Informed consent

1. INFORMED CONSENT
-Dr.M Sai Mahitha
-Faculty: Dr. Sudha, Dr.V.Swathi

2. Definition
Legal and moral imperatives for informed consent are based on
ethical principle of respect for patient autonomy, i.e., ability to
choose without controlling interference by others and without
personal limitations which prevent meaningful choices.

3. Components
• Name and purpose of diagnostic test or procedure
• Most significant risks of test/procedure
• Benefits of intervention, including chances of success if pertinent
• Probable outcome of intervention/refusal of proposed plan
• Possible alternatives and procedure
• Patient must be free from concerns

5. • Consent requires an active communication between doctor and patient wherein the
physician educates the patient explaining the nature and purpose of the proposed
procedure or therapy, along with the attendant risks and benefits.
• Respect for Autonomy :Clinicians are obligated to respect patients as individuals
and to honor their preferences.
• Beneficence: Physicians have a responsibility to act in the patient’s best interest.
Respect for patient autonomy may conflict with beneficence. In general, if a patient is
mentally competent, respect for patient autonomy supersedes beneficence even if
the physician believes the patient is not acting in his or her best interest.
• Nonmaleficence: “Do no harm.” All medical interventions involve benefits and
risks, and physicians should generally only recommend treatments where the likely
benefits outweigh the known risks.
• Justice: Health care is a scarce resource. Fairness and equality in distribution and
delivery of health care are ongoing challenges for health policy and in the clinical
arena.

6. • Competence: A person’s global and legal capacity to make decisions and
to be held accountable in a court of law.
Incompetent patients, as assessed by the courts, or temporarily
incapacitated patients may still be able to provide assent for treatment or
refuse treatment.
• Capacity: The ability of a patient to understand relevant information,
appreciate the severity of the medical situation and its consequences,
communicate a choice, and deliberate rationally about his or her values in
relation to the decision being made. This can be assessed by the physician
In general, patients who have decision-making capacity have the right to
refuse or discontinue treatment.
capacity is best understood as varying with the complexity of the decision
involved.
A patient’s decision to refuse treatment can be overruled if the choice
endangers the health and welfare of others.
It is task specific and relative.

7. How does anesthesiologist determine competency of the
patient?
• UNDERSTANDING
• APPRECIATION
• REASONING
• EVIDENCE OF CHOICE
-If surgery is emergency , anesthesiologist may have to rely on the surrogate decision
maker or proceed with best determination of patients interest in mind.

8. Documentation of consent
• Hand written note:
• Is the best evidence of discussion and consent?
• Time consumed in the process however, is unacceptable.
• Separate anesthesia consent form required, with common risks
detailed in separate form.
• Reliance on surgical consent is not very reliable.

9. Legal Aspects of Consent
• Touching a patient without consent may lead to chain of battery or
assault
• Treating doctor is responsible for ensuring that patient has consent
for treatment
• Consent is valid if given voluntarily by appropriately informed patient
who has capacity to exercise a choice
• Patient without capacity to consent, may be treated without consent,
if it is in their best interest/consent is taken from guardian
• Pain, illness, premedication does not necessarily render a patient
incompetent to consent

10. Informed Refusal
• Informed consent is meaningless if patient cannot also refuse medical
treatment.
• If a patient demands a technique that is inappropriate or outside of the
realm of reasonable practice, the anesthesiologist is under no ethical
obligation to provide that care. No physician can be compelled by a patient
to practice negligently.
Disclosure:
Informed consent requires honest disclosure of medical information to
patient.
-two standards of disclosure
reasonable person (or objective person) standard and subjective
standard

11. Reasonable person standard:
The physician must disclose any information that a theoretically
reasonable person would want to know, and the risks or cluster of risks to
which a reasonable person in the patient’s position would attach significance
in deciding whether or not to forgo the proposed therapy. This standard does
not require an exhaustive recitation of facts.
Subjective standard :
Recognizes that some patients may have special needs for specific
information, and when that need is obvious or has been brought to the
attention of the physician, the information must be disclosed. A concert
violinist may have a specific need to know about the potential for nerve
damage from an axillary block.
The doctrine of therapeutic privilege is sometimes cited to avoid
discussing risks, the reasoning being that discussing risks can psychologically
or physically harm the patient by increasing stress.

12. Special Issues in Informed Consent and Informed Refusal
• The classic example of a patient who refuses therapy in anesthesia practice is
that of Jehovah’s Witnesses, many of whom believe that accepting a blood
transfusion violates a Biblical injunction.
• Any patient has the right to refuse blood transfusion therapy, regardless of
whether this desire is founded in religious preference. Such refusals have
become more common in patients who are not Jehovah’s Witnesses, as blood
transfusion therapy has been connected to infection risk and other
complications.
• Children are examples of persons who may or may not yet be autonomous.
Laws in each state define the age at which children become legally competent
to make medical decisions (usually 18 years), but many younger children have
the mental and emotional capacity to make medical decisions. Forcing such
individuals to undergo treatments they do not want is unethical and could be
illegal as well.

13. • “emancipated minor” status, in which a court determines that a minor can
legally make medical decisions for himself or herself.
• Legal exceptions to the age of consent :
-Treatment is believed to be in the minor’s best interest and when a
requirement for parental consent would interfere with the child’s ability to
receive medical help.
-some conditions for which a minor seeks therapy may even be the result of
parental abuse and seeking parental permission for treatment may actually
further endanger the minor.
-consent for treatment for substance abuse, sexually transmitted disease,
mental illness, and medical care affecting pregnancy, including abortion,
without seeking parental consent.
• Mature Minor:When a minor has decision-making capacity but is not
emancipated

14. • Informed consent in pregnant women:
The validity of informed consent for epidural anesthesia in laboring women is a
topic of concern to anesthesiologists, who periodically raise the question
whether laboring women are able to consider and weigh the risks of labor
analgesia sufficiently while they are in pain.
most studies show that laboring women have the same capacity to give
informed consent as the general surgical population.
An ethical conflict can arise in the case of so-called Ulysses directives in which,
before labor, a woman executes an advance directive that refuses epidural
analgesia and instructs doctors to ignore her pleas for epidural anesthesia at the
time of labor should she change her mind. Although some experts suggest that
ignoring the Ulysses directive disrespects a woman’s long-term preferences,
others argue that “information and valid experience are critical prerequisites for
autonomous decision making” and that only the current wish (to receive an
epidural) is ethically relevant.

15. • Mother-Fetal conflicts:
In general, the rights of pregnant women to refuse therapy, even if it will be
detrimental to their fetuses, are protected under right-to-privacy provisions in the
U.S. Constitution. Those rights are weighed against potential harms to the fetus in a
decremental fashion as the fetus approaches and surpasses viable age. When the
fetus is of nonviable age, the mother’s rights prevail.
The American Academy of Pediatrics Committee on Ethics outlined conditions that
in their view are necessary to override a mother’s refusal of care:
(1) the fetus will suffer irrevocable harm without the treatment,
(2) the treatment is clearly indicated and likely to be effective, and
(3) the risk to the woman is low.