March 12, 2012

NIH and Dual-Use Research: Congress Focuses on H5N1 Virus

It was to be expected that the recent controversy over the deliberate genetic engineering of a possibly pandemic-level H5N1 influenza virus would not go unnoticed by Congress. Although much of the controversy regarding the research did center on whether the leading scientific journals would publish the details of the research (after being asked not to by the National Science Advisory Board for Biosecurity (NSABB), an NIH advisory committee) a threshold question remained: should the research have been done at all, or more precisely, funded by NIH?  The focus on publication was a concession to the reality that these viruses now exist, so attention focuses on containment, whether physical (obviously) or intellectual (publication strategy).  Currently, the journals are reviewing fairly detailed publications; the recent WHO meeting of public health and influenza experts expressed a preference for full, not redacted publication. But who is asking whether NIH should have funded this research?  Here it is: Congressman James Sensenbrenner, Vice-Chair of the House committee on Science Space, and Technology sent a letter to the White House Office of Science and Technology Policy (OSTP; the President’s in-house scientific experts) that asked the relevant question: “Is the NIH’s review system adequate to identify potentially dangerous dual use research?  Why did it fail to identify the avian flu research until it was completed and submitted for publication?” Note the attention in the letter to dual-use research (capable of benign and malicious uses) and whether NIH proactively considers this dimension when making funding decisions.  We might expect a Congressional hearing down the road, where both NIH (funding the research) and the NSABB (managing its publication risks) are called to account. However, full public discussion of the details of the work (to make this more complicated, the risk of the virus is now contested in a more recent and relaxed view of the dangers of the virus by investigator Ron Fouchier) might be resisted. Unresolved legal issues remain regarding the publication debate –  e.g., questions of First Amendment protection for scientific inquiry – but this is a grey area, with an advisory body (NSABB) issuing recommendations that lack the force of law. The larger question of research funding is even less clear, because NIH has wide discretion to establish the bases on which it allocates federal funding; nonetheless, Congress funds NIH annually and is legitimately positioned to magnify public scrutiny of research with potential biosecurity implications. We could imagine that a more rational scheme would consider potential complications of publication at the time of grant review and have contingencies on hand ex ante. The scramble to contain publication of the H5N1 virus details is testimony to a lack of regulatory foresight.

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