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Invited commentary

Mohamed Salah Ben Ammar,¹ Ahmed Mandil ² and Samar El-Feky ³

¹Former Minister of Health, Tunisia, and Former Vice-President, International Bioethics Committee.

²Coordinator, Research, Development and Innovation, WHO Regional Office for the Eastern Mediterranean, Cairo, Egypt.

³Technical Officer, Research Policy and Development, WHO Regional Office for the Eastern Mediterranean, Cairo, Egypt.

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Background

Ethics has been an integral part of medicine at least as far back as the time of Hippocrates.

While the terms bioethics and medical ethics are often used interchangeably, traditionally medical ethics is mainly patient-oriented and focuses on health care services while bioethics is predominantly society-oriented and centres on maximizing total human well-being. Medical ethics and law are closely related and regulations generally exist in countries which govern how physicians should handle ethical issues in patient care and research (1). Conversely, bioethics usually concerns ethical questions related to health research and the application of biotechnology in medicine and biology (2).

Research ethics as a particular area of concern evolved from the growing conduct and formalization of research and the need to address ethical issues arising from such research on human subjects (3). The key ethical principles of health research include honesty, objectivity, integrity, carefulness, openness, respect for intellectual property, confidentiality, responsible publication, responsible mentoring, respect for colleagues, social responsibility, non-discrimination, competence, legality, animal care and human subjects’ protection (4).

In this regard, the World Medial Association has developed internationally recognized global policies on key ethical issues related to medical practice and research, including the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects and the International Code of Medical Ethics and Human Rights. Other documents guiding ethical standards have been developed by organizations including WHO, the Council for International Organizations of Medical Sciences (CIOMS), UNESCO, the Committee on Publication Ethics, the International Committee of Medical Journal Editors, and the World Association of Medical Editors. In fact, such ethical standards promote other important moral and social values such as social responsibility, human rights, patient welfare and safety, and compliance with the law (5,6).

Regionally, the Eastern Mediterranean Health Journal (EMHJ), the flagship journal of the WHO Regional Office for the Eastern Mediterranean, has recently formulated ethical guidelines for scientific research and publication, based on these international guidelines, to ensure that articles submitted for publication in the Journal conform to these standards (7).

Developing bioethics in the EMR

Ethics is an important aspect of the work of WHO and the Organization provides guidance and resources for Member States on a range of bioethics issues, supports training on public health and research ethics, and hosts the secretariat of WHO’s Research Ethics Review Committee.

In the WHO Eastern Mediterranean Region (EMR), in order to plan for the most doable and needed interventions to scale up bioethics in countries of the Region, the WHO Regional Office conducted a bioethics survey in 2015 to map the current situation in Member States and to identify areas of progress and improvement in bioethics for each country. The mapping survey aimed to analyse the situation in the Region in order to better assist Member States through prioritizing the needs and identifying the most appropriate approaches in view of the strengths and constraints identified.

The results of the survey revealed a scarcity of structured curricula or training programmes on bioethics in most health sciences’ colleges across the Region (the Islamic Republic of Iran being among the few examples where it exists). Only a few countries in the Region offer formal training facilities for bioethics education. Furthermore, the laws, policies and rules related to bioethics are not always well understood by health professionals and the community.

The results underscored the need to determine some key actions for further improvement of bioethics in the Region, including enhancing the role of civil society, as a key stakeholder, establishing laws according to local needs and context, and developing/fostering a core bioethics curriculum within the health sciences’ curricula of academic institutions in the Region.

The 2013 World Health Report, Research for universal health coverage (8), emphasized the role of WHO in advancing research that addresses the dominant health needs of Member States, supporting national health research systems, setting norms and standards for the proper conduct of research, and accelerating translation of research findings into health policy and practice. To ensure the scientific rigour and ethical conduct of health research recommended for WHO funding, an essential requirement of the research is its compliance with recognized ethical standards. Therefore, the Eastern Mediterranean Ethics Review Committee was established in 2007. It was reformulated in 2014 to include external (from Egypt, Islamic Republic of Iran, Lebanon, Morocco, Tunisia, UNESCO) and in-house (WHO) members and was renamed the “Eastern Mediterranean Research Ethics Review Committee”. Its primary function is to “review the protocols of all health research projects involving human subjects submitted to WHO for funding in the Region” in order to safeguard the dignity, integrity, human rights, safety and well-being of all the human participants. The Review Committee can also has verify that ongoing studies comply with WHO policies and regulations for the conduct of health research in the Region.

