Human Research Standards in Africa by Country

Clinical Trial Registries

Pan African Clinical Trials Registry

• PACTR, Terms and Conditions
• PACTR, FAQs
• African Clinical Trials Community

General

Key Organizations

• National Institute for Health Research (INIS)
• INIS Ethics Committee (CEINIS)

Relevant Standards

• INIS/CEINIS, Documents and Forms Required for Submitting Protocols

General

Key Organizations

• Ministry of Health

Relevant Standards

• Law No. 2010-40 of 8 December 2010 Regarding the Ethical Code and Duties in Health Research in the Republic of Benin

General

Key Organizations

• Ministry of Health and Wellness

Relevant Standards

• Anthropological Research Act 45 (1967)
• Botswana National Drug (Medicine) Policy, Section 15 (2002, First Edition published 2005)
• Guidelines for Application for Research Permit
• National Health Quality Standards (2013)

Drugs, Biologics, and Devices

Key Organizations

• Ministry of Health and Wellness

Relevant Standards

• Drugs and Related Substances Regulations (1993)
• SADC Guidelines for Regulating Clinical Trials in Human Subjects (2006)
• Guideline for Regulating the Conduct of Clinical Trials Using Medicines in Human Participants (2012)

General

Key Organizations

• Ministry of Health and Public Hygiene
• Technical Directorate of the National Institute of Public Health (INSP), The MURAZ Center
• Ministry of Health and Public Hygiene, Fundamental Texts

General

Key Organizations

• Cameroon Bioethics Initiative
• Republic of Cameroon, Presidency of the Republic

Relevant Standards

• Ministerial Order No. 079/A/MSP/DS of MINSANTE (1987)
• Law on Medical Research Involving Humans (2022)

General

Key Organizations

• Ministry of Health

Relevant Standards

• Order No. 1250 on the Organization of the National System of Pharmacovigilance in the Democratic Republic of Congo (2015)
• Guidelines for the Ethical Evaluation of Research Involving Human Subjects in the Democratic Republic of Congo (2011) (French)

General

Key Organizations

• Ministry of Health, Public Hygiene and Universal Health Coverage

Drugs, Biologics, and Devices

Key Organizations

• Ivorian Authority for Pharmaceutical Regulation (AIRP)

Relevant Standards

• Decree No. 2020-407 of April 22, 2020, Regulating Clinical Trials
• Order Relating to the Organization and Operation of the National Committee for Ethics in Life Sciences and Health (2018)
• Decision No. 03, Regulation of Medical Devices (2022)

General

Key Organizations

• Ministry of Health
• Ethiopian Science and Technology Commission, Health Department

Relevant Standards

• Proclamation 60/1999, Section 21
• National Health Research Ethics Review Guideline (2020)

Drugs, Biologics, and Devices

Key Organizations

• Ethiopian Food and Drug Authority (EFDA)

Relevant Standards

• Drug Administration and Control Proclamation No. 176/1999, Article 21
• Pharmacovigilance and Clinical Trial Lead Executive Office Guideline for Clinical Trial Authorization
• Proclamations, various
• Regulations, various
• Policies, various

General

Key Organizations

• MRC: The Gambia Unit (London School of Hygiene & Tropical Medicine)
• Gambia Research Ethics and Methodology Training Initiative (GamREMTI)

Relevant Standards

• MRC, Research Governance & Integrity
• Guidelines of the National DNA Bank (2001)

Drugs, Biologics, and Devices

Key Organizations

• Food and Drugs Authority

Relevant Standards

• Act 851, Public Health Act, 2012
• Applications for Clinical Trials as Defined Under Section 150-166 (Part 8) of the Public Health Act 2012, Act 851
• Clinical Trials, Biological Products, Devices, and More, Guidelines and Forms, various
• Clinical Trials, Biological Products, Devices, and More, Operational Guidelines, various

General

Key Organizations

• National Ethics Committee on Health Research (CNERS)

Relevant Standards

• Public Health Code, Articles 237-316 (1997)
• Decree No. D/218/PRG/SGG: On the Establishment, Functions and Organization of the National Ethics Committee for Research in Health (CNERS), Chapters I and II (1998)
• CNERS, Frequently Asked Questions

Research Injury

Key Organizations

• National Ethics Committee on Health Research

Relevant Standards

• Public Health Code, Articles 301-302 (1997)

General

Key Organizations

• National Council for Science and Technology (NCST)
• Ministry of Health (MOH)

Relevant Standards

• Science and Technology Act (2001)
• HIV and AIDS Prevention and Control Act, Chapter 14 (2006)
• MOH, National Guidelines for Ethical Conduct of Research Involving Human Subjects (2008)

Drugs, Biologics, and Devices

Key Organizations

• Pharmacy and Poisons Board

Relevant Standards

• MOH, Kenya National Guidelines for Research and Development of HIV/AIDS Vaccines (2005)
• Guidelines for the Conduct of Clinical Trials in Kenya (2022)
• Guidelines for the conduct of clinical trials during public health emergencies and pandemics in Kenya (2022)

Human Biological Materials

Key Organizations

• Ministry of Health (MOH)

