‫الدليل السعودي لإلذن الطبي‬

Saudi Guidelines
for Informed
Consent

First Edition
1440H (2019G)
 Saudi Guidelines for Informed Consent 1

Index:
A Letter from the Ministry of Health 3

Introduction 4

Acknowledgment 6

Working Team 6

Vision , mission, goals 9

Definitions 9

Informed Consent’s Definition 14

Types of informed Consent 15

Guardianship of the Minor and Persons Lacking Legal Capacity 16

Guardianship Expiration 18

Delegation and Authorization of Informed Consent to Others 19

Informed Consent Parties: The roles and responsibilities 20

Informed Consent Special Cases 22

Informed Consent Documentation 29

Validity of Forms Signature 32

Informed Consent Forms 33

Simplified Form to Unify Informed Consent Process Within the Facility 72

Appendix (1) 79

References 82
2 Saudi Guidelines for Informed Consent

A Letter from the Ministry of Health:

As it is the concern of the Ministry of Health (MOH) in the Kingdom of
Saudi Arabia to improve the patient experience through the provided
health services and to increase the satisfaction level, they ensured to
take on improvement projects and initiatives based on the global best
practices in the healthcare field. Since we believe in the importance
of empowering and involving patients with the treatment plan and
dealing with it in line with the vision and in a way that ensures quality
improvement and increases performance, we developed the Saudi
informed Consent Guide which will significantly contribute to preserving
the patient and family rights, and the practitioner as well as health
care providers.
The need of developing this guide comes from the demand of involving
patients or their representatives in many procedures and decisions
related to their health condition, which will help to find radical solutions.
Accordingly, this will have a massive impact on the increase in the
satisfaction level of the health services and quality improvement at
different health sectors around the kingdom.
 Saudi Guidelines for Informed Consent 3

Introduction:
The Saudi Guidelines for Informed Consent emanates from an initiative
adopted by the Patient Experience Center at the Ministry of Health,
in cooperation with the Saudi Patient Safety Center approved by the
Minister of Health Dr. Tawfiq Al-Rabiah, and participation of a group
of physicians, health practitioners and administrators who have the
experience in health care, patient rights and Sharia issues related to
the informed consent.
This guide aims to preserve the patient, family rights on the one hand,
and the healthcare practitioner and provider on the other hand. The
need to develop this guide is that many procedures require engaging
the patient, his guardian, or his representative in the health decision-
making regarding their health status. It is also considered a parallel step
of the progress and diversity of the health services provided with KSA.
Furthermore, it is an evidence of the country›s eagerness to protect
human rights in event of wellbeing or sickness, while implementing
the tolerant Islamic law regarding litigation between the patient and
the healthcare provider in case of a medico-legal complaint or a claim
of medical error.
The patient’s condition, eligibility, and ability to give consent at the time
is taken into consideration, or if there is a medical excuse, which may
require patient’s representative or not. In all conditions, the patient’s
interest always comes first. Efforts and alternatives, if any, are made
available to the patient to alleviate their suffering, and the opportunity
for him to choose with conviction and transparency, which helps
-God willing - providing smooth healthcare and raise the satisfaction
level of the patient and their family while allowing them to participate in
the treatment planning as recommended in the latest global healthcare
approaches.
This guideline also provides a comprehensive and simple reference
that can be learned easily to tackle complex medical practice issues.
4 Saudi Guidelines for Informed Consent

Acknowledgment:
The Patient Experience Center thanks the First Health Cluster in
Riyadh, represented by King Saud Medical City, for participating in
reviewing the translation and proofreading of the guide.
The Patient Experience Center extends its sincere thanks to the
Saudi Center for Patient Safety, especially the Director-General of the
Saudi Center for Patient Safety, Dr. Abdullah Hawsawi, and all those
who participated in this work and helped in preparing and releasing
the Saudi Guidelines for Informed Consent, and we also thank all
members of the Committee.
 Saudi Guidelines for Informed Consent 5

Working Team:

The team consists of an elite group of physicians, health practitioners, and administrators with experience
in health care field, patient rights, and sharia matters related to the informed consent. The team has long
and varied experiences in the research methodology. Saudi Guidelines for Informed Consent included the
study of the status quo and access to international experiences in the informed consent. Accordingly, they
developed and modified the guidelines and it will be applied to health services provided by the Ministry of
Health and the private health sector in KSA. It can also be applied to all health care facilities in KSA.

Dr. Abdullah Mohammed Hawsawi Director General of the Saudi Center for Patient Safety

Ms. Eman Mohammed Alturaiki Director General of the Patient Experience Center

Professor and consultant, Family and Community Medicine,

Prof. Jamal Saleh AL-Jarallah King Saud University, and Chairman of the Clinical Ethics
Committee at King Saud University Medical City

Consultant and head of infertility and In-vitro Fertilization, King

Prof. Saad Hamad AL-Hassan
Faisal Specialist Hospital

Dr. Ahmed Saleh Saber Director of Development, Patient Experience Center

Pediatric Intensive Care Consultant, Facility Accreditation

Dr. Ahmed Safwat AL-Assal
Officer at Ministry of Health

Anesthesia and Neurological Intensive Care Consultant,

Dr. Saleh Abduallah AL-Khunayn
Prince Sultan Military Medical City

Dr. Abdul Hamid Abdul Mohsen AL- A pediatrician consultant at the Maternity and Children
Bunyan Hospital in Al-Ahsa

Obstetrics and Gynecology Consultant and patient experience

Dr. Fatimah Yousef Al-Jawan
expert

Consultant Neonatologist, Hospital Surveyor, Saudi Central

Dr. Fahad Shoja’ AL-Harbi
Board for Accreditation of Healthcare Institutions

Chairman of the Scientific and Professional Council of Saudi

Dr. Nofel Abdullah AL-Jaryan
Commission for Health Specialties

Consultant in neurological diseases- Intensive Care -

Dr. Faisal Abdul Rahman AL-Suwaidan
neurological intensive care, King Fahad Medical City

Mr. Ibrahim Mubarak Bal-Harith Director of Nursing Department, Najran district

Former Director of Patient Safety Programs and Collaboration

Ms. Shorouq Yahya Zakaria
Department

Director of Academic Affairs and Training Department in Al-

Mr. Mohammed Saud AL-Omar
Ahsa

Director of Medical Records Department at the Ministry of

Mr. Mushabab Abduallah Asiri
Health

Ms. Abeer Ogab Abn Abood Legal Specialist in Patient Safety center
6 Saudi Guidelines for Informed Consent

Vision:
Saudi Guidelines for Informed Consent is issued to raise awareness by
engaging patients, and their families in the health care according to our
tolerant Sharia and international standards to be used as guidelines in
all health institutions in KSA regions.

Mission:
We are committed to developing the Saudi medical consent guide for
the patient through the participation of persons with expertise in many
fields and the community as a whole.

Goals:
1-Developing the Saudi Guidelines for Informed Consent.
2-Sharing the medical opinion with the patient, his guardian, or his
representative.
3-Raising awareness of the health practitioners and spreading the
concept of the informed consent among community members.
4-Unifying the current informed consent forms.
5-Participating and benefiting from experts, scholars (Islamic
Jurisprudence) and health practitioners.
6-Protecting the rights of the patient, the health care provider, and the
health facility.
 Saudi Guidelines for Informed Consent 7

Definitions:
1-General Informed Consent (for Registration/Admission): Approval or refusal of the patient, his/her
guardian, or his/her representative to receive the treatment service voluntarily by the health facility and his ability
to communicate with health practitioners concerning the informed consent for any non-emergency medical
procedure.
2-Special Informed Consent:
Approval or refusal of the patient, his/her guardian or his/her representative to receive the treatment service
voluntarily by a licensed health practitioner and his/her ability to communicate with health practitioners concerning
the informed consent to perform a specific medical intervention, provided that sufficient information on this non-
emergency medical intervention, such as (surgery - anesthesia - blood transfusion, etc.), is provided to the patient.
3-Informed Consent Documentation:
Legal documented process regulates the conduct of medical relationship between the patient and the health
practitioner or the treatment facility according to the laws, regulations and medical requirements. Informed consent
documentation aims to explain the elements of the treatment agreement conducted between the patients and
practitioner or treatment facility. Further, it guarantees the compliance of the parties with the non-emergency
treatment agreement and resolves the conflict between the parties to the agreement by explaining the rights,
duties, and obligations of each party towards the medical procedure taken and determined in advance. Moreover,
it explains the method, mechanism, outcome, and possible complications of the procedure The document issued
by the medical institution is called “Informed Consent Document” where the title of medical consent must be
pointed out.
4-The Guardian:
A person represents and gives Informed Consent on behalf of someone who lacks the capacity (mentally
incompetent) or on behalf of a minor under 18-years old.
5-Patient’s Agent/ Representative:  
A person assigned by the patient with full mental capacity to act on his behalf regarding his medical procedures.
6- Child:
A person under the age of 18 years.
7- Capable Individual:
Mature adult, mentally competent adult (male or female).
8- The Capability of an Underage:
An underage with incomplete perception. However, the age of maturity is 18 years.
9- Person lacking legal capacity:
A person who lost his sense and ability to understand the speech or act in his/her own affairs. However, if
someone lost his/her sense and perception at some point he will be treated as incompetent at that point, but if
they regained sense and perception, they will be considered a capable individual.
10-The Responsible Physician :
A consultant or a specialist who is responsible for providing medical care, procedures, or operation at that time.
However, he could be the treating physician.
11-The Treating Physician:
A physician who admits a patient under his name. He could be the responsible physician about a medical
procedure for the patient.
12-Intervention/Invasive procedure:
Any medical procedure performed by a practitioner where a complication is considered possible to occur including,
but not limited to, amputating, stings, or the insertion of any material into the patient’s body.
13-High-Risk Procedure:
Any medical procedure holds potential by more than 50% of losing an organ or its function or death as one of the
possible complications. In such cases, the patient must be clearly and explicitly informed.
14-The Health Facility:
Any licensed medical institution provides health services whether it is a clinic, general and private hospital, or
others.
15- Health Practitioner:
Anyone with a license and eligible to practice and provide health services including the following: physicians,
8 Saudi Guidelines for Informed Consent

