VA Animal Research IACUC

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VA NEBRASKA-WESTERN IOWA HEALTH CARE SYSTEM

VA Animal ResearchIACUC


• IACUC (Institutional Animal Care and Use Committee) Charged with ensuring compliance

• ACORP (Animal Component of Research Protocol) Official VA animal protocol form

• AAALAC (Assoc. for Assessment & Accreditation of Lab Animal Care) Accrediting body for animal research recognized by VA

• OLAW (Office of Laboratory Animal Welfare) PHS office that administers policy on animal use and care.

• ORO (Office of Research Oversight) VA advising office on compliance and assurance


The Components of our Animal Research Program

The lines of authority and responsibility for administering the animal research program and ensuring compliance.

DIRECTOROmaha Veterans Affairs Medical Center

Research and Development Committee

Subcommittee of Animal StudiesIACUC

Administrative OfficerResearch Service

Ellis G. Jensen, D.V.M.P.D. Westenburg, D.V.M.

Veterinary Consultants

Associate Chief of Staff/Research ServiceACOS/R&D

Robert WiegertARF Supervisor

Animal Caretaker TBA

Subcommittee of Animal StudiesIACUC

DVMVeterinary Consultant

ARF Supervisor

IACUC Coordinator:402- 995-3940


IACUC

Self-regulatory body for animal research

• Responsibilities: Perform review and oversight functions

PHS Policy- The Guide VHA Handbook 1200.07

Review and approval of animal research protocols

Perform semi-annual program & facility reviews, annual PAM audits


IACUC Members (2013)

5

• Voting: VA Scientist, Chair

VA Scientist, Vice Chair ScientistVA ScientistScientist

Veterinary Medical OfficerNon-Science Member

Non-Science Member Unaffiliated Member Veterinarian ARF Supervisor

• Non-voting:Deputy ACOS, Research ServiceIACUC Coordinator AO, Research ServiceACOS, Research Service

• Alternates:Scientists (3)

•A quorum must be met and maintained throughout the meeting. •Quorum is defined as a majority (more than 50 percent) of voting members.


Application to perform animal research

6


Animal specific forms:

7


Protocol Review

Required submissions:

• Initial – entire ACORP

• Annual Continuing review

• Triennial – entire ACORP

Optional submissions:

• Amendment –entire ACORP with highlighted changes

• Amendment to add new personnel:

expedited- DMR


Initial / Triennial– entire ACORP

9


Protocol Review








expedited- DMR


Annual Continuing review

11


Protocol Review








expedited- DMR

VA NEBRASKA-WESTERN IOWA HEALTH CARE SYSTEM 13


Protocol Review








expedited- DMR

VA NEBRASKA-WESTERN IOWA HEALTH CARE SYSTEM 15


Protocol review

16

Overall, three Rs (Replacement, Reduction, and Refinement)

1. Scientific justification- initials that are not peer reviewed

2. Pain category

3. Training of personnel

4. Justification of animal numbers

Required Elements

From IACUC ACORP, SOP andVHA Handbook 1200.7 Appendix D

Section j. Justification for Number of Animals Requested and Group Sizes. Describe how the estimated number of animals needed for the experiments was determined. When appropriate, provide the following: •the number of experiments planned

•the number and type of experimental and control groups in each experiment

•the number of animals in each group

The GUIDE also states that whenever possible, the number of animals requested should be justified statistically. A power analysis is strongly encouraged to justify group sizes when appropriate.

Justification of Animals

Protocol types when statistical justification is inappropriate

There are certain types of protocols for which statistical evaluation is ineffective. Often studies in which no analytical comparison between any of the groups can be made. Examples: •Pilot studies

•Breeding protocols

•Teaching protocols

•Non-interventive studies, such as behavioral observations.

Justification from PI may include personal experience or reference to a comparable study in which the desired effect sizes were shown to be statistically significant.

When statistical justification is appropriateRequired information from PI’s

• Clear hypothesis-driven description/outline of experimental design (ACORP Section C2):

1) How many experiments in each study (specific aim).

2) How many experimental and control groups within a particular experiment.

3) Number of animals needed per group.

4) Total number of animals for the entire project (all specific aims).

• Consideration for additional animals needed to account for experimental losses: (i.e. morbidity, mortality, or other difficulties with experimental procedures).

Power Analysis

Power analysis is a statistical rationale for the number of animals requested.

•Power analysis is a declaration of estimates of minimum effect size:-mean differences between groups-variability

•Description of how precise the analysis will be and what the significant limits will be for obtained values. (PI to determine)

•Determination of the beta error rate (risk of missing a true effect or difference). (PI to determine)

•Evaluation of experimental design and power analysis (IACUC responsibility)

Power Analysis Review

Questions to help IACUC reviewers

The following are questions that pertain to the statistical justification of animal numbers pertaining to Section K:

• In the Power analysis table are the number of Specific Aims and Experiment numbers

listed correlate to the experimental design described in Section C2 ?

• Is a Representative Assay listed for each experiment and does the information correlate to what was given in Section C2 and does it seem to be the assay that would have the highest error in the data obtained?

• Does the value for (N) equal “r x n” ? If the value of (N) is not equal to “r x n”, then is Does the value for (N) equal “r x n” ? If the value of (N) is not equal to “r x n”, then is an explanation provided following the statistical table?an explanation provided following the statistical table?

r = The number of experimental groups (including controls) planned for the experimentn = Sample size per group determined from the “Statistical Power Table”N = Number of animals per experiment


Protocol Review- process

Go back to Full Committee

APPROVAL

Go to Designated Member Review(DMR)

Modification:

Outcome choices:1. Approval2. Table/ Withhold Approval3. Requires modification

Minor: Administratively changed

APPROVAL

Proceed by DMR


PAM (Required action- ORO)

• Program to audit approved animal use protocols yearly • PIs will be notified by letter two months prior to deadline

given audit form that will be usedcontacted by PAM team member to schedule visit

• What is expected at the visit:All in PIs lab - have read IACUC protocol

- familiar with approved proceduresVisual inspection of lab, surgical and recovery areas Have records available


Guidance Documents

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Research Service Internet Site-•IACUC Forms•IACUC/ARF Standard Operating Procedures (SOP)

http://www.nebraska.va.gov/services/Research/iacuc/iacuc_forms.asp

1200.07- VHA Handbook- Use of Animals in Research-http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2464

PHS Policy -http://grants.nih.gov/grants/olaw/faqs.htm

Guide for the Care and Use of Laboratory Animals- http://grants.nih.gov/grants/olaw/Guide-for-the-Care-and-Use-of-Laboratory-Animals.pdf


Questions?

25

VA Animal Research IACUC

Documents

Transcript of VA Animal Research IACUC