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August 05, 2016
INFORMED CONSENT
Maria Ana B. Mariano, MD.
Department of Bioethics and Legal Medicine

TOPIC OUTLINE 5 Nature of Consent as act of Authorization

I. The Elements of Informed Consent
a. Disclosure UNDERSTANDING
b. Understanding • Information presented by the physician should at a level that a
c. Voluntariness (not discussed/just mentioned) HYPOTHETICAL REASONABLE patient would understand
d. Competence o Physician should assume always that every patient is capable of
i. Factors used in decision regarding Patient understanding any medical information that the physician gives
Competence o Physician should take note of patients who are well-educated
ii. 2 parameters to determine if patient considered and well-informed about their medical condition
competent
e. Consent COMPETENCE
i. Demand of Futile Treatment • Factors used in decision regarding Patient Competence
ii. Considerations for DNR • Two parameters to determine if patient is considered competent
iii. Considerations for Required Informed Consent
II. Professional Community Standard 6 Factors used in Decision regarding Patient Competence
III. Reasonable Patient Standard
IV. Patient-centered Standard Factors Examples
V. Therapeutic Privilege 1 Sufficient Information and e.g. Is the patient mentally capable,
VI. Doctor-Patient Relationship intellectual capacity to does the patient suffer from
VII. Informed Consent make rational choices depression, Is the patient reliable in
a. Relevance terms of making his decision
b. Features of an Informed Consent 2 Choices made consistent e.g. Does the patient have full
c. Prerequisites of a Valid Informed Consent with his own values autonomy in his decision, Is there a
i. Adequate Information Choices sufficiently sign of coercion from relatives or
ii. Competence in decision-making independent and not from the physician himself,
iii. Voluntary and Free controlled by others Patient is able to request a DNR
VIII. History of Informed Consent regardless of refusal of other
IX. Succession of Relatives in Giving an Informed Consent relatives
X. When an Informed Consent is not Required 3 Age-Refusal in life- e.g. Patient at the right legal age
XI. Forms of Consent threatening situations have autonomy on what procedure
XII. Scope of Consent Form should be done to them during life-
XIII. DOH Consent Form threatening situations as long as
XIV. Process at Arriving at an Informed Consent they are mentally capable
XV. Important Point to Remember For children, a proxy or legal
XVI. Sample Quiz guardian (i.e. relative/s) is needed
XVII. References 4 Nature of Illness e.g. Patient is able to understand
his/her condition, significant
prognoses, as well as able to choose
THE ELEMENTS OF INFORMED CONSENT treatment options
• Disclosure 5 Attitudes and values of the Physician as well as moral, religious
• Understanding background, attitudes towards life and death
• Voluntariness 6 Clinical Setting Diffused in health care team vs.
• Competence private setting in a physician’s office
• Consent or the patient’s home

DISCLOSURE Two parameters to determine if patient is considered competent
• Does the patient understand the nature of the condition and the
Parameters Examples various options available?
1 Nature of the Condition e.g. Is the physician able to explain • Is the decision-making progress rational?
fully the disease of the patient, as well
as the severity of the disease? CONSENT
2 Various Options of e.g. Is the physician able to give • Demand of Futile Treatment
Treatment alternative forms of treatment other • Considerations for DNR
than the standard treatment (e.g. • Considerations for Required Informed Consent
alternative medicine, palliative,
medicine, etc. THE DEMAND OF FUTILE TREATMENT
3 Potential Risks e.g. Is the physician able to inform the • “The customer is always right” does not apply always
patient the risks involved (i.e. side o A patient with chest pain does not have the right to demand an
effects, possible disability, etc.) if the unnecessary cardiac bypass
patient would undergo the chosen
treatment CONSIDERATIONS of “Do Not Resuscitate” (DNR)
4 Professional’s e.g. Is the treatment presented is based • With CPR (There is 1:1000 chance of survival)
Recommendation on evidence (i.e. EBM)

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• Who determines what chance of life is too remote to consider (e.g.
counseling to the family and opening up the possibility of DNR to the RELEVANCE
patient) • Facilitates recovery/cure
• Respecting the patient’s decision of “DNR” • Increases compliance
• Patient’s Values vs. Physician Values (i.e. must consider the • Promotes trust
ideologies of both parties: some physicians would still opt to • Empowers patients’ decision-making
resuscitate due to religious belief that life is sacred, etc.) • Protects physician from liabilities

