A talk delivered by Prof Faisal Ghani for 3rd year medical students at Alfarabi Medical College about the informed consent.

1. Asst. Prof. of Medical Ethics
Alfarabi Medical College
Dr. Ghaiath M. A. Hussein
Ethical, Legal & Fiqhi Issues (ELFIs)
Consent to Treatment
‫العالج‬ ‫على‬ ‫المرضى‬ ‫موافقة‬
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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
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3. What is an informed consent?
Informed consent is the process by which a fully
informed patient can freely (without undue influence)
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.
‫المتبصرة‬ ‫الموافقة‬‫العالجي‬ ‫والفريق‬ ‫المريض‬ ‫بين‬ ‫تواصل‬ ‫عملية‬ ‫هي‬
‫بعد‬ ‫وصحته‬ ‫جسده‬ ‫تخص‬ ‫التي‬ ‫القرارات‬ ‫في‬ ‫المريض‬ ‫فيها‬ ‫يشارك‬‫اطالعه‬
‫وت‬ ‫يقبلها‬ ‫وطريقة‬ ‫يفهمها‬ ‫بلغة‬ ‫له‬ ‫والمقدمة‬ ‫الكافية‬ ‫المعلومات‬ ‫على‬‫كون‬
‫الضغوط‬ ‫من‬ ‫نوع‬ ‫أي‬ ‫أو‬ ‫تهديد‬ ‫أو‬ ‫إغراء‬ ‫بأي‬ ‫متأثرة‬ ‫غير‬ ‫قراراته‬
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4. Why to Take Consent?‫العالج؟‬ ‫على‬ ‫مرضانا‬ ‫موافقة‬ ‫نأخذ‬ ‫لماذا‬
 Ethically: it reflects the ethical principle of respect of autonomy.
It establishes trust in the healthcare providers. ‫أخالقيا‬ ‫مطلوب‬
‫القرار‬ ‫اتخاذ‬ ‫في‬ ‫حقه‬ ‫احترام‬ ‫عن‬ ‫كتعبير‬
 Legally: It expresses the right of people to make informed
decisions about health treatment. It is against the law to
interfere with people’s bodies without their consent.
 ‫إذنه‬ ‫بدون‬ ‫إنسان‬ ‫جسم‬ ‫في‬ ‫التدخل‬ ‫يمنع‬ ‫النظام‬ ‫ألن‬ ‫قانونيا‬ ‫مطلوب‬
 Professionally: All guidelines and codes request healthcare
professionals to obtain their patients’ consent
 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. ‫شرعا‬
‫يحمي‬ ‫الشرع‬ ‫وألن‬ ‫العكس‬ ‫يثبت‬ ‫لم‬ ‫ما‬ ‫ليقرروا‬ ‫مؤهلون‬ ‫الناس‬ ‫أن‬ ‫هو‬ ‫األصل‬ ‫ألن‬
‫عليها‬ ‫التغول‬ ‫من‬ ‫الناس‬ ‫نفوس‬
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5. ‫السنة‬ ‫في‬ ‫المريض‬ ‫موافقة‬ ‫اشتراط‬ ‫أمثلة‬ ‫من‬
• ‫عنها‬ ‫هللا‬ ‫رضي‬ ‫عائشة‬ ‫عن‬«‫إلينا‬ ‫يشير‬ ‫وجعل‬ ‫مرضه‬ ‫في‬ ‫وسلم‬ ‫عليه‬ ‫هللا‬ ‫صلى‬ ‫هللا‬ ‫رسول‬ ‫لددنا‬" :‫ال‬
‫تلدوني‬"‫فقلنا‬:‫قال‬ ‫أفاق‬ ‫فلما‬ ‫للدواء‬ ‫المريض‬ ‫كراهية‬" :‫تلدوني‬ ‫أن‬ ‫أنهكم‬ ‫ألم‬"‫قلنا‬:‫للدواء‬ ‫كراهية‬
‫وسلم‬ ‫عليه‬ ‫هللا‬ ‫صلى‬ ‫هللا‬ ‫رسول‬ ‫فقال‬" :‫لم‬ ‫فإنه‬ ‫العباس‬ ‫إال‬ ‫أنظر‬ ‫وأنا‬ ‫لد‬ ‫إال‬ ‫أحد‬ ‫منكم‬ ‫يبقى‬ ‫ال‬
‫يشهدكم‬"»(3.)
• ‫اللدود‬ ‫أسقيناه‬ ‫أي‬ ‫لددناه‬:‫والشدق‬ ‫اللسان‬ ‫بين‬ ‫المريض‬ ‫فم‬ ‫جانبي‬ ‫أحد‬ ‫في‬ ‫يصب‬ ‫دواء‬ ‫وهو‬.
