Context: With the re-emergence of the Wuhan lab-leak origin theory, questions are also being raised on what gain-of-function research is, and whether the benefits of conducting such research outweigh the risks of pathogens escaping from labs.
About Gain-of-function research

• In virology, gain-of-function research involves deliberately altering an organism in the lab, altering a gene, or introducing a mutation in a pathogen to study its transmissibility, virulence and immunogenicity.
• It is believed that this allows researchers to study potential therapies, vaccine possibilities and ways to control the disease better in future.
• Gain-of-function research involves manipulations that make certain pathogenic microbes more deadly or more transmissible.
• This is done by genetically engineering the virus and by allowing them to grow in different growth mediums, a technique called as serial passage.

Antithesis to this theory

• There is also ‘loss-of-function’ research, which involves inactivating mutations, resulting in a significant loss of original function, or no function to the pathogen.
• When mutations occur, they alter the structure of the virus that is being studied, resulting in altered functions. Some of these significant mutations might weaken the virus or enhance its function.

Associated risks

• Some forms of gain-of-function research reportedly carry inherent biosafety and biosecurity risks and are thus referred to as ‘dual-use research of concern’ (DURC).
• This indicates that while the research may result in benefits for humanity, there is also the potential to cause harm — accidental or deliberate escape of these altered pathogens from labs may cause even pandemics.

Essential component of vaccine development

• The current medical countermeasures are often insufficient largely because of resistance mechanisms that lead to ‘escape mutants’, i.e., drug-resistant strains.
• There is, hence, a continual need to develop new antiviral drugs and additional options, such as immunotherapy, based on neutralizing monoclonal antibodies.
• Ultimately, gain-of-function studies, which enhance viral yield and immunogenicity, are required for vaccine development.

What is the situation in India?

• In India, all activities related to genetically engineered organisms or cells and hazardous microorganisms and products are regulated as per the “Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells Rules, 1989”.
• Last year, the Department of Biotechnology issued guidelines for the establishment of containment facilities, called ‘Biosafety labs’, at levels two and three.
• The notification provides operational guidance on the containment of biohazards and levels of biosafety that all institutions involved in research, development and handling of these microorganisms must comply with.

Should research continue?

• Scientists have differing opinions on the issue, particularly since the emergence of the COVID-19 pandemic.
• While those on the side of gain-of-function research say that it makes science and governments battle-ready for future pandemics, there have been a rising number of calls to suspend such research.
• Proponents of gain-of-function research believe that “nature is the ultimate bioterrorist and we need to do all we can to stay one step ahead”.

Some researchers thinks it is time to stop such research.

• Science policymakers “must wrestle with defining the rare instances in which the benefits of experiments that enhance a virus’s capacity to survive and flourish in human hosts outweigh any risks.