Fogarty-Funded Research Ethics Training Programs in Eastern Europe

Abstract

Low and middle-income countries (LMICs) in Eastern Europe are attractive to global companies as sites for clinical trials, but there are gaps in research oversight and limited in-country expertise in research ethics, raising concerns that research participants may be at risk of exploitation and harm. Three NIH Fogarty International Center-funded research ethics training programs in Eastern Europe address these gaps, developed by partnerships between: the Icahn School of Medicine at Mount Sinai (ISMMS) in New York and the Medical Faculty at the University of Belgrade in Serbia; ISMMS and the Iuliu Haţieganu University of Medicine and Pharmacy in Cluj-Napoca, Romania; and Ukrainian Catholic University in Lviv, Ukraine, and Loyola University Chicago. Here we provide an overview of the health systems and research activity in the region as well as the rationales, aims, accomplishments, and future needs of these Master’s (Serbia and Romania) and doctoral-level (Ukraine) research ethics training programs.

Although most of the research ethics training programs funded by the National Institutes of Health (NIH) Fogarty International Center (FIC) during the past 25 years are centered in Africa, South America, and the Middle East, low and middle-income countries (LMICs) in Eastern Europe also need to strengthen their biomedical research ethics capacity. The region is attractive to global companies as sites for clinical trials because their national health care systems make it relatively easy to identify appropriate study participants. Additionally, patients in LMICs are typically naïve to new drugs which in turn facilitates study design. There are, however, gaps in research oversight and limited in-country expertise in research ethics. These gaps raise concerns that research participants in Eastern European LMICs may be at risk of exploitation and harm.

To address these gaps in oversight and expertise, currently there are three NIH FIC-funded research ethics programs in Eastern Europe – two R25 programs, which support Master’s level training, and one D43 program, which supports doctoral and post-doctoral level training. A previous special issue of JERHRE described two NIH FIC-funded bioethics programs supporting trainees in multiple post-Communist countries (Strosberg et al., 2013). These programs have since ended. A partnership between the Icahn School of Medicine at Mount Sinai (ISMMS) in New York and the Medical Faculty at the University of Belgrade in Serbia (UBSM) established a Master’s program in research ethics at UBSM, serving scholars from Serbia as well as Albania, Bulgaria, Macedonia, Montenegro, and Romania (R25 TW008171, PIs: Rhodes and Markovic, 2012–2024). A partnership between ISMMS and the Iuliu Haţieganu University of Medicine and Pharmacy (UMFIH) in Cluj-Napoca, Romania, supports a Master’s program in ethics and research methods in medicine, serving scholars from Romania and the Republic of Moldova (R25TW010518, PIs: Rhodes and Colosi, 2018–2024). Since 2020, through a partnership with Ukrainian Catholic University (UCU) in Lviv, Ukrainian physicians and scientists are funded to complete a doctorate in bioethics (DBe) at Loyola University Chicago (LUC) with a focus on research ethics (D43TW011506, PI: Anderson, 2020–2024).

Here we describe these NIH FIC-funded programs in terms of their rationales, aims, accomplishments, and future needs. We set the stage by providing some background information on the health systems in the region. Romania, Serbia, and Ukraine are geographically close neighbors with historical interactions and similarities in culture. All three have regained democracy after 40 years of imposed Communism following WW II. Because of their shared recent history, these countries have similar approaches to public health, healthcare, research, and education. Romania joined the European Union (EU) in 2007, and both Serbia and Ukraine strive to eventually join the EU. They are mounting robust efforts to conform with democratic values and standards in culture, science, and civil rights (European Observatory on Health Systems and Policies, 2019). The most significant difference between them is the ongoing war in Ukraine which started with Russia’s invasion in 2014 and escalated in 2022.

Health Systems

Serbia, Romania, and Ukraine all provide state-supported medical insurance coverage. In Romania and Serbia, most health facilities are state-owned, while in Ukraine the health system is decentralized, with regional health administrations responsible for managing healthcare services within their respective territories (European Observatory on Health Systems and Policies, 2019; 2023).

Serbia:

Serbia’s health system is primarily based on mandatory health insurance covering nearly the entire population (98%). The principle that all people legally recognized as subjects of the state of Serbia have access to healthcare is codified in the 2019 Health Care Law. The state owns most health facilities and equipment, with the National Health Insurance Fund (NHIF) serving as the main purchaser of publicly funded health services. Serbian citizens and residents, whether permanent or temporary, have the right to access these publicly financed health services (European Observatory on Health Systems and Policies, 2019).

National legislation permits private healthcare providers to operate, though their services are predominantly funded by out-of-pocket payments. The Ministry of Health regulates both state and private sectors, with the Institute of Public Health (IPH) of Serbia and the network of 25 regional IPHs playing a key role at regional and national levels. Health care is organized at three levels: primary, secondary, and tertiary. Health care delivery is centered around the “chosen general practitioner” model in primary care centers, where a designated primary care physician acts as a gatekeeper to higher levels of care. In 2019, 350 facilities made up the country’s network of publicly provided health care institutions. The hospital sector has approximately 560 curative beds per 100,000 people. Serbia has around 310 physicians and 610 nurses per 100,000 people (European Observatory on Health Systems and Policies, 2019).