• ‫عليه‬ ‫هللا‬ ‫صلى‬ ‫الرسول‬ ‫فقد‬ ‫فلما‬‫وآله‬‫أسماء‬ ‫ومعهن‬ ‫عنهن‬ ‫هللا‬ ‫رضى‬ ‫زوجاته‬ ‫بادرت‬ ‫الوعي‬ ‫وسلم‬
‫بلده‬ ‫عميس‬ ‫بنت‬.
• ‫لكم‬ ‫أقل‬ ‫ألم‬ ‫قال‬ ‫أفاق‬ ‫فلما‬‫أالتلدوني‬‫قلن‬ ‫؟‬:‫تلد‬ ‫بأن‬ ‫فأمر‬ ‫للدواء‬ ‫المريض‬ ‫كراهية‬ ‫من‬ ‫ذلك‬ ‫أن‬ ‫ظننا‬
‫األخرى‬ ‫واحدة‬ ‫كل‬...‫أمره‬ ‫مخالفة‬ ‫على‬ ‫لهن‬ ‫عقوبة‬ ‫ذلك‬ ‫فتم‬.
• ‫معين‬ ‫عالج‬ ‫رفض‬ ‫أو‬ ‫بقبول‬ ‫المريض‬ ‫يوصي‬ ‫أن‬ ‫جواز‬ ‫ذلك‬ ‫من‬ ‫العلماء‬ ‫أخذ‬ ‫وقد‬.
• ‫في‬ ‫التداوي‬ ‫عنهم‬ ‫هللا‬ ‫رضى‬ ‫وغيرهم‬ ‫جبل‬ ‫بن‬ ‫ومعاذ‬ ‫الدرداء‬ ‫وأبو‬ ‫الصديق‬ ‫بكر‬ ‫أبو‬ ‫رفض‬ ‫وقد‬
‫الموت‬ ‫مرض‬...‫الموت‬ ‫مرض‬ ‫في‬ ‫وخاصة‬ ‫التداوي‬ ‫رفض‬ ‫في‬ ‫المريض‬ ‫حق‬ ‫ذلك‬ ‫من‬ ‫فثبت‬.
• ‫وهو‬ ‫معينة‬ ‫حالة‬ ‫الى‬ ‫المريض‬ ‫وصل‬ ‫اذا‬ ‫الطبي‬ ‫التصرف‬ ‫بنوعية‬ ‫الوصية‬ ‫شرعا‬ ‫يصح‬ ‫كله‬ ‫ولهذا‬
‫القرار‬ ‫اتخاذ‬ ‫على‬ ‫القدرة‬ ‫أو‬ ‫للوعي‬ ‫فاقد‬.
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6. (C) Patient’s Consent (Saudi Code of Ethics)
• The adult conscious patient’s permission
(consent) should be sought (whether the
patient is male or female), or from his/her
representative in case the patient is not
competent to deicide, before any medical or
surgical intervention.
• This is because the human’s body and soul are
from the person’s privacies that no one should
deal with unless with prior permission.
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7. When is Consent Needed?‫المريض؟‬ ‫إذن‬ ‫نحتاج‬ ‫متى‬
Consent would include any procedure undertaken for the purpose
of treatment : ‫بغرض‬ ‫المريض‬ ‫مع‬ ‫تدخل‬ ‫أي‬ ‫أن‬ ‫األصل‬ ‫أن‬ ‫هو‬ ‫الضابط‬
‫الضمني‬ ‫أو‬ ‫الصريح‬ ‫بإذنه‬ ‫يكون‬ ‫العالج‬
1. Anesthesia ‫التخدير‬
2. Fluid infusion ‫الوريدية‬ ‫السوائل‬ ‫إعطاء‬
3. Blood transfusion ‫الدم‬ ‫نقل‬
4. Any form of medical/ surgical treatment ‫الجراحية‬ ‫العمليات‬
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8. Conditions for a Consent to be Valid? ‫شروط‬
ً‫ا‬‫صحيح‬ ‫المريض‬ ‫إذن‬ ‫اعتبار‬
Capacity‫األهلية‬
Understand‫المعلومة‬ ‫فهم‬
Appreciate‫الخطر‬ ‫تقدير‬
Remember‫المعلومة‬ ‫تذكر‬
Communicate‫على‬ ‫القدرة‬
‫الرف‬ ‫أو‬ ‫القبول‬ ‫عن‬ ‫التعبير‬‫ض‬
Disclosure
‫المعلومات‬
Relevant information
‫المناسبة‬ ‫المعلومات‬
Understandable‫بطريقة‬
‫مفهومة‬
Without
misrepresentation or
fraud ‫تضليل‬ ‫أو‬ ‫تزييف‬ ‫بال‬
Voluntariness
‫الطواعية‬
Free from undue
influence‫عليه‬ ‫التأثير‬ ‫عدم‬
No coercion‫الضغط‬ ‫عدم‬
‫عليه‬
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9. Principles of consent
 Every person is presumed to be capable of
(a) giving or refusing consent to treatment; and
(b) making a health care directive, until the contrary is demonstrated.
