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Research Ethics Committees (RECs- IRBs)
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. 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
8. 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
9. 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
10.
11.
12.
13.
14.
15. Before any research activity
At least 2 weeks before meeting date
Allow at least 1 month “for full board
review”
No post-conduction approval
19. 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
20. 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
21. Level of Risk DeterminesType of Review
Low Risk Higher Risk
Expedited Full
Tamer Hifnawy MD. Dr.PH
22.
23.
24. 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.
26. 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
29. 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
30. 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
31. 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
32. National regulation
Research Ethics Committee
Investigators
Study subjects
Translation
Informed consent
Tamer Hifnawy MD. Dr.PH
33. 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.
34. 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
35. 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)
36. 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)
37. 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
38.
39.
40.
41. 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
42. Up to your knowledge;is there
any Interactionsbetween
differentIRBs/RECs in the
MENA region?
Tamer Hifnawy MD. Dr.PH
43. 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.
44.
45. 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
46. 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
47. 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
48. 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
49. Interim monitoring:
efficacy
safety
study conduct
external data
Making recommendations:
protocol changes
termination
Tamer Hifnawy MD. Dr.PH
50. • 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
51. • 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
52. 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
53. 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
54. • 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
55. • 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
56.
57. 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
Hinweis der Redaktion
21 CFR Part 56.107 (US) At least 5 members of diversebackgrounds to promote complete andadequate review of research activitiescommonly conducted by the institution Every non-discriminatory effort toensure males and females, and notentirely of one profession 1 scientist, 1 non-scientist At least 1 member who is nototherwise affiliated with the institutionnor part of the family of a person whois affiliated with the institution Members with a conflict of interest in aproject may be invited to provideexpertise but may not participate in thereview of that projectICH GCP E6 Reasonable number of members, whocollectively have the qualifications andexperience to review and evaluate thescience, medical aspects, and ethics ofthe proposed trial At least 5 members At least 1 member whose primary areaof interest is in a non-scientific area At least one member who isindependent of the institution/trial site Only those members who areindependent of the investigator and thesponsor of the trial shouldvote/provide opinion on a trial-relatedmatter