Informed consent became a major part of
medical ethics and legality after World War II when the Nuremberg Code was
written. During the war, the Nazis experimented on the prisoners in the prison
camps. The Nuremberg Code stated that consent from the participant is essential
for the experiment to happen. This doctrine transformed into what informed
consent is today. Prior to informed consent, doctors often kept information
from the patient in order to remain in control. However, that has been changed
much to our relief as patients. Informed consent is defined as the process by
which a person agrees freely to undergo a treatment or procedure, or to
participate in research. It applies to both therapeutic and research settings.
Without the attainment of informed consent, the medical professional cannot
begin treatment or experiments. A violation of this right can lead to legal
action.
In
order to obtain informed consent, the patient must first be considered
competent. Competency is the ability to perform a task, in this case consenting
receive treatment or enter into medical research. If the patient is considered
incompetent, there is often family available or appointed surrogates who are
trusted to make a wise decision for the incapable patient. However, the physician
can change the decision if he/she finds the decision to be harmful or the
decision-makers to also be incapable of making an informed decision. For the
consent to be valid, the patient must also be provided the necessary
information by the physician. This includes the purpose of the procedure, the
components of the procedure, possible inconvenience and pain, and any risks or
side-effects that can result. This information should be shared in a discussion
setting with the patient and the family. This allows the patient to ask any
clarification questions and discuss anything that may be influencing the choice
to consent or not. Sharing the information in simple terms is also important,
so that the patient will fully understand everything. The health care professional
must ensure understanding is maintained and any changes to the procedure are
shared and understood. After the conference, the patient must read and sign an
agreement form. In less invasive cases consent is given in a different way.
Walking through the door of the hospital or clinic or rolling up a sleeve can
display patient consent to blood pressure readings, temperature readings, and
blood drawings. More explicit consent is needed for more invasive procedures
and medical research.
Many
problems can occur with informed consent. First of all, it is only necessary for
the physician to provide extra information that the patient requests. Some
patients may ask many clarifying questions. However, others may not ask any.
This can result in them being unaware of certain parts of the procedure that
may influence their decision to consent. The physician is supposed to explain anything that will affect the decision, but
the patient may not be known well enough to accomplish this. Another problem is
that of reading the consent form. I’m sure many patients do not read into the
information fully. Therefore, they are consenting to something uninformed. They
did sign the form though, so the
procedure can go ahead and take place. One article I read suggests that the
consent process include a conference between the physician, the patient, and
the family, during which all information is laid out on the table and all
questions and concerns are brought up. This way the patient is obligated to
fully comprehend all necessary aspects of the research or procedure. During the
conference, the article suggests things may be changed if the patient or family
sees fit. Lastly, the concept of a surrogate is always confusing, especially
when the physician can take over the decision according to his/her preference
anyway. The question is always who determines whose decision is in the best
interest of the patient? Generally the family’s decision is honored by the
physician because they know the patient the best and are trusted to know what
the patient would decide. However, as stated before, if their decision seems
entirely out of line, the physician can challenge it and appoint a different
surrogate or determine the next course of action him/herself.
Informed
consent has not been around forever, but now it is necessary in all health care
practices and goes hand in hand with patient autonomy. Patients are able to
make the decisions themselves and preserve dignity and bodily integrity. A
section from a book I read predicts that informed consent will be required in
more and more situations in medical settings due to the support it has in
America as well as the growing number of lawsuits and issues brought to court. A
patient shall not be treated without obtaining informed consent from the patient
or surrogate unless it is an emergency. “Emergency” is narrowly-defined and
very specific. The exceptions to informed consent include the incapability of
patient or surrogate, a life-threatening condition, or the need for immediate
treatment. Informed consent is not a pliable law in any way, but it may
increase its scope as time goes on.
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