Ohio Administrative Code › Title 3364 - University of Toledo › Chapter 3364-70 - Research Protection and Practices › Section 3364-70-29 - Dual use research of concern (DURC) - research involving select agents or toxins that provides knowledge but can also be misapplied

Current through all regulations passed and filed through July 1, 2024
(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.