dentists, pharmacists, health technicians in radiology, nursing, anesthesia, laboratory, pharmacy, optics,
epidemiology, prosthetic limbs, physical therapy, dental treatment, CT-scans, nuclear treatment, laser machines,
operations, psychologists, nutritionist, public health, midwifery ambulance services, speech and auditory therapy,
vocational rehabilitation, vocational therapy, treatment in medical physics and others.
16-Side Effects of Medicines:
Unwanted effects of medicines that occur because of giving medication correctly in therapeutic medical based
doses and by the medical rules and it may occur in varying degrees.
17-Minor Complications:
Unwanted harm to the patient resulted from the medical procedure or treatment that does not lead to the loss of
an organ, its function or cause death. However, it is possible to occur permanent or temporary.
18-Major Complications:
Unwanted harm to the patient resulted from the medical procedure or treatment that may lead to loss of an organ,
its function or cause death. However, it is possible to occur permanent or temporary.
19-Medical Procedure:
All actions taken by the practitioner including examination, assessment, diagnosis, or any medical intervention
whether it is pharmaceutical, surgical, psychotherapy, or any similar procedure.
20-Medical Case Manager:
A responsible employee of following-up and coordinating all health services provided to the patient as well as
facilitating that between all health service providers in the entire facility.
21-Morbidity and Mortality Committee:
A committee studies the causes of morbidity and mortality in-detail to analyze the possible reasons, take necessary
preventive measures and improve the medical performance of the healthcare facility.
22- Interpreter:
A mediator who facilitates communication between the patient, his guardian, or his representative and the
practitioner in case they speak different languages, this might include using sign language or any similar method,
and the interpreter must be acceptable for both sides.
23- Medical Team:
A group of physicians and health practitioners responsible for all aspects of patient care by providing the necessary
medical
interventions for the patient and following-up the case for a specific period.
24-Technical or Regulatory Supervisory Entities:
Entities who are following the progress of medical intervention in the health facility and guarantee that the patient
is provided with medical services according to the applicable and agreed-upon standards, laws and regulations.
25-Informed Consent Procedures:
A detailed explanation provided by the physician or the health practitioner on the medical procedure and its
expected benefits without exaggeration, the possibility of causing harm without attenuation or overstatement, and
its alternatives if there are any, and all information that concern the patient.
 Saudi Guidelines for Informed Consent 9

Definition of Informed Consent:

Approval by the patient, his guardian, or his representative to the health facility or to the health practitioners
performing all necessary procedures to maintain and recover the patient’s health.

Components of Informed Consent:

1. Consent (the patient, his guardian, or his representative).
2. Authorized for (the healthcare facility or the practitioner).
3. Authorized action (the procedures required to maintain and regain health).
4. The format (indicate approval and consent – in verbal or written form).

Conditions of Informed Consent:

1. To be given by the authorized person.
2. The person who gives the Informed Consent must fulfill the legal capacity.
3. The consent procedure must be legitimate.
4. The consent shall be in a language to be understood by the patient, and shall be stated verbally in a clear
manner.
5. The consent is valid until the end of the specified medical procedure.
6. The approval must be voluntary to the consent not forced.
7. It must be given while the patient is fully aware and conscious.
Conditions of Medical Practitioners:
1. The medical practitioner shall be qualified, licensed to practice and provide the specified medical services.
2. To aim for the benefit of the patient and act in their best interest.
3. To follow the known healthcare standards of the medical profession.
4. The medical practitioner shall not violate or exceed the boundaries of the medical consent, except in life-saving
situations.
10 Saudi Guidelines for Informed Consent

Types of Informed Consent:

I) Types of informed consent according to the subject:

1. Unrestricted consent:
It is the patient consent for the healthcare practitioner to perform any medical procedure to preserve or recover
their health.
2. Restricted consent:
It is the patient consent for the healthcare practitioner to perform a specific medical procedure to preserve or
recover their health.
*Both types are valid whether it is unrestricted or restricted if the authorized procedure is legitimate.

II) Types of informed consent according to the way of expression:

1. Explicit verbal consent: (for instance, the patient says to the practitioner “I give you a consent to perform a
certain surgical operation or a certain examination”).
2. Inexplicit consent: (for instance, the patient approves to perform a specific examination or medical intervention,
but then the physician finds out that the cause of the illness is different compared to the cause that the patient has
been approved, In this case, the physician can proceed and perform the adequate medical procedure based on
the inexplicit consent that was given by the patient). However, the medical procedure must be restricted to achieve
health purposes to cure the patient.
3. Signal consent: (for instance, when the patient nods their head as a sign of approval).
4. Written consent: (for instance, when the patient writes his approval for medical procedures without any verbal
words).

*Anything indicating the approval of the patient is enough to obtain the consent to proceed with
the medical procedure. However, this should be documented in the patient medical record.

*Patient silence shall not be considered a consent to perform any medical procedure.

Written informed consent shall be obtained in case of dangerous procedures, with the risk of any side
effects that may occur to the patient, as follows:

1. Any surgical operation, intervention, or hospital admission.

2. Giving any type of anesthesia (general, regional anesthesia, or procedural sedation).
3. Performing interventional exams.
4. Giving chemotherapy or radiotherapy.
5. Taking a photograph of the patient for therapeutic or educational purposes.
6. Utilizing body parts and tissues that have been removed during operations.
7. Training during the internship year or before it with the required of written informed consent for all
disciplines.
8. Hemodialysis procedures.
9. Blood transfusion.
10. In case of compulsory admission for psychiatric patients, Mental Health Care Law is followed.

*In case of conducting scientific research, medical research regulations and guidelines in the Kingdom of
Saudi Arabia shall be followed.
 Saudi Guidelines for Informed Consent 11

Guardianship of the Minor and the persons Lacking Legal

Capacity:
First: Guardianship in informed consent:
A legitimate legal authority enables its holder to undertake the personal and financial matters of a minor, person
lacking legal capacity, or incapacitated patient.

Guardian responsibility:
The guardian is responsible for providing the informed consent and treatment which serves the benefit of the
minor, person lacking legal capacity, or incapacitated patient.
Who is the guardian?
The guardian of minor is the father because of the relationship and near relative that cannot be detached.

Second: The Guardians order:

The order of guardians in the right of informed consent for the ward is based on the order of the legitimate
guardianship and according to its provisions.
The guardian:
1. Father.
2. Grandfather ( Father side).
3. Mother.
4. Then to the closet male relatives.
5. The governor shall not be a guardian and there is no need to refer the matter to him unless there is no one from
the patient’s male relatives available.
6. If the patient is a rational, sane adult, then the informed procedure is a right of the patient, so no one can compel
him to authorize, nor authorize on his behalf; Unless the medical procedure is necessary to save his life, it takes
place without his consent, but if the patient is a minor, it is not permissible to perform the medical procedure for
him except after the consent of his guardian, and after his interest is achieved except in cases upon which the
saving of his life depends, the guardian’s consent is not required; because it is not considered in this case. In
the case of conflict between relatives in approval and disagreeing, then whoever had his opinion in the interest
of the patient according to the physician’s report is considered.
7. Consent of a capable patient is required, however, in case of they lack capacity or incapacitated the guardian’s
consent is imperative according to the legitimate guardianship order and its provisions in which serve the ward’s
benefits. Yet, if the guardian action may harm the ward, then the action is not considered valid and the right of
giving the consent is shifted to another guardian then to the judge.
8. Article (9/15L): The psychiatric patient has the right to appoint a legal guardian to defend his rights within and
outside the psychiatric treatment facility. The Local Council for Mental Healthcare manages the affairs of the
psychiatric patient who is unable to make the decision and has no guardian about the therapeutic decisions
until the appointment of a legal guardian.
9. Article (9/16L): Compulsory Decision form (1) and Compulsory Decision extension form (2) are used to inform
the patient or his guardian on compulsory admission or to inform him of the method to be followed if he wishes
to cancel the compulsory admission decision of the treatment facility.
10. If the psychiatric patient at the time of admission is unable to understand these rights, they are explained to
him when his condition is improved by the members of the treating team and documented in the medical file.

Third: Patients whose consents are deemed invalid:

1. Minors.
2. Unconscious patients.
3. Mentally incapacitated patients.
· Patients with mental illness such as schizophrenia.
· Patients with mental disabilities or dementia diseases that affect their perception, including:
· Mentally retarded patients (moderate to severe).
· Patients with dementia.
12 Saudi Guidelines for Informed Consent

Guardianship Expiration:
The guardian expires in the following cases:
1. When a minor reaches maturity.
2. When unconscious person regains his consciousness.
3. Return to sanity and perception regarding those who suffer from an illness that affects mental state and
perception.
*In the case where the guardian is absent, cannot be reached, or cannot wait for his attendance, a
committee is convened at the healthcare facility and authorized to give the consent on his behalf. This
committee must have the following characteristics:

First: the committee membership

1. Two specialized physicians who are not less than specialists and familiar with the medical condition.
2. Member or a representative of the medical administration.
3. Social worker.

Second: Convening of the committee:

1. The committee shall be held at the request of the treating physician or his representative.
2. The request shall be issued through informing the facility’s medical administration, or whoever represents
it.
3. The committee shall be held as soon as possible to ensure meeting its needed purpose.

Third: The committee could be permanent or temporary as the case requires, taking into
consideration the provisions mentioned in the first and second paragraphs.
*According to the Mental Health Care Law, the psychiatric patient shall be referred to the Local Council for
Mental Healthcare to be a guardian for the patient in case of absence of the guardian or his representative.
 Saudi Guidelines for Informed Consent 13

Delegation and Authorization of Informed Consent to

others:
The patient can authorize someone else to give the consent on his behalf provided that the authorizer and the
authorized shall have full capacity and competence to give the informed consent. On the other hand, the medical
procedure must be legally authorized.

