Not Just the Usual…IACUC Functions

byAlice Huang, Ph.D., CPIA

Deputy for IACUC GuidanceOffice of the CVMO

Usual IACUC Functions:

OProtocol ReviewOSemiannual Evaluations

OAddressing Potential Noncompliance

But…

PHS Policy and the Guide

make the IACUC responsible

for “oversight” which includes, but is not

limited to,“just the usual” functions

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?

Recent Proposals:

OProgram for veterans to interact with retired race horses as therapy

OTherapy dogs brought into the VAMC to interact with patients

OService dogs paired to support individual veterans with PTSD

OLAW Perspective

OIACUC review and approval required for vendor products “customized” to meet the needs of the specific research

ONo additional IACUC review and approval required for “standard off-the-shelf” products

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

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

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

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?

Institutional Oversight Needed

O It makes sense for the IACUC to be involved (expertise, awareness of issues)

OAlso crucial to involve:O Safety CommitteeO Occupational Health professionalsO Legal counsel (liability issues,

contracts)

OLAW Recommends …

OOversight can take many forms (e.g., SOP, consent agreement, summary description of plans)

OOnly use protocol review mechanism if it is necessary

OInstead, provide consultation, and advise re institutional interests related to the use of animals