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?”)