Inspection guidelines

• Procedures approved ARRP 114 9/2/99
• Revised procedures approved ARRP 129 27/3/2001
• Updated according to agreements of ARRP 132 (11/9/2001)

Inspection Procedures - Animal Research Act

This document is intended as a guide for Animal Welfare Unit Inspectors and members of the Animal Research Review Panel (ARRP). Procedures may be varied at the discretion of Inspectors and ARRP members.

1. Aims of inspections

1.1 Audit

1.1.1 Assess compliance with Animal Research Act 1985 and Regulation and the Australian Code of Practice for the Care and Use of Animals for Scientific Purposes.

1.1.2 Provide recommendations on actions to be taken to deal with non-compliance.

1.2 Educative

1.2.1 Assist Animal Ethics Committees (AECs), animal carers and researchers.

1.2.2 Raise standards (implementation of reduction, replacement, refinement).

1.2.3 Obtain overview of "problem areas" requiring further action.

1.3 Regulatory

1.3.1 Take action on non-compliance with Animal Research Act, Regulation and Code of Practice.

The emphasis given to the above aims may vary according to the purpose of the inspection (eg routine audit vs complaint investigation) and according to findings during the inspection.

2. Participants

2.1Inspectors under the Animal Research Act (see Section 50 of the Animal Research Act) - with or without members of Animal Research Review Panel (ARRP).

2.2Members of ARRP (see Section 10 of the Animal Research Act). Note the need to be authorised and to be in the company of an Inspector.

The inclusion of people apart from the above should only be done with the approval of the Institution or individual being inspected.

3. Organising and conducting announced inspections

3.1 Pre- inspection

3.1.1 Check file for information including proposed dates for AEC meetings, outstanding conditions of accreditation, previous inspections (especially previous recommendations).

3.1.2 Check inspection schedule to see if ARRP members have indicated they would like to attend.

3.1.3 Organise inspection date or dates with institution. Routine inspections should include a meeting with the AEC which is usually best organised on a day the AEC is already scheduled to meet. Best use of meeting with the AEC can be made if the inspection of animals and facilities has already occurred.

3.1.4 Write to the institution / individual confirming the inspection date(s), a broad plan for the inspection, people from the Animal Welfare Unit/ ARRP who will be attending (if known) and requesting specific information to be sent prior to inspection. If writing to accredited institution, write to CEO with copy to AEC Chair (and nominated contact person if appropriate). If writing to individual then write to licence holder or authority holder.

As a guide, write 2 months in advance of the planned inspection date if pre-inspection information is required (although this may not always be necessary or desirable).

3.1.5 Information requested will vary with the institution or individual but will usually include:

• minutes of AEC meetings (generally for the past 12 months)
• records of site inspections conducted by the AEC (generally for the past 12 months)
• current composition of the AEC (including names, categories and qualifications for these categories)
• most recent annual report of the AEC to the institution
• responses to outstanding conditions of accreditation (if not already obtained)
• responses to recommendations of previous inspection (if not already obtained)
• list of currently approved protocols and the chief investigators for these
• list of animal holding facilities and locations (if not clear in application forms)
• a copy of agenda papers, including protocols to be considered, for the AEC meeting to be attended by the inspection team

Examples of additional information that may be requested:

• institution’s grievance procedures
• AEC approved procedures/ guidelines for animal care and monitoring
• AEC approved standard operating procedures
• specific research applications

3.1.6 Send pre-inspection information to participating ARRP members. This should include

• pre inspection information sent by the institution
• most recent assessment of accreditation application
• most recent inspection report

3.1.7 Organise travel arrangements for self. Assist ARRP members with travel arrangements if necessary.

3.1.8 Assess pre-inspection information to enable specific items/issues to be checked during inspection (eg specific research protocols to be examined, particular research procedures to be discussed with AEC).

3.1.9 Ensure authorisation signed for ARRP members attending inspection.

3.2 Inspection

3.2.1 Inspection report form (G/data/welfare/siteinsp/lc6628 site inspection report form) should be used as a check list. Notes to be recorded in official notebook. Additional equipment for recording findings may include tape recorder, camera and video recorder.

