Texas Tech University (TTU) Institutional Biosafety Committee Guidelines
 
Contents Image
Click on the links below to go to a particular topic.
 Biosafety Manual
 Texas Tech Institutional Biosafety 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
 Registration Process & Biohazard Application Form (Doc File) & Amendment Form (Doc) & Assurances and Signature Form (PDF)
 Review and Approval Process
 Self-Audit Tools
        - Biosafety Level 2 Checklist (PDF File)
        - Instructional narrative (PDF File)
 IBC Charge
 IBC Structure
 
Texas Tech Institutional Biosafety 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://oba.od.nih.gov/rdna/nih_guidelines_oba.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. This review is conducted pursuant to the Centers for Disease Control and Prevention (CDC)/NIH publication, Biosafety in Microbiological and Biomedical Laboratories  (http://www.cdc.gov/biosafety/) and the Occupational Safety and Health Administration's (OSHA) Bloodborne Pathogen Standard (29 CFR 1910.1030).

The IBC is appointed by and reports to the Vice President For Reseach. 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.
 
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.)

 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.

 
Registration Process and Forms
Investigators will register by electronically submitting an Institutional Biosafety Committee Application/Registration Form to the Director, Environmental Health and Safety. Once finalized and accepted, a signed protocol must be mailed to Texas Tech University Environmental Health and Safety to be maintained in their files.
 
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 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:

  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 seven 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 7 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 7 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.

 
Committee Charge
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, 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, and to render advice in consideration for space and facilities for research involving recombinant DNA, microorganisms, select agents, biological toxins.
For additional Information contact Matt Roe (742-3876)