INFORMED CONSENT AND

PATIENT AUTONOMY

Jana Urbanová

INFORMED CONSENT effective medical treatment - a mutual

(bilateral) communication between a doctor and a patient

increases patient's legal and health awareness

represents a patient's consent to a medical treatment on the basis of previous instruction

is required in addition for the health care to be provided

INFORMED CONSENT The Convention on Human Rights

and Biomedicine „An intervention in the health field may

only be carried out after the person concerned has given free and informed consent to it. This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks. The person concerned may freely withdraw consent at any time.“ (Article 5)

INFORMED CONSENT 1957, in the case Salgo, the American

court gave an interpretation of what is considered to be a duty of doctor

“...any facts which are necessary to form the basis of an intelligent consent by the patient to the proposed treatment.”

THE PRINCIPLE OF AUTONOMY one of the basic principles accepted

worldwide contains:

1) a protection of autonomous decisions

2) a protection of bodily integrity Consists of more partial rights: the right of patient to know all the

information about a treatment the right to make decisions about

treatment

THE PRINCIPLE OF AUTONOMY the right to not be treated without

one's consent to it the right to either consent or refuse

proposed treatment If a consent to a treatment is given, a

particular treatment (intervention) can be done. However, there is a possibility to withdraw such consent at any time.

ELEMENTS AND REQUIREMENTS OF THE INFORMED CONSENT A valid consent is composed out of 3

segments, that need to be present all at a time:

given by a competent person; a person has to be overly informed

about the whole procedure or process to which he is giving his consent;

needs to be given voluntarily, not under any kind of pressure

ELEMENTS AND REQUIREMENTS OF THE INFORMED CONSENT The informed consent needs to

be:1) INFORMED

a) doctorsb) patients

2) CONSENT

ELEMENTS AND REQUIREMENTS OF THE INFORMED CONSENT „INFORMED“ - doctors 2 approaches of what the „informed

consent“ is: Patient standard - a patient has the

right to know all the relevant information and details concerning his case

therapeutic privilege – right of a doctor

ELEMENTS AND REQUIREMENTS OF THE INFORMED CONSENT Professional standard - a doctor

chooses the extent of facts, information and details that are necessary to divulged to the patient

still bound by all other principles and obligations that applied to them

ELEMENTS AND REQUIREMENTS OF THE INFORMED CONSENT „INFORMED“ – patients Patient understanding - the ability of a

single human being to analyse and understand information given by a doctor

Researchers found out that a number of patients who are competent, in some cases do not fully understand to what procedure or act they have consented

Appreciation – referred to as a deep understanding – ability of evaluation of the given information

ELEMENTS AND REQUIREMENTS OF THE INFORMED CONSENT sometimes, patient understands a given

information about particular treatment, but fails to understand the exact affect on his life

ELEMENTS AND REQUIREMENTS OF THE INFORMED CONSENT TIMING – not fulfilled if information is

given immediately after a procedure or right before a procedure doctor is liable for negligence

LANGUAGE OF GIVEN INFORMATION – a translation may be needed

GIVEN BY A PROFESSIONAL – not by a stuff that is not well-exprerienced and cannot answer all patient‘s questions

 FORM OF CONSENT Depends on legislation of a particular

state 1) Express consent to treatment

a) writtenb) oral

- “consent expressed “in form only” is no consent at all.”

2) Implied consent to treatment- can be understood from patient's behaviour

Problem of signing a consent without reading it

 REFUSAL OF PROPOSED TREATMENT NO obligation for a patient to stay

healthy and to accept all treatments Adult and competent (fully or partially)

patient can refuse a treatment regardless of his reasons (even if there are none)

“It is well established in law and ethics that competent adults have the right to refuse any medical treatment, even if that refusal results in their death.”

may be done partially or in its entirety concerning certain procedure

 REFUSAL OF PROPOSED TREATMENT patient autonomy patient can revoke

his refusal at any time when he decides he wants to undergo a certain procedure or he accepts a proposed treatment

“Our present knowledge suggests that well-informed patients are less likely to refuse treatment than those who are poorly informed.”

 EXCEPTIONS CONCERNING INFORMED CONSENT In case of their appearance in a

particular situation override the right to self-determination, and a doctor's act is allowed even without obtaining consent to a treatment

1) Emergency Exception 2) Incompetence 3) A Right to Not Know and

Therapeutic Privilege of Doctor  4) Compulsory Treatment

1) EMERGENCY EXCEPTION To disclose information to a patient is

very time-consuming process for a doctor

a lack of time to inform patient a lack of time to obtain consent from a

patient a doctor may render treatment without

a prior patient's consent it is seen as an implied consent to a medical treatment

1) EMERGENCY EXCEPTION Problems:

1) Word “emergency” no certain definition of this

term generally - the urgency of the

need for medical care makes a clear ground to a situation to be sorted as an emergency situation

how urgent a situation is - consider consequences and results that may occur in case of waiting for consent to be made

