What are the legal requirements of informed consent?
States have developed informed consent laws to govern certain types of communication between health providers and patients. These laws list the types of information that patients must be given so they can make an informed decision about getting medical care, diagnostic tests, or treatment.
These laws apply to doctors and sometimes to nurses. They vary from state to state. Some states have very specific laws about certain situations. For instance, some states dictate certain information be given about clinical trials (scientific studies of promising new treatments). Another difference is that some states call only for “reasonable” information; but others require “full and complete disclosure.” (Disclosure means making information known.) If you want to check with your state to find out more about the laws where you live, see the section called “How can I find out more?”
In general, informed consent assumes that you are legally able to make your own decisions. If you are not, the person who is legally allowed to make decisions for you goes through the same process on your behalf (see “Who besides the patient is allowed to consent?” below).
For informed consent to take place, the information that’s given must be understood. This responsibility is shared by the patient, since the doctor won’t know what you don’t understand unless you ask about it. The patient must have the chance to review the information and ask questions.
And finally, informed consent assumes that when you make your decision, you are not pressured – you freely choose based on what you feel is best for you.
Informed consent for a clinical trial is usually required to be more detailed and thorough than consent for a standard medical procedure or treatment. This is because there’s a bigger chance of unknown effects with new treatments, and it’s even more important that you know about these possibilities. (See the section, “How is informed consent for a clinical trial or research study different from consent for standard treatment?”)
- 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?