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IACUC Assurance

Federal

The Federal Government Animal Welfare Assurance for the University of Pennsylvania (Reference Assurance # A3079-01) is valid through July 31, 2014.  


 

Accreditation

The University Of Pennsylvania School Of Medicine is fully accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC).  The SOM was first accredited in July 1999.  The most recent AAALAC site visit was held in March 2012. 

 

 

Post Approval Monitoring Program

The Office of Regulatory Affairs animal welfare compliance staff conducts post approval monitoring (PAM) of research projects involving animals.  Formalized PAM programs employing dedicated staff have been developed at many institutions to ensure compliance with federal, state, local and institutional regulations and policies.   Compliance programs, similar to Quality Assurance programs, are intended to assess the animal care and use programs—monitoring not only protocol-related animal use in the laboratories, but also assessing standard operating procedures in facilities, the IACUC’s function and performance, and educating those involved in the animal research program about the federal, state, local and institutional regulations and policies that guide the animal research program.  Risks of the institution being found to be non-compliant by federal regulatory agencies can include: 

  1. loss of funding to an individual investigator
  2. loss of funding to the entire institution
  3. negative press 
  4. monetary fines

The goal of Penn’s PAM program is to emphasize compliance at all times, thus assuring a high standard of animal welfare and helping to protect the research animals, the “Institution”, and the investigators.   Penn’s PAM program involves the following areas: 

 

Review of IACUC approved protocols to ensure consistency with current federal regulations and institutional guidelines/policies, as well as to ensure completeness and consistency of the information provided.  Discovery of recurrent, program-wide issues may result in new guidance for research staff, IACUC member and/or investigator training, and other educational measures.       

    

Inspection of research laboratories and facilities to ensure that the facilities meet the federal and institutional standards with regards to facilities; including maintenance, surgical suite and support areas, housing areas, drugs and materials used in projects, recordkeeping, as well as other items.         

 

Discussion with laboratory staff to ensure that protocols and approved procedures are being followed and that research personnel performing the procedures have been appropriately trained and are approved by the IACUC to participate in research projects.  Federal regulations clearly state that any and all animal research, teaching or testing activities must be approved by the IACUC prior to initiation.  Discussions with research and non-research personnel may also occur in order to assure compliance with institutional training requirements.        

 

Review of records and other forms of documentation to further ensure that protocols and procedures are being conducted as approved in the IACUC protocols.  This may include, but is not limited to: clinical health records, procedure records, anesthesia records, post-operative monitoring records, drug inventories and controlled substance logs, and/or daily husbandry logs.           

 

Investigate reports of non-compliance and/or animal welfare concerns.  The compliance staff generally conducts the investigation regarding an incident of non-compliance while designated IACUC members (which include the compliance staff) conduct the federally-mandated investigation regarding any animal welfare concern. This may involve visiting the facility where the event is occurring or has occurred, speaking with those individuals who may be involved including veterinary staff, animal care staff, facility manager, research staff and principal investigator(s).  The compliance staff reports their findings to the IACUC Chair who determines what, if any, further action is needed.  This report is then discussed with the IACUC in their regular monthly meeting, for their review and decision as to what additional action(s) may be required to assure compliance.   

 

  • Self-reporting animal welfare and compliance-related incidents is an important component of Penn’s PAM program.  When deciding on how to best resolve the incident and prevent reoccurrence, due consideration is given to those individuals who self-identify and self-report potential issues to the IACUC.  
  • The institution is expected to self-report animal welfare concerns and non-compliances to federal regulatory and accrediting agencies. OLAW NOT-OD-05-034: Guidance on Prompt Reporting to OLAW under the PHS Policy on Humane Care and Use of Laboratory Animals  


The compliance staff generally conducts unannounced inspections.  This is done to ensure that the animal research program is compliant at all times.  Announced inspections may be arranged at any time by contacting the office (215) 898-2431 or This e-mail address is being protected from spam bots, you need JavaScript enabled to view it for first-time visits.  Investigators are encouraged to contact the office to voluntarily request a proactive assessment of an individual PI’s laboratory.    

 

The following are other resources which can provide more information on PAM programs.   

 

 
   Copyright 2008 University of Pennsylvania Office of Regulatory Affairs | 3624 Market Street, Suite 301 S., Philadelphia, PA 19104-6006
   Phone: 215.573.2540    Fax 215-573-9438.
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