Revision

Dr.Abeer AL Ghalbi
ILOS:
• Knowledge & Understanding:
-Describe the components of consent based on international standards.

• Skills :
-Reconstruct the skill of obtaining consent about clinical procedure.
-Take a complete consent as per given instructions.
What is “Consent’’ ?

Defined as permission, approval or assent.

Touching a person without consent constitutes as a battery.

Putting a person in fear of being touched without consent is an assault.

Types of consent :
• Either oral or written consent by the patient to
undergo a specific procedure or treatment.
Expressed consent: • Examples: disclosing personal health
information. ‫يعني مثال احد اتصل ويبغى معلومات عن املريض الفالني‬

Not written or verbal

• Inferred from the circumstances.
• It is rarely documented and is relied upon
some types of care or treatment that is ‫مثال واحد جاء يسوي‬
Implied consent: -Vaccination
routine and doesn’t involve significant risk. -Flu shot
• Examples: rolling up sleeve for flu shot.
What is ‘’informed’’ consent ?
• Consent given by the physician to the patient based on knowledge of
the procedure to be performed, including its risks and benefits as well
as alternatives to the propped treatment.
• The purpose of consent:
- Respect subject’s will.
- Understand nature of the research.
- Be informed of purpose, risks, benefits and alternative treatments.
-------------------- To Make a Voluntary Decision about Participations.
Informed consent elements:
A
Description
of the
procedure.

Assessment of
Risks vs.
patient
Benefits.
understanding.

Risks & Benefits

Alternatives.
of alternatives.
Continue informed consent elements
(usually research purpose):
Basic Additional
elements: elements:
elements: 0
Also called 8 mandatory
Unexpected risks,
costs, Termination,
-Purposes, risks , benefits, Consequences of
alternatives, withdrawal, number
confidentiality, Information of subjects, new
β
Compensation, Contact, findings.
Voluntary.
 o element (purpose and risks):
Basic
• Description purpose (duration, experimental or not &its nature)and of
any reasonably foreseeable risks or discomforts to the subject.
-Any risks that More likely to occur” are risks that are
frequent/common. E.g. ( minor bleeding from the sample
site).

-risks that are serious. For examples drugs that cause steven
Johnson's syndrome.

- risks that the research is evaluating and that an individual

would not otherwise be exposed to if they were to decide not
to participate in the research e.g. ( environmental and social )
 Basic element(benefits & alternatives):

• Description of any benefits to self or to others that result from

Benefits : the study or treatment. Financial or social.

• A disclosure of appropriate alternative procedures or courses

Alternatives of treatment, if any, that might be advantageous to the
subject. E.g. medical vs surgical.
 Basic element( confidentiality ):

A statement describing the extent, if any, to

‫ما يذكر أسم املريض لكن بعض‬
which confidentiality of records identifying the
‫املستشفيات تشير لهم بأرقام مثال‬
subject will be maintained;

For example, “confidential” information in drug used in

a psychiatric study will kept between a psychologist
and client may differ, depending on cultural or legal
influences. Some cultures allow for information to be
kept only between the individual client and
psychologists, whereas others may allow for close
family members to be consulted.
Basic element(compensation):

1-For research involving more than minimal risk, an explanation as to

whether any compensation ‫أوضح إذا كان فيه أي تعويض للخطر اللي يتعرض له‬

• Finical or social.

2-an explanation as to whether any medical treatments are available if

injury occurs.

s
• if so, what they consist of, or where further information may be obtained
Study on patient take hypertension drug and it can cause hypotension that lead to
drowsiness or syncope is there any compensation or treating him freely if the injury occurs
 Basic element ( contact & voluntary ):

• An explanation of whom to contact for answers to

pertinent questions about the research and research ‫يعني املريض الزم‬
subjects' rights, e.g. the researcher or the doctor. ‫يعرف يتكلم مع مني لو‬
contact ‫صار له مشاكل أو إذا‬
• 2-whom to contact in the event of a research-related ‫عنده اسئلة عن البحث‬
injury to the subject; doctor office or the emergency ‫أو العالج‬
department.
• statement that participation is voluntary, refusal to
participate will involve no penalty or loss of benefits to
which the subject is otherwise entitled, and the subject
voluntary may discontinue participation at any time without penalty
or loss of benefits to which the subject is otherwise
entitled.
Additional elements ( when appropriate ):

Unexpected risk : statement that the particular treatment or procedure may

involve risks to the subject e.g. Participant became pregnant.

