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SIUC Institutional Biosafety
Committee Safety Standards and Procedures
Southern Illinois University at Carbondale recognizes the need to
protect faculty, staff, students and guests from incidents involving
hazardous biological materials. To accomplish this, the University will
conform to the most recent versions of applicable federal and state
guidelines in letter and spirit with respect to acceptable standards for
individuals conducting research and educational activities with hazardous
biological materials. Current copies of safety standards are available
from the Dean of the Graduate School and the Biological Safety Officer
(BSO).
Responsibility for ensuring that faculty and staff who conduct research
with hazardous biological materials conform to acceptable standards shall
rest with the Institutional Biosafety Committee (IBC) and the Biological
Safety Officer (BSO).
DEFINITIONS
Acceptable Standards: Those standards stated or
implied in the most recent versions of the National Institutes of Health
(NIH) "Guidelines for Research Involving Recombinant DNA Molecules", the
NIH "Laboratory Safety Monograph", and the US Dept. of Health and Human
Services "Biosafety in Microbiological and Biomedical Laboratories". The
minimum standards contained in the above guides shall apply unless the IBC
establishes a more stringent requirement to better serve needs unique to
SIUC facilities and personnel.
Biological Materials: These shall include living organisms, products
produced by such organisms, organic chemicals produced to mimic
activity/actions of such products, and recombinant DNA molecules.
Hazardous Materials: Any biological materials which present a risk to
the well-being of humans, animals, or plants either directly or
indirectly.
Incident: Any situation involving a hazardous agent(s) that results in
potential imminent danger to the public health or welfare.
DUTIES AND POWERS OF THE IBC:
- The IBC shall be comprised of at least ten faculty/staff members
representing various areas of expertise (e.g., microbiology, chemistry
and biochemistry, zoology, plant biology, veterinary medicine, medicine)
appropriate to the duties and responsibilities of the IBC, two members
from the community at large, and the BSO.
- Members of the IBC and its chair shall be appointed by and report to
the Vice Chancellor for Academic Affairs and Provost, or the designee of
that office. Except for the BSO, terms of appointment shall be staggered
and last for three years. Thus, three or four new members will be added
to the IBC in any given year.
- The IBC shall have three principal functions:
- Dean of the Graduate School, and Graduate Council on the
development and implementation of policies for the safe conduct of
research involving potentially hazardous biological materials and any
research involving recombinant DNA. The Graduate Council will then be
responsible for approving such policies.
- Review, approve and oversee all projects involving potentially
hazardous biological materials or recombinant DNA through review of
each researcher's Memorandum of Understanding and Agreement (MUA).
- If proposed projects or activities involving potentially hazardous
biological materials or recombinant DNA are not approved by the IBC,
all activities shall immediately cease pending appeal. The
researcher(s), BSO, and the Vice Chancellor for Academic Affairs and
Provost will be advised of such action by the IBC Chair.
DUTIES AND POWERS OF THE BSO:
- The BSO shall be appointed by the Vice Chancellor for Academic
Affairs and Provost and shall function as a primary agent of the IBC in
the daily and routine administration of the biological safety program.
Specifically, the BSO shall monitor and enforce compliance with the
safety guidelines established by the IBC. As a voting member of the IBC,
the BSO shall report to the IBC Chair as well as to the Vice Chancellor
for Academic Affairs And Provost.
- The BSO shall have responsibility for making periodic, unannounced
inspections of all facilities using biological materials considered
hazardous under existing University standards. The BSO shall also have
the responsibility to inspect and regulate facilities not currently
registered with the IBC if sufficient cause for such action is deemed
warranted by the BSO and/or the IBC.
- Any actions taken by or recommendations made by the BSO shall be
fully complied with pending review by the IBC.
IBC AND BSO PROCEDURES FOR ACTING ON AND REPORTING
VIOLATIONS:
In the event of failure to observe safety
regulations and rules on the part of any University personnel, the BSO
shall:
- Inform the IBC Chair if such deficiencies are not corrected
promptly.
- If necessary, the BSO has authority to order immediate shutdown or
cessation of work in any facility where it is evident that health
hazards exist to the extent that continued operation would result in
violation of University-adopted biosafety standards.
The Chairperson of the IBC shall report the violation to the IBC at its
next regular meeting, or call a special meeting to review the violation if
urgency makes it necessary. The IBC, after consideration, may:
- Recommend mandatory remedial action to the Vice Chancellor for
Academic Affairs And Provost. Failure to comply may result in withdrawal
of IBC approval of the existing project/activities.
- Withdraw or rescind approval of the project. In the event the IBC
takes such action, the project may no longer be conducted at the
University until such time as corrections are made to qualify the
project for reinstatement.
APPEAL PROCEDURE:
Any restraining order, decision, or application
disapproval by the IBC or the BSO may be appealed directly to the IBC. The
staff member(s) involved in such consideration may be present at the IBC
meeting and may present facts pertinent to the deliberations. A simple
majority vote of the IBC is needed to uphold or reverse decisions made by
the BSO or IBC.
IBC decisions may be appealed to the Vice Chancellor for Academic
Affairs and Provost. Appeals must be submitted in writing with necessary
supporting documentation to the IBC Chair who shall forward the appeal to
the Vice Chancellor for Academic Affairs and Provost.
Actions/decisions by the BSO/IBC must be adhered to pending final
action on the appeal.
REPORTING INCIDENTS:
It shall be mandatory for University personnel
involved in or knowledgeable about incidents to immediately report such to
the BSO. In the event the BSO is unavailable, the incident shall be
reported to the IBC Chair. In the absence of the IBC Chair, the incident
shall be reported to a faculty member of the IBC (list of current members
available in the Office of the Dean of the Graduate School). All persons
listed above shall have the authority to evacuate and close down rooms,
buildings, or any affected areas if an incident warrants such action.
The affected areas shall remain closed until the BSO is available to
direct cleanup and/or decontamination procedures. The BSO and the IBC will
determine when and under what conditions a research facility may be
reopened following an incident. Written notification to that effect will
be sent to the principle investigator/facility supervisor and copied to
the Vice Chancellor for Academic Affairs and Provost.
PROCEDURES FOR SUBMITTING MUAs:
- The principle investigator shall be responsible to submit an MUA
(see appendix) to the BSO who will forward it to the IBC for review.
- The methods section must provide enough detail for the IBC to
evaluate biological hazard risk and judge if adequate safeguards are
incorporated in the experimental design. Properties of the biological
material(s) used must be fully described. If a Material Safety Data
Sheet (MSDS) is available for the substance, a copy must be attached to
the MUA.
- All personnel involved in the experimental work must receive
training regarding biological safety practices and procedures. The
principal investigator is responsible for ensuring that this training is
conducted and for providing the BSO with training verification.
- An approved MUA is valid for a period of three years. Researchers
wishing to continue work under an old MUA must notify the BSO who will
forward it to the IBC for review.
Revision proposed to IBC 8/08/94
Approved by the IBC 5/08/95
Accepted by the Graduate Council 2/01/96
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