Stakeholder Engagement Workshop on the Implementation of the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern: Workshop Report

This report documents the discussions of the 2017 Stakeholder Engagement Workshop on the Implementation of the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern. It is not an official record of the Stakeholder Engagement Workshop. It was compiled to assist the research and policy communities as they consider updating U.S. Government (USG) policies on Dual Use Research of Concern (DURC). Neither the National Institutes of Health (NIH) nor the National Science Advisory Board for Biosecurity (NSABB) produced a report out of the workshop, and it is hoped that this summary of the discussion, based on analysis of the videos of the workshop, will be useful for those interested in the development of the United States Policies on dual use research of concern.

Daniel Greene and I analyzed the workshop, and drew together four themes from the discussions:

  • There are many different ways that institutions have composed their Institutional Review Entities (IREs), which are responsible for assessing the DURC potential of research carried out at the institution.
  • While there were a wide array of mitigation strategies employed, institutions rarely used redaction or blocked publications, instead focused on tailoring communication of the scientists, emphasizing the value of the research to the public and avoiding being inflammatory or drawing attention to misuse. Institutions also increased safety and security measures after conducting DURC reviews, and modified experiments to reduce the risks they posed.
  • While most of the speakers at the workshop said that DURC policies had minimal impact on research productivity, several participants noted examples of research slowdown, and claimed that oversight burdens had disincentivized potential DURC research, with specific examples of researchers stopping their projects once it became apparent that their research might be DURC.
  • The question of whether the overall scope of implementation of the policy was sufficient to capture concerning research appeared throughout the conversations as a central and ongoing challenge. At least six participants at the workshop noted examples of research that either had been done or could be done that could merit the label “DURC”, but that did not involve the 15 agents and 7 experiments of concern named in the USG DURC policy.

Background

It is essential for the USG’s system of DURC governance to adapt to new potential risks as they arise. Indeed, this was part of the original mandate of the USG DURC policy.

Because oversight of DURC will be a new undertaking for many institutions, the USG has limited the scope of the [Policies] to a subset of life sciences research that involves 15 agents and toxins and seven categories of experiments. The USG will solicit feedback on the experience of institutions in implementing the Policy for Institutional Oversight of Life Sciences DURC. The USG will assess the benefits and risks of expanding the scope of the Policy for Institutional Oversight of Life Sciences DURC, and will update the Policy as warranted.

NIH (National Institutes of Health). “Implementation of the U.S. Government Policy for Institutional Oversight of Life Sciences DURC: Frequently Asked Questions.” September 2014.

This workshop report is intended to support the process of feedback described above. We hope that it facilitates continued refinement of US policy regarding dual-use research of concern.

The NSABB would logically be a main site where discussions could be had around whether current governance mechanisms for “dual use” biological research are adequate, but it is effectively dormant right now, and has been essentially since 2017. In its only meeting in the last four and a half years, held in January 2020, the NSABB was charged to reexamine both the DURC and subsequent P3CO policies. Work on this charge was delayed while responding to the COVID-19 pandemic, but the challenge remains of how we learn to deal with dual use. In the absence of the NIH reconvening the NSABB, we can still lay the groundwork for empirical assessments of what it is like “from the ground” to practically implement current policies of “dual use research of concern” (DURC). Increasingly, biosafety and biosecurity practitioners are documenting their current working practices, but we need more spaces to formally assess the adequacy of our current policies. We also need support from all quarters in experimenting with other biosecurity governance measures. This workshop report provides both a basis for us to compare other’s experiences with DURC oversight, and a chance to spark further discussion about what DURC policies miss and how they might change and be complimented.

Citation

Evans, Sam Weiss, Daniel Greene, Connor Hoffmann, and Stefan Lunte. “Stakeholder Engagement Workshop on the Implementation of the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern: Workshop Report.” SSRN Scholarly Paper. Rochester, NY: Social Science Research Network, November 2, 2021. https://doi.org/10.2139/ssrn.3955051.