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Dr.Tamer Hifnawy MD. Dr. “PH”
Associate Professor of Public Health
Faculty of Medicine BSU. University- Egypt.
College of ...
 What is an IRB/REC?
 The need for established REC`s
 When do I need REC?
 Roles and composition of REC.
 Ethics Revi...
Research Ethics committee (REC)
Institutional review board (IRB)
Tamer Hifnawy MD. Dr.PH
Research Ethics Committee (REC)
=
Institutional Review Board (IRB)
Tamer Hifnawy MD. Dr.PH
Advancement of Science
Protection of
SubjectWelfare/Rights
BalancingTwo Goals
Tamer Hifnawy MD. Dr.PH
International guidelines1 require that an
independent committee perform an
Ethical and Scientific review of
biomedical res...
 Make research studies better!!
Enhance study design
Enhance protection of
subjects
 Enhance researcher reputation
 Inc...
 Before any research activity
 At least 2 weeks before meeting date
 Allow at least 1 month “for full board
review”
No ...
TOO
LATE !!
No post Conduction approval
1. A signed and dated application form
2. Full protocol.
3. Informed consent
4. CV`s for the PI and co-investigators.
5. A...
Qualifications & experience
At least one
With the scientific
background
Include men and women A community representative
A...
Level of Risk DeterminesType of Review
Low Risk Higher Risk
Expedited Full
Tamer Hifnawy MD. Dr.PH
Sleem, H., El-Kamary, S., & Silverman, H. J. (2010). Identifying
structures, processes, resources and needs of research et...
Incomplete/insufficient description of
purpose, methods/procedures, subject
selection
Incomplete cover page, lack of con...
 Inappropriate language on the informed
consent document (too technical)
 Research-related documents are not included
in...
Increase
 The national budget devoted to research in small
Howdoes one explain the discrepancy between the
increase in the clinic...
Advantages to Pharma
 Large population
 Disease pattern:
 Cancer
 Diabetes
 Shistosomiasis,
 HCV
 Lower cost
 Fast...
Advantages to Host Countries:
 Exposure to recent technologies and recent
drug therapies.
 Training to local health prof...
 National regulation
 Research Ethics Committee
 Investigators
 Study subjects
 Translation
 Informed consent
Tamer ...
Alahmad, Ghiath, Mohammad Al-Jumah, and Kris Dierickx.
"Review of national research ethics regulations and guidelines in
M...
 Statistics between 2006 and 2010 show a 4 %
rise in the global number of drug trials conducted
in the Middle East, which...
 After the establishment of the first
international and Western clinical research
guidelines, it required a few decades f...
 in Saudi Arabia, the “Ethics of the Medical
Profession” (1998; renewed, 2007) and
 in Egypt, the “Profession Ethics Reg...
 The UAE’s “Guidance for Conducting Clinical
Trials Based on Drugs/Medical Products & Good
Clinical Practice” (2006)
 Ku...
Investigator / Sponsor
Submission of Research
Protocol & Required
Documents to IRB
National Scientific &
Research Ethical
...
Up to your knowledge;is there
any Interactionsbetween
differentIRBs/RECs in the
MENA region?
Tamer Hifnawy MD. Dr.PH
No common definition of what is
meant by a Central IRB Model
Centralization of IRB reviews have been increasing in the US ...
 Also termed DMC= Data Monitoring Committee in
some countries
 Independent body appointed for most clinical trials
 Maj...
 Monitor data throughout a trial
 Only group that has access to unblinded data before
the end of a study
 Analyzes data...
 Generally at least three members
 Clinicians and statisticians
 Sometimes ethicists and community representatives
 Ot...
Safety
 Long term trials that compare mortality or major morbidity
outcomes
 A priority reasons for safety concerns
 In...
Interim monitoring:
 efficacy
 safety
 study conduct
 external data
Making recommendations:
 protocol changes
 termi...
• Sources of data
 CRFs, SAE data, Randomization codes
 Up-to-date enrollment information
 Protocol violations/exemptio...
• Monitoring for effectiveness
• Estimates of treatment effect unstable at early points
• Futility analysis: benefit is un...
 Possible decisions:
 Continue with trial as planned
 Stop: safety problem
 Stop: efficacy established
 Stop: new kno...
 Need to be absolutely sure that you are making
the correct decision
 Need to adjust the p value if you are doing
multip...
• No commonly accepted standards for
composition and functions of DSMBs
• Not entirely independent in all situations
• Mig...
• Provide monitoring plan to institutional review
boards
• Provide summaries of study safety to
institutional review board...
Tamer Hifnawy MD. Dr PH.
Associate Professor of Public Health & Community Medicine
Faculty of Medicine, Beni Suef Universi...
