informed consent.ksa, 2017

I N F O R M E D C O N S E N T. K S A

( م�و��ا�ف�ق�ة )

Dr. Mohamad A l -Ga i l an i FRC S

ا�ل�ك�ي�ال�ن�ي م�ح�م�د� ا�ل�د�ك�ت�و�ر�Consu l tant B reast and Genera l

Surgeonا�ل�ج�ر�ا�ح�ة� و� ا�ل�ث�د�ي� ج�ر�ا�ح�ة� ا�س�ت�ش�ا�ر�ي�

ا�ل�ع�ا�م�ةA L H A M M A D I H O S P I TA L

R I YA D H , K S A , ا�ل�ر�ي�ا�ض ا�ل�ح�م�ا�د�ي� م�س�ت�ش�ف�ى�

ا�ل�س�ع�و�د�ي�ة ا�ل�ع�ر�ب�ي�ة� ا�ل�م�م�ل�ك�ة�

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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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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


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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 ( جميعا الناس أحيا فكأنما أحياها (ص) (ومن


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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


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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


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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 health


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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


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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


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GMC ASGBI

Consent Guidelines


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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


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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


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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!


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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 anxiety


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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


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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


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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


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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

Consent Gu ide l i nesKSA

Ethics of the Medica l Profess ion Art ic le (2 /11)

Saudi Council for Health Specialt ies


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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


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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


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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


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Saudi Council for Health SpecialitiesObtaining 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


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Saudi Council for Health SpecialitiesAdults 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


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Saudi Council for Health SpecialitiesWomen’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


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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


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Saudi Council for Health SpecialitiesEmergency Cases

• Consent in Emergency situations: in cases where a patient is in peril of death or imminent serious harm or 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

Consent :

KSA v UK

* A tti 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

http://www.ncbi.nlm.nih.gov/pubmed/?term=Jamjoom%20BA%5Bauth%5D

http://www.ncbi.nlm.nih.gov/pubmed/?term=Jamjoom%20BA%5Bauth%5D

http://www.ncbi.nlm.nih.gov/pubmed/?term=Jamjoom%20AA%5Bauth%5D



http://www.ncbi.nlm.nih.gov/pubmed/?term=Sharab%20M%5Bauth%5D



http://www.ncbi.nlm.nih.gov/pubmed/?term=Jamjoom%20AB%5Bauth%5D




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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


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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?


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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


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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


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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 KSA


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NEW: “Arabic” Patient Information Leaflets

ا�ل�ع�ر�ب�ي�ة ب�ا�ل�ل�غ�ة�


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New: ج�د�ي�د“Arabic” Patient Information Leaflets ا�ل�ع�ر�ب�ي�ة ب�ا�ل�ل�غ�ة�

ا�ل�ك�ي�ال�ن�ي ا�ل�د�ك�ت�و�ر� م�ح�م�د� ا�ل�ج�ر�ا�ح�ي�ة�-� ا�ل�ع�م�ل�ي�ا�ت� ب�ي�ا�ن�ا�ت� ح�و�ل�

1. Laparoscopic cholecystectomy المفتوح وبالطريق بالتنظير المرارة استئصال2. Laparoscopic appendicectomy الزائدة استئصال جراحة3. Haemorrhoidectomy البواسير جراحة4. Ventral hernia repair البطنية أو الجراحية الشقوق فتوق عالج5. Umbilical hernia repair السري الفتق عالج6. Inguinal hernia repair األربية الفتوق عالج7. Epigastric hernia repair البطن بتنظير الشرسوفي الفتق إصالح8. Thyroid surgery الدرق جراحة9. Colectomy for diverticular disease الجراحية والمعالجة الرتوج داء10. Colectomy for colon cancer القولون سرطان جراحة11. Breast cancer surgery الثدي سرطان جراحة12. Breast wide local excision & SNB وخزعة الثدي في الورمية الكتلة استئصال13. Breast reconstruction الثدي بناء إعادة14. Breast reduction الثدي تصغير15. Mammoplasty الثديين رفع


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Conclusion


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Consent: Conclusion

Consent must be voluntary, informed and with capacityAvoid consent under duress!Explanation of: Procedure, Risks and Benefits &

Alternative TreatmentsPaternalistic approach needs changing!Encouragement for more written patient informationMore space to document potential complications on the

consent form

informed consent.ksa, 2017

Health & Medicine