The system’s infrastructure and organization, largely inherited from the Yugoslav era, have been the focus of modernization efforts since 2000, including improvements in facilities, equipment, and technology. A major reform initiative, carried out between 2004 and 2010, focused on enhancing preventive services to reduce the incidence of preventable diseases and lower overall healthcare costs. Reforms since 2012 have emphasized improving infrastructure, integrating health information systems, and enhancing access to preventive services, particularly for vulnerable populations (European Observatory on Health Systems and Policies, 2019). Yet, the limitations of the healthcare system remain; similar to Romania, the majority of state-insurance funding is directed towards hospitals and specialized care. For example, the University Clinical Center of Serbia is the hospital with largest number of beds in Europe. It provides specialized care and tertiary services to the patients from throughout the region. Of note, however, a significant number of medical professionals have emigrated from Serbia and the Balkans. Unfortunately, this emigration pattern negatively affects the availability and quality of healthcare services (Juric, 2021).

Romania:

The Romanian health system is governed by the Romanian Ministry of Health and financed from public funds managed by the Romanian National Health Insurance House which provides all Romanian citizens with state-supported medical insurance coverage. Its policies currently prioritize secondary and tertiary care over primary and preventive care, leaving the existing network of general practitioner offices relatively under-funded and thus not able to focus on prevention. Similar to the Serbian healthcare system, general practitioners in Romania fulfill a “gatekeeper” role of consulting and referring already sick patients to the secondary and tertiary healthcare systems (European Observatory on Health Systems and Policies, 2023).

Several networks of privately-owned hospitals and clinics have developed over the last decade, offering health services covered by both private and state-supported medical insurance. Competition from these private facilities has stimulated investments in building new state-owned regional hospitals, and renovating and updating the existing ones, supported by Romanian state funds and EU loans. Despite visible progress in healthcare infrastructure, a significant number of healthcare professionals has left Romania for other EU countries over the past 15 years, overloading the remaining labor force and limiting the timely supply of certain medical services (European Observatory on Health Systems and Policies, 2023).

Ukraine:

Over the last decade, the Ukrainian healthcare system has radically changed from the post-Soviet system, implementing new approaches to primary care. The World Health Organization’s (WHO) 2020 report, Towards a Healthier Ukraine (WHO, 2020), calls this one of the most ambitious healthcare transformations in the world and highlights notable achievements such as improved access to medical care, reduction in neonatal and maternal mortality rates, and expansion of immunization programs. As a result of healthcare reform, extreme poverty, severe malnutrition, and greenhouse gas emissions have significantly decreased, while gender equality, health coverage, and capacity for compliance with international health regulations have increased (WHO, 2020).

Despite this progress, major challenges persist including high hospitalization rates and healthcare costs, as well as high rates of morbidity and mortality from chronic diseases among young men. The Ukrainian healthcare system continues to face many challenges, including underfunding, outdated infrastructure, and discrepancies between urban and rural areas in healthcare quality and accessibility.

The full-scale 2022 Russian invasion has resulted in widespread displacement of Ukrainians within and across borders, shortages of healthcare providers and supplies, and violent attacks on healthcare facilities and workers. The effects have significantly impacted the health of Ukrainians in ways that have yet to be adequately measured (Spiegel, Kovtoniuk, and Lewtak, 2023).

Biomedical Research

Research productivity at academic institutions in Romania, Serbia, and Ukraine lags behind other European nations, in large part due to limited investment by the federal governments (National Council for Scientific and Technological Development, 2023). Simultaneously, during the last decade, clinical research sponsored by global pharmaceutical companies from high income countries (HICs) has significantly increased in all three countries (WCG, 2023; also see http://martifarm.com). This is due to centralized healthcare systems and large pools of patients who are treatment-naïve to the newest therapies, factors which support successful patient recruitment (Rankovic, 2016; Rubin, 2022).

Clinical trials have significantly increased in the Balkans, with an average of 80–90 studies approved annually in Serbia (OXIMIO, 2021). Between 2014–2019, there were 406 registered clinical trials in ClinicalTrials.gov recruiting in Romania, compared with 108 between 2010–2014 and only 18 between 2000–2009 (Bartoszkiewicz, 2022). In Ukraine, which is significantly larger than Romania and Serbia combined, as of February 2022 (prior to the full-scale invasion) there were 786 planned or ongoing oncology trials, including 99 lung cancer studies and 78 breast cancer studies (www.globaldata.com), as well as over 600 non-cancer studies recruiting patients (Castaneda, 2022). Between 2014 and 2017, Ukraine was second only to India - which has a significantly larger population, about 30 times the size of Ukraine - among LMICs participating in oncology trials (Nuwer, 2023). The war in Ukraine has adversely impacted clinical trials due to disruptions to healthcare infrastructure, limitations on the movement of people and goods, and challenges in ensuring the safety and well-being of study participants and research staff. However, physicians and researchers are calling for the return of clinical trials, citing patient need, solutions to logistical challenges, and the relative safety in western Ukraine (Bondarenko et al., 2023; Talbot et al., 2022).

Serbia:

Since 2005, all Serbian healthcare institutions are mandated by law to establish an ethics committee (EC) to oversee and review research involving human participants, with members recruited from institutional employees (Law on Healthcare, 2023). There is no requirement for formal research ethics education for institutional EC members. Academic research must be approved by the institution’s EC, while commercial clinical studies require approval from two central bodies, the Ethics Committee of Serbia (EOS) and the Medicine and Medical Devices Agency of Serbia (ALIMS). Clinical trials in Serbia are regulated by the Law on Medicines and Medical Devices and the Rulebook on Clinical Trials. In 2019, the Ethics Board of Serbia was established to oversee ethical aspects of clinical trials, replacing the previous system where individual healthcare institutions’ ECs handled such reviews. This new approach aims to expedite the review, streamline decision-making on trial approvals, and ultimately create a more efficient framework for medical research involving human participants.