Relevant Standards

• Kenya National Guidelines for Research and Development of HIV/AIDS Vaccines, page 44 (2005)

General

Key Organizations

• Ministry of Health and Social Welfare

Relevant Standards

• Institutional Review Board (IRB) Policies and Procedures Handbook (2020)
• Ethics Committee Guidelines: Procedures for Researchers, Section 1 (2011)
• Operational Guidelines of the National Research Ethics Board (2019)
• Guideline for Application to Conduct Clinical Trials in Liberia (2014)

General

Key Organizations

• Ministry of Public Health (MSANP)

Relevant Standards

• National Health Policy (2016)
• National Health Research Policy (2016)

General

Key Organizations

• National Commission for Science and Technology (NCST)
• National Health Sciences Research Committee (NHSRC)
• College of Medicine Research and Ethics Committee (COMREC)
• Ministry of Health

Relevant Standards

• Constitution of Malawi, Article 19(5) (1994)
• NCST, Research Policies and Guidelines
• NCST, National Committee on Research In The Social Sciences And Humanities
• COMREC, Research Policies and Procedures

Drugs, Biologics, and Devices

Key Organizations

• Pharmacy, Medicines, and Poisons Board of Malawi

Relevant Standards

• Pharmacy, Medicines, and Poisons Act (2014)

Social-Behavioral Research

Key Organizations

• National Committee on Research in the Social Sciences and Humanities

Relevant Standards

• Framework of Guidelines for Research in the Social Sciences and Humanities in Malawi (2011)

Human Biological Materials

Key Organizations

• National Commission for Science and Technology

Relevant Standards

• National Regulatory Requirement and Position on Accessing, Collection, Storage, and Use of Human Biological Specimens for Research (2014)
• Circular on Human Biological Samples and Participants Recompense in Research Involving Human Subjects (2019)

Genetic Research

Key Organizations

• National Research Council of Malawi (NRCM)

Relevant Standards

• Procedures and Guidelines for Access and Collection of Genetic Resources in Malawi (2003)

General

Relevant Standards

• Law No. 09-059 of 28 December 2009 Governing Biomedical Research on Humans

General

Key Organizations

• Ministry of Health and Social Services

Drugs, Biologics, and Devices

Key Organizations

• Namibia Medicines Regulatory Council (NMRC)

Relevant Standards

• Namibia Medicines and Related Substances Control Act 2003 Act No 13 of 2003
• Namibia Medicines Regulatory Council Guideline for Section 27 Applications
• NMRC, National Guidelines for Medicine Safety Surveillance (2011)

General

Key Organizations

• National Health Research Ethics Committee
• Ministry of Health

Relevant Standards

• National Health Act (2014)
• Nigerian Code of Health Research Ethics (2007)
• Policy Statement Regarding Enrollment of Children in Research in Nigeria (2016)
• Guides and Forms, various

Drugs, Biologics, and Devices

Key Organizations

• National Agency for Food, Drug Administration and Control (NAFDAC)

Relevant Standards

• Decree No. 15 of 1993
• Good Clinical Practice Guidelines (2020)
• NAFDAC, Various Guidelines (filter by product type)
• NAFDAC, Various Gazette Regulations (filter by product type)

Clinical Trial Registries

Key Organizations

• National Health Research Ethics Committee

Relevant Standards

• Frequently Asked Questions

Social-Behavioral Research

Key Organizations

• National Health Research Ethics Committee

Relevant Standards

• Nigerian Code of Health Research Ethics (2007)

Human Biological Materials

Key Organizations

• National Health Research Ethics Committee

Relevant Standards

• Policy Statement on Storage of Human Samples in Biobanks and Biorepositories in Nigeria (2013)

General

Key Organizations

• Ministry of Health
• National Ethics Committee
• National Council for Science and Technology

Relevant Standards

• Laws, various

General

Key Organizations

• National Committee on Health Research Ethics (CNERS)

Relevant Standards

• For a comprehensive listing of research ethics standards in Senegal, visit https://www.cners.sn/, click on “About,” then click on “Resources.”

General

Relevant Standards

• Application Guidelines (2017)

Drugs, Biologics, and Devices

Key Organizations

• Ministry of Health
• Pharmacy Board of Sierra Leone

Relevant Standards

• Clinical Trials, Various
• Good Clinical Practice Guidelines (2021)
• Guidelines for the Application and Authorization of Clinical Trials of Medicines, Vaccines, and Medical Devices (2021)
• Guidelines for the Inspection of Clinical Trials (2021)
• Guidelines for Conducting Clinical Trials of Medicines, Food Supplements, Vaccines, and Medical Devices in Sierra Leone, Sections 3.1.7 and 3.2 (2014)
• Guideline for Good Clinical Practice (GCP) in Sierra Leone, Sections 3.2 and 3.3 (2018)

General

Key Organizations

• Department of Health (DH)
• Medical Research Council of South Africa (MRC)
• Human Sciences Research Council (HSRC)
• South African Health Products Regulatory Authority

