Description and Impact of the 20-Year Fogarty International Center/NIH Middle East Research Ethics Training Initiative

Abstract

The Middle East Research Ethics Training Initiative (MERETI), established in 2004 with funding from the Fogarty International Center at the NIH, aimed to enhance research ethics capacity in the Middle East North Africa (MENA) region. Initially focused on Egypt, MERETI expanded to other Arab countries, providing advanced training in international research ethics to over 100 individuals. The program emphasized additional skills in research methodology, pedagogy, scientific writing, and leadership. MERETI’s training evolved from a one-year program to a two-year model incorporating sequential hybrid/blended and asynchronous online components and, eventually, included a fully online 12-credit graduate certificate in research ethics. The program’s impact is demonstrated through the professional achievements of its trainees, which included publishing in peer-reviewed journals, assuming key roles in national research ethics committees and ministries of health and contributing to the development of ethics research practices in their respective countries. MERETI also fostered a sustainable Egyptian network of research ethics committees.

Introduction

With the growing number of collaborative global research studies and clinical trials conducted in the Middle East and North Africa (MENA) region, developing and strengthening health research ethics systems in the MENA region are vital for protecting participants and ensuring the integrity of research conducted in the region. Regional ethicists have taken the lead in identifying and defining key ethical issues in human research (Marzouk et al., 2014). Specific challenges to the development of robust research ethics systems in the MENA region occur at the national level (e.g., national legislation addressing research ethics and regulatory bodies that provide ethics oversight) and at the institutional level (e.g., robust research ethics committees and enhanced training in research ethics at the undergraduate and graduate levels).

To address these challenges, the Fogarty International Center (FIC) at the NIH funds competitive global training programs aimed at strengthening research ethics capacity in low- and middle-income countries. These training programs incorporate innovative activities to build trainees’ skills in delivering research ethics education, leading ethics review processes, and providing expert consultation to researchers, institutions, governments, and international research organizations (Fogarty International Center (FIC), 2024a). In 2004, the Middle East Research Ethics Training Initiative (MERETI) was established with funding from the FIC/NIH. While initially focused on Egypt, the program quickly expanded its reach to other Arab countries in the MENA region. Although Fogarty’s funding for the MERETI training program concluded in 2023, the MERETI training program continues as Fogarty scholars have sustained their leadership, educational, and consultant positions and continue to play pivotal roles in advancing research ethics training at the institutional and national levels.

Approximately 10 years after the establishment of MERETI, we conducted a comprehensive review of our training program. This review highlighted the program’s achievements, the accomplishments of our Fogarty trainees, and the capacity needs and gaps in research ethics at that time (Silverman et al., 2013). The current paper provides a follow-up and an update to our initial 10-year report. Specifically, we will:

1. Outline the current health and research profiles of several countries in the MENA region.

2. Revisit the gaps in research ethics and integrity highlighted in our 2013 paper and those identified in subsequent published articles.

3. Provide a detailed account of the evolution of the MERETI training program’s pedagogy, highlighting innovative teaching strategies, and the shift in learning modalities that shaped its development.

4. Highlight the significant program outputs achieved by our Fogarty scholars in addressing the gaps identified in 2013.

5. Conclude by assessing existing challenges and proposing future directions for further progress.

Regional Health Profile

The Arab countries of the MENA Region have unique health challenges driven by socioeconomic factors, political instability, and external pressures such as migration and conflict. The health profiles of Egypt, Sudan, Jordan, Lebanon, and Morocco reflect unique challenges and priorities within the context of the broader MENA region.

Egypt experiences a range of health issues common in the region, including high rates of noncommunicable diseases including cancer, diabetes, cardiovascular diseases, and chronic respiratory diseases. Additionally, Egypt faces challenges related to obesity, smoking, and air pollution, which contribute to health problems (World Health Organization. Regional Office for the Eastern Mediterranean, 2015a). There are efforts to expand primary care services and enhance family planning at the national level, and public-private partnerships are being encouraged to strengthen the healthcare sector.

Several health initiatives have been successful in the last decade:

• Mandatory immunization has eradicated poliomyelitis in Egypt (The Center for Global Health and Development, 2024)

• National programs have been established to combat tuberculosis and prevent viral hepatitis B/C (World Health Organization. Regional Office for the Eastern Mediterranean, 2023)

• Specialized facilities like the Children’s Cancer Hospital “57357” and the National Breast Cancer Screening Program have been established (The Center for Global Health and Development, 2024)

Egypt has also improved its patient safety practices through a patient-centered approach and embraced “doing no harm” by implementing universal injection safety, blood safety procedures, and harm reduction (Governance Health Unit Alexander University, 2023).

Despite progress, Egypt faces several health challenges (Fakhouri, 2016):

• The quality of public health services is questionable, with about 60% of health expenditure coming out of patients’ pockets.

• Egypt spends about 5.8% of its GDP on health, which is lower than OECD countries.

• The country is on course to meet all targets for maternal, infant, and young child nutrition (Global Nutrition Report, 2024).

Sudan is grappling with both communicable and noncommunicable diseases amidst ongoing conflict and economic difficulties. Diseases such as malaria, respiratory infections, and diarrheal diseases are prevalent, exacerbated by poor healthcare infrastructure and internal displacement due to conflicts (Charani et al., 2019). Noncommunicable diseases are also a concern, with increasing cases of cardiovascular, diabetes, and obesity (World Health Organization. Regional Office for the Eastern Mediterranean, 2015b).

