Guide to IACUC Application Process

 

 

 

Institutional Animal Care and Use Committee (IACUC)

I.  Guide to the IACUC Application Process

Researchers Start Here

Procedure

Initial review process

Amendment to protocol

IACUC supervises animal research in accordance with the regulations of the Animal Welfare Act and its amendments, which are administered by the USDA through the Animal and Plant Health Inspection Service (APHIS), and regulations in the Health Research Extension Act and its amendments, which are administered by the National Institutes of Health (NIH) through the Office of Laboratory Animal Welfare (OLAW.).  Prior to the initiation of any live vertebrate animal research at TAMIU, the IACUC has the responsibility to review and approve, require modifications to, or withhold approval to animal care and use protocols and to inspect all of the animal facilities at least once every six months.

The use of live vertebrate animals is essential to the teaching, extension, and research missions of Texas A&M International University. Significant benefits to the health and welfare of both animals and humans have resulted from animal use in research, and continued use is crucial to future advancements. Each faculty member, staff member, or student involved in the use of live vertebrate animals is directly responsible for promoting and protecting their welfare within the instructional, extension, and research programs of the University. Those who use animals should assume this responsibility through precept and example. The following policy provides guidance for the proper care and humane use of live vertebrate animals within University programs.

Texas A&M International University policy requires the submission and approval of an Animal Use Protocol Application  (AUP) or Field Research Application (FRA) for all activities involving the use of live vertebrate animals at TAMIU or by TAMIU faculty, staff and students. “Use” includes both unfunded and funded (either externally or internally) activities such as research, teaching, or public service. “Use’ also includes animals being bred, conditioned, or held for future use.

The TAMIU IACUC meets twice yearly in June and December.  Therefore, it is prudent to submit the forms to the IACUC as soon as the need is anticipated.  All protocols must be submitted to the IACUC no later than 10 days before the meeting (contact IACUC chair to find out the biannual meeting dates).  The IACUC cannot expedite the review of an application because the investigator failed to submit it in time. It is the responsibility of the principal investigator (PI) to submit an AUP or FRA with sufficient lead-time to meet all University and agency deadlines.

All use of live vertebrate animals at TAMIU requires prior IACUC approval.

 

Procedure: 

1.  Complete the Animal Use Protocol Application (AUP) or Field Research Application (FRA) form

2.  Complete the TAMIU Medical Health Questionnaire and have current tetanus vaccine

3.  Submit both the signed AUP or FRA application form and page 3 of the TAMIU Medical Health Questionnaire to the Office of Research and Sponsored Projects (KL 326). 

4.  All personnel listed on the application form who will either enter animal facility or directly handle animals must complete CITI IACUC Training, submit the TAMIU Medical Health Questionnaire (page 2 only) to the principal investigator of the Animal Use Protocol, and have a current tetanus vaccine prior to the initiation of any animal research.

5.  Any new personnel joining the lab must be added to the protocol using either the AUP or FRA amendment form, complete CITI IACUC Training, submit the TAMIU Medical Health Questionnaire as described above and have a current tetanus vaccine prior to the initiation of any animal research.

 

Initial review process:

1.  All protocols are reviewed by the entire committee. In additional, the IACUC may send the protocol to an outside reviewer who is expert in that area of animal research techniques.

2.  After review one of three outcomes is possible: approval with no modifications, conditional approval pending revisions, or disapproval.

a. Approval with no modifications - The protocol meets all standards and is approved without modifications by full committee

b.  Modifications required to secure approval - This is conditional approval with final approval by IACUC Chair (or designated member) or by Full Committee once PI has completed revisions necessary for approval. PI is notified in writing of the required changes that must be made to the protocol before approval will be granted.  Full Committee may defer approval of the required changes to the designated-member review method. 

c. Disapproval – The reasons for disapproval are given to the PI, who may submit a Revised Protocol.

3.  Upon approval the PI will receive written notification and is responsible for submitting annual review on the anniversary date of the approval and resubmission prior to the third anniversary. Failure to submit the renewal in time for review prior to the third anniversary will result in a lapse of approval.

4.  Note: Any revisions requested during the review process become a part of the official protocol file.

 

Amendment to protocols:

Any changes in the protocol procedures, number of animals, or personnel requires the submission of the AUP Amendment form or FRA Amendment form.  In addition to the amendment form, for additions of new personnel, the TAMIU Medical Health Questionnaire must also be submitted, completion of the CITI IACUC Training and a current tetanus vaccine are all required prior to the initiation of any animal research by the new personnel.   

The IACUC Chair will then:

a. Notify all members of the IACUC in writing that an amendment has been submitted. This written notification shall contain, at a minimum the title of the study and the number of the amendment.

b. The IACUC chair will forward a copy of the amendment and parent protocol to any member of the IACUC who requests such information.

Members of the IACUC may request:

a. A copy of the written amendment and supporting documentation.

b. Submission of the amendment to the full committee at the next scheduled meeting.

If full committee review is not requested by any member of the IACUC after distribution of the amendment within 10 business days, the review may be carried out using an designated-member review method. 

 

Designated-Member Review Method: the Chair, or one or more experienced reviewers designated by the Chair from among the members of the IACUC, shall carry out the review.  Any IACUC member who has a conflicting interest shall not participate in the review of that amendment except to provide information requested by the IACUC.  The IACUC Expedited Reviewer(s) or Subcommittee shall have the same responsibilities and authority as that of the full IACUC except disapproval.

 

 

     I.  Guide to the IACUC Application Process - Researchers Start Here

    II.  IACUC Forms, Guidelines/Regulations and Useful Links

   III.  Training - Required

   IV.  IACUC Members

    V.  Frequently Asked Questions

   VI.  IACUC Letter of Assurance

 VII.  Classroom Research Guidelines

VIII.  TAMIU IACUC Policy and Procedures Manual (available from IACUC Chair)

 

 

 

 

If you have questions, please contact the IACUC Chair, Dr. Roberto Heredia, (iacuc@lists.tamiu.edu, CH205B, 956-326-2637         

 

 

 

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