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The following policies and procedures have been adopted by the Wright State University Institutional Biosafety Committee.
This document was last updated: April 10, 1998
B. Establish policies and make recommendations to the University
regarding such activities.
C. Maintain and promote an open and cooperative relationship with
investigators and the greater University community.
D. Educate the Wright State University community concerning the
regulatory requirements for the use of these agents.
II. IBC Charge
B. The IBC is charged with:
2). reviewing facilities that require oversight, and
3). being aware of what agents are in which labs.
C. The Committee also has the charge of monitoring federal, state,
and local regulations and assuring WSU's compliance with these
regulations.
III. Responsibilities
Wright State University is responsible for providing a safe working
environment for all University activities and for compliance with
all applicable federal, state, and local regulations concerning
the use of biological agents, biological toxins, and recombinant
DNA. Institutional responsibilities include the establishment
and support of an Institutional Biosafety Committee, the appointment
of an Institutional Biosafety Officer, and the establishment and
support of a Department of Environmental Health and Safety.
2) Ensure that all members of the Institutional Biosafety Committee
are adequately trained in appropriate containment practices, secondary
containment procedures, and accidental spill containment procedures
to fulfill their responsibilities as members of the Institutional
Biosafety Committee.
B. Institutional Biosafety Committee (IBC)
2) Develop, recommend, and implement policies and procedures for
biological risk assessment and biological risk reduction throughout
the University.
3) Develop emergency plans for the containment and resolution
of accidental spills and other related emergencies with an emphasis
on risk reduction, personnel protection, and environmental protection.
4) Oversee all research and teaching activities involving biohazardous
agents including review and approval prior to initiation, annual
reviews and updates, reviews of laboratory safety equipment and
procedures, and certifications of compliance with all applicable
rules and regulations governing the use of biohazardous materials.
5) As an agent of the Institution, ensure that all principal investigators
are sufficiently trained in appropriate containment practices,
secondary containment procedures, accidental spill containment,
and their responsibilities as principal investigators.
6) Advise and provide technical expertise, whenever possible,
to the Institutional Biosafety Officer on matters regarding biosafety.
7) Conduct investigations of serious violations or problems and
to make recommendations to the Associate Provost for Research
for the resolution of continued non-compliance or serious infractions.
C. Institutional Biological Safety Officer (IBSO)
2) Investigate laboratory accidents and report problems, violations,
injuries, and illnesses associated with biohazardous research
activities to the Institutional Biosafety Committee.
3) Develop and implement emergency plans for handling accidental
spills and personnel contamination.
4) Provide advice and assistance to the Institutional Biosafety
Committee and Principal Investigators concerning containment procedures
and practices, laboratory security, recommended laboratory containment
equipment, rules, regulations, and other matters as may be necessary.
5) Provide oversight and assurance that laboratory safety containment
equipment is functioning properly including field testing and
certification, where appropriate, of all biosafety cabinets.
6) Serve as a member of the Institutional Biosafety Committee.
D. Environmental Health and Safety (EHS)
2) Transport and dispose of all infectious wastes in compliance
with all applicable federal, state, and local ordinances.
3) Assist, as necessary, in the emergency response, cleanup, and
decontamination of biological spills and accidents.
4) Administer the University Occupational Health Program.
2) Serve as the Office of Record for documentation involving the
Institutional Biosafety Committee.
3) Provide all necessary documentation, forms, regulatory guidelines
and regulations, etc., for Principal Investigators.
2) Ensure that animal housing systems are designed and utilized
in a manner that will minimize the potential exposure of other
animals or personnel to potentially biohazardous agents.
3) In cooperation with the investigator, the Institutional Biosafety
Officer, and the Institutional Biosafety Committee, develop and
implement specific standard operating procedures, in adherence
to the Animal Biological Safety Level (ABSL) classification of
the agent being used, addressing animal care, research procedures,
and procedures in case of accident or equipment failure.
4) Ensure that all animal care personnel are adequately trained
and aware of the potential risk associated with each agent.
5) Develop, in cooperation with the Institutional Biosafety Officer,
emergency plans for handling accidental spills, personnel exposures,
unintentional animal exposure, equipment failure, etc.
2) Submit protocol applications for all activities or modifications
of activities involving biohazardous materials and obtain approval
by the Institutional Biosafety Committee prior to initiation of
the activities or modifications.
3) Ensure that all laboratory staff, including students, are trained
in the accepted procedures in; laboratory practices, containment
methods, disinfectant and disposal practices, utilization of all
laboratory protective equipment (see Item H-3), and required
actions in the event of accidental spill.
4) Develop a Laboratory Safety Plan, including an emergency action
plan for accidents and spills, as an addendum to this manual,
when required.
