Table 2.

Human Research Standards in MENA Region.

Relevant Standards: • Law No. 214 of 2020, Regulating Clinical Research: https://www.edaegypt.gov.eg/media/cyyn0r4r/2020–214.pdf  • The law covers all types of human research: clinical trials, surveys, and interview studies. • Constitution of the Arab Republic of Egypt, Article 43: http://www.sis.gov.eg/Newvr/Dustor-en001.pdf

Regulatory Authorities • Egyptian Drug Authority (EDA): Egyptian Drug Authority: https://www.edaegypt.gov.eg  • The EDA is entrusted with reviewing the scientific aspects of clinical trial protocols, the medical interventions whether biological, pharmaceutical or a medical device and relevant pre-clinical studies.

Ethics Oversight • Institutional Review Boards (IRBs): The first level of oversight is performed by the IRBs of research institutes and university hospitals. There are more than 60 IRBs in Egypt. • The Supreme Council for Reviewing the Ethics of Clinical Medical Research: This entity established by the new law provides the final level of oversight. The Supreme Council provides oversight for any research conducted with a foreign entity. The Supreme Council has 15 members who will serve for four years. The council has one or more representatives from the different governmental ministries and representatives from the Interior and Defense, as both ministries manage the Egyptian army and police hospitals, respectively, where clinical trials are conducted. In addition, three representatives of the public will be members of the supreme council.

Privacy/Data Protection • The Egyptian Data Protection Law (July 2020) is modeled on the EU General Data Protection Regulation (GDPR). The same core principles of EU data protection law are replicated in this law. To transfer personal data out of Egypt, a company must obtain a license from the Personal Data Protection Centre and should only transfer personal data to a country which affords the same level of protection to personal data as Egypt under the Law. The Law has implications for research involving questionnaires and personal data. However, with the executive regulations and overseeing institutions yet to be established, the law’s full impact on research remains unclear.

Relevant Standards: • Protection of Persons Participating in Biomedical Research (August 2015) law Number 28–13. Bulletin Officiel. 2015. Loi n° 28—13 relative à la protection des personnes participants aux recherches biomédicales. Numéro 6396 (p3458–67)

Regulatory Authorities • Moroccan Directorate of Medicines and Pharmacy (the FDA equivalent) provides oversight for clinical trials and acts as an independent agency and is no longer a division of the Ministry of Health.

Ethics Oversight • Local Research Ethics Committees (RECs): Many universities and research institutions have their own IRBs that review and approve research proposals at the institutional level. • Regional Committees for the Protection of Persons (CPP): The Moroccan law provided an additional level for ethics oversight through the establishment of regional CPP for each of the 12 administrative regions in the country. Research approval must be obtained from the relevant regional CPP. The regional CPPs offer significant advantages, including accommodating regional cultural specificities and providing unified approval for multi-institutional research within a region, enhancing efficiency and consistency.

Privacy/Data Protection • Morocco - National Commission for the Protection of Personal Data Protection (CNDP) (2009) is responsible for implementing and enforcing the country’s data protection law. The law applies to the processing of personal data by natural or legal persons, public authorities, service providers, and other bodies that receive data.

Relevant Standards • National Guidelines for Ethics Conduct of Research Involving Human Subjects (2008) https://sites.google.com/site/healthresearchlibrary/national-guidelines: It is the guiding document that regulates the conduct of research that involves human subjects, identifiable information, or tissues in Sudan • NATIONAL APPLICATION FORM FOR ETHICS APPROVAL OF A RESEARCH PROJECT It describes in a step-by-step manner how to prepare the application forms that are submitted to the National Research Ethics Committee in Sudan.

Regulatory Authorities • Federal Ministry of Health (FMOH): Sets policies and guidelines for health research, ensuring alignment with national health priorities.

