Saudi Commission for Health

Specialties

Professionalism and Ethics Education for

Residents (PEER)

Consent to
Treatment
Ethical, Legal & Fiqhi
Issues

Dr. Ghaiath M. A. Hussein

Asst. Prof., Dept. of Medical Ethics

King Fahad Medical City Faculty of Medicine
King Saud Bin Abdul-Aziz University for Health

Outline
What is an informed consent to treatment?
What is the elf basis to consent?
What makes the consent an ethically valid one?
Types of Consent
When it is needed? When could it be waived?
How to take an informed consent?
What if the patient is not able to give consent?
Documentation of Consent
Special Issues about Consent

CASE
Mrs. Cope, the 42-year-old woman with insulindependent diabetes, is brought by her husband to
the emergency department. She is stuporous, with
severe diabetic ketoacidosis and pneumonia.
Physicians prescribe insulin and fluids for the
ketoacidosis and antibiotics for the pneumonia.
Although Mrs. Cope was generally somnolent, she
awoke while the IV was being inserted and stated
loudly: "Leave me alone. No needles and no
hospital. I'm OK."
Her husband urged the medical team to disregard
the patient's statements, saying, "She is not
herself."

What is an informed
onsent?
Informed consent is the process by which a fully
informed patient can participate in choices about
his/her health care.
Informed consent is a consent obtained freely,
without threats or improper inducements, after
appropriate disclosure to the patient of adequate
and understandable information in a form and
language understood by the patient.

Why to Take Consent?

Ethically: it reflects the ethical principle of
respect of autonomy.
Legally: It expresses the right of people to make
informed decisions about health treatment.
Fiqhi: In Shariah, every adult has his/her
competence (Zimma) to take permissible
(Mobah) decisions related to his/her life, unless
there are genuine causes to assume the
opposite.

When is Consent Needed?

Consent would include any procedure
undertaken
for the purpose of treatment :
1. Diagnosis
2. Anesthesia
3. Fluid infusion
4. Blood transfusion
5. Any operation
6. Any form of medical/ surgical treatment

What is the Treatment

that
Needs Consent?

Anything that is done for a therapeutic, preventive,

palliative, diagnostic, cosmetic, or
Other health related purpose by any health
practitioner (doctor, nurse, physiotherapist, etc.),
and
Includes a course of treatment or plan of treatment.

Conditions for a Consent to

be Valid?

Conditions for a Consent to

be Valid?

"Disclosure" refers to the provision of relevant

information by the clinician and its comprehension by the
patient.

"Capacity" refers to the patient's ability to understand

the relevant information and to appreciate those
consequences of his or her decision that might reasonably
be foreseen.

"Voluntariness" refers to the patient's right to come to a

decision freely, without force, coercion or manipulation.

It must not be obtained through misrepresentation or

fraud

1- Capacity

Presumption of Capacity
A patient is presumed to be capable unless a health
practitioner (e.g., doctor, nurse, physiotherapist)
has reasonable grounds to believe the patient is
incapable to consent to the specific treatment
they are proposing.
Give examples of reasonable grounds to doubts a
patients capacity?

Conditions to Capacity
A person is capable under the if:
1. They are able to UNDERSTAND
.The condition from which the treatment is proposed.
.The nature of the proposed treatment.
.The risk and benefits of the proposed treatment.
.The alternatives of the treatment presented by the
health practitioner including the alternative of not
having the treatment.

Conditions to Capacity Cont

A person is capable under the if:

2. They are able to APPRECIATE the reasonably

foreseeable consequences of a decision or lack of
decision by:
Acknowledge how the recommended treatment may
affect them.
Assessing how the proposed treatment and
alternatives,
including the alternative of not having the
treatment, could
affect their quality of life.
Their choice of treatment, is not substantially based
on
delusional belief.
Findings from the capacity
should
be
As per theassessment
Health Care Consent
Act of Canada

CASE
Mrs. Cope, the 42-year-old woman with insulindependent diabetes, is brought by her husband to
the emergency department. She is stuporous, with
severe diabetic ketoacidosis and pneumonia.
Physicians prescribe insulin and fluids for the
ketoacidosis and antibiotics for the pneumonia.
Although Mrs. Cope was generally somnolent, she
awoke while the IV was being inserted and stated
loudly: "Leave me alone. No needles and no
hospital. I'm OK."
Her husband urged the medical team to disregard
the patient's statements, saying, "She is not
herself."

DISCUSSION
Mrs. Cope has an acute crisis (ketoacidosis and pneumonia)
superimposed on a chronic disease (Type I Diabetes) and she
demonstrates progressive stupor during a two-day period.
At this time, she clearly lacks decisional capacity, although
she could make
decisions two days prior to the onset of her illness, and she
could possibly
make her own decisions again when she recovers from the
ketoacidosis,
probably within the next 24 hours.

Discussion Cont.
At this moment, it would be unethical to be guided
by the demands of a stuporous individual who lacks
decision-making capacity. The cause of her mental
incapacity is known and is reversible.
Physicians and surrogate concur on the patient's
incapacity and are agreed on the course of
treatment in accordance with the patient's best
interest. The physicians would be correct to be
guided by the wishes of the patient's surrogate, her
husband, and to treat Mrs. Cope over her
objections.

