A Compilation of Resources Discussing Informed Consent, Consent to Treat and Informed Refusal
As providers redefine processes to ensure more patient-centered care, you will want to reassess your informed consent approach to ensure that it abides by all regulations and protects the provider, patient and practice. Informed consent is a routine aspect of healthcare yet it is one of the most misunderstood concepts even among experienced physicians. This misunderstanding stems from a failure to understand all of the elements that comprise informed consent and recognize the ramifications of patient allegations that he or she did not understand the benefits versus drawbacks of a provider’s treatment recommendation.
A history of informed consent
Hippocrates, who gave us the first set of western writings
on conduct for medical professionals, suggested patients are best served when
physicians conceal most information. It was not until the 18th century
writings of physician Benjamin Rush that we began to see recommendations that
physicians share information with their patients. The publication of Medical
Ethics in 1803 by Thomas Percival advocated the notion that while patients have
a right to the truth, a physician might lie or withhold information if it
results in better treatment. Informed consent gained more ground as a result of
the atrocities committed by the Nazis who routinely experimented on human
subjects.
The American Medical Association via Opinion 8.08, Informed
Consent, says, “The physician has an ethical obligation to help the patient
make choices from among the therapeutic alternatives consistent with good
medical practice.” Adopted in 1981 and updated in 2006, the opinion reads,
“Physicians should sensitively and respectfully disclose all relevant medical
information to patients.
The main purpose of the
informed consent process is to protect the patient. A capable adult cannot be
forced to have any type of medical treatment. In general, anything other than a
life-threatening emergency in which the patient is unconscious requires consent
before treatment. Even in that situation, consent may be required if the
patient is known to have an advance directive.
The Advance Healthcare Directive
An advance health care
directive or advance directive is a kind of legal document that tells the
doctor your wishes about your health care.
Advance directives can be
general, with very few directions about your care. The directive may just name
a substitute person (proxy) to make these decisions for you if you are unable
to do so. Or it may include instructions for the chosen proxy.
Advance directives can also be
very detailed and clearly outline the different types of life-sustaining
treatments you would accept or refuse in certain situations. Some types of
advance directives are limited to certain situations, like the living will,
organ or tissue donation, or your wishes not to be revived (resuscitated) if
your heart or breathing stops.
Who besides the patient is allowed to consent?
For children or others who are
unable to make the decision for themselves, the parent or legal guardian is
legally responsible for getting the information, making the decision, and
signing the consent form. But that doesn’t mean that the child or patient who
is not considered mentally competent is always left out of the process. Some
facilities require the assent of older children before they go into a research
study, even after the parents have agreed on the child’s behalf. Assent means
that, even though the parents sign the form, the child must also be OK with the
plan before the facility will do the treatment.
Along the same lines, people
who are unable to manage their daily affairs because of impaired thinking or
emotional problems might still be able to understand the medical situation and
make their wishes known. They should be given information in a way they can
understand, and asked what they want to do.
In the event that you become
unable to take in information and make your wishes known, another person may be
asked to take part in the process of informed consent. There are several ways
that person can be chosen.
- Durable power of attorney for health care -- The only way you can choose the person to make these decisions for you is
to set up a durable power of attorney for health care (also called a health
care power of attorney). In this case, if you are unable to speak for yourself,
the person you chose becomes legally responsible for making medical decisions
on your behalf. This person is sometimes called your proxy, agent, or surrogate.
- Court-appointed proxy -- Another option is a court-appointed surrogate or proxy. This is someone a
judge chooses to make medical decisions for you. If you become unable to make
decisions for yourself, someone else – such as the doctor, facility, a friend,
or a family member – may ask (petition) the court to appoint someone to do it
for you. The process varies from state to state.
- State family agency acts -- Many states have passed family agency acts that choose which family
members (in a listed order of priority) may act on behalf of a person who
cannot speak for her- or himself. This option may be used if you don’t have an
advance directive or court-appointed proxy. Depending on your family situation
and which state you are in, that person may be your legal guardian, spouse,
parent, child, sibling, or other relative.
