December 9, 2012

Regulation of Highly Pathogenic Avian Influenza H5N1 Virus Research: NSABB, NIH, CDC

Earlier this year, the controversy over recent scientific experiments that produced potentially pandemic-level viruses (highly pathogenic avian influenza H5N1; HPAI) largely centered on the merits of publishing such research. The National Science Advisory Board for Biosecurity (NSABB) initially recommended against publication by scientific journals, but later relented and supported publication (one in full, one edited). The broader question of whether such experiments should be funded by the National Institutes of Health (NIH) at all – the HPAI H5N1 work in both laboratories received NIH support – was left unanswered. However, in March, the NIH published its policy for the oversight of life sciences dual research of concern (DURC) (research capable of benign and malicious uses, such as the recent HPAI H5N1 experiments). More recently, the NSABB has returned to the difficult questions regarding the funding of DURC. At last week's NSABB meeting, the NIH unveiled a potentially more exacting review process to determine whether or how the “gain-of-function” experiments that produced the HPAI H5N1 viruses should be funded. "Gain-of-function” refers to research that is undertaken to investigate the genetic structure of viruses, but, in the process, results in the production of an even more dangerous virus. Could such an outcome be avoided? To illustrate how NIH would assess that possibility, the proposed NIH framework asks that applicants declare that their work is unlikely to produce a “gain of function” virus, unless that could demonstrate that such a virus is likely to occur naturally. Can that be meaningfully answered? The wild card in the attempt to set up a risk-managed funding program is how scientists can imagine the biological sources of risk before actual research has identified or confirmed such details.

The proposed framework from NIH also links public funding with public disclosure: “As a general matter, HHS should only fund research that is reasonably anticipated at the proposal stage to generate information, products, and technologies that can be openly communicated.” This statement recalls the controversy earlier this year, where the risks from already completed research were to be managed by publication controls imposed after the fact. The NSABB will hold a public workshop on gain-of function experiments with HPAI H5N1 viruses on Dec.17-18, 2012 to discuss "the implications of such research for global public health, risks and concerns associated with this research; the risks of not pursing this type of research; fundamental principles regarding the conduct and oversight of such research; and conditions under which such research might be conducted." The lineage of these discussions post-9/11 goes back to the 2004 National Research Council report, Biotechnology Research in an Age of Terrorism (Fink Report), as well as the NSABB’s own 2007 framework, which amplified the Fink Report’s concerns and signaled the need for points of intervention at the funding or communication stages of the research trajectory. Thus, these questions are not new; they are just made more acute by recent events and HPAI H5N1 viruses have become the pathogens of concern. To illustrate that point, the Centers for Disease Control (CDC) has published an announcement in the Federal Register asking for comments on whether HPAI H5N1 influenza should be added to the CDC list of select agents (such classification would authorize closer monitoring of research projects). Further, HHS has carved out a class of select agents with the greatest risk of misuse (Tier 1) and asks whether the classification should obtain for this influenza strain, given its properties. Comments are due by December 17, 2012.

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