White Paper on Ethical Issues Associated with “Gain-of-Function” Research for US Government



In 2015 Professor Michael Selgelid was commissioned by the US National Institutes of Health to complete a White Paper providing ethical analysis of “Gain-of-Function” Research.

Gain-of-function (GOF) research involves experimentation that increases  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 (GOFR) 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 in particular. With announcement of this pause, the US Government launched a “deliberative process” regarding risks and benefits of GOFR to inform future funding decisions.  (For White House  announcement of research pause and deliberative process, see:  https://www.whitehouse.gov/blog/2014/10/17/doing-diligence-assess-risks-and-benefits-life-sciences-gain-function-research.)

As part of this deliberative process the National Institutes of Health (NIH) commissioned  Selgelid to  produce an Ethical Analysis White providing (1) review and summary of ethical literature on GOFR, (2) identification and analysis of existing ethical and decision-making frameworks relevant to (i) the evaluation of risks and benefits of GOFR, (ii) decision-making about the conduct of GOF studies, and (iii) the development of US policy regarding GOFR (especially with respect to funding of GOFR), and (3) development of an ethical and decision-making framework that may be considered by the  US National Science Advisory Board for Biosecurity (NSABB)  when analyzing information provided by GOFR risk-benefit assessment, and when crafting its recommendations  to the White House.

Selgelid’s work on this project was presented  at NSABB meetings in Bethesda, Maryland in September 2015 and January 2016–and at a public US National Academy of Sciences, Engineering, and Medicine Symposium in Washington DC in March 2016.  (For published report of latter meeting, see:  https://www.nap.edu/catalog/23484/gain-of-function-research-summary-of-the-second-symposium-march)

Following delivery to NSABB, Selgelid’s White Paper was also published in the journal Science and Engineering Ethics, where it is freely available here.

This project, and other related policy work by Selgelid, has also been featured in Monash News and the Faculty of Arts website.