Research ethics during infectious disease outbreaks: A survey of African research stakeholders using the Ebola virus disease outbreak as a case
Accepted: 25 April 2022
All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.
Conducting research during disease outbreaks can be ethically challenging as evidenced in the 2014‑2016 Ebola outbreak in West Africa and COVID‑19 pandemic. Yet, there has been little empirical research conducted for understanding the views and perspectives of different stakeholders regarding ethical issues in conducting research during disease outbreaks. This preliminary study was conducted to empirically explore African public health research stakeholders' views about research ethics issues during infectious disease outbreaks in Africa. We conducted an online survey of 330 participants attending the International Conference on Re‑emerging and Emerging Infectious Disease (ICREID) meeting that took place from 13‑15 March 2019 in Addis Ababa, Ethiopia to elicit their views on various research ethics complexities experienced in the 2014 Ebola outbreak. Study results revealed some divergent views on several ethical themes including: ethics of using unregistered interventions in outbreaks; acceptable study design; ethics review processes; risks‑benefit assessment; exclusion of pregnant women and children; and biological sample and data sharing. Majority (76.3%) of respondents felt that in the absence of available standard treatments or prevention modalities, the use of investigational interventions can be ethically justifiable if there is a strong scientific rationale and favorable risk‑benefit ratio. Regarding conventional placebo‑controlled trials during outbreaks with high case fatality rates, respondents that considered this unethical were more than three times those that felt such design were ethically justifiable. We were somewhat surprised that a majority (almost 60%) of respondents were satisfied with the exclusion of pregnant women and children in clinical trials during outbreaks. All respondents concurred with the prioritization of informed consent for research during an outbreak. Based on our findings, research ethics guidance is needed to equip research stakeholders in dealing with ethical complexities arising in the conduct of research during emerging disease outbreaks‑especially regarding using experimental interventions; placebo trial design; inclusion or justified exclusion of pregnant women and children; and biological sample/data sharing. The findings will be used in ongoing efforts of developing a consultative and coherent African‑centric framework to support ethical conduct of research for future emerging infectious disease outbreaks in Africa.
Heymann DL, Chen L, Takemi K, Fidler DP, Tappero JW, Thomas MJ, Kenyon TA, Frieden TR, Yach D, Nishtar S, et al: Global health security: The wider lessons from the West African Ebola virus disease epidemic. Lancet 385: 1884‑1901, 2015.
Macklin R and Cowan E: Conducting research in disease outbreaks. PLoS Negl Trop Dis 3: e335, 2009.
National Academies of Sciences, Engineering and Medicine Committee. Integrating clinical research into epidemic response: The Ebola experience. The National Academies Press, Washington, DC 2017. https://www.nap.edu/catalog/24739/integrating‑clinical‑research‑into‑epidemic‑response‑the‑ebola‑experience.
Calain P: The Ebola clinical trials: A precedent for research ethics in disasters. J Med Ethics 44: 3‑8, 2016.
O'Mathúna D: Research ethics in the context of humanitarian emergencies. J Evid Based Med 8: 31‑35, 2015.
World Health Organization. Research ethics in international epidemic response: WHO technical consultation 10‑11 June 2009 Meeting Report. Geneva, WHO Press, 2020.
Saxena A, Horby P, Amuasi J, Aagaard N, Köhler J, Gooshki ES, Denis E and Reis AA; ALERRT‑WHO Workshop and Ravinetto R: Ethics preparedness: Facilitating ethics review during outbreaks‑recommendations from an expert panel. BMC Med Ethics 20: 29, 2019.
Alirol E, Kuesel AC, Guraiib MM, de la Fuente‑Núñez V, Saxena A and Gomes MF: Ethics review of studies during public health emergencies‑the experience of the WHO ethics review committee during the Ebola virus disease epidemic. BMC Med Ethics 18: 45, 2017.
Bain LE, Ngwain CG, Nwobegahay J, Sumboh JG, Nditanchou R and Awah PK: Research ethics committees (RECs) and epidemic response in low and middle income countries. Pan Afr Med J 31:209, 2018.
Aarons D: Research in epidemic and emergency situations: A model for collaboration and expediting ethics review in two Caribbean countries. Dev World Bioeth 18: 375‑384, 2018.