• National Medicines and Poisons Board (NMPB): A semi-autonomous medicines regulatory authority, which was originally part of the Ministry of Health. https://www.nmpb.gov.sd/en/

Ethics Oversight • National Health Research Ethics Committee (NHREC): The NHREC oversees ethics review and approval of health research projects. It ensures compliance with national and international ethics standards. • Local Research Ethics Committees (RECs): Many universities and research institutions have their own IRBs that review and approve research proposals at the institutional level

Privacy/Data Protection • Public Health Act: Provides the legal basis for regulating health research, including participant protection and data privacy.

Relevant Standards The legal framework to regulate and oversee the ethics conduct of research in Lebanon is primarily guided by a combination of national laws, ministerial decrees, and institutional policies. • Law No. 27/2017: This law, also known as the “Clinical Trials Law,” was enacted to regulate clinical trials in Lebanon. It establishes the requirements for conducting clinical trials, including the need for ethics approval, informed consent, and protection of research participants’ rights. https://www.syndicateofhospitals.org.lb/Content/uploads/SyndicateMagazinePdfs/4642_8–9eng.pdf • The following link has all details about degrees and guidance on clinical trials in Lebanon. https://www.moph.gov.lb/en/Pages/3Z4760/clinical-trial-regulations • Law No. 78/2020: This law provides further regulations on biomedical research, emphasizing the importance of ethics considerations and the protection of human subjects. It outlines the roles and responsibilities of researchers, sponsors, and ethics committees. • Several guidelines such as the charter published by the National Council For Scientific Research in Lebanon titled “Charter of Ethics and Guiding Principles of Scientific Research in Lebanon” Charter_of_ethics_En_20l6.pdf (cnrs.edu.lb). • Law No. 574 of February 11, 2004 on the Rights of Patients and Informed Consent: استمارة (1) جراحية أو/و طبية معالجة لاجراء مسبقة موافقة (moph.gov.lb) • National Council for Scientific Research (NCSR): Published the ‘Charter of Ethics and Guiding Principles of Scientific Research’ in July 2016 (Atallah et al., 2018). However, little is known about the performance of the ethics review system and the adherence of research ethics committees (RECs) to this charter (Al-Omari & Al-Hussaini, 2017).

Ethics Oversight • Institutional Review Boards (IRBs): Research institutions, including universities and hospitals, are required to establish IRBs or Ethics Committees. IRBs are responsible for the ongoing monitoring of approved research projects to ensure continued compliance with ethics principles.

Privacy • Lebanon Law No. 81/2018 Relating to Electronic Transactions and Personal Data (2018). The Law contains provisions on data protection that are applicable in the Republic of Lebanon (One Trust Data Guidance, 2024).

Relevant Standards: • Law No. 24 of 2001: Clinical Studies Law (CSL): This law was enacted to regulate and provide oversight over the expanding number of clinical studies conducted in Jordan. The CSL mandates that only local organizations licensed by the Minister of Health are allowed to conduct clinical studies, and these organizations include public and private hospitals, universities and academic institutions, scientific research institutions (e.g., Clinical Research Organizations (CROs)), and pharmaceutical companies (Al-Omari & Al-Hussaini, 2017). • Law of Clinical Studies, Law No. 2 (2011) https://www.jfda.jo/EchoBusV3.0/SystemAssets/PDF/AR/LawsAndRegulation/Drug/PharmaceuticalStudies/50_2ll.pdf

Regulatory Authorities • Jordan Food and Drug Administration (JFDA). In 2003, the Jordan Food and Drug Administration (JFDA) was established as a stand-alone and independent entity to regulate and supervise medicinal products and medical devices in compliance with the effective Drug and Pharmacy Law for the year 2001. https://www.jfda.jo/Default.aspx

Ethics Oversight • Institutional Review Boards (IRBs): Research institutions, including universities, hospitals, and research centers, are required to establish IRBs. These boards are tasked with reviewing research proposals to ensure they meet ethics guidelines and standards. IRBs provide ongoing monitoring of research projects to ensure continued compliance with ethics principles.