Who is responsible for safety?
Safety in a clinical trial is a shared responsibility. Several groups work together to make sure trials are conducted safely, ethically, and according to strict rules. The people who participate also play an important role in protecting their own safety.
Shared responsibility in clinical trials
Sponsors
The sponsor is the pharmaceutical, biotechnology, or medical device company running the trial. Sponsors:
- Design the trial and provide the medication or device.
- Monitor incoming data for safety issues and report findings to the U.S. Food and Drug Administration (FDA).
- Ensure the products used are high-quality, stable, and strong enough to work before being used.
Researchers
The researcher in charge is called the principal investigator. They lead the trial at the site and oversees your health. Study staff (nurses, coordinators, research assistants) help by:
- Checking in at every trial visit
- Tracking symptoms and side effects
- Making sure the trial follows the approved protocol
Healthcare providers
Doctors, nurses, and other medical experts monitor your health and well-being throughout the trial. They help ensure any changes in health are addressed quickly.
Independent oversight
Institutional Review Board (IRB)
- Reviews the trial before it starts to ensure it is ethical, fair, and safe.
- Approves the informed consent process, which explains the trial, possible risks and benefits, and participant responsibilities in clear, easy-to-understand language.
- Monitors the trial while it’s running and can require changes or stop if safety issues arise.
U.S. Food and Drug Administration (FDA)
- Reviews clinical trials that involve potential treatments or certain devices before they begin to ensure safety based on lab and animal data.
- Sets rules for how trials must be conducted.
- Monitors side-effect reports and inspects trial sites.
- Reviews all trial results before a drug or device can be approved.
Data Safety Monitoring Board (DSMB)
- A panel of independent experts who monitor the trial in real time.
- Work separately from the sponsor and researchers.
- Can recommend pausing or stopping the trial if serious safety issues arise.
Responsibilities of participants
The clinical trial team goes to great lengths to keep the people who participate safe, but participants themselves also play a critical role in safety:
Understand the trial
Know what is expected, including time commitments, visits, and procedures.
Engage in informed consent
Read the consent form carefully, ask questions, and make sure the process is fully understood before agreeing to join.
Ask questions often
Know who to contact and how to reach them if there’s confusion, a missed dose, or a symptom of concern.
Follow instructions carefully
Take medications or use devices as directed and follow any diet, exercise, or other requirements.
Track and report symptoms promptly
Report side effects as soon as they occur rather than waiting for the next visit.
Remember, participation is voluntary
You can leave the trial at any time for any reason. Learn more about the informed consent process.
What should I learn next?
What is informed consent?
Understand the informed consent process and how it protects participants.
How do clinical trials work?
Learn how clinical trials are set up, how they work, and understand the different types of trials.
Find a clinical trial
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Find resources
Explore our clinical trials resource library for materials you can use to talk about clinical trials.