NSABB P3CO WG Preliminary Draft Findings and Recommendations RE 21 SEP 2022 NIH NSABB MEETING
NSABB P3CO WG Preliminary Draft Findings and Recommendations RE 21 SEP 2022 NIH NSABB MEETING
Finding 2. Exclusions and urgent review during public health emergencies. The identification of
ePPP research is informed by the current body of scientific evidence, knowledge, and adequacy
of biosafety controls, and necessarily entails some degree of uncertainty. It is therefore
important for assessments and evaluations to be made in light of current scientific knowledge
and to be updated in response to new findings. The focus for assessment should be on the
potential for an activity or a modification to produce a pathogen that meets the criteria for an
ePPP and not on the context in which this activity or modification is carried out.
All research activity that is reasonably anticipated to involve the creation, transfer, or use of
ePPPs should be subject to the additional consideration under the U.S. Government (USG)
P3CO framework. However, the often-critical contributions that surveillance and vaccine
research activities make to public health response are recognized and necessitate mechanisms
to ensure that if ePPP research is identified and deemed critical to public health or national
security, its review should not be unduly delayed.
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Recommendation 2. Because the review and evaluation of ePPP research considers risks and
benefits, including whether the research is critical to public health or national security, the USG
should reconsider the current exclusions for research activities associated with surveillance and
vaccine development or production, which could be broadly interpreted as blanket exclusions.
Processes should be instituted for urgent review or evaluation of ePPP research that is
determined to be critical for a public health response or national security under a declared
public health emergency, or as otherwise directed by the Secretary, Department of Health and
Human Services.
• USG P3CO framework should articulate the specific roles, responsibilities, and
expectations for investigators and institutions in the review or evaluation of research for
potential involvement of ePPPs, taking into account existing review and oversight
processes.
• Local compliance procedures should be better harmonized, strengthened where
needed, and resourced.
• A USG contact entity should be designated to assist investigators and institutions in the
review process and to provide oversight to ensure adequate evaluation.
Finding 4. P3CO policy and implementation directives. The additional review process outlined
under the OSTP Recommended Policy Guidance for Departmental Development Mechanisms
for Potential Pandemic Pathogen Care and Oversight (OSTP P3CO Policy Guidance) and HHS
Framework for Guiding Funding Decisions of Proposed Research Involving Enhanced Potential
Pandemic Pathogens (HHS P3CO Framework) are generally appropriate as designed at the
federal department level. However, Section III.3 and III.4 of the OSTP P3CO Policy Guidance
regarding risks and benefits are inconsistent with similar policies as described in the Belmont
Report. Additionally, Section IV.C of the HHS P3CO Framework indicates extra care in reviewing
proposed research that is reasonably anticipated to generate an outcome from one of the
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seven categories of research outlined in that section is only required at the HHS department
level review.
Beyond the HHS P3CO Framework, an implementation directive from HHS to HHS funding
agencies is lacking. Guidance from the federal funding agency for research institutions and
principal investigators are also lacking. Both are needed to effectively implement the HHS P3CO
Framework. The lack of an implementation directive and guidance has contributed to
uncertainty, resulting in a lack of clarity regarding the timing and expected requirements of the
review process, and potential opportunity costs associated with investigators being deterred
from pursuing important research or careers specializing in certain pathogens. Additional
education and guidance would facilitate consistent and efficient implementation by all
stakeholders and enhance awareness and consideration of potential biosafety and biosecurity
issues throughout the research life cycle, including during the development of research
proposals.
Recommendation 4. P3CO framework. Section III.3 and III.4 of the OSTP P3CO Policy Guidance
should be modified to be consistent with the Belmont Report. For example, Section III.3 should
be modified to, “There are no feasible, scientifically sound alternative ways of obtaining the
benefits sought in the research in a matter that poses less risk”. Section III.4, “Risks that are not
necessary to answer an important scientific question have been eliminated and an overall
assessment of remaining risks finds that they are justified by the potential benefits to society
from the research.”
The types of research of concern outlined in Section IV.C of the HHS P3CO Framework should
be given extra care and considered throughout the research proposal and review process, by
principal investigators, institutions, and federal funding agencies (including those outside HHS)
in addition to the federal department-level review.
Implementation directives. The USG should dedicate resources and personnel to the
development of an implementation directive/plan, additional guidance, educational materials,
and standard operating procedures, including regarding ongoing oversight, that can be used or
adapted by funding institutions, research institutions, and investigators when implementing the
policy. The companion guide and other material developed to aid implementation of the USG
dual use research of concern (DURC) policies may serve as a model. An implementation plan
should outline clear roles and responsibilities for investigators, institutions, federal funding
agencies, and federal departments. Guidance and education material should include:
• Steps, considerations, and criteria for identifying research that could generate ePPPs
• Types of questions and information considered at each stage of review
• Types of risks and benefits assessed (risks should include consideration of short and
long-term risks and potential consequences)
• The expected components of material evaluated (e.g., risk/benefit analysis, risk
mitigation plan, etc.)
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economic security, or national security by its impacts on animals or plants or to animal or plant
products.
Finding 7. P3CO and DURC. ePPP research can be considered a subset of DURC. There are
substantive overlaps between the intent, purpose, and entities involved in the implementation
of policies for the oversight of ePPP research and DURC. Acknowledging that the review and
evaluation of USG DURC policies is ongoing, this Working Group supports consideration of
possible revisions that would incorporate ePPP research into the DURC oversight framework.
However, it remains important that the principles identified above be included in a proposed
consolidation of ePPP research safeguards with DURC safeguards and that review and oversight
processes and risk mitigation measures be commensurate with the degree of risk posed.