Jennifer Davis, DVM, DACLAM

Compliance Liaison Veterinarian

Offi ce of Animal Welfare

University of Pennsylvania

THE ART OF AUDITING:

AN ACADEMIC PERSPECTIVE

PARTNERS IN RESEARCH COMPLIANCE:

AN ACADEMIC PERSPECTIVE

Jennifer Davis, DVM, DACLAM

Compliance Liaison Veterinarian

Offi ce of Animal Welfare

University of Pennsylvania

MY ROAD TO COMPLIANCE

DVM PAM Background: BS in Biology from University of SC

DVM from UGA

2 years in CV Research Lab at MUSC

Internship in Small Animal Medicine and Surgery

2 year residency in LAM at Emory University

CL Veterinarian at the University of Pennsylvania

ACLAM boards (2014) – WHEW!

16 years in Small Animal Private Practice

GOALS OF PAM

Ensure animal well-being Protect the institution Resource to research community Facilitate science Ensure regulatory compliance

WHAT DO THE REGS SAY?

• USDA – United States Department of Agriculture

• OLAW– Office of Laboratory Animal Welfare

• AAALACi– Association for the Assessment and Accreditation of Laboratory Care International

“Continuing IACUC oversight of animal activities is required by federal laws, regulations, and policies. A variety of mechanisms can be used to facilitate ongoing protocol assessment and regulatory compliance. Post-approval monitoring (PAM) … [consists] of all types of protocol monitoring after the IACUC’s initial protocol approval.” (Guide)

“PAM helps ensure the well-being of the animals and may also provide opportunities to refine research procedures. Methods include continuing protocol review; laboratory visits inspections…; veterinary or IACUC observation of selected procedures; observation of animals by animal care, veterinary, and IACUC staff and members; and external regulatory inspections and assessments.” (Guide)

PAM AND THE “GUIDE”

WHAT PAM IS NOT…

Not policing mechanism Not a replacement for IACUC or AV Not required by USDA or PHS Not a ‘must’ of AAALAC Not a funded mandate Not any easier at large or small institutions Not new ground or new regulation

WHAT PAM IS…

A conduit for information to researchers Disseminate information Answer questions

A liaison between the IACUC/laboratories Advocate for the PI Serve as the “eyes and ears” of the IACUC

A process to assure program integrity Encourage collegial dialogue Acknowledge compliance Assist to maintain compliance

Fosters a culture change Be personal Be nonjudgmental Be consistent

PI/Research Staff

WHAT IT SOMETIMES FEELS LIKE…

IACUCVeterinary Staff

WHAT IT SOMETIMES FEELS LIKE…

…WHEN INSTEAD,

…WHEN INSTEAD,

PI/Research

Staff

Veterinary StaffIACUC

PAMCompliance

Liaisons

Director of Animal Welfare (VMD)

ComplianceLiaison(DVM)

Senior Compliance

Liaison

Compliance Liaisons

N=2

IACUC Administration

Associate Director of

Administration

(DVM)

Protocol Specialist

(PhD)

Protocol Specialist

(DVM)

IACUC Administrat

or

Office Manager/

IACUC Administrat

or

PENN OAW ORGANIZATION

Compliance

PENN’S COMPLIANCE LIAISONS

Compliance

Compliance Liaison (DVM)

Senior Compliance

Liaison (MLAS, RLATg)

Compliance Liaison (RLATg)

Compliance Liaison

(MLAS, LAT)

PENN “REBOOT”

OAW Compliance LIAISONS OAW CLs are here to help the PIs and staff maintain

compliance NOT IACUC members – no conflict of interest Focus on high-risk models

USDA species Surgery TBI Unrelieved pain/distress

Risk-based prioritization of PAM USDA species – 1-2x per year Rodent “E” protocols – 2x per year Satellite housing – 2x per year

IACUC Compliance Subcommittee Three scientists, 2 veterinarians Ad hoc members: 4 OAW Compliance Liaisons Operates under clearly defined policies Review all PAM findings Determine actions following non-compliance

Contentious situations Meets regularly (3-4x/mo.)

