Human Research Standards in Middle East and North Africa by Country

Disclaimer: Though this Compilation contains information of a legal nature, it has been developed for informational purposes only and does not constitute legal advice or opinions as to the current operative laws, regulations, or guidelines of any jurisdiction. In addition, because new laws, regulations, and guidelines are issued on a continuing basis, this Compilation is not an exhaustive source of all current applicable laws, regulations, and guidelines relating to international human subject research protections. While reasonable efforts have been made to assure the accuracy and completeness of the information provided, researchers and other individuals should check with local authorities and/or research ethics committees before starting research activities.

This page provides an overview of standards for protecting research participants in the Middle East and North Africa region. Information is organized by country in alphabetical order, with details on laws, regulations, and guidelines for each country.

General

Key Organizations

Relevant Standards

Drugs, Biologics, and Devices

Key Organizations

Relevant Standards

General

Key Organizations

Relevant Standards

  • Protection Code for Human Subjects in Medical Research (1999)

Clinical Trial Registries

Key Organizations

General

Key Organizations

Relevant Standards

  • Public Health Regulations — Medical Experiments Involving Human Subjects (1999)

Drugs, Biologics, and Devices

Key Organizations

Relevant Standards

Privacy/Data Protection

Key Organizations

Relevant Standards

Genetic Research

Relevant Standards

  • Genetic Information Law (2000)
  • Instruction of the Supreme Committee for Clinical Studies on Humans — Establishment/Use of Genetic Samples Reservoir (2005; amendment 2007)

Embryos, Stem Cells, and Cloning

Relevant Standards

Drugs, Biologics, and Devices

Key Organizations

Relevant Standards

Research Injury

Relevant Standards

Embryos, Stem Cells, and Cloning

Relevant Standards

  • Stem Cell By‑law No. 10 (2014)

General

Key Organizations

Relevant Standards

General

Key Organizations

Relevant Standards

Human Biological Materials

Key Organizations

Relevant Standards

Genetic Research

Key Organizations

Relevant Standards

General

Key Organizations

Relevant Standards

General

Key Organizations

Relevant Standards

  • National Guidelines for Ethical Conduct of Research Involving Human Subjects (2008)
  • Accreditation Guidelines for Research Ethics Committees in Sudan (2017)
  • Operation Guidelines — Functions & Procedures (2016)
  • Sudan National Health Policy (2017–2030)

Drugs, Biologics, and Devices

Key Organizations

Relevant Standards

Human Biological Materials

Key Organizations

  • National Council on Biosafety

Relevant Standards

  • Human Organs and Tissues Transplant Legislation — Chapter 2, Articles 3 & 4 (1978)
  • Act on Biosafety (2010)

Genetic Research

Key Organizations

  • University of Khartoum — Institute of Endemic Diseases

Relevant Standards

  • Guidelines for Genetics Research on Sudanese Subjects (2005)

Drugs, Biologics, and Devices

Key Organizations

Relevant Standards

  • Conditions of contract & specifications related to medical/scientific experimentation of medicines for humans
  • Disposals & Director’s principles related to Good Practices in Clinical Trials

General

Key Organizations

Relevant Standards

Drugs, Biologics, and Devices

Key Organizations

Relevant Standards

Research Injury

Key Organizations

Relevant Standards

Social-Behavioral Research

Key Organizations

Relevant Standards

Privacy/Data Protection

Key Organizations

Relevant Standards

Human Biological Materials

Key Organizations

Relevant Standards

Genetic Research

Key Organizations

Relevant Standards

Embryos, Stem Cells, and Cloning

Key Organizations

Relevant Standards

General

Key Organizations

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