NSABB P3CO WG Preliminary Draft Findings and Recommendations RE 21 SEP 2022 NIH NSABB MEETING

Preliminary Draft for Deliberative Purposes
Preliminary Draft Findings & Recommendations

This document is intended to provide a basis for discussion and consideration of preliminary
draft findings and recommendations to help inform ongoing deliberations of the NSABB
Working Group to Review and Evaluate Potential Pandemic Pathogen Care and Oversight
(P3CO) Policy.
Policy scope and definitions

Finding 1. Potential pandemic pathogen (PPP) and enhanced PPP (ePPP) definitions. The
definitions of PPP and ePPP fail to adequately encompass pathogens that do not meet the
threshold of “likely highly virulent”, but which could also pose a severe threat to public health
or national security if the pathogen was capable of wide and uncontrollable spread in human
populations.
Recommendation 1. The definitions of PPP and ePPP should be modified to reflect the fact that
whether or not a pathogen poses a severe threat to public health, the capacity of health
systems to function, or national security is a function of both transmissibility and virulence.
Therefore, the definitions of PPP and ePPP should be modified to include potentially highly
transmissible pathogens having low or moderate virulence or case-fatality rates as well as
pathogens that are less transmissible but that have higher virulence or case-fatality rates.
Examples should be provided as an element of policy implementation guidance to illustrate
how modifications to a pathogen would or would not cross the threshold necessary to
constitute an ePPP (see recommendation 4).
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.
Policy and implementation

Finding 3. Enhanced institutional responsibility. Investigators and institutions are critical
components of a comprehensive oversight system, as they are most familiar with the research
proposed to be or being conducted in their facilities and are in the best positions to promote
and strengthen responsible conduct and ensure ongoing biosafety and biosecurity controls. The
current P3CO policy does not adequately incorporate the local review and oversight roles
played by investigators and institutions in the development, review, and ongoing oversight of
research.
Recommendation 3.
• 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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• Substantive information on biosafety and biosecurity standards, controls, and

safeguards
• Standards for review timelines under emergency and non-emergency conditions
• Expectations and standards for responsible communication of research
Other points to consider:

The USG should develop principles and guidelines that can be applied to substantiate, 1) there
are no feasible, scientifically sound alternative methods of obtaining the benefits sought in the
research in a manner that poses less risk; and 2) unnecessary risks have been eliminated and an
overall assessment of remaining risks finds that they are justified by the potential benefits to
society from the research.
Transparency and accountability

Finding 5. Review process transparency. Under the HHS P3CO Framework, proposed research
identified by the funding agency as reasonably anticipated to create, transfer, or use ePPPs
undergoes an additional multidisciplinary review by a federal department level review group.
The review group constituted by HHS appears to have the appropriate expertise, and the
process takes into account the need to protect potentially sensitive personal and proprietary
information and facilitates open discussion of issues relevant to national security and public
health preparedness within the review group. However, increased transparency in the review
process is needed. This would enable a greater understanding of, and engender trust in, review
and oversight processes for ePPP research.
Recommendation 5. The USG should take additional steps to increase transparency in the
review process. This would in part be accomplished by development and release of an
implementation plan and guidance (see recommendation 4), but the USG should also consider
sharing a summary of key determinants and decisions of USG review.
Additional Working Group considerations

Finding 6. Animal and plant pathogens. The focus of the current USG P3CO framework on
pathogens that are likely to cause disease in humans is appropriate. However, certain research
involving enhanced pathogens may pose significant threats to animal and plant health, which
could cause severe secondary impacts on human health, in addition to impacts on food
security, economic security, and national security. The USG may need to consider development
of analogous policies and processes for additional review and oversight of relevant research
involving enhanced pathogens likely to pose severe threats to human health, food security,
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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.

NSABB P3CO WG Preliminary Draft Findings and Recommendations RE 21 SEP 2022 NIH NSABB MEETING

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NSABB P3CO WG Preliminary Draft Findings and Recommendations RE 21 SEP 2022 NIH NSABB MEETING

Uploaded by

Copyright:

Available Formats

Preliminary Draft for Deliberative Purposes

Preliminary Draft Findings & Recommendations

Policy scope and definitions

Policy and implementation

• Substantive information on biosafety and biosecurity standards, controls, and

Other points to consider:

Transparency and accountability

Additional Working Group considerations

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