Enhancing Research Ethics Capacity in Asia: Fogarty International Center Supported Initiatives in India, Malaysia, Myanmar, and Pakistan

Abstract

Several Asian countries, including India, Malaysia, Myanmar, and Pakistan, face challenges aligning rapid healthcare and biomedical research growth with necessary ethics oversight. To help address this, the Fogarty International Center of the United States National Institutes of Health funded initiatives to enhance research ethics capacities in these countries. In India, the Yenepoya University’s Master’s in Research Ethics program was established in collaboration with Monash University. In Malaysia, the Master of Health Research Ethics (MOHRE) program, based at Universiti Malaya, was developed in collaboration with the Johns Hopkins University. In Myanmar, a Diploma in Research Methodology and Research Ethics (DipRMRE) was introduced in cooperation with the University of Maryland Baltimore. In Pakistan, a Master of Bioethics (MBE) program was designed to address the country’s unique ethical challenges in healthcare and research. Graduates from these programs have significantly contributed to health research and policy, enhancing research ethics infrastructure across these diverse Asian countries.

Introduction

Several Asian countries have faced challenges aligning rapid growth in biomedical research with necessary ethical oversight. Given this context and the expansion of internationally collaborative clinical trials, there is a need for improved bioethics infrastructure and research ethics training (Glickman et al., 2009; Frost and Sulivan, 2017). To help address this need, the Fogarty International Center (FIC) at the United States National Institutes of Health (NIH) has funded programs based in India, Malaysia, Myanmar, and Pakistan, which aim to enhance individual and institutional capacity in research ethics. Equipping professionals with the critical skills and competencies to navigate complex research ethics challenges can help advance ethically sound health research.

FIC-supported programs have made substantial contributions to research ethics capacity-building in low- and middle-income countries (LMICs) through its International Research Ethics Education and Curriculum Development Award (R25) mechanism (Millum & Sina, 2014; Matar et al., 2014). Programs that were previously funded tended to highlight the development of culturally relevant curricula, the integration of global and local bioethical principles, and the creation of networks of trained ethics professionals across LMICs (Pratt et al., 2014). This report focuses on the sustained efforts and advancements made in Southeast Asia over the last decade, particularly in addressing gaps in bioethics infrastructure and fostering institutional sustainability. Unlike the earlier programs, emphasis is now being placed on establishing structured master’s and diploma programs. In India, the focus has been on establishing a robust educational program to address the educational gap in bioethics. The Yenepoya University’s Master’s in Research Ethics program launched in collaboration with Monash University, Australia, was the first of its kind in the country. In Malaysia, the Master of Health Research Ethics (MOHRE) program was established through a partnership between Universiti Malaya and the Berman Institute of Bioethics at Johns Hopkins University, targeting the increasing need for ethics training amidst expanding research activities. In Myanmar, a Diploma in Research Methodology and Research Ethics (DipRMRE) program developed in cooperation with the University of Maryland, Baltimore was introduced to build local capacity and ensure sustainable training pertinent to the local context. In Pakistan, the Master of Bioethics (MBE) program was designed to address the country’s unique health research ethics challenges.

These programs integrate local cultural contexts with global ethics standards, employing innovative teaching methodologies and flexible learning formats to promote accessibility and relevance. They emphasize practical research experience and aim to develop professionals’ adept at navigating ethical complexities in their regions. Unlike the earlier FIC-programs (Millum & Sina, 2014; Matar et al., 2014), these programs reflect a deliberate shift towards long-term institutionalization and sustainability, fostering a new generation of ethics professionals equipped to address contemporary challenges. Collectively, these programs have produced graduates who have made significant contributions to health research and policy, enhancing the research ethics infrastructure and governance across South and Southeast Asia.

In this paper we summarize the progress and impact of these NIH-Fogarty-funded programs, highlighting the development of master’s and diploma programs in research ethics in the region. s.It also addresses ongoing challenges and outlines future directions to further enhance bioethics infrastructures in these countries, aiming to build sustainable research ethics capacity and improve ethics in healthcare research.

The Regional Health and Health Research Landscapes

The regional health and health research landscapes across India, Malaysia, Myanmar, and Pakistan encounter intricate and intertwined challenges shaped by their unique socio-cultural, economic, and demographic contexts.

In India, the diversity of its vast regions faces widely prevalent infectious (e.g., tuberculosis, malaria) and non-communicable diseases (NCDs; e.g., diabetes and heart disease). The country’s 28 states and eight union territories, each grapple with distinct health priorities shaped by demographics, geographies, socioeconomic factors, and healthcare infrastructures (Public Health Foundation of India [PHFI], 2017). While some localities boast advanced medical facilities and higher health indicators, others struggle with inadequate resources, disparities in access to care, and health inequalities. Strengthening regional health systems, promoting interdisciplinary research collaborations, and leveraging technology for data-driven interventions are pivotal to achieving equitable health outcomes across India’s diverse regions.