3.2.2 Aim to meet with the Chief Executive Officer of the institution, preferably at the beginning of the inspection and, if necessary, at the end of the inspection.

3.2.3 Aim to inspect facilities and view a selection of research applications prior to meeting with the AEC. This may all be done on one day or over a number of days - depending on the size of the institution, location of facilities etc.

3.2.4 Whether all facilities or a selection are inspected will depend on previous inspections. As a guide, all facilities should be inspected on first inspection of an institution.

3.2.5 Aim to meet with some researchers to discuss current research projects during the inspection.

3.2.6 Aims of meeting with the AEC include:

• to discuss particular issues raised by the inspection
• to give AEC members an opportunity to raise issues/ ask questions
• to view the normal running of an AEC meeting as an aid in assessing AEC effectiveness.

3.2.7 Where a breach of the legislation is suspected, for which legal action may be taken, inspection team members should be guided by the document "Regulatory Actions on Site Inspections - Animal Research Act".

3.3 Post-inspection

3.3.1 Send letter (to CEO with copy to AEC Chair and inspection team members) within one week (if possible) of inspection confirming inspection held, thanking institution, AEC etc and, if applicable, documenting specific issues raised during inspection. If specific issues raised then this letter should be drafted in consultation with inspection team members.

3.3.2 Prepare inspection report. Format will vary with inspector and institution. See "Site Inspection Report" form approved by ARRP on 8/9/98.

Broad format is:

• List of conditions
• List of recommendations
• Body of report documenting findings -AEC
• • Animal Care and Monitoring
  • Facilities
  • Research protocols / Procedures
  • Response to previous recommendations (if applicable)

Requirements of ARRP include:

• Include name of Chief Executive Officer
• Include statement that responses to recommendations will be assessed and written responses may be required
• Dates of current accreditation/ licence
• Date of previous inspection

Add conditions:

It is essential that the AEC members are provided with a copy of the inspection report of (date) and that the AEC is involved in the assessment of and provision of responses to the conditions, recommendations and observations contained in this report.

Regular reviews should be conducted of training for technical and professional staff involved in the care and use of animals.

Note:

Dates by which responses are required (to conditions and recommendations) rather than "within 3 months of the receipt of the report" should be used. Where a standard 3 month response time was required, the dates should be based on a 3 month period after the likely time that the inspection report would be received by the institution. It was noted that in applying these dates, in an attempt to avoid long delays in the consideration by ARRP of a response, dates that fell shortly after a scheduled ARRP meeting should be avoided if possible.

3.3.3 Send inspection report to participating inspection team members for comment within 6 weeks of the inspection. A date by which comments should be supplied may be included. Where possible, team members should be given at least a week to comment.

3.3.4 Incorporate comments of inspection team members (this is normally straight forward but on occasion may require measures such as meeting between team members to reach agreement on final report).

3.3.5 Include report on ARRP agenda, preferably within 3 months of the inspection.

3.3.6 ARRP to approve/ amend conditions and recommendations of report. ARRP to flag issues that require reinspection or early follow up. Where conditions are imposed, a standard condition requiring a response in 3 months (where applicable) is to be added.

3.3.7 Final report and cover letter sent via DG to CEO of institution and copy to AEC Chair.

Cover letter to request that the inspection report be tabled at an AEC meeting and that the AEC be consulted in formulating a response to the report. (ARRP 121)

3.3.8 Follow up conditions of accreditation and recommendations in 3 months or earlier if time limits applied (see document "follow up system for conditions and recommendations") - liaise with Licensing Clerk

4. Documents relating to inspections

4.1 Site Inspection Report form - Approved ARRP 111, 8/9/98

4.2 Animal Welfare Unit Inspectors’ Manual - Animal Research Act

4.3 Fact sheet 9 - Inspections under the Animal Research Act

4.4 Animal Research Act 1985 (especially Sections10; Part 6) and Regulation

4.5 Australian Code of Practice for the Care and Use of Animals for Scientific Purposes

4.6 ARRP housing guidelines:

• Guideline 14 - Care and Housing of Dogs in Scientific Institutions
• Guideline 18 - Housing Rabbits in Scientific Institutions