Informed Consent – What You Should Know

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In today’s healthcare industry, more and more people are becoming aware of their options in being an active participant in determining the path of healthcare that is best for them.   Making the right healthcare choices begins with being fully informed of options and treatments which may or may not be covered by insurance.  Insurance policies should not be the determining factor in treatments offered by physicians.  Be sure to talk to your doctor about all treatment options and the risks associated with those options before making a decision about consenting to a treatment plan.

The Purpose of Informed Consent

The idea of informed consent is to protect people from being used against their will, or knowledge, in medical experimentation. There is no standard across the world, country, within the states, or even within a single hospital of what informed consent is and how it is to be used.

Implied Consent

Examples of implied consent are dressing changes after a skin graft or the removal of additional tissue during a surgery to remove cancer. In other words, implied consent is implied from a previous conversation with the patient about a procedure or treatment. It has been stretched in the past to constitute what a reasonable person would agree to if the patient is unable to give consent.

Informed consent in today’s healthcare industry is defined as:

(1) An aspect of research in which the consent of the subject is obtained and the subject is informed of possible risks and benefits from participating in the research.

(2) Consent to medical procedures/treatment given by a patient after the potential risks, hazards, and benefits of the treatment have been explained.

(3) An agreement by a patient, verbal or written, after being told in sufficient detail of possible risks, to have a procedure performed.

(4) In law, voluntary agreement with an action proposed by another, e.g. agreement to treat, to euthanize.  Consent is an act of reason so that the person consenting must be sane and of sufficient age to be capable of giving consent.

(5) Agreement to a proposition when the consenting person is in possession of all of the facts relevant to the decision. In the eyes of the law the consent of a client to a surgical operation, to a financial expenditure, to euthanasia, carries no authority unless the client is fully informed about what is to be done and what the alternatives are.

There are some circumstances where the patient is unable to give consent due to being unconscious, medicated, in pain, or mentally unable (due to age or ability).

When every minute counts there may not be time to wait until the patient wakes up, contact the family, or wait for the medication to wear off. In these cases the doctor has to act to save the patient’s life, even without consent from the patient.

Patient Guardian & Informed Consent

There are circumstances where the patient is not able to give consent as is the case with children. The 1984 case of Baby Fae who was born with hypoplastic left heart syndrome (HLHS) is a good example.   HLHS leaves the left side of the heart and aorta underdeveloped and unable to pump blood through the body.  Most infants with HLHS die within two weeks.

Fae’s mother was unemployed and without medical insurance.   Doctors told the mother that her daughter would soon die or she could try a xenograft which was an experimental transplantation of an organ from one species to another.

The doctors offered Fae this treatment for free and did not discuss any alternative treatments with the mother; what choice was the mother given other than to watch her daughter die? There were alternate medical treatment options for Fae; search for a human heart that matched and a surgery that attempted to repair the left ventricle.

While all three options carried different risks and benefits, the mother was only offered one option; grafting a baboon heart into her daughter.

The question remains whether or not Fae’s mother did give informed consent as California law professor Alexander Capron addresses in his summary:

“Doubts linger, not only about the adequacy of the information supplied to Baby Fae’s parents but about whether their personal difficulties made it possible for them to choose freely, and whether the realization that their child was dying may have left them with the erroneous conclusion that consenting to the transplant was the only ’right’ thing to do”.

Not only is it possible that the mother was not given adequate information about the surgery and its outcomes, but the stress she was under, facing the possibility of her daughter’s death, may have led her to feel she had no other choice.   And, as is the case with other experimental treatments, the outcome is unknown as are the side effects and possible long term effects.

Know Your Rights & Ask Questions

Whenever possible, consent should be obtained before the treatment, procedure, tests, or medication is started.

The patient or patient guardian should understand the material risks and benefits, reasonable alternative treatments, and the consequences of no treatment at all. The patient or patient guardian needs to understand that consent can be withdrawn at any time for any reason.

Note: This article is not intended to provide legal or medical advice of any kind.  In the event of the need for legal representation, and/or medical care, consult a professional.