5) Ensure compliance with all shipping requirements for biological
agents and toxins.
6) Ensure proper handling and disposal of all infectious wastes
as outlined in the WSU Infectious Waste Management Guide. (See
Appendix D, Institutional Biosafety Manual.)
7) Request immunizations for all personnel when working with biological
agents for which there is an effective vaccine available.
8) Maintain all biosafety equipment in appropriate operating condition.
Decontaminate laboratory equipment prior to maintenance or disposal.
9) Maintain records of microorganisms and toxins used in the laboratory
and biosafety cabinets.
2) Follow all procedures and containment methods established for
activities conducted.
3) Properly utilize all laboratory protective equipment including
proper clothing, personal protective equipment, and containment
devices.
4) Report all accidents and spills to the Principal Investigator
or the Institutional Biosafety Officer as soon as possible.
5) Report unsafe conditions to the Principal Investigator, the
Institutional Biosafety Officer, or the Institutional Biosafety
Committee.
IV. Committee Composition & Structure
The following guidelines will apply to the IBC composition and
structure:
B. The IBC shall have a vice-chair who will execute the responsibilities
of the chair in the chairís absence.
C. The vice chair shall be someone who has served at least one
year as a member of the IBC and shall serve as vice-chair for
a term of two years. Service as vice chair will be renewable
for additional terms if agreeable.
D. Committee members shall serve for a term of two years. Service
will be renewable for additional terms if agreeable.
E. Committee members who have served a term of two years and choose
to discontinue service shall suggest potential replacements.
F. The IBC shall endeavor to have a non-faculty member of the
technical (e.g., Unclassified) staff represented on the IBC.
B. Meetings will be held monthly at a standing time and date.
Additional meetings may be called as described in section II.D.
C. Any member of the Committee may call for a role call vote on
any issue(s) being reviewed, discussed, or decided by the IBC.
D. Any member of the Committee may call for a special meeting
of the IBC to deal with a topic as specified by that member.
This request for a special meeting shall be made in writing to
the Chair and shall include the reason(s) for the request and
the topic(s) to be discussed. Such a special meeting shall be
called within 14 days of the written request for such meeting.
E. Any Committee member, acting on their behalf or on the behalf
of a non-member, may call for an investigation by the IBC of laboratories
or actions not in compliance with appropriate safety guidelines,
for a potential protocol violation, or for work not being done
on an approved protocol.
This investigation shall be conducted as described in the "Procedures
for Dealing with Allegations of Noncompliance" section of
this document.
F. Management of protocols containing proprietary information.
2) To resolve the conflict, protocol applications will be accompanied
by a letter which will specify whether proprietary information
is included in the application.
Types of information which may be considered proprietary:
3) This list is not inclusive. When questions arise relating to
specific guidelines or matters which may be unclear, investigators
should contact the Office of General Counsel.
4) The protocol will be discussed in executive session. The following
pertain to the conduct of executive sessions.
5) Following the executive session, the IBC will reconvene in open meeting for the purpose of a formal vote on any actions conducted during the executive session.
VI. General IBC Approval Procedures
2) All protocols will be reviewed via a Triage System:
3) Following review, one (1) of three (3) determinations will
be made:
4) At any meeting, action on a protocol also may be deferred (i.e.,
the protocol tabled) pending receipt of additional information
and/or clarifications. Any such tabled protocol shall be reconsidered
at the next convened meeting after receipt of requested information.
During an Administrative Review (see Item III. B., below),
the Institutional Biosafety Officer may also defer action on a
protocol pending additional information and/or clarification.
5) Multiple DNA segments can be incorporated into the same petition
if they share a similar source and/or host.
6) IBC numbers will be assigned to all petitions regardless
of review status (e.g., exempt).
7) P.I.'s may be invited to present their protocols to the committee
and to be available to answer committee questions. In such cases,
the P.I. will be excused prior to discussion and voting.
B. General IBC Approval Procedures for BSL-1 and BSL-2
2) Annual Review of BSL-1 and BSL-2 protocols are conducted administratively by the Biosafety Officer with notification of the IBC unless full Committee review is either requested by the administrative review or is mandated by other such policy.
3) Investigators may appeal usage decisions by the Institutional
Biosafety Officer through petitioning of the IBC followed by a
full Committee hearing. The IBC may call a special meeting to
expedite the appeal process if necessary
4) Written descriptions of protocols that involve the use of biohazards
shall be made available to all IBC members, and any member of
the IBC may obtain, upon request, full committee review of those
protocols.
2) Protocols that have been approved pending receipt of clarifications
not involving major changes may be approved by the Chair
plus one other IBC member with notification of the IBC.
