Review of the Saudi Guidelines for informed consent in Surgery as well as the international best practice guidelines for a better approach to Informed Consent in the Kingdom of Saudi Arabia.

1. D r. M o h a m a d A l - G a i l a n i F RC S
‫الكيالني‬ ‫محمد‬ ‫الدكتور‬
C o n s u l t a n t B r e a s t a n d G e n e r a l
S u r g e o n
‫ة‬ ‫م‬ ‫ا‬ ‫ع‬ ‫ل‬ ‫ا‬ ‫ة‬ ‫ح‬ ‫ا‬ ‫ر‬ ‫ج‬ ‫ل‬ ‫ا‬ ‫و‬ ‫ي‬ ‫د‬ ‫ث‬ ‫ل‬ ‫ا‬ ‫ة‬ ‫ح‬ ‫ا‬ ‫ر‬ ‫ج‬ ‫ي‬ ‫ر‬ ‫ا‬ ‫ش‬ ‫ت‬ ‫س‬ ‫ا‬
A L H A M M A D I H O S P I TA L
R I YA D H , K S A
‫ي‬ ‫د‬ ‫ا‬ ‫م‬ ‫ح‬ ‫ل‬ ‫ا‬ ‫ى‬ ‫ف‬ ‫ش‬ ‫ت‬ ‫س‬ ‫م‬,‫ض‬ ‫ا‬ ‫ي‬ ‫ر‬ ‫ل‬ ‫ا‬
‫ة‬ ‫ي‬ ‫د‬ ‫و‬ ‫ع‬ ‫س‬ ‫ل‬ ‫ا‬ ‫ة‬ ‫ي‬ ‫ب‬ ‫ر‬ ‫ع‬ ‫ل‬ ‫ا‬ ‫ة‬ ‫ك‬ ‫ل‬ ‫م‬ ‫م‬ ‫ل‬ ‫ا‬

2. Outline
• Concept
• History & Definition
• Principles of Care
• Requirements
• Guidelines
• Consent in KSA
• Conclusion
Dr Mohamad Al-Gailani Informed Consent.KSA 2017
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3. Consent
•Consent is derived from the latin “competens”
which means ‘coming together at one point’
being ‘fit for purpose’
•The principle of informed consent rests on the
autonomy of the patient which is explained as
being the legal embodiment of the idea that
each has the right to make decisions affecting
his/her wellbeing
Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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4. Concept
• The basis of the concept is related to self preservation and
could be considered religious in its origin
• Religions placed importance on the self-guarding of life as it is
considered a gift from God
• Islam in particular, has placed the preservation of human life
second in rank to preservation of religion
(‫يعا‬ِ‫م‬َ‫ج‬ َ‫اس‬َّ‫ن‬‫ال‬ ‫ا‬َ‫ي‬ْ‫ح‬َ‫أ‬ ‫ا‬َ‫م‬َّ‫ن‬َ‫أ‬َ‫ك‬َ‫ف‬ ‫ا‬َ‫ه‬‫ا‬َ‫ي‬ْ‫ح‬َ‫أ‬ ْ‫ن‬َ‫م‬َ‫و‬( )‫ص‬)
Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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5. History
• For centuries medicine was practiced in a very “Parental”
fashion
• The idea of obtaining a written informed consent from patients
was first introduced by Walter Reed in 1900 while he was
studying yellow fever in Cuba
• Informed consent for research however was defined by the
Nuremberg code of 1947 to ensure that the atrocities that
were committed during the second world war on human
beings in pursuit of clinical research were never repeated
Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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6. Definition
• “The voluntary and continuing permission of a competent
patient to receive a particular treatment based on an
adequate knowledge of the purpose nature and likely risks
of the treatment including the likelihood of its success and
any alternatives to it”
• Permission given under any unfair or undue pressure is not
consent
• All the elements of the above definition are important and
there are legal and practical implications attached to all of
them
Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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7. Principles of Care
• Informed consent requires time, patience and clarity of
explanation
• Discuss with patients what their diagnosis, prognosis,
treatment and care involve
• Share with patients the information they want or need in
order to make decisions
• Maximize patients’ opportunities and their ability to make
decisions for themselves
• Respect patients’ decisions
• Listen to patients and respect their views about their healthDr Mohamad Al-Gailani Informed
Consent.KSA 2017
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8. The 3 Essential Requirements for
Consent
• Voluntary: made by the person themselves and must not be influenced
by pressure from medical staff friends or family
• Informed: given all of the information; what the treatment involves,
including the benefits and risks, whether there are reasonable alternative
treatments and what will happen if treatment does not go ahead
• Capacity: capable of giving consent, which means they understand the
information given to them, and they can use it to make an informed
decision
Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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9. Lack of Capacity?
• Severe mental health condition
• Emergency situation and the person is unable to give
consent because they are unconscious or severely
unwell
• Discuss all those cases if at all possible with next of kin
• Consent signed by 2 consultants e.g. surgeon &
anaesthetist prior to emergency intervention
Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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10. Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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GMC ASGBI
Consent Guidelines