The Government of India established the Indian Research Fund Association (IRFA) in 1911 to sponsor and coordinate medical research. It was re-designated as the Indian Council of Medical Research (ICMR) in 1949 (Indian Council of Medical Research [ICMR], 2022). The ICMR currently operates 32 permanent research institutes and centers. However, the country contends with systemic issues, such as funding shortfalls and infrastructural gaps that hamper the effective translation of research into practice (ICMR, 2022).

Malaysia’s health research landscape is rapidly evolving, fueled in part by government efforts to boost the nation’s research infrastructure and international collaborations aiming to position the country as a global hub for medical research. This growth comes in response to a diverse set of health challenges, including the triple burden of rising NCDs, resurgent communicable diseases, and widespread injuries from road traffic accidents ((Institute for Public Health (IPH), 2023; World Health Organization (WHO), 2024). The country has experienced a significant increase in research funding and participation in clinical trials. Specifically, the gross expenditure on research and development increased from 8 billion to 12 billion USD between 2014 and 2018, resulting in an expansion of the researcher workforce (Abd Manaf et al., 2019). In 2023, Malaysia experienced its highest volume of research, with a total of 276 recorded studies; with 188 sponsored research projects carried out in Ministry of Health facilities, including state hospitals, district hospitals, and government clinics (Clinical Research Malaysia [CRM], 2023). International collaborations, such as a partnership between Malaysia’s Ministry of Health and the World Health Organization (WHO), have been crucial in addressing NCDs (World Health Organization (WHO), 2024a). Malaysia is also integrating advanced technologies including artificial intelligence, gene editing, and regenerative medicine into healthcare, which involve complex ethics, privacy, and security concerns.

In Myanmar, poverty and discrimination pose substantial hurdles to addressing population health. WHO has identified poor access to health services and essential medicines as a significant health system constraint (World Health Organization (WHO), 2023a). Additionally, Myanmar continues to face significant challenges with malaria, HIV/AIDS, and tuberculosis (TB), but recent data shows progress in some areas.

For malaria, Myanmar reported 157,533 total cases in 2022, a substantial increase from previous years due to political and social instability (Vivax Malaria Elimination, 2025; Trading Economics, 2025a). However, the country has made progress towards its National Plan for Malaria Elimination (2016–2030), which aims to eliminate indigenous P. falciparum malaria by 2025 and all species of malaria by 2030 (Vivax Malaria Elimination, 2025).

Regarding HIV/AIDS, the prevalence among adults aged 15–49 was reported at 0.9% in 2022, a decrease from previous estimates (Trading Economics, 2025b). HIV prevalence varies across different populations. While current data for high-risk groups is not available, the country continues to be one of 35 fast-track priority countries accounting for 90% of new HIV infections globally (World Health Organization (WHO), 2025).Myanmar’s health authorities are working towards eliminating mother-to-child transmission of HIV by 2025).The HIV infection rate among pregnant women declined from 0.84% in 2011 to 0.57% in 2018 (Reliefweb, 2019).Tuberculosis remains a significant health concern. The country continues to implement the DOTS (Directly Observed Treatment, Short-course) strategy, manage TB/HIV co-infections, and monitor and treat multidrug-resistant TB (MDR-TB) through the National Tuberculosis Program (NTP) with support from WHO and the Global Fund (World Health Organization (WHO), 2023b).

Research efforts continue to focus on understanding the epidemiology of these diseases, improving prevention and treatment strategies, and working towards elimination goals, particularly for malaria and HIV/AIDS.

Health research in Myanmar thrives through robust collaborations between local institutions, such as the University of Medicine-1 in Yangon and the Ministry of Health and Sports, and international organizations, including WHO, UNICEF, and the Global Fund. Equally vital are partnerships with non-governmental organizations (NGOs) like Médecins Sans Frontières (MSF) and Population Services International (PSI). These collaborations aim to tackle pressing barriers to healthcare access, such as poverty, discrimination, fragmented stakeholder coordination, funding limitations, and insufficient local research capacity.

To address these challenges holistically and ensure the success of interventions, enhancing community engagement emerges as a critical strategy. By involving community members in the design, implementation, and evaluation of programs, this approach fosters culturally sensitive and widely accepted solutions while creating a collaborative environment that empowers stakeholders to shape the initiatives that directly impact their lives (Hood, 2023).

Pakistan has a rapidly growing population with substantial healthcare needs (WorldOMeter, 2023). The country faces formidable challenges in meeting these needs, including having an uneven distribution of healthcare professionals, a workforce deficit, inadequate funding, and restricted access to quality healthcare services (WHO, 2024b). Despite noticeable growth in the healthcare infrastructure and workforce, a systematic approach to information generation is needed to inform impactful policy and practice (Akhtar and Khan, 2000). Established in 2002, the Higher Education Commission (HEC) of Pakistan is tasked with promoting higher education, research, and development within the country. The HEC endeavors to enable higher education institutions to serve as engines for socioeconomic development. Among its initiatives it has introduced research funding programs and emphasized publication as a critical criterion for academic promotion to senior faculty roles, resulting in a marked increase in publications (Haque et al., 2020; Haq and Faridi, 2021).

