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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.

Keywords

Bioethics developing countries ethics education international research research ethics

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References

All European Academies (ALLEA). (2017). The European code of conduct for research integrity. https://www.allea.org/wp-content/uploads/2017/05/ALLEA-European-Code-of-Conduct-for-Research-Integrity-2017.pdf

Antoniuk

O. I.

Pavliuchenko

Y. M.

Vyshnyvetskyy

I. I.

(2020). Contractual registration of organizational and legal relations between subjects involved in the conduct of clinical trials of medicinal products. Wiadomości Lekarskie Medical Advances, 73(12 cz 2), 2840–2847.

Bartoszkiewicz

Kufel-Grabowska

Litwiniuk

(2022). Number of clinical trials of new therapeutic agents in the European union countries of central and Eastern Europe, 2000–2019. Polish Annals of Medicine, 29(1), 26–30. https://doi.org/10.29089/2020.20.00146

Basarab

Anderson

E. E.

(2022). Research during wartime—ethical challenges faced by oncology researchers in Ukraine. JAMA Oncolology, 8(9), 1254–1255. https://doi.org/10.1001/jamaoncol.2022.2549

Bondarenko

Agarwa

l. A.

Van Hemelrijck

Lawler

Zubaryev

Sullivan

(2023). Far-reaching impact of the Russian invasion of Ukraine on global cancer research. European Journal of Cancer, 183(April), 95–97. https://doi.org/10.1016/j.ejca.2023.01.020

Borysov

V. I.

Antoniuk

O. I.

Vyshnyvetskyy

I. I.

(2019). Special features of the legal status of the research subject in clinical testing of medicines. Wiadomości Lekarskie Medical Advances, 72(12 cz 2), 2464–2472.

Castaneda

(2022). As Russia’s clinical trials sector falls, Ukraine rebuilds. Clinical Trials Arena. August 23. https://www.clinicaltrialsarena.com/ukraine-crisis/russia-clinical-trials-fall-ukraine-rebuilds/?cf-viewandcf-closed

Claudot

Alla

Ducrocq

Coudane

(2007). Teaching ethics in Europe. Journal of Medical Ethics, 33(8), 491–495. https://doi.org/10.1136/jme.2006.017921

Decree of the Cabinet of Ministers of Ukraine of 4^th July 2018, No. 528 ‘About the National Research Foundation of Ukraine’ with amendments from August 4, 2023. https://zakon.rada.gov.ua/laws/show/808-2023-%D0%BF#n2

10.

Dotsenko

(2024). A liberating breath. Narrative Inquiry in Bioethics, 13(3), E1–E4. https://doi.org/10.1353/nib.2023.a924194

11.

European Network of Research Ethics Committees (EUREC). (2023). Information - Romania. http://www.eurecnet.org/information/romania.html

12.

European Observatory on Health Systems and Policies. (2019). Serbia: Health systems review (HiT series). https://eurohealthobservatory.who.int/publications/i/serbia-health-system-review-2019

13.

European Observatory on Health Systems and Policies. (2023). Romania: Country health profile. https://eurohealthobservatory.who.int/countries/romania

14.

Hyder

A. A.

Dawson

Bachani

A. M.

Lavery

J. V.

(2009). Moving from research ethics review to research ethics systems in low-income and middle-income countries. The Lancet, 373(9666), 862–865. https://doi.org/10.1016/S0140-6736(09)60488-8

15.

Jeremic Stojkovic

Cvjetkovic

Stamenkovic

Jankovic

Piperac

Ignjatovic Ristic

Markovic

Rhodes

(2024). Research ethics education needs assessment in serbian medical researchers. Ethics and Behavior, 26(Online July 26), 1–3. https://doi.org/10.1080/10508422.2024.2382402

16.

Jurić

(2021). Medical brain drain from Southeastern Europe: Using digital demography to forecast health worker emigration. JMIRX Med, 2(4), e30831. https://doi.org/10.2196/30831

17.

Kachkovska

Dudchenko

Kovchun

Prystupa

(2024). Why we stay. Narrative Inquiry in Bioethics, 13(3), 158–160. https://doi.org/10.1353/nib.2023.a924179

18.

Kornatsky

Talaieve

Silantieva

(2011). Framework for activity of ethics committees in Ukraine European Network of Research Ethics Committees. National Information: Ukraine. http://www.eurecnet.org/information/ukraine.html

19.

Kubar

(2010). The current state of bioethics education in the system of medical education in the CIS member countries. Pasteur Institution. https://unesdoc.unesco.org/ark:/48223/pf0000187351

20.

Kundiyev

Y. I.

Chashchyn

M. O.

(2015). The development of bioethics in Ukraine. Asian Bioethics Review, 7(5), 491–500. https://doi.org/10.1353/asb.2015.0043

21.