First: Witnesses:
Two witnesses should be testified, preferably healthcare practitioners, especially if the medical procedure is
dangerous.
Second: Essentially, Informed consent is required except in the following cases:
1. Emergency cases that include that threatening to the person’s life or some of his important organs when
consent cannot be obtained from the patient or his guardian.
2. Cases in which the public interest requires the need to treat or prevent, like contagious infectious diseases that
poses a threat to the health of community members.
3. If the patient is suspiciously having a mental illness with clear indications that the person has a severe mental
disorder where the symptoms of which potentially can harm them or harm the others at the time of their examination.
they shall be treated or compulsory admitting them into the facility in an obligatory manner after taking the required
procedures according to the mental health care law and its implementing regulations.
Third: Expiration of the informed consent:
1. When the purpose is met or the specific period is expired: completion of the authorized procedure or complete
discharge from the hospital.
2. If the patient is fully cured of the treated disease.
3. Death.
Fourth: Child maturity:
Puberty is achieved by reaching 18 years old.
14 Saudi Guidelines for Informed Consent

Informed consent parties: roles and responsibilities:

Director of the healthcare facility: responsible for ensuring the safe therapeutic care is provided to the patients
and ensuring the fulfillment of the essential safety requirement of the patient safety through an administrative
and technical system and qualified licensed staff. Moreover, he is also responsible for implementing all informed
consent procedures that are adapted in this guide within the facility.
Quality or risk manager in the healthcare facility: responsible for providing and updating policies and
procedures of the informed consent in the healthcare facility and ensuring the compliance of practitioners with the
policies of the Informed Consent Guide and related standards. The manager also must spread awareness about
the policies between members of the medical and administrative team. However, he is responsible for monitoring
the implementation of the informed consent procedures by the medical staff, and in case of any violation, he must
report the incidence to the higher management to take an action.
Managing directors and technical supervisors in the healthcare facility (medical director – director
of nursing): They all have the same level of responsibility in regards of making their subordinates aware of the
informed consent policies, ensuring their attendance of training and that they have an equal sense of responsibility
regarding the supervision and observation of the fulfillment of these policies in cooperation with other clinical
department supervisors in the facility. The director of any administration or the supervisor must guarantee that all
staff members are aware of the informed consent policies and include such policy in the orientation program for
new physicians in the healthcare facility.
Clinical department supervisors in the healthcare facilities (nursing supervisor, Chief medical officer,
medical assistant): the supervisor of the department is fully responsible for the professional clinical practice
standards, guaranteeing the fulfillment of ideal standards and implementing policies and procedures. They are
also responsible for the health staff activities within the department including informed consent procedures and
ensuring the person approval is obtained before providing any medical examination or treatment.
The health practitioner and health service providers: all health practitioners and health service providers are
professionally responsible for the quality service that is provided including taking the right consent procedures
before any examination or treatment. All health practitioners and health service providers shall be aware of the
informed consent and informed consent guide, policy, procedures, implementation and to report any incident
or recent case regarding informed consent violation (e.g. incomplete the requirements of the informed consent,
expiring its purpose, or the patient is not aware of the procedures).
Technical and regulatory supervisory authorities outside the healthcare facility (senior central
management): responsible for reviewing the policies in the healthcare facility and ensuring that there is an Informed
Consent Guide of Ministry of Health and it is being implemented in each department within the healthcare facility.
Besides, monitoring the related effectiveness of policies and ensuring their implementation within the healthcare
facility, receiving any informed consent incident, sentinel events, and conducting the necessary investigations to
avoid and resolve it.
The physician/dentist: professionally responsible to explain the procedure to the patient, and to ensure that he
has adequate information about the benefits, risks, and alternatives of the procedure, to help and guide him, his
family or his representative in the approval or rejection process. Besides, he is responsible for documenting this
procedure, all matters that have been discussed, and the results whether approved or not.
The physician in charge, holds the legal responsibility to prove if a patient questions or impeaches the verbal
consent. For this matter, the consent is preferred to be written and signed by the patient or his representative is in
some therapeutic interventions that have serious risks and when it is necessary.
Patient experience, social service, and patient affairs departments: it is better to involve a representive of
one of the mentioned departments or other members of the healthcare team to participate in the discussion with
the patient or his guardian while taking the informed consent as they may be called witnesses when needed. The
physician or any participant from the team must document this in the patient file. In addition, they are responsible
to provide means to educate the patient and his family about the informed consent.
Nursing: they are responsible for ensuring that the treatment team applying the informed consent for the patients
and they fulfill its requirements in the patient file before performing any procedure, documenting them in the
nursing notes and informing the head of the department if it has happened otherwise.
Witness: a person who witnesses and signs the consent of the patient, his representative, or guardian to carry
out the medical procedure. (He confirms the identity of the patient or his representative who signed the informed
consent and his mental state and awareness of what he signed for at that time).

Special Cases of Informed Consent:

Some patients may need to obtain informed consent in a different way due to losing one or more of the
 Saudi Guidelines for Informed Consent 15

conditions of the right informed consent that may require involving a third party to complete the procedure
legally or to complete the medical procedure without the medical consent, such as the following cases:

One: informed consent regarding children under 18 years old

Written or oral approval must be taken from the guardian or representative of the children who are under 15 years
old, while who are 15-18 years old, a written or oral approval must be taken from the patient and his guardian or
his representative, except in the following case:
• The therapeutic intervention is necessary and can’t be postponed in order to achieve the physical and
mental health interest of the patient in admission or compulsory treatment.
Two: saving lives and critical conditions:
In cases of a disease, life-threatening injuries or an injury that may result in loss of an organ or its function, it is
permissible for the physician to ignore taking an informed consent under the following conditions:
1) Inability to take consent from a patient because of his lack of capacity.
2) The absence of a patient guardian or his representative with the possibility of his condition getting worse
because of delayed intervention.
3) If it is likely that without the medical intervention, a loss of an organ or its function or even death may occur.
4) A consensus of at least two specialist physicians and confirming the necessity of an immediate medical
intervention after examining the patient.
In such cases, medical or surgical intervention can be performed without the need for informed consent. However,
it must be documented in the patient file and informing the patient or his relatives upon their arrival about all
procedures that had to be taken after the treatment1.
Three: informed consent of a pregnant patient
· The informed consent is given by the pregnant patient herself if she has full capacity. It is not allowable to ignore
her, and she has the right to choose the person who will give the consent on her behalf. For instance, her father,
brother, husband, or anyone of her relatives whether it is a male or a female as long as the authorization was
approved2.
· In cases of medical abortion and the mother health is at risk or there was a risk of losing her life, it is enough to
take consent from her personally or from her representative.
· If the reason for abortion is life threatening fetal abnormalities, the consent of both the mother and the father is
required. If the father approved the abortion while the mother rejected it, the mother opinion shall be prevailed.
The abortion procedure must be completed before the 120th day of pregnancy.
Four: taking informed consent by force:
· It is not allowed to force a patient or his relatives to give informed consent if the patient has refused with full
capacity. This is deemed as a violation of the properly informed consent regulations.
Five: informed consent of a psychiatric patient
Similar to any normal patient, informed consent, whether written or verbal, must be obtained from a psychotic
patient regarding all medical interventions if the following conditions are met:
1. Meeting the requirements of full capacity, age and mental state like any other patient who is not psychotic.
2. The ability to fully understand all the given information about the disease and the treatment options.
3. The ability to choose between offered options, approving or refusing the treatment, or any other life matter
independently.
4. The ability to estimate the consequences and complications of the medical intervention whether it is approved
or not.
5. The condition does not need compulsory treatment or admission, and what is stated in the articles of mental
healthcare and its regulations of ambulatory admission, compulsory reservation, its periods ... etc. (article 11,
12, 13, and 14). In addition, in relation to compulsory treatment based on article 17 of the psychological and
health care law (article 17 L1 and article 17 L 2).

1 Example (2): An injured person has been brought from the building and construction sites; the physician found the patient unconscious
with no identity. Upon examination, he found a brain hemorrhage that requires immediate surgical intervention. After consultation with another
physician, both physicians decided on the necessity of an urgent operation. All the procedures including the operation have been documented
in the patient file. In the next day, the patient regained consciousness and his condition was explained to him and recorded in the file.
2 Example (4): A 9-month pregnant lady came with embryonic fluid leakage; all vital signs of the embryo were stable permitting normal delivery.
After examination, the gynecologist suggests to the husband doing a cesarean section giving that it is easier than normal delivery. The wife
refused but the medical team tried again by telling the husband of possible harm to the baby and leading him to force his wife to do the
unnecessary cesarean section even without taking the approval of the mother.
16 Saudi Guidelines for Informed Consent

6. The medical team should not force the patient or his relatives to give consent.
7. In cases where the patient lacks the full mental capacity, a psychiatric physician must be consulted to give a
medical report about the patient condition before taking informed consent is required3..
Six: informed consent of treatment that results in infertility or sterility
It is enough to obtain consent from a patient with full capacity in case:
· Not married status.
· In case of temporary futility because of the treatment for both married men and women alike.
If the treatment may lead to permanent sterility and completely prevent reproduction while there is a necessity for
the medical intervention, the informed consent is taken from a married male or female patient and they are asked
to inform their spouse without the need for their approval.
Seven: informed consent of an incapacitated adult and has no guardian or representative4
· In such cases, it is necessary to contact with the medical administration and inform the administrative governor
of the principality where the medical institution healthcare facility is located, or submit to the Local Supervisory
Board in case of the psychiatric patient, to assign a representative for the patient, if any, or to enable the medical
team to provide the necessary care, if it is not an emergency case.
· Basic and essential medical care is provided after an examination by two specialists and confirming the necessity
of the treatment, documenting it in the patient file. However, the informed consent is not required in such cases.

Eight: informed consent in cases of patients with unstable capacity due to temporary psychological
state or drug effects
Temporary psychological disorders of a patient:
· The decision-making ability of a patient may vary during different stages of the patient illness, caused by fear
or pain. This could be a temporary state, therefore, taking the required measures must be taking to ensure that
the patient is ready to give the informed consent at a proper time and to ensure that the patient mental state is
stable while giving his informed consent.
The effect of anesthetic drugs and medicines that may affect the mental abilities of a patient:
· It is important to make sure that the patient is free from any drug effects that may affect the activity of the
nervous system that may impact the patient’s decision-making ability. For instance, narcotics, strong painkillers,
such as opium, or other sedatives.
Nine: Deaf and dumb patients and patients with communication difficulty informed consent:
The medical team must provide maximum effort to communicate with deaf and dumb patients through the help of
sign language specialist or using any available ways. If this was impossible, consent can be given by a guardian
or a representative assigned by the patient himself.
If there is no guardian or inability to get in touch with him, the health facility administration is required to contact the
administrative Governor to assign the patient representative and entitle the medical team to provide the minimum
required treatment without the need of following the informed consent procedures.
Ten: consent to carry out medical research on patients in the medical facility
1. The researcher must follow the requirements of the implementing regulation of Research Ethics on Living
Creatures (statement of the National Bioethics Committee).
2. The medical facility must ensure that all medical research procedures are legally complete and to ensure patient
privacy and keep their information private during the research.
3. The medical facility is obligated to treat any possible complications that may occur because of patient
participation in the research.
Eleven: special consent of organ donation
Organ donation from a living person:
· The healthcare facility must follow the standards of organ donation consent as mentioned in the organ donation
procedure guide issued by the Saudi Centre for Organ Transplantation.