Romania:

Over the past three decades, the Romanian health research system has embraced internationally recognized health research standards. In 1997, less than a year after the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) finalized its harmonized Guideline, standards for good clinical practice (GCP) were included in the Romanian legislation. Seven years later, Romania was one of the first countries to incorporate the 2001 EU Clinical Trials Directive in its national legislation. Unlike most other EU countries, which have several research ethics committees (RECs) to review clinical trials, Romania has only one national REC mandated to approve this type of interventional medical research (Veerus, 2014). All clinical trials of medicines and medical devices conducted in Romania are subject to ethics review and authorization by the National Agency for Medicines and Medical Devices (NAMMD). According to the Romanian health research legislation, the National Committee of Medicines and Medical Devices (NCMMD), an independent body under the joint authority of the Romanian Health Ministry and the Romanian Academy of Medical Sciences, must approve clinical trials before they can begin (European Network of Research Ethics Committees, 2023). For the ethics review of observational clinical studies and preclinical studies, Romanian universities and other research institutions are required to have their own Institutional Ethics Committee (IECs) which assumes responsibility for assuring academic integrity and ethical conduct of research (Romanian Law on Proper Scientific Conduct, No. 206, 2004),. Meanwhile, interventional clinical studies, like clinical trials of therapeutic interventions or medical devices are still required to apply for the aforementioned centralized ethics review and approval by the national REC (NCMMD).

Ukraine:

Ukraine has implemented various mechanisms to improve the regulatory environment for biomedical research, standardize requirements related to insuring and taxing trials, pay local participating health care providers, and improve the training of local medical staff for conducting research (Borysov, Antoniuk, and Vyshnyvetskyy, 2019; Antoniuk, Pavliuchenko, and Vyshnyvetskyy, 2020). Although many basic regulations were inherited from the Soviet period, including the system of granting scientific degrees and funding, the 2015 law, “About Scientific and Technological Activity,” established an advisory body, the National Council of Ukraine on Science and Technology, acting under the Cabinet of Ministers of Ukraine, to bring together representatives of the scientific community, industry, and governing agencies to develop science and technology policy. This led to the establishment of the National Research Foundation of Ukraine to foster research progress by ensuring a competitive milieu and transparency in grant support (Cabinet Ministers of Ukraine, 2018, 2023).

Ukrainian research regulations reference ethical principles, and research ethics committees (RECs) exist at national and institutional levels. The “Order on Approval of the Procedure for Conducting Clinical Trials of Medicinal Products and Examination of Clinical Trial Materials and Standard Provisions on Ethics Commissions,” specifically regulates researchers’ activities in studies that involve human participants. This document is consistent with international best practices, but it applies only to clinical medical interventional studies. Primarily, it provides guidance for RECs regarding on-site review of trial protocols (Ministry of Health of Ukraine, 2009, 2012). There are approximately 400 RECs in Ukraine that review clinical trials (European Network of Research Ethics Committees, 2019). An update of the 2000 Order of the Ministry of Health No. 66 (Typical Ethics Regulations) was the first Ukrainian regulation to require independent ethics review and legal assessment of Ukrainian human subjects research (Pustovit and Paliei, 2014; Kornatsky et al., 2011). These regulations cover clinical research, but not observational studies or behavioral social science studies with human participants.

Research Ethics Capacity-Building [See Table 1]

Table 1.

Overview of Program Milestones and Achievements

Program Dates	Program Milestones	Trainee Achievements
ISMMS-UBSM, Serbia First NIH-FIC grant 2012–2017	Devised a two-year Certificate program in research ethics co- taught in person, online, and with tele-conferencing by ISMMS and UBSM faculty.	3 cohorts of a total of 25 trainees from Albania, Bulgaria, Montenegro, North Macedonia, Romania and Serbia completed the two- year Certificate program.
		23 earned a Certificate in Research Ethics, including 6 faculty members from universities in Cluj-Napoca, Romania who became core faculty for the Romanian training program described below.
Second NIH-FIC grant 2018–2024	Enrolled 6 UBSM faculty in Bioethics Master’s program at Clarkson University-ISMMS Bioethics Program to develop faculty expertise and provide faculty with critical bioethics credentials.	5 faculty members at UBSM earned a Master’s in Bioethics from the Clarkson University – ISMMS Bioethics Master’s Program.
	Applied for Master’s Program Accreditation.	Established an accredited sustainable Master’s program in Bioethics. To date 11 enrolled, 4 completed Master’s.
	Mentoring and co-teaching to support UBSM faculty in Master’s program curriculum development and teaching.
	Ongoing career mentorship and guidance from ISMMS faculty.
ISMMS-UMFIH Cluj-Napoca, Romania NIH-FIC grant 2018–2024	Devised a two-year Certificate program in research ethics co-taught in person, online, and with teleconferencing by ISMMS and UMFIH faculty.	10 trainees from Romania and the Republic of Moldova completed the Certificate program in research ethics at UMFIH.
	Enrolled 7 Cluj-Napoca faculty in Bioethics Master’s program at Clarkson University-ISMMS Bioethics Program to develop faculty expertise and provide faculty with critical bioethics credentials.	6 faculty members at UMFIH earned a Master’s in Bioethics from the Clarkson University - ISMMS Bioethics Program.
	Applied for Master’s Program accreditation.	Established an accredited sustainable Master’s program in “Ethics and Research Methods in Medicine” at UMFIH, Cluj-Napoca, Romania.
	Mentoring and co-teaching experience to support UMFIH faculty in curriculum development, teaching, and research on bioethics topics.	23 graduate students have enrolled in the UMFIH Master’s Program over four successive academic years / cohorts of graduate students.
	Ongoing career mentorship and guidance from ISMMS faculty.	To date, 9 of these 23 students have completed their Master’s training, defended their Master’s theses based on their mentored research projects, and earned scientific Master’s degrees (MSc) in Ethics and Research Methods in Medicine from UMFIH.
	Assure sustainability of the program by inaugurating ongoing activities to foster a collaborative research ethics community in Romania and Eastern Europe.
		15 Cluj-Napoca faculty members participated in developing and teaching the curriculum for the new Master’s program in Bioethics at UMFIH.
		More than 20 Cluj-Napoca faculty members have broadened their career goals and advanced their teaching and research productivity through their participation in this NIH FIC R25 program.
LUC - UCU Ukraine Doctoral and Post-Doctoral* Bioethics Training Program 2020–2024	Recruited 11 scholars to complete Loyola University Chicago’s online doctoral degree in bioethics (DBe) with a concentration in research ethics.	2 trainees have completed the DBe.
		4 trainees completed a Master’s degree and are currently enrolled in LUC DBe program.
	UCU has received approval from administration to develop an MA program in bioethics with a focus on research ethics.	4 students are expected to complete Master’s in 2024 and enroll in DBe in 2025.
		(One trainee is now deceased.)

