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Project Topic
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The SMERT project denotes streamlining the health research ethics review process and regulatory framework in Tanzania. Observing ethics and regulatory procedures is crucial for research and is the cornerstone for good laboratory, clinical and pharmaceutical practice. Bearing this in mind, SMERT set out to identify the needs with a view of developing capacity for health research ethics and medicines regulation in Tanzania. The main deliverable for SMERT is an efficient and effective ethics review process and regulatory monitoring system in Tanzania characterised by good ethical conduct in both research and clinical practice; harmonised regulatory and operational standards and compliance across sectors. Our first year activities have been geared towards achieving this goal. From the onset, SMERT passed the sustainability test by successfully getting all stakeholders to accept and own the objectives and co-implement the project. The SMERT launch in Dar es Salaam brought together all stakeholders including all heads of governmental and non-governmental research and medicines regulatory agencies, academic and non researchers, ethics committee members and policymakers from the Ministry of Health. Led by the Chief Medical officer, Director General of National Institute of Medical Research (NIMR) and Director General of Tanzania Food and Drug Authority (TFDA), all stakeholders pledged their commitment to accepting and implementing the SMERT deliverables. The same spirit of commitment was reflected at the SMERT Annual Forum. One of the fruits of the networking and discussion at the launch was the offer from TFDA to support the joint clinical trial monitoring visits with the National Health Research Ethics Committee (NatHREC) monitors. This would improve the current passive monitoring to active monitoring. Building on the momentum from the launch, SMERT went on to accomplish the needs assessment audit aimed at informing research ethics and medicines regulation capacity building. A total of 13 Institutional Research Boards (IRBs), including the NatHREC, five TFDA centres and the national TFDA headquarters were audited and areas for capacity strengthening were identified. These included the need for regular research site monitoring, facilities for secure storage of ethics applications and associated documents, regular update of research ethics guidelines and Standard Operation Procedures (SOPs) by NatHREC to IRBs, electronic platforms for submission of ethics applications (NatHREC) and real-time reporting of Adverse drug reactions/Serious adverse events (ADR/SAEs) from registered clinical trial medicines (TFDA), increasing awareness of ADR reporting by the public (TFDA), and last but not least holding refresher research ethics training for researchers and research monitors. On the training front, SMERT has successfully developed curricula for a short ethics course to be delivered by NatHREC in collaboration with Muhimbili University of Health and Allied Sciences and Bioethics module to be integrated in the biomedical training programme at Kilimanjaro Christian Medical Centre University College (KCMUCo). The training of IRB members and piloting the Bioethics module is planned for the first quarter of 2019. Beyond SMERT the short course will be a NIMR-NatHREC resource to use in refresher training of researchers and new IRB members whilst the Bioethics module at KCMCUCo will continue to be available to postgraduate students and as a continuing professional development programme (CPD) for healthcare practitioners and medical researchers in Tanzania and beyond. Apart from course curricula, SMERT has sponsored two postgraduate students at a Master's and PhD level investigating the ethics of clinical trials and quality assurance of medicines, respectively. Finally, SMERT has supported development of an electronic submission system of protocols to NatHREC by researchers and/or IRBs. The pilot testing of the platform is expected by April 2018 before launching for use by all researchers. This e-system will simplify protocol submission to the NatHREC for ethics review, act as a database that stores all information pertaining to proposals and approvals and also a tracking system for the review process. In addition, SMERT has also supported TFDA to develop a diversified e-platform that accommodates ADR reports from both pre- and post- registration medicines. The old Adverse Reaction electronic reporting system (ARRT) could only accommodate reports from post registration medicines leaving ADRs emanating from clinical trial (pre-registration) medicines unreported. The system is now being improved by developing a new interphase that enables reporting serious adverse events (SAEs) from clinical trials. Secondly, with SMERT support, TFDA is exploring ways to synchronise the National ARRT system and that of the World Health Organization (WHO) so that reports from Tanzanian pharmacovigilance centres are automatically fed into WHO without having to do it manually. In short, SMERT has developed tools and capacities that will live beyond its project lifespan. The second year will focus on consolidating these tools so that they are robust for long-term use.
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