Yes. Before a clinical trial can be approved to begin, Protections must be built into the clinical trial process to safeguard the wellbeing of participants. Below are just some of the different people and activities associated with clinical trials that are designed to keep participants safe.
The Healthcare Team
One of the responsibilities of the healthcare team who run clinical trials is to care for participants. They are trained to look after your safety and health. They may do this by talking with your personal healthcare team about your needs and treatment, or by talking to you about whether you want to continue in the trial.
Regulation and Ethics
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.
- making sure that a clinical trial meets overall safety requirements for participants.
Each clinical trial has different risks and benefits. And as each clinical trial participant is different, they will experience these risks and benefits in different ways. For example, one person may experience a side effect from the study medicine, but another person might not.
Informed Consent
Clinical trials are experiments, so the exact risks and benefits can be difficult to predict. Researchers only move forward with clinical trials when they are optimistic about the potential benefits and believe any risks for participants are acceptable. Researchers discuss the potential risks and benefits of a clinical trial with participants before the participant might agree to take part. This talk takes place during the informed consent process. This process helps participants understand what is involved in the study so that the participant can make an informed decision on whether to join.