INFORMED CONSENT 1-3

1
Dr. Melchor Frias, MD
“Our patients need to be informed of their diagnosis, the of his life and the fact that he was born, and will
reason behind it, and the treatment to be given to them. always be, free.
Not for the mere reason of educating them about their o That’s why he has the freedom to choose what
condition, but to give them HOPE.” (R.B.,2017) is going to be done on him. So that is essentially
what is the basis of getting the informed
OBJECTIVES consent during treatment.
At the end of the session, the student is able to: o It should be free, voluntary, and it should be
a. Explain the meaning of FIC, based on the decision of the patient (Essence of
b. Differentiate the elements of FIC, Free and Informed Consent).
c. Justify the ethical necessity of FIC, apply the  Respect for the values and wishes of the individual
principle in given situations, is a duty that becomes even stronger if the
d. Judge what is ethically/unethically acceptable as individual becomes vulnerable.
the principle is applied in given situations o Vulnerable means incompetent; unable to
e. Understand the purpose and intent of informed speak and decide for himself due to sickness.
consent, requirements for informed consent o In some cases, patients could be vulnerable.
process, required elements of the informed o Examples of vulnerable patients:
consent form, and requirements for documenting  Child
informed consent  Patient with high grade fever
 Patient in pain
TABLE OF CONTENTS  Elderly
o Vulnerability may depend on the disease, or
I. Introduction (Page 1) status of a particular individual
II. Informed Consent (Page 2)  Pediatric patients are not allowed to sign
III. Elements of Informed Consent (Page 2) the informed consent by themselves. They
a. Threshold (Page 2) need a proxy (parents) to sign.
b. Information (Page 3)  Prisoners (they are taken advantage
c. Consent (Page 4) because of the lack of freedom).
IV. Exceptions from Informed Consent (Page 4)  Students (they cannot say no to a professor
a. Therapeutic Privilege (Page 4) in joining/not joining a research)
b. Emergency (Page 5) o Vulnerability comes more from a situation
V. Right not to know (Page 5) where respect and individuality or
VI. Free and Informed Consent (Page 6) autonomy/independence is more important in
a. Obligations of the Hospital (Page 6) taking the informed consent.
b. Justification (Page 6)  Since the autonomy and responsibility of every
VII. General Ethical Principles (Page 6) person, including those who need health care, are
VIII. Elements of Research Ethics Informed Consent accepted as important values, reaching or
(Page 6) participating in decisions concerning one’s own
a. Role of the Ethics Review Committee body or health must be universally recognized as a
(Page 6) right.
b. Ethical Considereations in a o Informed consent is a right of every patient.
Research/Study Protocol (Page 6) Including those who are incompetent
c. Ensuring Quality Research (Page 6) (comatose patients, stuporous, child, pregnant
women, patient in pain)
o The right may not be exercised by themselves,
INTRODUCTION: Free and Informed Consent
hence a proxy is needed. There should always
 A person’s basic rights are established on be someone who will consent for them. The
recognition of his human status, the inviolability
Informed Consent 1-3 (Dr. Melchor Frias, MD)
August 31, 2017; September 22, 2017
 proxy should always be an individual who o Sometimes, Physicians will ask you certain
knows the values of the patient, the welfare questions to verify whether the patient
and the best interest of the patient. understood the explanation or not.
o In children, there is proxy consent. Unless
“How informed should informed consent be?” proven otherwise, adults are deemed to be
 There should be no physical or psychological competent ALWAYS.
therapy which may be administered without the
free and informed consent of the patient. Notes:
o Any treatment should not be administered There should be knowledge about the procedure to be
done. Physician may ask the patient certain questions to
without the consent of the patient. test the patient whether he understood the information that
he was given.
INFORMED CONSENT Information must be verified whether the patient
 In order to be fully legal, the patient’s consent understood the information given by asking the patient
what will happen and/or what will she do if these things
must be informed. happen: for example, its side effects or complication – so
o ALL pertinent information must be given to the the doctor will realize whether the patient can actually
patient. To make sure no information are situate himself in a particular experience during the
treatment.
missed, ask the patient if there are any more
questions.  No consent will be valid if it does not depend on
o Aside from being ethical, an informed consent willingness and voluntariness.
is a document that protects you (medical o Even though there is knowledge, but there is no
professionals) legally. (It protects you legally voluntariness, the consent is STILL invalid.
more than it does ethically).
 Being informed implies cognition, willingness, Notes:
consideration, intention and understanding. It should always be free; there should be no coercion, no
o The patient should be an adult and competent influence, no persuasion from the one getting the consent
– it should always be voluntary. It should not be because
while the doctor should be able to deliver the the Doctor or Nurse scared the patient.
information in a manner that the patient will Children/teenager/adolescent are vulnerable because we
understand (vernacular language, less technical don’t know whether the child voluntarily consents to a
particular procedure or treatment and not just because an
terms if possible). Also, give the patient time to
adult threatens him/her.
decide (hours, days).

