Ethics and Informed Consent Lecture

ETHICS AND CONSENT
HISTORY
Medical ethics traces its roots back as far as ancient Greece, but the
field gained particular prominence in the late 20th century.
The examination of moral issues in medicine largely began with the

Greeks in the 4th century. Hippocrates offers the following, “As to
diseases, make a habit of two things—to help and not to harm.”
Thomas Percival( British Physician-1803) urged a level of care and

attention that would “inspire the minds of their patients with
gratitude, respect, and confidence.”
In contemporary bioethics, the idea of autonomy- the right of

individuals to determine their own fates and live their lives the way
they choose has been of central importance in this tradition.
The American Medical Association (AMA-1847), issued its own code of

ethics, stating, “A physician shall be dedicated to providing
competent medical service with compassion and respect for human
dignity
The inhumane research by Nazi doctors in Germany on Jews and other

prisoners during the 2nd World War marked the beginning of modern
medical ethics. The international war crimes tribunal at Nürnberg
produced a document, which came to be called the Nuremberg Code,
stressed the importance of voluntary, informed consent of subjects in
well-designed experimental procedures that would aid society
without causing undue suffering or injury.
The American philosopher Tom Beauchamp (1970) introduced the

‘Four Principles Approach’. In this system decisions are made by
weighing the importance of four separate elements:
Respecting each person’s autonomy and their right to their own decisions
and beliefs;
The principle of beneficence, helping people as the primary goal; the

related principle of nonmalificence,
Refraining from harming people;

Justice, distributing burdens and benefits fairly.
INTRODUCTION
"Doctor knows best”
Traditional practice based on the theory that "doctor knows best”
AUTONOMY
The RIGHT of patients to decide about proposed medical interventions in
consultation with the physicians.
PARTNERSHIP
Decision-making power or authority is increasingly seen as something to be
shared by equal partners in the physician-patient
RESPECT
Personal values affect health care decisions, and physicians have a duty to
respect the autonomy, rights, and preferences of their patients and their
surrogates.
DEFINITION
What is informed consent?
• A process by which fully informed patients can participate in choices

about their health care.
• It originates from the legal rights of patients to direct what happens to
them and from the ethical duty of the doctor to involve the patient in their
health care.
GOAL
“Provide information, explanation and comprehensive understanding of the

clinical situation, and the timely exercise, by the patient, of active choices
regarding the circumstance, so the patient has an opportunity to be an informed
participant in his health care decisions.”
Types of Consent
1. Implied. Examples include routine tests such as blood tests, x-rays and
urinalyses. While implied consent to such tests is a variation of consent, it
is rarely informed.
2. Express. A patient may state thoughts or feelings in words for
examination and treatment. Differing recollection may lead to conflicting
testimony at a trial.
3. Informed. For complete written consent the doctor must discuss the
treatment or procedure with the patient and obtain a signed consent.
The Elements of Consent
1. Patient must have capacity to consent
• Determine the patient's capacity to consent to the proposed treatment.

• Capacity is defined as mental capacity.
• The physician is entitled to assume that a patient is capable unless there
are reasonable grounds to believe otherwise.
• The physician may not assume a patient is incapable just because of age,
disability or a psychiatric or neurological diagnosis, although such factors
may be relevant in the assessment of capacity.
The legislation states:
“A person is capable with respect to a treatment, admission to a care facility or a

personal assistance service if the person is able to understand the information that
is relevant to making a decision about the treatment, admission or personal
assistance service, as the case may be, and able to appreciate the reasonably
foreseeable consequences of a decision or a lack of decision”.
A person who is capable of providing consent is also capable of withdrawing

consent to treatment.
2. Consent must be related to treatment
'Treatment' is defined in the legislation as: "anything that is done for a

therapeutic, preventive, palliative, diagnostic, cosmetic or other health-related
purpose, research [and] includes a course of treatment or plan of treatment…"
• Nature of the disease or condition

• Nature of proposed diagnostic steps and/or treatment(s)
• Material elements of the proposed treatment
• Probability of success
• Nature of the risks involved and potential benefits
• Recommend alternative treatments (including the choice of no treatment).
• Prognosis without treatment
• Any other important factors
3. Consent must be informed
The patient's decision to consent to (or refuse) treatment must be informed;

that is, the patient must receive information about the nature of the proposed
treatment, its expected benefits, the material risks, special risks or material side
effects associated with it, alternative courses of action and likely consequences of
not having the treatment.
The information provided to the patient about such matters must be the
information a reasonable person in the same circumstances would require in
order to make a decision about the treatment. As well, the person must have
received responses to his or her requests for additional information about those
matters.
4. Consent must be voluntary
Freedom to choose medical alternatives without coercion or manipulation.
5. Consent must not be obtained through fraud or misrepresentation
This condition is self-explanatory.

Evidence of Consent
Although the Act states that consent to treatment may be express or implied,
physicians are strongly advised to obtain express consent from the patient and
to document the process of doing so.
Physicians should be aware that the critical element of the consent process is
the explanation given to the patient and the dialogue between physician and
patient around the proposed treatment.
Signed consent forms are simply documentary confirmation that the consent
process has been followed, and the patient has agreed to the proposed
treatment.
Documentation of consent discussions in the patient's chart by the physician is

also important evidence that the process has been followed.
What are the elements of full informed consent?
• the nature of the decision/procedure

