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28-02-2013 | Article

Pandemic-caliber research is a go depending on new review gauntlet

Abstract

HHS proposed policy

medwireNews: A voluntary moratorium to halt work on a deadly avian virus is over upon the release of a proposed framework for funding dual research of concern by the Department of Health and Human Services (HHS).

The rules impact experiments involving 14 potentially dangerous biological agents and, in particular, a highly pathogenic avian influenza (HPAI) H5N1 virus that can be transmissible by respiratory droplets between mammals.

The new review process will take into account the scientific and public health benefits, biosafety and biosecurity risks, and any safety measures that the proposed research might demand.

"Although this virus is not currently well adapted for sustained human-to-human transmission, there have been over 600 laboratory confirmed human cases reported since 2003 [with] a mortality rate of approximately 60%," Amy Patterson, Associate Director for Science Policy at the National Institutes of Health (NIH), told a teleconference.

The rules stem from a strong global reaction to two 2011 studies funded by the NIH that produced and examined the transmissibility of HPAI H5N1 with concern over the possibility of accidental or intentional release of an engineered virus that can transmit efficiently among humans can lead to a global pandemic.

"Recent surveillance studies indicate that this [the natural appearance of the virus] is a real possibility," Patterson said. "[F]urther understanding of this virus is a public health imperative." Proposals for research that require the production of HPAI H5N1 will undergo added scrutiny from funding agencies and Departments to ensure they meet HHS acceptability. The proposals must initially satisfy concerns based on scientific merit and dual use research, followed by the funding agency determining whether the research is in accord with other criteria.

These criteria include queries about the necessity of the research; whether a natural evolutionary process can produce the virus that is to be generated artificially, as well as if the research addresses a scientific question that carries high significance to public health. Questions about biosafety risks and how to mitigate them are also part of this review phase.

Any proposals that do not meet the standards that are considered acceptable for HHS funding through Department-level review are deemed ineligible for funding agency support.

The so-called "gain of function research" would look at laboratory modified strains of virus and the ability to obtain new attributes that cause and transmit disease.

The HPAI virus first appeared in Hong Kong in 1997 and is currently endemic in several countries around the world.

By Peter Sergo, medwireNews Reporter