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.
Click on the video below to hear a real story about safety and ethics in clinical trials.
Your rights are to:
Be treated with respect.
Be fully informed in different aspects of your treatment plan, outlined and explained during the consent process and within the clinical trial protocol.
Decide not to take part in a study.
Leave a study at any time.
Ask for information in the language of your choice or ask someone to help you interpret.
Note:
These are your rights whether you choose to take part in a study or not.
“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.
Note:
Sometimes researchers share study details with other researchers. These details will not have information that can identify you.
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 outlines who may have access to your information. By signing it, you acknowledge your rights and your role in the study. This may include researchers storing your information in a secure database.
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, clinical trials are conducted under strict guidelines, with oversight from the Food and Drug Administration (FDA).Every trial has a person in charge, usually a doctor, who is called the principal investigator. The principal investigator prepares a plan for the study, called a protocol, which explains what the trial will do, how the study will be carried out, and why each part of the study is necessary.
Your rights and safety are further protected by:
Institutional Review Board (IRB), which ensures researchers follow all ethical guidelines and laws.
Federal regulations, which requires that clinical trials are done ethically and you rights and safety are protected
Informed consent in which you learn important information about the clinical trial to help you decide whether to participate; you can leave the study at anytime.
Ongoing monitoring by research teams and study sponsors
Learn more of what the government and researchers do to protect participants today:
Gain understanding into research 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.
Find more resources
Lessons learned from past research mistakes
Click on a link below to learn about past mistakes and present improvements to protect study participants:
