Gain-of-function research: ethical analysis

Gain-of-function (GOF) research involves experimentation that aims to increase the transmissibility and/or virulence of pathogens. The ultimate objective of such research is to better inform public health and preparedness efforts and/or development of medical countermeasures.  Despite these important potential benefits, GOF research can pose risks regarding biosecurity and biosafety.  In 2014 the administration of US President Barack Obama called for a 'pause' on funding (and relevant research with existing US Government funding) of GOF experiments involving influenza, SARS, and MERS viruses. With announcement of this pause, the US Government launched a 'deliberative process' regarding risks and benefits of GOF research to inform future funding decisions – and the US National Science Advisory Board for Biosecurity (NSABB) was tasked with making recommendations to the US Government on this matter.

As part of this deliberative process the National Institutes of Health (NIH) commissioned Prof Selgelid to develop the Ethical Analysis White Paper, requesting that it provide:
(1) review and summary of ethical literature on GOF research;
(2) identification and analysis of existing ethical and decision-making frameworks relevant to
(i) the evaluation of risks and benefits of GOF research,
(ii) decision-making about the conduct of GOF studies, and
(iii) the development of US policy regarding GOF research - especially with respect to funding; and
(3) development of an ethical and decision-making framework that may be considered by NSABB when analysing information provided by GOF research risk-benefit assessment, and when crafting its final recommendations – especially regarding policy decisions about funding.

Chief Investigator Professor Michael J. Selgelid

Funder National Institute of Health, USA

Date of Award 2015