Termination: Anticipated circumstances under which the subject's

participation may be terminated by the investigator without regard to the
as
subject's or the legally authorized representative's consent.
‫يعني لو وقف املشاركة مايكون عليه مثال‬
facility‫مشاكل قانونية مع ال‬

Costs: Any additional costs to the subject that may result from participation in
the research. Travelling from facility
Continue Additional elements (when appropriate):

Consequences of withdrawal: Any consequences of a subject's decision to withdraw

from the research and procedures for orderly termination of participation by the
subject.

New findings: statement that significant new findings developed during the
course of the research that may relate to the subject's willingness to continue
participation will be provided to the subject.

Number of subjects: The approximate number of subjects involved in the study.

Requirement for consent :

Competence. Understanding.

Requirement of
consent

Voluntariness Disclosure.
Continue Requirement for consent :
• Competence: ability ( through value & assessment ) to perform a
certain task.
• Voluntariness: not forced by respecting the participant autonomy.
Continue Requirement for consent :
• Understanding :
The participant should be able to understand the nature of the procedure, risks
&alternative, benefits and probable outcome.
-Minors ( less than 18 years old) assent from them and consent from parents
should be obtain.
So, NO understanding = No consent. ‫ركزت عليها بالشرح واملراجعة‬

• Disclosure:
Discussing relevant information for shared decision-making.
 Exception to informed consent

the patient is life-threatening voluntary

‫غير مؤهل‬ incapacitated emergencies with waived
inadequate time consent.
to obtain consent ‫مثال املريض يقول‬
Child ‫للدكتور سوي كل اللي‬
lato ‫أنت تشوفه صح‬
Surgery
Adult unable to
make decisions Blood Patient loss a lot of blood during surgery
‫زي املجنون‬
transfusion
‫ وقالك ما اقدر اقرر خل زوجتي‬Severe depression ‫مثال واحد عنده‬
treatment ‫تقرر وش تسوي؟‬
Take wife decision about the procedure in the same
time (Share the decision between you and his wife)
Continue …Exception to informed consent
Incapacitated Patients:
• with exception :
‫ ونص متزوج‬17 ‫يعني مثال واحد عمره‬
• a-under 18 and married, 🤏 😬 ‫اخذ املوافقة منه مو من أهله‬
Minors • b-serving in the military,
(<18yrs ) in
• c- able to prove financial independence or
• d-mothers of children (married or not).
Divorced

• Unconscious patients.
• Mentally incapacitated patients:
a-Patients with mental illness such as schizophrenia.
Adult who is B-Patients with mental disabilities or dementia diseases
that affect their perception, including mentally retarded
patients (moderate to severe).
Mild mental retarded he will decide for himself
Continue …Exception to informed consent

Gradians of anticipated patients in KSA:

1-Father. ‫بالترتيب‬
2-mother.
3- Grandfather ( Father side).
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. ‫إذا مره ماعنده أي أقارب من جهة األب الحكومة تقرر‬

Guardianship Expiration:
1. When a minor reaches maturity. 1870
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.
Ca
Types of Decision-Making:
‫تقول مهمة مره الزم تعرفوا الفرق‬

Paternalistic Doctor give his opinion and patient just

Doctor
Dr opinion Patient complained for him

Informative Doctor give information and the

Doctor
Information Patient patient decide
Will decide eventually

Shared Info’s Doctor give information and his opinion

Doctor
Patient and both of them decide
+ opinion
Shared Decision Making:

‫نفس اللي تحت‬

5 steps to shared Designs Making.. Summary:
SHARE
Step 1: Seek your patient's participation.
Ask

Step 2: Help your patient explore and compare treatment options.

