The Hastings Center has assembled a set of resources that address many of the ethical and evidentiary issues being raised about conducting human vaccine and treatment trials during the Covid-19 pandemic. One question is whether the urgency of finding a vaccine or treatment for a deadly pandemic justifies relaxing typical standards for evidence if doing so can accelerate the research process. Another important question is how to maintain ethical standards for conducting research with humans during public health emergencies. There are lessons to be learned from recent epidemics and pandemics. The resources here include selected reports and articles about ethical and scientific challenges involving research in previous public health emergencies such as the 2013-2016 Ebola virus outbreak in western Africa and the 2015-2016 outbreak of the Zika virus in the United States and parts of South America. These resources will be useful to researchers, research ethics oversight committees, relevant community advisory boards (and other public engagement bodies), bioethics experts, policy makers, journalists, and the general public.

Covid-19 Vaccine and Treatment Research

Reports and Government Documents

International Coalition of Medicines Regulatory Authorities. Summary Report. Global Regulatory Workshop on COVID-19 Vaccine Development. March 18, 2020 https://www.icmra.info/drupal/sites/default/files/2020-03/First%20regulatory%20COVID-19%20workshop%20-%20meeting%20report_March%202020.pdf

Pan American Health Organization and World Health Organization. Guidance and Strategies to Streamline Ethics Review and Oversight of COVID-19 Related Research. April 7, 2020. https://www.paho.org/en/documents/guidance-and-strategies-streamline-ethics-review-and-oversight-covid-19-related-research.

U.S. Food and Drug Administration. Revised Information for Investigational COVID-19. April 3, 2020. https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/revised-information-investigational-covid-19-convalescent-plasma

U.S. Food and Drug Administration. Investigational COVID-19 Convalescent Plasma – Emergency INDs. March 24, 2020. https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-exemption-ide-process-cber/investigational-covid-19-convalescent-plasma-emergency-inds

World Health Organization. Ethical Standards for Research During Public Health Emergencies: Distilling Existing Guidance to Support COVID-19 R&D. 2020. https://apps.who.int/iris/handle/10665/331507

Articles, Commentaries, and Media Reports

Cohen, Jon. Infect Volunteers to Speed a Coronavirus Vaccine? Science 368(6486):16. April 3, 2020. https://science.sciencemag.org/content/368/6486/16.abstract

Eyal Nir, Marc Lipsitch, and Peter G. Smith. Human Challenge Studies to Accelerate Coronavirus Vaccine Licensure. The Journal of Infectious Diseases, jiaa152, https://doi.org/10.1093/infdis/jiaa152, March 31, 2020. https://academic.oup.com/jid/advance-article/doi/10.1093/infdis/jiaa152/5814216

Lurie, Nicole, Melanie Saville, Richard Hatchett, and Jane Halton. Developing Covid-19 Vaccines at Pandemic Speed. NEJM, March 30, 2020. https://www.nejm.org/doi/full/10.1056/NEJMp2005630

Morten, Christopher J., Amy Kapczynski, Harlan M. Krumholz, and Joseph S. Ross. To Help Develop the Safest, Most Effective Coronavirus Tests, Treatments, and Vaccine, Ensure Public Access to Clinical Research Data. Health Affairs Blog, March 26, 2020. https://www.healthaffairs.org/do/10.1377/hblog20200326.869114/full/

Mullin, Emily. An Experimental Coronavirus Vaccine is Already Being Tested in People. OneZero, March 24, 2020. https://onezero.medium.com/an-experimental-coronavirus-vaccine-is-already-being-tested-on-people-9541cec49097

Owermohe, Sarah. No ‘Magic Pill’: The Fight Over Unproven Drugs for Coronavirus. Politico, April 2, 2020. https://www.politico.com/news/2020/04/02/coronavirus-drugs-fda-162411

Silverman, Ed. We Shouldn’t Rush to Use an Unproven Malaria Drug to Treat the Coronavirus. STAT, March 31, 2020. https://www.statnews.com/2020/03/31/we-shouldnt-rush-to-use-an-unproven-drug-to-treat-the-coronavirus/

Research in Global Health Emergencies

Reports and Government Documents

Ethics Working Group on ZIKV Research & Pregnancy. Pregnant Women & the Zika Virus Vaccine Research Agenda: Ethics Guidance on Priorities, Inclusion, and Evidence Generation. June 2017. https://static1.squarespace.com/static/574503059f72665be88193e9/t/5954a4f6099c01adfc66f492/1498719491483/Full+Guidance%2C+Pregnant+Women+%26+the+Zika+VIrus+Vaccine+Research+Agenda.pdf

National Academy of Sciences, Engineering, and Medicine. Integrating Clinical Research into Epidemic Response: The Ebola Experience. 2017. https://www.nap.edu/catalog/24739/integrating-clinical-research-into-epidemic-response-the-ebola-experience

Nuffield Council on Bioethics. Research in Global Health Emergencies. January, 2020. https://www.nuffieldbioethics.org/publications/research-in-global-health-emergencies

Shah, Seema K., Jonathan Kimmelman, Anne Drapkin Lyerly, Holly Fernandez Lynch, Francine McCutchan, Franklin G. Miller, Ricardo Palacios, Carlos Pardo-Villamizar, and Carmen Zorrilla. Ethical Considerations for Zika Virus Human Challenge Trials. Report and Recommendations. 2017. https://www.niaid.nih.gov/sites/default/files/EthicsZikaHumanChallengeStudiesReport2017.pdf

World Health Organization. Vaccination in Acute Humanitarian Emergencies. A Framework for Decision Making. May 2017. https://apps.who.int/iris/bitstream/handle/10665/255575/WHO-IVB-17.03-eng.pdf?sequence=1

Articles, Commentaries, and Media Reports

Bambery, Ben, Michael Selgelid, Charles Weijer, Julian Savulescu, and Andrew J. Pollard. Ethical Criteria for Human Challenge Studies in Infectious Diseases. Public Health Ethics 2016;9(1):92-103. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5926904/

Calain, Philippe. The Ebola Clinical Trials: A Precedent for Research Ethics in Disasters. Journal of Medical Ethics 2018;44:3-8. https://jme.bmj.com/content/44/1/3

Cohen, Jon and Kai Kupferschmidt. Ebola Vaccine Trials Raise Ethical Issues. Science 2014;346(6207):289-290. https://science.sciencemag.org/content/346/6207/289.summary

Joffe, Steven. Evaluating Novel Therapies During the Ebola Epidemic. JAMA 2014;312(13):1299-1300. https://jamanetwork.com/journals/jama/fullarticle/1905875

Prescribing Experimental Treatments

Reports and Government Documents

European Medicines Agency. EMA Provides Recommendations on Compassionate use of Remdesivir for COVID-19. April 3, 2020. https://www.ema.europa.eu/en/news/ema-provides-recommendations-compassionate-use-remdesivir-covid-19

World Health Organization. Ethical Considerations for Use of Unregistered Interventions for Ebola Viral Disease: Report of an Advisory Panel to WHO. 2014. https://www.who.int/csr/resources/publications/ebola/ethical-considerations/en/

Articles, Commentaries, and Media Reports

Fernandez Lynch, Holly, Alison Bateman-House, and Arthur L. Caplan. ‘Panic Prescribing’ Untested Coronavirus Treatments: A Danger to Patients Today and Tomorrow. Health Affairs Blog, March 31, 2020. https://www.healthaffairs.org/do/10.1377/hblog20200330.265604/full/

Rid, Annette and Ezekiel Emanuel. Ethical Considerations of Experimental Interventions in the Ebola Outbreak. Lancet 2014;384:1896-1899. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(14)61315-5/fulltext