A consent form is not needed
for simple diagnostic tests and situations in which your actions imply consent.
For example, if you see your doctor and allow a blood sample to be taken for
lab tests, your consent is assumed because you went to the doctor seeking care
and allowed blood to be drawn. At any point, you could change your mind and
decide to refuse testing, leave the doctor’s office, or seek care elsewhere.
This is different from a treatment that puts you in a vulnerable position or
can possibly cause serious harm. You need more information about more risky
treatments so that you can weigh your options and consider your risks before
making a decision.
Even when there are no other
accepted medical treatment options, it’s still your right as a competent adult
to refuse a treatment that you don’t want or refuse to be in a study that you
didn’t choose. But once you sign the consent form, it’s taken to be a formal,
legal agreement that you are OK with the plan or procedure that’s listed on the
form unless you revoke (take back) your consent before treatment is given. The
doctor or facility will usually give you a copy of the consent form, but they
keep the original as a legal record that you agreed to the treatment.
For example, a physician makes a recommendation to a patient
for surgery and leaves the exam room. A nurse enters, puts a form in front of
the patient and asks if there are any questions. The patient, still absorbing
the news that he needs surgery, has no questions and signs the form. The
surgery proceeds but does not go as planned. Soon thereafter, the physician is
served with a claim for malpractice and medical battery citing, among other
issues, a lack of informed consent.
Who wins? The answer is that no one wins.
Whether there is an adverse event that permanently affects the patient’s health
or a patient believes he or she was not given all the necessary information,
the patient walks away feeling shortchanged and the trust established with the
physician is lost. Worst-case scenario, the patient’s health is adversely
affected by a decision that would not have been made with better information,
and the physician faces years of litigation that will affect the practice and
his or her personal well-being.
Informed consent has been referred to in terms of medical
ethics and treatment variation, but the task of obtaining informed consent is a
practical issue that can be included in process review and regular staff
meetings to ensure that providers are protected from malpractice allegations.
Far too often, physicians provide a treatment recommendation
and the implications for not following it stop there. And while informed
consent is a routine expectation, especially for high-risk procedures and
drugs, it generally is not a legal requirement though informed consent
requirements vary by state.
These requirements might be enacted by law or could be included
in the policy documents of a state governing medical board. They might also be
found in case law for malpractice claims. Because of failure to fully
appreciate what constitutes effective informed consent and the inconsistency of
requirements across the country, it is often not given its due diligence and
can become a pretense for doing the right thing in name only with no meaning.
Even when a physician believes they have imparted enough information for a
patient to make an informed decision, a patient and a jury might disagree.
Informed consent can take two forms: implied or express.
Implied consent is generally associated with lower risk
treatments and procedures, such as immunizations. While disclosure must be made
regarding benefits and risks of an injection, generally via a Vaccine
Information Sheet (VIS), we generally do not obtain signatures before an
immunization unless it carries significant side effects or unknown risks.
Instead, we rely on the patient rolling up their sleeve and presenting an arm as
evidence of consent. In comparison, express consent is more formal. It is
evidenced by a patient or guardian/power of attorney’s signature on a form.
While often referred to in varying terms, the elements that
make up an informed consent discussion can be broken down into four categories,
which should be included on your informed consent form:
Risks: What is the danger from a recommended treatment? Not
every potential adverse outcome has to be mentioned but physicians know which
outcomes are most likely to affect patients and those should be addressed. For
example, a hand surgeon would probably have a more in-depth conversation with a
world-renowned concert pianist than the average patient because an adverse
outcome would alter the pianist’s career and life in different ways. Groups
might want to consider what procedures or routine activities require express
versus implied consent and establish a policy to avoid staff and provider
confusion. When in doubt, go for the express consent to protect yourself. In
theory, if a patient is properly educated, the execution of a signature on
paperwork reflecting this should add very little time on the front end but
could save years of wasted time in litigation on the back end.
