The IBC administrator conducts a pre-screen of the application when it is submitted to determine if the application is complete. Applications that need modification before they are sent to the IBC committee members are sent back to the PI with comments.
To expedite the review process, the IBC utilizes three levels of review based on the nature of the hazard(s) involved — exempt, designated and full committee.
1. Recombinant DNA
Protocols involving the use of recombinant DNA are either reviewed as exempt or are non-exempt and receive full IBC committee review. This determination is made by the IBC chair after the IBC application is submitted. Exempt protocols, as defined by NIH, are those that present only minor hazards with very low risk that may be addressed in an application that is formally reviewed by at least the IBC chair and the biosafety officer (BSO) to validate the exempt status. Nonetheless, all protocols with a recombinant DNA component are available for review by all members of the IBC. Exempt protocols may be validated immediately upon review by the BSO and IBC chair, but will still require an annual review and are approved for up to 3 years.
2. Designated Review
Designated review is used for chemical and biological hazard protocols that present a moderate risk and require review by the BSO, IBC chair and usually at least one other IBC member with the appropriate expertise (designated by the IBC chair).
These protocols are sent to the members of the IBC for their comments as well. Protocols involving chemicals with vertebrate animals or protocols involving the use of hazardous biological agents may be reviewed as designated at the discretion of the chair and BSO. These protocols also require an annual review and are approved for up to 3 years.
3. Full Committee Review
Full committee review is used for protocols that may present significant hazards to humans, animals or the environment. Examples of significant hazards would be work with biological agents requiring greater than BSL2 containment facilities or practices, or the release of genetically modified organisms. Non-exempt recombinant DNA protocols will receive full committee review. All members of the IBC participate in a full committee review. These applications are discussed at the convened IBC meeting. These protocols also require an annual review and are approved for up to 3 years.
4. Amendments
Minor amendments and/or proposed changes in any protocol must be submitted and approved as an update prior to initiation using the minor amendment form. Changes of a more substantial nature require the submission of the appropriate section of the IBC application, e.g. Section B for biological agents, Section C for chemicals and Section D for recombinant DNA.
