Commentary

Enhanced Oversight of Selected Research Proposed

BY HENRY METZGER, NIAMS

The U.S. government is considering new regulations for mitigating the potential for harmful misuse of new research findings.

Almost 40 years ago, advances in recombinant DNA technology prompted the scientific community to confront public concerns about biosafety issues associated with the manipulation of genetic material. Biosafety risks include laboratory-acquired infections or accidental releases of microbes that could threaten public health or agriculture. In 1974, NIH established the NIH Recombinant DNA Advisory Committee to ensure the safety of recombinant DNA research.

The rapid advances in biomedical research stimulated the broadening of the government’s concerns to also include biosecurity risks, which include the intentional misuse of research products or information to threaten public health, the environment, agriculture, or other aspects of national security.

The 1999 report “New World Coming: American Security in the 21st Century” concluded: “Rapid advances in information and biotechnologies will create new vulnerabilities for U.S. security” (http://govinfo.library.unt.edu/nssg/NWR_A.pdf).

Those concerns were heightened by the terrorist attacks of September 11, 2001, and the deliberate distribution of anthrax spores in the U.S. mail shortly thereafter. In addition, the publication of certain types of research alarmed the government and the public. In the early 2000s, for example, the media reported that scientists had created viruses in test tubes and re-engineered a mousepox virus, a relative of the smallpox virus, to be so deadly to mice that antiviral drugs and vaccines couldn’t stop it.

A comprehensive consideration of the issues raised by such “dual-use” research findings—findings that advance technology and knowledge, but that could be misapplied to pose a threat to public health and safety—led to, in 2004, the landmark National Research Council report, “Biotechnology Research in an Age of Terrorism” (http://www.nap.edu/openbook.php?isbn=0309089778) and the establishment of the National Scientific Advisory Board for Biosecurity (NSABB). Although the NSABB published, for comment, a “Proposed Framework for the Oversight of Dual Use Life Sciences Research: Strategies for Minimizing the Potential Misuse of Research Information” in the Federal Register in June 2007, it did not trigger major new government oversight initiatives (http://oba.od.nih.gov/biosecurity/pdf/Framework%20for%20transmittal%200807_sept07.pdf).

In the ensuing years, national and international meetings have been held to discuss dual-use research issues but it was not until 2011 that new research prompted further action. In that year, two groups described—and submitted papers for publication about—genetic modifications that broadened the host range for the H5N1 avian influenza to include mammals. Naturally occurring H5N1 infects chickens and other birds and can infect humans—especially farmers and poultry workers—who are in close contact with infected birds. Alarmingly, 50-60 percent of those H5N1-infected humans die, yet they don’t transmit the virus to others.

It was scary that researchers could engineer a genetic mutation of H5N1 that could spread from mammal to mammal and conceivably from human to human. Scientists and non-scientists around the world engaged in an impassioned debate over the risks and benefits of such research. Some argued that the work should not be published because it might enable someone with ill intentions to create a mutated strain of H5N1 that could set off a catastrophic global pandemic. Others, including the scientists who created the mutant strains of H5N1, pointed out that influenza can mutate to virulent forms spontaneously and that it’s important to do research to understand the makeup of the virus and how it might become virulent naturally.

On March 29, 2012, the federal government issued a policy that required its funding agencies to review funded life-sciences “dual-use research of concern” (DURC), and to establish criteria for the management of any research that is identified as DURC (http://oba.od.nih.gov/oba/biosecurity/PDF/United_States_Government_Policy_for_Oversight_of_DURC_FINAL_version_032812.pdf). The NSABB defines DURC as “research that, based on current understanding, can be reasonably anticipated to provide knowledge, products, or technologies that could be directly misapplied by others to pose a threat to public health and safety, agricultural crops and other plants, animals, the environment or materiel.”

Now the government is proposing that the institutions that conduct U.S. government–funded potential life-sciences DURC assume responsibility for overseeing such research themselves. The dual dilemma is how to develop procedures that will promote safety and security without discouraging investigators from pursuing potentially useful research.

To review the proposed “Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern” and instructions for submitting comments, go to http://www.phe.gov/s3/dualuse/Pages/default.aspx. Comments must be received by April 22, 2013.