Law on health care. (2023). Official Gazette of RS 25/2019 and 92/2023. https://www.paragraf.rs/propisi_download/zakon_o_zdravstvenoj_zastiti.pdf [In Serbian]

22.

Mijaljica

(2014). Medical ethics, bioethics and research ethics education perspectives in south east Europe in graduate medical education. Science and Engineering Ethics, 20(1), 237–247. https://doi.org/10.1007/s11948-013-9432-9

23.

Ministry of Health of Ukraine. Typical position on ethics commissions at medical and preventive institutions that conduct clinical trials. https://zakon.rada.gov.ua/laws/show/z1236-12#Text [In Ukrainian]

24.

National Council for Scientific and Technological Development. (2023). Report on state of affairs in science in 2022 with proposals and suggestion for following year. https://nitra.gov.rs/images/nauka/dokumenta/Izvestaj%20o%20stanju%20u%20nauci%20za%202022g.pdf

25.

Nuwer

(2023). Ukraine Seeks to resume its role in cancer clinical trials. Nature, 621(7977), S2–S5. https://doi.org/10.1038/d41586-023-02606-5

26.

OXIMIO. (2021). Serbia: Logistics redesign for clinical trials. https://oximio.com/wp-content/uploads/2021/10/Oximio-Serbia-Report_FINAL.pdf

27.

Paryzhak

Vari

S. G.

(2024). Scientific integrity in biomedical research is a global problem. The Ukrainian Biochemical Journal, 96(2), 12–18. https://doi.org/10.15407/ubj96.02.012

28.

Pustovit

Paliei

(2014). Ukraine. In ten Have

Gordijn

(Eds.), Handbook of global bioethics (pp. 1597–1623). Springer Netherlands.

29.

Rankovic

Mijatovic

(2016). Research of clinical studies in Serbia. http://srbijaupokretu.org/Our program/wp-content/uploads/2016/07/Izveštaj-Klinička-ispitivanj-uSrbji.pdf

30.

Romanian Law on Proper Scientific Conduct, No. 206/2004

31.

Rubin

(2022). Clinical trials disrupted during war in Ukraine. Journal of the American Medical Association, 327(16), 1535–1536. https://doi.org/10.1001/jama.2022.5571

32.

Silverman

Strosberg

Luna

Philpott

Hemmerle

C. A.

(2013). An analysis of online courses in research ethics in the fogarty-sponsored bioethics training programs. Journal of Empirical Research on Human Research Ethics, 8(5), 59–74. https://doi.org/10.1525/jer.2013.8.5.59

33.

Spiegel

P.B.

Kovtoniuk

Lewtak

(2023). The war in Ukraine 1 year on: The need to strategise for the long-term health of Ukrainians. The Lancet, 401(10377), 623–625. https://doi.org/10.1016/S0140-6736(23)00383-5

34.

Strosberg

M. A.

Gefenas

Loue

Philpott

(2013). Building research ethics capacity in post-communist countries: Experience of two fogarty training programs. Journal of Empirical Research on Human Research Ethics, 8(5), 28–39.

35.

Sulaieva

O.N.

Artamonova

Dudin

Semikov

Urakov

Zakharash

Kacharian

Strilka

Mykhalchuk

Haidamak

Serdyukova

Kobyliak

(2023). Ethical navigation of biobanking establishment in Ukraine: learning from the experience of developing countries. Journal of Medical Ethics Published Online First: 09 November. https://doi.org/10.1136/jme-2023-109129

36.

Sulaieva

Dudin

Koshyk

Panko

Kobyliak

(2024a). Digital pathology implementation in cancer diagnostics: Towards informed decision-making. Frontiers in Digital Health, 6 (Published online May 30), 1358305. https://doi.org/10.3389/fdgth.2024.1358305

37.

Sulaieva

Shcherbakova

Dudin

(2024b). Adjusting laboratory practices to the challenges of wartime. Narrative Inquiry in Bioethics, 13(3), 155–158. https://doi.org/10.1353/nib.2023.a924178

38.

Talbot

Connor

S. G.

Austin

Hannon

Gabbay

Clay

T. D.

(2022). The impact of the 2022 Ukraine/Russian conflict on cancer clinical trials. Journal of International Medical Research, 50(12), 3000605221143284. https://doi.org/10.1177/03000605221143284

39.

Veerus

Lexchin

Hemminki

(2014). Legislative regulation and ethical governance of medical research in different European union countries. Journal of Medical Ethics, 40(6), 409–413. https://doi.org/10.1136/medethics-2012-101282

40.

WCG. CenterWatch. Clinical Trials Listing Service - Romania (2023). https://www.centerwatch.com/clinical-trials/listings/location/international/Romania/

41.

World Health Organization. (2020). Towards a healthier Ukraine. Progress on the health-related Sustainable Development Goals 2020. https://www.who.int/europe/publications/i/item/WHO-EURO-2020-1523-41273-56170

Fogarty-Funded Research Ethics Training Programs in Eastern Europe

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