^*We had initially hoped to recruit and train postdoctoral fellows who would complete mentored research projects but have not identified any qualified candidates.)

Normative guidance on research ethics is required in EU countries for undergraduate and postgraduate biomedical education, and the European Code of Conduct for Research Integrity requires research institutions and organizations to provide training in ethics and research integrity for researchers throughout their careers (All European Academies, 2017). However, in most Eastern European countries, integration of bioethics and research ethics in biomedical education is minimal (Claudot et al., 2007; Kubar, 2010; Pustovit and Paliei, 2014; Mijalaljica, 2014). As has been common in many other parts of the world, research ethics review tends to be cursory and approval perfunctory (Kundiyev and Chashchyn, 2015; Kornatsky et al, 2011). The scarcity of REC members with research ethics education constitutes a significant impediment to international competitiveness in the contemporary research context of rapidly developing technologies and innovative approaches (e.g., pandemic research, biobank research, artificial intelligence studies). Clinical research continues to increase in Eastern Europe, and thus more hours of graduate and post-graduate level bioethics education are needed in Romania, Serbia, and Ukraine to develop subject matter experts who can participate on national and institutional RECs, train REC members and researchers across all career stages, and engage in scholarship to inform and influence national policy.

Serbia:

In 2012, FIC funded the R25, “Research Ethics Education in the Balkans and Black Sea Countries,” to deliver a two-year regional certificate program in research ethics to three cohorts, including 33 trainees (scientists, physicians, veterinarians, stomatologists, psychologists, lawyers, philosophers, statisticians, journalists, and professionals from contract research organizations) from six countries: Albania, Bulgaria, Macedonia, Montenegro, Romania, and Serbia. Building on this program, FIC funded the establishment of a Master’s program in bioethics at UBSM in collaboration with the ISMMS (PI: Markovic and Rhodes, 2018–2024). This included an additional cohort of eight research ethics Certificate program trainees, faculty members at Serbian (Belgrade and Kragujevac) and Bulgarian universities, and provided an opportunity for teaching experience to four previous trainees from UBSM. Through this program, five UBSM faculty members who completed the previous Certificate program earned a Master’s in Bioethics (MBE) from the Clarkson University-ISMMS Bioethics Master’s Program (Jeremic Stojkovic et al., 2024).

In 2021, UBSM received accreditation from the National Entity for Accreditation and Quality Assurance in Higher Education of Serbia (NEAQA) for its one-year Master’s Program in Bioethics, delivered in both Serbian and English. In October 2021, the first cohort of eight Master’s students was enrolled, followed by the second cohort of two Master’s students. The Master’s program aims to teach students to conduct research and analyze ethical issues; participate in the implementation of legal norms in the field of biomedical research; develop, lead, and evaluate ethical aspects in research, application of new technologies and new therapeutic strategies; and create partnerships to implement ethical standards and principles.

Romania:

In Cluj-Napoca, Romania, a preliminary Certificate program in Medical Research Ethics was offered in 2018–2019 at UMFIH. It was co-taught by faculty from ISMMS and Cluj-Napoca to provide basic research ethics training for ten medical professionals from Romania and the Republic of Moldova. During the same period, six Cluj-Napoca faculty members earned Master’s degrees in Bioethics from the joint Clarkson University-ISMMS Bioethics Master’s Program and developed their skills in teaching the material with mentoring from ISMMS faculty.

To provide trained professionals able to support Romanian institution-based RECs and hospital-based clinical ethics committees, in 2021 UMFIH launched its NIH FIC R25 grant-funded two-year Master’s program in Ethics and Research Methods in Medicine. It was the first and so far only Master’s program in Romania to offer medical professionals simultaneous training in bioethics and medical research methodology – fundamental skills needed for the proper planning, implementation, and ethical oversight of medical research, as well as for assuming a constructive and active role in clinical ethics committees. After earning all needed accreditations from the Romanian National Authority for Qualifications (ANC) and the Romanian Agency for Quality Assurance in Higher Education (ARACIS), the program has enrolled its first six Master’s students during the 2021–2022 academic year, and seventeen more Master’s students over the following 3 academic years. As of October 2024, nine of these twenty-three Master’s students have completed all required coursework and practicum, successfully defended their Master’s theses based on their mentored research projects, and earned their Master’s (MSc) degrees.

