Document ‘informed refusal’ just as you would informed consent
James P.Scibilia, M.D., FAAP
Pediatricians and the Law
A parent refused pneumococcal vaccine for her infant. Later, the infant died of overwhelming
pneumococcal sepsis from a strain in the vaccine, and the parent sued the physician.
At trial, the parent and physician both acknowledged that the vaccine was recommended,
but the parent stated that the risk of death wasn't mentioned during the discussion.
If it had been discussed, she stated, the infant would have received the vaccine.
A verdict was awarded to the plaintiff for failure by the provider to warn of the
Most physicians are aware of the concept of informed consent, but many states now
recognize “informed refusal” as well.
A legal basis on informed refusal is found in Truman v. Thomas, 1980. A patient elected
not to have a Pap smear because of cost. The physician did not disclose the risks
of not having the test, and later the patient died from metastatic cervical cancer.
The court concluded that the physician had a fiduciary duty to explain the potentially
fatal consequences of the patient’s decision to forgo the test.
Generally, parents have broad legal protections to decide on care for their children,
even if there may be a negative consequence of that decision, unless there is a direct
threat to the child’s life.
Parental refusal of care or medical recommendations for a child is common, even when
the treatment may be lifesaving. For example, vitamin K refusal in newborns has increased
dramatically. A recent study showed that 3% of hospital deliveries and up to 30% of
birthing center deliveries in Tennessee declined this simple therapy despite an 80-fold
increased risk of vitamin K deficiency bleeding in unprotected newborns (http://bit.ly/2OroXpx).
Among parents who refuse, 70% state they have gotten information about vitamin K from
the internet, though one-third do not know that the risk of bleeding is a consequence
of failure to provide vitamin K to newborns. Parents who refuse vitamin K for their
newborns need to be informed refusers of this treatment, and providers must be a central
part of that process.
Similarly, 2% of the nearly 4.3 million infants born annually in the United States
do not have small blood samples taken from their heels during the first week of life
for newborn screening tests, largely due to parental refusal for religious or other
reasons. They pose another potential medical liability risk for providers (http://pedsinreview.aappublications.org/content/32/11/490).
Since Truman v. Thomas in 1980, many states have reaffirmed the principle of informed
refusal and several additional cases have supported the idea; no states have rejected
The requirements of informed refusal are the same as informed consent. Providers must
the proposed treatment or testing;
the risks and benefits of refusal;
anticipated outcome with and without treatment; and
alternative therapies, if available.
Documentation of this discussion, including all four components, in the medical record
is critical to mounting a successful defense from a claim that you failed to warn
about the consequences of refusing care.
Since state laws vary, it is good practice to check with your malpractice carrier
about preferred risk management documentation. Generally, the facts of these discussions
should be included and signed by the caretaker. This conversation and documentation
should not be delegated to other members of the health care team. At least one state
has affirmed through a Supreme Court decision that informed consent must be obtained
by the provider performing the procedure and not another team member; it is likely
the concept of informed refusal would bear the same requirements.
Perhaps the most common scenario for practicing pediatricians is a parent refusing
immunizations or altering the recommended vaccine schedule. The percent of pediatricians
who reported encountering parents who refuse to have their children immunized with
one or more vaccines increased from 75% in 2006 to 88% in 2013 (http://bit.ly/2QqeEza).
As the vignette above shows, the provider has a duty to inform about both risks and
benefits when a parent refuses an immunization. In this case, the physician ordering
the vaccine is responsible, not the nurse administering it.
The AAP Refusal to Vaccinate form can be used to document informed refusal in the
medical record (see resource). It clearly lays out the consequences of vaccine refusal.
Providers should not accept alternate forms or allow parents to redact portions of
If a caretaker refuses to sign, the document still should be included in the patient
record with a note stating the information was discussed with the patient.
Continuing care for a patient who refuses to acknowledge the informed refusal is an
individual decision by each practice (or physician).
This concept also can apply to patients or their parents/legal representatives reluctant
to take recommended medication, receive therapy, or obtain lab or radiographic testing.
Documentation in the record of the recommendation, potential consequences and outcomes,
and the alternatives (if available) should be stated clearly.
Pediatricians regularly encounter parents who decline care for their children, which
may result in severe medical consequences.
Claims of failure to warn of these consequences have been successfully litigated against
Clearly documented informed refusal creates a record of the interaction between patients/parents
and providers, and can show that the provider performed his or her duty to fully inform
them of risks associated with refusals.
Use the AAP Refusal to Vaccinate form each time a vaccine is refused; consider similar
documents for other areas where refusal is common (i.e., vitamin K refusal in the
Note in the medical record when parents have refused newborn screening tests during
the first week of an infant’s life. If possible, obtain copies of signed informed
refusal forms from your state or birth hospital.
Dr. Scibilia is a member of the AAP Committee on Medical Liability and Risk Management.