This site brings together a range of scholary work and resources which can be drawn on in learning and teaching about research ethics in epidemics and pandemics. All of these resources are freely available with Open Access licensing.
Online research ethics training courses
The two courses below are hosted by the The Global Health Network. A certificate is issued once a minimum of 80% is achieved in the final quiz for each module
Ethics in epidemics, emergencies and disasters: Research, surveillance and patient care This seven module e-Learning course has been adapted entirely from a WHO training manual. Language: English
Research in global health emergencies: Ethical issues. This specialist short course is based on Nuffield Council on Bioethics’ report Research in global health emergencies: Ethical issues. Languages:
English - Research in global health emergencies: Ethical issues
Español - Investigación en emergencias sanitarias globales: cuestiones éticas
Français - Étude sur les urgences sanitaires mondiales : problèmes d'éthique
Português - Pesquisa em emergências de saúde global: questões éticas
International guidance and reports
Nuffield Council on Bioethics (2020) Research in Global Health Emergencies. London: Nuffield Council on Bioethics https://www.nuffieldbioethics.org/publications/research-in-global-health-emergencies
Pan American Health Organization (2022) Catalyzing ethical research in emergencies. Ethics guidance, lessons learned from the COVID-19 pandemic, and pending agenda. Washington D.C.: Pan American Health Organization. https://iris.paho.org/handle/10665.2/56139
Pan American Health Organization and World Health Organization (2020) Guidance and Strategies to Streamline Ethics Review and Oversight of COVID-19 Related Research. Washington D.C.: Pan American Health Organization https://www.paho.org/en/documents/guidance-and-strategies-streamline-ethics-review-and-oversight-covid-19-related-research
Pan American Health Organization (2020) Guidance for ethics oversight of Covid-19 research in response to emerging evidence. Washington D.C.: Pan American Health Organization https://iris.paho.org/handle/10665.2/53021
Pan American Health Organization (2020) Template and operational guidance for the ethics review and oversight of COVID-19-related research. Washington D.C.: Pan American Health Organization. https://iris.paho.org/handle/10665.2/52086
Pan American Health Organization (2020) Emergency use of unproven interventions outside of research ethics guidance for the COVID-19 pandemic. Washington D.C.: Pan American Health Organization. https://iris.paho.org/handle/10665.2/52429.
World Health Organization (2023) Ethics and adaptive platform trial design in public health emergencies: meeting report,18-19 July 2022. Geneva: World Health Organization. https://www.who.int/publications/i/item/9789240079670
World Health Organization (2022) Emergency use of unproven clinical interventions outside clinical trials: ethical considerations. Geneva: World Health Organization. https://www.who.int/publications-detail-redirect/9789240041745
World Health Organization (2021) COVID-19 vaccine trial designs in the context of authorized COVID-19 vaccines and expanding global access: ethical considerations. Geneva: World Health Organization. https://www.who.int/publications/i/item/WHO-2019-nCoV-Policy-brief-Vaccine-trial-design-2021.1
World Health Organization (2020) Ethical Standards for Research During Public Health Emergencies: Distilling Existing Guidance to Support COVID-19 R&D. Geneva: World Health Organization https://apps.who.int/iris/handle/10665/331507
World Health Organization (2020) Emergency Use Designation of COVID-19 candidate vaccines: Ethical considerations for current and future COVID-19 placebo-controlled vaccine trials and trial unblinding. Geneva: World Health Organization. https://www.who.int/publications/i/item/WHO-2019-nCoV-Policy_Brief-EUD_placebo-controlled_vaccine_trials-2020.1
World Health Organization (2020) Guidance for research ethics committees for rapid review of research during public health emergencies. Geneva: World Health Organization. https://www.who.int/publications/i/item/9789240006218
World Health Organization (2020) Emergency use designation of COVID-19 candidate vaccines: Ethical considerations for current and future COVID-19 placebo-controlled vaccine trials and trial unblinding. Policy Brief. Geneva: World Health Organization https://www.who.int/publications/i/item/WHO-2019-nCoV-Policy_Brief-EUD_placebo-controlled_vaccine_trials-2020.1
WHO Working Group for Guidance on Human Challenge Studies in COVID-19. (2020) Key criteria for the ethical acceptability of COVID-19 human challenge studies. Geneva: World Health Organization.https://www.who.int/publications/i/item/WHO-2019-nCoV-Ethics_criteria-2020.1
Articles
Below is a snapshort of open access literature from 2020-2023 addressing a range of practical ethical issues arising in pandemic research. These papers have been drawn from a rich and extensive body of literature with the aim of complementing the Casebook materials by providing an illustration of the breadth of ethical issues identified, and a diversity of insights and perspectives about addressing them. The views expressed in these papers represent the views of their authors, and not necessarily those of the Casebook editors and authors, or their host institutions.