Ukraine:

The initial approach to research ethics education in Ukraine has been different from other FIC programs, in that it was funded by a D43 grant to provide doctoral and post-doctoral bioethics training as a collaboration of Ukrainian Catholic University (UCU) and Loyola University Chicago (LUC). Given the small number of individuals in Ukraine with training and expertise in bioethics or research ethics, our long-term plan is to first provide doctoral-level training to a core group of individuals with potential for institutional and national leadership who will also serve as directors and instructors in future training programs, including a planned Master’s program in bioethics with a research ethics concentration and additional certificate-level programs for REC members. Current doctoral trainees, all of whom are MDs and/or PhD-trained scientists, live in Ukraine, take online graduate-level courses in English through LUC’s doctoral program in bioethics, and participate in bioethics activities at LUC and UCU. In addition to individualized mentoring, the program provides fellows with other resources for academic and professional success through webinars in responsible conduct of research and with guest speakers who expose trainees to bioethics research, scholarship and policy in Ukraine, Europe, and worldwide. The program also includes in-person intensive meetings, networking opportunities, and English language tutoring.

Because the Ukrainian students enroll in an already established virtual online bioethics graduate program at LUC, as soon as we were funded, we began recruiting students for the Fall 2020 semester. Eleven students have enrolled with zero attrition to date. (Sadly, one student died in May 2022.) All students entered the program with no previous graduate-level training and thus are required to complete Master’s coursework en route to the doctoral degree. As of May 2024, two trainees have completed the Doctorate in Bioethics (DBe) degree; four have completed the Master’s degree and are now working towards the DBe; the remaining four are on track to complete the Master’s in Fall 2024 or Spring 2025 and then continue to doctoral coursework.

Programs and Achievements

In addition to establishing Master’s degree programs and supporting individuals to obtain certificates and graduate degrees, faculty and trainees of the three FIC-funded research ethics programs in Eastern Europe have produced peer-reviewed research publications, books, and book chapters, and have presented at national and international conferences (See bibliometric paper in this special issue).

Serbia:

Former FIC trainees from Serbia have published more than 15 papers on bioethics topics in peer-reviewed journals. Trainees have also published several book chapters and contributed as editors to four books on animal bioethics, ethics of artificial intelligence (AI), bioethics in the new era of science, and disaster ethics. Program trainees have also contributed chapters on ethics to textbooks for medical undergraduate students and residents in anesthesiology. Many of them are involved in research ethics review and oversight as members of the Ethics Committee of Serbia and Ethics Committees of their Medical faculties and Universities.

Romania:

Since 2018, UMFIH, Cluj-Napoca Master’s program faculty as well as current and former Master’s trainees have published over ten book chapters and 25 papers on bioethics topics in peer-reviewed indexed journals and numerous additional articles that have integrated bioethics knowledge and skills in planning and implementing medical studies. Master’s trainees and faculty have delivered over 20 presentations at national and international meetings on bioethics topics including ethical approaches to conducting research during the COVID-19 pandemic and the ethics of AI in medical practice and biomedical research. An international ethics conference was led and organized by faculty members at UMFIH in September 2021 in Cluj-Napoca, Romania: the 37th Annual Conference of the European Association of Centres of Medical Ethics (EACME), Smart Ethics: Trends to the Future.

Ukraine:

Most Ukrainian FIC trainees are still completing their degrees. Trainee scholarship is focused on research with vulnerable (e.g., oncology) patients; ethics and regulation of biobanking and research with human tissue samples; research misconduct and improving the ethical climate for research in Ukraine; informed consent and communication in research and clinical settings; the impact of the war on clinical trials and the obligations of research sponsors; and humanitarian health ethics. Three students have published four research ethics articles in peer-reviewed journals (Paryzhak et al. 2024; Sulaieva et al. 2024; Sulaieva et al., 2023; Basarab and Anderson, 2022); others have manuscripts in preparation, under review, or in revision at peer-reviewed journals. Three students who are MDs published narratives on their experience treating patients during war (Dotsenko 2024; Kachkovska et al., 2024; and Sulaieva et al., 2024.) Five students have presented at regional or international bioethics or scientific conferences, and several have also presented in UCU, LUC, and FIC bioethics trainee forums.

Overview of Program Impact

Beyond the success in establishing new accredited bioethics Master’s programs, the training provided has built bioethics capacity in the region. By increasing the number of health professionals with training in research ethics, these FIC programs have contributed to ethics review committees and other institutional initiatives. The training has also transformed trainees’ career trajectories and opportunities and allowed them to disseminate their learning to students and colleagues, prepare grant proposals, and offer advice on research design.

Serbia:

In Serbia, where the FIC-funded research ethics program has been operating for eleven years, we analyzed the program’s impact on building the country’s research ethics capacity by gathering data from case studies of individual alumni accomplishments, looking at the extent to which alumni participated in certain activities, categorized according to the Hyder et al. (2009) and Strosberg et al. (2013) models, including: research ethics review, institutional commitment, national and regional capacity, and researcher conduct.

