This work aimed at mapping research ethics governance at EMR countries.
Methods
The study used two tools shared with Eastern Mediterranean Region (EMR) countries. The first enquired about legal provisions and regulatory frameworks, as well as Research Ethics Committee (REC) composition, resources, procedures. The second covered ethical oversight of clinical trials (CTs), including coordination of ethical reviews.
Results
Most respondents (85%) indicated that they have national provisions requiring human subjects’ research to be REC-reviewed. Around half (46%) reported having legal provisions requiring CTs to be registered on a registry; having a national or institution-specific CT registry (43%); and protecting participants from any financial consequences if they suffer injury as result of their participation (54%).
Recommendations
EMR countries are encouraged to develop / foster / accredit national and institution-based RECs, as well as national CT registries. Members of REC committees should have knowledge and skills to ethically review research, in compliance with international standards.
Abdel-AalW.Abdel GhaffarE.El ShabrawyO. (2013). Review of the Medical Research Ethics Committee (MREC), National Research Center of Egypt, 2003–2011. Current Medical Research and Opinion, 29(10), 1411–1417. https://doi.org/10.1185/03007995.2013.815158
2.
AdebamowoC. A.CallierS.AkintolaS.MadukaO.JegedeA.ArimaC.OgundiranT.AdebamowoS. N.; Bridg ELSI. Project as part of the DS-I Africa Consortium. (2023). The promise of data science for health research in Africa. Nature Communications, 14(1), 6084. https://doi.org/10.1038/s41467-023-41809-2
3.
AguileraB.CarracedoS.SaenzC. (2022). Research ethics systems in Latin America and the Caribbean: A systemic assessment using indicators. Lancet Global Health, 10(8), e1204–e1208. https://doi.org/10.1016/S2214-109X(22)00128-0
4.
Al-BareeqJ. M. (1989). Medical Ethics 1, guidelines for research. Bahrain Medical Bulletin, 11(1), 28–29.
5.
AltafA.JafareyA.MandilA.RashidianA. (2024). Promoting health research governance in the Eastern Mediterranean Region. East Mediterranean Health Journal, 30(6), 397–398. https://doi.org/10.26719/2024.30.6.397
6.
ArawiT.DaherM.KallabK.SabraR. (2011). Foreword. Towards implementing medical ethics and bioethics education in Lebanon. Lebanese Medical Journal, 59(1), 2–3. https://pubmed.ncbi.nlm.nih.gov/21675015/
7.
AsifF.SultanF.MasoodI.BaigS.EkmeckiP. E.VaswaniV.BhuttaZ.CrawleyF. (2023). A scoping review of the literature of research ethics committees and ethics review framework in Pakistan: What we know and what we still need to learn. JPMA. The Journal of the Pakistan Medical Association, 73(8), 1667–1692. https://doi.org/10.47391/JPMA.8033
8.
BalkhyH. (2024). Adhering to ethics guidelines in biomedical research and medical practice is crucial to save lives. Eastern Mediterranean Health Journal, 30(6), 395–396. https://doi.org/10.26719/2024.30.6.395
9.
Ben AmmarM.MandilA.El-FekyS. (2016). Ethics in health practice and research: An EMR perspective. Eastern Mediterranean Health Journal, 22(1), 62–63. https://doi.org/10.26719/2016.22.1.62
10.
Canario GuzmánJ. A.OrlichJ.Mendizábal-CabreraR., et al. (2022). Strengthening research ethics governance and regulatory oversight in Central America and the Dominican Republic in response to the COVID-19 pandemic: A qualitative study. Health Research Policy and Systems, 20, 138. https://doi.org/10.1186/s12961-022-00933-z
11.
ChoO. H.HwangK. H. (2021). Integrating standardized patients into bioethics education for freshman nursing students. Nursing Practice Today, 8(1), 40–50. https://doi.org/10.18502/npt.v8i1.4495
12.
ElsayedD. (2006). National framework for ethics in health research involving human subjects. Sudanese Journal of Public Health, 1(3), 192–196. https://doi.org/10.13140/RG.2.2.14337.68969
HabibH. A. (2019). PART 3| Medical ethics in clinical practice. Iraqi New Medical Journal, 5(9), 66–68.
15.
HattabA.SariegoJ. (2003). Ethics of research in medicine and public health: Contemporary challenges. Yemeni Journal of Medical and Health Research, 2(2), 137–140. https://pmc.ncbi.nlm.nih.gov/articles/PMC9730179/
16.
HeitmanE.LitewkaS.VasconcelosS. (2016). Education in research integrity and governance of science in the United States, Argentina, and Brazil. In BretagT. (Ed.), Handbook of academic integrity. Springer. https://doi.org/10.1007/978-981-287-098-8_66
17.
HyderA. A.DawsonL.BachaniA. M.LaveryJ. V. (2009). Moving from research ethics review to research ethics systems in low-income and middle-income countries. Lancet, 373(9666), 862. https://doi.org/10.1016/S0140-6736(09)60488-8
18.
IsmailA. (2015). Stem cell research and ethics: An update. Oman Medical Journal, 30(1), 1–2. https://doi.org/10.5001/omj.2015.01
19.
