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Informed Consent

Informed consent is the process by which a physician educates a patient on a recommendation, which is then agreed to by the patient with complete understanding of what is being recommended. This process typically includes the signing of a legal release form.

The Centers for Medicare & Medicaid Services, HHS, specifies informed consent as a condition for participation, for surgical services. It says "A properly executed informed consent form for the operation must be in the patient's chart before surgery, except in emergencies."

The American Medical Association advises physicians to discuss with the patient:

  • The patient's diagnosis, if known
  • The nature and purpose of a proposed treatment or procedure
  • The risks and benefits of a proposed treatment or procedure
  • Alternatives, regardless of their cost or the extent to which the treatment options are covered by health insurance
  • The risks and benefits of the alternative treatment or procedure
  • The risks and benefits of not receiving or undergoing a treatment or procedure

The patient should then have an opportunity to ask questions to elicit a better understanding of the treatment or procedure, so that he/she can make an informed decision to proceed or to refuse a particular medical intervention.

This process is both an ethical obligation and a legal requirement in all 50 states.

Problems with Traditional Informed Consent
  • Written consent is often technical and incompletely understood by the patient.
  • Verbal explanations are dependent on the time, experience and communication skills of the explainer.
  • In-office explanations do not allow the patient sufficient time to review and ask questions about their procedure.
  • There is no clear way to ensure that the patient truly understands that to which they are consenting.
The Ideal Consent Solution

Ideal Consent is a novel, computer-based informed consent process that combines informative videos and the written consent form for optimal patient understanding prior to a medical procedure.

Ideal Consent offers 4 minute video clips, a question and answer option and written consent. Patients are able to create an account with Ideal Consent and access their consent at any time for further review.

References

"Informed Consent." Retrieved June 19, 2008, from American Medical Association Web site:
http://www.ama-assn.org/ama/pub/category/4608.html

"A Guide to Understanding Informed Consent." Retrieved November 22, 2009, from National Cancer Institute(U.S. National Institutes of Health) website:
http://www.cancer.gov/clinicaltrials/conducting/informed-consent-guide/page1

The Conditions of Medicare Participation for Hospitals are codified at 42 C.F.R. Part 482. The surgical informed consent requirement is codified at 42 C.F.R. § 482.51(b)(2).
http://edocket.access.gpo.gov/cfr_2005/octqtr/pdf/42cfr482.51.pdf