Phil Potter, Ph.D.

DURC Committee Chairman
IBC Vice Chair
St. Jude Children’s Research Hospital

Why does DURC/GOF affect St. Jude?




NIAID Centers of Excellence for Influenza Research and
Surveillance; WHO Collaborating Center for Studies on the Ecology
of Influenza in Animals (PIs Drs. Webby and Schultz-Cherry)
Influenza-positive samples (of unknown genotype) submitted to St.
Jude from all around the world
Highly pathogenic avian influenza virus is one of the organisms
regulated by DURC and GOF
Sequencing, biochemical and in vivo studies are performed on
derived virus
Swapping of viral segments is frequently undertaken to assess role
of identified mutations

DURC/GOF assessments

DURC committee consists of both scientists and nonscientists with PI responsible for espousing the
risks/benefits of the proposed studies

Areas of concern
– No GOF in virus resistant to antiviral agents
– Availability of vaccine
– Difficulty in evaluating ‘gray’ areas (‘altering host range and/or tropism’)
– Ferret as gold standard for biological testing

St. Jude DURC committee has categorized H7N9 studies as
‘durc’

NSABB draft recommendations

Good initial draft that provides guidance to PIs and Institutional
officials

Criteria for assessing GOF research are reasonable, but are
not specific (terms ‘highly’, ‘significant’ and ‘likely’ are used)

For example, point iii ‘pathogen generated is likely resistant to
control measures…’. St. Jude DURC committee would ensure
parental influenza virus is sensitive to oseltamivir prior to
approval

Questions to address

Where is the current policy framework succeeding?
– Criteria are well founded and cover required attributes of novel organisms
– Process for scientific evaluation is straightforward
– Expectations for PI and review committees are clear
– DURC committee would likely have expertise to assess GOF research

Major gaps and weaknesses in the current framework
– For DURC 15 selected organisms (excludes non-avian pathogenic influenza)
– Ambiguity in policy wording results in grey areas
– Unclear whether local IBC and DURC committees can categorize science as
DURC or GOF

What is the most important problem(s) that need(s) to be addressed?
– GOF guidelines need to be CRYSTAL clear
– Who to contact if issues arise?

Other concerns

If local IBCs and IREs can categorize science as DURC or GOF,
might this lead to a patchwork of institution-dependent rules?

If PI can justify risk/benefit to DURC/IBC committees and USG,
should GOF studies be prohibited?

For example, I would argue that we are scientifically more
informed for knowing the amino acid residues responsible for
enhanced mammalian transmission of influenza virus (residues
that were only identified via GOF studies)

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