PROFESSIONAL COMMUNITY STANDARD FEATURES OF AN INFORMED CONSENT
• Traditions or Beliefs of specific community towards a medical • Active process that mere assent or dissent (yes/no)
condition • Implies deliberation and reflection based on one’s values
• It is not on the patient’s personal understanding but the set beliefs • Obstacles to Informed Consent
of his/her community (e.g. “sabi daw kasi bawal maligo kapag may o Physical conditions of the hospital
tigdas” § Patient has restrictions: wearing of hospital gown, with an
assigned bed number, and an identification tag.
REASONABLE PATIENT STANDARD o Medications
• The patient is not to be identified with an ordinary person, who o Family dynamics
might occasionally do irrational things § Problems at home
• The patient is a careful person, who always up to the standard o Economic constraints
• “Also standard to test the Patient’s Competency” o Mental state of elderly, child

PATIENT-CENTERED STANDARD PREREQUISITES OF A VALID INFORMED CONSENT
• Relies on the uniqueness and abilities of the patient • Adequate information
o Consider the patient’s lifestyle when choosing a treatment • Competence in decision-making
plant • Voluntary
o Consider his/her beliefs (e.g. Health-Belief Model) • Freedom from coercion
• Legal
THERAPEUTIC PRIVILEGE
• Privilege that a Physician will claim in order to withhold the Adequate Information
information when the physician believes the information will be • Adequate information both from the patient and doctor
harmful or upsetting to the patient • Nature of the illness/procedure/research protocol
• Evidence based for the diagnosis & prognosis including what is
DOCTOR-PATIENT RELATIONSHIP unknown
• Asymmetrical, unequal • Available standard treatment/procedure
• Relationship based on trust o Benefits & risks – short & long-term
• Interplay of cultural, social, and economic factors affect the • Other options are available
relationship o Benefits & risks – short & long-term
• Changes in health care delivery • Effects of non-treatment
• Changes in health care financing • Process
• WHY ARE DOCTORS LIABLE? o Time
o Sudden worst situations § When is it best to disclose?
o Unexpected complications § How long will one wait?
§ Negligence § Obtaining an informed consent takes a long time with
• For example, a doctor started a surgery without an series of talking, exchange, and reflecting. It is not always
assist. Or a consultant after long work hours, already about the money but building trust to the patient by giving
very tired, just say yes to everyone, allowing a him/her time.
resident to do a task only fellows or consultant are • Place – private and quiet
allowed. o Informed consent must not be given in the ward or operating
§ Natural course room. Must be done in the clinic.
• There will be diseases with unexpected course such • Patient & significant family members
as complications after surgery. • Medium of communication
o Verbal
DOCTOR-PATIENT RELATIONSHIP o Illustrations
• Refers to the assent / agreement / compliance with the treatment • Informed Consent must be explained and obtained by the doctor not
plan / medications / surgical procedure /research protocol by a nurse, intern, clerk, resident, or fellow.
• Refers to the voluntary and uncoerced choice of the patient
o Uncoerced – not forced Competence in Decision-Making
o Voluntary – patient’s free will to undergo a consultation or • Capable of receiving information
operation • Capable of remembering received information
• Consent directly given, either viva voce (verbal) or in writing • Capable of assessing appropriately relevant clinical information
• Willing acceptance of a medical intervention of the patient after • Capable of making a sound decision
adequate disclosure of a physician of the nature of intervention, its • Capable of communicating one’s decision effectively
risks and benefits and also its alternatives *If one of these prerequisites is absent, there is no informed consent
• It is a positive, direct, unequivocal consent requiring no inference or
implications to supply its meaning (Legal Medicine) For instance:
o Unequivocal – hindi nagdadalawang isip • W h o will give con sent for a n 11-year old child with n o p a rent s?
o Inference – doctor will not deduce from the way the patient o Adult with direct linkage or relationship to the child based on
behaved or spoke; very clear that the patient agreed to the hierarchy or guardian appoint d by the pa re n t s.
treatment plan • W hat if relatives, grand p are n t s o n m other s id e and g rand pare n
t s o n father s id e are in conflict t of the con se n t?
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o Withhold the consent and let them sign when a unanimous DOH CONSENT FORM
decision has been made • Informed Consent
• Proper Party
Voluntary And Free • Signatures by the following:
• Absence of fear, fraud and manipulations o Patient – competent adult
• Previous experiences o Parent or guardian – minor or incompetent c)
Guardian or next-of-kin – incompetent
HISTORY OF INFORMED CONSENT • Witness – at least 1 5. Freely given
• 1930’s – Infamous Tuskegee syphilis study healthcare professionals • Date
have used people as research subjects without their informed
consent. In this study, researchers tracked the progress of the Source: 1994 DOH Management Manual
disease in subjects over many years, withholding penicillin that
might have helped or even cured them. *Readmitted patients must sign a new consent. Consent from previous
• The horrors of the experimental practices used by the ‘Nazi Doctors’ admission is not valid.*
during World War II led to creation of the Nuremburg Code, which
has as its first statement, “The voluntary consent of the human DOH Consent Form For Mental Patient
subject is absolutely essential.” • Only upon written authorization from
o Next-of-kin
SUCESSION OF RELATIVES IN GIVING A VALID o Court-appointed legal guardian
• From a mental institution where patient is presently confined
INFORMED CONSENT