Benefits: What can be gained from the treatment? Or what can
a patient realistically expect to achieve from adhering to the prescribed
treatment? For example, will a patient’s pain be minimized or disappear? Will
life expectancy increase? Are there limitations? A discussion about the likelihood
of potential benefits is prudent, and you should also talk about factors that
would prevent this patient from falling within the general expectations.
Alternatives: Are there other treatment choices that should
be considered? For example, should a patient consider a nonsurgical approach,
such as glasses or contacts in lieu of Lasik surgery? Keep in mind that
alternatives include pursuing no treatment, which should be included as an
option no matter how wrong you might think it is. The issue of cost for various
options might be worth mentioning if there is a significant difference,
especially for patients with no insurance. There will be varying opinions among
physicians about how to handle alternatives, which they might not advise but it
is important for physicians in groups to operate uniformly. Conflicts should be
resolved within the governance structure of the organization. Physicians should
be encouraged to consider their ethical obligations and reach consensus.
Physicians can certainly offer options without endorsing them and be as candid
as possible with patients.
Consequences: What are the potential implications of a
patient’s decision, whether it is to follow a recommended treatment, pursue an
alternative or do nothing? This is when most physicians typically are asked,
“What would you do?” There is no harm in answering this question, but remind a
patient that he or she has to make the decision based on his or her unique
situation.
While some states require signed consent for certain
procedures, such as sterilization, the vast majority have few or no rules. Even
when not required, an informed consent form is invaluable in defending a
malpractice claim. However, an informed refusal form is equally valuable.
An informed refusal form is really just a twist on an
informed consent form and while it is not commonly used, it is worth its weight
in gold from a defense perspective with a noncompliant patient. The real
difference is that instead of acknowledging and accepting the risks of
treatment with an informed consent form, a patient acknowledges the risks of
not following a physician’s recommendations. The form acknowledges that a
patient is choosing an alternative treatment or no treatment at all and any
accompanying consequences. These are particularly important with noncompliant
patients to demonstrate that they have made educated decisions to not follow
provider advice and knowingly accept the consequences.
As frustrating as it can be, competent adults get to make
their own healthcare decisions. That word “competent” is key here. Informed
consent discussions should occur while a patient is coherent and able to have
the discussion. Ideally, the conversation should occur when the patient is best
able to understand the information, which might require a follow-up appointment
if the patient has just received difficult news or needs a family member
present.
Do not initiate this type of discussion after drugs have
been administered or when a patient is distraught over a serious diagnosis.
That could result in a signed form being declared void for lack of competency
at that moment. (It has happened.) Obtaining a signed form at this point opens
a physician up to a “he said/she said” argument that can easily be avoided. And
while most physicians understand this, it is important to ensure that the team
members who assist a physician also understand these guidelines so they do not
pressure a patient for a signature after medications have been administered.
If a situation goes to court, a patient might allege that he
or she did not understand the conversation or did not have the opportunity to
ask questions. While a patient can still make this assertion, a signed form
goes a long way with a jury to show that processes were followed. And a jury
ultimately decides the issue in a trial situation. If you choose to not use a
form and obtain a signature, it is still wise to document the conversation in
the medical record. A note made at the time of the discussion bolsters a
physician’s account of what transpired. Lawsuits can take years to reach the
deposition or trial phase, and if a physician acts as a witness in his or her
own defense, citing a written note is more reliable than relying on his or her
memory.
Any number of resources can be used in the informed consent
process, such as printed patient education materials, websites and videos.
Physicians might also use experienced staff to talk with patients and address
questions. That team would include a nonphysician provider, nurse, medical
assistant or anyone else who a physician believes has the skill and knowledge
to discuss treatment options. However, the physician is ultimately responsible
for ensuring that the process was properly conducted and that he or she was
available to answer any questions. Failure to do so can result in dissatisfied
patients, which carries its own ramifications, and it can prompt needless
litigation.