Notes: ELEMENTS OF INFORMED CONSENT

 Cognition (awake, conscious) - patient must be able to
understand, comprehend on the information given, be  Threshold
able to situate himself in that particular instance o Competence
undergoing surgery, understanding what will happen to  Information
him as explained by the medical practitioner.
o Disclosure (data/info to be disclosed)
 Willingness (voluntary) – willingness to undergo such
treatment o Understanding (discern and understand the
 Consideration – able to reflect on the information given disclosure)
to him, and consider his situation in terms of his illness  Consent
and what is being recommended in terms of treatment
and diagnostic; patient must be given time to think o Voluntariness
about his decision, may not be in one seating but o Authorization
sometimes the patient may be given minutes, hours of
days to make his decisions
 Intention – intention of undergoing such procedure
ELEMENT: Threshold
 Understanding COMPETENCE
All of the above mentioned must be present to be A competent person is able to:
considered as an informed consent, these principles make  Understand the diagnosis (in layman’s term)
the patient informed of such medical procedure.

 Opinions and choice cannot be final and

acceptable unless they are based on knowledge.

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DR. MELCHOR FRIAS, MD
 Notes: Incompetent persons
The patient should be given the specific diagnosis.  Children (but not all pediatric patients are
Explain the (1) pathophysiology, (2) signs and incompetent)
symptoms, (3) prognosis, and (4) treatment. o Example: In research, an adolescent 15 yo and
For example, surgeons would draw the anatomy of the above may sign the informed consent. The
body then explain it to the patient. adolescent could sign the consent together with the
When several tests are done, separate consents should be patient. (No need for assent in persons 15 yo and
accomplished (for diagnostics – invasive and treatment). above)
During diagnostics, alternatives should also be given and o In clinical practice, adolescents are involved in
let the patient decide. decision making (only as far as assent is concerned)
The patient has the right to refuse any procedure, but it is but the parents still sign the consent.
the responsibility of the medical professionals to explain o Generally, an assent is required for adolescents less
everything about the procedure including its pros and cons. than 15 yo whereas children below 7 yo, assent is
not required.
o In the Philippines, emancipated law doesn’t exist. In
other countries, emancipated adolescent can sign
 Understand the therapy or procedure the consent.
 Deliberate regarding risks and benefits o Emancipated adolescent is someone who is
 Make a decision in light of this deliberation independent of his parents, lives alone, maybe
married, and not depending on his parents. He can
decide for himself regarding issues such as
Notes: reproductive health (taking pills, pregnancy issues,
Sometimes, it is essential to ask how did the patient arrived abortion, etc.)
at that decision before letting them sign the informed
consent. This will be the basis of determining whether the
patient understood or if he was really competent or not.
EMERGENCY is an exemption for informed consent
 Elderly
 Psychiatric patients
INCOMPETENCE  Comatose patients
An incompetent person is unable to:  Stuporous patients (temporary)
 Evidence a preference or choice,  Pregnant patient in labor pain or patients with high
o Sometimes, patient maybe confused but it’s up grade fever (temporary; relive the symptoms first
before getting the consent)
to the physician to make him understand and
resolve the confusion. If the confusion was not
resolved, you should doubt the competence of Dr. Frias (2017): “As a pediatrician, when I encounter a
the patient. pregnant adolescent patient and she asked me to keep it
 Understand one’s situation or relevantly similar confidential, I honor her request. However, if I determined
that the adolescent is still dependent on her parents, then I
situations would give her the option of telling her parents or me telling
o He should be able to situate himself from that the parents eventually. There is a limit to the confidentiality
disease. of a teenager for me to actually disclose the information to
her parents. Even if she is considered emancipated, just to
 Understand disclosed information protect myself because we don’t have such laws, then I
o At the end of the informed consent process, we would tell eventually the parents. But that is with the
should ask “are there any questions?”, “did I consent of the adolescent. I always respect the autonomy
made myself clear?”, “do you have concerns?”, of the adolescent. Otherwise, you’ll lose her trust and she
might not come back anymore and resort to other means
etc. like termination of the pregnancy.”
 Give a rational reason (especially when he refuses
a procedure)
 Give risk/benefit-related reasons,  Consent by proxy is permitted when the patient is
o Cannot weigh between benefits and harms. incompetent.
 Reach a reasonable decision. o Consent by proxy  immediate family
member/legal guardian/spouse