2023
Davies, A., Ormel, I., Bernier, A., et al. (2023). A rapid review of community engagement and informed consent processes for adaptive platform trials and alternative design trials for public health emergencies [version 1; peer review: 2 approved]. Wellcome Open Research, 8(194). https://doi.org/10.12688/wellcomeopenres.19318.1
Harbin, A., Laventhal, N., Navin, M. (2023) Ethics of age de-escalation in pediatric vaccine trials: Attending to the case of COVID-19. Vaccine 41(9) 1584-1588. https://doi.org/10.1016/j.vaccine.2023.01.055.
Hellmann, F., & Homedes, N. (2023) An unethical trial and the politicization of the COVID-19 pandemic in Brazil: The case of Prevent Senior. Developing World Bioethics 23, 229–241. https://doi.org/10.1111/dewb.12363
Nzinga, J., Oliwa, J., Oluoch, D. et al. (2023). The hidden emotional labour behind ensuring the social value of research: Experiences of frontline health policy and systems researchers based in Kenya during COVID-19. PLOS Glob Public Health, 3:e0002116. https://doi.org/10.1371/journal.pgph.0002116
Orievulu, K., Hinga, A., Nkosi, B., et al. (2023). A scoping review of the landscape of ethics review processes during public health emergencies in sub-Saharan Africa. https://doi.org/10.21203/rs.3.rs-3423510/v1
Rahimzadeh, V., Ambe, J., & Vries, J. de. (2023). Enhancing Reciprocity, Equity and Quality of Ethics Review for Multisite Research During Public Health Crises: The Experience of the COVID-19 Clinical Research Coalition Ethics Working Group. Journal of Law, Medicine & Ethics, 51(2), 258–270. https://doi.org/10.1017/jme.2023.75
Tilch, K., Hopff, S. M., Appel, K., et al. (2023). Ethical and coordinative challenges in setting up a national cohort study during the COVID-19 pandemic in Germany. BMC Medical Ethics, 24(1), Article 1. https://doi.org/10.1186/s12910-023-00959-0
Yu, V. G., Mendoza, J., & Lasco, G. (2023). Online qualitative research with vulnerable populations in the Philippines: Ethical and methodological challenges during COVID-19. SSM - Qualitative Research in Health, 4, 100349. https://doi.org/10.1016/j.ssmqr.2023.100349
Wright, K., Aagaard, N., Ali, A. et al. (2023). Preparing ethical review systems for emergencies: Next steps. BMC Medical Ethics, 24(1), 92. https://doi.org/10.1186/s12910-023-00957-2
Wright, K., Ali, J., Daviesm A., et al. (2023) Ethical priorities for international collaborative adaptive platform trials for public health emergencies. BMJ Global Health, 8(7). http://dx.doi.org/10.1136/bmjgh-2023-012930
2022
Atuire, C. A., Bull, S. (2022). COVID-19 Heightens the Imperative to Decolonize Global Health Research. Global Justice : Theory Practice Rhetoric, 13(02), Article 02. https://doi.org/10.21248/gjn.13.02.257
Buruk, B., Guner, M. D., Ekmekci, P. E. et al. (2022) Comparison of COVID-19 studies registered in the clinical trial platforms: A research ethics analysis perspective. Developing World Bioeth. 22: 217–230. https://doi.org/10.1111/dewb.12333
Canario Guzmán, J. A., Orlich, J., Mendizábal-Cabrera, R., 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(1), 138. https://doi.org/10.1186/s12961-022-00933-z
Fleschenberg A, Castillo RCA. (2022) Negotiating Research Ethics in Volatile Contexts. International Quarterly for Asian Studies 53(4), 495-503. https://doi.org/10.11588/iqas.2022.4.20801
