Guideline for Researchers

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 Baylor University, regardless of funding source, must be conducted in accordance with the NIH Guidelines for Research Involving Recombinant DNA Molecules and must be registered with the Baylor IBC.

The Baylor IBC is responsible for 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 (currently in 4th edition, 1999).

The Baylor IBC will also provide guidance to the Baylor research community regarding proper acquisition, handling, transfer, and disposal of potentially hazardous or regulated biological materials.

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 Baylor IBC.
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 Baylor IBC.
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 Baylor IBC prior to initiation of the experiment.

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 Baylor IBC before Institutional Animal Care and Use Committee (IACUC) approval will 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 Baylor IBC before IACUC approval will 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 submitting a Registration Application for Research with Recombinant DNA Molecules and/or Infectious Agents to the Biological Safety Officer.

Basics of Biosafety Level 1

The term containment is used in describing safe methods for managing biological materials in the laboratory environment where they are being handled or maintained. The purpose of containment is to reduce or eliminate exposure of laboratory workers, other persons, and the outside environment to potentially hazardous or detrimental materials.

The Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) established criteria for four levels of containment called Biosafety Levels (BSLs). These criteria consist of combinations of laboratory practices and techniques, safety equipment, and laboratory facilities. Each combination is specifically appropriate for the operations performed, biological materials to be used, and the laboratory function or activity.

Biosafety Level 1 (BSL1) practices, safety equipment, and facility design and construction are appropriate for undergraduate and secondary educational training and teaching laboratories, and for other laboratories in which work is done with de-fined and characterized strains of viable microorganisms not known to consistently cause disease in healthy adult humans. Bacillus subtilis, Naegleria gruberi, infectious canine hepatitis virus, and exempt organisms under the NIH Recombinant DNA Guidelines are representative of microorganisms meeting these criteria. Many agents not ordinarily associated with disease processes in humans are opportunistic pathogens and may cause infection in the young, the aged, and immunodeficient or immunosuppressed individuals. Vaccine strains should not be considered avirulent simply because they are vaccine strains.

Biosafety Level 1 represents a basic level of containment that relies on standard microbiological practices with no special primary or secondary barriers recommended other than a sink for hand-washing.

Basics of Biosafety Level 1
(Standard Microbiological Practices)

• Limit access to work areas. Close doors during work with research materials.
• Wash hands after handling biological materials, removing gloves, or before leaving work area.
• Don't eat, drink, etc. in the work area.
• Never mouth pipette.
• Use sharps only when no alternatives (e.g., safety devices or non-sharps) exist.
• Handle and dispose sharps carefully and properly.
• Minimize activities that are likely to create splashes, sprays, or aerosols.
• Decontaminate work surfaces at least daily.
• Decontaminate waste materials before disposal.
• Wear a BUTTONED lab coat to protect street clothes.
• Wear gloves if hands have broken skin or a rash.
• Wear eye/face protection if splashes or sprays are anticipated.
• Transport materials outside of the laboratory using secondary containment and a cart.
• Avoid public areas during transport.
• Transfer materials to and from the Baylor campus according to federal and international regulations.
• Be familiar with written instructions for laboratory procedures and proper responses to emergencies.

Basics of Biosafety Level 2

The term containment is used in describing safe methods for managing biological materials in the laboratory environment where they are being handled or maintained. The purpose of containment is to reduce or eliminate exposure of laboratory workers, other persons, and the outside environment to potentially hazardous or detrimental materials.

The Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) established criteria for four levels of containment called Biosafety Levels (BSLs). These criteria consist of combinations of laboratory practices and techniques, safety equipment, and laboratory facilities. Each combination is specifically appropriate for the operations performed, biological materials to be used, and the laboratory function or activity.

Biosafety Level 2 (BSL2) practices, equipment, and facility design are applicable to clinical, diagnostic, teaching, and other laboratories in which work is done with moderate-risk agents that are present in the community and associated with human. Hepatitis B virus, HIV, the salmonellae, and Toxoplasma spp. are representative of microorganisms assigned to this containment level. With good microbiological techniques, these agents can be used safely in activities conducted on the open bench, when the potential for producing splashes or aerosols is low. BSL2 is appropriate when work is done with any human-derived blood, body fluids, tissues, or primary human cell lines where the presence of an infectious agent may be unknown.