JafareyA.Siddiq ShekhaniS.RazaF.NazS. (2023). Situation analysis of research ethics governance in Pakistan. Eastern Mediterranean Health Journal, 29(7), 507–507. https://doi.org/10.26719/emhj.23.069
20.
JawaidS.JafaryM.KhanF.HashmiS.ShaukatI.JawaidA. (2010). National bioethics committee guidelines for healthcare professionals interaction with Pharma trade and industry. Pakistan Journal of Medical Sciences, 26(3), 503–509. https://www.pjms.com.pk/issues/julsep2010/pdf/specialCommunication.pdf
21.
KhayatM. (2006). Research ethics: Challenges in the Eastern Mediterranean Region. Eastern Mediterranean Health Journal, 12(Supplement 1), 13–20. https://pubmed.ncbi.nlm.nih.gov/17037684/
MandilA.DingwallP. (2017). Promoting bioethics in the Eastern Mediterranean Region. Eastern Mediterranean Health Journal, 23(4), 265–266. https://doi.org/10.26719/2017.23.4.265
24.
MandilA.El-JardaliF.El-FekyS.NourM.Al-AbbarM.Bou-KarroumL. (2018). Health research institutional mapping: An Eastern Mediterranean regional perspective. East Mediterranean Health Journal, 24(2), 189–197. https://doi.org/10.26719/2018.24.2.189
25.
MarzoukD.Abd El AalW.SalehA.SleemH.KhyattiM.MaziniL.HemminkiK.AnwarW. (2014). Overview on health research ethics in Egypt and North Africa. European Journal of Public Health, 24(Supplement 1), 87–91. https://doi.org/10.1093/eurpub/cku110
26.
MasriA.AlfryjatA.AlfryjatD.Abu saleemR.ElhajS. (2022). Medical students’ knowledge about research ethics. Jordan Medical Journal, 56(1). https://doi.org/10.35516/jmj.v56i1.228
27.
Nabyonga-OremJ.AsamaniJ. A.MakangaM. (2021). The state of health research governance in Africa: What do we know and how can we improve?Health Research Policy and Systems, 19, 11. https://doi.org/10.1186/s12961-020-00676-9
28.
NeilM.SaenzC. (2020). Advancing research ethics systems in Latin America and the Caribbean: A path for other LMICs?Lancet Global Health, 8(1), e23–e24. https://doi.org/10.1016/S2214-109X(19)30441-3
29.
NorooziM.LarijaniB.NedjatS.ArameshK.SalariP. (2020). Priority setting for research in the field of medical ethics in the Islamic Republic of Iran: A Delphi study. Eastern Mediterranean Health Journal, 26(5), 531–538. https://doi.org/10.26719/emhj.19.085
30.
Onyemelukwe-OnuobiaC. (2018). Health research governance in Africa: Law, ethics, and regulation (1st ed.). Routledge. https://doi.org/10.4324/9781315178332
31.
QidwaiW.WaheedS.FahimA. (2010, August). Status of clinical trials and research ethics in Pakistan. Isra Medical Journal, 2(2), 35–36. https://doi.org/10.26719/emhj.23.069
32.
QidwaiW.WaheedS.FahimA. (2010, January). Research ethics in developing countries: Issues, opportunities and challenges. Journal of the Dow University of Health Sciences, 4(2), 47–48. https://ecommons.aku.edu/pakistan_fhs_mc_fam_med/110/
Salamanca-BuentelloF.KatzR.SilvaD. S.UpshurR. E. G.SmithM. J. (2024). Research ethics review during the COVID-19 pandemic: An international study. PLoS One, 19(4), e0292512. https://doi.org/10.1371/journal.pone.0292512
35.
SchoemanM. I. (2019). Research ethics governance – An African perspective. In NortjéN.VisagieR.WesselsJ. (Eds.), Social science research ethics in Africa (Vol. 7, pp. 1–15). Springer. https://doi.org/10.1007/978-3-030-15402-8_1
36.
SerourG. (2016). Work of the research ethics review committee in the eastern Mediterranean Region. Eastern Mediterranean Health Journal, 22(1), 64–66. https://doi.org/10.26719/2016.22.1.64
37.
Shamsi-GooshkiE. (2024). Bioethics in the Eastern Mediterranean Region: Bridging national, regional and global bioethics imperatives. Eastern Mediterranean Health Journal, 30(6), 399–401. https://doi.org/10.26719/2024.30.6.399
TalebiA.AbadiB.Yeh LeeY. (2019). Research and publishing ethics among Iranian researchers: The realities. Archives of Iranian Medicine, 22(4), 211–212. https://pmc.ncbi.nlm.nih.gov/articles/PMC4192767/
WagerE.KleinertS. (2012). Cooperation between research institutions and journals on research integrity cases: Guidance from the committee on publication ethics. Saudi Journal of Anaesthesia, 6(2), 155. https://doi.org/10.4103/1658-354X.97030
42.
World Health Organization. (2020). Second Eastern Mediterranean/Arab States regional summit of national ethics and bioethics committees. Eastern Mediterranean Health Journal, 26(5), 620–621. https://doi.org/10.26719/2020.26.5.620
World Health Organization Regional Office for South-East Asia. (2023). Regional Consultation on Health Research Governance and Management in South-East Asia, Delhi, India. https://www.who.int/publications/i/item/sea-cd-336