Grimm, J.J. (2022) The Mixed Blessing of Digital Fieldwork: Digital Security and Ethical Dilemmas of Remote Research during and after the Pandemic. Qualitative and Multi-Method Research 20(2), 33-38. https://doi.org/10.5281/zenodo.7140163
Hinga, A., L. Jeena, E. Awuor, J. et al. (2022) Pandemic preparedness and responsiveness of research review committees: lessons from review of COVID-19 protocols at KEMRI Wellcome Trust Research Programme in Kenya. Wellcome Open Res https://wellcomeopenresearch.org/articles/7-75
Katz, R. A., Salamanca-Buentello, F., Silva, D. S. et al. (2022). R&D during public health emergencies: The value(s) of trust, governance and collaboration. BMJ Global Health, 7(3), e007873. https://doi.org/10.1136/bmjgh-2021-007873
Lysaght, T., G.O. Schaefer, T.C. Voo, et al. (2022) Professional oversight of emergency-use interventions and monitoring systems: Ethical guidance from the Singapore experience of COVID-19. Journal of Bioethical Inquiry 19, 327–339. https:/doi.org/10.1007/s11673-022-10171-1
Maketa, V., Luzolo, F., Muhindo Mavoko, H., et al. (2022). Boosting ethics review capacity in public health emergency situations: Co-creation of a training model for French-speaking research ethics committees. Tropical Medicine & International Health, 27(10), 934–940. https://doi.org/10.1111/tmi.13815
Marteau, T. M., Parker, M. J., Edmunds, W. J. (2022). Science in the time of COVID-19: Reflections on the UK Events Research Programme. Nature Communications, 13(1), Article 1. https://doi.org/10.1038/s41467-022-32366-1
Petrini, C., Mannelli, C., Riva, L. et al. (2022) Decentralized clinical trials (DCTs): A few ethical considerations. Front Public Health. 10:1081150. https://doi.org/10.3389/fpubh.2022.1081150
Seyferth AV, Wood SM, Kane RL, Chung KC. (2022) Representation of Ethics in COVID-19 Research: A Systematic Review. Plast Reconstr Surg. 149(5):1237-1244. https://doi.org/10.1097/PRS.0000000000009027
Steytler, M., Thaldar, D. W. (2022). Public health emergency preparedness and response in South Africa: A review of recommendations for legal reform relating to data and biological sample sharing. South African Journal of Bioethics and Law, 14(3), Article 3. https://doi.org/10.7196/SAJBL.2021.v14i3.772
Tan, Y., Agrawal, A., Matsoso, M.P., et al. (2022) A call for citizen science in pandemic preparedness and response: beyond data collection. BMJ Global Health https://doi.org/10.1136/bmjgh-2022-009389
Williams, E., Craig, K., Chiu, C., et al. (2022) Ethics review of COVID-19 human challenge studies: A joint HRA/WHO workshop. Vaccine, 40(26) 3484-3489. https://doi.org/10.1016/j.vaccine.2022.02.004
Wimmer, S., Keestra, S. M. (2022) Public Risk-Taking and Rewards During the COVID-19 Pandemic - A Case Study of Remdesivir in the Context of Global Health Equity. International Journal of Health Policy and Management, 11(5), 567-578. https://doi.org/10.34172/ijhpm.2020.166
2021
Achan, J., Serwanga, A., Aanyu, H. T., et al. (2021). Challenges and Strategies for Conducting Clinical Research During the COVID-19 Pandemic: Experiences from Resource Limited Settings. European Journal of Clinical Medicine, 2(1), 1–6. https://doi.org/10.24018/clinicmed.2021.2.1.9
Bahans, C., Leymarie, S., Malauzat, D., et al. (2021) Ethical considerations of the dynamics of clinical trials in an epidemic context: Studies on COVID-19. Ethics Med Public Health 100621. https://doi.org/10.1016/j.jemep.2020.100621