3 Example (5): An adult patient suffering from schizophrenia and has a diabetic foot that needs surgical intervention to amputate the leg. The
patient refused to give consent to do the surgery. Upon consultation with the psychiatrist, it was discovered that the patient was suffering
from advanced stage schizophrenia and incapable of estimating the consequences or defining the suitable options for himself. This case was
recorded in the patient file and informed consent was given by his brother to perform the operation.
4 Example (7): An elderly patient with dementia who does not have any children was admitted to a hospital due to a stroke. That stroke resulted
in difficulty swallowing which requires a feeding tube insertion. The medical team was unable to reach the patient’s relatives, however, after
getting the consent of the principality, the required medical care was provided to the patient including the surgical intervention without the need
of following the informed consent procedures.
 Saudi Guidelines for Informed Consent 17

· The healthcare facility must confirm the capacity of the donor before starting any donation process and taking
informed consent.
· The healthcare facility is obligated to treat any complication that is a consequence of the organ donation
process if ever happened.
Organ donation from a brain-dead person:
· The healthcare facility and the concerned medical staff must confirm brain death according to the standards of
the Saudi Center for Organ Transplantation.
· The healthcare facility must follow the standards of informed consent regarding organ donation as mentioned
in the organ donation procedure guide issued by (the Saudi Center for Organ Transplantation).
· The healthcare facility must provide the usual medical care to brain-dead patients until the end of the donation
process. Meanwhile, taking the patient dignity and psychological state of his relatives into consideration.
Twelve: Special consent of cosmetic surgeries and procedures:
A) Remedial operations or procedures:
Written approval must be taken from the adult patient or his guardian or his representative.
B) Non-remedial operations or procedures (for cosmetic purposes):
It depends on the extent of its need or necessity, and each case is taken separately, in which case what is stated
in the first point about informed consent must be applied.
C) Informed consent is not considered effective in cases where it has been forbidden, such as sex changes.
18 Saudi Guidelines for Informed Consent

Informed Consent Documentation:

It is the process in which the health practitioner or the healthcare facility save the informed consent content and
its procedures through writing, recording, or photographing to return to them whenever needed.

First: Documentation legitimacy:

The verse of loan is the longest one in the Holy Quran and considered to be the basis of documentation system
in Islam, in which Allah may be praised and exalted ordered people to document transactions be by writing them,
as in the words of the Almighty “O you who have believed, when you contract a debt for a specified term, write it
down. And let a scribe write [it] between you in justice;” {Quran 2:282}.

Second: Types of Documentation:

Informed consent documentation has two types:
One: Legal documentation (legitimate/ lawful)
This is the most important type of documentation. It combines both rules of testimony and codification. However,
this system is governed by the medical institutions and their legislative spheres and supervision.
Two: Customary/ verbal documentation
The verbal work of the medical staff or their institution to document a routine medical procedure that shall be done
once the patient enters the facility of the medical institution. This may include laboratory tests, vaccinations, or any
other documentation work that does not require registration of the person who holds the documentation validity
by the policies and procedures.
Customary documents: It is the approved form that is issued by the ones who has the authority for medical
documentation. It is attached to the official medical file, the paper allowed to be written by the patient personally
and signed by him provided that these papers are explanatory and complementary to the official informed consent
form and included within the patient progress follow-up notes.
The Fingerprint electronic signature of the informed consent that is included in the electronic file is subject to
the Islamic law provisions and the applicable law in the Kingdom of Saudi Arabia. As for the informed consent
for patients without limbs or those similar to them, it is by visual recording or audiobook saved electronically
in the medical file with legal documentation for that.

Three: Importance of documentation:

· The real foundation upon which the medical and legal authorities depend on to seek the legal authorization of
the medical consent.
· It is a reliable legal document that is being taken with precision and validity in medical and legal institutions.
· Facilitates the implementation process of medical procedure, brings attention to the importance of strengthening
the patient relationship with the medical staff and their institution, and emphasizes the importance of the patient’s
understanding of the medical procedure exact details.

Four: Governance of the Medical Consent:

A set of laws, regulations, and decisions which aim to achieve quality and excellence of medical documentation
by selecting the appropriate and effective methods to fulfill the plans and objectives of the documentation
process. However, it monitors the finding systems that control the relationship between the primary parties of
the documentation process which affects the performance. Furthermore, it includes the elements that reinforce
the legal aspect of the medical institution and its relationships with the patient in the long term. It identifies the
internal and external responsibilities and the responsible side while maintaining transparency, justice, patients and
institutional rights, and the rights to question medical institutes when needed. Therefore, protecting the patient
and the medical staff is achieved taking into consideration avoidance of exaggeration.
 Saudi Guidelines for Informed Consent 19

The governance of the informed consent documentation must involve all the technical and legal details
of the medical procedure consent document including:
1) Detailed information about the medical institution, departments, and administration.
2) Day, date, and hour.
3) Detailed information about the patient.
4) Detailed information about the medical staff.
5) Detailed information about the medical procedure, the complications, risks, outcomes and alternatives.
6) Detailed information about the witnesses, the guardian, the representative, and the interpreter.
7) Make sure that the patient has received a copy of the consent to perform the medical procedure.
8) An original official form subjected to document control procedures within the institute.
9) The validity of informed consent must be specified.
10) The abbreviations may not be used in the document.
20 Saudi Guidelines for Informed Consent

Validity of forms signature

1) 1-It must be issued by a medical institution registered with the Ministry of Health and government health sectors
(according to the applicable law in the Kingdom of Saudi Arabia).
2) The medical and the administrative practitioners must be registered in the medical institution.
3) All the medical team must hold a valid license in the Saudi Commission for Health Specialties.
4) The patient who signs the consent must be in full capacity.
5) The legal guardian or the person representing the patient must hold the status of guardianship legally and
attend what proves that. Or the presence of a representative of the patient for the mentally ill and those with
special social cases, with the need for special forms to prove the representation of the patient.
6) The form must be within the period of its legal validity.
7) There must be a full harmony and concordance between the Arabic document and the interpreted one.
8) Forms should be observed to be suitable for people with disabilities.
9) Forms should be observed to be suitable for Injured people on the battlefield with an inability to identify their
identity, expatriates with no guardian, and anonymous with unknown residence.
10) The medical team who is involved in the medical procedure is strictly prohibited to issue or to sign a form of
participation in a medical procedure to their first-degree relatives.
11) Regarding the military field or civil (Relief) common operations, it is a must to follow unified forms for all teams
which participate in the military medical and medical relief operations, however, it has to be approved by the
concerned and related supervisory and leading authority of the military and civil medical procedures.
· Regarding deaf, dumb and blind patients, the condition and the ability of the patient to communicate using
sight, sound, writing, sign language, or Braille language is documented by specialists in communication with
this category of patients or who represents them.
· Documenting the informed consent through the electronic fingerprint and include it within the electronic
medical record program for all medical centers and institutions in the kingdom.
 Saudi Guidelines for Informed Consent 21

Informed Consent Forms5

General forms Special forms

Authorizing medical institution to conduct Authorizing the medical institution to

medical procedures involving the following: conduct medical, surgical administrative
procedures and research that concern the
patient.

· Giving therapeutic and diagnostic elements to the patient by mouth, anus, or by dermal, intramuscular, and
intravenous injection.
· Blood sampling for laboratory examination.
· Radiation or scanning examination.
· Conducting an electrocardiography.
· Administration of fluids and drugs through intravenous cannulas.
· Applying splints.
· Dressing and disinfecting the wounds.
· Suturing the wounds and treating minor incisions.
· Discharging of cysts and minor abscesses.
· Removal of skin lumps and minor injuries.
· Taking specimens of superficial tissues.
· Insertion of nasal or gastrointestinal tubes for nutrition.
· Insertion of urinary Catheterization.
· Insertion of the arterial cannula for monitoring and taking blood gas samples.
· Dental procedures without sedation or general anesthesia.

First: (Consent of general and medical routine procedures: Minimum content of the form):

Content Explanation

Medical institution code According to the officially applicable rules

Informed consent title In both Arabic and English languages, with a bold and clear font.
Detailed information about the Date/ department/ ward/ specialist or the physician name/ Job code/
entity, department, and the contact number
physician.
General authorization formula. In both Arabic and English languages. However, the explanation must
include a consent acknowledgment to do all general and necessary medical
procedures that are required to be admitted to the medical institution,
the form may include acceptance of allowing trainees and students to
participate in providing medical care.

5 National Hospital Standards-CBAHI-6

22 Saudi Guidelines for Informed Consent

Patient information Full name

ID number
Medical file number
Age/date of birth
Signature/fingerprint
Full name of the legal guardian, if necessary
His relationship with the patient
Guardian signature
Date/time
Information about the Employee full name
documentation employee Employee No.
Signature
date/time
Additional instructions Form validity
General instructions about the patient’s legal state and capacity.
Witnesses The first and second witnesses: full name, signature, date, and time
Patient signature of receiving a
copy of the Informed consent
Form. “in case it requested”

Second: Consent that is supported by knowledge about the medical procedures or surgery:

Content Explanation

Medical institution code According to the officially applicable rules

Informed consent title In both Arabic and English languages, with a bold and clear font.
Detailed information about the Date/ department/ ward/ specialist or the physician name/ Job code/
authority, department, and the contact number
physician.
General authorization formula In both English and Arabic languages, However, the explanation has to
include an acknowledgment of the authority holder (the patient or his
guardian and his relationship to the patient) general clarification of the
procedure or the surgery and their details in both Arabic and English
languages.
Physician clarification Includes detailed information in both Arabic and English languages
about the medical and surgical procedure, the results, and any possible
complications. In addition, explaining in details to the patient about the
alternatives, the risks, and complications of these alternatives, possible
risks of not performing the procedure, and the chance to succeed.
Also, providing the patient enough time to read and ask questions.
A special part in the consent Adequate explanation about the procedure or the operation, the reason
for operations and high- risk why it was classified as high-risk, and the possible complications in a
procedures detailed and accurate manner.
Signature of the physician who Employee full name
took the consent Employee No
signature
date, time
 Saudi Guidelines for Informed Consent 23

Patient statement Detailed information using legal phrases regarding the patient’s
understanding of the procedure or the surgical operation and its
possible complications, including the fact that they were given enough
time to explain and ask questions. Also, permit the medical institution
to dispose of tissue and removed organs according to the Islamic law or
the possibility of keeping them for educational purposes, if necessary.
Patient or legal guardian Patient full name
signature Signature
Guardian or representative name and his relationship to the patient
Signature
Date, time
Interpreter statement, if Full name
necessary Employee No
signature
date, time
Emergencies Part of the form is for the signature of the physician or the specialist to
make an interventional procedure or surgery urgently to save the patient’s
life or to save one of his organs. It must include the acknowledgment of
two specialist physicians in which one of them is at least is specialized:
full name, Employee No, signature, date, and time.
Witnesses The first and second witnesses: full name, signature, date, and time
Patient signature of receiving a
copy of the Informed Consent
Form
The validity period of the form Must not exceed 30 days as of the date of signature or what is required
by the treatment plan.