Specific healthcare challenges include (Charani et al., 2019):

• Gaps in data and infrastructure essential for effective interventions

• Water and sanitation issues contribute to diarrheal diseases and neglected tropical diseases

• Climate events such as drought and flooding exacerbate health challenges

• Political conflicts and social instability impact living conditions and health outcomes

Jordan, while having a better-developed healthcare system compared to many of its neighbors, faces challenges with noncommunicable diseases such as heart disease, diabetes, and cancer, and maternal and child health (World Life Expectancy: Live Longer Live Better, 2024). The Kingdom has also been dealing with the health needs of many refugees from surrounding countries, which has put additional strain on its health services (WHO Regional Office for the Eastern Mediterranean, 2023).

Lebanon has been dealing with significant health challenges exacerbated by economic crisis and political instability (World Health Organization, 2024a). Noncommunicable diseases are the leading cause of death, and there is also a significant burden of mental health issues. The country’s health services are stretched thin, and recent crises have further strained resources and healthcare access (Republic of Lebanon. Ministry of Public Health, 2023a; World Health Organization. Regional Office for the Eastern Mediterranean, 2024). Despite these challenges, Lebanon has progressed in some areas, such as high rates of skilled birth attendance and access to essential sanitation services. However, there is room for improvement in areas like safely managed drinking water services (48% of the population) and maternal healthcare (World Health Organization, 2024a).

Morocco faces significant health challenges with communicable and noncommunicable diseases impacting the population. Noncommunicable diseases (NCDs) such as cardiovascular diseases, cancer, chronic respiratory diseases, and diabetes are significant concerns. Risk factors like tobacco use, unhealthy diets, physical inactivity, and harmful use of alcohol primarily drive these conditions. NCDs are responsible for a substantial number of premature deaths in Morocco, reflecting a global trend (World Health Organization, 2024b). On the infectious diseases front, Morocco continues to deal with diseases like tuberculosis and hepatitis alongside emerging global threats such as COVID-19. The country has implemented various measures to control these diseases, including vaccination programs and public health campaigns (Mahdaoui & Kissani, 2023).

Health Research Initiatives

Efforts to improve health outcomes are ongoing but face numerous obstacles, including financial constraints and infrastructural deficiencies. Research offers an approach to understanding the basis of illnesses and the underlying social interactions. Research efforts in Egypt, Sudan, Jordan, Lebanon, and Morocco are diverse and targeted at addressing specific health challenges prevalent in each country.

Table 1 outlines health research initiatives in Egypt, Sudan, Jordan, Lebanon, and Morocco, focusing on addressing unique health challenges within each country. In Egypt, research prioritizes infectious diseases such as Hepatitis C and Schistosomiasis, with noteworthy efforts dedicated to understanding their epidemiology and developing effective treatments. Noncommunicable diseases, particularly cardiovascular diseases, diabetes, and cancer, also receive considerable research attention. Public health and policy research aims to strengthen health systems and analyze the impact of socioeconomic factors on health outcomes.

Table 1.

Overview of the Types of Research Being Conducted in Several MENA Countries to Address Their Unique Health Issues.

Country	Types of Research to Address Unique Health Issues
Egypt	• Infectious Diseases:  • Hepatitis C: Given its high prevalence in Egypt, significant research focuses on the epidemiology, treatment, and prevention of Hepatitis C (Elgharably et al., 2017).  • Schistosomiasis: Research aims to understand transmission dynamics and develop effective treatment and prevention strategies (Elmorshedy et al., 2020). • Noncommunicable Diseases:  • Cardiovascular Diseases and Diabetes: Research is directed toward understanding risk factors and improving treatment protocols and preventive measures (Sidahmed et al., 2023).  • Cancer: Studies focus on early detection, treatment options, and the epidemiology of cancer, particularly breast and liver cancers (Hirsch et al., 2016). • Public Health and Policy:  • Research in this area includes strengthening health systems, policy analysis, and the impact of socioeconomic factors on health outcomes (Hirsch et al., 2016).
Sudan	• Infectious Diseases:  • Malaria: Research targets vector control, drug resistance, and the development of new treatments (Omer et al., 2017).  • Tuberculosis: Studies focus on diagnosis, treatment, and control measures, especially in multi-drug-resistant TB (Badawi et al., 2024). • Maternal and Child Health:  • Efforts are directed toward reducing maternal and infant mortality through improved healthcare practices and interventions (Sami et al., 2020). • Cancer:  • The focus is on breast, gynecologic, and prostate cancers (Amany Elamin et al., 2015). • Nutrition:  • Research addresses malnutrition and micronutrient deficiencies, particularly among vulnerable populations in conflict areas (Homeida, 2023).
Jordan	• Mental Health Research:  • Research addresses the prevalence, treatment, and stigma associated with mental health disorders (Okasha & Karam, 1998). • King Hussein Cancer Center (KHCC):  • The KHCC is a leading institution in Jordan that provides comprehensive care for all types of cancer. The center is involved in extensive research and clinical trials, focusing on various cancer types, including breast, colorectal, and pediatric cancers. The KHCC also collaborates with international cancer research institutions to enhance its research capabilities and adopt the latest treatment modalities (European Society for Medical Oncology, 2024). • Childhood Cancer Research:  • A recent study highlighted the burden and scope of childhood cancer among displaced patients in Jordan, particularly those treated at the King Hussein Cancer Center. The research emphasizes the need for improved healthcare services and funding to support cancer care for both local and displaced populations (Rihani et al., 2023). • Refugee Health:  • Given the large refugee population, the research includes health service delivery, care access, and displaced individuals’ health needs (Al-Soleiti et al., 2021).
Lebanon	• Mental Health Disorders:  • Research on the prevalence, treatment, and stigma associated with mental health disorders, including depression, anxiety, and PTSD, especially among populations affected by conflict (Kerbage et al., 2020). • Health Systems Strengthening:  • Research aimed at improving health system infrastructure, policy analysis, and the impact of socioeconomic factors on health outcomes (Orton et al., 2018). • Maternal Health:  • Research on improving maternal health outcomes, reducing maternal mortality rates, and enhancing prenatal and postnatal care (Tappis et al., 2017).
Morocco	• Infectious Diseases:  • Tubercolosis: Research focuses on mycobacterium drug resistance and care delivery and management (Ennassiri et al., 2018).  • HIV/AIDS: Studies aim to improve prevention, treatment, and care for people living with HIV (Kouyoumjian et al., 2013; Mumtaz et al., 2013).
	• Noncommunicable Diseases:  • Cardiovascular Diseases and Diabetes: Research aims to understand these conditions’ epidemiology, prevention strategies, and treatment approaches (Skalli et al., 2019).  • Cancer: Focus areas include early detection, treatment modalities, and cancer epidemiology, particularly breast cancer (El Rhazi et al., 2014).

