ArticleJournal of medical ethics2015
The ethics of biosafety considerations in gain-of-function research resulting in the creation of potential pandemic pathogens.
Article in Journal of medical ethics, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
19 citing papers in PubMed.
- Ethical criteria for self-identifying societal risk associated with dangerous gain-of-function research.mSphere · 2026Article
- Principal Investigator Responsibility for Flagging Research with Dual-Use or Pandemic Risk.Applied biosafety : journal of the American Biological Safety Association · 2025Article
- Dual-use capabilities of concern of biological AI models.PLoS computational biology · 2025Article
- Dual-use research and research using enhanced pathogens in high-income countries: whose business?mSphere · 2024Article
- Biosafety, biosecurity, and bioethics.Monash bioethics review · 2024Review
- Public role in research oversight.Journal of virology · 2024Article
- Bridging biosafety and biosecurity gaps: DURC and ePPP policy insights from U.S. institutions.Frontiers in bioengineering and biotechnology · 2024Article
- Socially responsible science: Exploring the complexities.European journal for philosophy of science · 2023Article
- Integrating evolutionary aspects into dual-use discussion: the cases of influenza virus and enterohemorrhagicEvolution, medicine, and public health · 2021Review
- Using, risking, and consent: Why risking harm to bystanders is morally different from risking harm to research subjects.Bioethics · 2020Article
- Article
- Regulating impact on bystanders in clinical trials: An unsettled frontier.Clinical trials (London, England) · 2019Review
- Opinion: Risk to study nonparticipants: A procedural approach.Proceedings of the National Academy of Sciences of the United States of America · 2018Article
- The dual use of research ethics committees: why professional self-governance falls short in preserving biosecurity.BMC medical ethics · 2018Article
- Ethical and Philosophical Considerations for Gain-of-Function Policy: The Importance of Alternate Experiments.Frontiers in bioengineering and biotechnology · 2018Article
- Why Do Exceptionally Dangerous Gain-of-Function Experiments in Influenza?Methods in molecular biology (Clifton, N.J.) · 2018Review
- The Silver Lining in Gain-of-Function Experiments with Pathogens of Pandemic Potential.Methods in molecular biology (Clifton, N.J.) · 2018Review
- Gain-of-Function Research: Ethical Analysis.Science and engineering ethics · 2016Article
- Article
Corrections and comments
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Authors and funding
3 authors.
Funding
Abstract
This paper proposes an ethical framework for evaluating biosafety risks of gain-of-function (GOF) experiments that create novel strains of influenza expected to be virulent and transmissible in humans, so-called potential pandemic pathogens (PPPs). Such research raises ethical concerns because of the risk that accidental release from a laboratory could lead to extensive or even global spread of a virulent pathogen. Biomedical research ethics has focused largely on human subjects research, while biosafety concerns about accidental infections, seen largely as a problem of occupational health, have been ignored. GOF/PPP research is an example of a small but important class of research where biosafety risks threaten public health, well beyond the small number of persons conducting the research.We argue that bioethical principles that ordinarily apply only to human subjects research should also apply to research that threatens public health, even if, as in GOF/PPP studies, the research involves no human subjects. Specifically we highlight the Nuremberg Code's requirements of 'fruitful results for the good of society, unprocurable by other methods', and proportionality of risk and humanitarian benefit, as broad ethical principles that recur in later documents on research ethics and should also apply to certain types of research not involving human subjects. We address several potential objections to this view, and conclude with recommendations for bringing these ethical considerations into policy development.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.