Eckstein, L., Rid, A., Kamuya, D. et al. (2021) The essential role of DSMBs in ensuring the ethics of global vaccine trials to address COVID-19. Clinical Infectious Diseases 73(11) 2126–2130. https://doi.org/10.1093/cid/ciab239
Etti, M., J. Alger, S.P. Salas, R., et al. 2021. Global research priorities for COVID-19 in maternal, reproductive and child health: Results of an international survey. PloS ONE 16(9): e0257516 https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0257516
Goldman RD, Gelinas L. (2021) COVID-19 and consent for research: Navigating during a global pandemic. Clinical Ethics 16(3), 222-227. https://doi.org/10.1177/1477750920971801
Hensen, B., Mackworth-Young, C. R. S., - Simwinga, M. et al. (2021) Remote data collection for public health research in a COVID-19 era: ethical implications, challenges and opportunities, Health Policy and Planning 36(3) 360–368. https://doi.org/10.1093/heapol/czaa158
Lapid, M., Meagher, K., Giunta, H. et al. (2021) Ethical Challenges in COVID-19 Biospecimen Research: Perspectives From Institutional Review Board Members and Bioethicists, Mayo Clinic Proceedings, 96 (1), 165-173. https://doi.org/10.1016/j.mayocp.2020.10.021
Macioce, F. (2021). Informed consent and group vulnerability in the context of the pandemic BioLaw Journal –Rivista di BioDiritto (2S), 17-33. https://doi.org/10.15168/2284-4503-844
Meyer, M.N., Gelinas, L., Bierer, B.E., et al. (2021) An ethics framework for consolidating and prioritizing COVID-19 clinical trials. Clinical Trials, 18(2), 226-233. https://doi.org/10.1177/1740774520988669
Palmero, A., Carracedo, S., Cabrera, N. et al. (2021). Governance frameworks for COVID-19 research ethics review and oversight in Latin America: An exploratory study. BMC Medical Ethics, 22(1), 147. https://doi.org/10.1186/s12910-021-00715-2
Pepperrell, T., Rodgers, F., Tandon, P. et al. (2021) Making a COVID-19 vaccine that works for everyone: ensuring equity and inclusivity in clinical trials. Global Health Action, 14, 1. https://doi.org/10.1080/16549716.2021.1892309
Pratt, B., & Bull, S. (2021). Equitable data sharing in epidemics and pandemics. BMC Medical Ethics, 22(1), 136. https://doi.org/10.1186/s12910-021-00701-8
Taylor, M.M., Kobeissi, L., Kim, C., et al. (2021). Inclusion of pregnant women in COVID-19 treatment trials: A review and global call to action. The Lancet Global Health 9(3): e366-e371 https://doi.org/10.1016/S2214-109X(20)30484-8
2020
Bompart, F. (2020). Ethical rationale for better coordination of clinical research on COVID-19. Research Ethics, 16(3-4), 1-10. https://doi.org/10.1177/1747016120931998
De Vries, J., Burgess, T., Blockman, M., & Ntusi, N.A.B. (2020). Research on COVID-19 in South Africa: Guiding principles for informed consent. South African Medical Journal = Suid-Afrikaanse Tydskrif Vir Geneeskunde, 110(7), 635–639. https://hdl.handle.net/10520/EJC-1ea79058eb
Doerr, M. & Wagner, J.K. (2020) Research ethics in a pandemic: considerations for the use of research infrastructure and resources for public health activities, Journal of Law and the Biosciences, 7(1) 1-12. https://doi.org/10.1093/jlb/lsaa028
Evans, N. G. (2020). Covid-19: the ethics of clinical research in quarantine. BMJ 369 :m2060 https://doi.org/10.1136/bmj.m2060
Gilson, L., Marchal, B., Ayepong, I., et al. (2020) What role can health policy and systems research play in supporting responses to COVID-19 that strengthen socially just health systems? Health Policy and Planning 35(9) 1231–1236 https://doi.org/10.1093/heapol/czaa112
