Exploring Beyond Traditional IACUC Functions
Not Just the Usual…
IACUC Functions
by
Alice Huang, Ph.D., CPIA
Deputy for IACUC Guidance
Office of the CVMO
Usual IACUC Functions:
O
Protocol Review
O
Semiannual Evaluations
O
Addressing 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:
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
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
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)
O
Also crucial to involve:
O
Safety Committee
O
Occupational Health professionals
O
Legal counsel (liability issues, contracts)
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
We’ve been focusing today on common problems that we run into,
So now we’re going to look at something that has been becoming more common recently,
which is the whole idea of what the IACUC’s role is in uncommon situations.
Dive into the expanded responsibilities of an IACUC beyond the usual protocol review, semiannual evaluations, and addressing compliance issues. Discover how the oversight includes unique scenarios like using animals as interventions for human studies and recent proposals involving therapy animals. Learn about the OLAW perspective on IACUC review for customized vendor products and exemptions for retired race horses, therapy dogs, and PTSD service dogs.
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Presentation Transcript
Not Just the Usual IACUC Functions by Alice Huang, Ph.D., CPIA Deputy for IACUC Guidance Office of the CVMO
Usual IACUC Functions: OProtocol Review OSemiannual 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) O Also crucial to involve: O Safety Committee O Occupational Health professionals O Legal counsel (liability issues, contracts)
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