Former trainees from the UBSM program have been actively engaged in ethics review activities at the national level. One certificate program trainee was recently appointed as chair and another as a member of the Ethics Commission of UBSM. Another former certificate program trainee was appointed to the Ethics Committee of Serbia, the central national body for ethics review that provides oversight of all clinical trials conducted in Serbia. In 2023, three certificate program trainees were involved in establishing an Ethics Commission for Student Research at UBSM which developed ethics guidelines for students’ research; one former trainee is Commission chair, and the other two are members.

Former FIC trainees have also been involved in the development of two ethics-related Continuing Medical Education (CME) courses at UBSM. A course for ethics committee members was established in 2023 and will be offered on a regular basis to ethics committee members throughout the country. Another course for physicians on contemporary issues in bioethics was taught in 2022 by former certificate trainees from Serbia, Montenegro, and Macedonia.

A former certificate program trainee organized the 3^rd International Conference in Bioethics in the New Age of Science (BNAS 2019) at the UBSM, gathering former trainees from the region and other multidisciplinary experts. Trainees participated in several international conferences with bioethics presentations and lectures, such as the 15^th World Congress of Bioethics, held online in 2020, the 2^nd Congress of the International Society for Preventive Pediatrics in Bosnia and Herzegovina in 2021, and SMART Ethics – Trends for the Future, the 38^th Annual European Conference of Centers of Medical Ethics (EACME), hosted in Romania in 2021. Former trainees have received three grants for bioethics research. One project focused on engaging vulnerable research participants in Montenegro, and another assessed the educational needs of Serbian biomedical researchers in order to inform our Master’s program curriculum. Both were funded by NIH. In addition, an EU START Danube Region Project Fund grant supported the BEST-NetWORK CONSORTIUM for developing a series of bioethics group meetings in the Danube region.

As most Serbian FIC trainees are academic faculty members, they are improving their existing courses and developing new research ethics courses to increase awareness of ethical issues and promote responsible behavior among future researchers. For example, former trainees revised and delivered a required research ethics course for PhD students at UBSM and created a novel elective course, Ethical Challenges in Human Subjects Research, for UBSM fourth year undergraduate medical students.

Overall, research ethics education has greatly impacted Serbian trainees’ professional development, with most trainees describing that it changed their perspective on ethical problems. They describe their training as having provided a richer view of their professional roles and expertise, and leading to new initiatives and collaborations.

Romania:

The program has had similar impact in Romania. Four members of the Master’s program at UMFIH Cluj-Napoca program are now members of institutional ethics boards or serving as advisors in the Ethics and Integrity Board of UMFIH Cluj-Napoca. Two faculty members served on grant review panels at NIH and the European Commission. UMFIH Cluj-Napoca is currently preparing a grant submission to the EU-Romania National Grants Program to support ethics education for medical practitioners at Romanian hospitals, with input and participation from a former FIC-funded trainee. A recent legal requirement for all researchers in Romania to be certified to perform research on animal models, called upon a former FIC-funded UBSM certificate trainee, who is a DVM and a Professor at the Faculty for Veterinary Medicine of Cluj-Napoca, to implement the first of its kind summer-school certification program for the ethical use of animals. Ten former certificate trainees are now integrating their ethics training into their teaching activities at their respective universities in Cluj-Napoca, Bucharest, and Chișinău, Romania. One who is an ICU coordinator at the Clinical Emergency County Hospital Cluj and an Associate Professor of Anesthesia and Intensive Care at UMFIH, is currently implementing and evaluating an ethics training course for ICU nurses as part of a research project.

Ukraine:

Ukrainian trainees are actively promoting a culture of ethical research in their home institutions and nationally in leadership roles. A graduate of LUC’s DBE program served on a committee that developed recommendations for national ethical guidelines for biobanks and research with banked human tissue samples. Another trainee led the establishment of a behavioral social sciences IRB at UCU and now serves as IRB chair and director of their human research protections program. Researchers from other universities have requested research review by the UCU IRB as well as consultation and technical support for development of institutional ethics review committees. Another two trainees are engaged in research ethics review at their home institutions; one was asked to suggest reform for the IRB and the institutional animal research review committee and to develop research ethics and RCR education for PhD and MD students and faculty members. Four current and former trainees will teach in a planned bioethics Master’s program at UCU that will include a research ethics concentration. One will also serve as director of ethics for the newly established UCU medical clinic. Two others are implementing responsible conduct of research education for undergraduate medical students at their university.

Overall, these achievements demonstrate that current and former FIC research ethics trainees in Eastern Europe have had a notable impact on research ethics capacity regionally and nationally. Testimonials by trainees from all three programs attest to their impact. [See Table 2.]

Table 2.

Testimonials from Former Trainees

“The Fogarty program made me understand how often ethical issues arise in critical care practice and that there might be multiple views regarding the way these ethical issues can be solved. Throughout the program, I have gained new skills regarding ethics in medical research, but even more important, the moral reasoning skills that I gained are useful for my clinical practice. The overlap of the program with the pandemic in 2019–2021 was a coincidence, but actually, this novel world context was an example for the use of bioethical principles in new situations. I studied bioethics in parallel to being the head of the ICU in my local hospital. So, I could use all skills in practice. I hope that I will be able to keep up with the ideas emerging worldwide in this domain.” – 2021 graduate of the UMFIH Cluj-Napoca Certificate Program in Research Ethics

“The program has helped me to develop my critical thinking with extensive exercises in understanding and constructing arguments for ethical issues that arise in all areas regarding medicine (patient care, public health, research with human subjects and animals, etc.). It was a wonderful experience that provided interaction with people from different fields (medicine, pharmacy, veterinary medicine, and ethicists) offering different and complementary perspectives on debated issues, and helped forming connections that will expand beyond the period of the program. Even though I am no longer in the academic field, when I was interacting with students it changed both my teaching method as well as the comprehensive knowledge background in ethics that I brought to my students. In my personal research for my PhD thesis, I used the research ethics knowledge for the research protocol and also the information from my final project.” – 2021 graduate of the UMFIH Cluj-Napoca Certificate Program in Research Ethics.

