Background
This consultation is part of the WHO Health Ethics and Governance Unit’s commitment to promoting ethical research. The Unit produced Key Criteria for the Ethical Acceptability of COVID-19 Human Challenge Studies (2020) and broader WHO Guidance on the Ethical Conduct of Controlled Human Infection Studies (2021). Controlled human infection studies (CHIS) were conducted with COVID19 in the United Kingdom during the COVID-19 pandemic public health emergency.
It is likely that CHIS may be considered in future infectious disease public health emergencies. The draft document circulated in this consultation aims to provide general ethics guidance for CHIS during emergencies. Such guidance is intended to supplement existing mechanisms for ethical consideration and research ethics review of CHIS by highlighting issues that would be likely to be highly salient to CHIS during an emergency.
Future emergencies may be caused by different types of pathogens and the features of future emergencies may be difficult to predict. However, recent experience has demonstrated that certain ethical issues may be particularly relevant to CHIS in such settings and that prospective ethical guidance may be useful to inform the evaluation of such studies. While the current draft document focuses on CHIS during emergencies, the Health Ethics and Governance Unit also aims to produce complimentary guidance on CHIS with pathogens of pandemic potential as part of emergency preparedness.
Objective of the consultation
The goal of this online, open public consultation is to gather feedback from stakeholders on the draft Key criteria for the ethical acceptability of controlled human infection studies during public health emergencies.
General guidance on providing comments
Download and review the draft guidance. Compose your responses to each question using your preferred word processor or text editing software and paste your responses into the online form.
Submissions cannot be made anonymously. You will be required to provide valid responses to questions that ask your full name, your organizational affiliation (if any), your role (job title), your country of residence, your personal email address OR your organizational email address (if submitting on behalf of an organization) in order to make a submission. Submissions that are not accompanied by valid responses to these questions may not be accepted for consideration.
By participating, you consent to providing your personal information and comments to the WHO to contact you, if needed.
All comments will be carefully reviewed. We might share a summary of key points raised in the public consultation with the participants’ demographics and their representation of stakeholder groups, without revealing any individual participants’ information or affiliations, on the WHO website. We do not intend to publish the ‘raw information’ from the individual responses.
For any query related to the consultation, please contact: ct_ethics@who.int with subject "CHIS emergencies consultation".
Comments on the Draft Guidance must be submitted by 11:59 on Sunday, 7th April 2024, Central European Time (GMT/UHC +1).