In 2018, the British Council and the HEC conducted a research initiative entitled “The University Research System in Pakistan.” Engaging over 200 faculty members and experts, the project aimed to identify challenges in the university research system and suggest improvements (Haque et al., 2020). Key recommendations included increasing the academic faculty’s role in setting the research agenda, establishing research councils, and creating a framework for research excellence. The report also called for more investment in research addressing Pakistan’s societal challenges and fostering local and international communities of practice and knowledge networks.

Despite marked geographical and cultural distinctions, these four countries share common threads in regard to health research. Each struggle with a mix of communicable and NCDs that significantly strain their healthcare systems. There is a collective push towards enhancing research infrastructures and collaborations to innovate and tailor healthcare solutions to local needs. However, as we describe next, these efforts encounter challenges related to ethics standards and infrastructure, highlighting a need for sustained investment and international cooperation in health research ethics.

Regional health research ethics system capacity and existing gaps

The adoption of formal approaches to contemporary bioethics within Asia has been agonizingly slow, yet there has been a gradual increase in awareness regarding ethics considerations in research. History shows that the path for research ethics has usually been paved through controversies, which arose due to lack of legislative and ethics oversight (Miteu, 2024).

In India, fraudulent activities concerning drug manufacturing and distribution led to the introduction of the Drugs and Cosmetic Act in 1940 and, subsequently, the Drugs and Cosmetics Rules of 1945 (Government of India, 1940;1945). This legislation established the Central Drugs Standard Control Organization (CDSCO), a division under the Ministry of Health and Family Welfare, Government of India (Barnes et al., 2018). CDSCO regulates the import, manufacture, distribution, and sale of drugs and cosmetics in India (Central Drugs Standard Control Organization [CDSCO], 2024). In addition, the Indian government established guidelines for clinical trials, known as Schedule Y, in effort to develop a robust health research ethics ecosystem (Barnes et al., 2018).

India subsequently became a popular destination for biomedical research with human participants due to its diverse patient pool, skilled personnel, relatively lax regulations, and cost-effectiveness. However, in 2013, public interest litigation was filed against a human papillomavirus vaccine study conducted among socioeconomically vulnerable children by Program for Appropriate Technology in Health (PATH), a US-based NGO. Consequently, the Supreme Court of India ordered the concerned authorities to strengthen the health research ethics system in the country. This led to several actions by CDSCO and the Indian government including mandatory registration of ethics committees (ECs), revised participant compensation requirements, and instructions for serious adverse event reporting, among others (Barnes et al., 2018). Voluntary accreditation by National Accreditation Board for Hospital and Healthcare providers (NABH) and assessment by the Forum for Ethical Review Committees in the Asian and Western Pacific (FERCAP) further strengthened EC functioning in India (Krishnan and Sherief, 2023). FERCAP is a regional initiative under the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), which aims to enhance the quality and consistency of ethics review systems. While FERCAP itself does not hold legal or regulatory authority, it promotes the accreditation of ethics committees based on internationally recognized standards, fostering trust and accountability in research ethics within the region.

In 2019, New Drugs and Clinical Trials Rules 2019 replaced Schedule Y governing the clinical trials and further directing biomedical and health research through the ICMR (Drugs and Cosmetics Act and Rules 1945). ICMR subsequently issued “Ethical Guidelines for Biomedical Research on Human Subjects” (Barnes et al., 2018). Despite these efforts, given India’s substantial size and opportunities for expanding biomedical research, there exists ample opportunity and a need to expand the number of professionals trained in research ethics in the country.

In Malaysia, there is a noticeable gap between the number of research studies being conducted and the available research ethics capacity. Although the number of research ethics committees (RECs) in Malaysia is growing, a lack of required accreditation and a shortage of formal research ethics training among members and researchers pose significant challenges. Currently, 13 RECs are registered with the Drug Control Authority (DCA) within Malaysia’s National Pharmaceutical Regulatory Agency (NPRA). Among these, only three are accredited by FERCAP. Furthermore, only a minority of RECs members have received proper training in research ethics (National Pharmaceutical Regulatory Agency [NPRA], 2024). To address these issues, the Network of Ethics Review Committees in Malaysia (NERCIM) was established in 2015 to standardize ethics review practices and promote structured, formalized graduate-level research ethics training. However, existing gaps critically hinder the ability to conduct research with the highest levels of integrity, respect, and ethics (Thanabalan et al., 2021).

In Myanmar, at the turn of the 21st century, the rapid expansion of externally funded research, supported by the Ministry of Health and Sports (MoHS), was anticipated to continue through the 2010s. This growth created a crucial need for research ethics capacity development and training in the responsible conduct of research (RCR). Given that this research would involve vulnerable groups participating in studies that pose more than minimal risk, it was essential to ensure local research ethics capacity to adequately protect participants’ rights and welfare. Fortunately, RECs are familiar to Myanmar. In 1980, Myanmar established its first REC in the Department of Medical Research (DMR) under the Ministry of Health (MoH). By 2018, there were 19 established RECs (Oo et al., 2018). Those within the DMR and at the Defense Services Medical Research Centre (DSMRC) were registered with the US Office of Human Research Protections and related to institutions with Federal Wide Assurance (FWAs) (OHRP, 2015).