Similarly, Sudan’s research efforts target infectious diseases like malaria and tuberculosis, with a focus on vector control, drug resistance, and new treatment development. Additionally, maternal and child health research in Sudan seeks to reduce mortality rates, while cancer research focuses on breast, gynecologic, and prostate cancers. Nutritional research addresses malnutrition and micronutrient deficiencies, especially in conflict areas.

In Jordan, mental health research addresses the prevalence, treatment, and stigma associated with mental health disorders. The King Hussein Cancer Center (KHCC) plays a pivotal role in cancer research, conducting extensive studies and clinical trials on various cancer types, including breast, colorectal, and pediatric cancers. The KHCC also collaborates internationally to enhance its research capabilities. Childhood cancer research highlights the burden on displaced patients, emphasizing the need for better healthcare services and funding. Refugee health research in Jordan focuses on healthcare access and the needs of displaced populations.

Lebanon is addressing an exacerbated healthcare crisis through the Lebanon Crisis Response Plan (LCRP), which aims to support over three million people, including local families and refugees from Syria and Palestine. This plan integrates health support with economic and social assistance, emphasizing the need for sustainable health and social services amid Lebanon’s severe economic crisis (United Nations News, 2022).

Under the guidance of The Lebanon National Health Strategy: Vision 2030 report, issued in January 2023 (Republic of Lebanon. Ministry of Public Health, 2023b), major strides have been made in enhancing the overall well-being of the population. The multifaceted approach has addressed key issues such as challenged healthcare accessibility, mental health, and maternal health.

In Morocco, research on infectious diseases like tuberculosis and HIV/AIDS aims to improve prevention, treatment, and care. Noncommunicable disease research focuses on cardiovascular diseases, diabetes, and cancer, with efforts directed toward early detection, treatment modalities, and understanding epidemiology. These diverse initiatives underscore each country’s tailored approaches to address its specific health challenges.

These initiatives illustrate the region’s diverse health challenges and research priorities, from infectious disease control in conflict zones to capacity building in health economics to manage limited resources effectively. Each country tailors its research efforts to address the most pressing health challenges, leveraging local expertise and international collaborations to improve health outcomes.

Current Regional Health Research Ethics Systems

Table 2 highlights the countries associated with the MERETI program, detailing their relevant research ethics standards, regulatory authorities, and systems of research ethics oversight. Egypt and Morocco have recently enacted national regulations governing research involving human participants.

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.

Regional Research Ethics Capacity and Gaps in the MENA Region

In our 2013 paper (Silverman et al., 2013), we analyzed the existing gaps in research ethics capacity and proposed strategic directions for addressing these gaps at both national and institutional levels. Subsequent literature summarized below has further explored and expanded upon these gaps over the past decade, providing deeper insights into the challenges that persist. We present an overview of these gaps in research ethics over the past ten years.

Gaps at the National Level

At the start of 2013, several countries in the MENA region lacked national regulations (e.g., Egypt, Morocco, Sudan). In a study conducted among members of RECs in Egypt, 92% ranked highly that the lack of appropriate national regulations in research ethics represents a key challenge for RECs and investigators (Sleem et al., 2010).

Systemic Gaps in Research Ethics Capacity

Significant systemic gaps in research ethics capacity have been identified across the MENA region.

Research Ethics Committee Capacity:

Many Research Ethics Committees (RECs) face challenges such as insufficient ongoing training for members and limited human and material resources (Matar & Silverman, 2022). While efforts to improve REC structures and operations have been initiated, further progress remains necessary. A study utilizing the Research Ethics Committee Quality Assurance Self-Assessment Tool (RECQASAT) compared RECs from Egypt, South Africa, and India, revealing deficiencies in key domains, including institutional commitment, policies and procedures, membership composition and training, protocol review processes, and criteria for continuing review (Silverman et al., 2015).

Further exploration of REC perspectives has highlighted gaps specific to genomic research ethics. For example, significant variability in informed consent forms, inadequate policies for returning individual research results, and missing elements in material transfer agreements were noted (Mohammed et al., 2024). These findings underscore the need for harmonized policies and enhanced training to address these challenges.