11. Royal College
Surgeons of England
• Consent should be considered informed decision making, or informed request
• It requires time, patience and clarity of explanation
• A patient’s consent should not be taken in the anaesthetic room!
• Where possible, you should provide written information to patients to enable them to
reflect and confirm their decision
• The risks inherent in the procedure, however small, the possibility of their
occurrence, side effects and complications
• The consequences of non-operative alternatives should also be explained
Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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12. The Process of Consent
• The seeking and giving of consent is usually a process, rather
than a one-off event!
• For major interventions, should be well in advance, when
there is time to respond to the person’s questions and provide
adequate information
• Check, before the procedure starts, that the person still
consents
Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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13. Consent Under Duress
• If a person is not asked to signify their consent until just
before the procedure is due to start, at a time when they may
be feeling particularly vulnerable, there may be real doubt as
to its validity!
• In no circumstances should a person be given routine pre-
operative medication before being asked for their consent to
proceed with the treatment
• A patient’s consent should not be taken in the anaesthetic
room!
Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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14. How Much Information?
• Over recent years, there has been a shift in the amount
of information given to support the consent process
• The traditional approach was for the healthcare
professional seeking consent to decide how much to
tell a patient about the risks and side-effects of
treatment
• However, the emphasis has changed in recent years,
and patients' questions must be answered honestly,
even though this might cause them anxietyDr Mohamad Al-Gailani Informed
Consent.KSA 2017
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15. Adjuncts to Consent
• Written patient information leaflets or special pre-printed
stickers attached to the consent form
• Advice on how they can obtain further information like
websites, internet or patient care organisations
• Other resources like educational videos
• Feedback from patients who had the same procedure
Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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16. Delegated Consent
• The clinician in immediate charge of the treatment should
usually be the person who seeks consent from the patient
• Delegation if person is:
A) is suitably trained and qualified
B) has sufficient knowledge of the proposed investigation or
treatment, and understands the risks involved
Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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17. Reasons For Not Sharing
Information With Patients
• No one else can make a decision on behalf of an adult who
has capacity!
• If patient does not want to know in detail about their
condition treatment, you should respect their wishes
• Record the fact that the patient has declined this information
• Provide written information and document in the consent
form
Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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18. Risk Assessment
• Clear & accurate information about the risks of any
proposed investigation or treatment, presented in a
way patients can understand, can help them make
informed decisions
• How common the risk? common, less common & rare,
or by % e.g. 1:100, 1:1000
Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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19. C o nse nt G u id e line s
KSA
Ethics of the Medical Profession
Ar ticle (2/11)
Saudi Council for Health
Specialties

20. Consent: KSA
•Guidelines related to informed consent had
been developed by the Saudi Council for
health specialties as a part of ethics of the
medical profession
•Ethics of the medical profession. Article
(2/11) of the Saudi Council for Health
Specialties Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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21. Saudi Council for Health Specialities
Obtaining Patient's Consent
• The human body and his whole being are among the
individual's own personal privacies, that no one
should deal with without his explicit consent; and in
order that a patient's consent be legally obtained
Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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22. Saudi Council for Health Specialities
Obtaining Patient's Consent
• The patient should be completely aware of the intended
medical intervention
• The physician should provide the patient with comprehensive
information about medical procedure he is about to do or
perform, and about what is required from him to do, and the
consequent risks and complications that might occur
Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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23. Saudi Council for Health Specialities
Obtaining Patient's Consent
• The patient should be capable of thoroughly comprehending
and understanding the information provided for him, so that
he may give his consent voluntarily, with complete content and
consciousness and without any deception or pressure
• The consent must be given in writing in case the physician
intends to perform an interventional procedure as in cases of
performing surgical operations, or in any other interventional
procedure such as liver biopsy
Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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24. Saudi Council for Health Specialities
Adults Consent
•Consent should be obtained from the adult
and mentally sound patient whether male or
female
•Or from his legal guardian or representative if
his consent is not legally recognizable before
any medical or surgical procedure
Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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25. Saudi Council for Health Specialities
Women’s Consent
• An adult mentally sound woman has the right to
consent to medical procedures intended to be done
on her body, including surgical operations
• Except for procedures relating to reproduction such as
usage of contraceptives, or hysterectomy or any other
procedure specifically those leading to infertility
Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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26. Saudi Council for Health Specialities
Special Cases
• Consent of a minor and the legally non-liable person
e.g. unconscious or insane the consent shall be
obtained from his legal guardian
• If it were not possible to obtain such consent and the
condition would result in grave harm or death, the
physician may proceed with the medical procedure
immediately
Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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27. Saudi Council for Health Specialities
Emergency Cases
• Consent in Emergency situations: in cases where a
patient is in peril of death or imminent serious harm
death is expected, the physician may perform the
necessary medical procedure immediately without
waiting for consent if he has reason to believe that
saving the life of the patient or prevention of serious
harm is an overweighing probability
Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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28. Consent:
KSA v UK
* A t t i t u d e s t o w a r d s i n f o r m e d c o n s e n t : a c o m p a r i s o n b e t w e e n
s u r g e o n s w o r k i n g i n S a u d i A r a b i a a n d t h e U n i t e d K i n g d o m . B a k u r
A . J a m j o o m , a i m u n A . B . J a m j o o m , m o m e n s h a r a b a n d a b d u l h a k i m
B . J a m j o o m . O m a n M e d J . 2 0 1 1 J a n ; 2 6 ( 1 ) : 2 9 – 3 3

