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Understanding Informed Consent Forms

Understanding informed consent forms: A doctor and patient reviewing a medical form.

The informed consent form puts you in control of your health decisions and protects your rights.

Before you join a cancer research study, you’ll receive an informed consent form to review, ask questions about, and sign. The form covers a description of the study’s purpose, procedures and safety measures researchers will follow, and what is expected of study participants. 

The form is part of the informed consent process. This process protects your rights. It also gives you control over your choice to take part in research.

Federal law requires that researchers give the informed consent form to potential participants. You will have a chance to ask questions about information you read in the form. Once you understand the study, you can choose if you want to sign the consent form and take part.

Understanding a consent form is an important part of the informed consent process. All informed consent forms are different. But most forms will have the same kinds of information about the study divided into sections.  

Overview of study
This section tells you: 

  • what question researchers are hoping to answer with the study 
  • the main potential risks and benefits of taking part in the study 
  • your responsibilities as a participant  



The overview also describes the choices you have if you do not take part in the study. And it explains the reasons you might leave the study early. This section also lets you know that taking part is voluntary and you may leave the study at any time.

Study design
This section describes:

  • each study group
  • what each group will be asked to do, including tests and procedures you will have and drugs you will take
  • how many people will be in each group
  • how long the study will last

Risks and benefits
This section describes:

  • all known potential risks and benefits of taking part in the study 
  • the most common side effects
  • how the study will help doctors learn about your disease

Cost
This section explains the costs of taking part in a study. Insurance and the study sponsor should cover some expenses. But you might have others, such as the cost of travel to the trial site. Learn more about who pays for clinical trials.

A doctor comforting a patient.

Safety and Clinical Trials

Explore the many safety measures in place to help keep you safe during a trial or study.

Your rights
This section covers your rights:

  • if you are injured because of the study or neglect 
  • to privacy when it comes to sharing your medical information 
  • to leave the study at any time

How to get more information on the study
This section provides ways to:

  • learn more about the study
  • learn more about your rights as a participant
  • reach the study team

Signature
As with most legal documents, informed consent forms require a signature. But it’s important to remember that you are not signing away your rights or binding yourself to the study. You may still leave the study at any time. If a participant is under 18 years of age, read about the children’s assent process. 

Read a sample consent form to become familiar with the content and sections. Note: this form is for informational purposes only and does not represent a real study. Your form may have other sections, and may present the information in a different way.

Amy Rose oversees the day-to-day operations of clinical research, including the informed consent process for potential research participants. She is the associate director in Clinical Research Services at University of Pittsburgh Medical Center Hillman Cancer Center.

If you are thinking about taking part in a clinical trial, Amy suggests that you: 

  • Bring a friend or relative to the appointment when your study team discusses the study and informed consent form. 
  • Take the form home. Read it in a comfortable place, take notes, and jot down questions for your doctor or study team. “You can highlight things and write down questions right on the consent form,” Amy said.  
  • Ask a close friend or spouse to read the form so you can discuss it with them. Have them take notes too, and compare your understanding. Reviewing it with your primary care provider can also be helpful, Amy said. 
  • Don’t be afraid to ask questions. Amy said she and other medical professionals don’t always realize when they aren’t explaining things clearly. They may be in a rush or too steeped in the language of medicine. 
  • You can decide not to take part before or after you sign the form. “We always tell people their participation is completely voluntary,” Amy said. “You do not have to continue just because you sign this consent today.” 

The informed consent process does not end when you sign a form and decide to take part. Your doctor and study team will keep you updated about the study so you can continue to make informed decisions. 

Representative on a headset helping a patient who has called in for assistance

Have questions about informed consent?

Connect with our cancer information specialists.

Phone: 1-800-4-CANCER 
Chat: LiveHelp
Email: NCIinfo@nih.gov

Available Monday–Friday 9:00 a.m. to 9:00 p.m. ET.

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