Current through all regulations passed and filed through September 16, 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.
(E)
IBC authority
(1)
The authority of
and the requirement for the institutional biosafety committee ("IBC") are
derived from the NIH guidelines, guidelines for human embryonic stem cell
research, the national institutes of health guidelines on human stem cell
research, rule
3364-70-29
of the Administrative Code (dual use research of concern) and this rule. The
UToledo IBC has responsibility to establish and maintain a system for the
control of biohazards and also to provide ethical review for research involving
the use of recombinant and synthetic nucleic acid molecules, biological and
infectious agents, gene therapy, select agents, and stem cells at the
university.
(2)
At its discretion, UToledo may choose to utilize an
externally-managed IBC to provide local review and oversight of research
involving biological materials (e.g., recombinant or synthetic nucleic acid
molecules, biohazardous or infectious materials), select agents and toxins
(e.g., carcinogens), human gene transfer, and stem cells.
(3)
Research
utilizing recombinant and synthetic nucleic acid technology, biohazardous or
infectious materials, select agents and toxins, or stem cells may not be
initiated until after IBC approval, or written confirmation of exempt status is
obtained. When such agents are to be introduced into live vertebrate
animals, final approval of the associated animal
use by the applicable university institutional animal care and use committee
("IACUC") will be contingent upon IBC approval of the associated protocol. When
such agents are to be introduced into live humans, final approval of the
associated human use by the applicable university institutional review board
("IRB") will be contingent upon IBC approval of the associated protocol.
Approval by the committee will be transmitted to the investigator in the form
of a memorandum from the committee chair or the designee.
(F)
IBC
roles and responsibilities:
(1)
To recommend to the vice president for research
guidelines and procedures which provide for the safe conduct of research work
involving recombinant and synthetic nucleic acid molecules, biohazardous
materials, select agents, and/or toxins;
(2)
To review and
approve protocols involving the use of potentially biohazardous materials,
recombinant and synthetic nucleic acid molecules, select agents and/or toxins
at UT;
(3)
To keep current with associated UT policies, and
federal, state, and sponsor regulations and guidelines;
(4)
To review
incident reports regarding: exposures of individuals to or accidents involving
recombinant or synthetic nucleic acid molecules and any non-compliance with IBC
requirements and determinations or the NIH guidelines. Reports of such verified
incidents will be reported to the IO and the NIH office of science policy
within thirty days, according to NIH regulation.
(5)
To develop
procedures for evaluating high risk operations involving biohazardous
materials, recombinant and synthetic nucleic acid molecules, select agents and
toxins;
(6)
To appoint a liaison to the safety and health committee
to maintain communication, and assist in laboratory inspection and
certification;
(7)
To serve as a resource to provide guidance to
investigators using biohazardous materials, recombinant and synthetic nucleic
acid molecules, and select agents and toxins.
(G)
Responsibilities
of the PI/PD
(1)
Per rule
3364-70-22
of the Administrative Code (principal investigator/project director
responsibilities on sponsored projects) the responsible party (i.e., principal
investigator/program director (PI/PD)) for research submitted to the IBC for
approval must have greater than a fifty per cent appointment as a UToledo
faculty member or staff. The PI/PD must be in a position to provide direct,
personal, day-to-day oversight of activities and personnel associated with the
IBC protocol. Any exceptions to the above criteria regarding the eligibility of
an individual to serve as the PI/PD of an IBC protocol must be approved by the
vice president for research.
(2)
The PI/PD or a
co-investigator on any research grant, agreement or contract requiring IBC
approval must be the PI/PD on the protocol(s) supporting the work described in
the research grant, agreement or contract. In the case of a fellowship
application, the faculty sponsor/mentor for the trainee applicant must be the
PI on the regulatory protocol(s) supporting the work described in the
application, and the trainee applicant must be among the authorized personnel
on the same regulatory protocol(s).
(3)
To acquire
knowledge and information needed to recognize and control biohazardous
materials in the laboratory, prior to receiving biohazardous
materials;
(4)
To select and employ laboratory practices and
engineering controls that reduce the exposure to biohazardous materials to the
lowest practicable level;
(5)
To obtain prior approval, when required, from the IBC
to conduct a high-risk protocol or procedure involving biohazardous materials,
recombinant and synthetic nucleic acid molecules, select agents and
toxins;
(6)
To adhere to IBC-approved research protocols involving
the use of potentially biohazardous materials, recombinant and synthetic
nucleic acid molecules, select agents and/or toxins;
(7)
To inform all
personnel for whom the investigator is responsible, of the hazards associated
with research involving the use of biohazardous agents, recombinant and
synthetic nucleic acid molecules, and select agents and/or toxins; instruct
them in the use of laboratory practices, engineering control, and procedures
for safe handling and for dealing with accidents involving such
materials;
(8)
To supervise the safety performance of laboratory staff
to ensure that the required laboratory practices and engineering controls are
employed;
(9)
To arrange for immediate medical attention and
occurrence reporting of any incident that results in (a) inoculation of
biohazardous materials, (b) ingestion of biohazardous materials, or (c) any
incident resulting in overt exposure of personnel or danger of environmental
contamination by biohazardous materials and immediately notify UToledo
environmental health and radiation safety;
(10)
To investigate
and report protocol deviations and problems pertaining to operation and
implementation of timely laboratory practices and engineering controls to the
biosafety officer and IBC; in accordance with applicable policy, procedure,
law, or regulation;
(11)
To report any accidents or exposures involving
recombinant or synthetic nucleic acid molecules to the biosafety officer in
environmental health and radiation safety.
(H)
Responsibilities
of laboratory personnel, including students:
(1)
Comply with
safety guidelines, regulations, and procedures required for the task
assigned;
(2)
Report unsafe conditions to the principal investigator,
immediate supervisor, or the department of environmental health and radiation
safety;
(3)
Report to the principal investigator or immediate
supervisor all facts pertaining to every accident resulting exposure to
biohazardous materials.
Appendix
The NIH "guidelines for research
involving recombinant and synthetic nucleic acid Molecules" can be obtained at
<http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html>.
Additional information regarding the
process for applying for approval for research involving recombinant DNA and/or
biohazardous materials and/or select agents/toxins may be obtained from the IBC
office. The application form is available via the university research and
sponsored programs web site < http://www.utoledo.edu/research/rsp/rc/biosafety.html>.
See also the following university
policy and federal publications:
HM-08-009 "Biohazardous agents standard
(universal) precautions for laboratories" CDC/NIH "Biosafety in microbiological
and biomedical laboratories," fifth edition, https://www.cdc.gov/labs/BMBL.htmlCDC/USDA
https://www.selectagents.gov/SelectAgentsandToxinsList.html
NIH "National institutes of health
guidelines for human stem cell research" https://stemcells.nih.gov/policy/2009-guidelines.htm
NRC Guidelines for human embryonic stem
cell research (2005) https://www.nap.edu/read/11278/chapter/1
1Human tissues, fluids, and other products (including blood,
urine, saliva, fecal materials, etc.) are only included if they are taken to or
analyzed in the research laboratory. Human tissues, fluids, and other products
that are taken to and analyzed in the hospital clinic or pathology laboratory
exclusively are not included.
