Informed Consent

Informed consent is a persons agreement to allow something to happen, such as surgery or an

invasive diagnostic procedure, based on a full disclosure of risks, benefits, alternatives and
consequences of refusal. Informed consent creates a legal duty for the physician and/or
healthcare provider to disclose material facts in terms the client can reasonably understand to
make an informed choice. Ok, thats pretty much a textbook definition.
We have said it is a legal duty between the doctor or healthcare provider and the patient. All legal
duties come with legal paperwork, so once that consent form is signed its full steam ahead for
whatever the patient has agreed to, right?
It is not that easy. To quote the American Medical Association (AMA) Informed consent is
more than simply getting a patient to sign a written consent form. This process should be a
specific communication between the patient and physician about what the doctor wants to do,
possible complications, and likely outcomes. In other words, they need to sit down and talk and
there should be documentation that echos what is discussed. The following factors are required
for informed consent:
1. A brief, complete explanation of the procedure or treatment must be given.
2. Names and qualifications of persons performing and assisting in the procedure
should be provided.
3. A description of the serious harm, including death, which may occur as a result of
the procedure, as well as anticipated pain and/or discomfort, should be provided.
4. An explanation of alternative therapies to the proposed procedure should be
provided, as well as the risks of doing nothing.
5. The client must be advised or his or her right to refuse the procedure or treatment
without discontinuing other supportive care.
6. The client may refuse the procedure or treatment even after it has begun.
Now, what the physician describes and what the form says may not be exact, but as stated earlier,
it should echo it.
Nursings Role in Informed Consent
Because nurses do not perform surgery or direct medical procedures, in most situations,
obtaining clients informed consent does not fall within the nursing duty. Even though the nurse
often assumes the responsibility for witnessing the clients signature on the consent forms, the
nurse is not legally responsible for obtaining the informed consent.
What that means is you, as the RN, are merely collecting the signature, not responsible for the
information included on the form or provided by the physician. You are like a notary when you
sign it yourself. You are simply verifying that the patient signed the consent voluntarily.
Thats the legal standard, but the ethical standard, the moral standard is a little more complicated.
When you hand the patient that form you should ask, Do you understand the procedure you are
agreeing to? If they say no, or provide a description that is fuzzy, or if, as the nurse, you suspect
they dont really get it, you must notify someone. Call the physician, talk to your nursing
supervisor, let someone else know that there is a lack of understanding on the patients part and
dont let them sign until that has been clarified.

The reality is lots of people, healthcare workers included, get lost in the explanations. As they
teach us all in nursing and medical school, the worst time to talk to a patient is right after they
have been given a diagnosis. They often just dont hear you because their minds are wrapping
around the fact they have kidney disease, or cancer or whatever else. They nod, they agree to
things, but they dont really hear.
Informed consent is NOT the form. It is the explanation leading to understanding of the
proposed procedure or treatment by the patient. What defines reasonable and what steps a
nurse may take to ensure patient comprehension differs from place to place. It is defined by
individual states nursing scopes of practice and by each facilitys scope of practice and standard
protocols for nurses.
Who May Give Informed Consent?

If the patient is competent, the patient has the right to consent to, or refuse, the treatment.
Generally, it is assumed that an adult patient presenting for treatment is competent, unless
there is evidence to the contrary. Competency is generally defined as the ability to
understand the nature and consequences of the illness and the proposed treatment and
alternative to treatment and the ability to make a reasoned decision in this regard. The law
presumes the competency of every person 18 years of age or older.
Parents are usually the legal guardians for pediatric patients and will sign the consent
forms. If the parents are divorced the parent with legal custody must give consent.
Sometimes, getting informed consent is difficult, for example, the client is unconscious.
Then, consent can be obtained from a person legally authorized to give it on the patients
behalf, like a wife or husband.
In emergency situations, if it is impossible to obtain consent from the client or an
authorized person, the procedure required to benefit or save the patients life may be done
without liability for failure to obtain consent. In such cases the law assumes the client
would wish to be treated.
Psychiatric clients must also give consent. They retain the right to refuse treatment until a
court has legally determined that they are incompetent to decide for themselves.