Nevertheless, gaps still need to be addressed in research ethics capacity. For example, the RECs in Myanmar, like other low-and-middle-income countries (LMICs) (Silaigwana & Wassenaar, 2015; Moodley and Myer, 2007; Sleem et al., 2010; Silverman et al., 2015) face several challenges (Oo, Wun, Oo, & Silverman, 2020). These include: the lack of a nationwide regulatory framework to ensure consistency of standards and to enforce compliance with those standards; no authority to provide oversight; lack of research ethics expertise among the REC members; and inadequate human and material resources Hence, RECs in Myanmar and the overall research review system require strengthening.

There is also a need to enhance capacity in research ethics for post-graduates. For example, a recent survey study among postgraduates in Myanmar showed that while Myanmar investigators desire educational programs in research ethics, many lack such training (Than et al., 2020). This study also revealed that some investigators harbor several problematic attitudes. For example, approximately 15% believed giving potential research participants complete information is unnecessary if they have limited understanding of the research. These results are comparable with studies from other LMICs (Asem and Silverman 2009; Kandeel et al., 2011; Joint United Nations Programme on HIV/AIDS [UNAIDS], 2014; Haq and Faridi, 2021).

Additionally, training in Responsible Conduct of Research (RCR) needs to be strengthened in Myanmar. For instance, a study by Phyo et al. (2022) found that postgraduate students exhibited only a moderate level of disapproval toward plagiarism. The investigators concluded that plagiarism is a significant ethical issue in Myanmar and recommended that universities in the country implement comprehensive RCR training programs.

Finally, there is a need to develop local scholarship in research ethics, as applying Western notions of bioethics can be challenging in countries that embrace dissimilar cultural, social, and religious values (Tosam, 2020; Beck, 2015; Chattopadhyay & De Vries, 2008). To adequately address the need for research ethics training in Myanmar, the country must develop sustainable programs in research ethics. Establishing training at the local level is likely to foster continued training of researchers and REC members while ensuring that the training is pertinent to the local context.

Research ethics governance in Pakistan has progressed incrementally but continues to face systemic challenges. The National Bioethics Committee (NBC), established in 2004 to coordinate Ethics Review Committees (ERCs) across institutions, remains constrained by inadequate funding and staffing, limiting its oversight capacity (National Bioethics Committee Pakistan, n.d.). ERCs, though increasing in number, operate without standardized accreditation or registration frameworks, leading to significant variability in the quality of ethics reviews.

A pivotal 2021 situational analysis conducted by the Centre of Biomedical Ethics and Culture (CBEC) at the Sindh Institute of Urology and Transplantation (SIUT), in collaboration with WHO-EMRO, identified key deficiencies. The study combined literature reviews, surveys, and interviews to map the state of ethics governance. Findings revealed that many ERCs in universities are established ad hoc, with hospitals and tertiary care centres frequently lacking such committees. This fragmented structure compromises the integrity of research ethics oversight and reflects a mismatch between expanding research activities and underdeveloped governance mechanisms (Jafarey et al., 2023). The report also highlighted the absence of locally tailored research ethics guidelines and significant gaps in training, with many ERC members lacking formal education in research ethics. To strengthen the system, recommendations included establishing a unified accreditation system for ERCs, mandatory training for ERC members and administrative staff, and enhancing human and material resources to support research ethics practices.

Despite these efforts, research ethics governance remains fragmented, and its development lags behind the surge in research activities in Pakistan (Syed, 2017). Implementing these recommendations is essential to ensure ethical and accountable research practices, particularly as the demand for high-quality research continues to grow.

Thus, in these four countries there is a need to further enhance capacity in research ethics and ethics review systems and to develop educational programs for REC members and investigators. Challenges include the lack of oversight, lack of expertise in research ethics among the REC members, and inadequate human and material resources (Silaigwana & Wassenaar, 2015; Moodley and Myer, 2007; Sleem et al., 2010; Silverman, Edwards, Shamoo, & Matar,, 2013) and the need for sustainable research ethics capacity building.

Program descriptions aimed to address existing research ethics gaps

The complexity and volume of biomedical research in the South and Southeast Asian regions underscore the critical need for robust ethical oversight and specialized training in research ethics. This necessity has driven the development of advanced educational programs to address the significant gaps in bioethics expertise and infrastructure. As described below, innovative and contextually tailored programs in India, Malaysia, Myanmar, and Pakistan are contributing to this effort by fostering a new generation of bioethics professionals. These initiatives seek to bridge the educational void, cultivate bioethics, and elevate ethics standards across diverse cultural and scientific landscapes.

