Changes to Use Categories (UC) - PI/Lab Personnel Overview

Currently the Institutional Animal Care & Use Committee (IACUC) requires that the Animal Protocol identifies the number of animals that are expected to endure research using a Humane Use Category (UC) scale of 1-9 for all species.  The use of this scale is also required when reporting, ordering or transferring animals via an Animal Use Form.

Recently, the IACUC has decided to move to an UC scale that is more aligned with the rest of the industry.  This was driven by the desire to relieve administrative burden and based on feedback from AAALAC International.

Because eRAM has been in service for over five years and the eRAM database was designed around the 1-9 UC scale, this change will not be easy to implement.  Accordingly, the Animal Care & Use Office (ACUO)/IACUC and eRAM have developed a plan to implement this change in phases.

Both teams are doing their best to accomplish this with as few changes to the PI/Study Team as possible, and the ACUO will absorb most of the phasing/transition work.  While the impact on PI/Study Teams will be mainly visual in nature, they will need to have a basic understanding of the changes and how those changes will be phased in.


New UC Scale

Animal Protocols for all species will now go to a letter scale (C, D and E).  The previous 1-9 scale loosely maps to the new letter scale as follows:

Use Categories 1-2 = C

Use Categories 3-6 = D

Use Categories 7-9 = E


Use Categories for USDA and Non-USDA Species

Animal Usage (via Animal Use Forms and Breeding Sheets) for USDA species will be reported and calculated based on the appropriate C, D or E Use Category, providing relief of some administrative burden.

Animal Usage (via Animal Use Forms and Breeding Sheets) for non-USDA species will be classified as a single category moving forward. Until further notice, Use Category C will be used as a temporary assignment for all applicable studies. As the bulk of U-M studies are non-USDA, Use Category C will be the only choice for the vast majority of protocols. This transition should provide relief of some adminitrative burden.


Protocol Types: What PI/Study Teams will see (and do) in eRAM

Legacy Protocols - Expired or Cancelled before 7/11/16

No changes will be made to these protocols or any associated Animal Use Forms, Cage Cards or Breeding Sheets.


New Protocols - Protocols not approved prior to 7/11/16, and new protocols created after 7/10/16 (via the New button, the Renewal functionality or the Copy functionality)

Use Categories and Justification page (Protocol): Use Categories C,D and E will be editable prior to approval and via an Amendment after approval.

If your protocol is in a state of Pre-Submission through Pre-Approval, the data that was in Use Categories 1-9 will be automatically converted to the C-E categories.  The ACUO may require that you change verbiage in other protocol questions that referenced Use Categories 1-9 prior to approval.

Use and Justificaiton page grid for new protocols not approved prior to july 11, 2016

Approved Protocols - Approved after 7-11-16

Animal Use Forms: The process for completing these has not changed; however, an additional column displays next to the Use Category column showing the mapping of UC 1-9 to C, D and E.

Cage Cards and Breeding Sheets: The process for requesting these has not changed; however, Use Categories C, D or E will display instead of 1-9 in some instances.

Animal Transaction and Numbers Tab (Protocol Workspace): A column has been added next to the Use Category column that displays the mapping of UC 1-9 to C, D and E.  New Animal Transactions and Numbers will only ever occur for Use Categories C, D or E.



ACUO Transitioning Protocols to New UC Scale

Sometime during the first few months of the rollout, the ACUO will evaluate and transition all protocols to align with the new UC scale.  Each approved protocol will be reviewed and transitioned based on items such as USDA priority, existence of in-progress amendments, etc.

The ACUO will have a special Animal Use Form to move unused animals to the correct Use Category based on the new scale.  The new form will be visible to the PI/Study Team and will be listed on the Use Forms tab in the protocol workspace.  Once the process is completed, these protocols will be considered “Transitioned to New.”


Transitioning Protocols - Protocols that are in the Approved state prior to 7/11/16

Use Categories and Justification page (Protocol): Before the protocol is transitioned, an additional Use Category column will display the mapping of UC 1-9 to C, D and E.  Edits via an amendment will use the 1-9 scale for edits, and animal numbers will automatically be subtotalled in the new C, D and E Use Categories.

Use and Justification page grid for transitioning protocols


Animal Use Forms: The process for completing these has not changed; however, an additional column displays next to the Use Category column showing the mapping of UC 1-9 to C, D and E.  Users will edit 1-9 as they did prior to the rollout. Animal Transactions and Numbers will also use the 1-9 scale.

Cage Cards and Breeding Sheets: The process for requesting these has not changed.  Visually, there will be C, D or E displayed instead of UC 1-9.  UC 1-9 should be used based on their old definitions.  Breeding sheets will be ordered using UC 1-9.

Animal Transactions and Numbers tab (Protocol Workspace): A column has been added next to the Use Category column that displays the mapping of UC 1-9 to C, D and E.  New Animal Transactions and Numbers will only ever occur for UC 1-9.


Transitioned to New - Protocols that are in the approved state prior to 7/11/16 and the ACUO has reviewed and modified the UCs to be aligned with the new C, D and E scale

Use Categories and Justification page (Protocol): Use Categories C, D and E will be editable via an amendment. Data that was entered in Use Categories 1-9 will have been automatically mapped to the appropriate C-E categories. The ACUO may require that you change verbiage in other protocol questions that referred to the 1-9 scale at your next amendment (or at a time in the future).

Animal Use Forms: The process for completing these has not changed; however, an additional column displays next to the Use Category column showing the mapping of UC 1-9 to C-E.

Cage Cards and Breeding Sheets: The process for requesting these has not changed; however,  Use Categories C, D or E will display instead of 1-9.  When ordering Breeding Sheets, HUC options are based on what was originally authorized and new UCs of C, D or E if they were added by the ACUO during the Transition.

Animal Transactions and Numbers tab (Protocol Workspace): A column has been added next to the Use Category column that displays the mapping of UC 1-9 to C, D and E.  New Animal Transactions and Numbers will only ever occur for C, D and E. Transactions prior to the Transition to the new UC scale will not be changed.  They will be in UCs 1-9 as they originally occurred.

 

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