On October 17th this year, the United States government announced that it will not fund new viral research it sees as a threat to public safety and it asked researchers currently engaging in related research to cease their work pending further risk assessment. Our government is specifically condemning "gain-of-function" experiments that explore viral acquisition of new pathogenic capabilities due to deliberate genetic mutations introduced by researchers. Though some researchers disapprove of the edict while others consider it a step in the right direction, one beneficial consequence of the edict has been its ignition of important conversations about biological and ethical considerations in viral research.
Research on viral pathogenicity and its genetic basis rests on a fundamental tradeoff: Maintaining and manipulating viruses in a laboratory setting always poses a risk (albeit a small risk if proper precautions are taken) to public safety if the virus should accidentally be released into the greater human population. However, this same research is necessary for understanding viral biological processes and thereby necessary for the development of effective prevention and treatment strategies to mitigate the spread of the virus and its effects in the world. Researchers who endorse the new edict cite recent and historic episodes of improper handling of dangerous viruses and argue that this new policy will offer a much-needed platform for establishing and upholding better standards for laboratory practice. On the other hand, researchers who oppose the edict posit that it will stall or prevent important work from taking place (and assert that incidences of clumsy or negligent mishandling have been few and far between). "Gain-of-funciton" experiments, in which researchers amplify the potency of viruses, involve the same tradeoff but offer a context for heightened worry and fiercer argument because the danger of the virus is increased and, arguably, the implications of the associated gains in our scientific understanding of the virus are especially significant for the development of vaccines and treatments. Perhaps this new policy, if it is not upheld indefinitely, could motivate improvements in standards of laboratory practice but, once lifted, not significantly stall important scientific work.
This edict also highlights the challenge of developing policies around certain facets of biological research when our understanding of the underlying biology is far from complete. The challenging question raised here is not whether a mutation causes a "gain-of-function" or not (that much is often readily apparent) but to what extent researchers are deliberately introducing gain-of-function mutations. The amount a researcher knows about a certain target region for mutation before the experiment is conducted is highly variable. What if the introduced mutation is in a relatively uncharacterized region of a genome or in a poorly-understood virus? The investigators may not have any reasonable grounds to predict whether or not a mutation will result in a gain-of-function or not. Furthermore, viruses, as live biological entities, mutate on their own and it can be difficult to predict how or when a mutation will arise in a laboratory culture. But then consider a case in which a certain genome region has already been demonstrated to be associated with pathogenicity. At what point do researchers cease trying to understand that region and its function through mutation experiments for fear of producing a gain-of-function outcome?
I hope these questions will be ones you can mull over, investigate further, or discuss over coffee with a fellow amateur virologist!
If you are interested in reaching the Nature discussion of the subject, visit: http://www.nature.com/news/us-suspends-risky-disease-research-1.16192