international dialogue on bioethics ethical rules in egypt lamis ragab, md, mhpe prof of pediatrics...
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International Dialogue on Bioethics
Ethical Rules in Egypt
Lamis Ragab, MD, MHPEProf of Pediatrics & Medical Education
Former DeanFaculty of Medicine
Cairo University
Copenhagen 19/6/2012
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Present Regulations in Egypt
• Egypt Constitution 1971 (part 3), Egypt Constitution 1971 (part 3), Article 43 Any medical or scientific experiment may not
be undergone on any person without his free consent.
• Profession Ethics RegulationsProfession Ethics Regulations issued by the Resolution of the Minister of Health & Population No. 238/2003, Articles 52-61
Copenhagen 19/6/2012
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Copenhagen 19/6/2012
•Egyptian clinical trial directive: assuring the rights & benefits of subjects participating in clinical research
•National law for clinical research
•National committee formed by the Ministry of Research
•Law is under processing
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The Standard Operating Procedures on CT Submission & Privacy-Confidentiality
Copenhagen 19/6/2012
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• Ministry of Health & Population• Central Directorate for Research & Health
Development• Required documents and procedures for the
proposal to the REC• Application form code• 3 files + 5 files + 3 CDs• [email protected]
Copenhagen 19/6/2012
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• Approval of the site• Approval of the ethics committee• Type of the study: Interventional (non-
pharmaceutical) Observational Health System Research• Amendment• Annual follow up• Timeline
Copenhagen 19/6/2012
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Copenhagen 19/6/2012
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Faculty of Medicine
Cairo University Since 1827
Copenhagen 19/6/2012
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9684 undergraduate & 8300 postgraduate students
2702 faculty members & 2000000 patients
UC Davis October 2009
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9684 undergraduate & 8300 postgraduate students
2702 faculty members & 2000000 patients
UC Davis October 2009
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Cairo University hospitals comprise more
than 5200 beds (over 9 premises)
UC Davis October 2009
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Research Ethics Committee
Faculty of Medicine
Cairo University
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Cairo University MREC
• Established in 2003
• Current committee was formed in 2008
• Most recent regulations were approved in 2011– Rules governing research protocol evaluation
– Required documents
– Details of consent form
• REC convenes monthly
• The protocol to be submitted 1 month before REC meeting Copenhagen 19/6/2012
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International Guidelines
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• Professional Membership• USA Office for Human Research Protections
registration • IORG0002878- IRB00003475- FWA00005111• Egyptian Network of Research Ethics
Committee ENREC Founding Member
Copenhagen 19/6/2012
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Members
• Prof .Dr. Mohsen Ibrahim Professor of Cardiology- Chairman President of the EHS • Prof.Dr.Lamis Ragab Professor of Pediatrics- Vice dean for post graduate studies &• research • Prof.Dr.Sohier Mahfouz Professor of Pathology-Head of Pathology department • Prof.Dr.Samia Rizk Professor of clinical Pathology Certified trainer of human subject research ethics
• Prof.Dr.Maha El Rabbat Professor of Public Health • Prof.Dr.Omar El Khashab Professor of Internal Medicine• Prof.Dr.Adel Zaki Professor of Cardiology
• Prof.Dr.Maher fawzy Professor of Anesthesiology• Dr.Hany Sleem Consultant of Dermatology and Andrology National Institute for tropical and Liver diseases Certified trainer of human subject research ethics• Dr.Abdel Rahman El Nagar Professor of Pharmacology-Head of the national center for toxicology
• Dr.Noha Assem Assistant Lecturer of Public Health Certified trainer of human subject research ethics• Mr.Ahmed Darwish Manger of legal affaires in Kasr Al Aini
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Training • Four committee members are internationally
certified form Maryland University USA • All members attended training sessions held
during REC meetings
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Study Title:
Principal investigator &Department name
Source of Funding Governmental Non governmental Self
Sponsor :
Background and Rationale (no more than 5 lines )
Objectives:
Study population & Sample size :
Study Design :
Interventions :
Possible Risk (s):
Outcome parameter (s):
Statistical analysis plan:
Time plan:
Cairo UniversityFaculty of MedicineMedical Research Ethics Committee
Protocol summary
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البحث عنوان جامعة: الباحثون دكتور استاذ
جامعه دكتور استاذجامعه دكتور استاذ
الدراسة من :الغرضالمشارك / من المطلوبة األعمال :اإلجراءات
للمشاركة المطلوبة الزمنية :الفترة
.المخاطروالمجتمع للمشارك :الفوائد
البيانات سرية و المشارك خصوصية :حماية
تطوعية :المشاركة
البحث فى المشاركة :تكاليف :التعويض
االنسحاب فى :الحق : المشاركة فى الرغبة عدم حالة فى المتاحة يمكنك البدائل الدراسة هذه عن المزيد لمعرفة
بالدكتور .--------------االتصال02ت: ------------- .