ELEMENT: Information
DISCLOSURE
The patient is given information concerning:
1. the diagnosis (should be explained to the patient
not just given as a mere diagnosis itself in light of
that diagnosis),

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DR. MELCHOR FRIAS, MD
 2. the nature and purpose of the proposed procedure or treatment (to gauge if the patient
treatment or procedure (should be accompanied understood, make him explain the decision, in the
by a thorough explanation of the procedures to be line that the risks and benefits were presented to
done. If the Doctor isn’t sure of the exact diagnosis, him).
he has to be able to give you a differential diagnosis  The fact that the patient makes a decision contrary
of what are the most probable diagnosis), to that recommended by the MD, does not prove
3. the known risks and consequences of the that he is incompetent because of lack of
treatment including the alternate treatment (don’t understanding (it doesn’t mean that when the
just focus on the benefits. Whether mild or severe, patient refused a beneficial treatment, that he is
consequences should be provided to the patient. It incompetent).
is their responsibility to weigh the risk and  In general, the assumption is that adults are
benefits), competent unless there is clear evidence to the
4. the expected benefits contrary.
5. alternative treatments/procedures with their risks
and benefits (there is always another alternative. ELEMENT: Consent
However, NO TREATMENT is also an alternative. VOLUNTARINESS
Cancer patients in terminal stage MAY refuse  Freedom from:
chemotherapy), o Coercion
6. the prognosis of the treatment or non- treatment o Undue manipulation
7. all costs (Not just the cost of treatment itself, but o Persuasion
also the cost of the follow up drugs, check ups, o Natural reaction to illness
treatments, etc.) o Influence of drugs or alcohol
 Factors:
TWO WAYS OF DISCLOSURE o Medical
1. The prudent person rule (reasonable patient o Family pressures
standard) rests on the assumption that the MD’s o normal/natural factors
disclosure to the patient should be measured by  The question the MD must answer is whether any
the patient’s need for information relevant to the of these influences substantially diminish the
decision to refuse or accept the treatment or patient’s freedom so that there is inadequate
procedure (based on the level of education and capacity for a valid consent.
profession. Ex. If patient is Doctor, you can give  Emergencies are an exemption from consent
more info. But if elementary grad, taylor it  Short of substantial evidence of incompetence,
according to his understanding as he is still choices deserve to be honored
competent.)
2. The subjective substantial disclosure rule calls for AUTHORIZATION
the MD to describe to the patient everything that  This is obtained when the patient gives his/her and
would be material or important to the patient as he informed consent. The physician acts according to
makes the decision (Be detailed based on your what has been communicated and decided upon.
observation of the patient. If they want all the info,
give them). EXCEPTIONS FROM INFORMED CONSENT
1. Therapeutic Privilege
UNDERSTANDING OF INFORMATION 2. Emergency
 To actually communicate and not merely to
blabber out words or present facts (Preferably THERAPEUTIC PRIVILEGE
face-to-face to see patient’s reactions, responses  The withholding of information from the patient
and you can build from there). when the disclosure will have an adverse effect on
 Use a language that is understood by the patient. the patient’s condition or health.
 Do not use medical terms; use commonly o The decision is made by the doctor
understood terms by non-doctors (Explain it by  Information may be withheld from patients in
“story telling” or by drawing except when they’re exceptional cases only when there is good reason
also in the field medicine or science). to believe that the disclosure of certain information
 The competent patient has to understand the
consequences of his decision to reject or accept a
INFORMED CONSENT 1-3 4
DR. MELCHOR FRIAS, MD
 would endanger the patient’s life or detrimentally EMERGENCY
affect his physical or mental health.  Treatment without informed consent is justified in
emergencies.
THREE CONDITIONS ON THE USE OF THE PRIVILEGE:
1. The actual use must be on a case-to-case basis. THREE CONDITIONS ON THE USE OF EMERGENCY
o It is not a general thing. In most cases, patients 1. The patient must be incompetent, no lawful
must know all information from the doctor surrogate is available to give consent, and the