The Master’s in Research Ethics in India provides comprehensive training to address the observed educational gap in research ethics. The program offers an in-depth, two-year curriculum to cultivate professionals’ ability to navigate the ethical aspects of research. This curriculum covers research methodology, biostatistics, leadership skills, and scientific writing. The program emphasizes practical research experience at institutions such as the Centre for Ethics, Yenepoya (deemed to be University). Innovative teaching methodologies and culturally relevant content distinguish the program, ensuring that it effectively addresses local ethical challenges while maintaining global relevance. It blends global best practices with local perspectives, such as gender ethics and AYUSH (Ayurveda, Yoga, Naturopathy, Unani, Siddha, and Homeopathy) medicine, helping to ensure that graduates have an understanding of universal ethics principles and socio-cultural dynamics shaping research in India.

The two-year, full-time, on-campus course is structured over four semesters. The curriculum includes 42 compulsory modules, excluding internships. Semester one covers bioethics foundations and the history of research drawing from the Indian Council of Medical Research (ICMR) Ethical Guidelines for Biomedical Research on Human Participants (Indian Council of Medical Research [ICMR], 2017). Semester two addresses research regulatory frameworks, both Indian and international, guided by the New Drugs and Clinical Trials Rules, 2019 (Government of India, 2019) and the Declaration of Helsinki (World Medical Association, 2024). Semester three focuses on cutting-edge research areas including genetics, stem cells, artificial intelligence, research integrity, and publication ethics. Semester four involves writing research projects and completing logbooks. Students participate in journal clubs, seminars, and interdisciplinary research methodology sessions throughout the program. Internships, lasting two to four weeks, are undertaken during vacations (Yenepoya [deemed to be University], 2024).

The program in Malaysia, which is a collaboration between Universiti Malaya and the Berman Institute of Bioethics at Johns Hopkins University, developed and implements the Master of Health Research Ethics (MOHRE) program in effort to help improve research ethics capacity in Malaysia. No other institution in Malaysia currently offers a postgraduate program in health research ethics (Johns Hopkins University, 2024; Master of Health Research Ethics [MOHRE], 2024; National Institute of Health, 2024a). The MOHRE program addresses critical deficiencies identified through rigorous stakeholder engagement and research efforts, ensuring its design is both contextually relevant and culturally sensitive. The MOHRE program tackles regionally specific ethical challenges such as navigating informed consent in multilingual and low-literacy populations, addressing religious and cultural sensitivities in biomedical research, and ensuring equitable community engagement, particularly in rural and indigenous settings. Additionally, it confronts pressing issues such as maintaining participant confidentiality in studies involving sensitive health data (e.g., HIV serostatus or risk factors, sexual and gender identity, genetic information) and ensuring fairness in global health research collaborations. The curriculum covers fundamental principles of ethics and their practical applications, including clinical trials, public health research, digital health ethics, and emerging technologies such as biobanking. It uses local case studies, interactive sessions, workshops, and hands-on training through a practicum with local RECs and health research institutions, enhancing students’ critical thinking and problem-solving skills (MOHRE, 2024).

The MOHRE curriculum seeks to create a cadre of professionals who are well-versed in the intricacies of ethical decision-making in the face of evolving health challenges. The one-year, full-time, on-campus program consists of two regular semesters (14 weeks each) and one short semester (8 weeks). It requires eight core courses and two electives. Semester one includes four core courses and one elective on health research methods, foundation in research ethics, responsible conduct of research, and healthcare law and ethics. Semester two includes three core courses and one elective. A research project is undertaken in semester two, guided by close mentorship from program faculty, allowing students to tailor their educational experience and explore areas of personal interest in depth. This is complemented by a practicum in health research ethics during the short semester. The program adopts a blended learning approach with formative assessments (MOHRE, 2024). The team has secured a renewal grant to establish a part-time program and continue training faculty members to promote program sustainability.

A FIC grant to develop a master’s degree in research and research ethics in Myanmar was awarded in 2017 (National Institute of Health, 2024b), recognizing the need for a country-specific sustainable program in research ethics. Subsequently, a Diploma in Research Methodology and Research Ethics (DipRMRE) program supported by FIC was introduced, which aimed to address primary research ethics capacity-building. The long-term goal of the DipRMRE program was to achieve sustainability in research ethics capacity at individual and institutional levels.

The diploma program utilized a blended learning methodology, combining in-person workshops with asynchronous learning via the Moodle platform. The curriculum covered a comprehensive range of topics, including research ethics, international research ethics, public health ethics, ethics theories and principles, research methodology, RCR, biostatistics, critical thinking, and scientific writing. Additionally, workshops in research ethics were organized for faculty and graduate students from all medical universities and research institutes in Myanmar to enhance their understanding and application of ethics principles in research.

To provide advanced training in research ethics and promote sustainability, the Myanmar Fogarty Program offered qualified candidates the opportunity to pursue an online 12- credit Certificate Degree in Global Research Ethics provided by the Graduate School at the University of Maryland, Baltimore (UMB) (University of Maryland,2025). After completion of the certificate degree, several participants pursued an online Master of Science in Health Science. The FIC program also included professional development opportunities for trainees emphasizing competencies in scientific writing, critical thinking, pedagogy, mentorship, and community engagement.

