Letters

Extra Oversight for H7N9 Experiments

Science  07 Aug 2013:

DOI: 10.1126/science.1244158

Abstract

The U.S. Department of Health and Human Services (HHS) announces a new review process for certain gain-of-function (GOF) experiments with the avian influenza A (H7N9) virus, some of which are proposed this week by influenza scientists. Specifically, before being undertaken using funds from the HHS, proposed studies that are reasonably anticipated to generate H7N9 viruses with increased transmissibility between mammals by respiratory droplets will undergo an additional level of review by the HHS.

The U.S. Department of Health and Human Services (HHS) announces a new review process for certain gain-of-function (GOF) experiments with the avian influenza A (H7N9) virus, some of which are proposed this week by influenza scientists (1). Specifically, before being undertaken using funds from the HHS, proposed studies that are reasonably anticipated to generate H7N9 viruses with increased transmissibility between mammals by respiratory droplets will undergo an additional level of review by the HHS.

The HHS review will consider the acceptability of these experiments in light of potential scientific and public-health benefits as well as biosafety and biosecurity risks, and will identify any additional risk-mitigation measures needed. The review will be carried out by a standing, multidisciplinary panel of federal experts with backgrounds in public health, medicine, security, science policy, global health, risk assessment, U.S. law, and ethics. This approach, similar to that for certain H5N1 influenza virus experiments (2, 3), allows the HHS to focus special oversight efforts on experiments of concern while allowing routine characterization and other fundamental research to proceed rapidly, thereby enabling a robust public-health response.

GOF studies can provide important insights into how the A (H7N9) virus adapts to mammalian hosts, causes disease, and spreads to other hosts, but they may also pose biosafety and biosecurity risks. To ensure that research involving H7N9 virus is conducted safely and securely, the U.S. Centers for Disease Control and Prevention recently re-examined the requisite biosafety conditions for conducting experiments involving H7N9 and, in June 2013, issued interim risk assessment and biosafety level recommendations (4).

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