Informed Consent

Autor: OncoLink Team
Fecha de la última revisión: January 11, 2024

What is Informed Consent?

Informed consent is 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 explains the risks and benefits of a prescribed medical procedure, intervention, or treatment. Healthcare providers (HCP) are required by both law and ethics to obtain informed consent from any competent patient before any treatment.  Informed consent includes a discussion about the planned treatment, including:

  • 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 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 tell your HCP so that they can use other methods to help you understand the treatment/procedure. Many medical professionals use medical terminology that the general public doesn’t understand. It is ok to ask for more information.

The Informed Consent Document

You (or your surrogate) will be asked to sign one or more informed consent form(s). Look over the document and ask any questions before you sign. This form is to protect you and to prove that you have not been forced into treatments or procedures. 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. Review the document, discuss it 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 healthcare proxy or durable power of attorney for healthcare.
  • If no one is a healthcare proxy, many states have a hierarchy system to select a decision-maker, often beginning with a spouse or parent. Alternatively, a provider may ask about the appointment of a legal guardian to make decisions on your behalf.
  • Your healthcare team can help you understand the decision-making laws in your state.
  • A healthcare proxy should ask the same questions of the HCP during the informed consent process.
  • If you recover and are able to make decisions for yourself, the informed consent process should be repeated.

What about medical emergencies?

The HCP is can make medical decisions in certain 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.

Resources

American Cancer Society

https://www.cancer.org/cancer/managing-cancer/making-treatment-decisions/informed-consent/what-is-informed-consent.html

American College of Surgeons

https://www.facs.org/education/patient-education/patient-resources/informed-consent

National Cancer Institute

https://www.cancer.gov/about-cancer/treatment/clinical-trials/patient-safety/informed-consent

Referencias

Glaser, J., Nouri, S., Fernandez, A., Sudore, R. L., Schillinger, D., Klein-Fedyshin, M., & Schenker, Y. (2020). Interventions to improve patient comprehension in informed consent for medical and surgical procedures: an updated systematic review. Medical Decision Making, 40(2), 119-143.

Perni, S., Jimenez, R., & Jagsi, R. (2023, October). Optimizing Informed Consent in Cancer Clinical Trials. In Seminars in radiation oncology (Vol. 33, No. 4, pp. 349-357). WB Saunders.

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