(A)
Purpose
The purpose of this rule is to ensure
the proper management and disposal of cadaveric tissue within the
university.
(B)
Scope
This rule governs the acquisition of
cadaveric tissue to be used and disposed on the Rootstown campus as part of any
research or educational presentation.
(C)
Definitions
(1)
"Cadaveric
tissue" refers to tissue, including parts thereof, from a cadaver, or the dead
body of an animal or human. Cadaveric tissues can be fixed or
unfixed.
(2)
"Fixative" refers to a substance that is added to
products such as biological samples, or tissue to prevent decomposition by
microbial growth or by undesirable chemical changes.
(3)
"IACUC" refers to
the institutional animal care and use committee.
(4)
"Preservative"
refers to a substance that is added to products such as biological samples, or
tissue to prevent decomposition by microbial growth or by undesirable chemical
changes.
(D)
Procedure
(1)
Notification and request to use procedures
(a)
Any person
seeking to bring non-human cadaveric tissue to the Rootstown campus must
provide written notification to the institutional animal care and use committee
(IACUC) regarding the acquisition of the cadaveric tissue before it is brought
to and used on campus. The IACUC must also approve all cadaveric tissue
requests, from both NEOMED and non-NEOMED individuals who wish to use tissue
from cadavers of animals previously utilized in NEOMED research.
(i)
Any individual
intending to use non-human cadaveric tissue must inform the IACUC in writing of
the plan to do so. This communication must contain the following
information:
(A)
Type of tissue to be acquired;
(B)
Amount of tissue
requested;
(C)
Source of the tissue (Note: if an abattoir is to be
used, please include the facility's United States department of agriculture
registration number);
(D)
Description of how the tissue is preserved (if
applicable);
(E)
Where the tissue will be used;
(F)
Brief description
of the proposed tissue use;
(G)
How will the
tissue be disposed of (coordinated via the safety office per paragraph (B) of
this rule; and
(H)
A statement must be included that states the animal
were not euthanised specifically for the intended purpose.
(ii)
The
communication shall be addressed to the current IACUC co-chair via e-mail or
written correspondence, with a copy sent to the regulatory affairs coordinator
in the comparative medicine unit (CMU). All such communications should be
forwarded to the regulatory affairs coordinator.
(iii)
The IACUC
co-chair will review the request and send their acknowledgment, or request for
additional information, to the regulatory affairs coordinator. Once
acknowledged, the regulatory affairs coordinator will notify the requesting
individual(s) in writing of the IACUC decision. A copy of the communication
will be kept on file with the IACUC records. The CMU manager also will be
notified of the tissue request and IACUC decision.
(b)
Request for use
of human cadaveric tissue shall be referred to the chair of anatomy and
neurobiology for appropriate consideration and handling in accordance with
university practices and the standards of the NEOMED body donor
program.
(c)
Request and use of any human cadaveric tissue related
to an approved research project and unrelated to the NEOMED body donor program
will be subject to the approval of the appropriate safety committee(s) and in
accordance with regulations in place on the NEOMED campus that governs such
use.
(2)
Requirements for the safe use and disposal of
tissue
(a)
Personal protective equipment (PPE)
Any person handling of any form of
tissue is required to wear steril gloves at all times. If a significant splash
hazard exists, safety goggles or glasses are required. If the tissue contains a
formalin-based preservative, additional PPE or controls may be recommended or
required.
(b)
Preservative (fixative)
Tissue must be preserved in a fixative
that is free of any carcinogenic properties (i.e. formalin, formaldehyde,
paraformaldehyde) if the tissue will be used or handled as part of a
demonstration to minors. If a preservative is present, the chemical mixture of
the preservative must be reported to the NEOMED safety office. Additional
safety requirements may be applicable, particularly the tissue is preserved in
a manner different than required by this rule.
(c)
Waivers
Educational events for minors that
utilize cadaveric tissue may require waivers, permission slips or additional
requirements as determined by guidelines on waivers for minors by the office of
the general counsel.
(d)
Request for
supplies and/or disposal
(i)
All disposal must be coordinated through the office of
environmental and occupational health and safety.
(ii)
To ensure proper
disposal for tissue that is unrelated to an approved research project, a work
order must be submitted to campus operations with the details of the event,
including the following:
(A)
Date and time of event;
(B)
Date and time of
pickukp of tissue or sharps for disposal;
(C)
Location of
event;
(D)
Responsible person for event;
(E)
Any supplies
requested for disposal (sharps containers, tissue containers and regular trash
cans for waste not otherwise regulated);
(F)
An indication of
whether the tissue (or any related sharps) used are infectious. The infectious
nature of any tissue or sharps is determined based on the following
considerations:
(i)
Whether the sharps were used on people;
(ii)
Whether the
tissue was deliberately infected with an infectious agent or biohazard;
and
(iii)
Whether the tissue is human in origin.
(G)
An
index to which any fees for disposal or containers can be
charged.
(iii)
Disposal related to an approved research project will
be subject to the appropriate safety committees and regulations in place on the
NEOMED campus that govern the disposal and will be subject to separate "lab
disposal" requirements.
(iv)
If the tissue is being purchased and utilized during an
educational event provided on the Rootstown campus by a third party, the
organizer of the educational event should address the appropriateness of the
tissue being disposed of by the third party with the office of environmental
and occupational health safety.
Replaces: 3349-3-143
Notes
Ohio Admin. Code
3349-1-143
Effective:
10/14/2024
Promulgated Under:
111.15
Statutory
Authority: 111.15
Rule
Amplifies: 3350.12
Prior
Effective Dates: 07/29/2024