Third: Consent that is supported by knowledge about the procedures of electroconvulsive therapy- an
electric shock for the psychiatric patient:

Content Explanation

Medical institution code According to the officially applicable rules

Informed consent title In both Arabic and English languages, with a bold and clear font.
Detailed information about the Date/ department/ ward/ specialist or the physician name/ Job code/
authority, department, and the contact number
physician.
General authorization formula In both English and Arabic languages. However, the explanation has
to include acknowledgment of the authority holder (the patient or his
guardian and his relationship to the patient), general clarification about the
treatment procedure using electric shock, number of sessions, treatment
duration, and the possible results in both Arabic and English languages.
Physician clarification Includes details in both Arabic and English languages and illustrative
details of the medical procedure, the possible results and complications,
details about the procedures of the sessions and benefits, alternatives,
and related risks of using electric shocks, including the fact that everything
was explained to the patient or his legal guardian (with clarification of the
patient’s capacity medically and legally).
Also, the fact that he was given enough time to read and ask questions.
24 Saudi Guidelines for Informed Consent

Signature of the physician who Employee full name

took the consent Employee No
Signature
date/time
Patient statement Detailed information using legal phrases regarding the patient’s
understanding and the eligibility of the patient, his legal guardian, or
his representative for signing the medical procedure, and its possible
complications. Also, the fact that he was given enough time to read and
ask questions.
Patient or legal guardian Patient full name
signature Signature
Guardian full name and his relationship to the patient
Signature
Date, time
Interpreter statement and Full name
pledge, if necessary Employee No
signature
date, time
Witnesses The first and second witnesses: full name, signature, date, and time.
Degree of confidentiality High

Patient signature of receiving a

copy of the Informed consent
Form.
The validity period of the form Must not exceed 30 days from the date of signature or specified by the
number of sessions.

Fourth: Consent that is supported by knowledge about the chemotherapy procedures:

Content Explanation

Medical institution code According to the officially applicable rules

Informed consent title In both Arabic and English languages, with a bold and clear font.
Detailed information about the Date/ department/ ward/ specialist or the physician name/ Job code/
authority, department, and the contact number
physician.
General authorization formula In both Arabic and English languages. However, the explanation must
include the acknowledgment of the authority holder (the patient or his
guardian and his relationship to the patient), general clarification of
the chemotherapy procedure, its possible results, and whether it is a
radical, secondary, or palliative treatment. All of that must be written in
detail in both English and Arabic languages.
Physician clarification Includes detailed information in Arabic and English languages,
illustrative details about the procedure including the condition of
the patient, the nature of the chemotherapy procedure, its possible
benefits, the alternatives and related risks, the results, and the possible
complications and details about the transparency of the physician
explanation to the patient. Also, the fact that he was given enough time
to explain and ask questions
 Saudi Guidelines for Informed Consent 25

Signature of the physician who Employee full name

took the consent Employee No
signature
date, time
Patient statement Detailed information using legal phrases regarding the patient
understanding of the mentioned medical procedure, its possible
complications, the required precautions before and after the procedure.
Also, the fact that he was given enough time to explain and ask
questions.
Patient or legal guardian signature Patient full name
Signature
Guardian full name and his relationship to the patient
Signature
Date, time
Interpreter statement and pledge, Full name
if necessary Employee No
signature
date, time
The witnesses The first and second witnesses: full name, signature, date, and time.
The validity period of the form Must not exceed 30 days from the date of signature or specified by the
number of sessions.
Patient signature of receiving a
copy of the Informed consent
Form. “in case it requested”

Fifth: Consent that is supported by knowledge about the radiotherapy procedures:

Content Explanation

Medical institution code According to the officially applicable rules

Informed consent title In both Arabic and English languages, with a bold and clear font.
Detailed information about Date/ department/ ward/ specialist or the physician name/ Job code/
the authority, department, contact number
and the physician.
General authorization formula In both Arabic and English languages. However, the explanations must
include the acknowledgment of the authority holder (the patient or his
guardian and his relationship to the patient), general clarification of the
radiotherapy procedure, its possible results, and whether it is a radical,
secondary, or palliative treatment. All of that must be written in detail in both
English and Arabic languages.
Physician clarification Includes detailed information in Arabic and English languages, illustrative
details about the procedure including the condition of the patient,
radiotherapy procedure, its possible benefits, the alternatives, and related
risks, the results, the possible complications and the required precautions
before and after the procedure and details about the transparency of the
physician explanation to the patient. Also, the fact that he was given enough
time to read and ask questions.
26 Saudi Guidelines for Informed Consent

Signature of the physician Employee full name

who took the consent Employee No
signature
date, time
Patient statement Detailed information using legal phrases regarding the patient understanding
of the medical procedure, its possible complications.
Also, the fact that he was given enough time to explain and ask questions.
Patient or legal guardian Patient full name
signature Signature
Guardian full name and his relationship to the patient
Signature
Date, time
Interpreter statement, if Full name
necessary Employee No
signature
date, time
Witnesses The first and second witnesses: full name, signature, date, and time.
The validity period of the form Must not exceed 30 days from the date of signature.
Patient signature of receiving
a copy of the informed
consent form. “in case it
requested”

Sixth: Consent that is supported by knowledge about Hemodialysis procedures:

Content Explanation

Medical institution code According to the officially applicable rules

Informed consent title In both Arabic and English languages, with a bold and clear font.
Detailed information about the Date/ department/ ward/ specialist or the physician name/ Job code/
authority, department, and the contact number
physician.
General authorization formula In both Arabic and English languages. However, the explanation must
include the acknowledgment of the authority holder (the patient or his
guardian and his relationship to the patient), general clarification of the
hemodialysis procedure and the fact that it is not a radical treatment of
kidney failure but merely eliminating and discharging waste products and
fluids outside the body.
All of that must be written in detail in both English and Arabic languages.
Physician clarification Includes detailed information in Arabic and English languages, illustrative
details about the procedure including the condition of the patient,
hemodialysis treatment procedure, its possible risks and complications
during or after hemodialysis, possible benefits, alternatives, and short
or long-term risks and details about the transparency of the physician
explanation to the patient. Also, the fact that he was given enough time to
read and ask questions.
Signature of the physician Employee full name
who took the consent Employee No
signature
date, time
 Saudi Guidelines for Informed Consent 27

Patient statement Detailed information using legal phrases regarding the patient understanding
of the medical procedure, possible complications, and the fact that he was
given enough time to explain and ask questions.
Patient or legal guardian Patient full name
signature Signature
Guardian full name and his relationship to the patient
Signature
Date, time
Interpreter statement, if Full name
necessary Employee No
signature
date, time
Witnesses The first and second witnesses: full name, signature, date, and time.
The validity period of the form Must not exceed 30 days from the date of signature or the number of
sessions.
Patient signature of receiving a
copy of the Informed consent
Form. “in case it requested”

Seventh: Consent supported by knowledge about Peritoneal Dialysis procedures:

Content Explanation

Medical institution code According to the officially applicable rules

Informed consent title In both Arabic and English languages, with a bold and clear font.
Detailed information about Date/ department/ ward/ specialist or the physician name/ Job code/ contact
the authority, department, number
and the physician.
General authorization In both Arabic and English languages. However, the explanations must include
formula the acknowledgment of the authority holder (the patient or his guardian and his
relationship to the patient), general clarification of the Peritoneal Dialysis and
that it is not a radical treatment of kidney failure but to eliminate and discharge
waste products and fluids from the body.
All of that must be written in detail in both English and Arabic languages.
Physician clarification Includes detailed information in Arabic and English languages, illustrative details
about the Peritoneal Dialysis including its possible risks and complications
during and after hemodialysis, possible benefits, the alternatives, and short
and long-term risks. and details about the transparency of the physician
explanation to the patient. Also, the fact that he was given enough time to
read and ask questions.
Signature of the physician Employee full name
who took the consent Employee No
signature
date, time
Patient statement Detailed information using legal phrases regarding the patient’s understanding
of the medical procedure, its possible complications.
Also, the fact that he was given enough time to explain and ask questions.
28 Saudi Guidelines for Informed Consent

Patient or legal guardian Patient full name

signature Signature
Guardian full name and his relationship to the patient
Signature
Date, time
Interpreter statement, if Full name
necessary Employee No
signature
date, time
Witnesses The first and second witnesses: full name, signature, date, and time.
The validity period of the Must not exceed 30 days from the date of signature or by the treatment
form procedure.
Patient signature of
receiving a copy of the
Informed consent Form.
“in case it requested”

Eighth: Consent supported by knowledge about receiving diagnostic examination in nuclear medicine:

Content Explanation

Medical institution code According to the officially applicable rules

Informed consent title In both Arabic and English languages, with a bold and clear font.
Detailed information about the Date/ department/ ward/ specialist or the physician name/ Job code/
authority, department, and the contact number
physician.
General authorization formula In both Arabic and English languages. However, explanations must
include the acknowledgment of the authority holder (the patient or his
guardian and his relationship to the patient), general clarification about the
medical procedure of using radioactive materials for examination whether
introduced through the mouth or the vein, and any other examination
related to this procedure.
All of that must be written in detail in both English and Arabic languages.
Physician clarification Includes detailed information in Arabic and English languages, illustrative
details about examination using radioactive material including its possible
risks and complications during or after examination, possible benefits,
the alternatives, and short and long-term risks. And details on the
transparency explanation to the patient. Also, the fact that he was given
enough time to read and ask questions.
Signature of the physician who Employee full name
took the consent Employee No
signature
date, time
Patient statement Detailed information using legal phrases regarding the patient›s
understanding of the medical procedure, its possible complications, and
the fact that he was given enough time to explain and ask questions.
 Saudi Guidelines for Informed Consent 29

Patient or legal guardian Patient full name

signature Signature
Guardian full name and his relationship to the patient
Signature
Date, time
Interpreter statement, if Full name
necessary Employee No
signature
date, time
Witnesses The first and second witnesses: full name, signature, date, and time.
The validity period of the form Must not exceed 30 days from the date of signature or the number of
sessions.
Patient signature of receiving a
copy of the Informed consent
Form. “in case it requested”

Ninth: Consent supported by knowledge about receiving diagnostic Medical Imaging with contrast
examination:

Content Explanation

Medical institution code According to the officially applicable rules

Informed consent title In both Arabic and English languages, with a bold and clear font.
Detailed information Date/ department/ ward/ specialist or the physician name/ Job code/
about the authority, contact number
department, and the
physician.
General authorization In both Arabic and English languages. However, explanations must
formula include the acknowledgment of the authority holder (the patient or
his guardian and his relationship to the patient), general clarification
about the nature of the medical imaging, type and the contrast dye
that is being used.
All of that must be written in detail in both English and Arabic
languages.
Physician clarification Includes detailed information in Arabic and English languages,
illustrative details about medical imaging procedures, type of the
used dye, and its related risks.
The procedure must include a chart of surveying questions to collect
the related necessary information (with Yes/No) Checklist.
The site where the dye will be injected in, type of the dye, the amount
of the injected material, possible benefits, the alternatives, and related
risks. and details about the transparency of the physician explanation
to the patient. Also, the fact that he was given enough time to read
and ask questions.
30 Saudi Guidelines for Informed Consent