 Authority to give consent includes authority to refuse
consent or revoke a consent previously given
 Every patient who is capable of giving or refusing
consent to treatment has the right
(a) to give consent or to refuse consent on any grounds, including moral
or religious grounds, even if the refusal will result in death;
(b) to select a particular form of treatment from among those proposed
by a health practitioner on any grounds, including moral or religious
grounds;
(c) to be assisted by an associate; and
(d) to be involved to the greatest degree practicable in case planning
and decision making.

10. What we should tell our patients to get their consent
‫هي‬ ‫ما‬‫المعلومات‬‫الطبي؟‬ ‫اإلذن‬ ‫أخذ‬ ‫قبل‬ ‫بها‬ ‫المريض‬ ‫إخبار‬ ‫يجب‬ ‫التي‬
Patient must receive information on the:
 Nature and the process of the intervention‫الطبي‬ ‫التدخل‬ ‫طبيعة‬
 Nature of the treatment ‫العالج‬ ‫طبيعة‬
 The diagnosis and the prognosis‫المرضي‬ ‫والتنبؤ‬ ‫التشخيص‬
 Expected benefits of the treatment ‫العالج‬ ‫من‬ ‫المتوقعة‬ ‫الفوائد‬
 Material risks of the treatment ‫العالج‬ ‫من‬ ‫المتوقعة‬ ‫والمخاطر‬
 Material and possible undesirableside effects ‫الجانبية‬ ‫اآلثار‬
‫المتوقعة‬
 Alternative course of action‫وجدت‬ ‫إن‬ ‫األخرى‬ ‫العالجية‬ ‫البدائل‬
 Possibilities, benefits and risks of alternative
interventions‫األخرى‬ ‫الخيارات‬ ‫ومخاطر‬ ‫فوائد‬
 Likely consequences of not having the treatment ‫يترتب‬ ‫قد‬ ‫ما‬
‫العالج‬ ‫عدم‬ ‫على‬
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11. (C) Patient’s Consent (Saudi Code of Ethics)
• For a patient’s consent to be considered valid; the following
conditions must apply:
1. The healthcare practitioner should present enough
information in a language that the patient can understand
2. The patient should be able to understand and appreciate the
information that he/she has been provided so that he/she
decides with full consciousness, awareness and conviction.
3. The patient’s consent should be made voluntarily without
pressure or coercion.
4. The consent should be written at the time the healthcare
practitioner will perform any intervention
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12. (C) Patient’s Consent (Saudi Code of Ethics)
• Woman’s Consent: The conscious adult woman
has the right to give consent to any medical
interventions that is related to her, including
surgical operations, except for what is related to
reproduction, like the use of family planning
methods, hysterectomy or other procedures.
• In such procedures, the acceptance of the
husband must be obtained too. In emergency and
life-threatening conditions, the woman’s consent
is sufficient.
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13. (C) Patient’s Consent (Saudi Code of Ethics)
• Incompetent Patient’s Consent If the patient cannot
give an informed consent, for example in case of
unconsciousness, or children, or the insane; his/her
legal guardian should be the person to give this proxy
consent.
• If there is potential loss of life or severe harm to the
patient, then the healthcare practitioner can do these
interventions without consent.
