Ohio Administrative Code › Title 3364 - University of Toledo › Chapter 3364-70 - Research Protection and Practices › Section 3364-70-06 - Use of biohazardous materials, recombinant and synthetic nucleic acids, stem cells, and toxins in research

Current through all regulations passed and filed through July 1, 2024
(A)
								Policy
			 statement
The university of Toledo ("UToledo")
				assumes responsibility for reviewing research involving biohazardous or
				infectious materials, recombinant and synthetic nucleic acids, select agents
				and toxins, and stem cells. UToledo has a responsibility to comply with
				applicable state and federal laws and regulations, including the department of
				health and human services ("HHS") select agent regulations ( 42 C.F.R. 73 ),
				the national institutes of health ("NIH"), national research council and CDC
				guidelines (e.g. guidelines for research involving recombinant or synthetic
				nucleic acid molecules, the national institutes of health guidelines on human
				stem cell research, guidelines for human embryonic stem cell research, and
				biosafety in microbiological and biomedical laboratories) and rule
				3364-70-29
				of the Administrative Code (dual use research of concern) for microbiological
				practices, stem cell research, laboratory facilities, and safety equipment for
				select agents and toxins.
(B)
								Purpose of
			 policy
This policy summarizes UToledo
				requirements for conducting research involving the use of biohazardous or
				infectious materials, recombinant and synthetic nucleic acids, select agents
				and toxins, and stem cells conducted at the institution.
(C)
								Scope:
This policy applies to all UToledo
				faculty, students, and staff using recombinant and synthetic nucleic acids,
				biohazardous or infectious agents, select agents, and stem cells in
				research.
(D)
								Definitions
(1)
									Human stem cells ("HSC"): cells characterized by the
			 ability to renew themselves and develop into a diverse range of specialized
			 cell types. For the purposes of this policy, human stem cells include all
			 derivations of human stem cell lines and all research using human stem
			 cells.
(2)
									Human stem cell research oversight ("HSCRO") committee:
			 an ad-hoc group of the IBC created pursuant to the recommendations in the
			 guidelines for human embryonic stem cell research and the national institutes
			 of health guidelines on human stem cell research to initially and periodically
			 review, recommend modifications, secure approval, or recommend disapproval of
			 research involving the use of human stem cells.
(3)
									Institutional
			 biosafety committee ("IBC"): a university committee responsible for review and
			 approval of research involving recombinant and synthetic nucleic molecules and
			 other forms of research that entail ethical concerns and/or biohazardous
			 materials as determined by the university. Committee consists of no fewer than
			 five members. It is required that two members not be affiliated with the
			 university. Members and the chair of the IBC are appointed by the vice
			 president for research.
(4)
									Institutional official ("IO"): the individual who, as a
			 representative of senior administration, bears ultimate responsibility for the
			 program, communication to the relevant federal funding and regulatory agencies
			 (e.g., national institutes of health, center for disease control, etc.) as
			 necessary, and is responsible for resource planning and ensuring alignment of
			 program goals with the institution's mission. At UToledo the IO is the vice
			 president for research ("VPR") or his/her designee.
(5)
									Potential
			 biohazard: any agent that presents a risk or particular risk to the health of
			 humans, animals, or the environment. Biological agents or other substances
			 which could be biohazards include, but are not limited to, infectious or
			 parasitic agents; non-infectious microorganisms such as some fungi and algae;
			 human and animal cell lines; human tissues, fluids, and other
			 products1; human cadavers; human stem cells; plant products, and
			 animal tissues, fluids, and other products. Biological hazards are classified
			 as:
Biosafety level 1 Agents of no or
				minimal hazard to laboratory personnel and the environment.
Biosafety level 2 Agents of moderate
				potential hazard to personnel and the environment.
Biosafety level 3 Agents involving
				indigenous or exotic agents which may cause serious or potentially lethal
				disease as a result of exposure by the inhalation route.
Biosafety level 4 Agents involving
				dangerous and exotic agents which pose a high individual risk of
				life-threatening disease.
(6)
									Recombinant or
			 synthetic nucleic molecules ("rsNA"): under the NIH guidelines, these are
			 molecules constructed outside of living cells by joining natural or synthetic
			 nucleic acid segments to nucleic acid molecules that can replicate in a living
			 cell, or molecules that result from their replication.
(7)
									Select agents or
			 toxins: agents that HHS and USDA consider to have the potential to pose a
			 severe threat to human, animal or plant health. A list of these agents may be
			 found in the select agents' regulation ( 42 C.F.R. 73 ). High consequence
			 livestock pathogens and toxins are agents that the USDA considers to have the
			 potential to pose a severe threat to animal or plant health or to animal or
			 plant products. The plant pathogens listed by USDA have been deemed a threat to
			 plant health or products. Agents that pose a severe threat to animal health,
			 animal products and also public health are referred to as "overlap agents."
			 These agents appear on both the HHS and USDA list of agents and toxins.