Research Ethics Committee Administration in Uganda: The Research Ethics Committee (REC) Administrators’
Perspective
Aida Nakawunde, MSc. CEB , REC Administrator School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda
MAKEREREMAKERERE UNIVERSITYUNIVERSITY
Focus of the Presentation• Definition and Roles of RECs• Establishment of Research Ethics Committees (RECs) • Overview of RECs in Uganda• The Research Approval Process in Uganda• Role of REC Administrators in Uganda • Strengths of the REC Administration system• The gaps within the REC Administration system• MakCHS case study • Conclusion
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Definition and Role of RECsAccording to UNCST, RECs are independent committees established inor by an institution:
• To conduct initial and continuing review of research projects with agoal of protecting rights and welfare of research participants.
• Responsible for safeguarding the dignity, safety, and wellbeing of allpotential research participants.
• Maintain ethical standards of practice in research
• Protect participants and researchers from exploitation
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Establishment of Research Ethics Committees (RECs) in Uganda
• 1960s-70s---ethical issues were guided by Helsinki Declaration 1964 & Nuremburg Code 1947;
• RECs operate under the supervision of Uganda National Council for Science and Technology (UNCST)
– In charge of research coordination and oversight
• Ethical review in Uganda was mainly triggered by pressure of conducting clinical trials.
• First REC was established in 1986 (NARC).
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Overview of RECs in Uganda (1)
Year of existence:
Most RECs have existed for more than 5 years
Accreditation: 24 RECs accredited by UNCSThttps://uncst.go.ug/research‐ethics‐committee‐accreditation/
Source of funding:
Mainly review fees
Host institution: Hospital(s) Academic institution
Research institution
National agency
6 8 6 4
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Overview of RECs in Uganda (2)
• Number of REC Administrators: One fulltime administrator per REC
• Number of REC members: Mainly 11-15 members with 50% quorum
• Meeting schedule: Majority hold meetings once a month
• Number of protocols reviewed annually: 90-120 proposals
• Protocol submission, review, tracking and archiving: Mainly manual
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The Research Approval Process in Uganda
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UNCSTNDA
Office of the President
Foreign REC Local REC
Community Advisory Board
Scientific Committee
Data Safety Monitoring Board
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Inve
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L3
Independent Monitor
UNHRO
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Role of REC Administrators in Uganda
General office administration• Check submitted proposals for completeness • Communicate feedback to investigators • Assign reviewers • Organize trainings and REC workshops • Write annual REC reports • File REC documents and other material for approved studies • Procure office supplies • Respond to queries raised by investigators• Develop site monitoring plans• Write site monitoring reports
REC meetings • Schedule REC meetings • Draft REC meeting agenda • Take REC review minutes
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Strengths of the REC Administration System
1. National guidelines for Research involving human participants
2. Research registration and clearance policy and guidelines
3. Accreditation system of RECs4. Network of REC chairpersons (FRECU)5. Network of REC Administrators 6. The Credit point system7. Annual Research Ethics Conference (ANREC)8. Research oversight
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National guidelines for Research involving human participants
• Provide mechanisms for protecting research participants
• Provide ethical standards and procedures for conduct of research
• Ensure that researchers take into account social and cultural values
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Evolution of research ethics guidelines in Uganda
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<1997May 1997
March 2007
July 2014
Ethical review largely based on Helsinki Declaration & Nuremburg code
Research registration and clearance policy and guidelines
• Guard against research misconduct
• Assist researchers access data for research
• Prevent unnecessary duplication of research
• Avoid unauthorized collection and transfer of research material or information
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Regulation by National Drug Authority
Clinical Trials have additional regulation by NDA;NDA Act Cap (206):
• S. 40a. “The authority (NDA) may issue a certificateto any person for the purpose of carrying out clinicaltrials in respect of a drug that may be specified in thecertificate.”