Pakistan’s Master of Bioethics (MBE) program aims to address the country’s research ethics governance challenges by building capacity through a master-level program tailored to the needs of Pakistani professionals. The program is designed to be affordable and financially sustainable beyond the grant funding period, accommodating mid-career professionals who are balancing work and family commitments. It also adopts a blended learning approach leveraging AKU’s resources, reducing operational costs and facilitating international educator involvement.

The MBE program is delivered in a hybrid format, combining in-person and online learning (synchronous and asynchronous). Students spend three weeks per semester in person, with the rest completed online. The program requires core courses, elective courses, and a research thesis. The four-semester curriculum covers foundations in bioethics, research design and methods, and health and human rights in the first semester; research ethics, clinical ethics, and health equity and policy in the second; academic writing, bioethics education, public health ethics, and biostatistics in the third; and organizational ethics, ethics of genetics, and genomics in the fourth. Experiential learning is emphasized through a research ethics practicum, enabling students to engage in various research types and monitor ethical compliance, bridging theoretical knowledge and application. Tailored to Pakistan’s needs, the program uses local case studies to address challenges and provide practical solutions. Integrating Western and Islamic ethics perspectives enhances students’ analytical skills to navigate complex ethical issues, reflecting Pakistan’s Islamic ideology. Global engagement is fostered through connections with different AKU and regional entities as well as faculty from its collaborating institution (Milken Institute School of Public Health, George Washington University, Washington, DC USA) promoting rich discourse in bioethics and research ethics.

In summary, the bioethics programs in India, Malaysia, Myanmar, and Pakistan share several commonalities. Each program is designed to meet its respective country’s specific needs and challenges, offering in-depth curricula that blend global best practices with local perspectives. They all emphasize practical research experience, innovative teaching methodologies, and flexible learning formats, ensuring accessibility and relevance. Additionally, these programs integrate diverse ethics perspectives and foster global engagement, aiming to cultivate a new generation of research ethics practitioners and educators capable of advancing ethical standards and responsible research conduct in their regions. The collective emphasis on cultural sensitivity, practical application, and sustainable capacity-building underscores their commitment to enhancing research ethics infrastructure and governance across South and Southeast Asia.

Program outputs to date

The Yenepoya University’s Master of Research Ethics (YU-FIC) in India, the Universiti Malaya’s MOHRE in Malaysia, the DipRMRE in Myanmar, and the MBE initiative at AKU, in Pakistan, have made substantial strides in advancing the field of research ethics, producing graduates who are making impactful contributions to health research and policy.

Trainees of the YU-FIC are from India, Zimbabwe, Nigeria, and Bhutan. So far, 36 have enrolled, with 28 having successfully completed the master’s program and eight current ongoing. Among the alumni, three are serving on ethics committees, three are pursuing PhDs, one has obtained a seed grant for Community Participatory Action Research, and six are employed in various institutions’ secretariat of ethics committees. The YU-FIC program has produced seven research papers on various topics, including ethics review guidelines for COVID-19 and its challenges (See bibliographic paper in this special issue). Graduates and trainees have also presented their findings at national and international conferences, either in person or virtually. The program has also conducted seminars and journal clubs, providing a platform for trainees and faculty to exchange ideas and perspectives. In addition to the master’s sessions, the trainees participate in webinars, workshops, and conferences in research ethics, including the Fogarty Trainee Bioethics Webinar.

The MOHRE program has graduated 36 trainees, with seven more currently enrolled. These master trainees come from Malaysia, the Philippines, Indonesia, China and Botswana. Among the graduates, 23 have already reported a positive impact on their careers, such as taking on new roles as members of ethics committees and receiving promotions. Additionally, two graduates are pursuing doctoral degrees in ethics. MOHRE trainees have published six articles on various topics, including human genomic research, electronic informed consent, and developing a framework for assessing competency during the informed consent process. The program also secured a supplementary grant to develop the Framework for Research Ethics Competencies and Outcomes (FRESCO) to help ensure that the MOHRE program addresses important health research ethics competencies (Tackett et al., 2023; Tackett et al., 2022). In addition to its basic academic offering, the program organizes Hot Topic webinars to engage emerging issues in research ethics. Furthermore, MOHRE has developed an online region-specific casebook which was soft-launched in 2024 and is currently undergoing beta testing. The casebook is accessible to users, who are encouraged to provide comments and feedback to refine its content and usability (Ali and Gopalan, 2024).

The program in Myanmar comprised several distinct initiatives. The first provided advanced research ethics training for graduate students, enhancing their pedagogy and mentoring skills and fostering ethics leadership. Eight FIC scholars completed the UMB online certificate degree program in research ethics, with three continuing on to earn a master’s in health science. Among these scholars, five completed research projects that were subsequently published in peer-reviewed journals, while several others are in the process of completing their projects or preparing manuscripts. Additionally, several scholars have presented their findings at national and international conferences.