29. Consent:
KSA V UK
•KSA surgeons look at informed consent as not
only an ethical and legal obligation but also of
benefit to patients
•Written information leaflets are provided by
only 21% of KSA surgeons compared to 47% of
their UK counterparts
Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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30. Consent:
KSA V UK
•Significantly more KSA surgeons believe that
informed consent is unnecessary because
disclosing information to patients about
potentially harmful risks may dissuade patients
from undergoing the procedure!
•This may be a reflection of a paternalistic
attitude?
Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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31. Consent:
KSA V v UK
• This may be explained because KSA surgeons are more likely
to deal with patients of a wider range of intellect, health
awareness and faith in their medical profession
• Belief that conveying serious but highly rare complications to
patients during informed consent leads to information
overload of which there is no guarantee that the patient will
retain or correctly understand the risk information
Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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32. Consent:
KSA v UK
• The amount of information KSA surgeons gave to their patients
during informed consent was significantly influenced by a
number of factors which were patient and non patient related
• These included; the patient’s age, gender, level of education,
social class, source of funding for treatment, clinical
presentation whether emergency or elective, complexity and
duration of surgery, timing of surgery, how busy the surgeon is
at the time and the need for referral to another doctor or
hospital Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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33. Consent
KSA V UK
Summary
• More doctors in KSA should become aware of the
informed consent guidelines that were developed by
the Saudi Council for Health Specialties
• The paternalistic approach to consent needs
addressing
• There is room for the introduction of formal training on
informed consent and for making written information
more widely available for doctors in KSADr Mohamad Al-Gailani Informed
Consent.KSA 2017
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34. NEW:
“Arabic” Patient Information Leaflets
‫العربية‬ ‫باللغة‬
Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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35. New: ‫جديد‬
“Arabic” Patient Information Leaflets ‫العربية‬ ‫باللغة‬
‫الجراحية‬ ‫العمليات‬ ‫ل‬‫حو‬ ‫بيانات‬-‫الكيالني‬ ‫محمد‬ ‫ر‬‫الدكتو‬
1. Laparoscopic cholecystectomy ‫المفتوح‬ ‫وبالطريق‬ ‫بالتنظير‬ ‫المرارة‬ ‫استئصال‬
2. Laparoscopic appendicectomy ‫الزائدة‬ ‫استئصال‬ ‫جراحة‬
3. Haemorrhoidectomy ‫البواسير‬ ‫جراحة‬
4. Ventral hernia repair ‫ة‬ّ‫ي‬‫البطن‬ ‫أو‬ ‫الجراحية‬ ‫الشقوق‬ ‫توق‬ُ‫ف‬ ‫الج‬ِ‫ع‬
5. Umbilical hernia repair ‫ي‬ّ‫السر‬ ‫تق‬َ‫ف‬‫ال‬ ُ‫ج‬‫ال‬ِ‫ع‬
6. Inguinal hernia repair ‫ة‬ّ‫ي‬‫رب‬ُ‫أل‬‫ا‬ ‫وق‬ُ‫ت‬ُ‫ف‬‫ال‬ ‫الج‬ِ‫ع‬
7. Epigastric hernia repair ‫الفتق‬ ‫إصالح‬‫الشرسوفي‬‫البطن‬ ‫بتنظير‬
8. Thyroid surgery ‫ق‬َ‫َر‬‫د‬‫ال‬ ‫جراحة‬
9. Colectomy for diverticular disease ‫داء‬‫الرتوج‬‫الجراحية‬ ‫والمعالجة‬
10. Colectomy for colon cancer ‫القولون‬ ‫سرطان‬ ُ‫جراحة‬
11. Breast cancer surgery ‫الثدي‬ ‫سرطان‬ ‫راحة‬ ِ‫ج‬
12. Breast wide local excision & SNB ‫ُتلة‬‫ك‬‫ال‬ ‫ئصال‬ِ‫ت‬‫اس‬‫ة‬َّ‫ي‬‫الورم‬‫وخزعة‬ ‫الثدي‬ ‫في‬
13. Breast reconstruction ‫الثدي‬ ‫بناء‬ ‫إعادة‬
14. Breast reduction ‫الثدي‬ ‫تصغير‬
15. Mammoplasty ‫الثديين‬ ‫رفع‬
Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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36. Conclusion
Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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37. Consent:
Conclusion
Consent must be voluntary, informed and with capacity
Avoid consent under duress!
Explanation of: Procedure, Risks and Benefits & Alternative
Treatments
Paternalistic approach needs changing!
Encouragement for more written patient information
More space to document potential complications on the
consent form
Dr Mohamad Al-Gailani Informed
Consent.KSA 2017
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