- Informed Consent
- What is informed consent and what does it involve?
- Why does the doctor need me to sign a consent form?
- What are the legal requirements of informed consent?
- How will I be given information for an informed consent?
- What questions should I ask during informed consent?
- Can I change my mind after I’ve signed the consent?
- What if I don’t want the treatment that is being offered?
- How is informed consent for a clinical trial or research study different from consent for standard treatment?
- How is shared decision-making different from informed consent?
- What if I want my doctor to make the decisions about my care, and I don’t want more information?
- How can I find out more?
- To learn more
What questions should I ask during informed consent?
You will, of course, have your own questions, especially once the doctor starts sharing information. But some basic questions you might ask include:
- What is my diagnosis (the medical name for the illness I have) and what does that mean?
- How serious is my diagnosis?
- What treatments are recommended?
- Are there other treatment options? What are they?
- What benefits would you expect from the recommended treatments and the other options?
- What are the risks or complications of the recommended treatment and the other treatment options?
- Are there problems or side effects that may be caused by the treatments?
- What methods will be used to prevent or relieve these problems or side effects?
- What are the side effects of the treatment—immediate, short-term, and long-term?
- How will having treatment affect my normal functions and everyday activities?
- How would not having treatment affect my normal functions and everyday activities?
- How long will treatment last?
- How long will it be before I can go back to my normal activities?
- How much does the treatment cost?
- Will my insurance cover it? How much can I expect to pay?
It’s a good idea to write down your questions and bring the list to your appointments, take notes on the responses, or bring a voice recorder to record the discussion. (You will want to check with the doctor before you record your talks.) Good health providers usually appreciate a patient’s efforts to understand the challenges they face and to make informed decisions.
How long does the informed consent process take?
The entire informed consent process can take place in one short visit for a fairly simple procedure about which you have few questions. On the other hand, it may take 2 or more conversations for something more complex. For instance, if you are looking at more than one treatment option, a long course of treatment, or a clinical trial, it may take some time. In fact, even after you have signed up for a clinical trial and signed a consent form, the researchers running the trial should keep you updated about new information that affects you as a volunteer. This is part of an ongoing informed consent process, which can sometimes go on even after the clinical trial ends.
Last Medical Review: 07/27/2012
Last Revised: 07/27/2012