ALL OPTIONS MUST BE DESCRIBED
You must fully inform the patient of the risks and benefits of each procedure prior to
undergoing the procedure. The explanation must be in language that the patient understands
and include full information regarding alternative treatments. The patient cannot make an
informed choice for one treatment if she does not know of the existence of others.
For example, you inform a patient about the risks and benefits of bone marrow
transplantation for chronic myelogenous leukemia. You fully inform the patient about the
risk of transplantation, including the possibility of developing graft versus host disease. After
the transplantation the patient develops graft versus host disease, which is hard to control.
The patient learns that there is an alternative treatment called imitanib (gleevec), which does
not include the risk of graft versus host disease, but which will not cure the leukemia. The
patient files suit against you. What will be the most likely outcome of the suit?
In this case the patient will probably win the suit because he was not fully informed about
the alternatives to the therapies mentioned. The physician has an ethical duty to inform the
patient about all the treatment options and then allow the patient to decide among them.
Although the physician’s preference of procedure or treatment may differ from what the
patient chooses, the patient has the option to choose therapy that may not be what the doctor
deems is best for him.
ALL MAJOR ADVERSE EFFECTS MUST BE DESCRIBED
Adverse effects and injury from medical care do not necessarily represent a mistake or
failure of therapy. In the case described in the previous example, the error was not that graft
versus host disease developed. The patient was fully informed that this could occur and he
chose the bone marrow transplantation anyway. The error was not informing the patient of an
alternative option in treatment. At the same time, a patient could potentially die as an adverse
effect of treatment. This is only an ethical and legal problem if the adverse event happens and
the patient was not told that it could have happened. The patient might say, “Doctor, 1 would
never have taken digoxin if you had told me it might cause a rhythm disturbance or visual
problem” or “I would never have had surgery if you had told me I might need a blood
transfusion.” The main point is to respect autonomy.
The patient must be informed of the therapeutic options, the adverse effects of the
procedure, and the harm of not undergoing the procedure. If they have the capacity to
understand and they choose to do it anyway, they have made an autonomous therapeutic
choice, and therefore, the patient bears the burden of any adverse effect, not the physician.
For example, a man undergoes coronary angioplasty. He is informed that the artery may
rupture and that there is a small chance he could bleed to death during the surgery to repair
the damaged vessel. He knows he could have bypass surgery instead. He understands and
chooses the angioplasty. He dies from a ruptured blood vessel. The family files suit against
you. What will be the most likely outcome?
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Although it is unfortunate that the patient died in this case, there is no liability with regard
to informed consent or ethical error. The patient was informed of his treatment options and
the possible complications, and he chose the treatment.
The patient must understand the risks of a procedure just as a driver must understand the
risks before getting behind the wheel of a car. Why can’t you sue a car manufacturer if you
die in a car accident? Predominantly because you are an adult with the capacity to understand
the risks of driving and you chose to drive anyway. The licensing process is an education
process that both tries to make you a safe driver, while also properly informing you of the
risks of driving. Each time you get in a car, there is implied consent that you are choosing the
risk of driving. Even if you get into a car accident and are injured or killed, the manufacturer
has no liability, as long as the car is well made, because as a competent adult you chose to
put yourself at risk.
In addition to understanding the risks of the procedure, you must inform the patient of what
could happen if she does not choose therapy that you offer.
For example, a patient comes to the emergency department with appendicitis. He
is informed of the risks of surgery, and refuses the procedure both verbally and in
writing. The patient dies. What was done wrong here?
The patients must be informed both of the risk of the treatment as well as what will happen
if they don’t undergo the procedure. In this case the physician is liable in court because he
never documented that he informed the patient of the possibility of appendiceal rupture and
death if the patient did NOT have the procedure.
CONSENT IS REQUIRED FOR EACH SPECIFIC PROCEDURE
If the patient signs a consent form for an operation on her left knee, you cannot, in the
operating room, decide to operate on her right knee and assume that you have consent. If a
patient signs a consent for an appendectomy, but when you open her up you find colon
cancer, you cannot just do the colectomy without first informing the patient of the additional
procedure and obtaining her consent. There can be no presumption for consent for anything
beyond what the patient specifically said she consented to. Either the patient has to sign
consent in advance for the other procedures or she has to regain consciousness and have the
additional procedure explained to her.