1) EMERGENCY EXCEPTION

different consequences depending on how serious a situation is

- the nature, degree and duration of consequences

Each case needs to be solved ad hoc concerning above-mentioned issues

First aid to stabilize a patient may be done without a prior consent to it, but if it then becomes possible to receive consent for subsequent treatment, it is needed to be done so

1) EMERGENCY EXCEPTION Can be used in case that a doctor can

assume that the patient would normally consent to a treatment

In case „...there is strong evidence to the contrary, the physician may not override the patient's wishes.“

1) EMERGENCY EXCEPTION

2) Minimal disclosure contains a probability of

success and if the results in case of failure of a procedure are to be grave or minimal

patient is capable to give a consent to treatment and there is a little time to ask for it and explain quickly a treatment

if possible a minimal disclosure should be made

1) EMERGENCY EXCEPTION

3) Case of an Incompetent Patient general rule: if there is enough

time to obtain consent from a proxy, it is required to obtain it

no-use of emergency exception in cases of possible surrogate consent to treatment

2) INCOMPETENCE definition of word “incompetence” a legal point of view: “a determination that

the patient does not have the requisite capacities to make a medical decision.”

general incompetence holds person unable to do decisions in all cases for any purposes

specific incompetence includes only one or more (but not all) certain areas in which a person is not competent to act on his own behalf

Incompetence to make medical decisions is a specific incompetence

2) INCOMPETENCE 2 approaches if a person is fully capable to

make decisions: status approach - one's capacity of

making decisions depends on a status requirement (mostly age) regardless of a real capacity of each “child”

functional approach - composed of a one's real capability each case is judged individually

“The current position is to assume capacity unless there is strong evidence to the contrary.”

2) INCOMPETENCE “Individuals below the age of consent are

presumed to lack capacity unless shown otherwise, and those above the age of consent are presumed to have capacity until shown otherwise.”

surrogate - a person “liable” for decision-making process in the areas that patient is not competent to decide by himself

“guardian” or “proxy” guardian - a court-appointed surrogate proxy - a surrogate chosen by the patient

himself

2) INCOMPETENCE Surrogate may be:

1) somebody who is close to a patient (usually a family member); or2) a person who did not know a patient before - in this case, there is a liability for surrogate to get to know a patient more personally

choose an option that is either the best one possible for a patient, as well as the one that in case a patient would be fully competent he would choose for himself

3) A RIGHT TO NOT KNOW AND THERAPEUTIC PRIVILEGE OF DOCTOR therapeutic privilege – doctor‘s right

to not divulge all the details to patient in case that there is a strong reason to think that a disclosure of such information may result in his psychologically or physically harm or endanger his health

used mostly in case of an incurable disease

The main purpose: to “free physicians from a legal requirement which would force them to violate “primary duty” to do what is beneficial for the patient.”

3) A RIGHT TO NOT KNOW AND THERAPEUTIC PRIVILEGE OF DOCTOR Problems:

a threat of taking advantage of this doctor's right

- particular information cannot be withhold just because of possible refusal of a treatment

- in case of any disputes arisen, a burden of proof lays on a doctor (persuade that he had reasonable grounds for executing this privilege)

3) A RIGHT TO NOT KNOW AND THERAPEUTIC PRIVILEGE OF DOCTOR right of a patient to not know about

the treatment one of patient‘s right to be executed in

case he wants to patients may state they do not want to

receive the information or they do not want to decide or possibly both

to protect a person who makes such a statement

can be presented in writing or given orally

3) A RIGHT TO NOT KNOW AND THERAPEUTIC PRIVILEGE OF DOCTOR “The knowledge requirement raises the

issue of capacity. A patient must be competent to waive a right as well as to exercise one.”

does not necessarily need to have such a capacity to waive a right to treatment as it is required in case of giving consent (because it is easier to come to understand it)

has to be given freely out of person's own decision

reason of such decision: person's psychological state of mind

3) A RIGHT TO NOT KNOW AND THERAPEUTIC PRIVILEGE OF DOCTOR sexually transmitted diseases – this

right cannot be executed by a patient even though he would like to do so

purpose: to protect other people

4) COMPULSORY TREATMENT By this exception is protected:

1) health of an individual;2) society‘s interest in protecting other people

may apply only upon a previous valid court order or statute authorizing such treatment

for example: prisoners, alcohol or drug abusers or mentally ill people with dangerous infectious disease

sometimes to order a treatment over patient's religious objections

4) COMPULSORY TREATMENT It “must be potentially beneficial for the

patient but it may not be in patient's best interests as the patient defines them.”

SUMMARY Valid informed consent needs to meet all the

mentioned requirements (competent patient, overly informed patient, given voluntarily).

Consists of more partial rights: the right of patient to know all the information about a treatment the right to make decisions about treatment the right to not be treated without one's consent to it the right to either consent or refuse proposed treatment

SUMMARY Form of a consent:

Expressed (in writing or given orally) Implied

Consent, as well as, refusal and withdrawal of consent/refusal can be done at any time

Exceptions are: 1) Emergency Exception 2) Incompetence 3) A Right to Not Know and Therapeutic

Privilege of Doctor  4) Compulsory Treatment

THANK YOU FOR YOUR ATTENTION!