Investigator Capacity:

Research has also pointed to the need for research ethics capacity building among investigators, particularly in genomic research. Ibrahim and colleagues examined ethics challenges in biobank research, emphasizing the importance of improving investigators’ understanding of community engagement and addressing concerns about data sharing within and beyond national borders (Ibrahim et al., 2024). These findings call for targeted educational initiatives to strengthen ethics competencies in this area.

Research Integrity:

Concerns about research integrity have been highlighted in several studies. Felaefel and colleagues assessed research misconduct in universities across Egypt, Lebanon, and Bahrain, finding that 59.4% of respondents self-reported engaging in at least one form of misconduct, such as circumventing ethics regulations (50.5%) and fabrication or falsification (28.6%). A significant predictor of misconduct was the lack of prior ethics training, underscoring the need for robust training programs (Felaefel et al., 2018).

Similarly, Abdelnaby and colleagues investigated plagiarism practices among postgraduate students and faculty members in Egypt and Lebanon. Their findings revealed moderate knowledge of plagiarism, permissive attitudes toward plagiarism, and low self-reported instances of plagiarism. The authors recommended that universities in the Arab Middle East develop comprehensive research ethics training programs focusing on responsible conduct in research (Abdelnaby et al., 2024).

Research Participants’ Rights:

Several studies have explored the knowledge and attitudes of research participants toward their rights. A survey in Egypt, Lebanon, Saudi Arabia, and Sudan by Hifnawy and colleagues uncovered troubling perceptions, with 20% of participants believing research could occur without their knowledge, over one-third fearing a loss of quality care upon withdrawal, nearly half unaware of their right to withdraw without penalty, and 25% worried about harm for lodging complaints. Vulnerable groups, such as the illiterate and unemployed, were particularly uncertain of their rights. The researchers called for proactive education to ensure participants are well-informed. Additionally, a study in Egypt revealed widespread therapeutic misconceptions regarding informed consent, prompting recommendations for enhanced education for both participants and investigators to mitigate these issues (Mansour et al., 2015).

Evolution of the Structure of the MERETI Program

Rationale:

The last ten years of the MERETI program aimed at addressing several challenges presented to research ethics capacity in the MENA region by providing targeted training to enhance individual and institutional competencies in research ethics. The overall goal of the MERETI program was to enhance the capacity for research ethics in the MENA region. The OBJECTIVES included:

• Provide a cadre of individuals with competencies to provide research ethics education, perform studies involving human participants that investigate an issue of research ethics, provide research ethics review expertise, and be experts in research ethics.

• Facilitate the development of sustainable degree programs in research ethics in the MENA region.

• Promote the professional development and career advancement of program participants and provide them with networking opportunities to sustain their capacity to direct research ethics activities.

• Enhance the sustainability of an existing network of research ethics committees (RECs) in Egypt.

Program Description

The MERETI program matured through three phases, each marked by increases in academic rigor. This evolution is visually shown in Figure 1 below.

Figure 1.

Evolution of the structure of the middle east research ethics training initiative program.

Initially, MERETI constituted a one-year program comprised of an initial two-month in-person training at the University of Maryland, Baltimore (UMB), followed by trainees conducting a practicum or a research project at their home institutions for the remainder of the year (Phase 1: Years 2005–2009, see Figure 1 above).

From 2009 to 2023, the MERETI program incorporated a Phased Sequential Hybrid/Blended and Asynchronous eLearning.

• Phased Sequential: Indicates a step-by-step progression with distinct phases of learning.

• Hybrid/blended/online: This term specifies that training consists of simultaneous in-person and virtual training supplemented with asynchronous online learning materials. This combination enhances learner engagement across a spectrum of learning styles.

• Asynchronous eLearning: Specifies that the model consists of a stand-alone asynchronous online program.

The program’s evolution shifted towards a hybrid/blended/asynchronous model in 2009, enhancing its rigor and regional presence in the Middle East (Phase 2 2009–2013: see Figure 1). This model included: (1) a five-day hybrid/blended workshop in research ethics in a country in the MENA region; (2) a one-month in-person session at UMB during the summer, where trainees engaged with institutional review boards, practice mock protocol reviews, and hone their skills in scientific writing, teaching, and presenting; and (3) a nine-month asynchronous online segment. The first year was also devoted to planning research ethics projects to be executed in the second year.

The program’s development culminated in 2013 with Phase 3 (See Figure 1). The transition in the training model was prompted by a desire to conduct all the in-person training in Egypt. Specifically, the training program transitioned to an initial one-month hybrid/blended learning model in Egypt rather than the U.S. This change made it more convenient to attend the MERETI program by reducing the travel time. This phrase also included the launch of a 12-credit, fully online graduate certificate in research ethics offered through UMB’s Graduate School. This degree program consisted of six courses totaling 12 credits that could be completed in 9 months (University of Maryland Baltimore, 2024). The curriculum is comprehensive, covering areas such as the foundations of research ethics, ethics issues of international research, regulatory matters concerning research ethics committees, ethics theory, responsible conduct in international research, and global ethics. The program’s second year involved the trainees undertaking a practicum project, typically a research initiative.

