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    Question ID:   23410         Current Version: 1
Question: What are some of the "Myth and Reality" about clinical trial informed consent?
Category: Diseases & Conditions > Other
Keywords: myth, reality, clinical trial, informed consent
Type: what
Rating:(0 ratings)    Views: 33    Discussions: 0   In Watch Lists: 1  

 
    Answer:
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 personnel-before, 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 one-not even medical experts-can 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.

Sources:

[1] A Guide to Understanding Informed Consent, National Cancer Institute

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[QID:23430]    What will I find in the clinical trial informed consent document?  
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[QID:8841]    What does "Informed Consent" mean in clinical trials?  
[QID:23429]    What should I expect during the clinical trial informed consent process?  
[QID:23411]    What is the history of clinical trial informed consent and the system of protections?  
[QID:3981]    What is clinical trial?  
[QID:23369]    What are imaging clinical trials?  
[QID:21895]    What is a clinical trial protocol?  
[QID:18658]    Who manages clinical trials?  
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