Biorisk Management

Biorisk management refers to risk-benefit assessment for high-risk research on pathogens.

Biorisk management includes:

identification of proposed high-risk research on pathogens (i.e., proposed research activities reasonably anticipated to increase a pathogen’s transmissibility, pathogenesis, ability to overcome immune response, or ability to overcome a vaccine or drug, or to reconstruct an eradicated pathogen)

formal risk-benefit assessment of identified high-risk research on pathogens

enumeration of risks and benefits

weighing of risks and benefits

decision to proceed as proposed, to proceed with additional risk mitigation measures, or to not proceed

before 2014: no national or international oversight of high-risk research on pathogens other than smallpox virus

2014-2017: a moratorium on federal funding for “selected gain-of-function research on influenza, SARS, or MERS viruses,” defined as research activities reasonably anticipated to increase transmissibility or pathogenicity of influenza, SARS, or MERS viruses (the “Pause”).

18 projects were paused

7 of the 18 projects subsequently were exempted (based on a declaration by the then-NIH Director Francis Collins that the projects were “urgently necessary to protect the public health or national security”)

many other projects that should have been covered under the moratorium–including the project by EcoHealth Aliance and Wuhan Institute of Virology on construction of novel enhanced SARS-related coronaviruses–were not paused, due to a failure of the NIH to identify covered projects

2014-2017: a federal deliberative process to develop a framework for oversight of gain-of-function research (the “Deliberative Process”).

2017-present: requirement for HHS-level risk-benefit assessment prior to funding of “enhanced potential pandemic pathogen research (ePPP research),” defined as research activities reasonably anticipated to increase transmissibility or pathogenicity of a potential pandemic pathogen (the “HHS P3CO Framework”)

covered projects are to be identified by HHS funding agencies (NIH and CDC)

covered projects are to be reviewed by HHS-Secretary-level committee

only 2 of the previously paused projects were reviewed under this policy

only 1 new project has been reviewed under this policy, and no projects have been reviewed since 2018

many projects that should be covered under the moratorium–including the project by EcoHealth Aliance and Wuhan Institute of Virology on construction of novel enhanced SARS-related coronaviruses–were not paused, due to a failure of the NIH to identify and forward covered projects for review

Oversight of biorisk management is performed by federal agencies that perform research and fund research, which present inherent conflicts of interests.

There are no regulations with force of law for biorisk management of research on pathogens other than smallpox virus.

The current system of risk-benefit review exists only on paper, not in practice. The NIH has nullified the current system, by failing to fulfill its responsibility to identify and forward covered projects for review. The current system of risk-benefit review is completely non-transparent. The names and agency affiliations of members of the HHS-Secretary-level committee have not been disclosed, and the proceedings and decisions of the committee have not been disclosed.

Oversight of biorisk management should be assigned to an independent national agency–i.e., an agency that does not perform research and does not fund research. (The Nuclear Regulatory Commission provides a potential model.)

Regulations with force of law for biorisk management should be enacted.

Regulations for biorisk management should be universal (i.e., independent of funding source and independent of classification status), specific, monitored, and enforced.

Oversight of biorisk management should be harmonized internationally, and oversight of highest-risk subset of research with with dangerous pathogens should be assigned to an international agency. (The WHO Advisory Committee on Variola Virus Research, which currently oversees research on smallpox virus, provides a potential model.)

Mechanisms to identify all covered research should be implemented to ensure that all covered research receives risk-benefit review.

Policies to ensure mandatory compliance with review decisions should be implemented.

Policies to ensure monitoring and enforcement of compliance with review decisions should be implemented.

The identification and review of covered research should be fully transparent.