“The ethical side of the Master program has proven to be beneficial to my self-development and I have also improved the process of my critical, analytical thinking as well as the decision-making skills, found to be useful in any facet of my life. Both the Ethics and the Research Methods in Medicine parts are very useful for me in my professional life. For instance, a possible future employer has selected my application as first-choice among several candidates, after letting me explicitly know that this was largely due to my very rare qualification as an MS in Ethics and Research Methods in Medicine. Thank you for this opportunity!” – 2023 graduate of the UMFIH Cluj-Napoca Master’s program in Ethics and Research Methods in Medicine.

“In my profession as a surgeon I frequently have cases where good ethical knowledge and applicability of ethical principles is necessary, starting directly from the informed consent for each procedure, the reflection of autonomy. As part of the teaching staff in the university, I also gained a solid base in research methodology and increased confidence when discussing ethics subjects over practical activities. One day maybe I will even have the chance to be part of an Ethics Committee, since our institution recently started the necessary procedures for the implementation of a liver transplant program. I appreciate very much the opportunity I received. Thank you!” – 2023 graduate of the UMFIH Master’s program in Ethics and Research Methods in Medicine.

“Participation in the program enriched and broadened my professional work and development by focusing on the ethical aspects of practicing forensic medicine and pathology, and led to a different and broader view of my field of work, and by focusing on this the ethical aspects of practicing forensic medicine and pathology. The Certificate program also led to inclusion in the Master’s program at Clarkson University. From both of these program, the practical gain is the establishment of the Ethic Committee for the scientific research work of students and the establishment of principles for the scientific research work of students, which until then had not been formally formulated.” – Certificate program trainee, enrolled in 2019, professor at UBSM, Serbia

“Program has been extremely influential and enabled me to develop professionally and personally, filling the gaps that my pre-graduate and postgraduate studies couldn’t. I applied knowledge acquired through Fogarty education through participation in various institutional and IRBs and other professional bodies, as well as in practical and professional work of designing and implementing continuous medical education of health professionals in the country.” – Certificate program trainee, enrolled in 2015, Social and Behavioural Change Officer at UNICEF Montenegro

“I apply the knowledge acquired in the Certificate program in teaching students, in the work of the ethics committee I am member of, in designing research projects applications, in advising colleagues when submitting research proposals for approval from the ethics committee.” – Certificate program trainee, enrolled in 2013, Assistant Professor at UBSM, Serbia

“Pursuing a doctorate at Loyola has had lasting effects on me both personally and professionally. It has improved my teaching, research, and clinical practice. Recently, higher educational institutions in Ukraine have engaged in creating strong international collaborations, implementing international educational standards, and participating in international scientific projects. Implementing major changes in a university requires both the acquisition of new knowledge and skills, as well as the openness and readiness of university management. These initiatives require a deep understanding of bioethics as a foundation for scientific research. My greatest joy is to inspire and contribute to significant transformation.” – 2024 Ukrainian graduate of DBe at Loyola University Chicago

“Learning bioethics was not only the goal but involved a process of being embedded in an alternative culture of education and research. Loyola’s online graduate program provided a new experience for Ukrainian students in terms of methodology and clear organization of learning and applying new skills. It also became a platform for networking with mentors and classmates, allowing us to look at different moral dilemmas through the eyes of colleagues from other fields (e.g., lawyers, physicians, nurses, pastors, social workers. Etc.), learning bioethics to complement their current professional expertise. Courses on academic writing, participating in online discussion, and completing written assignments improved our writing skills and our ability to articulate thoughts clearly, breaking down language barriers. Regular discussion of complex questions facilitated critical thinking and argumentation skills, providing deep insight and stimulating reconsideration of long-held dogma.” – 2024 Ukrainian graduate of DBe at Loyola University Chicago

Lessons Learned and Innovations

Although our programs are independent, operate in different countries, and have slightly different specific aims, we have learned some shared lessons. First, the process of creating and accrediting new degree programs can be long and arduous. We all recognize a need for patience, tenacity, and flexibility in creating degree programs that meet the requirements of FIC funding, our individual institutions, and national accrediting bodies, especially as we are simultaneously developing capacity for individuals to teach in those programs.

Second, although the primary focus of our training programs is ethical issues in human subjects research, trainees in Eastern Europe need broad education in bioethics (including clinical and organizational ethics) and responsible conduct of research (including publication ethics, animal research ethics, ethics of international collaboration) as capacity in these areas is also lacking. Among U.S. and European bioethicists, it is very common to work in both clinical and research ethics, as it is also common for those whose scholarship is in human research ethics to teach responsible conduct of research courses to graduate students in a variety of disciplines. Conceptually and practically, dilemmas of clinical, organizational, and public health ethics are not independent of research ethics challenges. The need for comprehensive bioethics education is even more critical in Eastern Europe, where relevant applied ethics expertise remains particularly scarce. Many of our trainees’ career trajectories reflect these broad needs.