The asynchronous online degree programs introduced during Phases 2 and 3 significantly broadened participation by accommodating individuals unable to attend the University of Maryland, Baltimore (UMB) due to professional or personal commitments. By eliminating the need for relocation, these programs reduced barriers such as housing, living, and travel expenses, making the training more accessible. Additionally, the online format fostered essential skills in time management, self-directed learning, and technological proficiency among participants. The asynchronous online program proved advantageous during the COVID-19 pandemic and is highly relevant in today’s dynamic educational environment. Moreover, exposure to online courses empowered several trainees to adapt UMB’s curriculum to better align with the cultural contexts of their respective countries.

Another key aspect of the MERETI program through its 20-year existence included the requirement of trainees to perform a practicum or research investigation of an issue in research ethics. Many of our trainees pursued multiple projects: 84% completed research investigating a research ethics issue (59.5%), organized a workshop in research ethics (52.4%), developed an undergraduate or graduate course in research ethics (42.9%), authored an article analyzing a research ethics issue (16.7%), and developed training for a research ethics committee (28.6%). Many of these activities resulted in a published manuscript (66.7%).

Enhancement of the MERETI Program to Include Additional Skills and Competencies

• Research Methodology Skills: A significant portion of the training program involved pursuing a practicum or a research project, with most trainees opting for the latter. A crucial step in a research project is selecting a topic to identify a research gap that generates a research question, objectives, and methodology. Most trainees selected either a quantitative approach, such as a survey, or a qualitative approach, like an interview or focus group study, each with its challenges. Conducting a survey requires knowledge of designing questionnaires and survey validation, while an interview study demands proficiency in interviewing techniques, coding methods, and thematic development. We observed that many trainees lacked these skills. Consequently, we dedicated more time in the training program to enhancing skills and capabilities in conducting social science research.

• Scientific Writing Skills: We observed early on that most trainees needed help with scientific writing when preparing their proposals and manuscripts. In response, we established hands-on workshops in scientific writing.

• English Language Proficiency: Although most trainees possessed adequate English-speaking skills, many still needed to achieve the required TOEFL or IELTS scores for admission to the University of Maryland, Baltimore’s (UMB) graduate school to pursue the online certificate degree in research ethics. We funded trainees to study for and take these English proficiency tests to address this issue.

• Critical Thinking Skills: During the review of the trainees’ initial manuscript drafts, we identified a notable deficiency in critical thinking abilities. In response, we dedicated a specific program segment to addressing and enhancing this essential skill.

• Public Speaking Skills: We encouraged trainees to present abstracts at professional meetings, but they needed to improve their presentation skills. To address this, we secured the services of a professional speaker for one year and incorporated the practice lessons this professional expert gave in subsequent years. We also encouraged trainees to attend and present at the monthly “Fogarty Bioethics Trainee Webinar” to enhance their presentation skills.

Specific Program Outputs of the MERETI Program

Professional Accomplishments of Trainees:

While we evaluated the trainees from each program year, we also assessed the long-term evaluation of the overall MERETI Program.

In June 2023, we emailed 92 previous trainees requesting they complete a survey we adapted from the Johns Hopkins Fogarty Bioethics Training Program to document individual achievements and any associations between individual characteristics, the type of Fogarty training program, and post-training accomplishments (Kass et al., 2016). Post-training accomplishments included service on research ethics committees, teaching activities in research ethics, publications, conference presentations, and leadership roles.

We received 52 responses for a response rate of 58%. Of these trainees, 76% were females and 34% males; 73% were in academic institutions, 24% from governmental institutions, and 3% from a contract research organization. The highest academic degree pretraining was MBBS (2.3%), postgraduate diploma (2.3%), Master’s (31.8%), PhD/MD (61.4%), and PhD (2.3%). The mean age when entering the training program was 32.6. Figures 1–5 present our survey results from the 52 MERETI Fogarty scholars comparing their achievements before and after training.

Figure 5.

Professional time spent on bioethics of the Fogarty trainees pre- and post-training.

Figure 2 illustrates that, compared with pretraining, more trainees were instructors and mentors, served on national and international committees, and secured leadership positions within their countries after training. Figure 3 highlights key increases in research ethics achievements among trainees post-training compared to their pretraining status. Figure 4 demonstrates that trainees enhanced their service on RECs after training. Finally, Figure 5 reveals that trainees dedicated more time to research ethics issues following their training than they did beforehand. Collectively, these results demonstrate that many participants in the MERETI program engaged more deeply in research ethics and achieved higher levels of professional success following their training.

Figure 2.

Professional achievement of the Fogarty trainees pre- and post-training.

Figure 3.

Bioethics achievement of the Fogarty trainees pre- and post-training.

Figure 4.

Service on a research ethics committee (rec) of the Fogarty trainees pre- and post-training.

• Publications: Trainees collectively served as primary authors or co-authors on 46 manuscripts published in peer-reviewed journals (see bibliometric paper also in this special issue).

• Book Contributions: Fogarty scholars authored chapters in “Research Ethics in the Arab Region” (Silverman, 2017).

Table 3 shows how the trainees ranked the degree of impact of the different MERETI training components on their understanding of research ethics. Academic coursework was ranked the highest (77.5%), followed by networking with MERETI colleagues (55.0%), their practicum or research experience (50.0%), attendance at conferences (47.5%), and individual mentorship (42.5%).

Table 3.

Which Component of Your MERETI Training had the Greatest Impact on Your Understanding of Bioethics? (n = 40).

