Information Session2015

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IACUC Leadership Team

Brian Crooker, PhDIACUC ChairProfessor, Animal Science

Melanie Graham, PhDIACUC Vice-ChairAssistant Professor of Surgery

Cyd Gillett, DVMAttending Veterinarian, Director, Research Animal Resources

Cory Goracke-Postle, PhDDirector, IACUC Office

Ben Clark, PhDFaculty Liaison & Assistant Director, IACUC

Office

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New RAR Director/AV

Dr. Mark Suckow, DVM, DACLAM Dr. Suckow is presently Associate Vice President for Research and Director, Freimann Life Science Center, University of Notre Dame. He's also a research professor in the Department of Biological Sciences.

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Committee Composition • Medical School

– Neuroscience– Pharmacology– Surgery– Dermatology– NeurologyCancer Center

• College of Pharmacy– Pharmaceutics – Experimental and Clinical

Pharmacology– Medicinal Chemistry

• School of Dentistry• College of Biological Sciences

• Community Members Non-Affiliated with the University (2)

• College of Food, Agriculture & Natural Resource Sciences

– Animal Sciences– Fisheries, Wildlife, Conservation

Bio.• College of Veterinary

Medicine– Veterinary Population Sciences– Veterinary Clinical Sciences

• Southern Research and Outreach Center (Waseca)

• Center for Agriculture and Natural Resource (Crookston)

• Hormel Research Institute• RAR Director (Institutional

Veterinarian)

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Average Times from Submission to Approval

*~25 days to approval as of this May. Total submissions 529

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Trends in Inspection Findings:Finding Type as % of Total Findings

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AAALAC

• AAALAC - Association for the Assessment and Accreditation of Laboratory Animal Care, Intl.- nonprofit voluntary accreditation organization- “gold standard” for quality animal care and use

programs

• AAALAC uses established guidelines as the basis for its review: 2011 Guide for the Care and Use of Laboratory Animals, USDA Animal Welfare Act Regulations, CDC Biosafety Manual, etc. and our own institutional policies (IACUC, RAR, DEHS, OHS, etc.)

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AAALACRoutine triennial site visit in June 16-19 2015:

- AHC, CLA & Hormel Institute included- 6 visitors here for four days- Visit every animal housing area, most surgical areas

(any species), many laboratories where animal activities are conducted Let the IACUC Office know if you would like a pre-inspection.

- Review IACUC, health & safety practices, RAR procedures

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1. Personnel working with animals not listed as staff on study2. Use of expired anesthetics/analgesics/paralytics or euthanasia solutions 3. Not giving pain medications or not giving them for the duration approved in the protocol4. Use of an anesthetic/analgesic that is not approved in the protocol5. Use of a method of euthanasia that is not approved in the protocol6. Surgical procedure conducted without approval7. Housing of animals outside of RAR without permission8. Animals undergoing multiple survival (non-surgical) procedures under anesthesia but procedures not approved in protocol9. Tumor endpoint criteria not followed10. Blood collection from animals conducted on study but not approved in protocol

Ten Most Common Significant Findings

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Questions?

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Faster Review/Approval of Some Significant Protocol Amendments

Recent guidance from NIH’s OLAW now allows for a Veterinary Verification and Consultation (VVC) Process: a faster process for approving items that fall into specific categories such as changes in analgesia, anesthesia; euthanasia; blood collection; routes of administration. Please continue to submit an amendment the standard way and the items will be triaged accordingly.

If the item is urgent, please call the IACUC office and the change may be able to qualify for same day/next day approval.

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Recent Changes & Updates

• Tail Snip: anesthesia is now required for animals over 21 days

• Controlled Substances: Requires a completion of a Controlled Substances Protocol in eProtocol (this is separate from the IACUC protocol)

• Non-pharmaceutical grade pentobarbital (next slide)

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Non-pharmaceutical grade pentobarbital

From OLAW: Recent exorbitant cost increases of pentobarbital have placed it logistically into the unavailable category. Pentobarbital from a reagent or analytical-grade powder, properly prepared by a pharmacist or other knowledgeable individual (e.g., chemist, veterinarian, researcher), with assurance of appropriate storage and handling, and approval by the IACUC is acceptable.

If you would like to use non-pharmaceutical grade pentobarbital but were previously approved for only pharmaceutical grade, please submit an amendment describing your handling practices and a justification that quotes the pricing of pharm grade pentobarbital.

http://www.research.umn.edu/iacuc/guidelines/documents/UseofNonPharm aceuticalGradeCompounds1.10.pdf

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More Recent Changes & Updates• Cervical dislocation and decapitation of small rodents no longer

require scientific justification or an explanation of why other methods are not suitable.  With some exceptions, small rodents may be euthanized by these physical methods if performed by individuals with a demonstrated high degree of technical proficiency. In lieu of demonstrated technical competency, animals must be first rendered unconscious or anesthetized.

• The administration of carbon dioxide gas euthanasia, previously based on a maximum psi (pounds per square inch) delivery, is now based on a maximum flow rate causing displacement of no more than 30% of chamber/cage volume per minute.  RAR Animal Facilities have instructions posted for CO2 euthanasia based on whether the carbon dioxide cylinder is a regulator unit or a flow meter unit.

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Pending eProtocol Changes

• Analgesic Table• Behavioral Procedures- templates• Injection- templates• Euthanasia Table

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• Be sure all lab safety procedures are being followed including

– All gas tanks secured– Sharps containers used properly, no recapping of

needles– Controlled drugs locked up– Correct labeling of all containers– SOPs for chemical use and disposal of hazardous waste– Ensure gas anesthesia scavenging systems meet DEHS

criteria and/or has been approved by DEHS– Consult your RSO and DEHS with questions

Self-Audit - Lab Safety Issues

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What Investigators Need to Know• Records, records, records

– Intra-operative monitoring records, surgery, anesthesia, neuromuscular blocking agent monitoring, etc.

– Post-procedural monitoring records (post-surgery, post-anesthesia)

– Personnel training records (complete and up to date)– Food/water restriction/special diets – records of food/water

administration, body weights– Single housing animals is justified & approved in protocol– Controlled substance use records and inventory logs– Lab Safety plan and annual training updates

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What Investigators Need to Know

• Ensure that the following do not occur without IACUC approval

– Changing the type of euthanasia or anesthesia– Changing the type or frequency of analgesia

administration– Collecting more blood or tissue or using an altered

collection schedule– Changing the type or dose of drug administered– Changing the endpoints defined in an approved

protocol– Involving personnel not listed on the protocol– Conducting unapproved pilot studies

Questions?

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New and Changes in Protocol Approved Annually

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MN Data Privacy Act & Animal Activists

• Records Requests - protocols, photos, surgical records, emails

• All record requests should be forwarded to the Records & Information Management Office for processing.

• Do not respond to suspicious emails, letters or phone calls related to the use of animals. Please contact the RAR Director and forward the email/voice mail, etc. for review and handling.