Institutional Animal Care and Use Committee

Standard Operating Procedures

For Blanket Application for Vertebrate Animal Use
For Review of Applications for Vertebrate Animal Use
For Significant Changes in an Approved Application for Vertebrate Animal Use
For Semiannual Facilities Inspections

For Blanket Application for Vertebrate Animal Use

Principal Investigators (PIs) may wish to seek “blanket” approval for animal use where procedures can be described, but specific treatments and/or animal numbers are not yet determined. The potential advantage of this approach is that only an amendment would need to be filed, as these additional details are known. However, the process for approving amendments that involve significant changes requires essentially the same steps as a new submission; therefore, there may not ultimately be significant time savings in review. On the other hand, if amendments include only non-significant changes, then those changes would generally be approved quickly.

If a PI has special need for rapid turnaround time on review of an Application for Vertebrate Animal Use (AVAU), s/he should contact the Killgore Research Office.

The Institutional Animal Care Use Committee requires a complete description of the animal-use activity. This description includes not only the procedures performed with/on animals, but also details of the experimental treatments: specific drugs, dosages (volume and mg/kg), and routes of administration; dietary manipulations; justification of animal numbers based on the experimental design; etc.

The above information may be supplied in some combination of AVAU and amendment form, and must be reviewed and approved by the IACUC before an animal activity begins.

If details of animal use are not available at the time of initial AVAU submission, then the AVAU should indicate specifically what additional information will be provided as an amendment.

For each amendment submitted, the IACUC Chair decides whether the proposed changes are “significant.” This decision is based on the IACUC Guideline, “Review Procedures for Significant Changes in an Approved AVAU.”

For Review of Applications for Vertebrate Animal Use

Initial Processing of New AVAUs

New protocols (Applications for Vertebrate Animal Use; AVAUs) received in the Killgore Research Center office are logged into a spreadsheet maintained by the research secretary
The Killgore Research Center office checks the names of the individuals named in the application against the list of names of individuals who have completed an approved animal care and use training. A waiver of training is available through the dean of graduate school and research. Animal care training must be within three years of the date of receipt of the application. If this is not the case, the research secretary sends a notification to the applicant regarding the training and/or waiver requirements, informing them that Institutional Animal Care and Use Committee (IACUC) approval will be withheld if the requirements are not met.
The dean of graduate school and research conducts an administrative review of the AVAU to identify gross omissions before continuing the review process. In cases where need for significant revision is apparent, the dean of graduate school and research may recommend that the Principal Investigator (PI) seek immediate assistance from an IACUC member in revising the AVAU.
The dean of graduate school and research assigns the Application for Vertebrate Animal Use (AVAU) a designation of “biomedical,” “agricultural,” or “other,” using the definition of “animal” included in 9 CFR 1.1 ( http://www.aphis.usda.gov/ac/cfr/9cfr1.html ) as a guideline to identify which projects are subject to USDA reporting. The designation is subject to change during the review process. This designation is not final until the protocol is approved (after the third tier of review).

Three Tiers of AVAU Review:

NOTE: All correspondence related to all veterinary and primary reviewer (PR) reviews of an AVAU will be copied to the dean of graduate school and research for documentation of the file.

First Tier of Review

To facilitate the PI's submission of the AVAU, the dean of graduate school and research assigns a veterinary reviewer and a primary reviewer (PR). The veterinary reviewer will conduct the initial review with regard to veterinary issues and copy all correspondence with the PI to the PR . The veterinarian will usually be a current IACUC member; however, other reviewers may be utilized from an approved list of veterinarians. The PR will usually be a current IACUC member, but others may be utilized from an approved list of consulting reviewers. The veterinary reviewer should contact the PI within five (5) working days, if changes are necessary. If revisions are recommended by the veterinary reviewer, the PI will return the revised application directly to the veterinary reviewer. Upon finding the application satisfactory with regard to veterinary issues, the veterinary reviewer then forwards the revised AVAU to the dean of graduate school and research for the next tier of review.

