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Texas Tech University |
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Texas Tech University (TTU) Institutional Biosafety & Hazardous Material
Committee Guidelines |
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Click on the links below to go to a particular topic.
 Biosafety
Manual
Texas Tech Institutional Biosafety and Hazardous Material
Committee
Registration Requirements
- recombinant DNA
- infectious agents (human, animal & plant pathogens)
- human or non-human primate materials (body fluids,
tissues, cell lines, etc.)
- human gene transfer
- investigational live, recombinant and/or attenuated
virus strains
- recombinant DNA or infectious agents with animals
- hazardous chemical research protocol review
Registration Process & Biohazard Application Form (Word
File)
Review and Approval Process
Self-Audit
Tools
- Biosafety Level 2 Checklist (Word
File or
PDF File)
- Instructional narrative (Word
File or
PDF File)
IBC Members
IBC Charge
IBC
Structure
Biosafety
Resources |
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Texas Tech Institutional Biosafety and Hazardous
Material Committee (IBC) |
An Institutional Biosafety Committee (IBC)
is required at institutions that receive funding from the National Institutes of
Health (NIH) for research involving recombinant DNA molecules. All recombinant
DNA research at Texas Tech University (TTU), regardless of funding source, must
be conducted in accordance with the NIH Guidelines for Research Involving
Recombinant DNA Molecules (http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html)
and must be registered with the TTU IBC.
The TTU IBC is further charged with reviewing and approving research conducted
with microorganisms pathogenic to humans, plants, or animals and substances that
are known to exhibit unusual acute or long-term chronic health hazards
(carcinogens, reproductive toxins and highly acutely toxic pressurized gases).
This review is conducted pursuant to the Centers for Disease Control and
Prevention (CDC)/NIH publication, Biosafety in Microbiological and Biomedical
Laboratories (currently in 4th edition, 1999; (http://www.cdc.gov/od/ohs/biosfty/bmbl4/bmbl4toc.htm)
and the Occupational Safety and Health Administration's (OSHA) laboratory health
standard (Occupational Exposures to Hazardous Chemicals in Laboratories (29 CFR
1910.1450)).
The IBC is appointed by and reports to the Provost. The composition of the
committee meets the requirements as specified in the NIH Guidelines which
includes two community members that are not affiliated with TTU. The
Environmental Health and Safety Department provides the necessary administrative
support for the functions and business of the IBC. The TTU IBC will also provide
guidance to the TTU research community regarding proper acquisition, handling,
transfer, and disposal of potentially hazardous or regulated hazardous
materials. |
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Registration Requirements |
Investigators must register with the IBC if they are:
1. Creating recombinant DNA/RNA constructs (vector plus gene)
2. Inserting recombinant DNA/RNA constructs into cell lines/tissue
cultures, whole animals, humans, or plants
3. Using a microorganism that is pathogenic to humans
(including immunocompromised individuals), plants, or animals (based on
wild-type organism)
4. Using or collecting human or non-human primate
materials (body fluids, tissues, cells, etc.)
5. Under some circumstances a particular chemical substance and
associated laboratory operation, procedure or activity may be considered
sufficiently hazardous to require prior approval from the Institutional
Biosafety and Hazardous Material Committee before research begins. A list of
chemicals and threshold quantities requiring review and approval is located in
the Regulated Chemicals & Particularly Hazardous Chemicals Table. With the
exception of pressurized hazardous gases, the review and approval procedure goes
into effect only if the user selects safeguards that differ from those specified
in these Special Handling Procedures. Researchers anticipating use of these
materials in a manner requiring review should notify the Institutional Biosafety
and Hazardous Material Committee and complete a Research Protocol Chemical
Safety Review Form. A completed form should be sent to the Institutional
Biosafety and Hazardous Material Committee. The Environmental Health and Safety
Department will visit the laboratory, conduct a survey of facility controls and
review the research protocol.
For
work with human subjects, the following specifically apply:
1. Experiments involving the deliberate transfer
of recombinant DNA or RNA, or DNA or RNA derived from recombinant DNA into one
or more human subjects must be approved by the TTU Institutional Biosafety
Committee before final Protection of Human Subjects Committee approval may be
granted.
2. Experiments utilizing live, recombinant, and/or
attenuated microorganisms for the purposes of vaccination of one or more human
subjects must be approved by the TTU Institutional Biosafety Committee before
final Protection of Human Subjects Committee approval may be given.
3. Investigators utilizing recombinant DNA or potentially infectious
microorganisms in the course of their research, but not for direct and
deliberate transfer into human subjects, may require approval from the TTU
Institutional Biosafety Committee prior to initiation of the experiment;
however, this approval is not required for final Protection of Human Subjects
Committee approval.