Research Ethics Committees (RECs- IRBs)
Research Ethics Committees (RECs- IRBs)
Research Ethics Committees (RECs- IRBs)
Research Ethics Committees (RECs- IRBs)
Research Ethics Committees (RECs- IRBs)
Research Ethics Committees (RECs- IRBs)
Research Ethics Committees (RECs- IRBs)
Research Ethics Committees (RECs- IRBs)
Research Ethics Committees (RECs- IRBs)
Research Ethics Committees (RECs- IRBs)
Research Ethics Committees (RECs- IRBs)
Research Ethics Committees (RECs- IRBs)
Research Ethics Committees (RECs- IRBs)
Research Ethics Committees (RECs- IRBs)
Research Ethics Committees (RECs- IRBs)
Research Ethics Committees (RECs- IRBs)
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Research Ethics Committees (RECs- IRBs)

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Research Ethics Committees; Composition and Functions

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Research Ethics Committees (RECs- IRBs)

  1. 1. Dr.Tamer Hifnawy MD. Dr. “PH” Associate Professor of Public Health Faculty of Medicine BSU. University- Egypt. College of Dentistry-Taibah University- KSA.
  2. 2.  What is an IRB/REC?  The need for established REC`s  When do I need REC?  Roles and composition of REC.  Ethics Review process….  Rrole of Central or National IRBs  The interactions between IRBs from different countries  Composition & Function of DSMB
  3. 3. Research Ethics committee (REC) Institutional review board (IRB) Tamer Hifnawy MD. Dr.PH
  4. 4. Research Ethics Committee (REC) = Institutional Review Board (IRB) Tamer Hifnawy MD. Dr.PH
  5. 5. Advancement of Science Protection of SubjectWelfare/Rights BalancingTwo Goals
  6. 6. Tamer Hifnawy MD. Dr.PH
  7. 7. International guidelines1 require that an independent committee perform an Ethical and Scientific review of biomedical research. 1Declaration of Helsinki/CIOMS Tamer Hifnawy MD. Dr.PH
  8. 8.  Make research studies better!! Enhance study design Enhance protection of subjects  Enhance researcher reputation  Increased requirements for ethical approval in different scientific bodies  More likely to get published in good journals  More likely to get funding/ grants. Tamer Hifnawy MD. Dr.PH
  9. 9.  Before any research activity  At least 2 weeks before meeting date  Allow at least 1 month “for full board review” No post-conduction approval
  10. 10. TOO LATE !! No post Conduction approval
  11. 11. 1. A signed and dated application form 2. Full protocol. 3. Informed consent 4. CV`s for the PI and co-investigators. 5. Additional tools for the study” 6. For clinical trials…safety reports, previous studies.. 7. Arabic Summary Tamer Hifnawy MD. Dr.PH
  12. 12. Qualifications & experience At least one With the scientific background Include men and women A community representative At least 5 members There are minor variations between guidelines on composition
  13. 13. Level of Risk DeterminesType of Review Low Risk Higher Risk Expedited Full Tamer Hifnawy MD. Dr.PH
  14. 14. Sleem, H., El-Kamary, S., & Silverman, H. J. (2010). Identifying structures, processes, resources and needs of research ethics committees in Egypt. BMC Medical Ethics, 11(12), 1–8.
  15. 15. Incomplete/insufficient description of purpose, methods/procedures, subject selection Incomplete cover page, lack of contact information Typographical errors Tamer Hifnawy MD. Dr.PH
  16. 16.  Inappropriate language on the informed consent document (too technical)  Research-related documents are not included in the application (questionnaires, advertisements, surveys, informed consent, etc.)  Proposals are delivered at the last minute  Post Conduct application Tamer Hifnawy MD. Dr.PH
  17. 17. Increase
  18. 18.  The national budget devoted to research in small Howdoes one explain the discrepancy between the increase in the clinical trial activity with the small amount of funding for research by the national government? Tamer Hifnawy MD. Dr.PH
  19. 19. Advantages to Pharma  Large population  Disease pattern:  Cancer  Diabetes  Shistosomiasis,  HCV  Lower cost  Faster patient recruitment  Avoid regulatory restrictions  Avoid elaborate safety and compensation requirements
  20. 20. Advantages to Host Countries:  Exposure to recent technologies and recent drug therapies.  Training to local health professionals.  A road paving to upgrade local drug/ biotech industry
  21. 21.  National regulation  Research Ethics Committee  Investigators  Study subjects  Translation  Informed consent Tamer Hifnawy MD. Dr.PH
  22. 22. Alahmad, Ghiath, Mohammad Al-Jumah, and Kris Dierickx. "Review of national research ethics regulations and guidelines in Middle Eastern Arab countries." BMC medical ethics 13.1 (2012): 34.
