Series of lectures I gave for the PEER (Professionalism and Ethics Education for Residents) Project sponsored and organized by the Saudi Commission for Health Specialties (SCHS). 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

1. Asst. Prof., Dept. of Medical Ethics
King Fahad Medical City – Faculty of Medicine
King Saud Bin Abdul-Aziz University for Health Sciences
Dr. Ghaiath M. A. Hussein
Professionalism and Ethics Education for Residents (PEER)
Ethical, Legal & Fiqhi Issues
Consent to Treatment

2. 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

3. CASE
 Mrs. Cope, the 42-year-old woman with insulin-dependent
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."

4. 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.

5. 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.

6. 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

7. 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.

8. Conditions for a Consent to be Valid?
Capacity
Understand
Appreciate
Remember
Communicate
Disclosure
Relevant information
Understandable
Voluntariness
Free from undue
influence
No coercion

9. 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

10. 1- Capacity

11. 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 doubt’s a patient’s
capacity?

12. 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.

13. Conditions to Capacity Cont…
A person is capable under the if:
As per the Health Care Consent Act of Canada
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 assessment should be
documented in the progress notes as the time of each consent
process.

14. CASE
 Mrs. Cope, the 42-year-old woman with insulin-dependent
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."

15. 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.

16. 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.

17. 2- Disclosure

18. 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

19. 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

20. 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

21. 3- Voluntariness

22. Voluntariness:
Refers to a participant’s 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

23. Documentation of Consent

24. 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 patient’s record, except when this is not possible.

25. Consent in Special Conditions
(Incompetent Patients)

26. Who May not be Able to Consent?
 Emergency
 Children (& adolescents?)
 Alcohol or substance abuse
 Mentally disabled
 Others?

27. 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

28. Consent and Refusal of Treatment for
Incompetent Adults and Children Cont.
Consent for children Cont.
Assent: A child’s 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

29. 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.

30. 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

31. 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

32. Advocacy Centre for the Elderly
2010
32
General Challenges to Patient-Physician
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)

33. Watch the Differences on How we Make
Decisions
The Patient The Health Care Professional
 Values and priorities
 Culture
 Religious beliefs
 Desire for information and
control personality and
coping style
 Roles: spouse, parent,
child, provider
 Degrees of dependence
upon and trust in the
professional
 Education
 knowledge
 experience
 communication style
 values and priorities
 demographic profile
( e.g. gender, age )

34. 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

35. •
•
•
•

36. 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.

37. 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