Research and Activity Requiring Review and Approval from the IBC
The IBC reviews and approves many areas of biologically related activities, including research, teaching, and diagnostic projects.
The IBC defines biohazardous materials to include all infectious organisms that can cause disease in humans, animals, or plants, or have a significant negative environmental or agricultural impact. Any materials that are capable of harboring infectious organisms, such as human or primate tissues, fluids, cells, cell cultures or environmentally acquired samples that are or could be considered biohazardous material. Biological toxins are also considered biohazardous material.
The IBC Manual outlines work that requires IBC approval. Biohazardous materials are outlined in Chapter 4.
The planning and implementation of safety protocols to prevent laboratory-acquired infections and to eliminate the spread of contamination must be part of every laboratory’s routine activities and lab specific biosafety manual. No work should be considered so important that it jeopardizes the well-being of the worker or the environment.
The handling of biological agents and recombinant/synthetic nucleic acid materials requires the use of precautionary measures dependent on the agents involved and the procedures performed. It is the purpose of this manual to provide background information and guidelines to be used in conjunction with other resources for the evaluation, containment, and control of potentially biohazardous materials in laboratories.
IBC Protocols
A PI applying for IBC approval for research or diagnostic activities needs to submit a completed IBC protocol. The IBC protocol process is conducted in Cayuse. The PI applying for approval must submit an original protocol for review and approval. The PI is responsible for ensuring that all laboratory workers are listed on an approved IBC protocol and trained prior to working with the infectious organisms and/or biohazardous material. The BSO will act as a resource to assist the PI in the IBC submission and approval process.
A PI applying for approval of teaching activities involving potentially biohazardous material must contact the BSO. The BSO will assist the PI in developing a teaching protocol and determining the appropriate biosafety training for teaching assistants involved in the teaching activities.
Protocol Amendments
Amendments are required for any modification to research activities involving biological materials, including changes to personnel, procedures, agents, or containment measures. Amendments are categorized as either minor or major. Minor changes—such as adding lab personnel, updating safety practices, or using new cell lines from an approved organism—can often be reviewed and approved by the Biosafety Officer (BSO) and/or IBC Chair without a full committee review. Major changes—such as introducing a new biological agent, changing biosafety levels, or modifying a transgene—must be reviewed and approved by the full IBC at a convened meeting. All amendments should be submitted at least 30 days before implementation, and the PI must ensure that affected personnel complete required training and that updated protocols are available in the lab. Unauthorized changes may result in suspension of research activities or other institutional actions.
Examples of Minor Amendments:
- Adding/removing personnel or locations
- Updates to procedures or PPE that do not increase risk
- New strains or constructs within previously approved organisms
Examples of Major Amendments:
- New species, transgenes, or infectious agents
- Changes in containment level or NIH classification
- Any change increasing biosafety or public health risk
For any amendment, supporting documents such as SOPs, training records, or risk assessments may be required. The BSO and IBC Chair may request more information or escalate the review as needed. Once approved, the PI is notified, and all changes must be fully implemented before work proceeds.
Protocol Lifecycle
Requests for Amendments After IBC Approval
All amendments to currently approved research and diagnostics activities are required to have IBC review and approval prior to implementation. Minor changes that do not increase the risk to workers, the community, and/or the environment may be processed and approved by the BSO. Examples of administrative modifications may include the addition of personnel and change of laboratory room (if change is to an equivalent and approved facility).
More significant IBC protocol modifications would include the addition of potentially biohazardous materials or procedures that would likely increase the safety risks to researchers. The PI must submit these modifications to the IBC for review. An IBC modification approval is valid until the end of the original approval period (3 years).
Continuing Review
A Continuing Review (CR) notice serves as a mechanism for the PI to provide an annual update of the research occurring on an IBC protocol. The PI must submit a CR the first and second year after initial approval/renewal of a protocol. The PI is asked to list any updates to the protocol as initially approved (or since the last amendment or renewal notice); changes in laboratory staff working on the project, changes to funding, report of any research- related problems/adverse events, and to provide a summary of the project over the last year.
As an essential part of the annual update process, all lab safety training requirements are verified as up to date.
De Novo Review/Renewal
A de novo review or renewal protocol is submitted every three years following initial approval. Renewal protocols are sent to full committee review. During review of a De Novo submission changes may be made to the protocol, if scope of work has changed.