because it is pertinent for the patient to make a wishes of the patient are unknown.
decision. o During trauma cases, in an accident and
o In terminal cancer cases, patient or relatives brought in by a stranger
may need to decide whether to continue the 2. There is danger to life or danger of a serious
medication or not. Sometimes they do not impairment of health.
want to disclose their decision yet. o When you don’t do anything, the patient will
2. The physician must have a founded belief based die or some form of disability will form if you
on an intimate knowledge of the person that the don’t do anything
full disclosure will have a significantly adverse 3. Immediate treatment is necessary to avert those
effect on the patient. dangers.
o This applies when the physician knows the o When there is a proxy present and did not gave
patient very well (eg. Family physician). This the consent yet basis of the treatment is
makes the physician assess if it will have an provided (i.e. surgery or blood transfusion
adverse effect or not. would save the patient), you may continue to
o Referred doctor will have to consult with the do the treatment and not be liable for it.
family physician whether to apply the privilege o Religious beliefs must always be considered.
or not. (eg. does not allow blood transfusions)
3. Reasonable discretion must be used in the manner
and extent of the disclosure. RIGHT NOT TO KNOW
o There should be discretion on how certain  One of the most difficult social, moral and medical
information (eg. Poor prognosis, degree of risk) problems is the issue of the appropriate approach
would be disclosed to the patient. Not to a patient suffering from an incurable disease. A
everything should be kept a secret because patient’s right to know or be informed of the
patient needs information. seriousness of his illness needs to be balanced with
o If the patient says “do not tell my the right not to know, when knowing might cause a
family/wife/husband” – you can see to that traumatic state of helplessness and collapse, since
request but be clear that there is a limit on how active problem-solving behavior is necessary for
long or until when you can withhold survival.
information.  Patients have the right not to be informed on their
o If the patient is competent, family members explicit request. The right not to know provides an
should still be present during discussion but it instrument to prevent the receipt of unwanted
would still be the assessment of the physician- information.
in-charge to decide to continue medication or  The right not to know is important, for instance,
not depending on the patient’s condition. when examination generates knowledge about
o When patient says, “you ask my wife/family”- genetic predisposition, genetic risks and early
an implicit consent for the patient to talk to the prediction of still latent diseases which could
family members. At that point, the family become manifest sometimes many years after they
members may have a say on the decision. The are diagnosed (such as Huntington’s disease).
patient should always know that you are  On the other hand, this right not to know is not
consulting with the family members. applicable when a person should be given
o REMEMBER: In patient-doctor relationship, your information allowing him/her to protect other
primary relationship is with the patient, not the people by an adapted behavior. For instance, the
family. positive result of a sexually transmitted disease
investigation should not be held back from a
patient. The possible result of the investigation and
the consequences of this result should be
INFORMED CONSENT 1-3 5
DR. MELCHOR FRIAS, MD
 anticipated with the person before they are GENERAL ETHICAL PRINCIPLES
performed. RESPECT FOR PERSONS – INFORMED CONSENT
 Respect for persons incorporates at least two other
FREE AND INFORMED CONSENT fundamental ethical considerations:
OBLIGATIONS OF THE HOSPITAL 1. Autonomy
 To ensure that informed consent has been obtained  Requires that those who are capable of
for diagnostic and therapeutic procedures deliberation about their personal goals
performed in the hospital. should be treated with respect for their
 To develop educational programs that teach capacity for self-determination.
effective ways of getting ethically and legally 2. Protection of Persons with Impaired or
acceptable informed consent. diminished Autonomy
 To make certain that patients are aware of their  Requires that those who are dependent or
right to consent or reject proposed procedures and vulnerable be afforded security against harm
treatments. or abuse.

