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Office of Animal WelfareResearch Support Services
How to Write an Effective Significant Change to your IACUC Protocol
J. Preston Van HooserReview Scientist &
Senior Scientific Liaison
March 31, 2014
April 4, 2014
April 10, 2014
UNIVERSITY of WASHINGTON Office of Animal Welfare
Overview
OAW
Protocol Lifecycle
What is a Significant Change
Approval process
UNIVERSITY of WASHINGTON Office of Animal Welfare
Mission and Vision
Protect the integrity and excellence of vertebrate animal research and teaching at the University of Washington
Provide comprehensive resources and outstanding services to the UW IACUC, faculty, staff, and other partners for navigating and complying with the rules and regulations regarding use of vertebrate animals
UNIVERSITY of WASHINGTON Office of Animal Welfare
Office of Animal Welfare
Administrative Unit
IACUC Meetin
g Suppor
t
Protocol
Admin Review
and Trackin
g
Site Visit
Tracking
Review Scientists
Protocol and
Change Reques
ts
Side by Side
Grant and
Protocol
Review
DMR
Animal Use Training
Online Trainin
g
Hands-on
Training
Certs
Scientific Liaisons
Protocol Life Cycle
Protocol and
Change Reques
ts
All things
…
UNIVERSITY of WASHINGTON Office of Animal Welfare
Who we are
What we value
Professionalism
Compassion
Ethics
Service
Competence
UNIVERSITY of WASHINGTON Office of Animal Welfare
UNIVERSITY of WASHINGTON Office of Animal Welfare
What we do
.... regulations regarding vertebrate animal use in – research, teaching and testing
AAALAC
SPAERC
DOD
SAGE
USDA
WSBOP
JIT
DEA
OSPEH&S
IBCAUMS
UNIVERSITY of WASHINGTON Office of Animal Welfare
UNIVERSITY of WASHINGTON Office of Animal Welfare
Avoiding this…
UNIVERSITY of WASHINGTON Office of Animal Welfare
And this…
grant/funding congruency
OAW ≠ IACUC
OAWManages communications between the IACUC and the PI
regarding protocols and site visitsEnsures grant/funding proposal is congruent with animal use
protocolSubmits updates to regulatory agencies on the UW
performanceEnsures that training is up to date for all personnel working
with animals
IACUCSite Visits – semi annual visits to all facilities where
vertebrate animals are used or housedProtocol Life Cycle – review/approve all vertebrate animal
use proposals
UNIVERSITY of WASHINGTON Office of Animal Welfare
UNIVERSITY of WASHINGTON Office of Animal Welfare
Plan
Write
Pre-review
IACUC Review/Approval
Monitor
Change
Protocol Life Cycle
Grant review
Change review
Significant Changes:
new aim or experiment
pain or distress
Δ anesthesia, analgesia, sedation, or euthanasia
Δ frequency, interval, type, number or anatomical location of:
procedures
administered substances
UNIVERSITY of WASHINGTON Office of Animal Welfare
Significant Changes (cont’d):
animal #
add new species
new housing/use locations
scope of an approved animal activity
Δ Principal Investigator (PI)
UNIVERSITY of WASHINGTON Office of Animal Welfare
UNIVERSITY of WASHINGTON Office of Animal Welfare
Significant ChangeSubmission
• Protocol change submitted to the IACUC
• Semi-monthly distribution
• 1 week for IACUC to review and comment
Questions compiled and sent to PI
• PI responds to questions/comments
• Sends answers and/or revisions back to the OAW
Reviewer
• Reviews answers/revisions to IACUC comments
• Works with PI to resolve any outstanding issues
Significant Change Approval
Significant Change Approval Process
- opportunity for any member to call for a Full Committee Review (FCR)
- assigned to a designated member reviewer (DMR)
DMR vs FCR:
How do I write a Significant Change?
UNIVERSITY of WASHINGTON Office of Animal Welfare
General requirements
Goals and objectives (include species!)
Describe requested changes; relevant PRF items
Summarize the relevant parts of your approved protocol (IACUC will not re-read your entire protocol)
Describe experiments, not isolated procedures/drugs
Sequence of events from enrollment to euthanasia
Complex experiments: flowcharts and timelines
UNIVERSITY of WASHINGTON Office of Animal Welfare
Four questions:
Are you…
increasing animal numbers?
adding or modifying any animal use procedures?
adding a new species?
adding a new strain/line?
