IRB oversight
An independent ethics board approves and monitors each study.
Volunteer safety
Your safety and your rights come first.
Clinical trials in the United States follow federal rules designed to protect the people who take part.
Informed consent
You get every risk and benefit in writing, in your language, before anything happens.
Voluntary
You can say no or leave at any time without affecting your care.
Privacy
Your medical information is protected under HIPAA.
Your rights
Questions about safety.
Learn more from the FDA at fda.gov and search studies at ClinicalTrials.gov.
Who reviews the study before it starts?
An independent Institutional Review Board (IRB) reviews every study, consent form and advertisement to protect your rights and safety. The FDA also regulates studies of new medicines.
Can I leave the study?
Yes, at any time and for any reason, with no penalty and no change to your regular care.
What if I have a side effect?
Tell the study team right away. The investigator evaluates every side effect, and serious ones are reported to the sponsor and IRB.
Is my information private?
Yes. Your records are protected under HIPAA and coded before they leave the site.