What Goes Into the IBC Review & Approval Process

The Institutional Biosafety Committee (IBC) reviews any proposed research involving the use of biological items like recombinant DNA, select agents, bloodborne pathogens, or other areas, depending on your institution. Before an investigator can begin a research project involving these items, they must first go through an IBC approval process. This means that the committee evaluates the investigator’s application to ensure that appropriate biosafety plans are in place and that researchers will follow IBC protocols.

IBC vs. IRB

IBC reviews and Institutional Review Board (IRB) reviews are very similar, but they have some distinct differences. For both, committee makeup is prescribed by the applicable regulations.

• IBC: The purpose of IBC reviews is to ensure protection from any possible exposure to bio-hazardous material. This includes protection for researchers, human research subjects, the community, and the environment. IBC approval is also required any time a study involves genetic engineering or gene therapy. These reviews are required for all genetic engineering research that intends to receive NIH funding or will take place at any institutions receiving NIH funding, even if the proposed work is not funded by the NIH.
• IRB: IRB reviews are required by the FDA/DHHS when a human is involved as a research subject. It is used to ensure the correct steps are being taken to protect the rights and welfare of these human research subjects. Human research subjects are seen across disciplines, including biomedical research and social sciences research.

Because research projects dealing with biohazardous material or genetic engineering can also involve human participants, such experiments would need to be approved by both IBC and IRB.

Things to Remember When Completing Your Application

When submitting applications, be sure to be as specific and detailed as possible to avoid possible delays in the IBC approval process. The more details you can provide about the project you plan to work on, the easier it will be for the IBC to evaluate your application and determine the risk involved and whether or not you have the proper biosafety plan to handle the risk.

Pay special attention to how you write your application, and keep your intended audience in mind. The IBC consists of scientists, non-scientists, and members of the public, and some of them could be unfamiliar with science or lab jargon. Make sure that your application can be easily understood by all members of the IBC.

If there is any missing information or your application needs any revisions, the IBC will send it back to you. Responding and resubmitting your application as soon as possible will prevent further delays.

After Application Submission

Once you have completed and submitted an application, a staff review is performed to ensure the application is complete and consistent. It then moves on to a committee review where they evaluate the description of the proposed project, including the safety risks associated with both the biological elements involved and the techniques that will be used, as well as the biosafety containment plan.

IBC Review Outcomes

Members of the IBC typically meet monthly for careful review of all applications that have been submitted for review. After review, the members vote on the outcome. Voting options include:

• Approved: The submission addresses every issue and is approved without further modifications.
• Approved with contingencies: Some minor issues remain and must be addressed by the submitter. Certain requirements must be completed, and the revised application must be reviewed again before any proposed research can begin.
• Tabled: An application may be tabled if there are significant issues or missing information. Once these issues are addressed, a full IBC review may be required.
• Unapproved: The application isn’t approved, and the submitter cannot proceed with the proposed research.

‍The Right Technology for Your Institution

Kuali provides modern software with a modular solution for the whole research lifecycle — including the IBC approval process. Using the correct Electronic Research Administration software can help reduce risk, improve efficiency, and increase the effectiveness of the research process. Learn more about Kuali Research today to see how our software can enhance your institution’s IBC approval process, or check out our resource library to learn more about other parts of the research process.

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