Research Impact


Establishing ethical standards for clinical research during public health emergencies

UCL research has informed the World Health Organisation’s Ethics Guidance, with over 88 million participants of 4,955 studies into priority infectious diseases and pathogens globally. 

Doctor reading notes

12 April 2022

Professor Sarah Edwards’ (UCL Department of Science, Technology, Engineering and Public Policy - STEaPP, previously Science & Technology Studies, UCL Mathematical & Physical Sciences) research shaped the World Health Organisation’s (WHO) ‘Guidance For Managing Ethical Issues In Infectious Disease Outbreaks’ for clinical research during public health crises, and also helped to inform the WHO training programme.

The WHO training manual, ‘Ethics in epidemics, emergencies and disasters: research, surveillance and patient care, was published in 2015 and later translated into Chinese. It had been downloaded more than 4,000 times by 31 December 2020.

The manual discusses Professor Edwards' 2013 paper ‘Drug discovery at the bedside: ethics of clinical science during a pandemic’ under three of its seven core competencies and contains a case study based on the paper.  

Ethics within the response to COVID-19 

Professor Edwards participated in the WHO R&D Blueprint meeting on COVID-19 in Geneva in February 2020 where she helped identify important gaps in knowledge in the social sciences and in ethics – regarding limits to extrapolating social and cultural acceptability of new therapeutics and vaccines from other contexts, such as Influenza or Ebola, and from other countries in which previous study had been undertaken.

She was invited as a member and key advisor to join the APANDEMIC initiative, which aims to inform and support real-world evidence for COVID-19 research and decision-making, with the aim of encouraging regulators and researchers to design studies which are methodologically efficient and ethical. 
Professor Edwards helped set up a compassionate access to medicines programme at St George’s Hospital NHS Trust and Medical School establishing access to the drug Tocilizumab, which turned out to be life-saving.

She was also invited to give a keynote lecture in November 2020 to help shape and formalise early approval of new or repurposed medicines and vaccines for COVID-19 in Israel which has seen the first mass population vaccine programme for COVID-19 in the world with extensive ‘real-world’ research. 

Working with African nations  

Through PANDORA-ID-NET, a consortium of organisations across Africa and Europe supporting research in emerging and re-emerging infectious diseases, Professor Edwards was enlisted in 2018 to support the newly formed Africa Centres for Disease Control (Africa CDC), part of the African Union, to initiate the development of an authoritative African ethics framework for research during epidemics across Africa.

Professor Edwards has contributed to training more than 300 members of research ethics committees and regulators in central Africa.  

Research synopsis

Establishing ethical standards for clinical research during public health emergencies 

Edwards’ research informed the World Health Organisation’s (WHO) Ethics Guidance and a Training Manual for clinical research during epidemics of emerging and re-emerging infectious diseases, for which no effective treatments or vaccines are known. The ethics guidance applied to 4955 studies undertaken into WHO’s priority infectious diseases and pathogens with over 88 million participants globally.  

Her expertise has been consulted over clinical research for COVID-19 by organisations such as WHO, Africa CDC, and the US FDA which issued new guidelines leading to more than 370 early approvals of medicines and medical products with surveillance for research.