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14. Tips to Disclosure‫للمريض‬ ‫المعلومة‬ ‫إيصال‬ ‫قواعد‬
In carrying this information physician should:
 Avoid technical terms ‫والفنية‬ ‫الطبية‬ ‫المصطلحات‬ ‫تحاشى‬
‫المحضة‬
 Attempt to translate statistical data into everyday
probabilities‫حياته‬ ‫في‬ ‫مشاهدة‬ ‫بأشياء‬ ‫األرقام‬ ‫له‬ ‫ترجم‬
 Enquire whether patient understand the information
‫له‬ ‫مفهومة‬ ‫بطريقة‬ ‫تتحدث‬ ‫كنت‬ ‫إذا‬ ‫ما‬ ‫باستمرار‬ ‫المريض‬ ‫اسأل‬
Use language appropriate to the patient's level of
understanding in a language of their fluency ‫إليهم‬ ‫تحدث‬
‫يفهمونها‬ ‫بلغة‬
 Pause and observe patients for their reactions ‫توقف‬
‫المريض‬ ‫أفعال‬ ‫ردود‬ ‫وتابع‬
 Invite questions from the patient and check for
understanding‫لك‬ ‫فهمه‬ ‫من‬ ‫وتأكد‬ ‫ليسألك‬ ‫المريض‬ ‫ادع‬
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15. ‫الطبي‬ ‫لإلذن‬ ‫الضابطة‬ ‫الشرعية‬ ‫القواعد‬
•‫مبدأ‬ ‫للتصرفات‬ ‫المنظمة‬ ‫المبادئ‬ ‫من‬ ‫إن‬(‫الحق‬)‫ف‬ ‫أو‬ ‫للعباد‬ ‫كان‬ ‫إن‬ ‫السيما‬‫ملكهم‬ ‫ي‬
‫بمبدأ‬ ‫الصلة‬ ‫شديد‬ ‫وهو‬(‫اإلذن‬)‫الشارع‬ ‫إلى‬ ‫يرجع‬ ‫أن‬ ‫إما‬ ‫واإلذن‬ ‫الحق‬ ‫من‬ ‫وكل‬
(‫هللا‬ ‫حق‬)‫و‬(‫الشرعي‬ ‫اإلذن‬)‫اإلنسان‬ ‫إلى‬ ‫أو‬(‫العبد‬ ‫حق‬)‫و‬(‫المالك‬ ‫إذن‬)
•‫يعا‬ ‫أن‬ ‫بموجبه‬ ‫الطبيب‬ ‫يتعهد‬ ‫والمريض‬ ‫الطبيب‬ ‫بين‬ ‫عقد‬ ‫الطبي‬ ‫اإلذن‬‫المريض‬ ‫لج‬
‫الطب‬ ‫أهل‬ ‫عند‬ ‫عليها‬ ‫المتعارف‬ ‫األصول‬ ‫وفق‬.
•‫مج‬ ‫بمجرد‬ ‫العقد‬ ‫يتم‬ ‫بل‬ ‫والقبول‬ ‫اإليجاب‬ ‫وجود‬ ‫العقد‬ ‫لصحة‬ ‫يشترط‬ ‫وال‬‫يء‬
‫يتص‬ ‫أن‬ ‫للطبيب‬ ‫يجوز‬ ‫ال‬ ‫ولهذا‬ ‫له‬ ‫نفسه‬ ‫وتسليم‬ ‫الطبيب‬ ‫إلى‬ ‫المريض‬‫جسد‬ ‫في‬ ‫رف‬
‫حاالت‬ ‫في‬ ‫إال‬ ‫إذنه‬ ‫بغير‬ ‫المريض‬.
•‫وس‬ ‫الغير‬ ‫خصوصية‬ ‫على‬ ‫اعتداء‬ ‫ألنه‬ ‫الحرمة‬ ‫أصل‬ ‫على‬ ‫يبقى‬ ‫ذلك‬ ‫عدا‬ ‫وما‬‫دا‬
‫إذن‬ ‫غير‬ ‫من‬ ‫ونحوه‬ ‫الفحص‬ ‫عن‬ ‫تنتج‬ ‫قد‬ ‫التي‬ ‫الفساد‬ ‫لذريعة‬.
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16. When consent isn't needed
‫إذن‬ ‫نحتاج‬ ‫ال‬ ‫متى‬(‫من‬ ‫كتابي‬)‫المريض؟‬
• It may not be necessary to obtain consent if a person:
• requires emergency treatment to save their life, but
they're incapacitated ‫للحياة‬ ‫المنقذ‬ ‫الطارئ‬ ‫التدخل‬ ‫حاالت‬ ‫في‬
• immediately requires an additional
emergency procedure during an operation – ‫حدوث‬
‫الجراحية‬ ‫العمليات‬ ‫اثناء‬ ‫طارئ‬
• with a severe mental health condition – such
as schizophrenia, bipolar disorder or dementia –
‫وليه‬ ‫من‬ ‫اإلذن‬ ‫يؤخذ‬ ‫وعندها‬ ‫الشديد‬ ‫النفسي‬ ‫أو‬ ‫العقلي‬ ‫االختالل‬
• is a risk to public health (notifiable disease) ‫عن‬ ‫اإلبالغ‬
‫عنها‬ ‫التبليغ‬ ‫الواجب‬ ‫االمراض‬
• Complementary procedures ‫الكشف‬ ‫أثناء‬ ‫المكملة‬ ‫اإلجراءات‬
‫المريض‬ ‫على‬(‫الدم‬ ‫ضغط‬ ‫قياس‬ ‫مثل‬)
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17. Challenges to informed consent
• Doctors’ paternalism (doctors know best)
• Uncertainties about many medical conditions
• Difficulty in explaining/translating some
medical information
• Telling how much information is enough
• Some patients prefer verbal consents & refuse
to sign forms
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