Portal de Periódicos da CAPES

Beyond gain of function: strengthening oversight of research with potential pandemic pathogens

2023; Taylor & Francis; Volume: 118; Issue: 3 Linguagem: Inglês

10.1080/20477724.2023.2265627

2047-7732

Gregory D. Koblentz, Rocco Casagrande,

Ethics in Clinical Research

ABSTRACTIn 2017, the Department of Health and Human Services adopted a policy, known as the P3CO Framework, to govern proposed research that could enhance the lethality or transmissibility of a potential pandemic pathogen. The prospect of a human-made virus with artificially enhanced lethality and transmissibility has raised serious biosafety and biosecurity concerns. The COVID-19 pandemic has generated new concerns about the risks posed by such research. Even if the origins of the pandemic are presumed or proven to be the result of a natural zoonotic spillover event, the pandemic has placed greater scrutiny on research that could generate pandemic-capable viruses and dramatically illustrated the consequences if such a virus were released from a laboratory. This article assesses the strengths and weaknesses of the P3CO Framework and provides recommendations for strengthening oversight of research with potential pandemic pathogens. The P3CO Framework should be replaced by a national policy that would apply to all relevant research, regardless of the source of funding and be implemented by a new national agency for biorisk management. This new policy would need to be accompanied by a comprehensive analysis of potential pandemic pathogen risks, clear guidance on how to identify research that falls within the scope of the policy, a rigorous process for reviewing the risks and benefits of such research, and criteria for determining the appropriate measures needed to conduct such research safely, securely, and responsibly.KEYWORDS: Biosafetybiosecuritypandemicdual-use researchrisk assessment Disclosure statementNo potential conflict of interest was reported by the author(s).Notes1 Department of Health and Human Services (HHS). 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