بالدكتور االتصال يمكنك الدراسة فى المشاركة نتيجة صحية متاعب حدوث حالة .------------فى02ت:---------- - .
/ محسن الدكتور البحوث اخالقيات مراجعة لجنة بمكتب االتصال يرجى شكوى، وجود حالة فىرقم إبراهيم تليفون
0103657120
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إذا كنت توافق على االشتراك فى هذه الدراسة، قم •باإلشارة فى المكان المناسب فى الجزء التالى:
____: لقد تم شرح كل المعلومات الواردة فى هذه •االتفاقية.
____: لقد قرأت وفهمت المعلومات الواردة فى هذه •االتفاقية.
اسم المشارك: _________________________ توقيعه: •______________________
شاهد علي إجراءات الموافقة : ____________________ •توقيعه: _______________________
توقيع مسئول الدراسة: •________________________________________________
التاريخ: _______________________•ال تعتمد إال إذا كان خاتم لجنة مراجعة اخالقيات البحوث •
عليها . 201 / / إلى 201 / / سارية من : •تسلم نسخة للمشارك وتحفظ النسخة األصلية مع •
الباحث فى ملف المشارك
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• Application for REC Review • Section One: Application Information • Principal Investigator/s:• Department:• Title:• Phone/Pager:• Fax:• E-mail address:• Mailing Address: • Title of Project• Purpose of Project (one or two sentences)
REC ID
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Summary of Reviewers Evaluation (cont.)
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Research Ethics CommitteeReview Procedure/ Check List
• Thoroughness and completeness of the information submitted
• Suitability of the protocol and the data collection forms in relation to the objectives of the study
• Suitability of the investigator for the proposed study
• Adequacy of the site, including the supporting staff and available facilities
• Adequacy of medical supervision and follow-up
• Sources of funding, sponsor and other potential conflict of interest
Copenhagen 19/6/2012
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Research Ethics Committees Review Procedure/ Check List (cont)
• Provisions made for monitoring and auditing the conduct of the research
• Means by which initial recruitment is to be conducted
• Vulnerable subjects
• Content and the wording of the informed consent form
• Provisions for compensation/treatment in the case of disability
• Confidentiality of personal subject information
Copenhagen 19/6/2012
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• Establishment of REC filing system and database for activities
• Documents produced by the committee • Standard operating procedures SOP`s• Standardized Kasr Al-Ainy REC application form• Standardized Kasr Al-Ainy REC review form• Standardized letters for REC decisions • Continuing review requirements and review form• Conflict of interest management plan• Confidentiality agreement form• Release of REC annual report• Complete list of REC advisory board.
Copenhagen 19/6/2012
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Number of submitted protocols:
Year 2008 2009 2010 2011
No. 21 42 49 104 applications
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Decisions of REC for submitted protocols:
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Source of Funding
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Types of Research Projects
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Multicenter trials
• Lack of harmonization of procedures among countries
• Difficult approach• Trials in developing countries and the risk of
double standards• From a purely economical or utilitarian
perspective developing countries represent a unique, cheaper and large source of subjects
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Categories of submitted studies
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Compensation
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Applied Studies
Copenhagen 19/6/2012
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Presence of Data Safety Monitoring Board
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Previous Scientific Review
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Type of Consent
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Pediatric Clinical Research in Egypt
Experience of the FMCU
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• The pediatric population has the right to use medicines that have been appropriately evaluated and tested.
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•Protection of children FROM research
•Protection of children THROUGH research
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Scientifically and ethically sound methodological standards:
•Benefit/risk balance
•Consent/Assent
•Placebo
•Interventional vs observational
•Therapeutic vs non-therapeutic
•Compensation/Insurance
•Legal guardian
•Post-trial benefitCopenhagen 19/6/2012
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Research involving children
2008 2009 2010 2011
N. % N. % N. % N. %
4 33.4 15 35.7 10 25.7 20 22
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2008N.=4
2009N.-15
2010N.=10
2011
N=20
N. % N. % N. % N. %
Peculiar to
pediatric age2 50% 11 73.3% 8 80% 16
8
0
%
Children and
adults 2 50% 4 26.7% 2 20% 4
2
0
%
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Research category Single site project 1 25.0
4 26.7
5 50.0 6
Multi-center project 2 50.0
8 53.3
3 30.0 12
National collaborative project
1 25.0
2 13.3
0 0 1
International collaborative project
0 0 5 33.3
3 30.0 5
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Research type
Research type Experimental study 1 25.0 7 46.7 5 50.0
12
Observational Descriptive Study
0 0 2 13.3 2 20.0
2
Observational Analytic study 3 75.0 5 33.3 3 30.0
4
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Copenhagen 19/6/2012
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Copenhagen 19/6/2012
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Phase of Experimental studies
Phase I 0 0 1 14.3
1 20.0 2
Phase II 0 0 0 0.0 0 0 3Phase III 1 10
06 85.
