I needed to know that researchers had my best interest in mind and that I was safe. So I asked questions.
Before you enroll in a clinical trial, research staff will tell you all about the trial. Research staff will also tell you about all treatments and tests that are part of the study. Research staff keep all information protected as required by law.
“Remember, you can choose to leave a study at any time.”
You can choose to take part in a study, or you may choose not to be part of a study.
You can decide to leave a study at any time.
It is important to talk to you doctor about your concerns before leaving a study. Your doctor can tell you about any medical risks due to leaving a study.
If you change your mind in the middle of a study:
The consent form has details on how to leave the study, including a telephone number. [You get a consent form when a researcher explains the study to you. You have to sign a consent form before you join a study.]
Click on the video below to hear about protecting your information in clinical trials.
Research staff can see your information. These researchers received special training about how to protect your privacy.
Sometimes researchers share study details with other researchers. These details will not have information that can identify you.
Before you can join a study, you need to sign a consent form. This form shows that you have talked to the researchers about the study and that you agree to participate. When you sign this form, it means that you understand your rights and your role in the study. This might mean researchers can put your information in a secure database.
Some studies collect information that can identify you. Researchers will keep this information separate from other information. Information that can identify you has extra levels of protection to keep it safe.
Your consent form lists people who can see your information.
Click on the video below to hear about identity protection in clinical trials.
Researchers must follow federal laws that protect your privacy.
Only approved study team members can see your personal health information.
Some studies collect information that can identify you. Research staff will remove this information so that it cannot be linked to you. For example, research staff may replace your name with a special code that is not connected to you.
Researchers will not publish information that can identify you.
How do I know that negative research stories from the past won’t happen again?
Click on the video below to hear about safety and ethics in clinical trials.
Today, researchers learn to prevent the mistakes of our past:
Tuskegee Study (1932-1972) researchers did not tell participants all the study information. By today’s standards, participants could not join a study without all the information. The Tuskegee Study also withheld medical treatment from participants. Today, research studies can’t prevent high quality medical care.
Henrietta Lacks received a medical procedure in 1951. Medical research staff did not inform her about using a sample of cells from the procedure. Today, a study cannot use someone’s cells unless they consent to the research plan.
Today, the Food and Drug Administration oversees clinical studies. Each research site also has an Institutional Review Board (IRB). This IRB makes sure researchers follow all ethical guidelines and laws.