Detoxicol

SDLS 2008
Medicine for the intoxicated
Subject: Bioethics Lecture Date: June 24, 2005
Topic: Free and Informed Consent Transcriber(s): ??? and ???
Lecturer: Dr. Melchor Frias No. of pages: 4

FREE AND INFORMED CONSENT

• pertains to the AUTHORITY given by the patient to the physician with regards to disease management/
treatment
• no physical or psychological therapy may be administered without the voluntary permission of the patient
• physician VOLUNTARILY gives information to the patient so that he/she may decide whether to
participate in the treatment or not
• the patient has the right to know information with regards to prognosis or diagnosis
• the physician SHOULD NOT influence the decision of the patient
• a protection for physicians from legal complications
• a waiver should still be signed by the patient stating that he refused treatment
• in emergency cases the doctor do not need anymore to get the consent of the patient (malamang, paano
kung in the verge of death na yung pasyente tpos you waste time pa to get the consent, malamang pag nakuha
mo na yun corpse na sya)
• in non-emergency situations a doctor can refuse a patient if his/her beliefs and values are against her

Justification:
• Autonomy
o respect for the person and his freedom
o encourage rational decision making
o in law, related with: right to privacy and law on assault and battery

• Human Dignity

• Human Rights

• Stewardship

Elements of Free and Informed Consent

1. Threshold
o competence

2. Information
o disclosure
o understanding

3. Disclosure
o voluntariness
o authorization

THRESHOLD ELEMENT

Competence
• patient is able to understand information of his disease, such as diagnosis
• not only able to comprehend but also make a decision

A Competent Person is Able to:

1. understand the diagnosis

o the physician should explain the diagnosis in a manner that the patient will understand

2. understand the therapy or procedure

3. deliberate regarding risks and benefits

o give the consequences of the treatment
o physician should also explain the possible unknown risks
 4. make a decision in light of this deliberation

An Incompetent Person is Unable to:

1. evidence a preference or choice

o common in minors

2. understand one’s situation or relevantly similar situation

o some patients are in denial and refuse to understand

3. understand disclosed information

4. give a rational reason

o can’t give a reason for refusing treatment

5. give risk/benefit-related reasons

6. reach a reasonable decision

List of Incompetent Patients:

• geriatrics especially senile patients
• delirious patients
• unconscious, in coma
• psychiatric patients
• children/ minor (below 18)

***Consent by proxy is permitted when the patient is incompetent

***Proxy should be known to the patient since he/she knows what is for the best interest of the patient

***Decision making for minors is often done by the parents. However, an assent (verbal consent) is needed when the
patient is 7 years old and above, by this way you respect their dignity and autonomy. If the patient’s decision is in contrast
to the parent’s decision, the loyalty of the physician is to the child especially when it is a life-saving
procedure/treatment.

If Life Threatening, the Order of Physician’s Loyalty is:

1st – patient
2nd – biothics department of the hospital / court
3rd - parents

INFORMATION

Disclosure
• the patient is given information concerning
o the diagnosis (patient can raise questions regarding the treatment/procedures)
o the nature and purpose of the proposed treatment or procedure (what is the objective of the procedure?
What goes with it?)
o the known risks and consequences of the treatment (possible outcomes, complications, unknown risks)
o the expected benefits
o alternative treatments/procedures with their risks and benefits (treatment options for patient)
o the prognosis of the treatment and non-treatment (tell the consequences of no treatment)
o all costs

***The recommended treatment is the BEST treatment.

***In emergency situations, the physician cannot refuse a patient from treatment.

Understanding of Information
• to actually communicate and not merely to blabber out words or present facts
o turn facts to useful information that will help in decision making and compliance to treatment

• use a language that is understood by the patient

o don’t use medical terms; if the patient can’t understand the diagnosis/treatment even in the
language best understood, physician can do alternative ways of explaining like drawing the structure
involved or pointing in a picture)

• do not use medical terms; use commonly understood terms by non-doctors.