3) Clarifications involving major changes are returned
to the full committee. The IBC determines whether a clarification
should come back to the committee at the time it grants approval
pending clarification to the protocol.
4) Annual Reviews of BSL-3 protocols are conducted by the
full IBC Committee.
E. Certifications of Current Protocol Approval
are carried out by Research and Sponsored Programs (RSP) with
notification of IBC.
F. The five (5) year review of a protocol
will be conducted following the ìFive (5) Year Review Policyî.
G. Protocols involving the use of Class 4 Biohazards
are not permitted.
H. Where required, the need for multiple-committee review (e.g.,
IBC and LACUC) will not be waived.
VII. Procedures For Conducting a Continuing (Annual) Review
of Protocols
2) If a response is not obtained, the protocol will be inactivated
after an appropriate warning.
B. Screening
b. If there are no changes, or minor changes, then continuing
protocol approval will be handled as a minor amendment.
c. If the Biosafety Officer believes the committee should review
the continuing review information, the protocol will be handled
as an amendment.
2) Screening procedures for BSL-3
b. Any changes in protocol/procedures will be handled as an amendment.
VIII. Procedures for Dealing with Allegations of Noncompliance
(e.g., Laboratories or Actions Not in Compliance with the Appropriate
Safety Guidelines, for Potential Protocol Violations, or for Work
Being Done Without an Approved Protocol).
B. The IBC Chair will appoint a subcommittee to determine if the
complaint has sufficient substance to warrant a full investigation.
All persons involved in the investigation will be informed of
the purpose of the investigation and the manner in which it will
be conducted. In its investigation, the subcommittee will examine
all pertinent documents and procedures, will interview involved
personnel and will report its findings to the Chair. If there
is an indication of noncompliance, the Chair will call for an
investigation by the full IBC. If there is indication of serious
noncompliance, the IBC may recommend that the Institutional Official
suspend impacted activities pending the outcome of the full investigation.
The full committee investigation will be held during an executive
session and all persons against whom the complaint is made will
be given the opportunity to appear. Following the executive session
and in an open meeting, any recommendations from the investigation
will be voted upon and Committee members will be given the opportunity
to present minority views. The IBC will inform all parities involved,
including the complainant, of the committeeís findings.
C. Following the investigation, the committee will recommend to
the Institutional Official any appropriate remedial action warranted
and an appropriate specified time period for compliance.
IX. Five (5) Year Review Policy
Each protocol shall be unique and shall be active for a maximum
period of five (5) years. At the end of this five year period,
it shall be automatically inactivated and all activities covered
under it shall be considered complete.
Ongoing or additional activities as may be required by the specific
protocol must be submitted and reviewed as a new protocol
which will be assigned a new IBC number.
IBC Numbers shall be unique and not reused.
X. Facilities and Program Review
As part of its ongoing duties, the IBC needs to assure itself
that its facilities oversight is adequate and that its policies
and procedures, petitions, and method for conduction reviews are
up to date.
To that end, the following procedures have been adapted.
2) Acting as support/liaison between EHS and the administration
in issues concerning biological safety.
3) Continuation of the monthly EHS report to the IBC.
B. Program Evaluation:
The IBC should conduct a periodic self-evaluation of its overall
program. This review will be an agenda item at least annually.
This evaluation should include a review of all aspects of the
IBC program, including, but not limited to, review of its Policies
and Procedures document, its petition for requesting review of
activities, its administrative procedures, previous year activities,
and its protocol review procedures.
C. Facilities Walk-through:
The IBC should conduct a periodic 'walk-through' of the laboratories
with approved IBC protocols. The purpose of this 'walk-through'
would be to maintain open communications between the Committee
and investigators and also to ensure that the Principal Investigators
and all associated laboratory personnel are complying with generally
accepted safety practices, containment procedures, and approved
protocols. These walks-through will make every attempt to minimize
disruptions to laboratory functioning and should not cause intentional
disruptions of normal laboratory safety conditions.
XI. Principal Investigator's Training Requirements
B. This training may be demonstrated by either completing
the Wright State University biosafety training course or,
if they have previous training, by completing a questionnaire
in which such prior training is documented.
C. Any such documentation of previous training will be evaluated
by a standing subcommittee of the IBC.
D. Prior to biohazard use, all training documentation must be
on file with the Institutional Biosafety Officer.
E. Principal Investigators are responsible for insuring that their
staff will be trained regarding the appropriate Biosafety Level
policies and procedures to employ with each agent and that this
training is documented.
XII. Miscellaneous
2) After major repairs and changes of the filter
3) When relocated
4) No less frequently than annually
B. The Committee strongly encourages that all new BL-2 cabinets purchased by WSU have National Sanitation Foundation (NSF) certification.