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Informed Consent Forms

What is an Informed Consent Form (ICF)?

Informed Consent Forms are important aspects of a clinical trial. An ICF is a document that provides a potential clinical trial participant information about the clinical trial and any risks there may be in participating. The goal behind the ICF is to present information about the trial to participants in a way that is understandable, so a potential participant can make the right decision for themselves.

Why are ICFs needed for research studies and clinical trials?

Informed consent forms are put in place to protect the participant. ICF’s are needed for research studies and clinical trials to allow the participant to voluntarily agree to participate in the study or trial while having been informed of all the potential benefits and risks of participation in the study. These forms are a legal document that ensures ongoing communication between the participant and the researcher.

What am I agreeing to when I sign the form?

A potential participant is typically agreeing to participate in the clinical trial or research study and acknowledging that they have been informed of what the study involves.  If you have questions about what you are signing or any aspects of the study, ask! The most important thing is that you are fully informed.

Can I change my mind after I have signed the form?

Yes! You can change your mind at any time. Let the study coordinator, researcher or investigator know that you have changed your mind and no longer want to participate in the study.

What if I do not understand what the form says?

Ask the Research Coordinator or the Researcher to expand further on anything you do not understand in the ICF or if you need clarification. You may also want to have a family member review the ICF with you, prior to signing. The reason it is called an informed consent form is because it is expected that the form is written in language that potential participants will understand.

 

Other Helpful Resources:

https://www.fda.gov/patients/clinical-trials-what-patients-need-know/informed-consent-clinical-trials

https://www.ciscrp.org/education-center/important-information/#faq

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