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)

As a participant in a health science research project, you should know that:

1. Your participation in the research project is entirely voluntary and can only occur after you have received both written and oral information about the research project and signed the consent form.
2. You can withdraw your consent to participate at any time, verbally, in writing, or by any other clear indication, and exit the research project. If you withdraw your consent, it does not affect your right to current or future treatment or other rights you may have.
3. You have the right to bring a family member, friend, or acquaintance to the information meeting.
4. You have the right to a reflection period before signing the consent form.
5. Information about your health conditions, other purely private matters, and other confidential information about you that emerges in connection with the research project is subject to confidentiality.
6. The processing of information about you, including information in your blood samples and tissue, is done according to the rules in the General Data Protection Regulation, the Data Protection Act, and the Health Act. The data controller in the trial must inform you more about your rights under the data protection rules.
7. There is the possibility to access trial protocols under the provisions of the Public Access to Information Act. This means you can access all papers regarding the arrangement of the trial, except for parts containing trade secrets or confidential information about others.
8. There is the possibility to complain and receive compensation according to the rules in the law on complaints and compensation access within the healthcare system. If an injury occurs during the trial, you can contact the Patient Compensation Association, see more at www.patienterstatningen.dk

This guide is prepared by the scientific ethics committee system and can be downloaded as a PDF version here (Danish) and attached to the written information about the health science research project. Questions about a specific project should be directed to the project's trial responsible. General questions about trial participants' rights can be addressed to the committee that has approved the project.

Contact information for The Regional Scientific Ethics Committees