Phil Potter, Ph.D.

DURC Committee Chairman

IBC Vice Chair
St. Jude Childrens 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)