A laboratory animal protocol refers to the investigator's "Application for the Use of Laboratory Animals", any modifications which have been made to the application, and its annual progress reports. A laboratory animal protocol is required for any project in which laboratory animals will be used, whether for research or teaching. Each protocol is assigned a unique protocol number which will remain associated with that project throughout its duration. The protocol number indicates the protocol's identification number, species, year and classification. Once a protocol has been approved by the IACUC, the principal investigator will receive a copy of the approved protocol and its approval letter. It is the investigator's responsibility to notify the funding agency of the protocol's approval.

• The Application
• The Progress Report
• Modifications
• Ordering Laboratory Animals

1. The "Application for the Use of Laboratory Animals" is the document which includes all of the information about the laboratory animal work that will be performed in a particular project. It indicates:
• the purpose of the project,
• the procedures to be performed,
• a justification for the use of laboratory animals,
• the number of animals required for the duration of the project and how the number was determined,
• those individuals that will be working with the animals, and
• where the animal procedures will be performed.

Application Explanation: MS Word .doc or Acrobat .pdf

2. The IACUC requires "The Application for the Use of Laboratory Animals" to be submitted:
• For each new proposal.
• For proposals submitted to a different funding source that are identical to the procedures of an approved protocol. (A separate application must be submitted for each grant.)
• For modifications to an approved protocol which involve:
• an alteration* to an approved protocol's procedures
• an addition of new procedures or species to an approved protocol.
* Simple modifications may be submitted as a memorandum.
3. The application is available as a hard copy through the IACP office, via E-mail, or on the forms page.
4. Applications must be submitted to the IACP office as a hard copy. New applications submissions will not be accepted via E-mail or on disk. However, the IACP will accept requested modifications as e-mail attachments (see amendments & modifications policy).
5. The title and investigator listed on the application should match that of the grant application.
6. The review process requires the application to be reviewed by several individuals. It will take 4-6 weeks from the time the application is submitted to when it is approved by the IACUC. (Those protocols going through Full Committee Review must be reviewed by the full committee, which meets only once a month. They must be submitted by the 15th of the month prior to the month they will be reviewed.)

   For example, if you submit your qpplication no later than June 15th, it will be placed on the July agenda for the IACUC meeting. If you submit your application after June 15th, your application will be on the August IACUC agenda.

7. Pending letters may be issued for new applications that have been or have yet to be submitted for IACUC approval. This letter states that the protocol will be approved within 60 days of the date the letter is issued. (Please consider this when requesting a letter before submitting the application. Some funding sources require approval before they will evaluate the grant proposal. The IACP office is not responsible for applications approved beyond the 60 days if the application was not submitted at the same time as the pending letter was issued.)

The Progress Report

1. Federal regulations require an annual review of all projects involving the use of laboratory animals. The IACUC Progress Report asks:
• the status of the protocol,
• a description of the work done and data collected during the past year,
• a brief explanation of what is to be studied in the coming year, and
• a summary of the number of animals used to date.
An explanation of the progress report is available on the "Progress Report Explanation" page.
2. The IACP office will automatically send the progress report to the principal investigator approximately eight weeks prior to the protocol's expiration. (A copy of the report is available at the "Forms" page or via E-mail or on disk.)
   (Progress report .doc || Progress report .pdf)
3. Progress reports must be submitted to the IACP office as hard copies. Disk or e-mailed copies will not be accepted.
4. It will take 3-4 weeks from the time the report is submitted to when it is approved. Those progress reports which contain modifications may take longer.
5. Modifications to the protocol may be included in the progress reports. (Since this is not a full application, be sure to include all the information that would have been included if it had been.)
6. Pending letters are not issued for progress reports.

Modifications

A modification of a protocol is required whenever the procedures described in the protocol are being altered, different procedures and/or species are being added, or when the number of animals approved for the current year is being increased.

Modifications may be submitted to the IACP office for IACUC approval by completing an "Application for the Use of Laboratory Animals", "Request to Increase Animal Usage" or as a memorandum. Once submitted, the it will take 3-6 weeks for the modification to be approved. (See amendments & modifications policy.)

Ordering Laboratory Animals

All laboratory animals and laboratory animal supplies must be ordered through the Department of Laboratory Animal Resources. The IACP office sends copies of the applications, progress reports with copies of approval letters, and modifications once they are approved. Laboratory animals may be ordered once a project has an approved laboratory animal protocol and has been funded.

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