Relevant Standards

• Constitution of South Africa, Section 12 (2) (1996)
• National Health Act No. 61, Chapter 9 (2003)
• Regulations Relating to Research with Human Participants No. R719 (2014)
• MRC, Various Guideline Documents
• DH, Ethics in Health Research: Principles, Structures, and Processes (2015)

Drugs, Biologics, and Devices

Key Organizations

• Department of Health (DH)
• Health Products Regulatory Authority

Relevant Standards

• Medicines and Related Substances Control Act, 101 of 1965
• General Regulations Made in Terms of the Medicines and Related Substances Act, 1965 (2003)
• South African Good Clinical Practice: Clinical Trial Guidelines (2020)

Clinical Trials Registry

Key Organizations

• South African National Clinical Trials Register

Relevant Standards

• FAQs

Social-Behavioral Research

Key Organizations

• Department of Health (DH)

Relevant Standards

• Ethics in Health Research: Principles, Processes, and Structures, Section 3.3.7(i) (2015)

Human Biological Materials

Key Organizations

• Department of Health (DH)

Relevant Standards

• National Health Act No. 61, Chapter 8, Sections 53-68 (2003)
• Regulations Relating to the Use of Human Biological Material, 2 March 2012
• Regulations Relating to Blood and Blood Products, 2 March 2012
• Regulations Relating to Artificial Insemination of Persons (2016)

Genetic Research

Key Organizations

• Medical Research Council of South Africa (MRC)

Relevant Standards

• Guidelines on Ethics for Medical Research, Reproductive Biology and Genetic Research (2002)

Embryos, Stem Cells, and Cloning

Key Organizations

• Medical Research Council of South Africa (MRC)

Relevant Standards

• National Health Act No. 61, Chapter 8, Section 57 (2003)
• Regulations relating to Stem Cell Banks, 2 March 2012
• Guidelines on Ethics in Reproductive Biology and Genetic Research (2002)

General

Key Organizations

• Ministry of Health (MOH)
• National Institute for Medical Research (NIMR)
• National Health Research Ethics Committee (NHREC)
• Tanzania Commission for Science and Technology (COSTECH)

Relevant Standards

• National Institute for Medical Research, Act of Parliament No. 23, of 1979
• Tanzania Commission for Science and Technology, Act No. 7 of 1986
• NIMR, Research Policies, Guidelines, and Regulations (1979)
• Guidelines on Ethics for Health Research in Tanzania (2009)
• The Personal Data Protection (Personal Data Collection and Processing) Regulations, 2023

Drugs, Biologics, and Devices

Key Organizations

• Tanzania Medicines and Medical Devices Authority

Relevant Standards

• Tanzania Food, Drugs, and Cosmetics Act, Sections 61, 66, 67, and 69 (2003)
• Medical devices, various
• Tanzania Commission for Science and Technology (COSTECH)

General

Key Organizations

• Ministry of Health
• Uganda National Council for Science and Technology (UNCST)

Relevant Standards

• Uganda National Council for Science and Technology Act of 1990 (CAP 209)
• National Guidelines for Research Involving Humans as Research Participants (2014)
• Research Registration and Clearance Policy and Guidelines (2016)
• National Guidelines for the Conduct of Research During the COVID-19 Pandemic (2020)

Drugs, Biologics, and Devices

Key Organizations

• National Drug Authority

Relevant Standards

• Human Medicine Guidelines, including Guidelines for the Conduct of Drug Related Clinical Trials (2019)
• National Drug Policy and Authority Act Regulations
• Clinical Trial Application Forms

Human Biological Materials

Relevant Standards

• National Research Biobanking Guidelines (2021)

General

Key Organizations

• Ministry of Health

Relevant Standards

• National Health Research Act (2013)

Drugs, Biologics, and Devices

Key Organizations

• Zambia Medicines Regulatory Authority

Relevant Standards

• Medicines and Allied Substances Act, Part VI: Regulation of Clinical Trials, 2013
• Guidelines on Regulating the Conduct of Clinical Trials in Human Participants, First Edition

Human Biological Materials

Relevant Standards

• National Health Research Act, Part VI (2013)

General

Key Organizations

• Ministry of Health and Child Care
• Medical Research Council of Zimbabwe

Relevant Standards

• Research Act (1986)
• Medical Research Council of Zimbabwe, Various Protocol-related Forms

Drugs, Biologics, and Devices

Key Organizations

• Medicines Control Authority of Zimbabwe

Relevant Standards

• Medicines and Allied Substances Control Act, Chapter 15:03 (1997)
• Medicines and Allied Substances Control Act, General Regulations (1991)
• Statutory Instrument 150 of 1991
• Pharmacovigilance and Clinical Trials, Various Guidelines

Privacy/Data Protection

Key Organizations

• Zimbabwe National Statistics Agency

Relevant Standards

• Constitution of Zimbabwe of 2013, Section 57
• Access to Information and Protection of Privacy Act, Chapter 10:27

Human Biological Materials

Key Organizations

• Medical Research Council of Zimbabwe

Relevant Standards

• Research Act (2001)
• Various

Genetic Research

Key Organizations

• National Biotechnology Authority of Zimbabwe

Relevant Standards

• National Biotechnology Authority Act, Chapter 14:31 (2006)