Gbesemete, D., M. Barker, W.T. Lawrence, et al. 2020. Exploring the acceptability of controlled human infection with SARS-CoV2 – A public consultation. BMC Medicine 18. https://doi.org/10.1186/s12916-020-01670-2
Goyal, P.K., Mathur, R. & Medhi, B. (2020 Understanding the challenges and ethical aspects of compassionate use of drugs in emergency situations. Indian Journal of Pharmacology 52(3), 163-171. https://doi.org/10.4103/ijp.IJP_665_20
Kumar, N. K., & Muthuswamy, V. (2020). Fostering ethical biomedical and health research in India during the COVID-19 pandemic. Research Ethics, 16(3-4), 1-10. https://doi.org/10.1177/1747016120941632
London, A.J., & Kimmelman, J. (2020) Against pandemic research exceptionalism. Science 368(6490): 476–477. https://doi.org/10.1126/science.abc1731
Ma, X., Wang, Y., Gao, T. et al. (2020). Challenges and strategies to research ethics in conducting COVID-19 research. Journal of Evidence-Based Medicine 13, 173–177. https://doi.org/10.1111/jebm.12388
Mathur, R. (2020). Ethics preparedness for infectious disease outbreaks research in India: A case for novel coronavirus disease 2019. Indian Journal of Medical Research 151(2-3):p 124-131, DOI: 10.4103/ijmr.IJMR_463_20
Meagher, K. M., Cummins, N. W., Bharucha, A. E., et al. (2020) COVID-19 Ethics and Research. Mayo Clinic Proceedings (95)6, 1119-1123. https://doi.org/10.1016/j.mayocp.2020.04.019
Milner, R., Donington, J., Matthews, J. B., et al. (2020). Is it ethically appropriate to continue surgical clinical trials during the COVID-19 pandemic? Surgery, 168(1) 1-3 https://doi.org/10.1016/j.surg.2020.04.024
Monrad, J. T. (2020). Ethical considerations for epidemic vaccine trials. Journal of Medical Ethics 46, 465-469. https://doi.org/10.1136/medethics-2020-106235
Moodley, K., Allwood, B. W. & Rossouw, T. M. (2020). Consent for critical care research after death from COVID-19: Arguments for a waiver. South African Medical Journal 110(7), 629-634. http://www.samj.org.za/index.php/samj/article/view/12955
Reyes, M. (2020). Research in the Time of COVID-19: Challenges of Research Ethics Committees. Journal of the ASEAN Federation of Endocrine Societies 35(1), 29–32. https://doi.org/10.15605/jafes.035.01.07
Shah, S.K., Miller, F.G., Darton, T.C., et al. (2020) Ethics of controlled human infection to address COVID-19. Science 368(6493) 832-4. https://doi.org/10.1126/science.abc1076
Singh JA, Bandewar SV, Bukusi EA. (2020) The impact of the COVID-19 pandemic response on other health research. Bull World Health Organ. 98(9), 625-631. https://doi.org/10.2471/BLT.20.257485
Tindana, P.O., De Vries, J., Kamuya, D. (2020) Ethical challenges in community engagement practices in research during the COVID-19 pandemic in Africa AAS Open Res 3:23 https://doi.org/10.12688/aasopenres.13084.1
van der Graaf, R., Hoogerwerf, MA. & de Vries, M.C. (2020) The ethics of deferred consent in times of pandemics. Nat Med 26, 1328–1330. https://doi.org/10.1038/s41591-020-0999-9
Wieten, S., Burgart, A. & Cho. M. (2020) Resource Allocation in COVID-19 Research: Which Trials? Which Patients? The American Journal of Bioethics 20(7) 86-88 https://doi.org/10.1080/15265161.2020.1779392
Witham, M.D., Anderson, E., Carroll, C.B. et al. (2020) Ensuring that COVID-19 research is inclusive: guidance from the NIHR INCLUDE project. BMJ Open 10:e043634. https://doi.org/10.1136/bmjopen-2020-043634