Abstract
Ethical alternatives to experiments with novel potential pandemic pathogens.
Highlights
Risk evaluations surrounding biomedical research have not kept pace with scientific innovations in methodology and application
We argue here that accepted principles of biomedical research ethics present a high bar to potential pandemic pathogen (PPP) experiments, requiring that risks arising from such experiments be compensated by benefits to public health not achievable by safer approaches
The object of most current PPP experimentation, we further argue that there are safer experimental approaches that are both more scientifically informative and more straightforward to translate into improved public health through enhanced surveillance, prevention, and treatment of influenza
Summary
Two recent publications reporting the creation of ferret-transmissible influenza A/H5N1 viruses [1,2] are controversial examples of research that aims to produce, sequence and characterize ‘‘potential pandemic pathogens’’ (PPPs) [3], novel infectious agents with known or likely efficient transmission among humans, with significant virulence, and for which there is limited population immunity. Related studies have genetically combined less pathogenic zoonotic avian viruses, such as H9N2, with human seasonal influenza viruses to generate strains that exhibit enhanced transmissibility, and to which humans would be immunologically susceptible [13,14,15]. These studies have typically been conducted in biosafety level (BSL) 3 or 3+ containment facilities. N ‘‘Gain of function’’ experiments involving the creation and manipulation of novel potential pandemic pathogens (PPPs) deserve ethical scrutiny regarding the acceptability of the risks of accidental or deliberate release and global spread. We advocate a dispassionate review of pertinent evidence and calculations of the probabilities and magnitudes of potential risks parameterized for specific PPP research programs
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