- Informed Consent
- What is informed consent and what does it mean?
- Why does the doctor need me to sign a consent form?
- What are the legal requirements of informed consent?
- Who besides the patient is allowed to consent?
- Are there times when the usual consent requirements do not apply?
- How will I be given information for 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’s 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 about informed consent
How will I be given information for informed consent?
The way in which information about the treatment must be given (for example, verbally or in writing) may be listed in your state’s laws. Other methods, such as videos, audio files, interactive computer modules, booklets, and fact sheets, may be used by your doctor or facility to make the information easier to understand. The most important thing is that you understand and are allowed to get answers to your questions, so that you have all the information you need as you consider your decision.
Sometimes, a person other than the doctor who will be giving the treatment is asked to give you the information for your informed consent. If this person is unable to answer your questions to your satisfaction, you might wait to sign the consent form until you can talk to someone who can answer your questions more completely.
How much detail should I expect?
Material information: Informed consent requires disclosure of “material” (significant or important) information that will help the patient make an informed choice. The law defines material information in 2 ways:
- The professional’s point of view: In this view, the health provider’s responsibility is limited to telling you those things that a health professional who works in your community would tell you under the same or similar circumstances.
- The patient’s point of view: A patient-oriented standard of disclosure means that the health provider must tell you all the facts, risks, and alternatives that a reasonable person in your situation would find important in deciding whether to have a recommended treatment.
Some of the material information a patient wants may not be available. For example, the long-term risks of a new method of treatment may not be known. If this is the case, the spirit of the laws of informed consent require the health provider to give the best answer possible, which may be “we don’t know that yet.”
Limited knowledge shouldn’t stop you from asking questions at whatever level of detail you want. Some people want to know as much as possible about the treatment or procedure before they agree to it, while others want to know very little. Again, the doctor may not have all the information you’d like, but you can find out what is and isn’t known.
What if I am having trouble understanding the information?
It’s your job to be sure that you understand the information you’ve been given, even if it means going over the information many times.
Sometimes health care workers use words that are hard to understand. Ask the doctor to define words and explain terms. Be sure to tell them what you understand and what you don’t. Sometimes it helps to have a nurse, social worker, or patient advocate with you. They may be able to re-phrase and explain things in ways that are clearer to you.
If you are facing an important health decision, it may help to bring a spouse, relative, or friend with you. That way, there’s a second listener to help process the information and ask questions.
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 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: 07/14/2014
Last Revised: 07/28/2014