A Word From the President

Dual-Use Research in the Post-9/11 World

September 11, 2001. The United States and much of the rest of the world had the mother of all wake-up calls on that day, and hardly anything has been the same since. Many of the changes have been all too obvious: color-coded alerts, endless lines in airports, ubiquitous metal detectors and political debates dominated by talk of terrorism. Other changes have been a bit less obvious but no less indicative of the new reality that is likely to mark the way we live for a very long time.

The putatively sheltered realm of academe has certainly not been spared. Most academics have focused on the precautions being taken by the U.S.Citizenship and Immigration Services in the form of added scrutiny given visiting faculty, students and trainees from abroad during the visa application process. My guess is that the aggravation caused by these understandable precautions will recede with time as better information systems and better-trained personnel come on line. What worries me more is how we're going to accommodate the understandable concern about so-called "dual-use" biological research. That term applies to research yielding novel findings and biotechnologies that can be used both for the beneficent purposes of medicine and for the evil purposes of bioterrorism.

The dilemma, put simply, is how to avoid the misuse of science without stifling its legitimate ends. Not a new dilemma, to be sure. Indeed, it has been a constant companion of science throughout history. While scientific knowledge itself may be morally indifferent, virtually all science-based technological advances, from the invention of the wheel to the decoding of our genome, have the potential for malevolent applications. In the post- 9/11 world, however, the malicious use of modern biotechnologies could potentially elevate the stakes to levels rivaled only by a nuclear holocaust. One need only recall the horrific scenarios conjured up by someone's intentional release of highly refined anthrax spores shortly after 9/11.

For that reason, policymakers have been hard at work trying to find a resolution of this timeless dilemma that is commensurate with the enormity of its contemporary importance. The National Research Council (NRC) of the National Academies of Science released a report in October 2003 that acknowledged the unprecedented threat of dual use biological research and recommended obligatory review, either before undertaking or before publishing, of research that increases the virulence or transmissibility of known pathogens, creates new pathogens, confers greater resistance against standard vaccines or therapies, helps pathogens evade detection or enables weaponization of agents or toxins. Even studies of the fundamental mechanisms of disease can lead, unexpectedly, to such discoveries. In an attempt to balance the need for potentially oppressive scrutiny with science's prerequisite for free inquiry and open communication, the NRC proposed a system of review that would rely entirely on self-govern- ance by scientists and scientific journals but that would be overseen by a National Science Advisory Board.

Two months ago, HHS Secretary Tommy G. Thompson responded to the NRC's recommendations by announcing the formation of the National Science Advisory Board for Biosecurity (NSABB). Those of you familiar with the Recombinant DNA Advisory Committee (RAC) will recognize the model envisioned for the NSABB. Like the RAC, the NSABB is slated to work with the same Institutional Biosafety Committees (IBCs) that must be functioning before an institution can receive NIH support for recombinant DNA re- search. The plan is for the IBCs to conduct the first level of review for biologic experiments that have the potential for misuse. The NSABB will establish standards and guidelines for the local review and approval processes, taking into consideration both national security concerns and the needs of the research community. In so doing, it will set forth criteria to be used by the IBCs in deciding which classes of research or specific experiments should be referred to the NSABB for guidance such as:

Although this framework holds promise for addressing national security concerns while retaining open communication and local control, several questions remain to be answered by actual experience including:

• What classes of research will the IBC be required to refer to the NSABB for guidance? Given the virtually limitless scope of dual-use biological research, the potential exists for overreaching and there-by hobbling large categories of important research.
• Are IBCs, as currently configured, in a position to fulfill the purposes envisioned by the NSABB plan? Their activities in fulfilling the purposes of the RAC are viewed by many as more proscriptive and bureaucratic than deliberative. Moreover, the additional burdens being placed on IBCs could compromise their ability to carry out their other important functions.
• Will the creation of the NSABB open the way for a new and untested mechanism for controlling the dissemination of scientific information and, even more important, the performance of research itself? At present, the only reliable mechanism for preventing the sharing of research results is to "classify" the research prospectively as secret. No provision currently exists for prospective identification of a "sensitive but unclassified" category of research or information, and the NRC's report specifically recommended against adopting such a category. Nevertheless, it is not hard to envision some "classification creep" occurring over time that could culminate in precisely the kind of scientific censorship and constipated information flow that could have a chilling effect on our scientific enterprise.

There are no tailor-made answers to dealing with the unique set of realities that 9/11 laid at our feet. Finding a satisfactory resolution to the dilemma posed by dual-use biological research is a challenge we cannot duck. The test of our free society will be the extent to which we can meet such challenges while preserving our values, both scientific and otherwise.

Jordan J. Cohen, M.D.
AAMC President

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