Gain of Function Research (GoFR) is a hot topic in the news these days, but what is it and why would we even consider doing it?

GoFR is the alteration of an organism in order to increase specific abilities for future study. Virologist use GoFR to study three areas: pathogenesis, transmissibility and type of hosts.

Pathogenesis is the process by which a virus causes disease and how that disease develops. Transmissibility is the mechanism by which a virus is transferred from one organism to the next and how infectious a pathogen is.

The last area of study, and probably the most important for GoFR, is related to the type of host that a virus can infect. Viruses are often species specific, so GoFR can expand that and enable researchers to study dangerous viruses without risking human subjects.

At its most fundamental, GoFR attempts to enhance viruses’ properties in order to simulate the natural evolutionary process. The information gained can be used to develop vaccines and therapeutics and to enhance future public health planning.

If scientists were solely restricted to waiting for a virus to evolve, then it might be too late to develop a plan or cure. GoFR gives scientists a head start on viral evolution.

It is easier to see this with regard to influenza where typically we see two types of influenza: influenza A and influenza B.

Influenza A is common in birds, swine, bats and people. Some strains impact seals and even whales.

Because influenza A infects many species, researchers are able to study and evaluate how the strains of influenza A might impact human beings without touching a human subject.

Influenza B, on the other hand, has few species that it infects, mostly impacting human beings. Therefore, researchers have difficulty studying the two different lineages of influenza B without studying real live human subjects.

This can be dangerous for the subjects, so GoFR can help here.

By enhancing the type of host that a virus can infect, researchers could design a strand that impacts mice or monkeys and then study the impact of the virus on those species. Then, vaccines could be developed and tested using nonhuman subjects prior to human trials.

GoFR enables scientists and vaccine developers to study viruses more efficiently without risking humans. In addition, GoFR can be used to alter transmutability to safely study how a virus might impact humans.

By altering influenza strands that only impact bats but are similar to existing stands that infect humans, researchers can project the level of exposure that might impact the public prior to the evolution of the human version of that virus.

This also could be done safely in a lab without risking human subjects.

In brief, GoFR enables researchers to study theoretical viral abilities before they evolve into reality and create the next pandemic. This is science at its best.

Just like every other avenue of scientific advancement, we need to consider more than just the advantages by seriously evaluating the risks.

GoFR has been equated with bioterrorism – an unfair classification.

While GoFR could, in theory, be used to enhance an existing virus for military purposes, it is unlikely. It would take a tremendous amount of resources for a bad actor to weaponize an existing virus, and doing so without it becoming public is doubtful.

While viruses are dangerous, they do not make good mass weapons because the deploying force cannot necessarily control future viral mutations after deployment and the creator would always run the risk of infecting themselves.

While GoFR for bioterrorism is unlikely, there are still other concerns linked to human error.

The concern with creating novel viruses centers around biolab safety. Careless procedures and safety standards could lead to one of these novel viruses escaping lab containment and entering the wild.

Some have pointed to the Wuhan Institute for Virology as an explanation for COVID-19, but no evidence has emerged to substantiate such claims.

While investigations are ongoing, reaching conclusions will be difficult because, as one genetic engineering specialist explained, “I know a lot of people want to have a smoking gun. … It’s more like breadcrumbs everywhere, and they’re not always leading in one direction. It’s like the whole floor is covered in breadcrumbs.”

Yet, we only need to look within our own borders to see potential safety risks.

From 2012 to 2016, U.S. labs have had a string of safety failures.

In 2014, the USDA’s Southeast Poultry Research Laboratory in Athens, Georgia, had two documented failures of its air-purifying respirators that could have exposed workers to the highly contagious H5N1 influenza.

From 2013-2014, the University of North Carolina-Chapel Hill lost eight different mice infected with SARS or H1N1 influenza.

Even the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick, Maryland, reported 37 incidents of BSL-4 biohazard suits failing.

Most disturbing was the discovery of rat nests made from shredded biohazard bags that contained lab supplies in a fenced-off medical waste area at the University of California-Los Angeles in 2014.

All these facilities research dangerous pathogens and are located in populated areas.

This illustrates the risk of GoFR. It is not the research itself, but the possibility of human error that is most concerning.

GoFR has the potential of aiding the medical establishment in battling the next pandemic, but public safety demands that such research be conducted better or not at all.

While GoFR has good intentions, poor execution could lead to untold suffering.

So, for GoFR to be morally acceptable, safety measures need to be iron clad with redundant safety mechanisms in triplicate.

The ethics community needs to spend more time focused upon GoFR and its unintended consequences. The science is beneficial but is the risk-benefit equation justified?

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