Irb ghiath alahmad
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Transcript of Irb ghiath alahmad
19791947 1964 20101982 1996 2004
19791947 1964 20101982 1996 2004
199619791964 2004 201019821947
19961964 2004 2010198219791947
19961964 2004 20101979
International Ethical Guidelines for Biomedical Research Involving
Human
1947 1982
19791964 20101982 20041947 1996
19791964 20101982 1996 20041947
19791964 20101982 2001 20031947
19791947 1964 20101982 1996 2004
Informed Consent
Benefit and Risk
Ethics Committee
Respect for Person
Benef icence
Just ice
(1) Approval from relevant regulatoryauthorities
(2) Ethical approval(3) Informed consent
The interests and welfare of the individual should havepriority over the sole interest of science or society.
The role of the REC extends beyond theinitial review
and approval of research study, including:
Conductingregular review ofongoing research
Reviewing allmodificationsand amendments toapproved research
Monitoring activeresearch studies forcompliance
Investigatingproblems that couldimpact the safetyof participants
• Review continues after initial approval:
▫ Amendments/Revisions
▫ Serious Adverse Events
▫ Continuing Review
After Approval
C o n t i n u i n g R e v i e w
IRBAnnually
If requested
Make sure that the informed consent still
reflects current risks, benefits and
alternativespurpose
C o n t i n u i n g R e v i e w
IRBAnnually
If requested
Information desiredNumber enrolled
Problems encounteredIs the study still appropriate (literature
review)?
AE
SAE
Product
•Death• Life threatening•Hospitalisation•Persistent disability/incapacity•Congenital anomaly
Unanticipated
AE
USAE
No Reporting
Reporting in 48 hours
Reporting in 10 days
SignSymptomDisease
AR
•Clinical investigators
•Study coordinators
•Research technicians
•Research officials
•IRB members
•Consulting fees
•Stock ownership
•Honoraria & Salary
•Intellectual propertyrights
•Enrollment bonuses
•Spouse / dependentfinances
•Pressure to publish
•Professional competitions
•Career advancement
Types of Conflict of Interest
Individual Institutional Financial Professional
•Financial holdings ofthe institution
•Decisions regardingresearch funding
•or allocation ofresources forresearch
National CommitteeOf
Bio-Medical Ethics
Monitoring officeOf
Research Ethics
Local Committees
National
KACST
Saudi
Conflict of interest
Just through emails!
Appointed to only one member
Uncompleted IC
……………………
…………
Try to avoid…
Final words