Rose-Hulman Institute of Technology
Fresh Frozen Cadaveric Tissue Policy
Version 1.0
I.
Introduction
a. Policy Scope
This cadaveric tissue usage policy is a generalized procedural guideline for the
utilization of fresh frozen cadaveric tissues in research conducted on the campus
of Rose-Hulman Institute of Technology (RHIT), supplemental to the RHIT
Environmental Health and Safety (EH&S) Exposure Control Plan. The utilization
of tissue specimens preserved using methods other than fresh freezing requires
separate and specific safety and management protocols not included within this
policy.
b. Policy Governance
This policy in itself is only a partial governing document for the utilization of
cadaveric tissues for research purposes. Each proposed research project utilizing
fresh frozen cadaveric tissue will be individually regulated by a governing
document composed of this tissue usage policy in addition to a detailed, projectspecific research safety protocol and expense plan.
It is important to establish the fact that research conducted with cadaveric tissue
specimens is significantly different in procedure and regulation to research
involving human subjects or live animals. The use of cadaveric tissue does not
involve living human subjects; however, each proposed study should be presented
to the RHIT Institutional Review Board (IRB) for a letter of exemption.
A complete cadaveric research governing document includes the following subdocuments:
1.
2.
3.
4.
5.
Fresh Frozen Cadaveric Tissue Use Policy
Rose-Hulman EH&S Exposure Control Plan
Project Specific Research and Safety Protocol
Project Specific Authorized Personnel List
Project Specific Project Expense Plan
The entirety of the documents must be approved by the EH&S manager, and the
acting head of the Applied Biology and Biomedical Engineering Department prior
to tissue acquisition. A copy of this governing document must be available at all
times in the cadaveric laboratory.
c. Ethics
With the use of cadaveric tissue in the laboratory, the ethical and respectful use of
donated tissue is appropriate and essential in honoring the tissue donor.
II.
Authorization Procedures, Training, and Record Keeping
The principal investigator of each study is responsible for the coordination of training
procedures and record keeping with the RHIT Manager of Environmental Health and
Safety prior to the commencement of any research activities. Only trained and
authorized individuals, whether faculty, staff, students, or otherwise are permitted
access to handle and work with cadaveric tissue.
The following serves as minimum training and authorization qualifications for
authorization to work with cadaveric tissues. Training and preparatory procedures to
be coordinated with RHIT EH&S include:
a. Vaccinations
i. All personnel must have a fully completed series of Hepatitis B
vaccinations on file with RHIT EH&S as designated in Section 5 of the
RHIT Exposure Control Plan. Vaccinations may be coordinated through
EH&S, Rose-Hulman Health Services, or a personal health care provider.
ii. Any required vaccinations of RHIT students and personnel will be the
financial responsibility of the research sponsoring entity.
b. Universal Precautions Training
i. All personnel are required to complete training and gain certification in
universal precautions on an annual basis. Proof of certification must be
obtained before granted access to cadaveric facilities.
c. Bloodborne Pathogens Training
i. All personnel must complete Bloodborne Pathogen training and should be
familiar with and maintain compliance with OSHA 1910.1030 Bloodborne
Pathogens regulations. A copy of this regulation must be available in the
cadaveric laboratory at all times.
d. Exposure Control Plan Training
i. All personnel should be familiar with the RHIT EH&S exposure control
plan. A copy of this document must be available in the cadaveric
laboratory at all times.
e. Record Keeping
i. Training and vaccination records consistent with EH&S policies must be
coordinated by the principal investigator with the EH&S Manager for all
completed training sessions.
III.
Tissue Acquisition
a. Tissue Banks
i. Tissues must be acquired through registered tissue donor banks. (Contact
David Burr, IUPUI (317-274-7496) or Anatomic Gift Registry
(www.anatomicgift.com))
ii. Prior to tissue acquisition, usage, and return policies specific to the
collaborating tissue bank must be followed and made available in the
cadaveric laboratory at all times.
b. Serological Testing
i. Prior to tissue acquisition, all tissues must undergo serological testing and
be deemed free of HIV, Hepatitis B, Hepatitis C, and Syphilis.
c. Privacy
i. Following HIPAA 45CFR 1910.103 guidelines, individually identifiable
information must be removed from tissue samples prior to acquisition of
tissue.
IV.
