Application Review Process through eProtocol IACUC

Unlike the old paper-based protocols, e-protocol IACUC completes much of the review of a protocol in pre-review. This allows more efficient use of the IACUC's meeting time and can speed up the review process for the Principal Investigator (PI).

Who can write and submit an e-Protocol IACUC? Only UMass Amherst faculty and some staff can be PIs on an animal use protocol. However, the PI can allow a colleague (graduate student, co-PI, technician) to access to the e-Protocol for writing/editing by entering them in the Personnel Information of the e-Protocol from as “Primary Associate” or “Other Submitter”. Both the PI and the Associate will then have the same access to the protocol for writing/editing at all stages of the submission and review. Personnel listed on the protocol under “Other Personnel” have read only access to the protocol.

Submitting an animal use protocol through e-Protocol. Once you are satisfied with your draft protocol click “submit” to send it to the IACUC office. E-Protocol notifies IACUC office staff that a new protocol has been submitted for review. IACUC office staff review the protocol for completeness and you may receive an email asking you edit the protocol to make corrections or add information.

IACUC review of an e-Protocol. Following the pre-submission review, the IACUC office submits the protocol to the IACUC. Two or more IACUC members conduct a pre-review. The reviewers' comments are forwarded to the (PI) to address by revising, elaborating on, or otherwise modifying the protocol. Once the PI has addressed the reviewer's comments, and the reviewers are satisfied with the revised protocol, it is distributed to the IACUC for discussion at the next IACUC meeting. This describes the full review process. The designated review process is similar except that the review does not require discussion at a convened meeting.

For full review, following discussion members present vote on the outcome of the review. A protocol may be approved, require additional information/clarification to complete the review, or be disapproved. If the IACUC has comments/questions that need addressing the PI addresses the comments by revising the protocol before the protocol can be finally approved.

Notification of approval. The e-Protocol IACUC system will notify you when your protocol has been approved but will not send you an approval letter. The email also includes instructions on how to generate a approval letter for your protocol through the e-Protocol website.

Protocol approval is for 3 years, but continued approval is subject to annual continuation review. e-Protocol will record an expiration date that is one year from the date of approval. PIs receive an automatic reminder to complete an annual report for IACUC annual review and re-approval.

Amending a protocol. The UMass IACUC must be notified and approve, any proposed changes in animal species, increase in numbers that will exceed the approved totals by > 10%, changes in procedures from those in the original approved protocol, changes in personnel conducting the research protocol. Changes to a protocol must be submitted for IACUC review by modifying the most recent version of the protocol in e-Protocol and submitting the revised protocol to the IACUC office for IACUC review. Please note that federal law requires that change in PI and major departures from the original protocol must be addressed by submitting a new protocol.




Research Home Compliance Home Animal Use Biological Safety Feedback Forms Human Subjects Research Policies Responsible Conduct Staff		Application Review Process through eProtocol IACUC Unlike the old paper-based protocols, e-protocol IACUC completes much of the review of a protocol in pre-review. This allows more efficient use of the IACUC's meeting time and can speed up the review process for the Principal Investigator (PI). Who can write and submit an e-Protocol IACUC? Only UMass Amherst faculty and some staff can be PIs on an animal use protocol. However, the PI can allow a colleague (graduate student, co-PI, technician) to access to the e-Protocol for writing/editing by entering them in the Personnel Information of the e-Protocol from as “Primary Associate” or “Other Submitter”. Both the PI and the Associate will then have the same access to the protocol for writing/editing at all stages of the submission and review. Personnel listed on the protocol under “Other Personnel” have read only access to the protocol. Submitting an animal use protocol through e-Protocol. Once you are satisfied with your draft protocol click “submit” to send it to the IACUC office. E-Protocol notifies IACUC office staff that a new protocol has been submitted for review. IACUC office staff review the protocol for completeness and you may receive an email asking you edit the protocol to make corrections or add information. IACUC review of an e-Protocol. Following the pre-submission review, the IACUC office submits the protocol to the IACUC. Two or more IACUC members conduct a pre-review. The reviewers' comments are forwarded to the (PI) to address by revising, elaborating on, or otherwise modifying the protocol. Once the PI has addressed the reviewer's comments, and the reviewers are satisfied with the revised protocol, it is distributed to the IACUC for discussion at the next IACUC meeting. This describes the full review process. The designated review process is similar except that the review does not require discussion at a convened meeting. For full review, following discussion members present vote on the outcome of the review. A protocol may be approved, require additional information/clarification to complete the review, or be disapproved. If the IACUC has comments/questions that need addressing the PI addresses the comments by revising the protocol before the protocol can be finally approved. Notification of approval. The e-Protocol IACUC system will notify you when your protocol has been approved but will not send you an approval letter. The email also includes instructions on how to generate a approval letter for your protocol through the e-Protocol website. Protocol approval is for 3 years, but continued approval is subject to annual continuation review. e-Protocol will record an expiration date that is one year from the date of approval. PIs receive an automatic reminder to complete an annual report for IACUC annual review and re-approval. Amending a protocol. The UMass IACUC must be notified and approve, any proposed changes in animal species, increase in numbers that will exceed the approved totals by > 10%, changes in procedures from those in the original approved protocol, changes in personnel conducting the research protocol. Changes to a protocol must be submitted for IACUC review by modifying the most recent version of the protocol in e-Protocol and submitting the revised protocol to the IACUC office for IACUC review. Please note that federal law requires that change in PI and major departures from the original protocol must be addressed by submitting a new protocol.


© University of Massachusetts Amherst. Site Policies. This page is maintained by the Office of the Vice Chancellor for Research and Engagement.