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Dr Ghaiath Hussein
Dr Ghaiath Hussein
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Informed Consent Ghaiath M. A. Hussein MBBS, MHSc. (Bioethics)
INFORMED CONSENT ,[object Object],[object Object],Ghaiath Research Ethics, Dec. 08.
Definition : ,[object Object],[object Object],Ghaiath Research Ethics, Dec. 08.
Components of FIC : ,[object Object],[object Object],[object Object],Ghaiath Research Ethics, Dec. 08.
FORMS OF CONSENT ,[object Object],[object Object],[object Object],[object Object],Ghaiath Research Ethics, Dec. 08.
Practical challenges to a "Fully Informed Consent" ,[object Object],[object Object],[object Object],[object Object],[object Object],Ghaiath Research Ethics, Dec. 08.
Ghaiath Research Ethics, Dec. 08.
1. Disclosure ,[object Object],Ghaiath Research Ethics, Dec. 08.
Eight Required Elements [45 CFR 46.116(a) & 21 CFR 50.25] ,[object Object],[object Object],[object Object],[object Object],[object Object],Ghaiath Research Ethics, Dec. 08.
Eight Required Elements [45 CFR 46.116(a) & 21 CFR 50.25] ,[object Object],[object Object],[object Object],Ghaiath Research Ethics, Dec. 08.
Six Additional Elements ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Ghaiath Research Ethics, Dec. 08.
Informed Consent Document and Risks to Subjects ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Ghaiath Research Ethics, Dec. 08.
Waiver of Informed Consent (not permitted in FDA-regulated studies) ,[object Object],[object Object],[object Object],[object Object],[object Object],Ghaiath Research Ethics, Dec. 08.
Documentation of Informed Consent ,[object Object],[object Object],[object Object],[object Object],[object Object],Ghaiath Research Ethics, Dec. 08.
Principles for providing information to the participant: ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Ghaiath Research Ethics, Dec. 08.
2. Capacity : ,[object Object],[object Object],[object Object],Ghaiath Research Ethics, Dec. 08.
3. Voluntariness : ,[object Object],[object Object],[object Object],[object Object],[object Object],Ghaiath Research Ethics, Dec. 08.
VOLUNTARINESS ,[object Object],[object Object],[object Object],[object Object],[object Object],Ghaiath Research Ethics, Dec. 08.
MANIPULATION ,[object Object],[object Object],[object Object],[object Object],Ghaiath Research Ethics, Dec. 08.
CIRCUMSTANTIAL INFLUENCE ,[object Object],[object Object],[object Object],Ghaiath Research Ethics, Dec. 08.
C. Confidentiality ,[object Object],Ghaiath Research Ethics, Dec. 08.
Measures to respect confidentiality ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Ghaiath Research Ethics, Dec. 08.
Case ,[object Object],[object Object],Ghaiath Research Ethics, Dec. 08.
Case …cont. ,[object Object],[object Object],[object Object],Ghaiath Research Ethics, Dec. 08.
DISCUSSION… Q & A Now try your own consent form… Ghaiath Research Ethics, Dec. 08.
References ,[object Object],[object Object],[object Object],[object Object],[object Object],Ghaiath Research Ethics, Dec. 08.

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informed consent

Editor's Notes

  1. Prospective IC: This approach suffers from all the weaknesses associated with advance directives, and is rarely applicable to the conditions relevant to emergency research, such as sudden cardiac arrest or motor vehicle trauma.