Access to Compensation in the Healthcare Sector, see
  11. When the trial is completed, you have the right to receive information about the results of the trial.
  12. The person responsible for the trial must ensure that an information unit is made available to you from which you can obtain more information about the trial.

[1] Regulation 2016/679 of the European Parliament and of the Council of April 27, 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). Act no. 502 of May 23, 2018 on data protection and medical device regulation. Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.


Last updated 01-02-2024

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