The second involved developing the 10-month DipRMRE. Faculty and FIC scholars played integral roles in its development, teaching, and mentoring. Launched in Fall 2020, the program featured a hybrid pedagogy consisting of five 3-day in-person workshops held every two months, complemented by asynchronous learning. The DipRMRE enrolled its first cohort of 26 graduate students in Fall 2019, followed by another in January 2021. However, the program was disbanded following the military coup in February 2021, and plans for a master’s program were similarly abandoned. Despite the disruption caused by the military coup and ensuing chaos in higher education, the Myanmar program steadfastly pursued its educational objectives.

In the spring of 2021, a FIC supplement grant was secured to develop a one-year program focused on Advancing Research to Address Health Equity. During the inaugural year, educators from international NGOs, faculty formerly associated with public universities, and faculty from UMB collaboratively designed a curriculum that included weekly webinars and asynchronous learning modules. Critical programmatic components encompassed the foundations of health equity, research methods, statistical analysis, best practices in community engagement, scientific writing, and research integrity. The program’s first cohort consisted of 12 post-graduates, each of whom developed and completed a research project addressing a health equity issue. Furthermore, to support other Myanmar students who had relocated to Thailand to continue their education, workshops in scientific writing were conducted at Chulalongkorn University and the ASEAN Institute for Health Development (AIHD) at Mahidol University in Bangkok. Several participants in these workshops were involved in Fogarty-supported D43 programs.

In Pakistan, the current initiative at AKU spearheaded a bioethics faculty development program in its first year to overcome the absence of a dedicated department or section for bioethics. The initiative successfully convened professionals from various departments with diverse expertise and educational backgrounds, forming a multidisciplinary team adept at teaching complex ethical issues in healthcare and research. By leveraging the expertise of these diverse professionals, a contextual curriculum was developed to address Pakistan’s unique healthcare challenges. Multiple educational bodies and the Higher Education Commission of Pakistan approved this curriculum, which integrates cultural, religious, and regional considerations. In February 2024, the program inducted its first cohort of 14 Master of Bioethics (MBE) students.

Critical Reflection Regarding all the Programs

The experiences of the FIC programs in the Asian region offer several insights, including:

1. Local Capacity Building: A key achievement of these programs is the development of research ethics curricula specifically tailored to the unique ethical challenges and healthcare priorities of each region. By integrating local case studies and contextual examples, the training ensures that participants gain practical and actionable insights relevant to their environment.

2. Sustainability: Collaboration with international experts has helped establish a robust cadre of local faculty and experts who can maintain the programs beyond the grant period.

3. Professional Development: The programs’ support of research projects and publications promotes professional development.

4. Flexibility and Adaptability through Online Learning: Online learning enhances the impact of the programs by broadening recruitment efforts and allowing full-time professionals to participate. Online platforms also provide flexibility, adapting to difficult circumstances such as the COVID-19 pandemic and political upheaval as experienced in Myanmar.

5. Incorporating Diverse Cultural and Medical Systems: The programs emphasize the importance of cultural sensitivity in research ethics by examining how diverse cultural norms, religious beliefs, or traditional medical systems shape ethical considerations in research. This equips trainees with skills to navigate complex ethical conflicts and make informed decisions in culturally diverse research settings, fostering ethics practices that respects and align l with local contexts.

6. Influence on Policy Making: Leveraging the developed expertise to influence national and international policy making will help ensure that internationally recognized ethics guidelines have broad applicability to low-and-middle-income countries as well as remain robust and responsive to evolving research practices.

Conclusion

We believe that our outcomes show that the NIH-Fogarty-funded bioethics initiatives in India, Malaysia, Myanmar, and Pakistan have made notable progress in addressing the ethical challenges in biomedical research within these countries. Through the development and implementation of advanced FIC funded educational programs, these initiatives have enhanced research ethics capacity, fostering a new generation of bioethics professionals’ adept at navigating complex ethics issues. The contributions of graduates from these programs—serving on ethics committees, pursuing advanced bioethics education, and producing scholarly outputs on ethical challenges in biomedical research—serve as clear evidence of their impact. A key factor in the success of these programs has been their ability to integrate local cultural contexts with global ethics standards, such as those outlined by the Council for International Organizations of Medical Sciences and the Declaration of Helsinki. This helps to promote the relevance, adaptability, and sustainability of these programs within diverse socio-economic healthcare settings.

As these initiatives continue to evolve, sustained investment in research ethics infrastructure, regional collaborations, and innovative educational methodologies will be vital. The incorporation of emerging tools and methods such as artificial intelligence (AI), social media research, mobile health and the ethical implication of climate change within curricula will further enrich these programs. Strengthening online and hybrid learning models will ensure greater accessibility and resilience, especially in politically or economically unstable contexts, while also attracting a broader pool of professionals. Additionally, fostering regional collaborations and implementing robust contingency plans should enhance the ability of these programs to adapt to evolving challenges. By equipping professionals with the skills to address ethical issues with cultural sensitivity and global awareness, these initiatives contribute to the practice of ethically sound global health research in Asia and beyond.