Second Tier of Review

Upon receipt of the reviewed AVAU from the veterinary reviewer, the dean of graduate school and research will forward it to the PR who will be responsible for reviewing the entire AVAU for IACUC concerns and coordinating revisions to be presented to the full committee. There are special considerations for Category E protocols (see Third Tier of Review, below). The PR should contact the PI within five (5) working days after receipt of the revised AVAU. The PI should return the revised application directly to the PR for review and recommendation to the full committee.

Third Tier of Review (Final Review)

Non-Category E protocols (as outlined in Specific Instructions by AVAU Sections):

If the PR is satisfied that the application requires no further revision, the PR will recommend, by email to the dean of graduate school and research, approval of the application without further discussion.
If the PR is not satisfied with AVAU revisions and is unable to recommend approval of the protocol, the AVAU is placed on the agenda for discussion at the next convened quorum. The PI will be invited to address the committee concerning unresolved issues.
Non-Category E applications recommended for approval without further discussion are distributed to the full committee by the Killgore Research Office. Members are notified that they have five (5) working days to review the applications and flag them for discussion at the next scheduled meeting.
If an application is flagged for discussion, the PR and the dean of graduate school and research are notified of the concerns raised. In the event that the concerns are resolved prior to the meeting, to the satisfaction of the member(s) raising the concerns, the AVAU is removed from the agenda and approved without further discussion.
At the end of the final review period, the IACUC Chair acts as designated reviewer for all AVAUs not flagged for convened quorum review. As designated reviewer, the Chair may approve the AVAU, require modifications, or bring the AVAU to a convened quorum.

Category E protocols (as outlined in Specific Instructions by AVAU Sections):

The PR should advise PIs that, in accordance with WTAMU IACUC policy, all applications involving Category E (as outlined in Specific Instructions by AVAU Sections) animal use must be presented for discussion at a convened quorum. The PR is asked to inform PIs that the IACUC requires a revised copy of the application at least one week prior to the scheduled meeting for distribution to the full committee. If the revised AVAU is not received in the proper time allocated it will be considered at the next convened quorum.
When the PR is satisfied that the application requires no further revision, the PR will recommend, by email to the dean of graduate school and research, that the application be placed on the agenda for the next meeting.

Convened Quorum Review

Applications involving Category E animal use, those for which the PR or IACUC Chair have requested discussion at the next meeting, and those that have been flagged for discussion by any voting member of the committee during final review are placed on the agenda for discussion at the next meeting.
AVAUs discussed at a convened quorum are processed according to the approved motions resulting from the committee's discussions. If an application is not approved, the dean of graduate school and research drafts a notification to the applicant. If further revisions are requested by the committee, they are coordinated by the original PR, unless specified otherwise in the committee's action.

Final Processing

Once approved, a signed copy of the AVAU is mailed to the PI with a cover memo from the IACUC Chair. A copy of the approved AVAU is forwarded to the animal facility identified in the protocol as the location/site of the animal use.

For Significant Changes in an Approved Application for Vertebrate Animal Use

Changes in vertebrate animal use in research and teaching are inevitable, but protocol changes categorized as significant must not be implemented prior to IACUC review and approval. The Principal Investigator (PI) is responsible for informing the IACUC of any significant changes by filing an Animal Care and Use Protocol Amendment form with the IACUC. Amendment forms will be reviewed for veterinary care issues by a veterinarian who will make recommendations to the IACUC chair. If the chair judges that proposed protocol changes are significant, the amendment form, along with the original AVAU, will be forwarded to an IACUC primary reviewer. (In some cases, the Chair may judge that changes are sufficiently different from the original protocol that a new AVAU be completed.) A copy of the amendment form is sent to each IACUC member to permit opportunity to request additional information or convened IACUC review. In all other respects, IACUC review is the same as review of an original protocol.

Significant changes include but are not limited to:

changes in the objectives of a study;
proposals to switch from nonsurvival to survival surgery;
increased degree of invasiveness of a procedure , or increased duration, frequency, or number of procedures performed on an animal;
any change with potential for increased pain or distress;
change in species;
increase in the approximate number of animals used;
changes in key personnel involved in animal procedures (i.e., those working unsupervised);
changes in veterinary care, such as anesthetic agent(s), the use or withholding of analgesics, and methods of euthanasia;
change in hazardous substance use.

