Visibility Initiative for Responsible Science (VIRS)
The aim of VIRS is to share information about how life science stakeholder organizations approach biorisk management and the value of assessing and managing biorisks.
Rationale for VIRS
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 poses 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.
By sharing this information, we aim to help organizations initiate biorisk management programs, learn from their peers, establish norms, and improve their practices over time.
The Biorisk Management Casebook
The Biorisk Management Casebook describes an initial effort by researchers and policy experts at Stanford University, Harvard University, and NTI | bio to serve the goal of VIRS by compiling and summarizing case studies and interviews with organizations with biorisk management practices. By providing concrete details of real practice, VIRS uniquely complements other initiatives that have developed high-level recommendations for biorisk management. The approach adopted in VIRS is distinct from, and complementary to, related efforts because (i) it is grounded in original qualitative research and (ii) it serves as a pilot for using case studies as mechanisms for knowledge sharing. VIRS begins from the assumption that the details are important, both as a source of information for others to learn from and as a normative signal that sharing is safe and valuable.
This report 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.
- Additional resources and details about the methods used in this report
Our approach piloted the use of case studies as formal mechanisms for information sharing. The central premise of VIRS is that formalizing and sharing risk management practices can help to establish norms and promote cross-organizational learning. We tested this premise by co-creating case studies and by hosting two workshops with case-study organizations (comprising life science researchers, funders, service providers, and publishers) and coordinating bodies such as NTI | bio and WHO to receive feedback on our approach. Effectively, the case studies captured the “how” and “why” of organizations’ biorisk management practices in addition to the “what” of shareable information and “with whom."
|Case Study||DOI Access|
|American Society for Microbiology (ASM)||https://doi.org/10.25740/wb258gg9708|
|Centre for Biosecurity and Biopreparedness (CBB)||https://doi.org/10.25740/bz140yy7585|
|Colorado State University (CSU) Biosafety Office||https://doi.org/10.25740/ck629kc3503|
|International Genetically Engineered Machine (iGEM) Foundation||https://doi.org/10.25740/cc191wv3999|
|Massachusetts Institute of Technology (MIT)-Broad Foundry||https://doi.org/10.25740/mq491gw2822|
|National Institute for Public Health and the Environment (RIVM)||https://doi.org/10.25740/bq389xk1015|
|US Department of Energy Joint Genome Institute (JGI)||https://doi.org/10.25740/rr427mq4842|
This work is sponsored by the Nuclear Threat Initiative Global Biological Policy & Programs (NTI | bio)
To reduce these risks and strengthen biosecurity, NTI | bio works with governments, industry, academia, international organizations, and NGOs to foster multilateral dialogue, identify weaknesses, and promote systemic change to improve biotechnology governance and national health security capacities.