Investigator Guidance
Registration Requirements
Review Process
Registration Requirements
Investigators must register with the IBC if they are:
- Creating recombinant DNA/RNA constructs (vector plus gene)
- Inserting recombinant DNA/RNA constructs into cell lines/tissue cultures, whole animals, humans, or plants
- Using a microorganism that is pathogenic to humans (including immunocompromised individuals), plants, or animals (based on wild-type organism)
- Using or collecting human or non-human primate materials (body fluids, tissues, cells, etc.)
For work with human subjects, the following specifically apply:
- 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 OSU Institutional Biosafety Committee before final Institutional Review Board (IRB) approval may be granted.
- Experiments utilizing live, recombinant, and/or attenuated microorganisms for the purposes of vaccination of one or more human subjects must be approved by the OSU Institutional Biosafety Committee before final IRB approval may be given.
- 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 OSU Institutional Biosafety Committee prior to initiation of the experiment; however, this approval is not required for final IRB approval.
- Other protocols, upon IRB request, may receive IBC review/approval.
For work with whole animals, the following specifically apply:
- Experiments involving the deliberate transfer of recombinant DNA or RNA into whole animals must be registered (submitted) with the OSU Institutional Biosafety Committee before IACUC approval may be granted. The registration application must be approved before animals can be ordered.
- Experiments involving the deliberate transfer of any human, animal, or plant pathogen into whole animals must be registered (submitted) with the OSU Institutional Biosafety Committee before IACUC approval may be granted. The registration application must be approved before animals can be ordered.
- Other protocols, upon IACUC request, may receive IBC review/approval.
Review Process
Pre-Review
The IBC Chairperson or the Biological Safety Officer (BSO) will review applications and provide a preliminary recommendation for biosafety containment (BSL1, BSL2, BSL3.) and may request protocol modifications prior to full committee review.
Exempt Applications
The IBC Chairperson will review applications for exemption to determine whether or not the application meets the criteria for exemption from the NIH Guidelines for Research with Recombinant DNA Molecules. The Biosafety Coordinator, ORRP will inform the investigator that the work is exempt and that BSL1 containment applies. The IBC must be informed 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 BSO, 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. Should the application 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 expedited review group will approve the application at the approved BSL on behalf of the committee. The IBC will be informed at the next convened meeting of any expedited applications.
The expedited review process pertains to protocols that only involve biohazards and may not be used for recombinant DNA research that is not exempt.
Facility Walk-Through
For applications requiring BSL2 and higher, the BSO and / or Office of Environmental Health and Safety 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 walk through checklists and narratives developed by the BSO 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. Designated reviewers are assigned to each protocol. Designated reviewers present the application to the committee and provide a written reviewer form 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.
Full Committee Review by Fax, Email, Mail, Teleconference
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 Biosafety Coordinator, ORRP.
Approval
Approval letters are generated by the Biosafety Coordinator, ORRP and sent to the PI. 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, 5th 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 IBC via an amendment application. The IBC Chair and / or BSO 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 provided the new methods do not change the biosafety level that was previously assigned to the laboratory.