In view of the recent reformulation of the Committee, the Regional Office convened a meeting of the Committee in September 2015. The objectives were to: review the work of the Committee since October 2014 when its functions were updated; ensure compatibility of the work with international guidelines for review of health research on human subjects; update the current review process for health research supported by WHO; and address new health research challenges in the Region, including health policy and systems research (9). To enhance ethics in medical practice and health research in EMR, attention was given to ensuring compatibility of the Committee’s work with international guidelines for health research (including CIOMS, WHO and UNESCO guides). Additionally, the ethical review process was updated through critical review of current checklists for evaluating submitted research proposals and sections on “conflict of interest” and “informed consent process for vulnerable groups”, (including minors, pregnant women, emergencies, and mentally challenged persons) were added.

Moreover, the Committee recommended: developing national laws and regulations which govern bioethics and related research; developing/accrediting national bioethics committees which could oversee the work of institutional committees; establishing ethical review committees according to need (e.g. for research on human subjects, on animals); establishing national registries for clinical trials and research; regulating pharmaceutical companies’ contributions to clinical studies; and ensuring a rigorous ethical review process on different levels (institutional, national, regional).

For its part, the Regional Office aims to use the expertise of global WHO collaborating centres for bioethics-related matters, establish a regional WHO collaborating centre network on bioethics, and support capacity-building activities in bioethics and ethical conduct of health research. Furthermore, WHO is encouraging research on public health priorities in the Region, especially on crises and emergencies, in order to generate much-needed, ethically sound, health-related data and evidence to support health policy-making.

The effort to develop bioethics has been undertaken to serve all, within and beyond the Region, in particular to ensure that the voice of the voiceless is heard and taken into account globally.

References

1. Medical ethics manual, 3rd edition. World Medical Association; 2015 [Online]. (http://www.wma.net/en/30publications/30ethicsmanual/pdf/ethics_manual_en.pdf, accessed 12 February 2016)
2. Teaching bioethics. Report from a seminar organized by the Nordic Committee on Bioethics. Copenhagen: Nordic Council of Ministers; 2002 (http://ncbio.org/nordisk/arkiv/2002-2.pdf, accessed 12 February 2016).
3. European Commission. European textbook on ethics in research. Luxembourg: Publications Office of the European Union; 2010 (https://ec.europa.eu/research/science-society/document_library/pdf_06/textbook-on-ethics-report_en.pdf, accessed 12 February 2016).
4. Resnik D. What is ethics in research & why is it Important? [Online]. National Institute of Environmental Health Sciences; 2013 (http://courses.washington.edu/bethics/Homepage/What%20is%20Ethics%20in%20Research%20%26%20Why%20is%20it%20Important_.pdf, accessed 12 February 2016).
5. Elsayed D, Ahmed R. Medical ethics: What is it? Why is it important? Sudanese Journal of Public Health. 2009; 4(2) (http://www.sjph.net.sd/files/vol4i2/SJPH-vol4i2-p284-287.pdf, accessed 12 February 2016)
6. The ethics of research related to healthcare in developing countries. London: Nuffield Council on Bioethics; 2014 (http://nuffieldbioethics.org/wp-content/uploads/2014/07/Ethics-of-research-related-to-healthcare-in-developing-countries-I.pdf, accessed 12 February 2016).
7. EMHJ Guideline on Ethical Conduct and Publication of Health Research; 2016 [Online] (http://www.emro.who.int/emh-journal/authors/emhj-guidelines-on-ethical-conduct-and-publication-of-health-research.html, accessed 12 February 2016).
8. World health report: research for universal health coverage. Geneva: World Health Organization; 2013 (http://apps.who.int/iris/bitstream/10665/85761/2/9789240690837_eng.pdf, accessed 12 February 2016).
9. Research ethics in the Eastern Mediterranean Region. Eastern Mediterranean Health Journal. 2015; 21(9):702-3 (http://applications.emro.who.int/emhj/v21/09/EMHJ_2015_21_9_702_703.pdf?ua=1, accessed 12 February 2016).