Regulatory updates for research in LMICs
Regulatory approvals including research permits, ethics and national drug authorities (for trials involving drugs, vaccines and medical devices) are a requirement for human health research studies.
In context of the current Covid-19 pandemic, The African Academy of Sciences highlighted the need to have “accelerated ethical review with protocols reviewed and approved on much shorter timelines while retaining the rigorous protection needed from African Ethics Review Committee (ERC’s)”. The WHO document Ethical standards for research during public health emergencies: Distilling existing guidance to support COVID-19 R&D provides guidance on ethical considerations during public health emergencies.
The Indian Academy of Sciences released a Covid-19 statement
The National Institute of Allergy and Infectious Diseases (NIAID)’s ClinRegs website is an online database of country-specific, clinical research regulatory information for researchers involved in planning and implementing international clinical research.
ClinRegs provides country-specific regulatory information on specific country regulatory authority, ethics committee, informed consent and investigational products.
Latest information regarding regulatory approvals for Covid-19 research in LMICs
African regulatory agencies, ethics committees to expedite COVID-19 clinical trial reviews
Uganda National Council for Science and Technology (UNCST) Information for researchers in light of the COVID-19 pandemic. New procedures for research registration and clearance by UNCST.
The Tanzania Commission for Science and Technology (COSTECH) Information for research stakeholders regarding Covid-19 research studies. COSTECH has already taken various measures on internal approval procedures of research permits. In collaboration with National Medical Research Institute (NIMR), COSTECH have agreed to fast track ethical and research permits approvals as much as possible without jeopardizing the quality of processes.