  23. 23.  Statistics between 2006 and 2010 show a 4 % rise in the global number of drug trials conducted in the Middle East, which was the largest increase in any region of the world.  Many factors make the Middle East attractive for clinical research:  Patient diversity,  Good medical facilities,  Cost advantages, and  Favorable infrastructure,  Many new universities and research centers have appeared
  24. 24.  After the establishment of the first international and Western clinical research guidelines, it required a few decades for decision makers in the Arab countries in the Middle East to begin thinking about their own guidelines.  The first attempts at crafting clinical research regulations appear as summarized chapters in the general medical ethics guidelines: in Lebanon, the “Law of Medical Ethics” (1994)
  25. 25.  in Saudi Arabia, the “Ethics of the Medical Profession” (1998; renewed, 2007) and  in Egypt, the “Profession Ethics Regulations” (2003)  The Jordanian “Law of Clinical Studies” (2001)  Ten years after establishing universal ICH-GCP guidelines (1995), the first local GCPs began to appear in the region through the Saudi Food and Drug Authority’s (SFDA)  “ClinicalTrial Requirement Guidelines” (2005; renewed, 2008)
  26. 26.  The UAE’s “Guidance for Conducting Clinical Trials Based on Drugs/Medical Products & Good Clinical Practice” (2006)  Kuwait’s “Ethical Guidelines for Biomedical Research” (2009)  Qatar’s “Guidelines, Regulations and Policies for Research Involving Human Subjects” (2009)  The Saudi law, “System of Ethics of Research on Living Subjects” (2010) Tamer Hifnawy MD. Dr.PH
  27. 27. Investigator / Sponsor Submission of Research Protocol & Required Documents to IRB National Scientific & Research Ethical Committee Rejection Modification Prior to Approval Yes Approval Negative opinion Protocol Amendment Modification Prior to Approval Protocol Amendment Checklist fulfilled Yes Approval Letter Investigator Commencement of the study Approval No
  28. 28. Up to your knowledge;is there any Interactionsbetween differentIRBs/RECs in the MENA region? Tamer Hifnawy MD. Dr.PH
  29. 29. No common definition of what is meant by a Central IRB Model Centralization of IRB reviews have been increasing in the US and elsewhere, but many questions about it remain. In the US, a few centralized IRBs (CIRBs) have been established, but how they do and could operate remain unclear Klitzman, Robert. "How local IRBs view central IRBs in the US." BMC medical ethics 12.1 (2011): 13.
  30. 30.  Also termed DMC= Data Monitoring Committee in some countries  Independent body appointed for most clinical trials  Major role is to ensure safety of participants  Assures validity of results by overseeing conduct of a trial  Protects investigators  Advises investigators (often the Steering committee) and the sponsor Tamer Hifnawy MD. Dr.PH
  31. 31.  Monitor data throughout a trial  Only group that has access to unblinded data before the end of a study  Analyzes data by treatment arm  Are there concerns about safety?  Is there already enough proof that the intervention works?  Also considers  New evidence that might be relevant to the trial  Practicalities -is it still feasible to continue? Tamer Hifnawy MD. Dr.PH
  32. 32.  Generally at least three members  Clinicians and statisticians  Sometimes ethicists and community representatives  Other members to address specific issues  Ideally independent of sponsor and investigators  Clinicians and biostatisticians  relevant expertise  clinical trials experience  freedom from conflicts of interest Tamer Hifnawy MD. Dr.PH
  33. 33. Safety  Long term trials that compare mortality or major morbidity outcomes  A priority reasons for safety concerns  Intervention is invasive or has serious toxicity  “fragile” population – elderly, children  Population is at higher risk  SAEs are expected  Study is large, of long duration, and multi-center Practicality • Not required for short duration trials Scientific validity • External consideration might warrant changes in trial design
  34. 34. Interim monitoring:  efficacy  safety  study conduct  external data Making recommendations:  protocol changes  termination Tamer Hifnawy MD. Dr.PH
  35. 35. • Sources of data  CRFs, SAE data, Randomization codes  Up-to-date enrollment information  Protocol violations/exemptions  Special assays/lab tests that could un-blind sponsor  Last-minute endpoint or mortality data prepared via endpoint sweep  Timely data more important than totally clean data. Tamer Hifnawy MD. Dr.PH
  36. 36. • Monitoring for effectiveness • Estimates of treatment effect unstable at early points • Futility analysis: benefit is unlikely • Monitoring for Safety • Subjects given the investigational intervention are experiencing worse outcome  Demand less rigorous proof of harm to justify early stopping Tamer Hifnawy MD. Dr.PH
  37. 37.  Possible decisions:  Continue with trial as planned  Stop: safety problem  Stop: efficacy established  Stop: new knowledge (usually from other trials suggesting risks)  Stop: futile.Trial unlikely to show a result  Modify trial design Tamer Hifnawy MD. Dr.PH
  38. 38.  Need to be absolutely sure that you are making the correct decision  Need to adjust the p value if you are doing multiple interim analyses  Establish these “stopping rules” at the beginning of the study Tamer Hifnawy MD. Dr.PH
  39. 39. • No commonly accepted standards for composition and functions of DSMBs • Not entirely independent in all situations • Might not be responsible for data monitoring plan if formed late • Little communications directly with IRBs Tamer Hifnawy MD. Dr.PH
  40. 40. • Provide monitoring plan to institutional review boards • Provide summaries of study safety to institutional review boards at agreed-upon intervals Tamer Hifnawy MD. Dr.PH
  41. 41. Tamer Hifnawy MD. Dr PH. Associate Professor of Public Health & Community Medicine Faculty of Medicine, Beni Suef University, Egypt College of Dentistry,Taibah University, KSA AssistantVice Dean for Quality and Development CertifiedTrainer in International Research Ethics Email: tamer.hifnawy@bsu.edu.eg thifnawy@yahoo.com Mobile: +201114130107 Egypt +966564356123 KSA

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