Durham VA Medical Center Animal Research Program Lessons Learned

Sequence of Events: July 2006: Focused review by ORO  Lack of understanding by investigators and IACUC of their roles in reporting protocol changes and adverse events;  Lack of communication between Duke and Durham VAMC IACUC, with differing approved protocols;  Adversarial relationship between current VMO, research administration, and research community. August 2006: Site visit by ORD  Confirmation of ORO findings  Serious concerns about multiple aspects of ACUP  IO suspended animal research

Sequence of Events: August 2006: Full ORO review of ACUP “Significant deficiencies warranting ongoing suspension”  Leadership by IACUC  Insufficient understanding of roles and responsibilities by key staff members  Lack of population management and animal tracking by protocol  Policies and procedures lacking or not enforced  Security concerns  Occupational safety and health concerns

Why did this happen? Beneath the surface:  Sudden, unexpected death of VMO with one year gap before new VMO hired;  Reputation and credentials led to a lack of questions – assumption that they must know what they are doing;  Former VMO vs new VMO – a world of difference;  IACUC not invested and it showed;  Research as its own world.

Steps Taken  Suspension of animal research and notification of OLAW, AAALAC, and USDA  Appointment of Acting ACOS/R  New chairman and new beginning for IACUC  Town Hall for animal research employees to explain findings, suspension, and waiver process  Director-led weekly meetings of research team; detailed action plan  VISN and 10N closely kept informed of progress  Mentoring relationships established for IO, ACOS/R, Chair of IACUC, and VMO  Enhancements made to R&D Committee structure and function

More Steps Intensive training:  Six hours of training on IACUC, institutional responsibilities, Semi-Annual Facility and Program review.  IACUC 101 for all members, management, and key staff.  Three Town Hall meetings with research community – education about roles and responsibilities Staff added:  Full time IACUC Coordinator  Industrial Hygienist for Research  Research Safety Technician  Occupational Health midlevel provider  Additional Research Administration employee

Lessons Learned: Research & Development Committee  Expanded oversight role: Increasing communication between IRB, ACUC, and SRS sub-committees Increasing oversight of administrative duties of research and development program; agenda changes Serving as venue for research employee or animal welfare concerns and conducting administrative investigations  Director and Chief of Staff must be active participants on R&D Committee

Lessons Learned: ‘IACUC Without Borders’  IACUC members’ responsibility goes beyond meetings and reviews IACUC has responsibility for the program Members available and engaged with investigators about their work Strong focus on balance between animal welfare and scientific progress for veterans  Investigators must view themselves as part of the IACUC process not just users of IACUC services responsible for ultimate success of program

Lessons Learned: Institutional Official  Team approach and ongoing communication – foster questioning of the status quo  Active member of R&D Committee  Treat like any other service in the hospital  Careful selection of leadership roles – IACUC chair, R&D chair, VMO, ACOS/R  Close communication with affiliate  By current policy, IACUC issues go to ORD – communication essential – know what is happening  Ask questions and see in person

Toward a Gold Standard... Suspension lifted January 2007  A strong and effective IACUC  Intimate knowledge of requirements on the part of key officials  New approach that integrates Research with all aspects of facility operations