Inform Consent for Ethical Issues in health care

1. (
‫التوفيق‬ ‫هللا‬ ‫نسأل‬ ‫للجميع‬ ‫هدية‬ ‫المحاضرات‬ ‫هذه‬
)
INFORMED CONSENT
‫المتنورة‬ ‫الموافقة‬
Dr EZIZ ALFAHD
afkaabba@gmail.com

3. ‫قبل‬ ‫إذن‬ ‫على‬ ‫للحصول‬ ‫عملية‬ ‫هي‬ ‫المستنيرة‬ ‫الموافقة‬
‫أو‬ ،‫ما‬ ‫شخص‬ ‫على‬ ‫الصحية‬ ‫الرعاية‬ ‫تدخل‬ ‫إجراء‬
‫الشخصية‬ ‫المعلومات‬ ‫عن‬ ‫للكشف‬
.
‫مقدم‬ ‫يطلب‬ ‫قد‬
‫العالج‬ ‫تلقي‬ ‫على‬ ‫الموافقة‬ ‫المريض‬ ‫من‬ ‫الصحية‬ ‫الرعاية‬
‫ف‬ ‫ا‬ً‫ك‬‫مشار‬ ‫السريري‬ ‫الباحث‬ ‫يطلب‬ ‫قد‬ ‫أو‬ ،‫تقديمه‬ ‫قبل‬
‫ي‬
‫سريرية‬ ‫تجربة‬ ‫في‬ ‫الشخص‬ ‫هذا‬ ‫تسجيل‬ ‫قبل‬ ‫البحث‬
.
‫ي‬
‫تم‬
‫من‬ ‫التوجيهية‬ ‫للمبادئ‬ ‫ا‬ً‫ق‬‫وف‬ ‫المستنيرة‬ ‫الموافقة‬ ‫جمع‬
‫البحث‬ ‫وأخالقيات‬ ‫الطبية‬ ‫األخالقيات‬ ‫مجاالت‬
.

4.  Obligation to be Truthful
 Engenders Patient Trust
 Develops Patient
Autonomy
 Integrity of the Profession
 Legal issues

5.  Beneficence
 Obligation to maximize benefit
 Obligation to minimize harm
 Non-maleficence
 Doctrine of “primum non nocere”
 No deliberate harm
 Justice
 Equals should be treated equally
 Autonomy (self governance)

6.  The Physician:
 Must have the best interests of the patient in mind
 Minimally influenced by other concerns
 The Patient:
 Must trust that the physician their advocate/agent

7.  The Physician:
 Must not intentionally harm or disadvantage a
patient.
 The Patient:
 Must trust that the physician will not willingly
harm

8.  Prohibition against denying benefit:
 Capriciously
 By selective criteria
 Obligation not to “selectively burden”

9. Patient’s self governance: “Being one’s
own person, without constraints either by
another’s action or by psychological or
physical limitation.”

10. Informed Consent
 NOT just a signed document
 NOT a one time event
A process of shared
decision-making
between subject
and investigator.
• Consent- is An
Autonomous
authorization of
a medical
intervention
by… individual
patients-
(Beauchamp
(2004)

11. Historical Background
 THE BELMONT REPORT (1979)
 DECLARATION OF HELSINKI (1964, as
amended 1975, 1983, 1989, 1996 and
2000,2004,2008,……)
 The NUREMBURG CODE (1949)

12. Declaration of Helsinki
 World Medical Association (WMA) -General
Assembly (GA), Helsinki, Finland, June 1964
◦ Amended by WMA-GA –Tokyo, Japan, Oct 1975
◦ Amended by WMA-GA – Venice, Italy, Oct 1983
◦ Amended by WMA-GA – Hong Kong, Sept 1989
◦ Amended by WMA-GA – South Africa, Oct 1996
◦ Amended by WMA-GA – Edinburgh, Scotland, Oct 2000
◦ 2004,2008,…………