• Legitimate spouse;
Source: 1994 DOH Management Manual
o Not the mistress
o Not the boyfriend/girlfriend

• Adult competent children PROCESS OF ARRIVING AT AN INFORMED CONSENT
• Ascendants in the direct line
o Parents on the paternal/maternal side C Competent to make your decision
o Grandparents on the paternal/maternal side O Open to making the decision
o Aunt/uncle on the paternal/maternal side N Necessary background information to make decision
• Brother or sister S Steps to be followed
• Guardian E Explanation of those steps
N Notify someone of the decision
*Informed consent is always dependent on the patient as long as he is T Tick the boxes and sign the form
mentally capable. Don’t proceed when the patient is still ambivalent.*
IMPORTANT POINTS TO REMEMBER
INFORMED CONSENT IS NOT REQUIRED (NOT DISCUSSED)
• Emergency • The Patient Himself can give consent if he is of legal age, of a sound
• Exercise of “therapeutic professional discretion” Dependence on mind, and not otherwise disqualified by law
healthcare professionals’ assessment whether to divulge everything or • Generally, a minor (below 21 years old) may not give consent
not to the patient so informed consent is not obtained. unless he is emancipated
• Waiver of the patient o Emancipation is renunciation of parental
• Previous similar experience o authority over a child.
• Requires disclosure of facts when the procedure: o A minor is emancipated by:
o Entails a proven risk § Marriage of the minor
o Is experimental or innovative § By the attainment of the majority
• Full disclosure may not be necessary when: § By the concession of the father or the mother who
• The disclosure may cause emotional upset to the patient exercises parental authority
• The procedure is publicly known to be safe o Non-emancipated minors, insane, or demented individuals,
and deaf-mutes who do not know how to write may not give
consent.
SCOPE OF THE CONSENT
• If the patient is married, the consent of the spouse in not necessary
• GENERAL OR BLANKET CONSENT
unless it will affect their right of consortium in marriage.
o Proposes to give the physician unlimited authority
o If the patient is incompetent, the spouse may give the
and discretion to apply any procedure
consent.
• LIMITED OR CONDITIONAL CONSENT ü Imposing certain
• If the patient is a minor, consent must be obtained from the
conditions
parents.
o Physician must respect and comply with such
o Father and mother jointly exercise parental authority over
limitation and condition otherwise he will be held
their legitimate children who are not emancipated.
liable for breach of legal duty
o In case of disagreement, the father’s decision prevail, unless
o Physician is only justified for not complying with the
there is judicial order to the contrary.
condition in case of emergency
o For illegitimate children, the mother’s consent must be
• NON-LIABILITY OR EXCULPATORY CLAUSE IN THE CONSENT
sought.
o “The hospital or any member of its staff shall not be
• In the absence of the parents, the consent must be obtained from
held liable civilly or criminally to whatever be the
the grandparents.
consequence” of the procedure mentioned on which
o The grandparent shall exercise parental authority in case of
the patient gave his consent
death or the absence of the child’s parents.
o Purpose is to make the patient assume the inherent
o Substitution of parental authority shall be exercised by the
risk of operation
grandparents in the following order:
§ Parental grandparents
§ Maternal grandparents

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• In the absence of the parents and grandparents, the ELDEST
brother or sister may give consent provided he or she is of age
and is not disqualified by law.
• Other persons who may give consent in the their capacity as
substitute parental authority:
o Guardians
o Teachers and professors
o Heads of children’s homes, orphanages, and similar
institutions
o Directors of trade establishments, with regard to apprentices
• Under special circumstances, the minor patient himself, may give
consent:
o A minor may enter into a valid contract of medical service
with a physician if it will rebound to the preservation of his life
and health
o BUT, the consent of the minor is not valid if the procedure
will not benefit him.

• Other issues:
o What if the doctor intentionally withheld a treatment option
for fear of losing the patient to the specialist?
o What if the doctor withheld a treatment option because the
family could go to financial debts?

QUIZ

1. What are the 3 features of informed consent
2. What are the 4 elements of informed consent
3. What is Therapeutic Privilege
4. Give a type of patient who is unable to give a sound informed
consent


Answers:
1.
-Active process that mere assent or dissent (yes/no)
-Implies deliberation and reflection based on one’s values
-Obstacles to Informed Consent
2.
-Disclosure
-Understanding
-Voluntariness
-Competence
-Consent
3.
-Privilege that a Physician will claim in order to withhold the
information when the physician believes the information will be
harmful or upsetting to the patient
4.
-Mentally unstable, Under-aged, etc.

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