UNIVERSITY of WASHINGTON Office of Animal Welfare
“Yes” to at least one
Are you increasing animal numbers?
UNIVERSITY of WASHINGTON Office of Animal Welfare
PRF Section I
H*N*
PRF Section II
None
* required
Section I, Item H: Animal numbers table
UNIVERSITY of WASHINGTON Office of Animal Welfare
Section I, Item N: Animal numbers justification
Things to consider:
Experimental animals
Breeders, litter/clutch size, maintaining rare lines
Unwanted genotypes/gender
UNIVERSITY of WASHINGTON Office of Animal Welfare
Are you adding or modifying animal use
procedures?
UNIVERSITY of WASHINGTON Office of Animal Welfare
PRF Section I
DFGI/JK
PRF Section II
1-32 as applicable
* required items depend on specific added procedure(s)
Section I, Item D: New protocol hazard(s)?
UNIVERSITY of WASHINGTON Office of Animal Welfare
Helps identify Occupational Health issues
Section I, Items F/G: New housing or procedure location(s)?
UNIVERSITY of WASHINGTON Office of Animal Welfare
Section I, Items I/J: New procedure(s) ( pain or distress)?
UNIVERSITY of WASHINGTON Office of Animal Welfare
Section I, Item K: Ascites production?
Section II, Items 1-32: Animal use procedures
Relevant items for new and modified procedures
Complete the entire item
If modifying: Call out what is new (bold/italics)
UNIVERSITY of WASHINGTON Office of Animal Welfare
Section II, Item 16: If adding survival surgery, identify all protocol personnel who will perform the surgical procedure(s), and list their years of experience conducting each procedure
UNIVERSITY of WASHINGTON Office of Animal Welfare
Are you adding a new species?
UNIVERSITY of WASHINGTON Office of Animal Welfare
PRF Section I
D*F*G*H*I/J*K*L*M*N*
PRF Section II
1-32*
* required
AlsoIdentify protocol personnel who will work with the NEW species and their duties*
Section I, Items L and M: Applies to new species
UNIVERSITY of WASHINGTON Office of Animal Welfare
Are you adding a new strain/line?
UNIVERSITY of WASHINGTON Office of Animal Welfare
PRF Section I
D*F*G*H (likely)KN (likely)
PRF Section II
1-21 as applicable
22*23-32 as
applicable
* required
Section II, Item 22:
Deleterious phenotypes?Special husbandry (e.g., weaning variance)?
UNIVERSITY of WASHINGTON Office of Animal Welfare
Friendly reminders…
No new personnel!
S.O.A.
Minimize jargon (use lay speak)
Hazardous agents? BUA application/change to EH&S
Grant/contract-related? Note eGC1 #(s)
Timing (e.g., JIT requests, BUAs, subcontracts)
UNIVERSITY of WASHINGTON Office of Animal Welfare
UNIVERSITY of WASHINGTON Office of Animal Welfare
All done?
Submit to [email protected]
BUT, despite your best efforts…
… you may get IACUC questions/comments
Unclear? Contact Reviewer or Scientific Liaison
Vet questions? Contact VS: [email protected]
Hazardous agents? Contact [email protected]
Point-by-point responses
Highlight changes: bold/italics
“Pre-review” of responses/revision
UNIVERSITY of WASHINGTON Office of Animal Welfare
Submit revision/responses to [email protected]
Conclusions
Think aheadThe IACUC greatly appreciates it when groups allow plenty
of time to consider and approve a protocol change
Talk to your Scientific LiaisonFor help and/or to have your Significant Change pre-
reviewed
Write clearly and completely about what you are changingSummarize the relevant parts of your approved protocol
Consider joining the IACUCYou can help yourself and your colleagues by joining the
committee
UNIVERSITY of WASHINGTON Office of Animal Welfare
Contact us
OAW main #: 685-7363
Website: http://depts.washington.edu/oawhome/
Scientific Liaisons:
Kelly Heffernan [email protected] Schoenleben, Ph.D. [email protected]. Preston Van Hooser [email protected]
Submissions: [email protected]
UNIVERSITY of WASHINGTON Office of Animal Welfare