13. Nuremberg
Code
Informed Consent
IOMS
Autonomy
Respect for Persons
CIOMS
Belmont
Report
Declaration of
Helsinki
Codes of Research Ethics

14. WHY is Consent important?
• Ethics -Autonomy: Respect for persons
– Allows individuals to decide for themselves and fully
informed consent is an ethical issue to be considered
• Self-protection from risky research – benefits of people
• Law and Regulation- it is a legal requirement to
obtaining a consent for patients.
• Fiqihi in Islamic Culture
• Policy
international health organizations support informed
consent polices

15. Requirements of Research Ethics
 1.Community Partnership
 2.Social value
 3.Scientific validity
 4.Fair subject selection
 5.Favorable risk-benefit ratio
 6.Independent review
 7.Informed consent
 8.Respect for human subjects

16. In what situations might you
need informed consent?
 Treatment
 All surgical operations
 Most other medical interventions
 Tissue/Organ donation
 Research

18. 18
Consent across cultures
It takes a community to make
a decision
Boateng
Sadaf
Ghaiath
Mary Anne

19. Informed consent
(Disclosure)
‫واإلفصاح‬ ‫األخبار‬
Informed
Relative
informations
Voluntary
(Free and No
coercion ‫بدون‬
‫وباختياره‬ ‫إكراه‬
)
Decision-
Making
Capacity
Understanding
Appreciation
communication
Reasoning
Expression of
a Choice
VALID CONSENT

20. Informed Consent Process
 Contents:
 1. Purpose of informed consent
 2.explian the Procedures
 3. Risks (DO NOT MINIMIZE)
 4. Benefits (DO NOT OVER ESTIMATE)
 5. Alternatives treatment
 6. Confidentiality of Record
 7. Withdrawal any time
 8. Medications and their side effects
9.Compensation
 10.Who will contact

22. Who Gives Informed Consent?
Informed consent is …
“consent given by a
competent individual who:
• has received the necessary information
• has adequately understood the information
• arrives at a decision without being subjected
to coercion or undue influence

23. Capacity
 How would you assess capacity
of the subject to make a
decisions?
◦Short interview after disclosure
◦Short answer questions
◦Distinguish between short-term
memory and understanding

24. WHAT to Disclose?
Elements of informed consent

25. 25
 Physical / mental.
 Social.
 Do not over
promise benefit.
 Physical / mental.
 Social.
 Psychological
(anxiety).
 Risks to personhood
(being violated).
 Inconvenience (time).
 Do not under estimate
risks.
Types of benefits: Types of Risks:

27. WHO MAY NOT ABLE TO
DO INFORMED CONCENT
1-Childres
2- Elderly- Old
3- Mentally Disable
4-Emergency cases
5-Alchohol or Drugs Abuser
6- Others- delivery baby

28. Challenges regarding informed
consent
Four main challenges:
◦Illiteracy
◦Culture, traditions and religion
◦Stored biological samples
◦Child assent

29. Children
 Every routine intervention that is undertaken
on the child requires consent from the
parents.
 If the child is able to understand some
aspects of the research study, then his or
her “assent” must be obtained in addition to
the parents’ permission.

30. Child Assent
 What ages?
◦ 7 years – 14 years – 16 years – 18 years – 19
years – less than 21 years???
 Written vs oral
 What information should be given?

32. ‫والطبي‬ ‫الحيوية‬ ‫لألخالقيات‬ ‫الوطنية‬ ‫اللجنة‬
‫ة‬
‫التالي‬ ‫العنوان‬ ‫على‬ ‫للجنة‬ ‫اإللكتروني‬ ‫الموقع‬
:
www.kacst.edu.sa/bioethics

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34. Informed Consent
 NOT just a signed document
 NOT a one time event
A process of shared
decision-making
between subject
and investigator.
• Consent- is An
Autonomous
authorization of
a medical
intervention
by… individual
patients-
(Beauchamp
(2004)