o liver

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  atay

o pancreas
 lapay

o spleen
 pale

o gallbladder
 apdo

o cervix
 kwelyo

CONSENT

Voluntariness
• freedom from:
o Coercion
 the doctor is unaware that he is already persuading the patient towards his preferred
treatment
 The physician only concentrates on the benefit of a certain procedure when in fact the
alternative procedures will yield the same results

o Undue manipulation
 physician concentrates on the moderate side effects of a certain procedure and not all
the possible side effects that the patient can get
 physician does not give choices

o Persuasion
 telling the patient that he/she will die if he/she will refuse treatment

o Natural Reactions to illness

 depression may affect the decision making capacity of the patient
 parents who are in a state of shock or denial may not be able to make the best decision

o Influence of drugs and alcohol

 patient is temporarily incompetent

Authorization
• this is obtained when the patient gives his/her free and informed consent
• if the patient asks a doctor to do anything possible…
o the patient already gave authority to the doctor
• the physician acts according to what has been communicated upon
• example:
o case of C section and appendectomy
 the doctor should secure a separate permission for C section and appendectomy

EXCEPTIONS FROM INFORMED CONSENT

Therapeutic Privilege
• the withholding of information from the patient when the physician believes that the disclosure will
have an adverse effect on the patient’s condition or health

3 Conditions on the Use of the Privilege:

1. The actual use must be on a case to case basis (there should be an established patient-doctor relationship)
2. The physician must have founded belief based on an intimate knowledge of the person that the full disclosure will
have a significantly adverse effect on the patient.
3. Reasonable discretion must be used in the manner and extent of disclosure.

***It is never acceptable to keep secrets from the patient. If relatives request to keep a secret from the patient, the
physician should ask them to set a deadline of until when they will keep it secret. Otherwise the physician will be the one
to tell the patient of his/her real condition.

Emergency
• treatment without informed consent is justified in emergency situations

3 Conditions:
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 1. The patient must be incompetent and no lawful surrogate is available to give consent and the wishes of the
patient are unknown.
• the proxy should be known to the patient

2. There is danger to life or danger of a serious impairment of health.

• the physical integrity of the patient should be preserved

3. Immediate treatment is necessary to avert those dangers

Obligations of the Hospital:

• to ensure that informed consent has been obtained for diagnostic and therapeutic procedures performed
in the hospital
• to develop educational programs that teach effective ways of getting ethically and legally acceptable
informed consent
• to make certain that patients are aware of their right to consent or reject proposed procedures and
treatments

CASE

A 30 year old, male, elementary graduate was advised to undergo liver biopsy.

• Threshold
o competence
 ability to make choices based on an understanding of the relevant consequences of that
choice on oneself and others

 the ability to understand the relevant is to be judged by common sense rather than a
technical or professional standard

 the competent patient is not to be judged by his educational level, nor does he have to
understand everything about the condition, treatment or procedure.

Dr. M explained the procedure to the patient in medical terms and the patient refused.

• Information
o understanding
 the competent patient does have to understand the consequences of his decision to
reject or accept a procedure or treatment

 the fact that the patient makes a decision contrary to that recommended by the MD, does
not prove that he is incompetent because of lack of understanding

 in general, the assumption is that adults are competent unless there is clear evidence to
the contrary.

 the prudent person rule (reasonable patient standard)

 rests on the assumption that the MD’s disclosure to the patient should be
measured by the patient’s need for information relevant to the decision to refuse or
accept the treatment or procedure

 the subjective substantial disclosure rule calls for the MD to describe to the patient
everything that would be material or important to the patient as he makes the decision

Dr. M explained that the procedure has to be done or else the patient will not be admitted again in the future.

• Consent
o factors :
 medical
 family pressures
 normal/ natural factors
 the question the MD must answer is whether any of these influences substantially diminish the
patient’s freedom so that there is inadequate capacity for valid consent.

o short of substantial evidence of incompetence, choices deserve to be honored.

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