BENEFICENCE IS NOT SUFFICIENT TO ELIMINATE THE NEED FOR
CONSENT
Trying to be sincere and to do good is very important and takes primacy; however, the
patient’s right to control what happens with his own body is more important.
For example, a 40-year-old man is undergoing a nasal polypectomy. In the
operating room you see a lesion on the nasal turbinate that the frozen section
determines to be a cancer. You have found the cancer early but will need to resect the
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nasal turbinate to cure it. What should you do?
You cannot remove the cancerous lesion without the patient’s approval. This is true even if
the physician is sincere, talented, accurate, and helpful. This is true even if the procedure will
save the patient’s life, unless the illness is an emergency in an unconscious patient.
Beneficence does not eliminate the need for informed consent. If you live in a very messy
apartment your neighbor cannot break into your apartment to clean it even if he doesn’t steal
anything. You must consent to the cleaning. His good intentions are not as important as your
right to do what you want with your own property.
DECISIONS MADE WHEN COMPETENT ARE VALID WHEN CAPACITY IS
LOST
We must respect the last blown wishes of a patient if she loses the capacity to
communicate and state those wishes. Although it is preferable to have the patient’s last
known wishes documented in writing, following verbally expressed wishes is perfectly valid.
Oral consent is valid for any level of procedure if the oral consent can be proven. The basis
for validity of oral or written consent is not whether the procedure is large or small. In other
words, it is not the case that oral consent is valid for a sigmoidoscopy but a brain biopsy
requires writ¬ten consent. A patient can give oral consent for a heart transplant if the patient
is unable to write. The only difficulty is that if challenged, orally expressed wishes for
treatment are more difficult to prove than written ones.
For example, a 42-year-old man with leukemia repeatedly refuses chemotherapy.
He loses consciousness and his mother tells you to give the chemotherapy. What
should you tell her?
You must respect the last known wishes of the patient. If the patient does not want a
treatment, you cannot just wait for him to lose consciousness and then perform the treatment.
If this were permissible, then no one could have an estate will. The ultimate form of loss of
decision-making capacity is death. We make out a will so that when we lose the capacity to
speak for ourselves, our wishes for what to do with our property are respected after death.
For example, a 64-year-old woman accompanied by her husband comes to the
emergency room seeking treatment for chest pain. The patient clearly tells you that
she wants to have her aorta repaired and she signs consent for the procedure. She later
becomes hypotensive and loses consciousness. Her husband is now the decision
maker and says, “Let her die.” What do you tell him?
A patient’s family member cannot wait for her to lose consciousness and then go against the
patient’s previously expressed wishes regarding treatments and procedures. In the case above,
because the patient expressed that she would like to have her aorta repaired her hus¬band
cannot go against this after she loses consciousness. The same reasoning holds true if a
patient refuses a procedure or treatment and then loses consciousness.
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CONSENT IS IMPLIED IN AN EMERGENCY
For example, a 50-year-old construction worker arrives at the emergency room by
ambulance after an accident lacerating his arm. He has lost so much blood he is
unconscious. There is no family member available to sign consent. What should you
do?
The management of an emergency is different. Consent is implied in an emergency for a
patient without the capacity to speak for himself. This would not apply to a terminally ill
patient with a pre-existing DNR order. Neither a court order, nor a hospital administrator, nor
the ethics committee is required to give permission before the doctor can administer therapy
in an emergency.
THE PERSON PERFORMING THE PROCEDURE SHOULD OBTAIN CONSENT
The person who is most knowledgeable about the procedure should obtain informed
consent. Because we must inform the patient about all the options of treatment, risks of the
options, and risks of not performing the procedure in a language the patient can understand,
the consent must be obtained by a person qualified to make the explanation.
For example, you are an intern who has consulted surgery to place a subclavian
central venous line. You only know access must be obtained. You do not know why
the internal jugular approach is not being used. On the phone the surgical resident
says, “Can you go get the consent while I am coming up?” What should you do?
You must not be in a position to explain the risks of procedures that you did not decide on.
If the patient develops a pneumothorax and you do not know why the internal jugular
approach is not being used, you cannot adequately inform the patient. You are not certain
why central access is being obtained at all. You must, at the risk of seeming difficult, tell the
surgical resident that he must obtain the consent himself. If a complication occurs, you
cannot say, “1 was just getting a paper signed; I didn’t know what it meant.”
