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International Dialogue on Bioethics Ethical Rules in Egypt Lamis Ragab, MD, MHPE Prof of Pediatrics & Medical Education Former Dean Faculty of Medicine.

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Presentation on theme: "International Dialogue on Bioethics Ethical Rules in Egypt Lamis Ragab, MD, MHPE Prof of Pediatrics & Medical Education Former Dean Faculty of Medicine."— Presentation transcript:

1 International Dialogue on Bioethics Ethical Rules in Egypt Lamis Ragab, MD, MHPE Prof of Pediatrics & Medical Education Former Dean Faculty of Medicine Cairo University Copenhagen 19/6/2012

2 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 Regulations Profession Ethics Regulations issued by the Resolution of the Minister of Health & Population No. 238/2003, Articles Copenhagen 19/6/2012

3 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

4 The Standard Operating Procedures on CT Submission & Privacy-Confidentiality Copenhagen 19/6/2012

5 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 Copenhagen 19/6/2012

6 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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8 Faculty of Medicine Cairo University Since 1827 Copenhagen 19/6/2012

9 9684 undergraduate & 8300 postgraduate students 2702 faculty members & patients UC Davis October 2009

10 9684 undergraduate & 8300 postgraduate students 2702 faculty members & patients UC Davis October 2009

11 Cairo University hospitals comprise more than 5200 beds (over 9 premises) UC Davis October 2009

12 Research Ethics Committee Faculty of Medicine Cairo University

13 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

14 International Guidelines Declaration of Helsinki CIOMS Council of international organization of medical sciences ICH 6 GCP International Conference of Harmonization, Good Clinical Practice

15 Professional Membership USA Office for Human Research Protections registration IORG IRB FWA Egyptian Network of Research Ethics Committee ENREC Founding Member Copenhagen 19/6/2012

16 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

17 Training Four committee members are internationally certified form Maryland University USA All members attended training sessions held during REC meetings Copenhagen 19/6/2012

18 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 University Faculty of Medicine Medical Research Ethics Committee Protocol summary

19 عنوان البحث الباحثون : استاذ دكتور جامعة استاذ دكتور جامعه الغرض من الدراسة : الإجراءات / الأعمال المطلوبة من المشارك : الفترة الزمنية المطلوبة للمشاركة : المخاطر. الفوائد للمشارك والمجتمع : حماية خصوصية المشارك و سرية البيانات : المشاركة تطوعية : تكاليف المشاركة فى البحث : التعويض : الحق فى الانسحاب : البدائل المتاحة فى حالة عدم الرغبة فى المشاركة : لمعرفة المزيد عن هذه الدراسة يمكنك الاتصال بالدكتور ت : فى حالة حدوث متاعب صحية نتيجة المشاركة فى الدراسة يمكنك الاتصال بالدكتور ت : فى حالة وجود شكوى، يرجى الاتصال بمكتب لجنة مراجعة اخلاقيات البحوث الدكتور / محسن إبراهيم تليفون رقم

20 إذا كنت توافق على الاشتراك فى هذه الدراسة، قم بالإشارة فى المكان المناسب فى الجزء التالى: ____: لقد تم شرح كل المعلومات الواردة فى هذه الاتفاقية. ____: لقد قرأت وفهمت المعلومات الواردة فى هذه الاتفاقية. اسم المشارك: _________________________ توقيعه: ______________________ شاهد علي إجراءات الموافقة : ____________________ توقيعه: _______________________ توقيع مسئول الدراسة: ________________________________________________ التاريخ: _______________________ لا تعتمد إلا إذا كان خاتم لجنة مراجعة اخلاقيات البحوث عليها. سارية من : / /201 إلى / / 201 تسلم نسخة للمشارك وتحفظ النسخة الأصلية مع الباحث فى ملف المشارك

21 Application for REC Review Section One: Application Information Principal Investigator/s: Department: Title: Phone/Pager: Fax: address: Mailing Address: Title of Project Purpose of Project (one or two sentences) REC ID

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25 Summary of Reviewers Evaluation (cont.)

26 Research Ethics Committee Review 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

27 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

28 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 formapplication form Standardized Kasr Al-Ainy REC review formreview 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

29 Number of submitted protocols: Year No applications Copenhagen 19/6/2012

30 Decisions of REC for submitted protocols: Copenhagen 19/6/2012

31 Source of Funding Copenhagen 19/6/2012

32 Types of Research Projects Copenhagen 19/6/2012

33 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

34 Categories of submitted studies

35 Compensation Copenhagen 19/6/2012

36 Applied Studies Copenhagen 19/6/2012

37 Presence of Data Safety Monitoring Board Copenhagen 19/6/2012

38 Previous Scientific Review Copenhagen 19/6/2012

39 Type of Consent Copenhagen 19/6/2012

40 Pediatric Clinical Research in Egypt Experience of the FMCU Copenhagen 19/6/2012

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42 The pediatric population has the right to use medicines that have been appropriately evaluated and tested. Copenhagen 19/6/2012

43 Protection of children FROM research Protection of children THROUGH research Copenhagen 19/6/2012

44 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 benefit Copenhagen 19/6/2012

45 Research involving children N.% % % % Copenhagen 19/6/2012

46 2008 N.= N N.= N=20 N.% % % % Peculiar to pediatric age 250% % 880%16 80%80% Children and adults 250%4 26.7% 220%4 20%20%

47 Research categorySingle site project Multi-center project National collaborative project International collaborative project

48 Research type Experimental study Observational Descriptive Study Observational Analytic study

49 Copenhagen 19/6/2012

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51 Phase of Experimental studies Phase I Phase II Phase III Phase IV Copenhagen 19/6/2012

52 Insurance Copenhagen 19/6/2012

53 Consent form Copenhagen 19/6/2012

54 Assent 2011 applications 2011 Assent4 No Assent16

55 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

56 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

57 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 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

58 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 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 January 2011 International sentinel site surveillance of patients with transfusional hemosiderosis treated with Exjade in actual practice setting September 2010 February 2012

59 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 in patients with Gaucher disease Type 1 who have reached therapeutic goals with enzyme replacement therapy Nov 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 A randomized, open- label, multi-dose study of HQK-1001 in subjects with sickle cell disease Oct 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

60 12 recruiting European Centres (from Italy, Greece, Cyprus) and 3 recruiting non-European Centres (from Egypt, Albania, China) with scientific partners from EU

61 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.

62 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

63 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

64 Ethics and science: hand in hand Copenhagen 19/6/2012

65 International Cooperation Cooperation Information sharing Training Sharing best practice Regulatory authorities Copenhagen 19/6/2012

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