4. Other protocols, upon Protection of Human Subjects Committee request,
may receive IBC review/approval.
For work with whole animals, the following specifically
apply:
1. Experiments involving the deliberate transfer of recombinant DNA or
RNA into whole animals must be registered (submitted) with the TTU Institutional
Biosafety Committee before Institutional Animal Care and Use Committee (IACUC)
approval may be granted. The registration application must be approved before
animals can be ordered.
2. Experiments involving the deliberate transfer of any human, animal, or
plant pathogen into whole animals must be registered (submitted) with the TTU
Institutional Biosafety Committee before IACUC approval may be granted. The
registration application must be approved before animals can be ordered.
3. Other protocols, upon IACUC request, may receive IBC review/approval.
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Registration Process and Forms |
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Investigators will register by submitting a
Institutional Biosafety Committee Application/Registration Form (PDF
File or
Word File) to the Director,
Environmental Health and Safety. |
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Review and Approval Process |
Pre-Review
The Director of Environmental Health and Safety or the Chemical and Biological
Safety Specialist in the Environmental Health and Safety Department will review
applications to ensure that they are complete and provide a preliminary
recommendation for biosafety containment (BSL1, BSL2, etc.).
Exempt
Applications
If the application meets the criteria for exemption from the NIH Guidelines for
Research with Recombinant DNA Molecules, the Director of Environmental Health
and Safety may inform the investigator that the work is exempt and that BSL1
procedures apply. The Director of Environmental Health and Safety must inform
the IBC at the next convened meeting of any exempt applications.
Review
and Approval Process
Institutional Biosafety and Hazardous Material Committee (IBC) Review/Approval
Forms are received in the Environmental Health and Safety (EH&S) Department. The
IBC Chair, Director of Environmental Health and Safety and/or the Chemical and
Biological Safety Specialist review the protocol to determine one of the
following review processes:
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1. Designated Review: The
proposed recombinant DNA, microorganisms, select agents, and/or biological
toxins that are not classified as Risk Group 3 (RG3) agents or require Biosafety
Level 3 containment are reviewed as followed:
a. The IBC Review/Approval Form for the
protocol in question is distributed to all committee members electronically.
b. Members have four days to review the
protocol and return to the Director of Environmental Health and Safety a
recommendation on whether the protocol should receive full-committee review or
be referred to the Designated Member Reviewer. If no member calls for a
full-committee review, the IBC Chair appoints a member of the committee as a
designated reviewer (Designated Member Reviewer).
c. The Designated Member Reviewer will
review the protocol. All committee members are invited to share comments about
the protocol with the Designated Member Reviewer, who will either:
i. approve the protocol;
ii. approve pending clarifications/modifications (modifications
required to secure approval);
iii. request full-committee review.
d. The Director of Environmental Health and
Safety or his/her designee compiles a list of the recommendations from the
Primary Reviewer, and the Principal Investigator is informed of the IBC
recommendations.
i. If “approved”, the IBC Review/Approval Form is assigned an IBC
approval number and the Principal Investigator receives the approval letter.
ii. If “approved pending clarifications/modifications”, the Principal
Investigator is informed of the required clarifications/modifications and has 30
days to return the IBC Review/Approval Form with the
clarifications/modifications. The IBC chair, the Director of Environmental
Health and Safety and/or the Chemical & Biological Specialist review the IBC
Review/Approval Form for the required clarifications/modifications. IBC members
may also review the changes. The IBC Review/Approval Form is assigned an IBC
approval number, and the Principal Investigator receives the approval letter.
iii. If “request full-committee review”, is indicated by any IBC
member, the IBC Review/Approval Form will be reviewed at the next scheduled IBC
meeting under the guidelines for full-committee review.
e. The discussions and review of the IBC
Review/Approval Form are documented in the IBC minutes.
2. Full Committee Meeting Review:
This process is used if either a single IBC member requests full committee
(live) review or the proposed recombinant DNA, microorganisms, select agents,
and/or biological toxins are classified as Risk Group 3 (RG3) agents or require
Biosafety Level 3 containment.
a. These protocols must be received one week
before the scheduled meeting.
b. The IBC Chairman assigns a Primary
Reviewer to the protocol. These protocols are held until the information for the
IBC meeting is distributed to all members one week before the scheduled meeting
for pre-meeting review.
c. At the scheduled monthly meeting, the
Primary Reviewer reports to the Committee his findings after reviewing the
protocol before the Committee. All questions are asked and discussed at the
meeting during this time.
