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Gain-of-function research (GOFR) enhances understanding of pathogens but carries biosafety risks. A new ethical framework evaluates GOFR on a spectrum, guiding responsible funding and conduct for public health benefits.

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Area of Science:

  • Biosecurity and Biosafety
  • Infectious Disease Research
  • Public Health Policy

Background:

  • Gain-of-function research (GOFR) aims to increase understanding of pathogen transmissibility and virulence to improve pandemic preparedness and medical countermeasures.
  • GOFR presents significant biosecurity and biosafety risks, prompting a 2014 US government funding pause and a deliberative process on its ethical implications.
  • The National Institutes of Health commissioned an ethical analysis to inform policy decisions and the National Science Advisory Board for Biosecurity's recommendations.

Purpose of the Study:

  • To review and summarize the ethical literature concerning GOFR.
  • To identify and analyze existing ethical frameworks for evaluating GOFR risks and benefits, guiding study conduct and US policy.
  • To develop a novel ethical and decision-making framework for assessing GOFR, informing funding and policy recommendations.

Main Methods:

  • Systematic review of ethical literature on GOFR.
  • Analysis of existing ethical and decision-making frameworks relevant to GOFR.
  • Development of a new ethical framework based on multiple ethically relevant dimensions.

Main Results:

  • GOFR offers potential public health benefits but entails inherent risks.
  • Existing frameworks require adaptation for comprehensive GOFR risk-benefit assessment.
  • A novel ethical spectrum framework, considering dimensions like proportionality, risk minimization, and governance, was developed.

Conclusions:

  • GOFR should be evaluated on an ethical spectrum rather than a binary acceptable/unacceptable scale.
  • The proposed framework aids in determining the ethical acceptability of specific GOFR studies and informs funding decisions.
  • Responsible pursuit of GOFR, guided by ethical considerations, is crucial for maximizing benefits while minimizing risks.