Amendment

An amendment is required whenever you need to change your protocol.

Remember: Any changes require approval by the IBC prior to implementation.

A minor amendment is a change that is grammatical or administrative in nature.

The following amendments may be reviewed by the IBC Chair or designee:

• Correction of typographical errors;
• Correction of grammar;
• A change of the project title;
• Updates to contact information;
• Updates to funding information; 
• Personnel change, other than the PI; and
• Adding or removing laboratory room numbers for approved labs.

A change involving biological hazards, beyond minor grammatical or administrative changes.

Changes requiring IBC Full Board approval include any change involving biological hazards beyond minor grammatical or administrative changes including, but not limited to:

• New pathogens
• New vector systems
• Adding a new plant or animal species
• Adding/changing transgene
• Adding/changing infectious agents
• In vitro work being changed to work in vivo
• In vivo work being changed to in vitro procedures
• Work with new cell lines, which change the biosafety level or whose use causes a significant change to the protocol
• Changes in constructs or systems that result in significantly higher titers
• Enhanced replication or infectivity
• Expression of toxic products
• Partial viral genomes increased to more than two-thirds of whole genome
• New or altered procedures that pose increased risk of aerosol or other types of exposure
• Change in sections of the NIH Guidelines
• Upgrade in containment levels
• Any change that does not fall within the categories listed above as a minor amendment

After administrative review by the IBC office, you will be notified that your major amendment must receive full committee review and made aware of the date of the scheduled IBC meeting where that review will take place. 

To have your major amendment reviewed at the next IBC meeting, the completed amendment must be submitted on or before the protocol submission deadline for that meeting.