PENN “REBOOT”

LABORATORY ANIMAL RESEARCH COORDINATOR

LARCLaboratory Animal Research Coordinator

University of Pennsylvania Laboratory Animal Research Coordinator Voluntary formal education program

Supplement ULAR training Covers regs, policies, Penn’s who’s who

Learn to navigate the system Protocol review process

Improved submission quality = quick approval 1st class – 24 participants, 9 mo. curriculum

Lectures, AALAS modules, mock site visits, meetings, recordkeeping

Laboratory Liaison Coordinate lab for SAs, others if applicable (e.g. AAALAC) Manage lab’s compliant practices and make corrections Mentor junior lab members Builds rapport btw OAW/research staff/IACUC Provide feedback for policy and training development

CONDUCTING OF PAM

Communication, communication, communication! Before, during, and after

Remember purpose of visit Good performance “Find it/fix it”

Various PAM types at Penn General protocol review

Clarify ambiguities Update for major changes in policies and guidance Correct inconsistencies

Specific procedure review Procedural/surgical observation Site visit follow up (SAs, AAALAC, USDA) For cause (Adverse event, WB)

CONDUCTING OF PAM

PAM procedure Schedule in advance

“Dropping by” likely not successful Be professional – be prepared Exit briefing

Encourage PI resolution input Acknowledge “Gold Star” labs

Post-visit correspondence Recordkeeping

ID’s trends for improvement Chronic NCs may need CSC input

SCHEDULING A VISIT

Typical request for PAM:

Continuing IACUC oversight of animal activities is required by federal laws, regulations, and policies. As such our IACUC has instructed the compliance staff to perform post-approval monitoring of any animal care activities on campus. Our goal is to visit all laboratories throughout the year and your group has been randomly chosen. These visits can last about 1 hour and the purpose is to simply document evidence of good performance.

The PAM visit is intended to be collegial and supportive of animal-based research on our campus. The objective is not to be obstructive but rather to help maintain compliance so that the scientific work may continue without disruption.

As an aside, this meeting is open to anyone in the lab; some investigators have used this meeting as an opportunity to educate new lab personnel to federal and university regulations.

POST-APPROVAL MONITORING POLICY

(Available on Penn IACUC website)

COMPLIANCE CHECKLIST

Develop standardized checklist*

Send with “PAM Request” email The protocol and personnel

Read protocol? Study procedures

Procedures consistent? Anesthesia/analgesia Surgery, other procedures Post-operative care Euthanasia

Consistent with 2013 AVMA GLs General recordkeeping

CS records General lab management

Approved satellite housing Safety concerns

(*Available on Penn IACUC website)

POST-VISIT CORRESPONDENCE

Thank you for meeting with me today to discuss your animal use procedures. I appreciated the time you took to explain some of the procedures, which gave me a better idea of the overall study needs. Our discussion reaffirms the OAW’s mission to work openly and cooperatively with scientific staff so the research continues.

Acknowledge compliant and non-compliant activities Itemize resolution plan discussed Advise all PAM are reviewed by the IACUC CSC Warn of potential additional action items

Hopefully you found today’s visit helpful and our office is open to any feedback. Please feel free to contact with any future questions or concerns.

Typical highlights in post-PAM email:

COMPLIANCE CONCERN REPORTS

Develop internal recordkeeping PI/protocol number Species/# of animals Funding source Issue or incident/date Date of CSC review Immediate actions by PI

Amendment SOP Voluntarily stopped NC Retraining

CL summary Further actions Further meetings, follow-up

ACKNOWLEDGEMENTS

1. Drs. Julie Sharp and Troy Hallman 2. My co-CLs: Alli Czarnecki, Amanda O’Hara, Rebecca Spangenberg3. The OAW administrative staff4. Dr. James Wilson – the inspiration behind my title slide5. Animal Care Training Services for the opportunity

REFERENCES

http://www.aaalac.org/accreditation/faq

Banks RE, Norton JN. 2008. A Sample Postapproval Monitoring Program in Academia. ILAR 49(4): 402-418.

Banks, RE. 2014. Post-Approval Monitoring. In: Silverman J, Suckow MA, Murthy S, eds. The IACUC Handbook, 3rd ed. Boca Raton, London, New York: CRC Press, p 719 – 750.

NIH, Office of Laboratory Animal Welfare. 2012. FAQ G.6, Is post approval monitoringRequired? http://grants.nih.gov/grants/olaw/faqs.htm#instresp_6.

National Research Council. 2001. Guide for the Care and Use of Laboratory Animals, 8th ed. Washington DC: The National Academies Press.

CONTACT INFO

Feel free to contact me:

Jennifer Davis, DVM, DACLAMOffice of Animal Welfare

University of Pennsylvaniajennifd@upenn.edu

215-573-0790

http://www.upenn.edu/animalwelfare