A Federal Pause in Potentially Risky Influenza Research

A Federal Pause in Potentially Risky Influenza Research

CRS Insights
A Federal Pause in Potentially Risky Influenza Research
Dana A. Shea, Specialist in Science and Technology Policy (dshea@crs.loc.gov, 7-6844)
November 24, 2014 (IN10184)
Overview
Over several decades, Congress has enacted legislation to fund research into the origins and
mechanisms of the causes and transmission of disease with the intent to spur the development of
treatments and to improve public health. It has also enacted legislation in order to improve the security
of biological pathogens. A recently implemented federal research moratorium has highlighted concerns
about the general appropriateness of this research and the sufficiency of these biosecurity efforts.
Policymakers focused on the intersection of public health and scientific research may question whether
a moratorium appropriately balances federal interests in developing disease countermeasures with
concerns over the potential of altered pathogens escaping research laboratories.
On October 17, 2014, the White House Office of Science and Technology Policy (OSTP) and the
Department of Health and Human Services (HHS) announced a government moratorium on certain
research projects involving influenza, Middle East respiratory syndrome (MERS), or severe acute
respiratory syndrome (SARS) viruses. The moratorium applies to projects in which the intent of the
research is to impart to the virus enhanced pathogenicity or transmissibility in mammals. Such research
is known as "gain-of-function" research. As written, the moratorium will last until the executive branch
adopts a new gain-of-function research policy. The HHS has established the deliberative process that
will develop this policy. The process will have several parts: the development of draft recommendations
by the National Science Advisory Board for Biosecurity (NSABB) and a subsequent review and
discussion of these recommendations at a conference convened by the National Academies. The
NSABB, informed by this feedback, will then provide its final recommendations to those federal entities
that conduct, support, or have an interest in life sciences research. These recommendations will inform
the development of the new federal policy. The goal is to complete this process in less than one year.
Scope
The gain-of-function moratorium affects a small portion of federal research. The primary source of
funding for such research is the National Institute of Allergy and Infectious Diseases (NIAID), one of
the National Institutes of Health. Federal funding agencies will release no new grant funds for this
research, and federal agencies have directed their contractors to cease such work. The moratorium
allows the head of the federal funding agency to exempt on a case-by-case basis research deemed
urgent for public health or national security. In addition, OSTP and HHS encourage scientists to
voluntarily cease nonfederally funded research involving gain-of-function of these viruses until the risks
and benefits are more fully addressed.
The current mandatory moratorium follows a voluntary moratorium undertaken by scientists performing
gain-of-function research on H5N1 ("avian") influenza virus in 2012-2013. The voluntary moratorium
began after scientific and public debate over gain-of-function research performed in 2011. The
scientists involved in that research asserted that all necessary biosecurity and biosafety measures were
followed, making this research safe to perform.
Federal officials have discovered recent biosafety breaches at federal laboratories, including those of
the Centers for Disease Control and Prevention (CDC), which regulates certain laboratories for
biosecurity. Officials found undeclared pathogens located in insecure laboratories, unprotected workers
potentially exposed to pathogens, and breakdowns in approved laboratory policies and procedures. The
CDC director stated that such failures at CDC laboratories might indicate carelessness on the part of
scientists who handle such pathogens on a regular basis.

The debate over gain-of-function research has multiple facets. Some scientists argue that such
research may improve understanding of and preparation against new virus strains arising in nature.
Other scientists express concern that a ban on gain-of-function research may be too broad or poorly
defined and might span a wide array of research from aerosol transmission of avian influenza to
modification of seasonal influenza for vaccine research. Some critics of gain-of-function research
question whether such work should be done at all, given the unknown risks and benefits, and question
whether existing biosafety and biosecurity requirements sufficiently reduce the risk of accidental
infection or release. Others raise objections to the broad dissemination of gain-of-function research
results, arguing that such results might be used for malevolent purposes.
Impact
The extent and impact of the 2014 federal moratorium is unclear. Such research is predominantly
funded by HHS. The NIAID sent letters regarding the moratorium to at least 14 institutions operating
under 18 grants or contracts. That said, NIAID alone issued 1,008 grants in FY2013. Therefore, the
impact of the moratorium is likely concentrated in a narrow field. Potential deleterious outcomes of the
moratorium might include delay in obtaining research results, movement of researchers out of this type
of research due to a lack of available funding, and movement of gain-of-function research to nations
with fewer or no such restrictions.
Arguably, the broader impact may lie in the potential applicability of such a federal moratorium to other
research areas. Federal funding moratoria are relatively uncommon. The federal government has not
used moratoria to address concerns raised since 2001 over the prospects of various types of biological
research being used by malicious actors to cause harm. Instead, it has approached this issue by
releasing guidance and guidelines for review of such research. For example, HHS has released
screening guidance for synthetic DNA and a guide for identifying, assessing, managing, and
communicating dual use research of concern (DURC). This approach has generally placed the
requirement for review at the institutional level, where proposed research would be individually
assessed. The use of a federal funding moratorium may indicate an increased willingness to restrict
such research at the federal level rather than relying on a case-by-case analysis of projects at the
institutional level.