MODIFICATIONS TO AN APPROVED PROTOCOL


Investigators are responsible for ongoing requirements in the conduct of approved research. This includes obtaining prior approval from the IBC before implementing any modifications to previously approved research. 

Modifications or changes to the protocol are sometimes referred to as “amendments” or “addenda.”

 

Amendment Classification & Review

The LSUHSC-NO IBC classifies proposed changes to an approved protocol as either minor or major amendments. Both minor and major amendments undergo an initial, administrative review by the IBC Office. Minor amendments typically are reviewed and, if appropriate, approved by the IBC Coordinator, foregoing review by the full committee. Major amendments are placed on the agenda for the next convened meeting for full committee review.

 

Examples of Minor Amendments

  • Adding/removing research personnel other than PI
     
  • Adding/removing laboratory room numbers
     
  • Adding/removing project funding source
     
  • Adding/removing cell lines of a previously approved organism
     
  • Adding/removing strains of a previously approved transgenic animals
     
  • Adding/removing vector constructs for a previously approved viral vector
     
  • Any change that does not fall into one of the categories listed above but would not be considered a major amendment 
     

 

Examples of Major Amendments

  • Adding new animal species
     
  • Adding/changing transgene
     
  • Adding/changing infectious agents
     
  • Change in sections of the NIH Guidelines
     
  • Change in containment level
     
  • Any change that does not fall into one of the categories listed above but would not be considered a minor amendment 
     

 

Please Note:

  • There are no deadlines for submitting minor amendments.
     
  • 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. See deadlines and meeting dates.
     
  • The review process and possible outcomes are the same as for new protocol submissions.
     
  • IBC approval of an amendment typically does not alter the original approval or expiration date of the protocol.

 

How to Submit?

All research applications for IBC review, including modifications/amendments, are submitted through the Kuali Research electronic submission platform which may be accessed by clicking one of the icons below.  Detailed instructions for submitting initial and post-approval applications to the IBC are available in the Kuali Quickguide, Creating and Submitting IBC Protocols in Kuali, that can be downloaded from the Resources page. 

 

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