Educational Implications

To remain relevant in an ever-evolving landscape of health and research, curricula must be updated to address emerging technologies and methods. Incorporating topics such as AI, social media research, mobile health, and climate change will prepare trainees to navigate the complex ethical challenges they present. For instance, AI in healthcare raises questions about bias, privacy, and decision-making transparency, while research involving social media and mobile health requires careful consideration of consent, data security, and participant anonymity. Addressing the ethical dimensions of climate change and research should help prepare professionals to consider public health and other ethics concerns that are broader than traditional research ethics. By integrating these contemporary issues, programs will not only remain forward-thinking but also provide trainees with the tools to contribute meaningfully to discussions at the intersection of ethics, health, and technology.

Strengthening online and hybrid learning infrastructure is equally critical to ensuring high-quality, uninterrupted education, especially in politically unstable contexts where traditional classroom learning may be disrupted. Investments must be made to improve internet access and digital literacy among students and faculty, enabling more seamless participation in online learning environments. Furthermore, developing flexible training options—such as part-time and hybrid enrollment models—can broaden access for professionals who are unable to commit to full-time, on-campus programs due to work or personal commitments. Current requirements for predominantly in-person study have limited recruitment, particularly among working professionals. By addressing these barriers, institutions can expand their reach and provide opportunities for a more diverse pool of trainees to benefit from advanced ethics education.

Future Needs

Expanding regional collaborations is essential for enriching research ethics education and fostering shared learning. Partnering with regional and international institutions can provide broader perspectives, access to diverse resources, and opportunities for cross-border knowledge exchange. Joint programs, faculty and student exchange initiatives, and collaborative research projects with neighboring countries, promise to strengthen the capacity of research ethics programs while promoting the harmonization of ethics standards across the region. These partnerships also promise to serve as a platform for addressing shared challenges and advancing research ethics collectively.

Research Agenda

Assessing the long-term accomplishments of graduates from advanced degree programs in research ethics is critical to understanding their impact on the field. This evaluation should aim to learn how graduates apply their training in professional settings, contribute to governance in research, and influence policy development. Tracking their career trajectories and professional contributions should help identify strengths in program design and areas for enhancement, ensuring that research ethics education continues to meet the evolving needs.

In addition, conducting research to explore the challenges faced in conducting and publishing research in peer-reviewed journals is essential. This research may uncover barriers such as limited access to resources, lack of mentorship, and challenges in meeting international publication standards. By identifying these obstacles, programs can design targeted interventions, such as enhanced training in scientific writing, mentorship programs, and workshops on navigating the peer-review process. These efforts will not only improve publication outcomes but also elevate the visibility and influence of bioethics research globally.

Biographies

Nishakanthi Gopalan is a senior lecturer at the Universiti Malaya, Faculty of Medicine. Being a part of the Medical Humanities and Ethics Unit (MedHEU), Dr. Gopalan has contributed extensively to the research in bioethics in Malaysia. She is also involved in the development bioethics education, the creation of the “Cases in Bioethics” casebook, focusing on Southeast Asian contexts, and has collaborated with international experts to enhance research ethics capacities in the region.Dr Gopalan has authored the section on Malaysia and played a key role in coordinating the manuscript.

Robyna Irshad Khan serves as an Associate Professor, Consultant Anesthesiologist, and Associate Dean at the Aga Khan University in Karachi, Pakistan. She is the Program Director of the Master of Bioethics program offered by the university, where she teaches multiple courses. Dr. Khan is an experienced professional in the fields of Anesthesiology, Bioethics, and Allied Health Education. Her interests encompass pain management, regional anesthesia, clinical ethics, research ethics, ethics education, and the training and education of allied health professionals. Over the past two decades, Dr. Khan has been actively involved in the teaching and training of healthcare professionals in the field of Bioethics in Pakistan. She has authored the section on Pakistan and contributed to editing other sections.

Henry J. Silverman is a Professor of Medicine at the University of Maryland School of Medicine. 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. Dr Silverman has authored the section on Myanmar and assisted in editing the other sections.

Jeremy Sugarman is the Harvey M. Meyerhoff Professor of Bioethics and Medicine in the Department of Medicine and the Berman Institute of Bioethics at the Johns Hopkins University. He works on a variety of issues in bioethics including global health research, HIV prevention, research, research ethics oversight and informed consent. He is the Co-Principal Investigator of the US National Institutes of Health Fogarty International Center grants that support the development of the Master of Health Research Ethics program based at Univesiti Malaya. Dr Sugarman contributed to the design of the paper and assisted in editing the manuscript.

Vina Vaswani is a Professor, Department of Forensic Medicine & Toxicology and Director, Centre for Ethics, Yenepoya (deemed to be University), Mangalore. She has started several first in India ethics-specific academic programs and is a senior faculty in those programs such as Post Graduate Diploma in Bioethics and Medical Ethics (PGDBEME), Post Graduate Diploma in Clinical ethics (PGDCE) and several value added courses for undergraduates and postgraduates like Bioethics and Environmental Ethics, Clinical Ethics and Medical Humanities. She is currently principal Investigator for Yenepoya University-Fogarty International Center’s Research Ethics Masters program for India, supported by NIH, USA under the grant number 1R25TW010305. She has authored the section on India and contributed by providing critical inputs in revising all other sections in the manuscript.