How is participant wellbeing protected during a clinical trial?
One of the responsibilities of the healthcare team who run clinical trials is to care for participants. The healthcare team is typically made up of doctors, nurses, and trained researchers. This means that they are trained to look after your safety and health.
Clinical trials also have a regulatory and ethical framework to protect participants. Everyone conducting a clinical trial has strict regulatory and ethical duties. Teams of people, called an Ethics Review Board (ERB) or Institutional Review Board (IRB), operate independently from the day-to-day conduct of research. An ERB or IRB reviews every clinical trial before people can take part. This is to ensure that the correct steps are taken to protect participants' welfare and rights. An ERB or IRB protect participants by:
- making sure that clinical trial risks are as low as possible for participants;
- ensuring the potential benefits of the clinical trial outweigh the risks; and
- making sure that a clinical trial meets overall safety requirements for participants.
After joining a trial, can a participant stop taking part?
A participant may stop taking part in a clinical trial at any time, for any reason. No matter the stage of the trial, a participant has the right to change their mind and withdraw. If a participant decides to withdraw, the study doctor will remove them from the trial in a way that is safe for the participant.