Schopper D, Ravinetto R, Schwartz L, Kamaara E, Sheel S, Segelid MJ, Ahmad A, Dawson A, Singh J, Jesani A and Upshur R: Research ethics governance in times of Ebola. Public Health Ethics 10: 49‑61, 2017.
Hunt M, Tansey CM, Anderson J, Boulanger RF, Eckenwiler L, Pringle J and Schwartz L: The challenge of timely, responsive and rigorous ethics review of disaster research: Views of research ethics committee members. PLoS One 11: e0157142, 2016.
Tansey MC, Herridge SM, Heslegrave JR and Lavery VJ: A framework for research ethics review during public emergencies. CMAJ 182: 1533‑1537, 2010.
World Health Ogranization: Guidance for managing ethical issues in infectious disease outbreaks, 2016. https://apps.who.int/iris/handle/10665/250580.
Nuffield Council on Bioethics: Research in global health emergencies: Ethical issues, 2020 https://www.nuffieldbioethics.org/publications/research‑in‑global‑health‑emergencies.
Sison CP and Glaz J: Simultaneous confidence intervals and sample size determination for multinomial proportions. J Am Stat Assoc 90: 366‑369, 1995.
Edwards SJL: Experimental treatments for Ebola. Research Ethics 10: 126‑128, 2014.
Edwards SJL: Drug discovery at the bedside: Ethics of clinical science during a pandemic. Am J Bioeth 13: 3‑14, 2013.
Rid A and Emanuel E: Ethical considerations of experimental interventions in the Ebola outbreak. Lancet 384: 1896‑1899, 2014.
WHO: Notes for the record: Consultation on monitored emergency use of unregistered and investigational interventions for Ebola virus disease (EVD). Geneva, 2018. https://www.who.int/emergencies/ebola/MEURI‑Ebola.pdf?ua=1.
Richardson T, Johnston AM and Draper HA: Systematic review of Ebola treatment trials to assess the extent to which they adhere to ethical guidelines. PLoS One 12: e0168975, 2017.
World Health Organization: Ethical issues related to study design for trials on therapeutics for Ebola Virus Disease. WHO Ethics working group meeting 20‑21 October, 2014 Summary of discussion. https://apps.who.int/iris/handle/10665/137509.
Adebamowo C, Bah‑Sow O, Binka F, Bruzzone R, Caplan A, Delfraissy JF, Heymann D, Horby P, Kaleebu P, Tamfum JJ, et al: Randomised controlled trials for Ebola: Practical and ethical issues. Lancet 384: 1423‑1424, 2014.
London JA: Social value, clinical equipoise, and research in a public health emergency. Bioethics 33: 326‑334, 2018.
Schwartz DA: Being pregnant during the Kivu Ebola virus outbreak in DR Congo: The rVSV‑ZEBOV vaccine and its accessibility by mothers and infants during humanitarian crises and in conflict areas. Vaccines 8: 38, 2020.
Gomes MF, Fuente‑Núñez V, Saxena A and Kuese AC: Protected to death: Systematic exclusion of pregnant women from Ebola virus disease trials. Reprod Health 14: 172, 2017.
Council for International Organizations of Medical Sciences (CIOMS). International ethical guidelines for health‑related research involving humans. Geneva, Switzerland, CIOMS, 2016.
Krubiner CB, Faden RR, Karron RA, Little MO, Lyerly AD, Abramson JS, Beigi RH, Cravioto AR, Durbin AP, Gellin BG, et al: Pregnant women & vaccines against emerging epidemic threats: Ethics guidance for preparedness, research, and response. Vaccine 39: 85‑120, 2019.
Heymann DL: Data sharing and outbreaks: Best practice exemplified. Lancet 395: 469‑470, 2020.
Colonialists are coming for blood‑Literally https://www.wired.com/story/ebola‑epidemic‑blood‑samples/
Nordling L: African scientists call for more control of their continent's genomic data. Nature, 18 April, 2018. doi: 10.1038/d41586‑018‑04685‑1. https://www.nature.com/articles/d41586‑018‑04685‑1.
Copyright (c) 2023 the Authors
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.