Rank	MERETI Training Component	N (%)
1	Academic Coursework	31 (77.5)
2	Networking with MERETI colleagues	22 (55.0)
3	Practicum and Research Experience	20 (50.0)
4	Attendance at Conferences	19 (47.5)
5	Individual Mentorship	17 (42.5)

MERETI Accomplishments to Address Pre-Existing Gaps

In our previous paper (Silverman et al., 2013) describing the MERETI training program during its first ten years, we provided recommendations for future achievements to further enhance research ethics capacity (refer to Table 2 for more details) In response, Table 4 illustrates the extent to which these recommendations were met, and the mechanisms used to achieve them. As shown, most recommendations were successfully implemented.

Table 4.

Implementation of Activities to Address the Recommendations Made in 2014.

Recommendations in 2014	Achievements by 2024
• Provide advice regarding the establishment of national guidelines in those countries lacking such documents and review existing guidelines to ensure comprehensiveness	Egyptian law passed with several Fogarty scholars have served on the advisory committee.
• Provide consultancy role to their Ministries of Health regarding regulatory oversight of *RECs and conduct of clinical trials	Three Fogarty scholars assumed governmental positions involving research ethics.
• Apply for EDCTP funding to strengthen capacity in national regulatory framework	Three Fogarty scholars from Sudan received a two-year EDCTP grant.
• Help institutions promote a culture of ethical conduct by incorporating organizational structures and processes that implement a set of shared values	Three Fogarty scholars conducted a study to assess the perspectives of academics at three institutions regarding the ethical climate for research.
• Inclusion of ethics teaching in the curriculum	Several Fogarty scholars have developed courses in research ethics or incorporated research ethics in their existing syllabi
• Development of degree programs in ethics and research ethics	A diploma degree program in research methods and research ethics was established at Al-Neelan University in Sudan
• Advocate for adequate budgets for *RECs	Pursued by **ENREC
• Help RECs develop standard operating procedures	Performed by **ENREC
• Adopt policies that enhance *REC functioning (e.g., protocol	Performed by **ENREC
submission and review policies, training requirements)
• Adopt quality assurance mechanisms.	Provided by the MERETI self-assessment tool
• Conduct membership training.	Achieved by **ENREC and individual research ethics committees
• Conduct training in research ethics and Good Clinical Practice	Provided by **ENREC
• Conduct research to document participants’ knowledge of research and awareness of their rights.	Three research studies were performed assess patients’ attitudes about aspects of research and their rights.

^*REC: Research Ethics Committee.

^**ENREC: Egyptian Network for Research Ethics Committees.

Addressing Gaps at the National Level

Passage of National Legislation in Research Ethics:

Egypt and Morocco have recently enacted national regulations governing research involving human participants. Notably, our Fogarty scholars contributed to the deliberative processes that established these laws. Furthermore, two Fogarty scholars conducted a rigorous ethics analysis of these newly implemented regulations (Adarmouch, 2017; Matar & Silverman, 2022). Before these developments, another Fogarty Scholar undertook a comprehensive ethics evaluation of Jordan’s Clinical Trial Law (Ramahi & Silverman, 2009).

Receipt of funding to strengthen ethics capacity in the national framework in Sudan:

Three Sudanese scholars earned a prestigious two-year EDCTP grant valued at 200,000 Euros. This grant’s deliverables included bolstering the regulatory bioethics frameworks in Sudan by enhancing collaboration between the National Bioethics Committee and the National Medicines and Poisons Board (NMPB). Additionally, this grant led to establishing the Sudanese Research Ethics Network.

Addressing Systemic Gaps in Research Ethics Capacity

Leadership Positions/Activities:

Besides the scholars who obtained positions as chairs or vice-chairs of RECs and leadership positions in their institutions, others deserve special mention.

• Several of our scholars gained appointments at high-level governmental positions.

• Two scholars (MERETI 2006 and 2008) served as Chairman of the National Ethics Committee and the Minister’s Advisor for the Central Directorate for Research and Health Development (RHD) in the Ministry of Health and Population.

• Another scholar (MERETI 2008) was recently named the president of the Supreme Council of Research Ethics in Egypt. As the new Egyptian Clinical Research Law requires, the Council will provide its ethics approval for all clinical research.

• One of our scholars received a PhD in bioethics from Uppsala University.

Establishment of an Advanced Degree Educational Programs in Research Ethics:

Al-Neelain University in Khartoum, under the direction of Professor Sara Brair (Fogarty scholar – 2008), established a 12-credit diploma program in research methodology and research ethics in 2018. There were plans to extend this diploma program to a master’s program. However, the start of violent clashes between Sudan’s ruling forces in April 2023 frustrated efforts to convert this program into a planned master’s program.

Assessment of Egyptian Institutions to Promote a Culture of Ethics Conduct

Three Fogarty scholars used the Survey of Organizational Research Climate (SOuRCe) tool to assess the perspectives of academics at three Egyptian institutions regarding the research integrity climate research (Abdelkreem et al., 2024). This tool, developed by Martinson, Thrush, and co-workers, incorporates seven subscales that assess various aspects of the institutional research integrity climate (Martinson, Thrush & Lauren Crain, 2013). The findings in the Egyptian institutions revealed opportunities for improvement in the research integrity climate and highlighted the need for targeted interventions to strengthen it

Enhancement of Research Ethics Capacity

Continuing broadening of the Egyptian REC Network:

The Egyptian Network of Research Ethics Committees (ENREC) was established in 2010 to foster ethical research practices in Egypt (Sleem, 2024). Since 2013, ENREC has expanded to encompass more than 80 RECs nationwide. By conducting four workshops per year featuring insightful panel discussions and educational sessions on pertinent ethics dilemmas, ENREC has become an indispensable hub for fostering collaboration and partnership among key stakeholders.

