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New Review Process for Risky Research

02/25/2013
Kelly Rae Chi

What additional oversight will the United States impose on potentially risky research that it funds? Find out... 


The US Department of Health and Human Services (HHS) and the US Office of Science and Technology Policy (OSTP) issued two new policies that apply a higher level of scrutiny to life sciences research that could potentially be used to cause harm to the public.

The US Department of Health and Human Services (HHS) and the US Office of Science and Technology Policy (OSTP) issued two new policies that apply a higher level of scrutiny to life sciences research, such as research on the H5N1 virus seen here, that could potentially be used to cause harm to the public. Source: CDC/Cynthia Goldsmith/Jackie Katz




The guidelines are in response to a controversy that began in 2011, when two US-funded research groups submitted manuscripts for publication that described a modified H5N1 virus that could spread between ferrets through respiratory droplets.

In response to fears that the information might be misused, international researchers halted their riskiest projects in January 2012 so that governments could implement new security guidelines for such projects. Last month, after the European Union and the Netherlands implemented new guidelines, European H5N1 scientists resumed their research. But US H5N1 researchers were left without new federal guidelines, keeping their projects stalled.

But now, the HHS has announced a new framework specifically for research proposals to generate H5N1 viruses that are transmissible among mammals.

After routine scientific peer review and review for “dual-use research of concern” (DURC), which was developed last March, the framework requires two additional levels of review for such proposals.

First, proposals will undergo review at the HHS funding agency to determine whether they meet seven criteria, including whether biosafety risks to scientists and the public can be sufficiently managed and whether less risky alternative methods could address the same question.

If proposals pass this initial review, they will undergo department-level review to assess the risks and benefits in the context of HHS’s research portfolio. Department-level review will bring expertise from public health, scientific, security, and intelligence officials, and may draw in ad hoc consultants from other federal departments such as the National Science Advisory Board for Biosecurity (NSABB). This last step, which will apply only to proposals from a small number of labs across the country, will add three to four weeks to the funding application process.

Even with refinement to the criteria, some funding decisions will be subjective. “The criteria at the end of the day do require considerable judgment,” said Amy Patterson, associate director for science policy at the US National Institutes of Health, in a teleconference last week. “I don’t think that there’s any way around that.”

A proposed new policy, released by the OSTP last week and open to public comment for 60 days, applies to a broader range of experiments involving 15 pathogens or toxins, including H5N1, and experiments that qualify as potential DURC.

These rules add to the March 2012 US government guidelines, providing an explicit outline of the responsibility of federally funded researchers and institutions—including companies, associations, and universities—in developing appropriate containment strategies and other plans to carry out DURC.

Before resuming work on their ongoing projects, US researchers will need to submit an application for additional oversight.

“Making sure there are risk mitigation measures in place that don’t have the unintended consequence of preventing important science from being done—that’s another risk—while at the same time ensuring appropriate containment and observing the fact that we don’t have any instances of misuse will be the best measure that the risk mitigation has been effective,” Patterson said.

References

1. Imai, M., et al. 2012. Experimental adaptation of an influenza H5 HA confers respiratory droplet transmission to a reassortant H5 HA/H1N1 virus in ferrets. Nature 486:420–428.

2. Herfst, S. et al. 2012. Airborne transmission of influenzaA/H5N1 virus between ferrets. Science 336:1534-41.

3. Amy P. Patterson, Lawrence A. Tabak, Anthony S. Fauci, Francis S. Collins, Sally Howard. Science Express February 21, 2013 Epub ahead of print. A Framework for Decisions About Research with HPAI H5N1 Viruses. http://www.sciencemag.org/content/early/2013/02/20/science.1236194