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Treatment

Making Informed Medical Decisions

As a patient or parent, at some point you will likely face the need to make important medical decisions, and it is absolutely essential that you have full understanding of the procedure or treatment (and the alternatives) before making your decision. Some examples of medical choices that you could encounter may include whether to undergo a surgical procedure, a new medical treatment or participate in a research trial. In all instances you need to give your informed consent before any new treatment, surgery or research begins.

What is informed consent?
Informed consent is a communication process between patients and physicians, such that fully informed patients can participate in choices regarding their health care.

When should informed consent be obtained?
The goal of informed consent is for patients to have an opportunity to be informed participants in their health care decisions. Informed consent should be obtained for participation in all research studies as well as for any experimental or major therapeutic or diagnostic procedure for which disclosure of major risks involved would assist a patient in making a decision whether or not to undergo the proposed procedure.

Written informed consents obtained for research studies are signed by the participant (or legal guardian), the investigator, and a witness. A copy of the signed consent form is given to the participant.

What are the components of informed consent?
Complete informed consent should include a discussion of the following:

  • The nature and purpose of the proposed treatment or procedure
  • Reasonable alternatives to the proposed treatment or procedure
  • The relevant risks, benefits, and uncertainties related to the proposed treatment or procedure and for each alternative
  • The risks and benefits of not receiving or undergoing the proposed treatment or procedure
  • Assessment of patient understanding
  • Acceptance by the patient

In order for the patient’s consent to be valid, he/she must be considered competent to make the decision at hand and his/her consent must be voluntary. The patient should have an opportunity to ask questions to develop better understanding of the treatment or procedure, so that he/she can make an informed decision to proceed with or to refuse the proposed treatment or procedure.

Assent for older children and adolescents
Health care decisions regarding older children and adolescents should include, whenever feasible, the assent of the patient as well as the participation of the parents and the physician. Though consent must still be obtained from their legal guardian, minors should be given serious consideration within their developmental capacities for participation in decision-making and for their assent.

Assent from a minor should include the following:

  • Helping the patient achieve a developmentally appropriate awareness of the nature of his/her condition.
  • Describing for the patient at his/her level what to expect with the proposed procedure
  • Assessing the patient’s understanding of the situation and the factors influencing his/her response
  • Obtaining an expression of the patient’s willingness to accept the proposed care.

Related Webpages

The following web pages cover issues to consider and practical questions to ask as you go through your decision-making process: