TY - JOUR
T1 - Key criteria for the ethical acceptability of COVID-19 human challenge studies
T2 - Report of a WHO Working Group
AU - for the WHO Working Group for Guidance on Human Challenge Studies in COVID-19
AU - Jamrozik, Euzebiusz
AU - Littler, Katherine
AU - Bull, Susan
AU - Emerson, Claudia
AU - Kang, Gagandeep
AU - Kapulu, Melissa
AU - Rey, Elena
AU - Saenz, Carla
AU - Shah, Seema
AU - Smith, Peter G.
AU - Upshur, Ross
AU - Weijer, Charles
AU - Selgelid, Michael J.
N1 - Funding Information:
The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: [EJ has received consulting fees from WHO and funding from The Wellcome Trust for research on the ethics of human challenge studies. CW receives consulting income from Cardialen, Eli Lilly & Company, and Research Triangle Institute International. MJS is he has received funding from The Wellcome Trust for previous research on the ethics of human challenge studies. No competing interests: SB,CE,GK,MK,KL,ER,CS,PGS, SS, RU].
Publisher Copyright:
© 2020 The Authors
PY - 2021/1/22
Y1 - 2021/1/22
N2 - This report of the WHO Working Group for Guidance on Human Challenge Studies in COVID-19 outlines ethical standards for COVID-19 challenge studies. It includes eight Key Criteria related to scientific justification, risk-benefit assessment, consultation and engagement, co-ordination of research, site selection, participant selection, expert review, and informed consent. The document aims to provide comprehensive guidance to scientists, research ethics committees, funders, policymakers, and regulators in deliberations regarding SARS-CoV-2 challenge studies by outlining criteria that would need to be satisfied in order for such studies to be ethically acceptable.
AB - This report of the WHO Working Group for Guidance on Human Challenge Studies in COVID-19 outlines ethical standards for COVID-19 challenge studies. It includes eight Key Criteria related to scientific justification, risk-benefit assessment, consultation and engagement, co-ordination of research, site selection, participant selection, expert review, and informed consent. The document aims to provide comprehensive guidance to scientists, research ethics committees, funders, policymakers, and regulators in deliberations regarding SARS-CoV-2 challenge studies by outlining criteria that would need to be satisfied in order for such studies to be ethically acceptable.
KW - Bioethics
KW - Clinical trials
KW - Controlled human infection
KW - Coronavirus
KW - Covid-19
KW - Ethics
KW - Human challenge studies
KW - Research ethics
UR - http://www.scopus.com/inward/record.url?scp=85099271872&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85099271872&partnerID=8YFLogxK
U2 - 10.1016/j.vaccine.2020.10.075
DO - 10.1016/j.vaccine.2020.10.075
M3 - Comment/debate
C2 - 33341309
AN - SCOPUS:85099271872
VL - 39
SP - 633
EP - 640
JO - Vaccine
JF - Vaccine
SN - 0264-410X
IS - 4
ER -
