Types of Submissions

A new protocol is a new application for the use of animals in research, testing, or teaching

All new protocols will be reviewed via the FCR review process (see IACUC Review Process) . See the IACUC meeting schedule for dates when meetings will occur and submission deadlines. Protocols must be completed in eSirius/Cayuse and submitted by the submission deadline. Once submitted for review protocols undergo a pre-review by the IACUC office to check for completion. Following FCR review, notices reflecting committee action are generated in eSirius/Cayuse and a system generated notice is distributed by email to the PI.

When the Committee requests a response from a PI who has submitted a protocol, the PI has 2 weeks to respond. The Committee may archive the submission if the PI does not respond in 60 days. Animals cannot be ordered and work cannot begin until the IACUC has approved the submission.

For tips on how to properly complete sections of the protocol, please read this article “Everything You Need to Know About Satisfying IACUC Protocol Requirements”

All protocols must receive a complete review once every three years.

All renewal protocols will be reviewed via the FCR review process (see IACUC Review Process) . Renewal protocols must be reviewed at the meeting 2 months prior to expiration.) See the IACUC meeting schedule for dates when meetings will occur and submission deadlines. The requirement to submit early is to ensure that a renewal protocol can be reviewed with sufficient time to respond to any potential contingencies and then receive final approval before the current protocol expires. Lapses in protocol approval is considered noncompliance. Expirations reminders will be sent by the IACUC office to ensure renewals are submitted on time.

Please submit renewal protocols in Cayuse following the directions outlined in the expiration reminder email, following this process will ensure that the protocol number carries forward. Do not make a copy of the approved protocol as this will assign a new protocol number.

Per federal guidance, the 3-year renewal of a protocol even though it describes ongoing research, is reviewed by the IACUC as a totally new protocol that must contain all the information required to justify and describe the planned work. The work described must not, however, be needlessly duplicative of the work described and conducted under the previous version of the protocol. Thus, if a PI has used animals under the previous version of the protocol, that work must be described in the progress report, and experiments conducted should not be included in the new protocol, without justification as to why the work needs to be repeated. Preparing the 3-year renewal is the time to revise the protocol to describe the work that will be completed in the next 3 years by adding any new experiments that will be completed and removing experiments already completed. Please do not simply resubmit the same protocol that was previously approved unless the work has not been completed. Please remember any previous experiments, drugs, and/or procedures that are not included in the renewal cannot be performed/used. You may only perform experiments and procedures which are detailed in the current approved version.

When the Committee requests a response from the PI who has submitted a 3-year renewal protocol, it is the PI’s responsibility to respond in sufficient time for the Committee to review and approve the response before the old protocol expires. Allow at least two weeks for Committee review of the PI response. Animals cannot be ordered from the old protocol once it has expired, nor can any experiments be conducted on animals listed on the old protocol. Also, animals cannot be ordered from, nor experiments conducted on, the pending new protocol until it receives final approval from Committee. Protocol extensions are not permitted by regulatory agencies.

A Significant Amendment is defined as a modification to an already approved protocol, that does not meet the criteria for VVC or Administrative approval. All amendments must be submitted in Cayuse.

All amendments will be processed using the most appropriate review process see IACUC Policy Amendment Types and Review Processes.

Most amendments are sent out via the DMR review process (see IACUC Review Process).

Amendments will be batched together by week. Typically all amendments received by noon on Friday will be sent out for DMR review request the following Monday. (Note; Days and times may shift due to holidays or other schedule disruptions)

All protocol modifications MUST receive IACUC approval prior to the requested changes being implemented.

Significant changes must be reviewed and approved by the IACUC through Designated Member Review or Full Committee Review, but some changes may be reviewed and approved by a veterinarian following the IACUC Policy: Veterinary Verification and Consultation (VVC) .

Specific significant changes as outlined by NOT-OD-14-126 may be handled administratively according to IACUC-reviewed and -approved policies in consultation with a veterinarian authorized by the IACUC. See IACUC VVC policy for more information and examples of significant changes that may be reviewed by VVC. VVC amendment submissions will be reviewed by a veterinarian. Note: the veterinarian may still refer any request to FCR for any reason. All amendments must be submitted in Cayuse.

All protocol changes MUST receive IACUC approval prior to changes being implemented.

Administrative Amendments are minor changes that can be approved administratively by the IACUC staff. All amendments must be submitted in Cayuse.

All amendments will be processed using the most appropriate review process see IACUC Policy Amendment Types and Review Processes.

Changes include:

• Personnel (other than PI)- as long as all training requirements have been completed (See Training Information)
• Title
• Genotype
• Animal sex
• Funding change
• Location Change- Location changes to areas already part of the animal
  program overseen by the IACUC.
• Up to 10% increase in animal numbers is permitted as long as the study
  objectives remain unchanged. This is permitted for non USDA species
  only. A justification must be provided. Ex: breeding number increase
  due to small litter sizes, # of offspring with the correct genotype or
  other breeding difficulties. This may be used one time in a 3 year
  period.

All protocol changes MUST receive IACUC approval prior tochanges being impletmented

The Georgetown IACUC requires annual reviews to be completed for all protocols involving USDA regulated species and field study protocols. Annual Review submissions are reviewed via FCR and must be submitted for review for the 1st and 2nd annual review dates. Annual reviews must be submitted in Cayuse. Annual Review reminders will be sent by the IACUC office to ensure annual reviews are submitted on time.

Protocol modifications and personnel additions cannot occur during an annual review. The annual review submission requires a progress report update, information about adverse events and personnel check. Personnel can be deleted during an annual review but not added.