1. Not Just the Usual… IACUC Functions by Alice Huang, Ph.D., CPIA Deputy for IACUC Guidance Office of the CVMO

2. Usual IACUC Functions: O Protocol Review O Semiannual Evaluations O Addressing Potential Noncompliance

3. But… PHS Policy and the Guide make the IACUC responsible for “oversight” which includes, but is not limited to, “just the usual” functions

4. An Example: What do we do with the use of animals “in research”, when the animals are not the subjects of the research, but serve as the intervention, the effects of which are to be studied in human subjects?

5. Recent Proposals: O Program for veterans to interact with retired race horses as therapy O Therapy dogs brought into the VAMC to interact with patients O Service dogs paired to support individual veterans with PTSD

6. OLAW Perspective O IACUC review and approval required for vendor products “customized” to meet the needs of the specific research O No additional IACUC review and approval required for “standard off-the-shelf” products

7. For Retired Race Horses … O No training of the horses is required O Care of the horses is to be no different from the care they would otherwise receive Therefore, No requirement for IACUC review and approval

8. For Therapy Dogs in Established Programs… Training and handling all to be conducted according to protocols established independent of any research requirements Therefore, No requirement for IACUC review and approval

9. For PTSD Service Dogs… Vendors have established programs for training PTSD service dogs, not “customized for the purposes of the research” Therefore, No IACUC review and approval required

10. Other Concerns – What if… O … the animal bites someone while on VA property for purposes related to the study? O … the animal gets injured while on VA property for purposes related to the study? O … the animal carries pathogens that put humans or VA animals at risk?

11. Institutional Oversight Needed O It makes sense for the IACUC to be involved (expertise, awareness of issues) O Also crucial to involve: O Safety Committee O Occupational Health professionals O Legal counsel (liability issues, contracts)

12. OLAW Recommends … O Oversight can take many forms (e.g., SOP, consent agreement, summary description of plans) O Only use protocol review mechanism if it is necessary O Instead, provide consultation, and advise re institutional interests related to the use of animals