What is Informed Consent?
Healthcare providers (HCP) are required by both law and their ethical codes to obtain informed consent from any competent patient before any treatment. Informed consent is a communication between a medical care provider and a patient that results in the patient’s understanding and authorization for a specific medical intervention. The communication focuses on the explanation of the risks and benefits of a prescribed medical procedure, intervention, or treatment.
Informed consent includes a discussion about the planned treatment, including:
- Information about the purpose of the treatment, how and where it is done.
- The benefits and possible risks or side effects of the treatment/procedure.
- Alternatives to this treatment and their benefits and possible risks.
- The benefits and possible risks of not having any treatment.
In addition, if you are participating in a clinical trial, the research study, procedures, treatments, risks, and potential benefits must be explained to the study participant. Read more about clinical trials.
You should use the time during this discussion with your HCP to ask any questions you have about the treatment/procedure. Questions you may want to ask are:
- Why do I need this treatment/procedure?
- Are there any alternative treatments are available?
- What may happen if you don't have the treatment/procedure?
- How will the treatment/procedure improve my health or quality of life?
- Will I need to be hospitalized as a result of this treatment/procedure? And if so, for how long?
- How long will it take me to recover? What can I expect during my recovery?
- When can I return to work and resume other activities?
If you struggle with reading or writing, it’s important to inform your HCP so that they use other methods to help you understand the treatment/procedure. Many medical professionals use medical terminology that the general public doesn’t understand, so do not hesitate to ask for further clarification of anything you do not understand.
The Informed Consent Document
You (or your surrogate) will be asked to sign one or more informed consent form(s). Review the document and ask any questions before you sign. This form is to protect your autonomy (decision-making ability) and to validate that you have not been forced into receiving any type of treatment or procedure. You may want to ask for a copy of the form after you have signed it.
Informed consent is the law. State laws can dictate the format of these forms, so the form may vary from state to state.
You should not feel pressured or rushed to provide consent. Take time to review the document, discuss with family/friends, and ask questions.
You can change your mind about the treatment at any time, even after the treatment has started. You also have the right to decline the treatment that is being offered.
What if a patient cannot give consent?
If the patient is unable to give consent due to incapacity or being deemed incompetent by a court of law, the surrogate decision-maker would make healthcare decisions.
- This person is appointed through a health care proxy or durable power of attorney for healthcare.
- In the absence of this appointed person, many states have a hierarchy system to select a decision-maker, often beginning with a spouse or parent. Alternatively, they may require the appointment of a legal guardian to make decisions on behalf of the patient.
- Your healthcare team can help you understand the decision-making laws in your state.
- An alternate decision-maker should ask the same questions of the HCP during the informed consent process.
- If the patient's capacity to make decisions recover at any time, the informed consent process should be repeated with the patient, since they are now able to make their own decisions.
What about medical emergencies?
The HCP is permitted to make medical decisions in certain cases of medical emergencies. These treatments are focused on stabilizing the patient. These include:
- If the patient is unconscious and in immediate danger of harm or death without having an immediate medical intervention, informed consent may not be required before treatment is provided.
- If the patient has an advanced directive refusing care, the treatment may not be given.
American Cancer Society, Informed Consent
American College of Surgeons
National Cancer Institute