How is informed consent for a clinical trial or research study different from consent for standard treatment?
Informed consent for a clinical trial or investigational drug or procedure (where new treatments are compared to the current standard treatment) usually includes more information than the consent for standard treatment. The informed consent process should tell you: What the clinical trial is set up to find out What is expected of you — what will be done and how long you will take part Expected benefits What is known and not known about the new drug or procedure Any possible risks to you (if known) Whom you should contact with questions about or problems with the study Other possible treatment options That you can leave the study with no penalty and opt for standard medical care at any time How your personal information will be protected The informed consent process is meant to give you ongoing explanations that will help you make educated decisions about whether to start or stay in a clinical trial. The most important part of this process is your everyday interaction and discussions w
Related Questions
- If by law a child is able to consent to treatment without parental permission, can they also consent to participate in research related to that treatment?
- How is informed consent for a clinical trial different than consent for a standard medical procedure?
- How does HIPAA affect a research study that also involves health care treatment?
