Quality Assurance/Quality Improvement - Animal Research

The Quality Assurance/Quality Improvement (QA/QI) animal program, established in 2023, is a function of the Office of Research Integrity at Brown University. The QA/QI program was developed to strengthen animal subjects’ protection and to ultimately demonstrate Brown’s commitment to continuous improvement in research compliance. This program is a means to evaluate the level of compliance with federal, state and institutional regulations, in addition to AAALAC guidelines, ensuring the highest standards for animal subject protections. The QA/QI Animal Program Manager will focus on identifying the strengths and weaknesses of protection efforts and work with the ORI and IACUC to ensure continuous improvement.

The QA/QI program focuses on educating the University's researchers on the regulatory responsibilities by which animal subjects are protected. Additionally, the Animal Program Manager will provide the research community members with the following:

  • Act as a resource for all research labs, ORI and IACUC to provide constructive interactions and education. 

  • Assist with onboarding new PI or laboratory staff by providing a 1 on 1 consultation.

  • Gather feedback from PIs, laboratory staff and animal care, and report information to the ORI and IACUC to provide continuous program improvements. 

  • Helps to prepare for IACUC and external evaluator inspections.

  • Assesses and helps to resolve protocol deviations through education and/or protocol amendments

Visits with the QA/QI Animal Program Manager are kept as informal as possible and serve as an opportunity for PIs and lab staff to request help and to provide feedback on the protocol process. 

Visits are selected both randomly or for-cause. For more information about Brown’s Policies and Directives related to Post-Approval Monitoring, Audits, and Research Engagement Visits, please see our policy. 

Areas Observed during a Research Engagement Visit

REV visits are facilitated by ORI and are service oriented focusing on collaboration, education, and support.  The purpose of these visits is to build relationships, meet researchers in an informal capacity, learn about challenges, and provide education where needed.  The information obtained from these visits may be used for program improvement initiatives. REVs are catered to the specific needs of the researchers and can include visits to lab meetings, surgical or procedural observations or correspondence over email or zoom.

The following areas will be covered during the review:

  • Examination of surgical and non-surgical procedures including aseptic techniques

  • Review of animal and surgical records

  • Handling/storage and documentation of Controlled Substances

  • Observation of laboratory practices and procedures 

  • Review of compliance with training and Occupational Health & Safety program

  • Investigation of adverse events

  • Review of protocol adherence

  • Other areas as determined by review 

Preparing for a Scheduled QA/QI Review

Investigators and lab staff should review the information below prior to a scheduled QA/QI review:

  • Ensure all lab personnel is aware of the visit

  • Confirm the date and time for the visit, as well as the anticipated duration of the visit. 

  • Confirm with the reviewer, who needs to be present and which procedures the reviewer will be observing

  • Ensure the following documents will be available and accessible during the visit. 

    • Documents including, but not limited to:

      • Surgical records

      • Sanitation logs

      • Lab notebooks

      • Standard Operating Procedures

      • Adverse event reports

To help prepare for a visit from the QA/QI Animal Program Manager, please use the Quality Assurance Review Checklist. 

Tips for a Successful Laboratory

 

Questions/Contact

If you have any questions or would like to schedule a meeting/visit, please contact Rebecca Poncin ([email protected]) via email or telephone (401-863-2041).