Durham VA Medical Center

1
Durham VA Medical Center

• Animal Research Program
• Lessons Learned

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 RD 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 RD Committee

8
Lessons LearnedIACUC 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

9
Lessons LearnedInstitutional Official

• Team approach and ongoing communication foster
  questioning of the status quo
• Active member of RD Committee
• Treat like any other service in the hospital
• Careful selection of leadership roles IACUC
  chair, RD 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