What are the rights of the participants in a clinical trial?
Participants are entitled to a clinical trial that adheres to all legal and ethical standards. In addition, participants have a right to:
- A clear, transparent Informed Consent process before they agree to join the trial
- Withdraw from the trial at any point in time
The Informed Consent process aims at answering any and all questions that might be relevant to a participant’s decision to agree or decline to join a trial. Only participants who, after having all their questions answered, sign an Informed Consent form can enter the trial. With their signature, participants confirm that they believe they have been given all the important facts about a trial, that they understand them, and that they decided to take part in the trial of their own free will.
An Informed Consent document is not a contract. Therefore, a participant may change his or her decision – any participant has the right to withdraw at any point of the trial. A withdrawal will not affect the participant’s relationship with their doctor, nor will it result in a loss of benefits to which the participant is otherwise entitled. Potential medical risks of a sudden withdrawal from the trial should be detailed in the Informed Consent document.
Source: www.roche.com