74 80.0 5
Phase IV 0 0 0 0.0 0 0 2
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Insurance
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Consent form
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Assent 2011 applications
2011
Assent 4No Assent 16
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Clinical Research at the Pediatric Department
• An open-label, multi-center trial on efficacy and safety of lon-term treatment with ICL670 (10 to 20 mg/kg/day) in beta-thalassemia patients with transfusional hemosiderosis
May 2004
• An open-label, multi-center trial on efficacy and safety of long-term treatment with ICL670 (10 to 20 mg/kg/day) in beta-thalassemia patients with transfusional hemosiderosis ( Extension Phase)
June 2005
• A one year, open-label, single arm, multi-center trial on evaluating the efficacy and safety of oral ICL670 (20 mg/kg/day) in patients diagnosed with transfusion dependent iron overload
April 2005
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Clinical Research at the Pediatric Department
A one year, open-label, single arm, multi-center trial on evaluating the efficacy and safety of oral ICL670 (20 mg/kg/day) in patients diagnosed with transfusion dependent iron overload (Extension Phase)
July 2006
A one Year, open label, single arm, multi- center trial evaluating the efficacy and safety of oral ICL670 (20 mg/ kg/day) in patients diagnosed with transfusion dependent iron overload
May- 2007
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Clinical Research at the Pediatric Department
A five year observational study (registry) of children aged 2 to ≤ years at enrollment with transfusional hemosiderosis treated with deferasirox
Aug- 2007 Inhibitor development in previously untreated PUPs) or
minimally blood component treated patients ( MBCTPs) when exposed to plasma derived von Willebrand factor containing factor concentrate and to recombinant factor VIII :An International Independent Multicenter Prospective Controlled Randomized Open label Clinical Trial
March- 2009
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Clinical Research at the Pediatric Department
• A multicenter, randomized open label phase II trial evaluating deferasirox compared with deferoxamine in patients with cardiac iron overload due to chronic blood transfusion (CORDELIA)
Mar- 2010
• Phase II, open label single arm, multicenter study to evaluate the efficacy and safety of deferasirox in combination with deferoxamine followed by deferasirox monotherapy in patients with severe cardiac iron overload due to chronic blood transfusion (HYPERION)
Jul- 2010 January 2011 • International sentinel site surveillance of patients with transfusional
hemosiderosis treated with Exjade in actual practice setting September 2010 February 2012
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Clinical Research at the Pediatric Department
• A phase 3, randomized multi-center, open- label, active comparator study to evaluate the efficacy and safety of Genz- 112638 in patients with Gaucher disease Type 1 who have reached therapeutic goals with enzyme replacement therapy
Nov- 2010 • A multi- center, open-label, phase III study to evaluate the safety and efficacy of
ISU302 (Imiglucerase for injection) in patients with type 1 Gaucher disease Apr- 2011
• A randomized, open- label, multi-dose study of HQK-1001 in subjects with sickle cell disease
Oct- 2011 • Multicenter, randomized, open label, non- inferiority active controlled trial to
evaluate the efficacy and safety of deferiprone compared to deferasirox pediatric patients aged 1 month to less than 18 years affected transfusion dependent hemoglobinopathies
Development phase
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• 12 recruiting European Centres (from Italy, Greece, Cyprus) and 3 recruiting non-European Centres (from Egypt, Albania, China) with scientific partners from EU
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• DEEP intends to guarantee the respect of ethical rules, regardless of the country in which the research is carried out, in compliance with the current European and international legal frameworks.
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• Reflection Paper on ethical & GCP compliance in clinical trials conducted in Third Countries:
Ethical principles applied to the clinical trials in the EEA should also apply to trials conducted in non-EU Countries, taking into account local legal requirements and cultural background.
“International Ethical Guidelines for Biomedical Research Involving Human Subjects”
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• Double standards are not acceptable.
• Ethical principles applied to clinical trials should supervene everywhere,
considering local legal requirements and cultural backgrounds.
Copenhagen 19/6/2012
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• Ethics and science:
hand in hand
Copenhagen 19/6/2012
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International Cooperation• Cooperation
• Information sharing
• Training
• Sharing best practice
• Regulatory authoritiesCopenhagen 19/6/2012
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