Requirements for Informed Consent
Informed consent is an ethical concept—that all patients
should understand and agree to the potential consequences of their care—that
has become codified in the law and in daily practice at every medical
institution. One of the earliest legal precedents in this area was established
in 1914 when a physician removed a tumor from the abdomen of a patient who had
consented to only a diagnostic procedure (
Schloendorff vs. Society of New YorkHospital). The judge in this case ruled that the physician was liable for
battery because he violated an “individual’s fundamental right to decide what
is being done with his or her body.” The first
case actually defining the elements of informed consent occurred in the late
1950's and involved a question of potential negligence and whether a patient was
given sufficient information to make a decision.
The case law and rules pertaining to informed consent have
changed over the years and all 50 states now have legislation that requires
some level of informed consent. Although the details of these
laws vary from state to state, the bottom line is that failure to obtain
informed consent renders any U.S. physician liable for negligence or battery
and constitutes medical malpractice.
Exceptions are made for
emergencies or legally adjudicated mental incompetency or physical incapacity.
Several of the common elements required for full disclosure have been
summarized by the American Medical Association (Table 1 - below) and other groups
representing specialists or quality assurance organizations. For
example, federal regulations spell out the minimum requirements for a properly
executed informed consent form (Table 2 - below) and state that this form must be in
the patient’s chart before surgery. [
CFR Title 42] These regulations also
stipulate that the information must be given in a language or means of
communication that the patient understands. The U.S. government requires
interpretation and translation services for individuals with limited English
proficiency at institutions that receive federal funding; these regulations
also state that informed consent forms must be translated into languages spoken
by 5% or 1,000 of a provider’s patients—whichever is less. [
Executive Order13166]
The Basic Features of Everyday Informed Consent - [Table 1]
The physician (not a delegated representative) should
disclose and discuss:
- The diagnosis, if known
- The nature and purpose of a proposed treatment or procedure
- The risks and benefits of proposed treatment or procedures
- Alternatives (regardless of costs or extent covered by insurance)
- The risks and benefits of alternatives
- The risks and benefits of not receiving treatments or undergoing procedures
Source: AMA 1998
What’s Needed on the Informed Consent Form - [Table 2]
- Name and signature of the patient, or if appropriate, legal
representative
- Name of the hospital
- Name of procedure(s)
- Name of all practitioners performing the procedure and
individual significant tasks if more than one practitioner
- Risks
- Benefits
- Alternative procedures and treatments and their risks
- Date and time consent is obtained
- Statement that procedure was explained to patient or
guardian
- Signature of person witnessing the consent
- Name and signature of person who explained the procedure to
the patient or guardian
Source: Federal Code (Title 42 C.F.R. § 482.51 (b) (2))
Interpretive Guideline A-0392
Which procedures require informed consent? Unfortunately
there is no continually updated national list describing exactly when informed
consent is required. Again, it varies from state to state and is also
influenced by clinician or hospital interpretation of recommendations from
professional and specialty groups.
- Pennsylvania state law specifically requires that consent be obtained for blood transfusions, chemotherapy, and methadone use as part of a narcotics treatment program. [PA Law Code]
- Many states have developed specific laws governing breast cancer diagnosis and treatment. [ACS 2007]
- The American College of Obstetrics and Gynecology has developed detailed guidelines for informed consent issues related to sterilization and carrier testing for cystic fibrosis. [ACOG 2004]
- Increased levels of institutional quality (e.g., compliance with accreditation standards)
- Potential time and money savings (or offsets) related to reduced litigation
Thus, based on guidance from staff and counsel, each
institution generally develops its own list of surgeries, procedures, or
situations where full informed consent is needed. In fact, the
Joint Commission (formerly known as the Joint Commission on Accreditation of
Healthcare Organizations or JCAHO) has set a standard that hospitals must
establish and follow policies that describe which procedures or care,
treatment, or services require informed consent. [Joint Commission 2005] One of
the first steps recommended is to clarify your
institution's policies about when informed consent is required.