d. The committee will either:
i. approve the protocol;
ii. approve pending clarifications/modifications (modifications
required to secure approval);
iii. withhold approval.
e. If “approved”, the IBC Review/Approval
Form is assigned an IBC approval number and the Principal Investigator receives
the approval letter.
f. If “approved pending
clarifications/modifications”, the Principal Investigator is informed of the
required clarifications/modifications and has 30 days to return the IBC
Review/Approval Form with the clarifications/modifications. The IBC chair, the
Director of Environmental Health and Safety and/or the Chemical & Biological
Specialist review the IBC Review/Approval Form for the required
clarifications/modifications. IBC members may also review the changes. The IBC
Review/Approval Form is assigned an IBC approval number, and the Principal
Investigator receives the approval letter.
g. If “withhold approval”, the Principal
Investigator is informed of the IBC decision and the reasons for withholding
approval.
h. The discussions and review of the IBC
Review/Approval Form are documented in the IBC minutes.
3. Amendments: Amendments are
used when a Principal Investigator needs to change a protocol because of a
change in title, a change in personnel (adding, deleting, etc.), a change in
agents, procedures/practices, and facilities. Amendments must be submitted to
the Director of Environmental Health and Safety on the current IBC Amendment
Form. These are the following types of amendments and procedures:
a. Administrative Amendment: The IBC
Chairman, Director of Environmental Health and Safety and/or the Chemical and
Biological Safety Specialist may administratively approve the amendment that
changes personnel, protocol titles, funding source, and/or changes in an
investigator's protocol involving the same biological materials as previously
submitted if new methods do not change the biosafety level assigned to the
laboratory. The Principal Investigator is informed of the approval and the
amendment is attached to the original IBC Review/Approval Form.
b. Regular Amendment: Involves a change in
the agents, procedures/practices, and facilities. The review and approval
procedure for this amendment is identical to the review and approval procedure
for a regular IBC Review/Approval Form.
c. The review and approval of the IBC
Review/Approval Form Amendments documented in the IBC minutes.
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Committee Members |
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Faculty (All Voting)
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Dr. Randall Jeter (Chair) |
Biological Sciences |
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Dr. Hong Zhang |
Biological Sciences |
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Dr. Lauren Gollahon |
Biological Sciences |
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Dr. Robert Shaw |
Chemistry & Biochemistry |
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Dr. Jorge Vizcarra |
Animal & Food Sciences |
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Dr. Steve Presley |
TIEHH |
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LaQuetta Purkiss |
Chemistry & Biochemistry |
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Amber Matthews |
Animal Care Services |
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Administrative (All Voting)
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Dr. Kathleen Harris |
Senior Associate VP for Research |
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Randy Nix |
Director, Environmental Health & Safety |
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Matt Roe |
Environmental Health & Safety |
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Non-Institutional members (All Voting)
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Erick Quintela
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Community Member, Texas Commission for Environmental Quality |
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Steve Claybrook |
Community Member, City of Lubbock
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Committee Charge |
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The Institutional Biosafety Committee is
charged to consider policies and procedures pertaining to the safe handling,
transport, use, and disposal of recombinant DNA, microorganisms, select agents,
biological toxins, regulated and particularly hazardous chemicals and to
recommend the adoption of appropriate new or revised policies to the University
administration through Texas Tech Environmental Health and Safety; to review for
compliance with the NIH Guidelines for Research Involving Recombinant DNA
Molecules all recombinant DNA research and to approve research that is in
conformity with the Guidelines; to register and review research utilizing Risk
Group 2 or higher biological agents and to approve research that contains
adequate safeguards to protect the health and safety of the laboratory
personnel, students, staff, and visitors; to interpret guidelines and/or
regulations of the U.S. Public Health Service, the Occupational Safety and
Health Administration, and others pertaining to recombinant DNA, microorganisms,
select agents, biological toxins, regulated and particularly hazardous
chemicals, and to provide technical assistance to Texas Tech Environmental
Health and Safety on these matters; to review proposed or enacted legislation
impacting the Texas Tech University community and to inform Departments,
Schools, and Colleges of this legislation and its potential implications; in
conjunction with Texas Tech University Environmental Health and Safety, assist
Colleges, Schools, and Departments with safety committees or programs related to
the safe handling, transport, use, and disposal of recombinant DNA,
microorganisms, select agents, biological toxins, regulated and particularly
hazardous chemicals; and to render advice in consideration for space and
facilities for research involving recombinant DNA, microorganisms, select
agents, biological toxins, regulated and particularly hazardous chemicals. |
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For additional Information contact Matt Roe
(742-3876) |
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