• reasonable alternatives to the proposed intervention
• the risks, benefits, and uncertainties related to each alternative
• assessment of patient understanding
• the acceptance of the intervention by the patient
How much information is considered "adequate"?
1. Reasonable physician standard: What would a typical physician say about

this intervention? Based upon reasonable medical judgment of the doctor.
2. Reasonable patient standard: What would the average patient need to know
in order to be an informed participant in the decision? This asks whether
the doctor disclosed risks that a reasonable person would find important
for making an informed decision.
3. Subjective standard: what would this patient need to know and understand
in order to make an informed decision?
What sorts of interventions require informed consent?
• All invasive procedures including surgery and anaesthesia

• For a wide range of decisions, written consent is neither required
nor needed
When is it appropriate to question a patient's ability to participate in decision

making?
Generally you should assess the patient's ability to:
• understand his or her situation,

• understand the risks associated with the decision at hand, and
• communicate a decision based on that understanding.
Whenever this is unclear, a psychiatric consultation can be helpful
What should occur if the patient cannot give informed consent?
• If the patient is incapacitated/incompetent, a surrogate decision maker must speak for

him.
• There is a specific hierarchy of appropriate decision makers defined by law.
• If no appropriate surrogate decision maker is available, the physicians are expected to
act in the best interest of the patient until a surrogate is found or appointed.
These include in a ranking order and act in a person's best interests:
1. Personal care guardian

2. Attorney for personal care
3. Representative appointed by Consent and Capacity Board
4. Spouse or partner
5. Child or parent or individual/agency entitled to give or refuse consent instead of parent
6. Parent with right of access only
7. Brother or sister
8. Any other relative
9. Public Guardian and Trustee
What is the scope of consent? Generally, limited to specific procedure.
Extending. Caution advised when treatment exceeds the scope of consent
1. General Consent. When a patient consents to treatment of a CONDITION rather

than a specific procedure, the scope of treatment involves all measures reasonably
necessary to treat the condition.
2. Unexpected Circumstances. When an unexpected condition arises while performing a
consented procedure and the patient is unable to grant consent, the doctor must use
medical JUDGEMENT to decide on the appropriate action. If time allows the doctor
should consult the FAMILY or other LEGAL representative
Limiting
1. Limited to a particular procedure or prohibit a particular procedure.

2. Except in emergency, the doctor is bound by these limits.
3. The doctor should try to convince the patient to forgo such limitations when in his medical
judgment such procedure might be necessary.
Who May consent?

• The law presumes that patients 18 and over are competent to give consent
to treatment.
• For minors the doctor must look to the parents or legal guardian for
consent.
• Substituted consent must also be sought for incompetent adults and for
those whose judgment is impaired by their condition or medication.
.Exceptions:
(a) Waiver
• A patient waives his right to be informed or involved in decisions
regarding either his standard health care or his participating in
research.
• A patient may choose to delegate decision making to the physician.
• In other cultures, delegation of such authority to a community
leader may be the norm.
• Patients request to waive disclosure on any or all of the items above
must be treated with care and accepted only in writing.
(b)Emergency
• When life threatening demand immediate treatment and the patient is
unable to consent and time is not available to involve any other person
to be contacted for substituted consent the doctor may proceed
without consent.
• He should however carefully document the emergency and any
attempts to obtain alternative consent.
• The Act states that "there is an emergency if the person for whom the
treatment is proposed is apparently experiencing severe suffering or is at
risk, if the treatment is not administered promptly, of sustaining serious
bodily harm."
(c) Therapeutic privilege
If disclosure would result in actual physical or emotional harm to the
patient, jeopardize treatment or result in an unreasonable choice of non
treatment then the doctor may use reasonable medical judgment to restrict
disclosure.

Ethics and Informed Consent Lecture

Uploaded by

Copyright:

Available Formats

Ethics and Informed Consent Lecture

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Ethics and Informed Consent Lecture

Uploaded by

Copyright:

Available Formats

ETHICS AND CONSENT

The examination of moral issues in medicine largely began with the

Thomas Percival( British Physician-1803) urged a level of care and

In contemporary bioethics, the idea of autonomy- the right of

The American Medical Association (AMA-1847), issued its own code of

The inhumane research by Nazi doctors in Germany on Jews and other

The American philosopher Tom Beauchamp (1970) introduced the

The principle of beneficence, helping people as the primary goal; the

Refraining from harming people;

What is informed consent?

• A process by which fully informed patients can participate in choices

“Provide information, explanation and comprehensive understanding of the

The Elements of Consent

1. Patient must have capacity to consent

• Determine the patient's capacity to consent to the proposed treatment.

The legislation states:

“A person is capable with respect to a treatment, admission to a care facility or a

A person who is capable of providing consent is also capable of withdrawing

'Treatment' is defined in the legislation as: "anything that is done for a

• Nature of the disease or condition

3. Consent must be informed

The patient's decision to consent to (or refuse) treatment must be informed;

4. Consent must be voluntary

Freedom to choose medical alternatives without coercion or manipulation.

5. Consent must not be obtained through fraud or misrepresentation

This condition is self-explanatory.

Documentation of consent discussions in the patient's chart by the physician is

What are the elements of full informed consent?

• the nature of the decision/procedure

How much information is considered "adequate"?

1. Reasonable physician standard: What would a typical physician say about

• All invasive procedures including surgery and anaesthesia

When is it appropriate to question a patient's ability to participate in decision

Generally you should assess the patient's ability to:

• understand his or her situation,

Whenever this is unclear, a psychiatric consultation can be helpful

What should occur if the patient cannot give informed consent?

• If the patient is incapacitated/incompetent, a surrogate decision maker must speak for

These include in a ranking order and act in a person's best interests:

1. Personal care guardian

Extending. Caution advised when treatment exceeds the scope of consent

1. General Consent. When a patient consents to treatment of a CONDITION rather

1. Limited to a particular procedure or prohibit a particular procedure.

Who May consent?

You might also like