Step 3: Assess your patient's values and preferences.

Step 4: Reach a decision with your patient.

Step 5: Evaluate your patient's decision.

 you have to know bene ts ‫قالت‬
‫بعدين قالت ال وسكبت الساليد‬
Benefits of shared Designs Making:
• Improved patient education
• Decreased patient anxiety
• Decreased decisional conflict
To the patient • Appropriate patient expectations
• Improved patient satisfaction
• Improved patient outcomes ‫الن املريض يكون مختارها معك وعارف فيلتزم بالخطة العالجية‬

• Setting appropriate patient expectations.

• Improving patient compliance & satisfaction. Fasting before endoscopy

The outcome • Reduce medical malpractice rates.

• Higher quality designs.
• Improving the outcomes.
Ethical consideration in shared-decision making :
Autonomy is the most
ethical method used in ‫اهم حاجة‬
Autonomy the informed consent
‫استقاللية املريض في القرار‬

Justice Beneficence

Fidelity Nonmaleficence
Autonomy in shared making decision:

It is the right of patients to make decisions about their medical care without experiencing
undue influence from their health care providers.

The word “shared” doesn’t refer to who makes the decision, but instead to the process
by which patients and physicians make those decisions.

Shared decision making is a process that promotes patients’ relational autonomy.

It means respecting the autonomous decision-making ability of the patient.

‫يعني حتى لو قرار املريض مو عاجب الطبيب الزم يمشي على حسب قرار املريض‬ Ex: pt. signed by DNR you have to respect it
Beneficence in shared decision making:
• It is the principle to benefiting patients and accepting the responsibility
to do good in professional way including the patient's decision-making
and applying it in the informed consents.
• that includes:

Providing best Provide best shared Referring patients when

management possible decision making statgies needed.
 ‫إخالص‬

Fidelity in shared-decision making

• This principle refers to being faithful to commitments, including
promise keeping, trustworthiness and loyalty by :

Avoiding conflicts of interest that

could compromise management. ‫اول مايشك املريض بالطبيب وقدرته‬

Keeping information confidential.

Adherence to therapeutic consent

Justice in shared-decision making:
• Never discriminate and treat everyone equally regardless of their:

age gender
color Socioeconomic
status
religion race

Origin
culture Disability
Challenges of shared Designs Making:

We do it already Takes too much time

Don’t have right

Patient don’t want it Pt. refuse make decision with his doctor
tools

Can't measure
it
‫? ‪How to perform a consent‬‬

‫مثال ما ألخمه واقوله اآلن توقع !‬

Continue…How to perform a consent ?
•Any consent 1-Name and purpose of treatment & the diagnosis of the condition.
should
include: 2-Benefits, risks, and alternative procedures & benefits and risks of each
alternative.
3-A statement that the study involves research. ‫الزم املريض يعرف كم معاه بالدراسة‬
‫ وكم‬outcomes‫ووش املطلوب منه وال‬
‫املدة وهل ممكن يترك املشاركة أو ال‬

4-An explanation of the purposes of the research.

5-The expected duration of the subject's participation.

6-A description of the procedures to be followed and Identification of any

procedures which are experimental.
7-A description of any reasonably foreseeable risks or discomforts to the
subject.
You must …ensure 4 things during the process:
• Introduce your self, smile and greet the patient.
Privacy
• asking the patient to talk privately (pt will choose alone or not).
8-4 ‫مثال ما اروح أوقات الزيارة من الساعة‬

• Ensure patient sanity, age, information processing capacity.

Cognition • Explain the treatment in understandable language and the
options.

• Asking: (do you understand your illness)? Tell me how much

you know about the procedure? What do you expect from the
Confirms pt understanding treatment? Do you understand your options? Do you
understand the risks ?

• Insure signing by his/her free well.

• Signing after fully understudying and offering shared
Consent signing decision making.
• Signing the document by (patient & physician) and greeting
Resources:
• Saudi-Guidelines-for-Informed-Consent.pdf (moh.gov.sa)
‫تقول مو الزم تقرون املرجع املحاضرة كفايه‬