(A)
Policy statement
The university of Toledo "UT" is
committed to safe, legal and ethical use of biologically-derived materials in
research. Some research, conducted for legitimate purposes, can yield materials
or knowledge that can be used for both beneficial and harmful purposes. Such
research can be dual use. Research is categorized as dual use research of
concern "DURC" as per federal regulation and guidance in the United States
government policy for institutional oversight of life sciences
DURC.
(B)
Purpose of policy
This policy outlines the UT
institutional review and oversight process for research involving certain
high-consequence pathogens and toxins in order to identify DURC and mitigate
associated risks.
(C)
Definitions
Dual use research: research conducted
for legitimate purposes that generates knowledge, information, technologies,
and/or products that could be utilized for both benevolent and harmful
purposes.
DURC: life sciences research that,
based on current understanding, can be reasonably anticipated to provide
knowledge, information, products, or technologies that could be directly
misapplied to pose a significant threat with broad potential consequences to
public health and safety, agricultural crops and other plants, animals, the
environment, material, or national security.
Institutional contact for dual use
research "ICDUR": an individual designated by the institution to serve as an
institutional point of contact for questions regarding compliance with the
implementation of the requirements for the oversight of DURC. The ICDUR is
appointed by the vice president for research "VPR." The VPR or his/her designee
will serve as the institutional official "IO" and report to the relevant
federal funding agencies as required.
Institutional biosafety committee
"IBC": a committee established by the institution to review all biohazardous,
recombinant and synthetic nucleic acid research as per rule
3364-70-06
of the Administrative Code.
Institutional review entity "IRE": a
sub-committee of the IBC appointed by the vice president for research to review
all research with dual use potential. The IRE will include a minimum of five
persons with sufficient expertise to assess the research and risk mitigation.
Ad hoc members may be added to the IRE as needed to provide specific expertise
for any matter under review. Ad hoc members will have voting
rights.
Principal investigator "PI": an
individual who is designated by UT to direct a project or program and who is
responsible for its scientific and technical direction.
(D)
Scope
(1)
All research
directly involving the biological agents and toxins listed in paragraphs (D)(3)
of this rule Is subject to additional review and oversight. PIs are ultimately
responsible for ensuring that all research involving these agents is submitted
to the IBC which may refer the research to the IRE for review of dual use
research potential.
(2)
Research that directly involves
non-attenuated1forms of one or more of the following
agents or toxins and produces, aims to produce, or can be reasonably
anticipated to produce one or more of the effects listed in paragraph (D)(4) of
this rule must be evaluated for DURC potential.
(3)
Agents and
toxins
(a)
Avian influenza virus (highly pathogenic)
(b)
Bacillus
anthracis
(c)
Botulinum
neurotoxin2
(d)
Burkholderia mallei
(e)
Burkholderia pseudomallei
(f)
Ebola
virus
(g)
Foot-and-mouth disease virus
(h)
Francisella tularensis
(i)
Marburg
virus
(j)
Reconstructed 1918 influenza virus
(k)
Rinderpest
virus
(l)
Toxin-producing strains of Clostridium
botulinum
(m)
Variola major virus
(n)
Variola minor
virus
(o)
Yersinia pestis
(4)
Effects of concern
(a)
Enhances the
harmful consequences of the agent or toxin;
(b)
Disrupts immunity
or the effectiveness of an immunization against the agent or toxin without
clinical and/or agricultural justification;
(c)
Confers to the
agent or toxin resistance to clinically and/or agriculturally useful
prophylactic or therapeutic interventions against that agent or toxin or
facilitates their ability to evade detection methodologies;
(d)
Increases the
stability, transmissibility, or the ability to disseminate the agent or
toxin;
(e)
Alters the host range or tropism of the agent or
toxin;
(f)
Enhances the susceptibility of a host population to the
agent or toxin;
(g)
Generates or reconstitutes an eradicated or extinct
agent or toxin listed in paragraph (D)(3) of this rule.
(E)
Responsibilities
(1)
PIs
(a)
Prior to
initiation of research, submit a protocol to the IBC for any research involving
infectious agents, recombinant or synthetic DNA, bacteria, viruses, plasmids,
fungi, parasite, protozoa, live cell analysis, human tissues, fluids or cell
lines (including stem cells), nanomaterials with biological properties, and
select agents and toxins or biological tissues.