Signature of the physician Employee full name

who took the consent Employee No
signature
date, time
Patient statement Detailed information using legal phrases regarding the patient›s
understanding of the medical procedure, its possible complications.
Also, the fact that he was given enough time to explain and ask
questions.
Patient or legal guardian Patient full name
signature Signature
Guardian full name and his relationship to the patient
Signature
Date, time
Interpreter statement, if Full name
necessary Employee No
signature
date, time
The witnesses The first and second witnesses: full name, signature, date, and time.
The validity period of the Must not exceed 30 days from the date of signature or by the procedures
form only.
Patient signature of
receiving a copy of the
Informed consent Form. “in
case it requested”

Tenth: Consent supported by knowledge about magnetic resonance medical imaging procedures:

Content Explanation

Medical institution code According to the officially applicable rules

Informed consent title In both Arabic and English languages, with a bold and clear font.
Detailed information Date/ department/ ward/ specialist or the physician name/ Job code/
about the authority, contact number
department, and the
physician.
General authorization In both Arabic and English languages. However, explanations must
formula include the acknowledgment of the authority holder (the patient or his
guardian, and his relationship to the patient), general clarification of the
magnetic resonance imaging procedure. All of that must be written in
detail in both English and Arabic languages.
 Saudi Guidelines for Informed Consent 31

Physician clarification Includes detailed information in Arabic and English languages,

illustrative details about the magnetic resonance imaging procedure.
The procedure must include a chart of surveying questions to collect all
related necessary information (with Yes/No).
Another chart to inspect the related safety and risk procedures.
( checklist)
and details about the transparency of the physician explanation to the
patient. Also, the fact that he was given enough time to read and ask
questions.
Signature of the Employee full name
physician who took the Employee No
consent
signature
date, time
Patient statement Detailed information using legal phrases regarding the patient›s
understanding of the medical procedure, its possible complications.
Also, the fact that he was given enough time to explain and ask
questions.
Patient or legal guardian Patient full name
signature Signature
Guardian full name and his relationship to the patient
Signature
Date, time
Interpreter statement, if Full name
necessary Employee No
signature
date, time
Witnesses The first and second witnesses: full name, signature, date, and time.
The validity period of the Must not exceed 30 days from the date of signature.
form
Patient signature of
receiving a copy of the
Informed consent Form.
“in case it requested”

Eleventh: Consent supported by knowledge about in-vitro fertilization and embryo transfer:

Content Explanation

Medical institution code According to the officially applicable rules

Informed consent title In both Arabic and English languages, with a bold and clear font.
Detailed information about Date/ department/ ward/ specialist or the physician name/ Job code/ contact
the authority, department, number
and the physician.
32 Saudi Guidelines for Informed Consent

General authorization In both Arabic and English languages. However, explanations must include
formula the acknowledgment of the authority holder (the patient or his guardian and
his relative relationship to the patient), general clarification of the couple
knowing about the Fertilization procedure, and transferring the fertilized
ovum into the Fallopian tube. All of that must be written in detail in both
English and Arabic languages.
Physician clarification Includes detailed information in Arabic and English languages, illustrative
details about the procedure including the condition of the female patient,
the nature of the procedure, its possible benefits, and the alternatives, the
results, and possible complications.
and details about the transparency of the physician explanation to the patient.
Also, the fact that he was given enough time to read and ask questions.
Signature of the physician Employee full name
who took the consent Employee No
signature
date, time
Husband and wife Detailed information using legal phrases regarding their understanding of the
statement medical procedure and its possible complications, besides the fact that they
were given enough time to explain and ask questions.
Signature of the couple Husband full name
Wife full name
Signature
The guardian is deemed invalid for both.
Date/time
Interpreter statement, if Full name
necessary Employee No
signature
date, time
The witnesses (preferably The first and second witnesses: full name, signature, date, and time.
one of the patient’s
relatives)
The validity period of the Must not exceed 30 days from the date of signature.
form
Patient signature of
receiving a copy of the
informed consent form.

Twelfth: Consent supported by knowledge about organ or tissue donation procedures:

Content Explanation

Medical institution code According to the officially applicable rules

Informed consent title In both Arabic and English languages, with a bold and clear font.
Detailed information about Date/ department/ ward/ specialist or the physician name/ Job code/ contact
the authority, department, number
and the physician.
 Saudi Guidelines for Informed Consent 33

General authorization In both Arabic and English languages. However, the explanation must include
formula the acknowledgment of the authority holder (the patient or his guardian
and the relationship to him), general clarification about the organ or tissue
donation procedure All of that must be written in detail in both English and
Arabic languages.
Physician clarification Includes detailed information in Arabic and English languages, illustrative
details about the organ or tissue donation procedure including the patient’s
condition, consequent results, the alternatives, the related risks, and possible
complications, details about the transparency of the physician explanation to
the patient and giving him enough time to read and ask questions. Explaining
the possible psychological risks, the donor expected future health problems,
available alternatives for the recipient, and the donor’s right to change his
mind about donation at any given time.
Signature of the physician Employee full name
who took the consent Employee No
signature
date, time
Patient statement Detailed information using legal phrases regarding the patient understanding
of the medical procedure, its possible complication, and the fact that he was
given enough time to explain and ask questions.
Patient or legal guardian Patient full name
signature Signature
Guardian full name and his relationship to the patient
Signature
Date, time
Interpreter statement, if Full name
necessary Employee No
signature
date, time
The donor relation to the
patient
The witnesses (preferably The first and second witnesses: full name, signature, date, and time.
one of the patient’s
relatives)
The validity period of the Must not exceed 30 days from the date of signature.
form
Patient signature of
receiving a copy of the
Informed consent Form.
34 Saudi Guidelines for Informed Consent

Thirteenth: Consent supported by knowledge about organ or tissue transplantation procedures:

Content Explanation

Medical institution code According to the officially applicable rules

Informed consent title In both Arabic and English languages, with a bold and clear font.
Detailed information Date/ department/ ward/ specialist or the physician name/ Job code/
about the authority, de- contact number
partment, and the physi-
cian.
General authorization In both Arabic and English languages. However, explanations must
formula include the acknowledgment of the authority holder (the patient or
his guardian and the relationship to the patient), general clarification
about the organ or tissue transplantation procedure All of that must
be written in detail in both English and Arabic languages.
Physician clarification 6 Includes detailed information in Arabic and English languages, illus-
trative details about the condition of the patient, the nature of the
organ or tissue transplantation procedure, the consequent results, the
alternatives, the related risks, and possible complications.
And details about the transparency of the physician explanation to the
patient and giving him enough time to read and ask questions.
It also includes the explanation of the patient’s medical history, the
organ age, and condition, the risk of having some infectious disease
or the ones that cannot be predicted by the donor, psychological and
social risks resulted from the donation process, the predicated sur-
vival rate, and the expected and actual length of stay in the hospital.
Also, mentioning the expected percentage of transplant rejection and
the potential cost of immunosuppressive drugs (for uninsured pa-
tients).
Signature of the physician Employee full name
who took the consent Employee No
signature
date, time
Patient statement Detailed information using legal phrases regarding the patient under-
standing of the medical procedure, it is possible complications and
the fact that he was given enough time to explain and ask questions.
Patient or legal guardian Patient full name
signature Signature
Guardian full name and his relationship to the patient
Signature
Date, time

6 Procedure Guide for Organ Transplantation in the Kingdom of Saudi Arabia – 2nd edition, 2014
 Saudi Guidelines for Informed Consent 35

Interpreter statement, if Full name

necessary Employee No
signature
date, time
The witnesses (preferably The first and second witnesses: full name, signature, date, and time.
one of the patient’s
relatives)
The validity period of the Must not exceed 30 days from the date of signature.
form
Patient signature of
receiving a copy of the
Informed consent Form.

Fourteenth: Consent supported by with knowledge about Blood / Blood components Transfusion
procedures:

Content Explanation

Medical institution code According to the officially applicable rules

Informed consent title In both Arabic and English languages, with a bold and clear font.
Detailed information about Date/ department/ ward/ specialist or the physician name/ Job code/
the authority, department, contact number
and the physician.
General authorization formula In both Arabic and English languages. However, an explanation must
include the acknowledgment of the authority holder (the patient or his
guardian and his relationship to the patient), general clarification about the
procedure of transfusion of blood, or its Components.
All of that must be written in detail in both English and Arabic languages.
Physician clarification Includes detailed information in Arabic and English languages, illustrative
details about the transfusion of blood or its components procedure,
the condition of the patient and the need for blood transfusion or its
components, the consequent results, the alternatives, the related risks, and
possible complications and details about the transparency of the physician
explanation to the patient, and giving him enough time to read and ask
questions.
Signature of the physician Employee full name
who took the consent Employee No
signature
date, time
Patient statement Detailed information using legal phrases regarding the patient
understanding of the medical procedure and its possible complications
and the fact that he was given enough time to explain and ask questions.
Patient or legal guardian Patient full name
signature Signature
Guardian full name and his relationship to the patient
Signature
Date, time
36 Saudi Guidelines for Informed Consent

Interpreter statement, if Full name

necessary Employee No
signature
date, time
The witnesses (preferably one The first and second witnesses: full name, signature, date, and time.
of the patient’s relatives)
The validity period of the form Must not exceed 30 days from the date of signature.
Patient signature of receiving
a copy of the Informed
consent Form.

