Designer pathogensNew framework for guiding controversial research still has worrisome gaps

GMU Biodefense professor and graduate program director Gregory Koblentz and Lynn Klotz, co-managing director of Bridging BioScience and BioBusiness LLC, have written an evaluation of the December 2017 release of the latest Gain of Function (GoF) research rules.

The Department of Health and Human Services (HHS) release lifted the funding moratorium on GoF research following the controversial projects involving H5N1 in 2011. Pandora Report’s editor Saskia Popescu notes that while the HHS policy (or “Framework for guiding funding decisions about proposed research involving enhanced potential pandemic pathogens”) is similar to the Office of Science and Technology Policy guidance which was released in January 2017 (the “P3C0 Framework”), it came with the bonus of restoring funding for such research. Unfortunately, there are still considerable concerns with how GoF research is evaluated and if these frameworks have really addressed the gaps.

———————————————————————————————————
Also read:

· “Preventing intentional or accidental creation of synthetic biological threats,” HSNW, 14 February 2018

· “Step-by-step horsepox study intensifies dual-use research debate,” HSNW, 24 January 2018

· Gregory Koblentz, “The synthesis of horsepox virus and the failure of dual-use research oversight,” HSNW, 24 January 2018

· “Ban on deadly pathogen research lifts, but controversy remains,” HSNW, 15 January 2018

· “U.S. ends 3-year ban on research involving enhanced-lethality viruses,” HSNW, 20 December 2017

· Jenna E. Gallegos and Jean Peccoud, “DNA has gone digital – what could possibly go wrong?” HSNW, 15 December 2017

· “Synthetic biology and bioengineering: Opportunities and risks,” HSNW 27 November 2017

· “Lax policies governing dual-use research, scientists unaware of research’s biosecurity implications,” HSNW, 15 September 2017

· Eric van der Helm, “Biosecurity and synthetic biology: it is time to get serious,” HSNW, 1 September 2017

· “Identifying vulnerabilities posed by synthetic biology,” HSNW, 25 August 2017

· “Making gene editing safer,” HSNW, 24 July 2017
 ———————————————————————————————————

Koblentz and Klotz write:

We, the authors, harbor concerns about adequate oversight of potentially dangerous research, and the framework incorporates several elements that address those concerns. The framework is thorough. It does a good job of laying out the principles and processes through which the Health and Human Services Department will make funding decisions regarding research that involves enhanced potential pandemic pathogens. The framework’s approach to dual-use research of concern is not based on lists of experiments or on specific pathogens, but instead takes a risk-based approach that focuses on the attributes of modified organisms. While the identity of starting organisms is central to existing oversight policy for dual-use research of concern, the framework emphasizes the importance of organisms’ properties once the experiment is over. This more comprehensive approach to dual-use research is a welcome change. Some elements of the new framework, however, remain worrisome.

Koblentz and Klotz point to several limitations of the new framework – it’s too narrow and not broad enough in that it only applies to research funded by DHHS, the terminology and definitions are lacking (especially in the definition of a potential pandemic pathogen), and the review process that was created is a limited. The framework also has new criteria for risks and benefits, which is “inherently problematic” and agreement is often never achieved.

The criteria used to judge which experiments involving enhanced potential pandemic pathogens warrant review by the Health and Human Services Department—and how the risks, benefits, and ethical aspects of such experiments are measured and weighed—are ambiguous enough to provide departmental reviewers wide latitude in their funding decisions. The process and outcomes must be transparent in order to demonstrate that the process is conducted in good faith and that policy is implemented appropriately. The framework, though it recognizes the importance of transparency for maintaining public trust in science, does not go far enough in actually providing the requisite level of transparency.

Lastly, Koblentz and Klotz point to the international considerations as a considerable weakness within the new framework. “Sadly, it only applies to research done within the United States and the truth is that this is an international issue and needs global consideration and collaboration,” Popescu writes.

— Read more in Gregory D. Koblentz and Lynn C. Klotz, “New pathogen research rules: Gain of function, loss of clarity,” Bulletin of the Atomic Scientists (26 February 2018)