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Annual Protocol Renewal

The approved protocol is valid for one year from the approval date. A renewal notification is sent to you one month prior to the renewal date by email. The renewal must be completed online and submitted promptly or the protocol will be suspended following its annual expiration. The renewal requires you to address changes in personnel, funding sources, animal numbers and procedures. Your protocol will require revision if these changes are required.

IACUCs do not have authority to administratively extend approval beyond one year. When IACUC approval expires the protocol lacks valid approval. Continuation of animal activities in the absence of valid approval is a serious and reportable violation of PHS Policy (see NOT-OD-05-034).

Three Year Protocol Renewal

Every three years, a full protocol must be resubmitted with a brief progress report to be reviewed by the IACUC. You will be notified by several emails beginning six months prior to the due date of your renewal. In order to assist the IACUC in its ongoing review of your project, you will be asked to provide a brief description of the project's progress. The only difference between a new protocol and a three year renewal is the need to submit a Progress Report which is a brief synopsis of the progress made and a brief overview of studies proposed for the next three years (i.e., new specific aims or procedures). The description should place the work proposed in the renewal in the context of the overall project, providing a basis for understanding the new work, e.g., the need to repeat certain experiments, changes in direction based on findings in your laboratory or reported by others, or the need to include additional factors to further explore the aim of the project, etc. This Progress Report should indicate whether the use of animals described in the renewal includes work that was described previously but not accomplished, or whether the animal use described is in addition to previously approved use. Therefore, a description of the number of animals used previously on this project is requested as part of the report. Your description should be understandable to a layperson.

Make sure you included the animals currently maintained in the facility on this protocol in your 3-year renewal. Unless they will be sacrificed before this 3-year renewal is approved, the animals must be included and justified in the renewal as they will be debited from the approved number on the renewed protocol after approval. The animals should be placed in the same USDA category as specified in the prior submission unless they are unmanipulated and will be subject to different procedures than described previously. They should also be assigned to a different USDA Category if your proposed experimental usage in the 3-year renewal is different than in the prior submission; however, they should not be assigned to a lower category.

IACUCs do not have authority to administratively extend approval beyond three years. When IACUC approval expires the protocol lacks valid approval. Continuation of animal activities in the absence of valid approval is a serious and reportable violation of PHS Policy (see NOT-OD-05-034).

Adding New Funding/Support

Each grant/contract that proposes the use of animals must be accompanied by an approved protocol that describes the animal use activities as proposed in the grant or contract, including the scientific rationale, hypothesis, species and numbers of animals requested, and methods and staff utilized, and the funding agency and grant/contract # is included in the protocol. If these conditions are not met, an animal care and use proposal must be submitted. Alternatively, if you have an approved protocol(s) that meets the criteria described above except the funding agency and grant/contract # were not included in the protocol(s) then you must submit an amendment to the protocol.

Submitting an Amendment

Any significant changes (personnel, animal numbers, species, procedures) to your Animal Care & Use Protocol requires the submission of an amendment. ONLY the Principal Investigator of the protocol can initiate an amendment.

To submit an amendment sign into EnCCoMPAss and select the protocol tab. Select the protocol you would like to amend from the list under ‘My protocols’. Select the history icon at the top of the most recent 3 year cycle. Click the icon pictured below.

= Create an Amendment

You will be directed to the amendment question set.