Fifteenth: Consent supported by knowledge about anesthesia and sedation procedures:

General/ local anesthesia/ Spinal anesthesia/ epidural anesthesia/ sedation

Content Explanation

Medical institution code According to the officially applicable rules

Informed consent title In both Arabic and English languages, with a bold and clear font.
Detailed information about the Date/ department/ ward/ specialist or the physician name/ Job code/
authority, department, and the contact number
physician.
General authorization formula In both Arabic and English languages. However, the explanation must
include the acknowledgment of the authority holder (the patient or his
guardian and his relative relationship to the patient), general clarification
about the anesthetic procedure, sedation and nature, and type of these
procedures (general anesthesia, local anesthesia, spinal anesthesia,
epidural anesthesia, and sedative drugs).
All of that must be written in detail in both English and Arabic languages.
Physician clarification Includes detailed information in Arabic and English languages, illustrative
details about the condition of the patient and the nature of the anesthetic
procedure, the consequent results, the alternatives, the related risks,
and possible complications and details about the transparency of the
physician explanation to the patient and giving him enough time to read
and ask questions.
Signature of the physician who Employee full name
took the consent Employee No
signature
date, time
Patient statement Detailed information using legal phrases regarding the patient
understanding of the medical procedure, its possible complications.
Also, the fact that he was given enough time to explain and ask questions.
Patient or legal guardian Patient full name
signature Signature
Guardian full name and his relationship to the patient
Signature
Date, time
 Saudi Guidelines for Informed Consent 37

Interpreter statement, if Full name

necessary Employee No
signature
date, time
The witnesses (preferably one The first and second witnesses: full name, signature, date, and time.
of the patient’s relatives)
The validity period of the form Must not exceed 30 days from the date of signature.
Patient signature of receiving a
copy of the Informed consent
Form.

Sixteenth: Consent supported by knowledge about giving patient’s information and data outside the
___domain of the direct medical care chain:
Provided that all the private/confidential information of the patient are not disclosed and that the
disclosure is only for its intended purpose as follows:
1) To report a death resulting from a criminal incident or to prevent the commission of a crime and may not be
disclosed in this case only to the relevant official authorities.
2) To report a communicable or infectious disease.
3) If the practitioner is defending a charge by the patient or his family related to his competence or his professional
practice.
4) To protect the patient or others from any risk.
5) If the patient/guardian agrees in writing to disclose it or disclosure to the patient’s relatives is useful for treatment.
6) If he is ordered to do so by a judicial authority.

Content Explanation

Medical institution code According to the officially applicable rules

Informed consent title In both Arabic and English languages, with a bold and clear font.
Detailed information about the Date/ department/ ward/ specialist or the physician name/ Job code/
authority, department, and the contact number
physician.
Required data In both English and Arabic languages. However, an explanation must
include adequate legal clarification of the required data and the reasons
related to their demands in both Arabic and English languages.
Patient or legal guardian Patient full name
signature Signature
Guardian full name and his relationship to the patient
Signature
Date, time
Interpreter statement, if Full name
necessary Employee No
signature
date, time
Signature of the patient affairs Full name
manager Employee No
signature
date, time
official seal
38 Saudi Guidelines for Informed Consent

Witnesses The first and second witnesses: full name, signature, date, and time.
The validity period of the form Must not exceed 30 days from the date of signature.
Patient signature of receiving a
copy of the Informed consent
Form. “in case it requested”

Seventeenth: Consent supported by knowledge about the rejection of examination and treatment:

Content Explanation

Medical institution code According to the officially applicable rules

Informed consent title In both Arabic and English languages, with a bold and clear font.
Detailed information about the Date/ department/ ward/ specialist or the physician name/ Job code/
authority, department, and the contact number
physician.
Required data Set the terms regarding common medical procedures that are being refused
including:
· Refusal of transfusion of blood or its components.
· Refusal of clinical examination.
· Refusal of the treatment, with clarification of the treatment type.
· Refusal of surgical procedure with an explanation.
· Refusal of taking a sample for examination with an explanation.
· Refusal of radiological examinations with an explanation.
Using proper legal phrases for disclaiming responsibility of the medical
institution and the staff for any complication that may occur because of the
refusal, written in both English and Arabic languages.
Patient or legal guardian Patient full name
signature Signature
Guardian full name and his relationship to the patient
Signature
Date, time
Interpreter statement, if Full name
necessary Employee No
signature
date, time
Exception Special cases for lifesaving or organ-saving are excluded.
The witnesses. “if any” The first and second witnesses: full name, signature, date, and time.
The validity period of the form Must not exceed 30 days from the date of signature.
Patient signature of receiving a
copy of the Informed consent
Form. “in case it requested”
 Saudi Guidelines for Informed Consent 39

Eighteenth: Consent supported by knowledge about participation in a research study:

Content Explanation

Medical institution code According to the officially applicable rules

Informed consent title In both Arabic and English languages, with a bold and clear font.
Detailed information about Date/ department/ ward/ specialist or the physician name/ Job code/
the authority, department, contact number
and the physician.
The approval number that
is issued by the research
ethics committee for scientific
research
General authorization formula In both Arabic and English languages. However, explanations must include
the acknowledgment of the authority holder (the patient or his guardian and
his relationship to the patient), general clarification about the procedures
that are related to the research study written in both Arabic and English
languages.
Researcher clarification Includes detailed information in both Arabic and English languages related
to the scientific research procedure and the policy of the medical institution
in the scientific research (giving the patient Arabic and English copies) with
an accurate description of the goals, procedures and consequent results
of the scientific research, the related alternatives, and risks, possible
complications, and services that will be offered to the patient in return.
Further, and details on the transparency explanation to the patient and
the fact of giving him enough time to read and ask questions. The patient
has the right to end his participation and quit the study providing that the
medical services offered to the patient won’t get affected.
In addition to explaining the patient role in the research and informing him
to maintain the confidentiality and security of information.
Signature of the researcher Employee full name
who took the consent Employee No
signature
date, time
Patient statement Detailed information using legal phrases regarding the patient understanding
of the medical and research procedure, its possible complications, and that
he was given enough time to explain and ask questions.
Patient or legal guardian Patient full name
signature Signature
Guardian full name and his relationship to the patient
Signature
Date, time
Interpreter statement Full name
Employee No
signature
date, time
The witnesses “if necessary” The first and second witnesses: full name, signature, date, and time.
The validity period of the form Must not exceed 30 days from the date of signature.
40 Saudi Guidelines for Informed Consent

Patient signature of receiving

a copy of the Informed
consent Form. “in case it
requested”

Nineteenth: Consent supported by disclaimer and knowing about photographic digital photography,
cinematographic and video recording, as well as using, storing, and retrieving of this data:

Content Explanation

Medical institution code According to the officially applicable rules

Informed consent title In both Arabic and English languages, with a bold and clear font.
Detailed information about the Date/ department/ ward/ specialist or the physician name/ Job code/
authority, department, and the contact number
physician.
Required data Set terms regarding necessary data and informative procedures to be
used including:
· Photographic images
· Digital images
· Video recording
· Digital recording
· Cinematography
· Data storing and restoring
· Satellite broadcasting (live or recorded) or through the internet.
· Broadcasting site, border, and details of the broadcast.
Using legal phrases in Arabic and English for disclaiming responsibility
of the medical institution and the staff in which the patient entitles the
medical institution and its staff to use these data according to the terms
within the agreement (newspapers- research magazines-medical books-
satellite broadcast channels –internet).
and details on the transparency explanation to the patient and giving him
adequate time to read and ask questions.
The patient has the right to end or quit participation in the agreement at
any time without affecting the provided medical services.
The purpose
Patient or legal guardian Patient full name
signature Signature
Guardian full name and his relationship to the patient
Signature
Date, time
Interpreter statement, if Full name
necessary Employee No
signature
date, time
Disclaim responsibility and
pledge not to reveal the patient
identity and not to use it for a
purpose other than that agreed
upon.
Witnesses The first and second witnesses: full name, signature, date, and time.
 Saudi Guidelines for Informed Consent 41

The validity period of the form Must not exceed 30 days from the date of signature.
Patient signature of receiving a
copy of the Informed Consent
Form. “in case it requested”

Twentieth: Consent supported by knowledge about the medical-dental procedure:

Content Explanation

Medical institution code According to the officially applicable rules

Informed consent title In both Arabic and English languages, with a bold and clear font.
Detailed information about Date/ department/ ward/ specialist or the physician name/ Job code/
the authority, department, contact number
and the physician.
General authorization formula In both Arabic and English languages. Explanations must include the
acknowledgment of the authority holder (the patient or his guardian and
his relationship to the patient), general clarification about the medical
and surgical dental procedure, and its details in both English and Arabic
languages.
Physician clarification Includes detailed information in Arabic and English languages about
illustrative details of the medical and surgical dental procedure, its results,
possible complications, details about the patient’s need for anesthesia or
sedation, the treatment plan, and details on the transparency explanation
offered to the patient and giving him enough time to read and ask questions.
Signature of the physician Employee full name
who took the consent Employee No
signature
date, time
Patient statement Detailed information includes legal phrases regarding the patient
understanding of the medical-dental procedure and its complications and
the fact that he was given enough time to explain and ask questions.
Patient or legal guardian Patient full name
signature Signature
Guardian full name and his relationship to the patient
Signature
Date, time
Interpreter statement Full name
Employee No
signature
date, time
The validity period of the form Must not exceed 30 days from the date of signature.
42 Saudi Guidelines for Informed Consent

Simplified Form to Unified Informed Consent Process

within the Healthcare Facilities:
First: Purpose
Unify the process of informed consent in the healthcare facility.

Second: Policies and Procedures

1) Healthcare facilities must provide a suitable environment when meeting the patient to take the informed consent.
2) Healthcare facilities must set policies and procedures to be followed whether the informed consent is signed or
not.
3) Healthcare facilities must introduce the healthcare practitioners and entitle them to implement the policies and
procedures of informed consent.
4) The physician or his deputy must explain the medical procedure before taking the informed consent from the
patient, his guardian, or his representative.
5) Healthcare facilities must follow a process that ensures easy delivery of the medical procedure information to
the patient, his guardian, or his representative before taking the informed consent.
6) The rights and obligations of the patient, his guardian, or his representative shall be taken into consideration
when obtaining the informed consent.
7) Healthcare facilities must protect the rights of medical practitioners.

Third: Procedures:
1) Informed consent place: At an office, emergency department clinic, a ward or the patient room, depending on
what is suitable and accessible for the case.
2) Convenient atmosphere with various amenities.
3) The patient privacy shall be taken into consideration.
4) Reachable place for the patient and the medical team.
5) The Attendance is limited to the concerned medical team and whoever the patient desire to attend from his
side.

Requirements to be fulfilled:
· Education tools and devices shall be provided to facilitate an explanation of the medical procedure.
· Illustrative diagrams of the procedure in the informed consent paper if necessary.
· In case of implantation of tools or devices in the patient body, the tools, and devices themselves or a photo
showing them must be displayed while taking the informed consent.
· Availability of a presentation tool to demonstrate the nature of the medical procedure.
· Providing suitable documents (software or hardware) to take the informed consent and all the required
stationaries.

