Building Trust in Clinical Trials

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, the research staff will explain everything about the study, including details about the treatments and tests involved. They are also trained to keep all your information protected as required by law.

Click a question below to learn more:

What are my rights as a research participant?

Click on the video below to hear a real story about safety and ethics in clinical trials.

You have the right to:

  • Be treated with respect.
  • Be fully informed about different aspects of your treatment plan, which are outlined and explained during the consent process, in the consent form, and in 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.
  • Those with special needs can receive assistance.
  • All hospitals are required to offer translation services.
  • Clinical trials must follow strict guidelines.

 

Can I change my mind?

 

  • You can choose to take part in a study, or you may choose not to be part of a study.
  • If you choose to take part in a study, you can change your mind and decide to leave at any time!
    • Always talk with your doctor and clinical care team about your concerns before leaving a study. They can answer any questions and discuss any medical risks associated with withdrawing from the study.
    • The consent form, which you must sign before participating, will also explain how to leave a study and who to contact.

Who can see my information?

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:

  • 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 or sharing study details with other researchers.
  • If a study gathers identifying information, additional safeguards are in place to protect it.

How is my identity protected?

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.
  • If a study collects 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.

Please let us know if you prefer one video to the other. Thank you!

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 your 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 for compliance

 

Find more resources

Patient Rights

 

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.

 

Lessons learned from past research mistakes

Click on a link below to learn about past mistakes and present improvements to protect study participants:

 

Trust and clinical trials research

Click on a link below to see what recent research says about trust in clinical trials

 

Find a clinical trial