Establishment of an Accreditation System in Egypt:

Under the leadership of Dr. Hany Sleem, ENREC developed a voluntary accreditation program for Egyptian RECs (Egyptian Network of Research Ethics Committees (ENREC), 2024). The accreditation process consists of RECs completing a self-assessment of their activities and a one-day site visit by individuals with expertise in research ethics. Presently, RECs from five institutions have achieved accreditation status.

Development of the Research Ethics Committee Quality Assurance Self-Assessment Tool (RECQASAT) self-assessment tool:

In 2010, several MERETI scholars developed a self-assessment tool for RECs (Sleem et al., 2010). Scores of Egyptian RECs have used this tool to perform a quality assessment of their structures and processes involved with their ethics review of research. Furthermore, a study compared the results of this tool among RECs in Egypt, South Africa, and India (Silverman et al., 2015). Recently, this tool was revised to include relevant elements for safeguarding participants’ rights and welfare (Sleem & Silverman, 2024).

Challenges Experienced by the MERETI Training Program

Over the years, the MERETI program experienced several challenges implementing its activities. The following are examples of the program’s specific challenges and our responses.

• Recruitment of qualified individuals: Our initial efforts at recruiting qualified individuals to the MERETI program consisted of targeted strategies (e.g., emails to individuals who attended our workshops in research ethics and members of RECs). We also sought input from institutional leaders regarding potential applicants. We also set application requirements that included the applicant’s CV, a personal letter explaining how the training program will enhance the applicants’ careers, and letters of support (including one from an institutional official stating the need and support of the applicant). Despite these efforts, several selected applicants fell below expectations during the subsequent training (e.g., absences from the in-person classes at UMB, failure to contribute to the class discussions, and failure to complete a scholarly project).

To enhance our efforts at accepting qualified individuals, we introduced an in-person three-day selection workshop to better evaluate the academic rigor of potential candidates. These workshops were rotated between the participating countries in the MENA region. We invited the top 25 applicants to the workshop from the application materials. Criteria included previous experiences in research ethics (e.g., REC member, attending relevant conferences, etc.), scholarly output (e.g., abstracts and publications in research ethics or the applicants’ home discipline), quality of their letter, and the need for the institution to have individuals trained in research ethics. At the workshops, the MERETI faculty assessed applicants based on their performance in group discussions, responses to an online forum, the sophistication of their questions, and their ability to collaborate with other applicants. This approach allowed us to better gauge applicants’ capabilities beyond their CVs, personal statements, and letters of recommendation. Although not without its flaws, this method led to the acceptance of more qualified candidates, as revealed in their subsequent efforts in their training programs (e.g., active participation in discussions and completion of a scholarly project).

• Changes in program content to incorporate additional skills competencies: Our experience made us aware that additional competency skills were needed to accompany research ethics training. These included research methodology, scientific writing, English speaking, critical thinking, and presentation skills.

• Impact on Trainees: Post-training assessments showed that trainees exhibited higher bioethics-specific achievements. Most reported being more involved as investigators on research grants, holding leadership roles, and serving as mentors compared to their pretraining status. They also showed significant increases in serving on RECs and administrative roles related to research ethics.

• Professional Advancements: Many trainees advanced into significant positions within national ethics committees and ministries of health, thereby influencing policy and practice at high levels within their respective countries.

• Impact on Society: Society’s attention to research ethics has become increasingly evident through the rise in Research Ethics Committees (RECs), the establishment of governmental positions dedicated to research ethics, and legislation concerning research ethics. We believe the MERETI Program has greatly contributed to this shift in focus. However, other developments also contributed to the growing emphasis on research ethics. These include the following:

• Global Initiatives: International organizations such as the World Health Organization (WHO) and UNESCO promote ethics standards in research through guidelines and training programs.

• Media Coverage: Growing media attention on cases of unethical research practices has led to greater scrutiny and reforms.

• Technological Advances: The rise of new methodologies and technologies, such as biobanking and genetic research, requires enhanced ethics oversight.

• Education Programs: Integrating research ethics into university curricula and professional development programs.

• Funding Requirements: Funding agencies, both local and international, are increasingly mandating adherence to ethics standards as a condition for research grants.

• Networking and Long-term Sustainability: The MERETI program facilitated the establishment of the Egyptian Network of Research Ethics Committees (ENREC), which actively trains REC members and ensures the quality of ethics review processes. ENREC also promoted and fostered collaborations and partnerships between key stakeholders involved in research ethics.

Summary

• The MERETI program has enhanced the capacity for research ethics in the MENA region over the past two decades. By providing comprehensive training and fostering a network of RECs, MERETI has contributed to developing ethics research practices and the professional advancement of its trainees. The program’s evolution from a one-year model to a two-year hybrid/blended/online model and the incorporation of a fully online graduate certificate in research ethics has been key to its success (see Figure 1).

• Moving forward, it is essential to continue expanding training programs, developing culturally relevant guidelines, and establishing robust support systems to address the complex ethics dilemmas in modern research settings. MERETI’s success highlights the importance of sustained efforts and strategic partnerships in building research ethics capacity in resource-limited settings.