2- Disclosure

Disclosure
Patient must receive information on the:
Nature and the process of the intervention
Nature of the treatment
The diagnosis and the prognosis
Expected benefits of the treatment
Material risks of the treatment
Material and possible undesirableside effects
Alternative course of action
Possibilities, benefits and risks of alternative

interventions
Likely consequences of not having the treatment

18

Tips to Disclosure
In carrying this information physician should:
Avoid technical terms
Attempt to translate statistical data into everyday
probabilities
Enquire whether patient understand the information
Interpret other information that patient has to
ascertain its
relevance
Use language appropriate to the patient's level of
understanding
in a language of their influency
Pause and observe patients for their reactions
Invite questions from the patient and check for
understanding

Comprehension
Invite the patient to share fears, concerns, hopes
and
expectations
Watch for patients' emotional response: verbal and
non-verbal
Show empathy and compassion
Summarize the imparted information
Provide contact information (and other resources)
Explanation should be given clearly and simple
questions asked
to assess understanding
Written instructions or printed materials should be
provided
CD or video given if necessary

3- Voluntariness

Voluntariness:
Refers to a participants right to make treatment decisions free of
any undue influence.
Influences include:
Physical restraint or sedation
Coercion involves the use of explicit or implicit threat to ensure that
the treatment is accepted
Manipulation involves the deliberate distortion or omission of
information in an attempt to induce the patient to accept a
treatment
Undue financial payment
Undue influence (Emotional?)
Fear of injury
Misconception of fact
22

Documentation of
Consent

Documentation of Consent
A consent may be expressed or implied
Example: A patient may imply consent to have a lacerated arm
sutured as proposed by the physician, by holding out the
arm, but the consent must be documented in the
progress note by the health practitioner obtaining
it,
e.g., Mr. Smith agreed to sutures.
The rule is that consent to treatment should be written and
reported in the patients record, except when this is not
possible.

Consent in Special Conditions

(Incompetent Patients)

Who May not be Able to

Consent?
Emergency
Children (& adolescents?)
Alcohol or substance abuse
Mentally disabled
Others?

Consent and Refusal of

Treatment for Incompetent
Adults and Children

Consent for children

Competent children can consent to treatment
but cannot refuse treatment. The consent of
one parent is sufficient if the other one
disagrees. Parental choice takes precedence
over the child's choice.
Life-saving treatment of minors is given even if
parents refuse. Parental choice is final in
therapeutic or non-therapeutic research on
children.
Advocacy Centre for the Elderly 2010

27

Consent and Refusal of

Treatment for Incompetent
Adults and Children Cont.
Consent for children Cont.
Assent: A childs affirmative agreement to
participate (without meeting all of the full
consent elements)
The mere failure to object, absent affirmative
agreement, should not be construed as assent.

Advocacy Centre for the Elderly 2010

28

Consent and Refusal of

Treatment for Incompetent
Adults and Children
Mental Patients
Mental patients cannot consent to treatment,
research, or sterilization because of their
intellectual incompetence. They are admitted,
detained and treated voluntarily or involuntarily for
their own benefit, in emergencies, for purposes of
assessment if they are a danger to themselves, or
on a court order. Suicidal patients tend to refuse
treatment because they want to die.

Consent and Refusal of

Treatment for Incompetent
Adults and Children
The unconscious
For patients in coma proxy consent by family
members can be resorted to. If no family members
are available, the physician does what he as a
professional thinks is in the best interest of the
patient.

Advocacy Centre for the Elderly 2010

30

Consent and Refusal of

Treatment for Incompetent
Adults and Children
Obstetrics
Labor and delivery are emergencies that require
immediate decisions but the woman may not be
competent and proxies are used. Forced medical
intervention and caesarean section may be ordered in
the fetal interest. Birth plans can be treated as an
advance directive.

Advocacy Centre for the Elderly 2010

31

General Challenges to PatientPhysician Communication

Time constraints
Language differences
Mismatch of agendas
Lack of teamwork
Discomfort with strong emotions
Quality of physician training
Resistance to change habits
Buckman (1984), Ford et al (1994), Buss (1998)

Advocacy Centre for the Elderly

2010

32

Watch the Differences on How

we Make Decisions
The Patient
Values and priorities
Culture
Religious beliefs
Desire for
information and
control personality
and
coping style
Roles: spouse,
parent,
child, provider
Degrees of
dependence

The Health Care

Professional
Education
knowledge
experience
communication style
values and priorities
demographic profile
( e.g. gender, age )

Difficulties With Informed

Consent
Many studies reveal that physicians consistently fail to
conduct ethically and legally satisfactory consent
negotiation.
Physicians may be having the following
problems
1.
Use of technical language
2.
Uncertainties intrinsic to all medical
information
3.
Worried about harming or alarming the patient
4.
Hurried and pressed by multiple duties

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Take home message

Informed consent is a process of
communication
between a clinician and a Patient/Patient
Representative.
It is not simply a matter of obtaining a
patient's
signature on a consent form.

References
Presentation by : Prof. Omar Kasule
Dr. Datuk Dr. Ahmad Tajudin Jaafar
Health Care Consent and Advance Care Planning Getting it Right, by: Judith Wahl, B.A., LL.B. &
Barrister and Solicitor - Advocacy Centre for the
Elderly
Consent and assent in the adolescent and young
adult with cancer by: Conrad Fernandez MD, FRCPC