Durham VA Medical Center

1. Animal Research Program Lessons Learned Durham VA Medical Center

2. 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

3. 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

4. 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.

5. 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

6. 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

7. 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

8. Lessons Learned:‘IACUC Without Borders’ • IACUC members’ responsibility goes beyond meetings and reviews • IACUChas 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

9. 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

10. 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