Abstract

Nearly a decade later, the Commission on the Prevention of WMD was in the formative stages of drafting its report, A World at Risk, when a senior scientist at the U.S. Army Medical Research Institute of Infectious Diseases killed himself, and the FBI quickly announced that they were about to identify him as the mailer of the deadly anthrax letters. The commission's report raised the risk of biological terrorism above nuclear terrorism and stated that the nation should “be more concerned that scientists will become terrorists than that terrorists will become scientists.” About the same time, Congressional testimony and concern in the science community resulted in 4 national level studies generally addressing what we now call “the insider threat” in biology. In addition, 2 working groups on biosecurity were established in response to 2 White House Executive Orders. The 4 committee studies were completed and released over the next year.
A Defense Science Board study, Department of Defense Biological Safety and Security Program (May 2009), acknowledged the insider threat as a very difficult problem, noted that the Department of Defense had the most stringent laboratory security regulations, recommended laboratory video cameras in labs rather than a 2-person rule (1 person to watch another scientist at work), encouraged tailoring the Personnel Reliability Programs (PRP) in biological labs to avoid having a negative impact on research, and underscored the importance of public awareness regarding risk reduction.
The National Science Advisory Board for Biosecurity study, Enhancing Personnel Reliability Among Individuals with Access to Select Agents (May 2009), noted that progress in biological research is essential for the nation's future and suggested the Select Agents and Toxins list be “stratified” by risk level and that PRPs not be made part of a nationally regulated program. The study underscored the importance of strong leadership and a culture of personal responsibility in laboratories.
The Trans-Federal Task Force report, Optimizing Biosafety and Biocontainment Oversight (July 2009), supported local oversight of laboratory security programs, transparency and accountability, and coordination of national oversight of select agents and toxins to reduce the redundant regulatory burden on labs. It also encouraged development of an equivalent of the Biosafety in Microbiological and Biomedical Laboratories guide for animal and plant disease research, and it encouraged more public outreach.
Finally, the National Academies of Science released a study, Responsible Research with Biological Select Agents and Toxins (September 2009), leading with the call for building a culture of trust, engaging stakeholders, requiring government inspectors to have technical and laboratory experience, and pointing out the futility of attempting to implement an overly stringent agent accountability program.
The reports from the science community, the National Academies of Science, and the National Science Advisory Board for Biosecurity, in particular, emphasized the importance of building a “culture of responsibility” and the value of leadership in making laboratories safe and the conduct of science responsible.
We have greatly increased security, installed cameras and stationed armed guards, and implemented PRPs at our government laboratories. We have implemented select agent rules—which have negatively affected our scientists' ability to share microbial isolates with colleagues at collaborating facilities here and abroad—and we have required scientists to keep even more detailed records in an attempt to account for unmeasurable quantities of readily multiplying microbes. But what have we done to positively change the culture in our laboratories? We've done the easy part—the part that can be readily purchased or that lends itself to regulation and checklist management.
We hear little of the value of “leadership” as a measure of safety and security in our select agent labs. Successful, enlightened leaders lead with quality science, an emphasis on safety, vision, education, responsibility, accountability, honesty, transparency, and ethics. From this, a culture of trust and accountability virtually always results. Regulatory oversight may call for varying levels of physical security, “lists” and pathogen controls, background checks and psychological evaluation of workers. These, without effective leadership, may only slow research progress and lead to a culture of frustration and mistrust.
Leadership has always been important in enhancing safety for our scientists when working with hazardous pathogens. Leadership may make an even larger contribution to laboratory security through establishing a culture of responsibility, accountability, trust, and openness. Today's laboratory leaders juggle numerous responsibilities, from soliciting and managing funding, through multiple layers of oversight and regulatory compliance, to employee rights and privacy. Good leadership is not just the responsibility of the facility director or commander; it is the duty of everyone carrying the burden of supervision and management, including department or division chiefs, unit leaders, laboratory directors, and anyone with the responsibility of managing staff. A leader who is engaged with his or her staff, who greets them by name and is perceived as accessible and caring, is more likely to be able to prevent an employee from becoming disgruntled, be aware of potential problems, and be better able to intervene to prevent the employee from becoming a crisis.
Our life science enterprise, ever more important to our nation's well-being in this global economy, will never be risk free. Official biosecurity policy must include means of fostering enlightened leaders; with the leadership approach comes better science, better safety, and, we believe, even better security. Without it, the other measures become little more than the appearance of security. Troubled scientists have and will come to an engaged and enlightened leader for help, where openness has been built and trust is the currency. There is too little data to know if he or she will go to a “regulator” in a laboratory where trust is lacking.
