Clinical trials are a major part of CF research. They help researchers understand how potential treatments work and whether they are safe and effective.

To help you make a decision about participating in a clinical trial, the research team will give you an informed consent form that explains the clinical trial in greater detail.

Your Rights Are Protected

It is your right to know everything about your or your child's role in a clinical trial.

Every clinical trial is different. The informed consent form will include information about the specific trial you are considering, including:

• The trial's purpose
• How long it will last
• Your responsibilities as a participant
• Possible benefits and risks

Consent vs. Assent

In the U.S., consent may only be given by individuals who are 18 years or older. A parent or legal guardian will need to give permission for a child under 18 years old to participate in a clinical trial.

Children usually must give their own assent, as well. Assent is the agreement of someone who is not able to give legal consent to participate in the trial. The assent form will explain the trial in language that is appropriate for the child's age. Asking for their assent allows children and adolescents to play a decision-making role in their health care.

What to Expect During the Informed Consent Discussion

• The principal investigator or research coordinator will start the discussion by giving you information about the trial. They will carefully go through the informed consent form with you and explain how the information relates to the trial you are considering.
• If you don't understand something, ask! The research team expects that you will have questions for them, so feel free to ask as many questions as you need.
• You can take the informed consent form home to give yourself more time to read about and consider the clinical trial.
• When you are ready and feel that your questions have been answered, the research team will have you sign and date the informed consent form. This shows that you fully understand the trial and that you wish to volunteer or give permission for your child to participate.

"It really is a team effort of partnership with the patient, with their clinical team, and with the research team." — Justin Anderson, a CF research coordinator

Consent Is an Ongoing Process

Informed consent is more than signing a form. It's a learning process that continues throughout the clinical trial.

Occasionally, new information becomes available or changes are made to the study that may affect your decision to participate. If this happens, it is your right to be notified, and you will receive a new informed consent form. If you wish to continue in the trial, you will be asked to review and sign this new form after all your questions are answered.

Remember: An informed consent form is not a contract. You can stop participating in a clinical trial at any time. If you decide that a particular trial is not a good fit for you or your child, your decision will not affect the care you receive at your CF care center.