Notify the IBC of the use of select
agents or toxins or effects of concern (paragraph (D)(4) of this
rule).
(b)
If the IBC identifies a DURC, the protocol will be
referred to the IRE:
(i)
No work can be conducted until a risk mitigation plan
has received approval from the NIH or U.S. government funding agency and final
approval is obtained from the IRE.
(ii)
The PI will work
with the IRE to assess the dual use risks and benefits of the DURC and develop
risk mitigation measures.
(iii)
The PI will
ensure that laboratory personnel conducting research determined as DURC by the
IRE have received instruction and training in DURC and work in accordance with
an approved risk mitigation plan.
(iv)
If changes are
needed in an IRE-approved risk mitigation plan, the PI will work with the IBC
and IRE to revise the plan. Prior to implementation of any changes, the IO will
provide such changes to the U.S. government funding agency or NIH for review
and approval.
(2)
Institutional
responsibilities
(a)
Establish and recommend policies and practices that
provide for the identification, oversight and mitigation of risk of
DURC.
(b)
The IBC will screen all IBC protocols for dual use
potential.
(i)
If the protocol involves any of the agents/toxins in
paragraph (D)(3) of this rule, the IRE will determine if the proposed research
meets the federal definition of DURC.
(ii)
If the protocol
does not involve one of the agents or toxins in paragraph (D)(3) of this rule,
but does produce or is reasonably anticipated to produce one or more of any of
the effects listed in paragraph (D)(4) of this rule, IBC will refer the
protocol to the IRE to analyze the risk/benefit and develop a risk mitigation
plan when necessary.
(c)
Within thirty
calendar days of the IRE's determination of that the research meets the
definition of DURC, provide notification to the applicable federal funding
agency (sponsor) of any research that involves one or more of the fifteen
agents and toxins and one or more of the seven experimental effects listed
above. The IO will provide notifications to the U.S. government funding agency
or NIH for review, approval or other required reporting. For non-federally
funded or unfunded research, notification will be made to NIH, which will in
turn refer the notification to an appropriate federal agency, based upon the
nature of the research.
(d)
Within ninety calendar days of the IRE's determination
that the research meets the definition of DURC, provide a copy of the draft
risk mitigation plan developed by the IRE and PI to the applicable federal
agency for its review and approval;
(e)
Within thirty
calendar days of any change in status of a DURC project (including when the
research is determined by the IRE to no longer meet the definition of DURC) or
any proposed change to the risk mitigation plan, provide notification of the
change to the applicable federal agency.
(f)
Within thirty
calendar days, provide notification of instances of non-compliance with this
rule, as well as mitigation measures undertaken to prevent recurrences of
similar non-compliance to the applicable federal agency.
(g)
The IRE will
review research which involves non-attenuated forms of one or more of the above
listed agents and toxins for DURC potential. The environmental, health and
radiation safety department will provide guidance on review, risk mitigation,
and training:
http://www.utoledo.edu/depts/safety/Dual%20Use%20Re
search%20of%20Concern.html
Appendix A: resources
Tools for identification, assessment,
management, and responsible communication of dual use research of concern: a
companion guide to the United States government policies for oversight of life
sciences dual use research of concern. Available from:http://www.phe.gov/s3/dualuse/Documents/durc-companion-guide.pdf
United States government policy for
institutional oversight of life sciences dual use research of concern.
Available from:http://www.phe.gov/s3/dualuse/Documents/durc-policy.pdf
United States government policy for
oversight of life sciences dual use research of concern. Available
from:http://www.phe.gov/s3/dualuse/Documents/us-policy-durc-032812.pdf
1 The
only forms of the listed agents and toxins that are considered to be attenuated
can be found in the Select Agent and Toxin Exclusions list under "Attenuated
Strains of HHS and USDA Select Agents and Toxins" athttp://www.selectagents.gov/SelectAgentsandToxinsExclusions.html.
If an attenuated form of any of the listed agents is subjected to any
manipulation that restores its virulence or toxic activity, the resulting agent
or toxin will be subject to oversight.
2
There are no exempt quantities of botulinum neurotoxin at UT for research or
clinical trials. Research or clinical trials involving any quantity of
botulinum neurotoxin must be reviewed by the IRE and evaluated for DURC
potential.