The same is true for a patient who signs consent. If you tell the patient that he could have a
pneumothorax and might need a chest tube and document this, and the patient still signs
consent, then you are not at risk. The patient also cannot say later, “I was just signing a piece
of paper. T didn’t know what it meant.”
TELEPHONE CONSENT IS VALID
Consent obtained by a family member, health-care proxy, or other valid surrogate decision
maker is valid even if obtained over the phone. This is a legitimate form of consent by an
authorized surrogate decision maker.
For example, a 65-year-old man is admitted to the hospital for a seizure. The head
CT shows a ring or contrast-enhancing lesion consistent with a brain abscess. The
patient remains persistently confused, but is not deteriorating. You need to perform a
brain biopsy but there is no family member or health-care proxy who comes to visit
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him. His wife is housebound from multiple sclerosis and cannot get to the hospital.
You have her on the phone but the nurse is refusing to be the witness for the consent,
saying that telephone consent is not valid. What should you do?
As with all forms of verbal communication, oral advance directives, and telephone consent
are more difficult to prove if contested. However, they are equally valid. If a health-care
worker is uncomfortable taking the telephone consent, use another member of the
health¬care team to act as your witness for the consent. You can educate the nurse later. You
can take consent for cardiothoracic surgery over the phone if that is the only way to speak to
the surrogate.
The real questions about telephone consent are these:
- Ts the person you are speaking to really the surrogate?
- Does the person know the patient’s wishes?
- Did you get the oral/telephone consent witnessed by another person so that the
person giving consent cannot later deny having given consent?
PREGNANT WOMEN CAN REFUSE THERAPY
The prevailing consensus holds that a fetus is not a ‘person’ until birth. Hence, no matter
what your personal feeling may be, the fetus does not have any intrinsic ‘rights’ as a person.
So, even though a 34-week-old fetus would be a viable child if the fetus were removed from
the uterus, all health-care decision making and ethics are based on the choices of the mother
and her interests. If parents have a child born at 34 weeks of gestational age in need of a
blood transfusion to save its life, they cannot refuse lifesaving therapy for the child even if
they are Jehovah’s Witnesses. The state would intervene in the interests of the child.
However, if the same child at 34 weeks of gestational age is still in the uterus, the mother can
refuse or accept whatever therapy she wishes without specific regard for the fetus. Hence, a
pregnant woman may refuse a lifesaving transfusion. She may refuse a Caesarian section to
remove the child even if this will put the life of the fetus at risk.
For any question concerning reproductive rights, decisions are based entirely on maternal
wishes. The father has no legal right to make an informed consent for any pregnancy-related
issue because the questions concern the body of the mother. A mother’s autonomy over her
own body is felt to be more important than the rights of the fetus or of the father. Only the
mother can sign informed consent for any procedure or treatment during pregnancy. Any
answer choice that has “Ask the father…” in it will always be wrong in terms of consent
issues during pregnancy.
INFORMED CONSENT FOR A NEVER-COM PETE NT PERSON
This is one of the most difficult subjects in ethics because the standard of this management
has significantly evolved over the last several years. If the patient has Down syndrome and
has a family member to make decisions for her then the question will be straightforward—
ask for the consent of the parent or guardian. If there is no parent or guardian, the
circumstance is much more difficult. A third-party court designee must make a decision
based on the best interests of the patient even though the patient may never have expressed
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her feelings before.
The best way to obtain consent for a person who has lost the capacity to make decisions for
him/herself is a health-care proxy or durable power of attorney. This is an advance directive
(written or formal). An advance directive cannot even be given by a patient who has never
had capacity. The same is true of a living will. The next best method of giving consent is
“substituted judgment.” In this case a person who knows the patient well tries to determine
what decision she would make for herself if she were awake. This is also not possible for a
person who has never been competent. The weakest form of consent is to act in the best
interests" of the patient. This is the weakest method of giving consent because it is filled with
subjectivity and imprecision. However, it is the best method of obtaining consent for doctors
treating a person who has never had capacity. A legal guardian who could be a family
member must make the decision on behalf of the patient. In the absence of a family member
the guardian is either appointed by the courts or is the administrator of the health-care
facility, such as the medical director.