Educational Implications

• Expansion of Training and Resources: Future training programs should include more diverse and comprehensive topics that can address the complex ethical dilemmas faced in modern research settings. These topics include the ethics of artificial intelligence, focus on community engagement research activities, gene editing, and research involving mobile health.

• Master-level degree programs: Efforts should focus on developing a sustainable degree program in research ethics in the region that would include the participation of individuals from several countries in the MENA region.

• Enhanced training in research methodology: Further efforts should continue to enhance the capabilities of investigators to perform qualitative and quantitative research

• Enhanced Training on the Scientific Writing and Publishing Process: Several of our trainees conducted research to examine the challenges associated with scientific writing and publishing (Elgamri et al., 2023). Based on these findings, targeted workshops should continue to address the issues raised in this research.

• Enhanced Skills in Grant Writing: Investigators at academic institutions need to enhance their grant writing skills to obtain internal and external funding.

Future Needs

• Development of Culturally Relevant Guidelines: The importance of developing localized guidelines that consider the cultural, social, and political contexts of the MENA region should be emphasized. This would ensure that research ethics guidelines are internationally compliant, culturally sensitive, and practically applicable. Educational activities should be pursued to ensure that training programs are culturally relevant.

• Strategic Partnerships: Our experience suggests fostering more robust partnerships between educational institutions, government bodies, and international ethics organizations (e.g., WHO and UNESCO) to enhance the scope and impact of research ethics training.

• Promote recruiting individuals with diverse perspectives in educational programs and research training: Research demonstrates that diverse teams, leveraging innovative ideas and distinct perspectives, excel compared to homogenous teams. Trainees from varied backgrounds bring unique perspectives, creativity, and experiences that will address complex ethics and scientific problems more effectively. Accordingly, future training programs should strive to recruit prospective trainees offering diverse perspectives reflecting different scientific expertise, educational backgrounds, or individual experiences. This includes those with a deep understanding of local research populations, individuals from economically disadvantaged or marginalized backgrounds, and those with disabilities (Fogarty International Center (FIC), 2024b).

• Establishment of a regional REC network: Strategies should be pursued to establish a region-wide REC network modeled after the Egyptian Network of Research Ethics Committees, where many of our Fogarty scholars in other countries can network with each other and other key stakeholders.

Research Agenda

• Additional Training Needs of Research Ethics Committees: Recent advancements in knowledge and technology have introduced novel challenges for research review. Research Ethics Committees (RECs) now encounter proposals involving stored samples and data, cell-based and stem cell therapies, gene editing, emergency research, social science research, community-based research, social media research, mobile health research, and artificial intelligence research. It is essential to investigate the training needs of RECs to effectively review these complex research domains.

• Further exploration of the research integrity climate in LMIC universities: Further efforts are needed to explore the research integrity climate in LMICs universities. MERETI scholars examined perceptions of the institutional research integrity climate at three universities in Egypt using the Survey of Organizational Research Climate (SOuRCe) tool. Their findings revealed opportunities for improvement in the research integrity climate and highlighted the need for targeted interventions to strengthen it (Abdelkreem et al., 2024). To enhance the generalizability of these findings, similar studies should be conducted at other universities across the Arab Middle East. Additionally, qualitative research is recommended to provide deeper insights into the responses obtained from the quantitative survey.

Biographies

Latifa Adarmouch is a Professor of Epidemiology and Public Health at Cadi Ayyad University. Her expertise includes epidemiology, public health, and ethics, focusing on integrating ethical considerations into public health practices. A 2014 MERETI Scholar, she earned a Certificate in Global Research Ethics from UMB in 2018. Dr. Adarmouch has co-authored more than 30 peer-reviewed articles, including five significant contributions to ethics. She provided information regarding Morocco in the manuscript and reviewed the entire manuscript.

Alya Elgamri is former Assistant Professor and Division Head at Khartoum University, transitioned to Almoosa Specialist Hospital amid the Sudanese Revolution. A MERETI Fogarty Scholar (2020), she obtained a Certificate in Research Ethics from UMB. Dr. Elgamri has co-authored six peer-reviewed journal publications. She provided information regarding Sudan in the manuscript and reviewed the entire manuscript.

Nevine Abbas is an Assistant Professor at the Department of Public Health, University of Balamand, Lebanon. A MERETI Fogarty Scholar (2019),she completed the UMB certificate degree in Global Research Ethics in 2020. She has co-authored several articles, and she is the primary author of six articles. She provided information regarding Lebanon in the manuscript and reviewed the entire manuscript.

Hany Sleem is a 2005 MERETI Scholar at Cairo and chaired the National Hepatology REC at the Tropical Medicine Research Institute in Cairo for ten years. With a Wellcome Trust Grant in 2010, he founded the Egyptian Network of Research Ethics Committees (ENREC). Dr. Sleem advises RECs nationwide, speaks internationally and helped create accreditation guidelines for Egyptian RECs. He provided information regarding Egypt in the manuscript and reviewed the entire manuscript.

Henry Silverman is a Professor of Medicine at the University of Maryland School of Medicine. His area of research is research ethics focusing in low- and middle-income countries. Dr. Silverman has spearheaded successful Fogarty programs in the Arab Middle East and Myanmar and is a co-principal investigator on a Fogarty grant in The Gambia. His mentorship has launched the careers of numerous Fogarty Scholars who have occupied pivotal leadership roles across their respective countries. Currently, he teaches online courses in research ethics and directs UMB’s online certificate degree in research ethics. He is responsible for writing the initial draft of the manuscript.