Downloaded 449 times
Uploaded byTamer Hifnawy
Research Ethics Committees (RECs- IRBs)
This document discusses the roles and functions of research ethics committees (RECs) and institutional review boards (IRBs). It provides an overview of when REC/IRB approval is required, the review process, and composition of RECs/IRBs. It also discusses interactions between IRBs in different countries and the roles of data safety monitoring boards. The document is authored by Dr. Tamer Hifnawy, an associate professor of public health in Egypt and Saudi Arabia who trains others in international research ethics.
More Related Content
Similar to Research Ethics Committees (RECs- IRBs)
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 isan 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
- 4. Research Ethics committee(REC) Institutional review board (IRB) Tamer Hifnawy MD. Dr.PH
- 5. Research Ethics Committee(REC) = Institutional Review Board (IRB) Tamer Hifnawy MD. Dr.PH
- 6. Advancement of Science Protectionof SubjectWelfare/Rights BalancingTwo Goals
- 7. Tamer Hifnawy MD.Dr.PH
- 8. International guidelines1 requirethat an independent committee perform an Ethical and Scientific review of biomedical research. 1Declaration of Helsinki/CIOMS Tamer Hifnawy MD. Dr.PH
- 9. Make researchstudies 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
- 15. Before anyresearch activity At least 2 weeks before meeting date Allow at least 1 month “for full board review” No post-conduction approval
- 17. TOO LATE !! No postConduction approval
- 19. 1. A signedand 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 Atleast 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 RiskDeterminesType of Review Low Risk Higher Risk Expedited Full Tamer Hifnawy MD. Dr.PH
- 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.
- 25. Incomplete/insufficient description of purpose,methods/procedures, subject selection Incomplete cover page, lack of contact information Typographical errors Tamer Hifnawy MD. Dr.PH
- 26. Inappropriate languageon 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
- 27.
- 29. The nationalbudget 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 HostCountries: 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, MohammadAl-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 between2006 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 theestablishment 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 SaudiArabia, 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
- 41. Investigator / Sponsor Submissionof 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 yourknowledge;is there any Interactionsbetween differentIRBs/RECs in the MENA region? Tamer Hifnawy MD. Dr.PH
- 43. No common definitionof 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.
- 45. Also termedDMC= 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 datathroughout 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 atleast 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 termtrials 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 ofdata 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 foreffectiveness • 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 tobe 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 commonlyaccepted 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 monitoringplan to institutional review boards • Provide summaries of study safety to institutional review boards at agreed-upon intervals Tamer Hifnawy MD. Dr.PH
- 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: [email protected] [email protected] Mobile: +201114130107 Egypt +966564356123 KSA
Editor's Notes
- #21 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