Personal Safety
Detailed safety procedures have been established in the RHIT EH&S Exposure
Control Plan. The Exposure Control Plan is the authoritative document regarding
bloodborne pathogen safety procedures on the RHIT campus. All policies within the
Exposure Control Plan must be followed. Those policies include but are not limited
to:
a. Accident Reporting
i. Injuries and accidents must be reported immediately to the principal
investigator and the EH&S Manager through the use of a Site Coordinator
Packet. Site coordinator packets must be made available at all times in a
cadaveric laboratory (contact Manager of Risk Management, currently
Susan Butts). An accident investigation will be initiated within 24 hours
by RHIT EH&S.
b. Personal Protection Equipment (PPE)
i. All personnel should be familiar with the proper storage, use, and disposal
of PPE, and must wear appropriate PPE at all times when handling
cadaveric tissue. Use of PPE is partially dependent on the planned project,
thus detailed PPE usage guidelines for each individual project must be
outlined in the corresponding research protocol. Potential PPE protections
include but may not be limited to:
1. Latex gloves or hypo-allergenic equivalent
2. Eye Protection
3. Lab Coats and/or water resistant body suits
4. Disposable shoe coverings
5. N95 respiratory mask
V.
Facilities
Plans pertaining to facility usage, including room and equipment usage and specific
cleaning and tissue and facility management must be specified and customized in
each Project Specific Research and Safety Protocol and must be compliant with the
EH&S Exposure Control Plan. These specific protocols should include the following
general guidelines:
a. Biohazard Compliance
i. Proper biohazard signage should be displayed at the entrance of all rooms
in which cadaveric tissue will be stored or handled
ii. Biohazard sharps containers must be available for scalpel disposal
iii. Proper biohazard waste bins and disposal bags must be available at all
times in the laboratory
b. Storage
i. All cadaveric tissues must be stored in a locked freezer in a controlled
access room
c. Dissection Table
i. A stainless steel table for dissection must be available for specimen
preparation.
d. Testing
i. Tissues must only be used on approved testing equipment placed in
biohazard labeled rooms. Tissues must be under continuous supervision
by authorized personnel while not locked in designated storage areas.
e. Equipment Decontamination
i. All equipment in coming into direct or indirect contact with cadaveric
tissue must be fully decontaminated following use following EH&S
Exposure Control Plan guidelines.
ii. All non-disposable tools must be sterilized in the ABBE autoclave prior to
reshelving; contact ABBE Laboratory Technician (currently Shannon
Tieken x8997).
f. Transportation
i. Tissues may be transported between biohazard rated rooms or facilities if
wrapped in a discrete waterproof container and marked with a biohazard
label.
g. Food and Drink
i. Food and drinks are strictly forbidden in any biohazard room at all times,
regardless of the presence of cadaveric tissue.
ii. Eating, drinking, smoking, applying cosmetics or lip balm, and handling
contact lenses are prohibited in work areas.
h. Visitors
i. Visitors are strictly prohibited in any laboratory in which cadaveric tissues
is under active use, unless given the authorization by and under the
supervision of the principal investigator.
VI.
Cleanup and Disposal
a. Disinfecting
i. A disinfectant plan must be included in the Project Specific Research and
Safety Protocol and must be approved by the EH&S manager.
Disinfectants are to be used to clean floors, instrumentation, equipment,
and other non-disposable items.
b. Laboratory Materials
i. All other disposable laboratory materials which come into direct or
indirect contact with cadaveric tissue must be disposed of in a biohazard
container following Exposure Control Plan procedures. These materials
include but are not limited to:
1. PPE including gloves, masks, and shoe coverings
2. Towels, rags, coverings, etc.
3. Shipping packaging
c. Contaminated Laundry
i. Contaminated laundry, such as medical scrubs and/or lab coats should be
bagged or containerized at the location where it was used and should be
transported in biohazard-labeled bags or containers. Contaminated
laundry should either be appropriately disposed of as biohazard material,
or collected and cleaned by a commercial biohazard laundry service.
d. Tissue
i. All tissue must be collected and returned to the tissue source at the
completion of research. Procedures for the return of tissue must follow
the regulations of the source tissue bank.
e. Clean-up and Disposal Fees
i. All associated clean-up and disposal fees must be paid by the research
sponsor as agreed upon by the department and sponsor prior to initiation
of research activities within the Project Expense Plan.
Policy Approval and Review
The initial policy and any subsequent proposed adjustments to the policy shall be submitted to
the group below for review, comments, and preliminary approval.
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Department Head of ABBE – Prof. Lee Waite
Engineering Director for the Orthopedic Biomechanics Laboratory – Scott Small
Manager – Environmental Health and Safety – Jacob Campbell
Faculty Representative from ABBE – Prof. Renee Rogge
Dean of Faculty – Prof. Bill Kline
VP and CAO – Rob Coons
Final approval for release of the policy shall be granted by the President.
Revision History
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Version 1.0 – September 24, 2010, Initial release