INFORMED CONSENT- 2023-.ppt
- 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
- 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)