INFORMED CONSENTDEFINITIONSInformed Consent

Also known as enlightened consent.

According to Sec. 3 (Definition of Terms) of House Bill No. 261 of the Republic of the Philippines during the 1st

Regular Session of the Thirteenth Congress,

…Informed Consent is the voluntary agreement of a person to undergo or be subjected to a procedure or other bodily intervention based on his understanding of the relevant consequences of receiving a particular treatment, as clearly, truthfully and reasonably explained by the health care provider in a manner and language understandable to the patient. Such permission must be in writing…

An agreement by a client to accept a course of treatment or a procedure after being provided with complete information.

The General Guidelines include:1. The diagnosis or condition that requires treatment.2. The purpose of treatment.3. What the client can expect to feel or experience.4. The intended benefits of the treatment.5. Possible risks or negative outcomes of the treatment.6. Advantages and disadvantages of possible alternatives to the treatment. (Including no treatment)

A person’s agreement to allow something to happen (e.g. surgery) based on a full disclosure of facts needed to make an intelligent decision (i.e., knowledge of risks involved, benefits, alternatives or consequences of refusal).

The Consent Form These are legal documents that serve as Prima Facie or

firsthand evidence in court cases. Hence, consent must be obtained in observance with the elements of informed consent.

THREE MAIN ELEMENTS OF INFORMED CONSENT1. VOLUNTARINESS. The consent must be given

voluntarily. 2. COMPETENCE. The consent must be given by a client or

individual with the capacity and competence to understand. Moreover, it must be given by a person who is in a domain of being mentally, emotionally and physiologically well and sane, which means: a. The individual is not under decision distress. b. The individual is not under the influence of any intoxicating chemical. c. The individual is not pathologically impaired. d. The individual is not threatened by any form of coercion.

3. THRESHOLD ELEMENTS. The client or individual must be given enough information to be the ultimate decision maker. a. Information Elements b. Disclosure – full information of the matter. E.g. If the topic is about a procedure, such as surgical intervention, the following shall be included:

Particular information about the part of the body involved

The procedure to be done The effects on the whole/entire system Cost of procedure Outcome of intervention

c. Recommendation (of plan) d. Understanding (of information disclosed and of the plan).

2 MAIN FUNCTIONS OF INFORMED CONSENT1. PROTECTIVE – to safeguard against tension of integrity.2. PARTICIPATIVE – to be involved in the health care

decision making.

TWO TYPES OF INFORMED CONSENT1. EXPRESSED – may be an oral or written agreement.2. IMPLIED – exists when the individual’s non-verbal

behavior indicates agreements.

WHO SHALL SIGN THE CONSENT FORM?THE COMPETENT ADULT

One who is in a legal age (18y/o), and is conscious and oriented.

One who can make decision regarding health if given sufficient information, and thus, is the one who can give an informed consent.

The following clients are not considered functionally competent, thus, there is a need for the presence of a relative, legal guardian or representative:

Confused Disoriented Sedated

EXCEPTIONSThree groups of people cannot give consent.

1. MINORS – the parents or guardian must give the consent. This is also true and applicable to adults who has the mental capacity of a child and who has an appointed guardian.

Special Considerations in Minors: In some states in the US, minors are allowed

to give consent for: a. Blood Transfusions b. Treatment for substance abuse c. Treatment for mental health problem d. Treatment for reproductive health concerns such as STD or pregnancy.

Certain groups of minors are often legally permitted to provide their own consent. These are the minors who are: a. Married b. Pregnant c. Parents d. Members of the Military e. Emancipated

2. PERSONS WHO ARE UNCONSCIOUS OR INJURED in such a way that they are unable to give consent.

Consent is usually obtained from the closest adult relative existing.

In a life-threatening emergency, if consent cannot be obtained from the closest adult/relative, the law generally agrees that the consent is implied to provide necessary care for the client’s emergency condition.

3. MENTALLY-ILL PERSONS – family/relatives are the ones who shall give consent in behalf of an individual who are judged by professionals to be incompetent.

COMMON PROCEDURES THAT REQUIRE INFORMED CONSENT1. Surgery2. Procedure requiring Anesthesia3. Procedures that may involve more than a slight risk of

harm.4. Experimental therapies or medications

AUTONOMY IN CULTURAL PERSPECTIVES US – the informed consent is based on the principle of

autonomy. SOUTHEAST ASIA, AMERICAN INDIAN – have group

perspective for decision making. PHILIPPINES – Autonomy in the Filipino Family considers

essentially the HIERARCHY OF FAMILY AUTHORITY. Elders have to be traditionally consulted before any decision is made.

PHILIPPINE SETTING

LEGAL BASIS: House Bill No. 261. An Act Declaring the Rights and Obligations of Patients and Establishing a Grievance Mechanism for Violations thereof and for other Purposes

Title III: Declaration of Rights, Sec. 4. The Right of Patients (2). Right to Informed Consent

The patient has a right to a clear, truthful and substantial explanation, in a manner and language understandable to the patient, of all proposed procedures, whether diagnostic, preventive, curative, rehabilitative or therapeutic, wherein the person who will perform the said procedure shall provide his name and credentials to the patient, possibilities of any risk of mortality or serious side effects, problems related to recuperation, and probability of success and reasonable risks involved: Provided, That the patient will not be subjected to any procedure without his written, informed consent, except in the following cases:

a. In emergency cases, when the patient is at imminent risk of physical injury, decline or death if treatment is withheld or postponed. In such cases, the physician can perform any diagnostic or treatment procedure as good practice of medicine dictates without such consent;

b. When the health of the population is dependent on the adoption of a mass health program to control epidemic;

c. When the law makes it compulsory for everyone to submit a procedure;

d. When the patient is either a minor or legally incompetent, in which case, a third party consent is required;

e. When disclosure of material information to patient will jeopardize the success of treatment, in which case, third party disclosure and consent shall be in order;

f. When the patient waives his right in writing.

Informed consent shall be obtained from a patient concerned if he is of legal age and of sound mind. In case the patient is incapable of giving consent and a third party consent is required, the following persons, in order of priority stated hereunder, may give consent:

i. Spouseii. Son or daughter of legal ageiii. Either parentiv. Brother or sister of legal age, orv. Guardian

If a patient is a minor, consent shall be obtained from his parents or legal guardian. If next of kin, parents or legal guardians refuse to give consent to a medical or surgical procedure necessary to save the life or limb of a minor or a patient incapable of giving consent, courts, upon the petition of the physician or any person interested in the welfare of the patient, in a summary proceeding, may issue an order giving consent.