JUSTIFICATION ELEMENTS OF RESEARCH ETHICS INFORMED CONSENT

 Autonomy INFORMED CONSENT
o Respect for the person and his freedom  For all biomedical research involving humans, there
o Encourage rational decision making must be a voluntary, informed consent of the
o In law, related with: right to privacy and law on prospective subject.
assault & battery  Waiver of informed consent is to be regarded as
 Human Dignity uncommon and exceptional, and must in all cases
 Human Rights be approved by an ethics review committee.
 Stewardship
ROLE OF THE ETHICS REVIEW COMMITTEE
CASE  Review the scientific merit and ethical acceptability
of any research involving human participants.
A 30 year old, male, elementary graduate was advised  Institutional IEC
to undergo liver biopsy. o Full Board and Expedited Review
 College EC
Threshold: Competence o Expedited review of student researches only
 Ability to make choices based on an
understanding of the relevant consequences ETHICAL CONSIDERATIONS IN A RESEARCH/STUDY
of that choice to oneself and others. PROTOCOL
 The ability to understand the relevant is to be INFORMED CONSENT
judged by common sense rather than a  Written in English and Filipino and the language
technical or professional standard. where the study is to be conducted
 The competent patient is not to be judged by  Who may solicit consent?
his educational level, nor does he have to  Who may give consent?
understand everything about the condition, o Patient and relatives
treatment, or procedure.
 In any event, the exact “how” of the treatment ENSURING QUALITY RESEARCH
is not always in itself ethically important, INFORMED CONSENT
whereas the consequences are crucial.  A statement that the study is investigative in
 The effect of treatment on the patient’s nature.
health, lifestyle, religious beliefs, values,  Specify the number of participants in the study.
family, friends, and society are all factors that  Express the purpose/objective of the study.
bear on the ethical decision to accept or reject  Disclose probability of random assignment to
treatment/procedure. treatment and trial treatments.
 Explain the procedure of the study including all
invasive procedures.
 Expected duration of the subject’s participation
including the follow-up visits.
INFORMED CONSENT 1-3 6
DR. MELCHOR FRIAS, MD
  Benefits to the subject.
 Alternative procedure/course of treatment that
may be available.
 Disclose risks, discomforts and inconveniences
associated with the study.
 Responsibilities of the subject.
 Statement of voluntary participation.
 Study participants have the option to withdraw
from the study anytime.
 Guarantee of confidentiality.
 Circumstances/reasons for the termination of the
subject’s participation.
 Statement regarding indemnification.
 Contact person.

“Diligent hands will rule;

but laziness ends with forced labor.”
-Proverbs 12:24

REFERENCES
1. Powerpoint
2. Batch 2019 Transcription
3. Class Recording
4. Books
5. Online references

TRANSCRIBED BY:
1. Group 2A, 8B, & 1A
2. Subtransheads: Athena Ortiz and Ivy Reginio

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DR. MELCHOR FRIAS, MD