Third, we learned the value of distance education models, especially for busy researchers, clinicians, and faculty members (Silverman, et al., 2013). In Serbia and Romania, we had to adapt to the unforeseen requirements of the recent COVID pandemics by revising our teaching methods and by completely switching to online teaching platforms. Recognizing the research opportunity it offered, we seized the chance to compare synchronous and asynchronous on-line learning methods by conducting a joint study. In Ukraine, a collaboration between UCU in Lviv and LUC in Chicago leveraged an existing US online doctoral program, initially determined to be a good option because of the large size of the country. Luckily, our online model also meant that we were not delayed in enrolling students in spite of the pandemic and that students have been able to continue their studies even after the full-scale invasion of Ukraine by Russia.

Recommendations

Advances in medical science and technology generate new bioethical challenges globally. Meeting those challenges requires professionals who are prepared to comprehend and analyze issues and grapple with identifying solutions in clinical and research settings. Educating a generation of health professionals and scientists in bioethics is essential in Eastern European LMICs who confront various forms of structural injustice and research misconduct. Learning about bioethics from internationally recognized experts allows future leaders to obtain the knowledge and skills necessary to transform research culture, improving analytical and critical thinking, facilitating leadership and creativity, and promoting further bioethics development in their countries.

It is almost certain that globally-funded clinical research will continue to increase in Eastern European LMICs. Conducting research in these countries hastens the development of new therapies that ultimately benefit the U.S. population as well as the U.S.-based and other global pharmaceutical companies that sponsor most of the studies conducted in Eastern Europe. Continued funding from FIC is critical for supporting collaborative training activities with U.S. bioethicists and institutions helping to develop research ethics capacity. Local funding for these efforts is minimal, making the goals of developing leaders who will conduct original bioethics scholarship, transform the ethical culture at their institutions, and advise their governments on science policy hard to achieve without support from countries that can lend a helping hand. Because of the low incomes for health professionals in these countries, traditions of reliance on government funding for education, and the lack of government funding for Master’s level education, it is crucial to provide ongoing support to sustain the programs we have worked hard to create through FIC grants.

In preparing this manuscript we learned the value of regional collaboration to promote sharing of lessons learned and innovations. Additional supplemental funding from NIH could support and promote productive collaborations across programs.

Biographies

Emily E. Anderson is Professor of Bioethics, Neiswanger Institute for Bioethics and Healthcare Leadership, Loyola University Chicago. Her research and scholarship focuses on ethical issues in research with diverse populations, community-engaged research, informed consent, and IRB quality. Her role in this manuscript has been in developing the outline, drafting sections on the progress of the bioethics training program in Ukraine, collating and editing other authors’ contributions, and finalizing the submission.

Horatiu A. Colosi is Associate Professor, Department of Medical Education, Division of Medical Informatics and Biostatistics, Iuliu Hațieganu University of Medicine and Pharmacy (UMFIH), in Cluj-Napoca, Romania. His scholarly interests focus on a broad range of interdisciplinary medical research, from restoring cranio-facial health to investigating infectious agents, endocrine dysfunction and stress. Dr. Colosi coordinated the development, accreditation and inauguration of the Master’s program in Ethics and Research Methods in Medicine at UMFIH, Cluj-Napoca, and is currently its program director. His role in this manuscript has been in developing the outline, drafting sections concerning the bioethics training program at UMFIH, Romania, as well as background on healthcare and research in Romania, editing and finalizing the submission.

Ivanka Markovic is Full Professor at the Institute of Medical and Clinical Biochemistry, Faculty of Medicine, University of Belgrade (FMUB). Her research background is neuroscience, and higher education reforms enabled her to coordinate development and accreditation and of Master’s program in Bioethics at FMUB, which has enrolled the third generation of students. Her role in this manuscript has been in developing the outline, drafting sections on the progress of the bioethics training program as well as background on healthcare and research in Serbia, editing other authors’ contributions, and finalizing the submission.

Oksana Sulaieva is Medical Director, Medical Laboratory CSD, Kyiv, Ukraine, and Professor and Chair, Department of Pathology, Kyiv Medical University. She is a recent graduate of Loyola’s DBe program and has written on the ethics of biobanking and precision medicine. Her role in this manuscript has been in drafting sections on the background on healthcare and research in Ukraine.

Vladyslava Kachkovska is Associator Professor, Department of Internal Medicine, Medical Institute, Sumy State University. She is a recent graduate of Loyola’s DBe program and has written on the ethics of biobanking and precision medicine. Her role in this manuscript has been in drafting sections on the background on healthcare and research in Ukraine.

Vida Jeremic Stojkovic is Assistant Professor, Department of Humanities, Faculty of Medicine, University of Belgrade. Her research interests include adolescent health, pediatric ethics, vaccination behavior, research ethics. Her role in this manuscript has been in drafting sections on the progress of the bioethics training program as well as background on healthcare and research in Serbia.

Rosamond Rhodes is Professor, Medical Education, Icahn School of Medicine at Mount Sinai and served as PI on the three FIC grants that supported development of Master’s programs in research ethics in Serbia and Romania. Professor Rhodes writes on a broad array of issues in bioethics. She has published six books and over 250 articles and chapters. Her most recent book is The Trusted Doctor: Medical Ethics and Professionalism (Oxford University Press, April 2020). For this manuscript, she participated in developing the outline, editing and revising sections, and finalizing the submission.