It’s really hard to talk about the actual practice of biorisk management. After brainstorming about this at a 2018 NTI workshop in London with Megan Palmer (Stanford) and Stella Hurley (Science), NTI funded Megan to run a team of postdocs led by her and myself to begin the Visibility Initiative for Responsible Science (VIRS) with a mandate to engage a diverse set of organizations that fund, support, perform, or publish life science research to identify insights and strategies that may enable systematic improvements in biosecurity and biosafety risk management across the research lifecycle.
Two years later, the VIRS team, including Daniel Greene, Melissa Salm, Kathryn Brink, and Connor Hoffman are pleased to release the Biorisk Management Casebook, an analysis of cross-cutting observations on biorisk management that apply broadly to organizations across the life science research ecosystem and to the ecosystem itself.
International advisory boards, national academies, professional societies, and members of the scientific community have called on organizations involved with life science research to manage the biosafety and biosecurity risks that can accompany discovery and innovation.
As a result, several initiatives have proposed biorisk management strategies in generalized frameworks and guidance documents. However, the breadth of biorisks and the diversity of life science research pose challenges to the development, adaptation, and consistent implementation of management frameworks. Moreover, organizations lack access to concrete examples of how extant frameworks are or have been implemented in practice, hindering their ability to learn from one another about what works and under which circumstances.
The Casebook synthesizes the observations from our research, expert consultations, interviews, and case studies and organizes them into four sections:
- Key Challenges & Opportunities: Cross-cutting observations on biorisk management gathered through VIRS that apply broadly to organizations across the life science research ecosystem and to the ecosystem itself.
- Detailed Findings: Summarized observations of biorisk management practices collected from our case studies and interviews, describing (i) the conditions organizations describe as important for establishing their practices, (ii) the practices they use, and (iii) the mechanisms they may use when coordinating their efforts with other stakeholders.
- Suggested Initiatives: Descriptions of options for future initiatives to further improve biorisk management and information sharing.
Complementing the Casebook are a collection of eight case studies containing descriptions of organizationsʼ practices. Here are links to each of the case studies:
- American Society for Microbiology (ASM) Journals
- Centre for Biosecurity and Biopreparedness (CBB)
- Colorado State University (CSU) Biosafety Office
- International Genetically Engineered Machine (iGEM) Foundation
- Massachusetts Institute of Technology (MIT)-Broad Foundry
- National Institute for Public Health and the Environment (RIVM)
- United States Department of Energy Joint Genome Institute (JGI)
Different ways to read the Casebook
You might review the Findings section and relevant individual case studies (Appendix 3) for the granular detail necessary to update or improve your practices. Case studies contain extensive detail about when and how risks are assessed and mitigated, and how risk management systems are reviewed and improved over time. Practitioners might also find value in using the case study template (Appendix 2) to document and reflect on their own biorisk management practices.
You might like to review the Key Challenges & Opportunities and Findings sections to learn about how current risk-management policies are implemented, identify their limitations, and take inspiration for potential improvements. For example, Section 3.2.1 notes the influence of policy frameworks on the scope of biorisks that organizations consider, and Section 3.3.1 describes the importance of government policy and legal frameworks for empowering organizations such as Denmarkʼs Centre for Biosecurity and Biopreparedness (CBB) to review research projects across the life science research life cycle.
If you are promoting the development and promulgation of biorisk management norms, you might like to connect with the individuals and organizations identified in the Contributors section and review proposed future work in Section 4, Suggested Initiatives.
Biological and Chemical Weapons Policy Analyst, Pacific Northwest National Laboratory
“This wonderful report is so well researched, detailed, and filled with useful information. It’s probably the best report on biorisk management I have seen.”
Former Assistant Director for Biosecurty and Emerging Technologies, White House Office of Science and Technology Policy
“This systematic study will be of considerable value to improving biorisk assessment and mitigation practices.“
Chief Executive Officer, National Institutes of Health of Pakistan
“A very consolidated and well written document, which will set the pace for future discussions to build upon!”
This work would not be possible without the contributions of:
- 16 collaborators from our case study organizations who worked extensively with us to ensure that the case studies accurately represented their organizations and their practices;
- 20 more individuals who, although unable to commit their organizations to the development of a full public case study, shared their experiences without attribution to the benefit of the Casebook and our analysis;
- 61 experts across a variety of fields with whom we consulted to refine our approach and our insights over the course of this project; and
- 17 external reviewers who provided extensive feedback on a draft of the Casebook.