A doctor examines her patient's hand
A doctor examines her patient's hand
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Participants’ Rights and the Role of Caregivers

Participants in a clinical trial are protected by various rights that are more important than all other considerations related to the research project.

Five Examples of Participants’ Rights

1
The right to understand the risks and benefits of participating in the clinical trial

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

2
The right to ask questions and receive answers at any time 

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.

3
The right to confidentiality and privacy 

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.

4
The right to leave the trial at any time 

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.

5
The right to file a complaint

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.

The Role of Caregivers in Clinical Trials

The Role of Caregivers in Clinical Trials

Caregivers supporting participants in a clinical trial play an important role. Caregivers, like participants, should also review the clinical trial to understand the implications of their supporting role.

Caregivers’ level of support may vary depending on the nature of the clinical trial. Here are some examples:

  • Emotional support: Regularly check the participant’s physical and emotional health.
  • Logistical support: Take the participant to appointments and provide assistance with completing health questionnaires and administering the treatment as prescribed.
  • Communication with the scientific team: If the caregiver is supporting the participant on a daily basis, report to the research team any significant changes in the participant’s health or behaviour.
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