Submitting Changes to a Biosafety Protocol

Any proposed modification to an approved protocol must be approved by the IBC prior to implementation. Once an amendment has been submitted to the committee, it is pre-reviewed by a subcommittee of the IBC. Reviewer comments and requests for revision are returned to the investigator with sufficient time to complete the revisions and submit a revised amendment for review at the next IBC meeting.  Personnel amendments are reviewed and approved by the biosafety coordinator on a rolling basis.

Once an amendment has been approved, an approval letter is prepared and sent to the investigator. The approval letter will include the amendment approval date, protocol expiration date, project title, amendment description, and IBC protocol number.

Amendments:

These forms can also be located in the
ORI Document Catalog - Category: Biosafety

Form E: Protocol Amendment Form [DOCX]

• Complete to make changes to an approved and active biosafety protocol for IBC review. This form can be used to:
  • provide information on new personnel to be added to the protocol,
  • indicate personnel who are no longer involved in the project,
  • indicate a change to the project that deviates from the approved protocol, or
  • record a change in the location of laboratory facilities.
• Amendments involving changes to procedure, use of new biohazards, changes in animal model, etc., will be reviewed by the full committee at the next meeting. For specific deadline and meeting dates, please see the Meeting Deadlines and Calendar.
• Addition/removal of personnel (except for a change in PI) and other administrative changes may be approved by the Biosafety Committee Coordinator. For a change in the PI responsible for the protocol, use Form G: Change in PI Amendment Form (below)
• Change in location may be approved by the Biosafety Committee Coordinator upon consulting with the Biosafety Officer.

Form G: Change in PI Amendment Form [DOCX]

• Complete to request a Change in Principal Investigator (PI).
• Signatures from the departing and incoming PI are required.
• An amendment involving changes to PI will be reviewed by the full committee at the next meeting. For specific deadline and meeting dates, please see the Meeting Deadlines and Calendar page.