What is informed consent?
ANNOUNCER: Before you take part in a study, it is important to fully understand it and to understand what participation may be like. Researchers will help by providing an “informed consent” document. This is a document that has detailed information about the study, including its length, the number of visits required, medications, and the medical procedures in which you will take part. The document also provides expected outcomes, potential benefits, possible risks, and other details. When needed, a translator may be provided.
Researchers will review the informed consent document with you and answer your questions. After reviewing the statement, getting all the information you need, and talking with staff and your family, you can decide whether you want to participate. If so, you will need to sign the informed consent statement. Your signature indicates that you understand the study and agree to participate voluntarily. You may still leave a study at any time and for any reason even after signing the informed consent document.
Sometimes, a potential participant may not be able to give informed consent because of memory problems or mental confusion. Someone else, usually a family member with a durable power of attorney, can give consent for that participant. That caregiver must be confident they are doing what the patient would have wanted.
Thank you for your interest in learning more about clinical research!