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Table 5 Regulatory bodies that approved the P1078 study

From: Prevalence of neurotoxicity symptoms among postpartum women on isoniazid preventive therapy and efavirenz-based treatment for HIV: an exploratory objective of the IMPAACT P1078 randomized trial

Country

IRBs

South Africa

­ University of Witwatersrand Research Ethics Committee

­ South African Health Products Regulation

Botswana

­ Botswana Ministry of Health -Health Research and Development Committee

­ Harvard University IRB - Harvard T.H. Chan School of Public Health Office of Regulatory Affairs and Research Compliance

­ Botswana Drug Regulatory Unit

India

­ Ethics Committee- B J Medical College and Sassoon General Hospitals

Tanzania

­ National Institute of Medical Research (NIMR)

Thailand

­ The Human Experimentation Committee, Research Institute for Health Sciences, Chiang Mai University

­ Research Ethics Committee, Faculty of Medicine, Chiang Mai University

Zimbabwe

­ Medical Research council of Zimbabwe

­ Medicine Control Authority of Zimbabwe

­ Research Council of Zimbabwe

­ Joint Research Ethics Committee for the University of Zimbabwe

College of Health Sciences and Parirenyatwa Group of Hospitals