- 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
Why does the doctor need me to sign a consent form?
The main purpose of the informed consent process is to protect the patient. As mentioned earlier, a capable adult cannot be forced to have any type of medical treatment. In general, anything other than a life-threatening emergency in which the patient is unconscious requires consent before treatment. Even in that situation, consent may be required if the patient is known to have an advance directive. (See “Who besides the patient can give consent?”)
A consent form is not needed for simple diagnostic tests and situations in which your actions imply consent. For example, if you see your doctor and allow a blood sample to be taken for lab tests, your consent is assumed because you went to the doctor seeking care and allowed blood to be drawn. At any point, you could change your mind and decide to refuse testing, leave the doctor’s office, or seek care elsewhere. This is different from a treatment that puts you in a vulnerable position or can possibly cause serious harm. You need more information about more risky treatments so that you can weigh your options and consider your risks before making a decision.
Even when there are no other accepted medical treatment options, it’s still your right as a competent adult to refuse a treatment that you don’t want or refuse to be in a study that you didn’t choose. But once you sign the consent form, it’s taken to be a formal, legal agreement that you are OK with the plan or procedure that’s listed on the form unless you revoke (take back) your consent before treatment is given. The doctor or facility will usually give you a copy of the consent form, but they keep the original as a legal record that you agreed to the treatment.
Last Medical Review: 07/14/2014
Last Revised: 07/28/2014