considering practical, less expensive construction and equipment options that could be sufficient in specific circumstances.
Many had similar concerns about systems used to classify pathogens (e.g., risk groups 1-4), indicating that prudent handling practices depend not only on the organism, but also the procedures to be performed and the endemic situation.2 Additionally, one person noted that for precautionary reasons, novel pathogens are usually assumed to be high-risk, and that the initial classification is rarely revisited unless the microbe causes an outbreak that overwhelms the public health system. Hence, the participant said, a systematic reassessment of organisms that downgrades pathogens when appropriate would likely speed research, improve preparedness, and increase the number of potential research collaborators.
As an alternative to the current systems, numerous participants proposed starting over and performing a full, situation-specific risk analysis. Several people pointed to the Global Laboratory Initiative’s (GLI) recommendations for tuberculosis (TB) procedures, which are described in Chapter 6, as a good example of the benefits of the risk-based approach. GLI abandoned the traditional BSL framework and instead characterized the risks associated with specific diagnostic and research procedures in detail. Instead of the previous blanket recommendation of BSL-3 labs for most TB work,3 the result is far more nuanced and allows groups to invest in infrastructure and precautions suited to the type of procedures that they actually perform.
Multiple attendees acknowledged that moving to a fully risk-based system, although desirable, would require an increase in both data and expertise. Some worried that the lack of funding for applied biosafety research and the paucity of formal accident reporting systems would make obtaining accurate information about how well particular precautions function difficult. Similarly, implementing new recommendations and procedures would require more training specific to the staff and the situation.
IMPORTANCE OF COLLABORATION
Many participants indicated that in their experience collaboration is the most successful way to transfer knowledge and expertise and that productive collaborations rely on the recruitment and involvement of credible, experience-appropriate individuals from both the donor and recipient countries. For countries that lack sufficient indigenous expertise, activities like WHO’s Train-the-Trainer programs can help fill the gap. Examples of collaborations included individual mentoring programs, such as those offered by many biological safety associations, and laboratory twinning programs like the ones sponsored by the World Organisation for Animal Health (OIE). Several individuals suggested that central (hub) laboratories could use similar mentoring and twinning mechanisms to strengthen the rest of their networks. Such a model would also allow donors and international collaborators to focus their efforts on a small set of hub labs and multiply the return on their investment. Along the same lines, assistance in ‘needs’ decision making in a region or country might consist of a joint analysis of needs rather than a simple declaration of, “Here’s what you need.” Some attendees also suggested drawing on the expertise of individuals in related fields such as those who design or work with hospital isolation rooms or members of the pharmaceutical industry who are familiar with working in a disciplined regulatory environment.
2 The BMBL does augment the classification with specific recommendations for many organisms.
3 See pages 145-147 of the BMBL (United States HHS, 2009) for current guidance on TB work.