Primary concerns at BSL2 include accidental needlesticks or cuts or mucous membrane exposures, or ingestion of infectious materials. Even though organisms routinely manipulated at BSL2 are not known to be transmissible by the aerosol route, procedures with aerosol or high splash potential may increase the risk of personnel exposure.

Basics of Biosafety Level 2

• Limit access to work areas. Close doors during work with research materials.
• Post biohazard warning signs at access points and on equipment containing or contaminated by potentially infectious materials.
• Wash hands after handling biological materials, removing gloves, or before leaving work area.
• Don't eat, drink, etc. in the work area.
• Never mouth pipette.
• Use sharps only when no alternatives (e.g., safety devices or non-sharps) exist.
• Take extreme precautions when sharps must be used. Dispose sharps carefully and properly.
• Conduct procedures likely to create splashes, sprays, or aerosols within a biological safety cabinet that is certified annually.
• Decontaminate work surfaces at least daily.
• Decontaminate waste materials before disposal.
• Wear a BUTTONED lab coat to protect street clothes.
• Wear gloves when hands may contact potentially infectious materials, contaminated surfaces, or equipment.
• Wear eye/face protection if splashes or sprays are anticipated during work outside a biological safety cabinet.
• Transport materials outside of the laboratory using secondary containment and a cart. Avoid public areas during transport.
• Transfer materials to and from the Baylor campus according to federal and international regulations.
• Be familiar with written instructions for laboratory procedures and proper responses to emergencies.
• Report spills, exposures, illnesses, and injuries immediately.

Review Process

Pre-Review
The Biological Safety Manager (BSM) will review applications 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 BSM may inform the investigator that the work is exempt and that BSL1 containment applies. The BSM must inform the IBC at the next convened meeting of any exempted applications.

Expedited Review
If an application receives a preliminary recommendation as a BSL1 application and/or if the application involves only human or non-human primate materials, the application may be expedited.

In expedited review, the application is circulated to the IBC Chair, the BSM, and a rotating voting member for review. These three persons review the protocol in depth and vote on appropriate biosafety containment and any additional practices/procedures. If the application is determined to require BSL2 containment (with the exception of human/non-human primate materials), the application will be brought to the full committee for review. Otherwise, the BSM will approve the application at the approved BSL, etc. on behalf of the committee. The BSM must inform the IBC at the next convened meeting of any expedited applications.

Facility Walk-Through
For applications requiring BSL2 and higher, the BSM (and/or staff) will conduct a facility walk-through of the identified research area to determine if the recommended containment can be achieved. Any concerns with the facilities will be provided to the committee for review with the application. Any committee member can request a facility walk-through for any research area, regardless of the biosafety level assigned. Research staff are encouraged to conduct self-audits of their facilities using walkthrough checklists and narratives developed by the BSM and staff.

Full Committee Review at a Convened Meeting
In full committee review (recommended BSL2 and higher), the application and accompanying materials, as necessary, are circulated to the committee membership. The application is reviewed at the next convened meeting of the IBC. Members provide their vote on a written vote sheet, which is submitted to the BSM prior to, during, or after the meeting. A simple majority of the committee represents quorum. Any committee action requires passage by a majority of quorum, but an application action vote must include a vote by at least one non-institutional member.

Full Committee Review by Fax, Email, Mail
Occasionally, biosafety registration applications are circulated to the full committee for review and voting without convening a meeting. This would only occur if the types of materials proposed to be used have been reviewed at a previously convened committee meeting and if there is no regularly scheduled IBC meeting within a time frame to allow the investigator to pursue the research or funding. At any time, any IBC member, voting or non-voting, may request that a full committee meeting be convened to discuss an application. Such a request should be provided to the BSM.

Approval
Approval letters are generated by the BSM and sent to the PI and all project personnel listed on the application. The approval letter indicates the biosafety level approved for the research in addition to any other conditions or stipulations assigned by the committee. The PI may appeal the decision of the IBC by providing, in writing, their objection and the rationale for the objection. The PI is referred to the appropriate biosafety level recommendations in the CDC/NIH publication, Biosafety in Microbiological and Biomedical Laboratories, 4th edition. The letter also states that the PI is responsible to ensure that s/he and her/his co-workers are familiar with and follow these recommendations

Conditions of Approval
The approval is for only the materials, personnel, and facility specifically provided in the application and is given only for the life of the listed grant title.

Continuing Approval/Updates
Changes in personnel or facilities as well as any significant modifications to methods or biological materials used must be reported to the BSM. The BSM has been given the authority to approve on behalf of the IBC 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.