X. Process for Requesting Amendments

Minor changes to rDNARDs can be approved as amendments by the IBC Chair without full committee review; major changes require review and approval by the full IBC. Requests for amendments will be processed by the BSO prior to their being sent to the IBC Chair or full committee. To initiate the process of amending an approved rDNARD the PI or authorized user must access their protocol online and amend the protocol with the proposed changes. To facilitate review and record keeping, it is requested that if appropriate, the PI insert the changes in highlighted form in the table that is attached to the approved rDNARD

  • Requests for changes will be reviewed on a case-by-case basis to ensure that the changes proposed qualify as a minor amendment. Examples of changes that could be considered a minor amendment include the addition of a co-PI, addition/change to a vector requiring the same BSL, use of a less or equally hazardous cell line, or adding a non-pathogenic host such as an E. coli K-12 strain.
  • The BSO will review the request and if appropriate notify the IBC Chair of the pending amendment. If the IBC chair agrees that the changes are appropriate for an amendment and approves them as such, he/she will communicate this by approving the amendment; an email notification will be sent to the PI, authorized users and Biosafety Office.
  • Requests that involve significant changes to the protocol will be sent to the full IBC to be reviewed at the next regularly scheduled meeting.
  • Requests to add or delete staff to rDNARDs will be processed by the BSO without IBC Chair involvement. Prior to approval the BSO will ensure that all online training is complete for added staff.