Monday, June 14, 2021

Gain of Function

 It is worth looking at the 2015 Gain of Function report by the NAS. They note:

On October 17, 2014, spurred by incidents at U.S. government laboratories that raised serious biosafety concerns, the U.S. government launched a 1-year deliberative process to address the continuing controversy surrounding so-called “gain-of-function” (GoF) research on respiratory pathogens with pandemic potential (White House, 2014a).1 GoF research is the latest example of U.S. efforts to develop oversight mechanisms for dual use research in the life sciences that can “reliably identify, and where necessary, mitigate risks while protecting scientific autonomy, discovery and innovation, public health, national security, and other critical interests”  The GoF controversy began in late 2011 with the question of whether to publish the results of two experiments involving H5N1 avian influenza and continued to focus on certain research with highly pathogenic avian influenza over the next 3 years.3 The new U.S. policy expanded the scope to include experiments with the coronaviruses that cause Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS). The heart of the U.S. process is an evaluation of the potential risks and benefits of certain types of GoF experiments with influenza, SARS, and MERS viruses that would “inform the development and adoption of a new U.S. Government policy governing the funding and conduct of gain-of-function research” (White House, 2014a:3). As part of the process, the government also instituted a pause in both new and current
funding for some GoF research projects while the evaluation was carried out.

 New USG funding will not be released for gain-of-function research projects that may be reasonably anticipated to confer attributes to influenza, MERS, or SARS viruses such that the virus would have enhanced pathogenicity and/or transmissibility in mammals via the respiratory route. The research funding pause would not apply to characterization or testing of naturally occurring influenza, MERS, and SARS viruses, unless the tests are reasonably anticipated to increase transmissibility and/or pathogenicity. In parallel, we will encourage the currently-funded USG and non-USG funded research community to join in adopting a voluntary pause on research that meets the stated definition. (White House, 2014a:2)

 Initially, 18 research projects funded by the National Institutes of Health (NIH) were halted, although several involving the effort to develop an animal model for studying MERS were later exempted