Recently, there has been a growth of scholarship in research ethics accompanied by several revisions of international research ethics guidelines highlighting issues pertaining to international collaborative research performed in low and middle income countries (LMICs) (Council for International Organizations of Medical Sciences (CIOMS) and World Health Organization (WHO) 2016; World Medical Association 2013). Several reasons explain for focusing the lens of research ethics on international collaborative research. First and foremost, commentators have expressed concerns regarding inadequate protection of the rights and welfare of research participants leading to unnecessary harms, exploitation, and injustices at both the micro and macro levels (Bhutta 2002; London 2010; Pratt and Loff 2014). Second, oversight mechanisms that exist in LMICs have not been able to respond effectively to the ethical and legal issues that arise from the growth of such research, especially clinical trials (Kirigia et al. 2005; Moodley and Myer 2007). Indeed, many commentators have expressed concerns about the lack of regulatory oversight and the ineffectiveness of ethics review in LMICs (Bhutta 2002; Hyder et al. 2009; Nuffield Council on Bioethics 2002). Third, there is a growing recognition that the local context governed by culture and religion warrant differences in the application of general principles of research ethics, but there is controversy regarding whether such applications of ethics principles respect local diversity or whether they represent inappropriate double standards (Christakis 1992; Landes 2005; Macklin 2004; Tangwa 2004). Finally, studies have demonstrated the marked prevalence of research misbehaviors that include data falsification and fabrication, plagiarism, inappropriate authorship practices, and lack of transparency regarding conflicts of interest (Okonta and Rossouw 2013, 2014).
- Abou-Zeid, A., M. Afzal, and H.J. Silverman. 2006. Informed consent as an ethical requirement for health research in the Eastern Mediterranean region of the World Health Organization. Washington, DC: PRIM&R Conference.Google Scholar
- Abraham, R. 2011. MENA: The dawn of a new era: The Middle East and North Africa region has seen a recent increase in clinical trials research. Applied Clinical Trials. Google Scholar
- Adams, K, C. King, D. Pendlebury, D. Hook, and J. Wilson. 2011. Global research report Middle East. Thomson Reuters. Available at: http://sciencewatch.com/sites/sw/files/sw-article/media/globalresearchreport-aptme.pdf
- Asem, N., and H.J. Silverman. 2009. Perspectives of faculty at Cairo Universitiy towards research ethics and informed consent. Nashville: Abstract Presentation at PRIM&R.Google Scholar
- Bhutta, A.Z. 2002. Ethics in international health research: A perspective from the developing world. Bulletin of the World Health Organization 80: 114–120.Google Scholar
- Council for International Organizations of Medical Sciences (CIOMS), and World Health Organization (WHO). 2016. International ethical guidelines for health-related research involving humans. Vol. Retrieved from: http://www.cioms.ch/index.php/12-newsflash/400-cioms-inernational-ethical-guidelines
- El-Dessouky, H.F., A.M. Abdel-Aziz, C. Ibrahim, M. Moni, R. Abul Fadl, and H. Silverman. 2011. Knowledge, awareness, and attitudes about research ethics among dental faculty in the Middle East: A pilot study. International Journal of Dentistry 2011: 694759. https://doi.org/10.1155/2011/694759.CrossRefGoogle Scholar
- Glickman, S.W., J.G. McHutchison, E.D. Peterson, C.B. Cairns, R.A. Harrington, R.M. Califf, and K.A. Schulman. 2009. Ethical and scientific implications of the globalization of clinical research. The New England Journal of Medicine 360 (8): 816–823. https://doi.org/10.1056/NEJMsb0803929.CrossRefGoogle Scholar
- Global Forum for Health Research. 2000. The 10/90 report on health research. Last Accessed 23 Apr 2013 at: http://announcementsfiles.cohred.org/gfhr_pub/assoc/s14791e/s14791e.pdf
- Gulf Daily News. 2016. Clinical trials to be rolled out in Bahrain. Retrieved from: http://www.tradearabia.com/news/HEAL_300785.html
- Kandeel, N., A. El-Nemer, N.M. Ali, H. Kassem, M. El-Setouhy, M.E. Elgharieb, et al. 2011. A multicenter study of the awareness and attitudes of Egyptian faculty towards research ethics: A pilot study. Journal of Empirical Research on Human Research Ethics 6 (4): 99–108. doi:https://doi.org/10.1525/jer.2011.6.4.99.CrossRefGoogle Scholar
- Marwan Felaefel, M., M. Salem, R. Jaafar, G. Jassim, H. Edwards, F. Rashid-Doubell, R. Yousri, N. Ali, and H. Silverman. 2017a. A cross-sectional survey study to assess prevalence and attitudes regarding research misconduct among investigators in the Middle East. Journal of Academic Ethics: 1–17. https://doi.org/10.1007/s10805-017-9295-9.
- Misik, V. 2012. Expected growth of industry-sponsored clinical trials in the Middle East bencharked on other global regions. Accessed 12 Jan 2014 at: http://www.quintiles.com/assets/2010/2111/2118/2233/1336/96587bf96585-cb96581e-94982-96588f96589b-bf96632aba99661.pdf
- Nuffield Council on Bioethics. 2002. The ethics of research related to healthcare in developing countries. London: Nuffield Council on Bioethics.Google Scholar
- Nwabueze, R.N. 2016. Legal and ethical regulation of biomedical research in developing countries. New York: Routledge (Taylor & Francis Group).Google Scholar
- Schipper I, and F. Weyzig. 2008. Ethics for drug testing in low and middle INcome countries: Considerations for European market authorisation. Centre for Research on Multinational Corporations (SOMO), Retrieved at: https://www.somo.nl/ethics-for-drugs-testing-in-low-and-middle-income-countries/
- Sleem, H., R. Adelhai, I. Al-Abdallat, M. Al-Naif, H. Gabr, E.T. Kehil, et al. 2010a. Development of an accessible self-assessment tool for research ethics committees in developing countries. Journal of Empirical Research on Human Research Ethics 6: 85–96.Google Scholar
- United Nations Educational, Scientific, and Cultural Organizations. n.d. UNESCO science report 2010. The current status of science around the world. Available at: http://unesdoc.unesco.org/images/0018/001898/189883E.pdf
- World Medical Association. 2013. Declaration of Helsinki. Available at: http://www.wma.net/en/30publications/10policies/b3/.