Stanford University's Bio Policy & Leadership in Society Initiative (Bio.Polis), in collaboration with the Program on Science, Technology & Society at the Harvard Kennedy School and with support from the Global Biological Policy and Programs team at the Nuclear Threat Initiative (NTI | bio), is pleased to announce the launch of The Biorisk Management Casebook: Insights into Contemporary Practices. The Casebook and the accompanying Biorisk Management Case Study Collection gathers and analyzes how biorisk management is practiced in diverse life science organizations across the research lifecycle.

As life science research matures globally, it is also vital to mature the management of biosafety and biosecurity risks that can accompany discovery and innovation. In this context generalized frameworks for biorisk management have been developed alongside guidance documents. However, the breadth of risks and the diversity of organizations supporting research pose challenges to the continued development, adaptation, and implementation of these frameworks. In addition, organizations lack access to concrete examples of how frameworks are or have been implemented in practice, hindering their ability to learn from one another. 

In response to these challenges, researchers from Stanford University and Harvard University launched the Visibility Initiative for Responsible Science (VIRS) to help organizations share their biorisk management approaches to help their peers to learn from and improve their practices. VIRS was conceived by a multi-stakeholder group that included funders, publishers and researchers during a 2019 workshop of the Biosecurity Innovation and Risk Reduction Initiative (BIRRI) - an NTI | bio project.

Supported by NTI, VIRS produced The Biorisk Management Casebook: Insights into Contemporary Practices and an accompanying collection of Biorisk Management Case Studies. 

About the Casebook and Case Studies

The Biorisk Management Casebook highlights the variety of practices that organizations throughout the world currently employ to manage risks related to lie science research. The Casebook compiles and summarizes findings generated from over two years of research, including consultations and interviews with over 70 experts and biorisk management practitioners that elicited insights from dozens of organizations. It identifies key challenges and opportunities, prototypes formats for sharing biorisk management practices, and suggests future initiatives to further improve biorisk management and information sharing.

VIRS collaborated with eight organizations to develop a collection of case studies containing detailed descriptions of local biorisk management practices. These Biorisk Management Case Studies prototype a format by which organizations can share their practices, and try to advance a norm that sharing can be valuable both for the organization being highlighted and others that seek to learn from its work.

The Casebook was launched last month at the Global Biosecurity Dialogue workstream meeting by Megan J. Palmer, Stanford University Adjunct Professor of Bioengineering and CISAC affiliate and former Executive Director of Bio Policy & Leadership Initiatives, and Sam Weiss Evans, Harvard Kennedy School Senior Research Fellow. The dialogues bring together senior officials from ministries of foreign affairs, health, defense, agriculture, and other relevant sectors to address these limitations and identify new and measurable actions to advance international biosecurity. 

"This Casebook is an initial step at addressing a major gap in biorisk governance today: the difference between top-level policy and the local processes that have to manage the 'grey zone' where it is unclear whether and how policies should be applied," said Evans.

"This work demonstrates that increased transparency around biorisk management can be useful and achievable if practically supported by efforts to document and facilitate exchanges between stakeholders," said Palmer.

Aamer Ikram, the CEO of National Institutes of Health of Pakistan, called the Casebook "a very consolidated and well-written document, which will set the pace for future discussions to build upon." Gerald Epstein, Former Assistant Director of Biosecurity and Emerging Technologies at the White house Office of Science and Technology Policy, notes the novelty of the report, saying that "the problem it addresses is important and previously unaddressed; the methodology taken is well-constructed and appropriate to the task, and the findings and initiatives are well-reasoned. This systematic study will be of considerable value to improving biorisk assessment and mitigation practices." Weiwen Zhang, distinguished professor of synthetic biology and biochemical engineering at Tianjin University of China, emphasized that "by sharing information about how and why organizations assess and manage biorisks, this work can serve as a foundation for future visibility initiatives in identifying emerging best practices and establishing norms." 

Research Team

VIRS and the Biorisk Management Casebook is one of the many projects coming out of the Bio Policy & Leadership in Society (Bio.Polis) Initiative at Stanford University. The project was led by Megan J. Palmer and Sam Weiss Evans, and carried out by CISAC Biosecurity Innovation & International Security Fellows Melissa Salm, Daniel Greene and Kathryn Brink, alongside social science research professional Connor Hoffman.

Megan J. Palmer now serves as Senior Director of Public Impact at Ginkgo Bioworks.

Daniel Greene now serves as Senior Analyst in Biosafety, Biosecurity and Emerging Technologies at Gryphon Scientific LLC.

Kathryn Brink now serves as an Associate Director in the Executive Office of BioMade.

About NTI

The Nuclear Threat Initiative is a nonprofit, nonpartisan global security organization focused on reducing nuclear and biological threats imperiling humanity. NTI's Global Biological Policy and Programs team (NTI | bio) provided support for this report.