You may already have experience with signing consent forms for other kinds of medical procedures, such as surgery, or for cancer treatments such as radiation or chemotherapy. However, informed consent for a clinical trial involves much more than just reading and signing a piece of paper. Rather, it involves two essential parts: a document and a process.
The informed consent document provides a summary of the clinical trial (including its purpose, the treatment procedures and schedule, potential risks and benefits, alternatives to participation, etc.) and explains your rights as a participant. It is designed to begin the informed consent process, which consists of conversations between you and the research team. If you then decide to enter the trial, you give your official consent by signing the document. You can keep a copy and use it as an information resource throughout the course of the trial.
The informed consent process provides you with ongoing explanations that will help you make educated decisions about whether to begin or continue participating in a trial. Researchers and health professionals know that a written document alone may not ensure that you fully understand what participation means. Therefore, before you make your decision, the research team will discuss with you the trials purpose, procedures, risks and potential benefits, and your rights as a participant. If you decide to participate, the team will continue to update you on any new information that may affect your situation. Before, during, and even after the trial, you will have the opportunity to ask questions and raise concerns. Thus, informed consent is an ongoing, interactive process, rather than a one-time information session.
Before you start exploring this section of the site, you may find it helpful to confront some of the most common misperceptions about informed consent and clinical trials. Even if these do not represent your thinking about informed consent, they can serve as a helpful reminder of what the process is really about before you go through it.
Myth: Informed consent is designed primarily to protect the legal interests of the research team.
Reality: The purpose of the process is to protect you and other participants by providing access to information that can help you make an informed choice. It also is designed to make you aware of your rights as a participant.
Myth: The most important part of this process is signing the informed consent document.
Reality: Actually, the heart of this process is your ongoing interaction and discussions with the research team and other medical personnelbefore, during, and after the trial. The document is designed to get this conversation started.
Myth: My doctor knows best; he or she can tell me whether or not I should consent to participate.
Reality: Your doctor is likely to be a valuable source of advice and information, but only you can make this decision. No onenot even medical expertscan predict whether a treatment, screening, prevention, or supportive care method under evaluation in a trial will prove successful. The informed consent process is designed to help you weigh all of the information and make the right choice for you or your child.
Myth: Once I sign the consent form, I have to enroll and stay enrolled in the trial.
Reality: That's not true. Even after you sign the form, you are free to change your mind and decide not to participate. You also have the right to leave a clinical trial at any time for any reason, without forfeiting access to other treatment.
Myth: Medical personnel are busy, so I can't really expect them to keep me informed as the trial progresses or listen to my questions.
Reality: The research team has a duty to keep you informed, make sure that you understand the information they provide, and answer your questions. If you ever feel that you are not getting what you need, do not hesitate to speak up. You will be given the name and phone number of a key contact person who can answer your questions throughout the course of the trial. Keep in mind that people like you are making this research possible through their willingness to participate.
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