- 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
Who besides the patient is allowed to consent?
For children or others who are unable to make the decision for themselves, the parent or legal guardian is legally responsible for getting the information, making the decision, and signing the consent form. But that doesn’t mean that the child or patient who is not considered mentally competent is always left out of the process. Some facilities require the assent of older children before they go into a research study, even after the parents have agreed on the child’s behalf. Assent means that, even though the parents sign the form, the child must also be OK with the plan before the facility will do the treatment.
Along the same lines, people who are unable to manage their daily affairs because of impaired thinking or emotional problems might still be able to understand the medical situation and make their wishes known. They should be given information in a way they can understand, and asked what they want to do.
In the event that you become unable to take in information and make your wishes known, another person may be asked to take part in the process of informed consent. There are several ways that person can be chosen.
Durable power of attorney for health care
The only way you can choose the person to make these decisions for you is to set up a durable power of attorney for health care (also called a health care power of attorney). In this case, if you are unable to speak for yourself, the person you chose becomes legally responsible for making medical decisions on your behalf. This person is sometimes called your proxy, agent, or surrogate. For more on health care powers of attorney, see our information, Advance Directives. (You can read it on our website, or call us for a copy.)
Another option is a court-appointed surrogate or proxy. This is someone a judge chooses to make medical decisions for you. If you become unable to make decisions for yourself, someone else – such as the doctor, facility, a friend, or a family member – may ask (petition) the court to appoint someone to do it for you. The process varies from state to state.
State family agency acts
Many states have passed family agency acts that choose which family members (in a listed order of priority) may act on behalf of a person who cannot speak for her- or himself. This option may be used if you don’t have an advance directive or court-appointed proxy. Depending on your family situation and which state you are in, that person may be your legal guardian, spouse, parent, child, sibling, or other relative.
Last Medical Review: 05/20/2016
Last Revised: 07/28/2014