Submissions to the IACUC

Protocol Submissions

Protocols must be submitted three weeks in advance of the scheduled IACUC meeting to be eligible for review. This allows adequate time for the committee to conduct a proper review and request any necessary modifications. Protocols submitted in less time may not be reviewed until the next scheduled meeting.

For questions regarding IACUC submissions and the review process, please contact the iacuc@bowdoin.edu

New Study and De Novo Application

Please build time into your research plan for back and forth communication as there are usually questions or requested revisions from the committee before approval can be secured. Once the approval has been granted, the researcher will receive a letter indicating the protocol number and expiration (3 years from date of approval).

Per federal regulations, animal research protocols may be approved for a maximum of three years. At the end of the three-year approval, a De Novo protocol application must be submitted to the IACUC for review.

No research may begin before written approval has been issued.

No research animals may be obtained prior to receiving written approval.

Submit your completed application along with any required supplemental documentation to iacuc@bowdoin.edu for review.

 

Amendments 

Principal Investigators must get approval before making significant changes to activities in approved protocols. To submit these changes to the IACUC. 

Guidance on what is considered a significant change to an ongoing animal activity that requires IACUC review can be found in NIH Guide Notice NOT-OD-14-126 or Significant Changes webpage.

 

Continuing Review

The continuing review form is submitted to the IACUC annually. A continuing review form helps to inform the IACUC of the current status of the project. It is meant to be a quick check-in and should not require a significant amount of time to complete.

 

Unexpected/Adverse Event(s)

Any unexpected or unforeseen events that negatively impacted the welfare of animals (death, disease or distress) or creates human health risks should be reported to the IACUC immediately. Please complete and submit the signed form to iacuc@bowdoin.edu

 

Protocol Closure

This form should be submitted to the iacuc@bowdoin.edu when all protocol-related activities have permanently ended. Use this form only when animal research activities and all data collection are fully complete. Upon receipt of this submission, the PI acknowledges that NO further data collection related to this protocol will be conducted.

Protocol Review Outcomes

There are three possible outcomes to the review of a research proposal:

  • Approval – A protocol that has been approved by the IACUC requires no further action by the investigator before the research may commence.
  • Request Modifications in Order to Secure Future Approval - The IACUC may request revisions to a proposal. The investigator will receive written details describing what additional information is required and the revised protocol will be reviewed at the next convened IACUC meeting.
  • Withhold Approval – A protocol that has been disapproved by the IACUC may not be initiated. The investigator will receive written details describing the reasons for denial of approval, and will be given an opportunity to respond.