Abstract
Over the past 15 years, Gryphon Scientific has studied the practices in high-containment laboratories as part of our work to inform risk assessments of research on pathogens, including the Site Specific Risk Assessment of the National Bio- and Agrodefense Facility, 1 the Gain of Function Risk and Benefit Assessment, 2 and the WHO's Global Action Plan to minimize poliovirus facility-associated risk. 3 In this research, we found that many high-containment laboratories have implemented practices that they created that were not found in other facilities. Although developed to address facility-specific gaps in biorisk management, these practices were mitigating risks that were commonly found in many facilities. These practices were often simple and low cost (such as policies, procedures, plans, or informational sheets).
Although the practices were relatively straightforward to implement, they were only found in one (an innovation) or a small handful of institutions (a best practice) simply because scientists and biosafety professionals at many other institutions were unaware of the practices. Moreover, researchers and biosafety professionals did not understand that they were being truly innovative and so rarely communicated their innovations to their peers.
We hypothesized that, if these innovative practices were gathered and discussed broadly, more institutions could copy or adapt those relevant to their facilities and immediately address residual risks. Therefore, funded by generous support from the Open Philanthropy Project, we set out in mid-2021 to systematically identify these valuable practices and disseminate them.
To identify potential best practices and innovations, we held one-on-one discussions with more than 50 biorisk management practitioners. In this phase, we focused our data collection on researchers and biosafety professionals in the United States and Canada, although we did interview a few experts from Europe and Australia. Previously, we have found that those with valuable practices did not know they were being innovative. Indeed, many people we reached out to for this study initially suggested that they did not have any ideas worth talking about (and perhaps this statement underscores how even those in the biosafety community feel about the subordinate status of biosafety to the bench research it is trying to enable).
For this reason, instead of asking participants to list their innovations, we held a discussion focused on the process of biorisk management, specifically how they managed risks that were unexpected or not encountered previously. Innovations were found when new tools or systems were needed to address risks that were previously underappreciated. From these discussions, we identified more than 150 practices. With help from seasoned biosafety professionals, we sorted these practices by novelty, their ability to substantially reduce biological risks, and their possibility for broad applicability.
To further evaluate these practices, we held a 2-day workshop in Washington DC on July 7 and 8, 2022. In this workshop, more than 20 speakers discussed the practices that we found were innovative and broadly beneficial with the assembled group. The discussion focused on exploration of potential barriers to the wider implementation of the practices and situations in which the practices would not be beneficial to implement.
Clearly, the discussion of 150 practices in 2 days is impossible. The presentations (and the discussions that followed each set of presentations) focused on practices that were more complex or had significant potential barriers to their implementation. For the rest of the practices, deemed more straightforward, obviously beneficial and/or with few barriers to their wider application, we used a survey to gather the group's opinion. We set aside time in the workshop to discuss practices for which the participants disagreed were beneficial or for which significant barriers were found in the survey.
The information gathered in the workshop is currently being analyzed and used to draft an article that describes the practices that were found to be widely beneficial, the barriers to the implementation of these practices, and means to overcome these barriers. To ensure the broadest dissemination of the information gathered, we intend to publish these best practices and innovations as an e-book on our company's website that will be feely accessible in early 2023. This editorial is our first measure to communicate with the biosafety community in anticipation of its publication.
Regarding what to expect next, we have already begun holding discussions with researchers and biosafety professionals in low-resource settings, to identify practices that are suitable for addressing biological risks in laboratories that may not have access to the consumables or equipment that benefit laboratories in more highly resourced parts of the world. We intend to reach a similar number of stakeholders in these settings as we did for the first phase of our study. In the winter of 2023, we will host a workshop similar to that held in Washington DC, but focused on participants and practices drawn from low- and middle-income countries. We intend to publish another article on these practices in the summer of 2023.
We are aware that the first phase of our work was heavily skewed toward a U.S. perspective in that fewer than 10 of our participants in the discussions came from outside the United States (primarily Canada and Europe). For this reason, in the third and final stage of this effort, we will reach out to researchers and biosafety professionals in well-resourced countries besides the United States. We hope to use this information to host a workshop in conjunction with the EBSA conference in the spring of 2023. We then plan to update our innovations and best practices article with a more global perspective.
Even though this project represents many months of research, we recognize that we are identifying only a fraction of the innovations and best practices that are implemented today. We talked to a very small portion of those working on pathogens. Moreover, we wished to hold discussions with many more people, but some were unavailable during the study period due to their duties during the pandemic. Given that there is probably a wealth of additional practices yet to be identified, future efforts may be valuable and could easily add to the studies we are currently developing. If others want to take on this research effort, we would be happy to share our discussion guides to help draw out the innovations.
In the next few years, this effort should be evaluated to determine whether the simple elucidation and dissemination of these practices truly do lead to their broader implementation and the betterment of biorisk management more broadly. This evaluation could be accomplished by a survey to determine who was aware of the study and what practices were adopted based on it. Future versions of the article could be updated to remove those practices that have become widespread and add newly contributed innovative and best practices.