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

1. Participating in a clinical investigation is completely voluntary. You are entitled to receive both oral and written information, and you must sign a consent form before you can participate.
2. You have the right to bring a family member, a friend, or an acquaintance to the information interview.
3. You are entitled to time for consideration before you sign the consent form.
4. You can withdraw your consent and leave the investigation at any time and without giving any reason. This will not affect your right to treatment nor any other rights.
5. Information about you, your health, your blood tests, etc. is subject to a duty of confidentiality and must be processed in accordance with the data protection legislation [1]. The data controller of the investigation must ensure that you are informed about these rules.
6. When you consent to the investigation, you give the investigator and the sponsor permission to obtain information about your health from your medical record whenever necessary for the purposes of quality control and monitoring of the investigation.
7. If any of your health information collected during the investigation is later used by the investigator for research or statistics, you cannot object to the processing and exchange of this information.
8. You have the right to refuse information on any new health findings that may emerge from the investigation, and that are not directly related to the investigation.
9. If the investigation is conducted by a public institution, you have the right to request access to documents related to the organization of the investigation, except for any parts containing business secrets or confidential information about others.
10. If you are injured during the investigation, you can file a complaint pursuant to the rules of the Danish Act on the Right to Complain and Receive Compensation within the Health Service. For more information, please see the website of the Danish Patient Compensation:  patienterstatningen.dk
11. By the end of the investigation, you have the right to receive information about the results.
12. The investigator must ensure you have access to an information centre where you can get more information about the investigation.

[1] Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 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).

Danish Act no 502 of 23 May 2018 on supplementary provisions to the regulation on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (the Data Protection Act)

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 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.