Fourth: Medical Team:

1) The physician who performs the medical procedure or someone to represent him.
2) If more than one specialty is required, the physician or someone to represent him from the involved specialties
shall be present.
3) The medical team members from other specialties who are involved in the medical procedure.
4) An interpreter if the physician and the patient have no ability to speak the same language or a sign language
specialist if necessary.
5) Medical case manager or his representative to arrange the meeting.
6) Any team members should not attend if the patient does not want his attendance.
7) Make sure that only the eligible person is authorized to explain the informed consent.
 Saudi Guidelines for Informed Consent 43

Medical team ethics:

· Confidentiality and not to reveal the patient information.
· Not to violate the patient privacy.
· Deliver the information professionally and suitably, and not using incomprehensible medical terms.
· Make sure that the patient understands the medical procedure by explaining the treatment, the plan, and the
options available in an understandable way.
· Inform the patient of the importance of his opinion and that he is a partner of the treatment plan.
· Avoid the attendance of unwanted companion by the patient during the meeting.
· Not to exaggerate or underestimate the expected complications and the benefits of the treatment.
· Advising the patient to take any decision instead of enforcing him.
· Making sure that the medical procedure matches the information that the patient signed upon on the informed
consent.
Taking into consideration the lack of conflict in the opinions of the medical team before the patient or speaking in
a foreign language. In addition to, avoid taking any action that was not signed with approval.

The dialogue and discussion

· Dialogue and communication skills of the medical team with the patient.
· Choosing the proper time to make the discussion with the patient and medical team.
· The physician must be in a comfortable state to ask the patient for informed consent.
· Considering the professional communications in clear and understandable way to the patient, his guardian, or
his representative.
· The medical team shall Introduce themselves to the patient, showing their ID cards and verify the patient
identity.
· Making sure that the patient understands the medical procedure before signing.
· Asking the patient to explain the medical procedure.

Patient negative behavior and how to handle it:

· Crying (express compassion and concern for the patient and reduce his anxiety).
· The patient raising his voice (keep calm and show sympathy toward the patient in an appropriate way).
· Committing an assault toward the medical team (beforehand preventive measures such as availability of security
if needed).

Complications of the procedure, treatment alternatives, and expected response ratio that should be
mentioned:
· All major complications that are more than 1% likely to occur and minor ones more than 5% likely to occur.
· Complications that occur directly after the procedure and the ones that occur later (within 30 days after the
procedure).
· The expected response percentage (success of the procedure).
· Different treatment alternatives accessible in the same facility or elsewhere according to the medical team
knowledge.

Fifth: Patient:
Conditions for whom entitled to take the treatment permission:
· Male or female patient with full capacity and awareness.
· In case of a child patient, one of the parents, preferably the father.
· In case the patient in coma state with no relatives while two specialist physicians of the same specialty agreed
the importance of an intervention and the patient shall be notified of it later.
· Children whose parents have divorced; the decision is taken by the child guardian (refer to the guardian part in
the informed consent).

Patient rights in taking the informed consent:

· The patient has the right to choose the physician according to the available capabilities of the healthcare facility
44 Saudi Guidelines for Informed Consent

and the adopted policy of distributing cases to doctors.

· The patient is entitled to the necessary treatment for his condition, respecting his right to refuse and interfere in
his condition in the case of life-saving , emergency intervention, or compulsory treatment. Not neglecting him if
he refuses any of the medical procedures.
· Knowing the other treatment alternatives available at the facility or elsewhere according to the offered information
for the treatment team.
· The patient has the right to take the opinion of another physician according to the capabilities and the availability
of the appropriate health services.
· All expected complications must be explained to the patient while mentioning its incidence rate including major
ones that are 1% or more likely to occur and minor ones that are more than 5% likely to occur.
· Giving the patient a suitable time limit to think before deciding on the medical consent.
· Cancellation of the consent of medical procedure after the sign.

Patient’s obligations for the informed consent:

1) The patient signature is necessary whether he accepted it or rejected it.
2) It is necessary to read the consent carefully, understand the medical procedures, and inquire before signing.
3) It is necessary that the patient, his guardian, or his representative disclose the health problems and medical
history that affect the medical procedure.
4) Commitment to the medical procedure instructions.

The result (approval and refusal):

Procedures and actions after taking the patient’s approval:
· Documenting the consent by writing it clearly in the patient file.
· Starting to prepare the patient for the medical procedure.
· Considering psychological and religious support of the patient.

Procedures and actions after taking the patient refusal:

· Respecting the decision of the patient, his guardian, or his representative. Also, giving medical advice when
necessary.
· Re-explain the medical procedure and clarification of the complications that may occur if the procedure was not
conducted.
· Make sure that the patient understands the consequences and risks and ask him to explain them.
· Patient signature of rejection with a declaration of the consequent complications if the procedure was not
carried out.
· His rejection must not affect his right to receive other treatment services.
· Considering the religious and psychological support according to the reason for rejection.
· Re-explain the alternative medical procedures.

Sixth: Responsibilities
Administration of the facility
· Making sure all the practitioners know the medical procedure consent policies.
· Ensuring that the medical procedure consent policy is followed and implemented by all the staff in the hospital
as part of the patient’s rights.
· Measuring the quality of the informed consent.
· Evaluating patient experiences with the informed consent.
· Improving patient experiences and quality of the informed consent.
· Protecting of the practitioner right in case of unexpected complication happened, knowing that it was mentioned
to the patient in the informed consent and the physician followed the known scientific procedure, in such case,
the facility holds the responsibility to defend the practitioner in front of the judiciary.

Department heads:
1) Making sure that all the staff in the department recognizes and implements the policy.
2) Providing prepared forms for common procedures in the department or taking forms presented by a specialized
 Saudi Guidelines for Informed Consent 45

scientific associations.
3) Measuring the quality of informed consent in the department.
4) Evaluating patient experience related to their department.
5) Improving patient experiences and quality of the informed consent in the department.
6) Activating the role of the audit committees in reviewing cases, morbidity, and mortality to distinguish between
complications and medical errors periodically and in line with safety standards and CBAHI requirements. Also,
to protect the rights of both patients and practitioners.

Physicians and nursing

1) Physicians, nursing, and medical staff cooperate to make sure of the written and signed patient consent before
the procedure date according to the policy of the informed consent, written with time being specified.
2) The nursing makes sure that the written consent exists in the patient’s medical file, complete and signed by the
patient, his guardian, or his representative.
3) Medical Records and Information System Department.
4) Making sure that all consents of patients who went through an operation in the hospital are included in the
patient’s file.

Forms:
· Unifying the forms of the informed consent.
46 Saudi Guidelines for Informed Consent

Appendix (1):
Recommendations that require attention when taking informed consent:

First: mistakes in choosing the medical team

• Unnecessary attendance of a medical team member.
• The absence of the physician who is responsible for the case or someone to represent him.
• Conflict of opinions between the medical team members during the meeting.
• The presence of unwanted practitioner by the patient.
• The physician failure to attend the meeting.
• Entitle another physician who lacks information about the procedure and not the physician himself to explain it.
• The absence of an interpreter despite the need.

Second: medical team mistakes during the discussion:

• Filling the informed consent form before meeting the patient.
• Frequent interruption of the patient.
• Failure to verify the patient’s identity.
• Giving wrong information to the patient
• Failure to follow the ethical dialogue when discussing with the patient.

Third: Mistakes from the patient side

• Failure to sign the refusal to carry out the medical procedure.
• Signing without reading the informed consent form.
• Hesitation of making the medical procedure to approve or refuse (a time limit is given depending on the case)
before having the committee opinion.
• Taking another information and patients experiences in non-medical procedures.

Fourth: medical team common mistakes

• Failure to document the informed consent in the patient file.
• Performing unnecessary medical procedures not included in the form signed by the patient.
• Failure to clarify the major and expected complications in case the patient refused to do the medical procedure
or to sign.
• Failure to ensure the understanding of the patient, his guardian, or his representative to what was explained to
them.
• Using medical terms or words that are not comprehensible to the patient.
• Asking to sign informed consent as a routine procedure.

Fifth: Common mistakes in choosing a place

• The existence of something that distracts or prevents the patient from understanding.
• The existence of something that violates the privacy of the patient during the process of explaining the medical
procedure.
• The presence of people or relatives that the patient does not want them to know about his condition.
• Unreachable place.

Sixth: Common mistakes from patient side:

• Failure to sign the refusal or acceptance to carry out the medical procedure.
• Signing without reading the informed consent form.
• Hesitation of making the medical procedure to approve or refuse (a time limit is given depending on the case)
before having the committee’s opinion.
• Taking another information and patients experiences in non-medical procedures and based on these the patient
accepts the informed consent or rejects it.
 Saudi Guidelines for Informed Consent 47

Additional notes:
• Training on the informed consent procedures is deemed a part of the professional training for every practitioner,
however, the head of the department sets all the requirements and submits them to the training department
that organizes training programs about the informed consent regularly, also there should be on site training to
ensures that these procedures are being implemented.
• The practitioner has to make sure that the patient is capable of understanding all the given information,
however, there might be a need for an interpreter if the patient speaks a different language to interpret all the
written information and help the patient to give the right consent.
• The practitioner must act within his authority and not accept any sort of pressure by anyone to acquire a patient’s
consent to perform a procedure that he does not feel competent to do. However, he must communicate with
the director for consultation and support.
• It is necessary for the practitioner to document the patient’s consent by writing all the discussions that have
led to the approval using the consent form and documenting them in the patient’s notes even in cases of
procedures requiring verbal consent.

The guide will be updated and we are pleased to receive your suggestions so that the committee can review
the proposals and include them in updated version via the following e-mail
[email protected]
48 Saudi Guidelines for Informed Consent

English references:
• Pollack, Daniel, Getting Informed Consent - More Than Just a Signature Policy & Practice, Vol. 62, No.
2, June 2004
• Stephen Wear, Informed Consent: Patient Autonomy and Clinician Beneficence within Health Care ,
Georgetown University Press, 2( 1998nd edition)
• Stunkel, Leanne Comprehension and Informed Consent: Assessing the Effect of a Short Consent Form;
etal IRB: Ethics & Human Research, Vol. 32, No. 4, July-August 2010
• Handbook of Surgical Consent Edited by Rajesh Nair and David J; 2011
• Consent: patients and doctors making decisions together - General Medical Council- 2008
• Informed Consent: Legal Theory and Clinical Practice; 2001
• Informed Consent; Sandra Glahn 2007
• Informed Consent: Patient Autonomy and Clinician Beneficence within Health Care ; 1998
• Joint Commission International Accreditation Standards for Hospitals -Joint Commission Resources
2017
• Policy and procedures of Informed consent at PSMMC, KFMC, KFSH
• Informed consent in health and social care research: guidance for nurses2011- Second edition
• The History and Theory of Informed Consent; 1986
• A Practical Guide to Informed Consent- https://www.templehealth.org/ICTOOLKIT/html/ ictoolkitpage1.
html – 2018
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