Another area subject to local interpretation is exactly how
much to disclose. How many potential risks must be described, for example, and
how many alternatives must be mentioned? While many states rely on a standard
of what a “reasonable physician” would provide or what a “reasonable patient”
would need, this still leaves room for interpretation. Most laws describe the need to cover all “material” (i.e., significant)
risks. But common sense suggests that not every potential risk can be described
in detail and that only the most prevalent and/or serious risks and side
effects would be covered. The number and type of complications
also may vary widely depending on the severity of the patient’s underlying
conditions or comorbidities (e.g., pneumothorax following central vein
catheterization may not be life-threatening in a patient admitted for a
soft-tissue abscess but could be extremely risky in a patient receiving
mechanical ventilation for severe acute respiratory distress syndrome). How can a single form cover both situations? Further
complicating the issue, of course, is the fact that there are limitations and
variations in the capacity of individual patients to comprehend many of these
details—and therefore the information needs to be tailored for each individual.
It is precisely these gray areas in the requirements for
informed consent - When is it needed? How much is needed? And how can I make sure
the patient understands? - that have opened the door for many of the documented
failures of informed consent in everyday practice. (See below: “Informed
Consent in Practice”).
One common defensive response to the
uncertainties about how much to disclose, for example, is use of “blanket”
informed consent forms that contain only boiler-plate generalities that “all
potential risks and side effects and alternatives have been explained and
understood by the patient.” If such a generic consent form is accompanied by
genuine documented education involving appropriate explanation and printed
material, this may work. (Attorneys also usually advise clinicians to document
the details of this interchange in the patient’s record.)
But on its own, an overly generic consent form without any significant
accompanying education, interchange and documentation - that is, a quick request for a signature
while the patient is on the gurney - is not adequate. On the other hand, an
exhaustive list of all the potential risks may be difficult for patients to
understand. (Attorneys reviewing such a list would also likely point out that
any omission from such a long and seemingly comprehensive list might be a red
flag, and that such a form would therefore need to state that the list is not
inclusive. [AMA 1998])
Informed Consent in Practice
- How often does informed consent work as intended?
- How do your practices match up to the national norms for informed consent?
- How does one even begin to measure the “success” of informed consent?
These are complex questions that have been tackled by clinicians and researchers from different settings and perspectives. Many studies have focused on one therapeutic area of interest. Others have analyzed the consent process only in the research setting. And some have evaluated the process in targeted patient groups such as those with low literacy.
Reviewing the results from such studies provides a sense of the problems that must still be overcome in planning for and delivering informed consent in everyday clinical practice. While much of this data comes out of the clinical research setting, many of the broader “lessons learned” in these studies are highly applicable to the setting of everyday informed consent.
Best Practices
Developing an Informed Consent Form
Download this Style Guide template for improving you Informed Consent Form(s).
In summary and based on all of this information, two points stand out: |
- Patients have a fundamental right and need to receive information, both orally and written, about their care in a manner they can fully comprehend and that will lead to truly shared decision-making, and
- current practices of informed consent are often inadequate and are especially hampered by growing rates of health illiteracy in the U.S.
A number of studies indicate that improving consent forms and the overall consent process can lead to better patient comprehension and recall. Although the research on improved consent forms has been mixed, some studies have found that when consent forms are improved, patients are more likely to read and understand them before signing. Using a consistent informed consent template as a starting point for the creation of forms for various procedures also appears to improve consistency and quality in the forms. Providing clear and simple information about procedures may also lower patient anxiety levels and increase understanding and recall in a way that produces a more deliberative decision-making process.
However, a clearly written consent form does not guarantee that patients will read and understand them. A properly constructed and clearly formatted consent form is a necessary but not sufficient condition for ensuring that patients read, understand, and remember the information presented. Thus, a variety of other methods are needed to increase patient involvement in the consent process and improve patient comprehension of the information presented. For example, several recent studies show that repeating information to patients in various formats and modes and at different times can strengthen comprehension and recall.
• The person(s), or class of persons, to whom you may make the requested disclosure. The specific entity(ies) to receive the information should be identified. A cover sheet stating who should receive the information is NOT sufficient.