For Semiannual Facilities Inspections

General

The WTAMU IACUC is responsible for the inspection of all sites where vertebrate animals are housed or used for purposes of research, teaching, and testing. The frequency and specific methodology of these inspections varies with the type of activity conducted, discussed further below. In general, all housing sites, and all areas where survival surgery is conducted are inspected at least once every six months. All areas where animals are used but not housed for more than 12 hours are inspected periodically. Each facility inspection will be the responsibility of an IACUC member, designated as the “inspection chair” for that site(s).

Overview of Inspection Frequency

All facilities where animals are housed more than 12 hours, except agricultural units and other remote facilities housing non-regulated species: inspected every six months by at least two voting members of the IACUC.
All facilities/areas where survival surgery is performed: inspected every six months by at least two members of the IACUC.
All other areas where animals are used, but not housed more than 12 hours: inspected periodically based on judgement of inspection chair; some but not necessarily all areas inspected every six months.

Responsibilities – Dean Graduate School and Research

Maintain schedule to ensure that visits are conducted at appropriate intervals.
Maintain list of facilities, including satellite areas
Maintain list of Dr. of Veterinary Medicine (DVM), and other contacts (as appropriate)
Maintain list of laboratories with animal use and contact

For IACUC inspections:

Begin planning inspection scheduling at least one month in advance of due date of inspection. All members should be notified of all inspection schedules at least two weeks in advance in order to allow them to participate if desired.
Provide to the Inspection Chair: list of inspection sites, contacts, laboratories, previous inspection report(s), and checklists
Arrange inspection schedule with Animal Research Dept. (ARD) and appropriate unit personnel in consultation with the inspection team captain
Arrange for transportation, in consultation with Inspection Chair
Notify IACUC members of inspection schedule
Receive inspection reports from inspection chair and distribute to committee
Distribute approved reports to ARDs (and other contacts) and ensure that responses are received as appropriate; distribute responses to IACUC members
Assemble final reports for retention in by the Killgore Research Center.

Responsibilities – Inspection Chair

For IACUC inspections:

Consult with dean of graduate school and research in arranging inspection schedule with ARD, appropriate unit personnel, and team members (including Lab Animal Researcher (LAR) veterinarian)
Use checklist specific to the facility (provided by dean of graduate school and research)
Obtain from previous inspection reports and lists of labs where animals are used/housed in facility/building from dean of graduate school and research
Lead inspection, including discussion of preliminary findings with unit personnel
Coordinate preparation of draft inspection report with team members
Provide draft report to the dean of graduate school and research for distribution to committee

Writing the report:

Use the attached format for drafting the inspection report. Each unit should have a separate report, although laboratories in the same building may be covered along with the central animal housing unit. Each deficiency or comment should be numbered, and the checklists should be attached.
Deficiencies are separated into significant vs. minor. A significant deficiency is one that is or may be a threat to the health or safety of the animals and/or something that poses a threat to personnel health or safety.
For each deficiency, include a description of the deficiency (what was seen and where), and explanation of why it's a deficiency (e.g., failure to satisfy specific regulation or guideline). The report may refer to group of common problems, as long as detailed on the attached checklist. For example, "There was chipped and peeled paint on walls and floors of several animal rooms (see attached)."
Comments/Suggestions may be used to document observations that are not, or perhaps should not, be considered a "deficiency." Include commentary that explains why the observed situation could be improved upon, and how it might be so improved. This section should include update on previously noted deficiencies, and it also may be appropriate to include here a commendation (statement that identifies program, physical plant and/or personnel strengths).
Present report at IACUC meeting

Responsibilities – IACUC Chair

Assign team captains and at least one additional member for each inspection. Conflict of interest should be considered when making assignments.

Responsibilities – Lab Animal Researcher (LAR)

Provide lab animal Dr. of Veterinary Medicine, as requested

Provide assistance with drafting of reports, as requested by team captains