Participants’ Rights and the Role of Caregivers

Participants should be provided with clear information suited to their level of understanding of the clinical trial, including the associated benefits and risks.

Participants may communicate with the contact(s) directly, for any reason and without risk of harm, at any stage of the clinical trial and even after the trial has ended. Contacts are responsible for responding to questions, doubts or concerns that participants may have.

The information collected during the clinical trial remains confidential and will only be shared with those who need it within the framework of the management and conduct of the clinical trial. In addition, participants’ names and contact information are protected and will not be shared unless required by law.

Participants may withdraw from the clinical trial at any time without having to explain their decision verbally or in writing. The quality of their care will not be affected.

In order to ensure participant safety and well-being following completion of participation in the clinical trial, a final follow-up visit may be proposed.

When the trial takes place at a health and social services network institution, participants have the right to file complaints with the local complaints and service quality commissioner if they feel their rights have not been respected or the service received is unsatisfactory.