IACUC Policy 12: Animal Protocol Control

advertisement
TEXAS TECH UNIVERSITY
Office of the Vice President for Research
Institutional Animal Care and Use Committee™
IACUC Policy 12: Animal Protocol Control
Policy Purpose: The intent of this policy is to describe the protocol approval process by the
IACUC committee.
Table of Contents
1.
2.
3.
4.
5.
6.
Purpose
General
Sequence of Events
After the DMR has sent in the review
Protocol Approval
IACUC AUF Numbering System
Revision No:
04
Authors:
Amber Matthews
Replaces: Date in effect:
03
9/10/2014
Responsible faculty:
(Signature/Date)
Phil Smith 9/10/2014
1. Purpose
The goal of this policy is to establish a process on how protocols are approved by the IACUC
committee.
2. General
One important function of the IACUC is to receive, review, approve (or not), and oversee animal care
and use activities as described in the Animal Use Form (AUF) which is also called the ACUC
Protocol. AUFs originate with investigators, teachers, veterinarians or others. This SOP describes
the document control system for AUFs.
3. Sequence of Events
a. A faculty member submits an AUF electronically to the IACUC Coordinator to the address:
iacuc@ttu.edu (Only faculty members can submit an AUF).
b. The IACUC Coordinator logs in the AUF in the review folder. Logging in entails:
i) Assigning the new AUF a unique number (see numbering system protocol below)
ii) Creating a folder in the Reviews file
iii) The protocol is sent electronically to the committee with a due date for comments.
c. The Coordinator will collect comments for the protocol and put them in the checklist to be sent to
the DMR for the review.
4. After the DMR has sent in the review the Coordinator sends those comments to the PI to make
revisions
a. When the revisions are made, the revised version will be sent to the DMR and chair
for approval. Their approval emails will be printed and put with the physical file.
5. Protocol Approval
a. Once a protocol is approved the T is removed and it is assigned the permanent
approval number and logged on the Database Spreadsheet.
Effective Date: September 10, 2014
IACUC Chair: Phil Smith
Page 1 of 3
TEXAS TECH UNIVERSITY
Office of the Vice President for Research
Institutional Animal Care and Use Committee™
b. A physical file is established for the AUF. The physical file contains printed copies of
the following:
i. The AUF
ii. Any and all emails regarding that AUF
iii. Any amendments
iv. All approval memos
v. Each annual review
vi. A termination documentation (the last annual review that indicates progress
made and requesting termination)
c. Terminated protocols are moved to an archive file. They are kept for 3 years.
Terminated AUFs older than 3 years can be destroyed about once every quarter.
d. A duplicate copy (by email) of the AUF fill will be given to and maintained by Animal
Care Services for projects conducted in their facilities. This group conducts rounds
of the animal facilities and requires up-to-date information on protocols.
e. Each AUF file will be maintained by number in the physical file.
f. An IACUC Main Data Set (Excel Spreadsheet) can be sorted in a number of ways,
electronically and on paper, and kept up to date daily. The sorted data sets include:
i. A sort by PI
ii. A sort by approval date and number
iii. A sort by pain category (B-E)
iv. A sort by USDA covered species (yes or no)
v. A list of non-compliant AUFs will be kept (these protocols can not use
animals until the compliance issues are resolved), or animals are placed on
the holding protocol.
6. IACUC AUF Numbering System
a. Each IACUC AUF is identified by:
i. The PI
ii. The title or titles (multiple titles are allowed)
iii. A unique numbers
b. The unique number will contain the year submitted or approved (which ever is later),
the AUF sequential number for that year, and the month in which its annual review
will be performed (same month as its original approval). For example:
07-054-May represents:
Year
Number within the year
07
054 (54th AUF for that year)
Approval Month
Month (Jan-Dec)
c. AUFs that have an anniversary date in a given month must have their annual review
completed and approved by the IACUC no later than the last day of their anniversary
month. AUFs must undergo annual review each year. After 3 years, the number is
terminated. If the work continues, a new AUF must be approved. The new AUF will
Effective Date: September 10, 2014
IACUC Chair: Phil Smith
Page 2 of 3
TEXAS TECH UNIVERSITY
Office of the Vice President for Research
Institutional Animal Care and Use Committee™
be assigned a unique number which will be linked, on the AUF and in the Main
Database, to the old AUF to avoid unnecessary duplication of animal work.
d. An AUF can never be more than 3 years old because the life of an AUF is 3 years or
less by law and regulation.
Effective Date: September 10, 2014
IACUC Chair: Phil Smith
Page 3 of 3
Download