Partnership to Strengthen Research Ethics and Medicines Regulation in Tanzania through the SMERT Project: An EDCTP Funded Project
SMERT: Streamlining health research ethics and medicines regulation in Tanzania is a two-year project funded by EDCTP (http://www.edctp.org). The National Institute for Medical Research (NIMR) through its Mbeya Medical Research Centre (MMRC) and the National Health Research Ethics Committee (NatHREC) Secretariat at NIMR Headquarters, the Tanzania Food and Drugs Authority (TFDA) and the Kilimanjaro Clinical Research Institute (KCRI) are the three Tanzanian Institutions that have teamed up in collaboration with the University of St. Andrews (USTAN) in Scotland, UK to achieve the objectives of the project. The project will investigate and streamline ethical review of health research and the regulatory framework within Tanzania.
The SMERT project was officially launched on 23rd April, 2018 at NIMR HQ in Dar es Salaam, Tanzania. The launch was officiated by the Chief Medical Officer of Tanzania’s Ministry of Health, Community Development, Gender, Elderly and Children (MOHCDGEC) in the presence of delegates from NIMR, TFDA and Institutional Research Ethics Boards (IRBs) across the country. SMERT will develop systems capacity to ensure compliance to ethics of health research, clinical trials and regulations for safety and quality of medicines.
(A group photo of delegates that attended the SMERT launch, lead by the Guest of Honour Prof Muhammad Bakari Kambi, Chief Medical Officer (standing in the front line with a blue necktie) from the Ministry of Health, Community Development, Gender, Elderly and Children, the NIMR Ag. Director General Dr Godfrey Mubyazi (on the left side of the CMO) as well as the representative of the TFDA Ag. Director General, Ms Kissa Mwamwitwa (on the right side of the CMO)
SMERT investigators include; Dr. Nyanda Elias Ntinginya (Principal Investigator and Lead Coordinator) and Dr. Ruby Mcharo (Co-Principal Investigator and Project Manager) based at NIMR-Mbeya Medical Research Centre; Ms. Kissa Mwamwitwa (TFDA), Dr. Ndekya Oriyo and Dr. Ahmed Abdallah (NatHREC Secretariat), Prof. Blandina Mmbaga (KCRI) as well as Mrs. Joyce Ikingura, former Head of the NatHREC Secretariat at NIMR HQ. Likewise, Dr. Wilber Sabiiti, Dr. Morven Shearer and Dr. Janet Gillespie are SMERT investigators based at the University of St. Andrews, UK.
SMERT will conduct a baseline assessment through an audit of IRBs and RECs, National Research Ethics Committee, Clinical Trials Control Technical Committee and TFDA’s pharmacovigilance system to identify needs for capacity development. SMERT’s approach is to deliver need-focused capacity development that will increase efficiency and promote compliance to ethical principles in research and clinical practice. The project will offer opportunities for training and education to members of the Ethics Committees and Regulatory authorities and to biomedical students. The University of St. Andrews will support development of training resources and split site training of Masters and PhD students. By building connections and improving communications, SMERT hopes to encourage the smooth transfer of important and appropriate information between key institutional players.
Furthermore, from these interventions, SMERT seeks to raise awareness and promote dialogue among policy makers and healthcare implementers about the importance of ensuring appropriate ethical standards for health research within Tanzania. Medicines are becoming more complex in their actions and interactions just when medical research is becoming more global in its organisation. SMERT highlights the importance of robust procedures that are open to public scrutiny so that the investigator has confidence in their administration and the investigated is confident that their welfare is both valued and safeguarded.