• S.40b. “No person may carry out any clinical trial in respect of any drug unless he or she is in possession of a certificate issued under subsection (1)”
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Accreditation system of RECsObjective:
• To improve efficiency and effectiveness of REC operation
• Ensure that RECs provide the highest possible ethical standards and protection to research participants
• Build public trust and confidence in national ethical review system
Benefits• Well constituted RECs • Refresher trainings for REC members and staff• Operational REC offices
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Network of REC chairpersons (FRECU)
• Updates of REC performance
• Knowledge sharing
• Share experiences and scenarios
• Settle grievances between RECs
• Ground for advocacy in amendments of
guidelines, REC operations
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Network of REC Administrators
• Knowledge acquisition towards office administration
• Share training opportunities
• Share experiences in office management
• Seek advise on how to handle critical situations
• Conduct exchange visits
• Develop guidelines for REC Administrators
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The Credit point systemObjective:
• Continuously improve the quality of REC review and research oversight
• Improve the skill and competence of REC members
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Annual Research Ethics Conference (ANREC)
Held since 2009 in JulyObjectives:
• Improve the efficiency in research protocol review• Build research ethics capacities of investigators and ethics
committees• Discuss topical and emerging bioethical issues.
Benefits • Share experiences • Sensitize the public about issues related to research ethics• Identify options to address ethical dilemmas encountered in
research• Opportunity to network
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Research oversightMain Objective:To ensure that research projects approved by the REC conform to the research guidelines right from their implementation throughout their completion.
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Benefits: • Opportunity to interact with research
participants• Interact with the study team
The gaps within REC Administration system (1)
1. Financial constraints• Entirely depend on review fees• Few grants fund REC activities• Structural issues i.e. most RECs are not institutionalized
Result into:• Turnover of REC Administrative staff due to inadequate
remuneration• Under staffing• Few site monitoring visits are conducted• Poor remuneration of REC members
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The gaps within REC Administration system (2)
2. Lack of formal training of REC Administrative staff and members in research ethics
• Affects the quality of review and administrative work
3. Failure to meet deadlines• Lack of commitment by REC members due to other
responsibilities• Quorum issues• Heavy workload
4. Inadequate filing systems• Limited office space• Under staffing• Huge volume of paper work
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The gaps within REC Administration system (3)
5. Perception towards research ethics committees• REC are looked at as a stumbling block for
researchers
6. Lack of a clear strategy to protect researchers against exploitation
• Data sharing• “Local researchers are used as data collectors”• Follow up on exported samples• Capacity building
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Case Study of MakCHS
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RECs at MakCHSHosts 4 RECs
• School of Medicine Higher Degrees Research Ethics Committee
• School of Public Health Higher Degrees Research Ethics Committee
• School of Biomedical Sciences Higher Degrees Research Ethics Committee
• School of Health Sciences Higher Degrees Research Ethics Committee
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Research Support CentreCentre for all research related activities at the College
Host:• 4 RECs
• Grants office
• Finance office
• IT department
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Research Support Centre
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MakCHS eIRB System
27http://chs.mak.ac.ug/eirb/
Research policy & guidelines• University research policy
• Research misconduct and misbehavior– Anti plagiarism detection software
• Conflict of interest
• National guidelines for Research involving human participants
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Bioethics activities
Bioethics centreIHRET program
Masters of Health Sciences in Bioethics (MHSc. Bioethics)
Short courses• Research Ethics• Responsible Conduct of Research • Clinical Ethics
Bioethics working group
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Clinical Trials Unit• Trainings
– Good Clinical Practice– Study designs– Data collection techniques – Data management – Data analysis – Informed consent process
• Seminars
• Monitor clinical trials30
Conclusion• UNCST has played a significant role towards establishment and
operationalization of RECs in Uganda in abide to protect all stakeholders involved in research
• Research should be done for the benefit of society
• Research integrity is essential
• The safety, rights, values, interests and welfare of the human research participants is essential
• A good research ethics system ensures beneficial research is done without harming or inconveniencing the research participant.
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Conclusion However:• Secure a reliable and sufficient source of funding for
REC activities
• Establish an eIRB system
• Formal training in research ethics of Administrative staff and REC members
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Aida NakawundeMSc. CEB
REC Administrator School of Medicine Makerere University College of Health
Sciences,Uganda Kampala
[email protected]+256704369754
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