1. Troubleshooting the VVC process
Anna Hampton, DVM, DACLAM, DACAW, CPIA
Director, Office of Animal Welfare Assurance, Duke University
Cell:         
Office:

2. Disclaimer
I hope everything I mention and my interpretation of the regulations and guidance material is accurate
I do not represent the USDA, OLAW, or AAALAC International or their point-of-view
I do not get offended if I am verbally corrected among peers, so please speak-up

3. Overview Regulatory review Where my program is in the process
Troubleshooting implementation
What other facilities are doing
Assumptions versus flexibility

4. PHS Policy
Functions of the IACUC: review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the use of animals in ongoing activities
Review includes determining that the proposed significant change is conducted in accordance with
PHS Policy
Your OLAW Assurance
The Guide
Animal Welfare Act/Regulations
Approval via FCR or DMR

5. Animal Welfare Act / Regulations
IACUC Functions: Review and approve, require modifications in (to secure approval), or withhold approval of proposed significant changes regarding the care and use of animals in ongoing activities
Review includes determining that proposed activities are in accordance with the Animal Welfare Act/Regulations unless acceptable justification for a departure is provided
Approval via FCR or DMR

6. NOT-OD-14-126: Guidance on Significant Changes to Animal Activities
Definition: significant changes include changes that have, or have the potential to have, a negative impact on animal welfare. In addition, some activities that may not have a direct impact on animal welfare are also considered to be significant.
Provides guidance on significant changes which can be handled via
Traditional: DMR or FCR
Administrative with Vet: Veterinary Verification and Consultation
Administrative

7. Veterinary Verification and Consultation
May be handled administratively according to IACUC-reviewed and -approved policies in consultation with a veterinarian authorized by the IACUC.
The veterinarian is not conducting DMR, but is serving as a subject matter expert to verify that compliance with the IACUC-reviewed and -approved policy is appropriate for the animals in this circumstance.
Consultation with the veterinarian must be documented.
The veterinarian may refer any request to the IACUC for review for any reason and must refer any request that does not meet the parameters of the IACUC- reviewed and -approved policies. 
This includes changes in:
anesthesia, analgesia, sedation, or experimental substances
euthanasia to any method approved in the AVMA Guidelines for the Euthanasia of Animals; and
duration, frequency, type, or number of procedures performed on an animal.

8. Seems simple …… right

9. What we do
Minor Amendments reviewed by the IACUC Leadership Review process that incorporates a veterinary review.
These categories of proposals have been determined by the IACUC of having a potential welfare \ well-being impact, but generally the outcome is more favorable and in the best interest of the animal.
These proposals may be reviewed as DMR, if determined by the IACUC leadership or veterinary review, or FCR if requested by an IACUC member.
We call these “Minor with Vet”

10. Examples in Policy of “Minor with Vet”
A change in anesthetic drug regimens which decreases the potential for pain or distress; or due to unavailability of protocol-approved medications; or change from pharmaceutical grade to non-pharmaceutical grade compounds.
A change in analgesic drug regimens which decreases the potential for pain or distress; or due to unavailability of protocol-approved medications, a change from pharmaceutical grade to non-pharmaceutical grade compounds.
A change in sedation drug regimens which decreases the potential for pain or distress; or due to unavailability of protocol-approved medications, a change from pharmaceutical grade to non-pharmaceutical grade compounds.
A change in humane endpoints which decreases the potential for pain or distress.
Addition of a procedure which should decrease the proportion of adverse outcomes (e.g. post-procedure death, distress, or pain).
A change in animal care and / or monitoring practices which increase the frequency or methodology of monitoring.

11. Examples in Policy of “Minor with Vet”
Addition of sample collection (as long as sample collection volumes do not exceed IACUC-accepted standards for the period of collection, such as the 24 hour maximum for blood collection from mice).
Repetition of an already approved experiment (where no additional animals are required) to re-affirm or replace questionable data.
Addition of noninvasive sampling/analysis (e.g., MRI, motion sensor, etc.).
A change or addition of euthanasia procedures that is/are approved in the AVMA Guidelines for the Euthanasia of Animals and Duke’s species-appropriate policy on euthanasia.
A request for delayed weaning (generally rodents) as described in the Cage Space Requirements for Mice Policy or the Policy for Enrichment for Species Other Than Non- Human Primates.
A request for single housing for animal welfare purposes (e.g., aggressive male rodents) as described the Cage Space Requirements for Mice Policy or the Policy for Enrichment for Species Other Than Non-Human Primates.
Addition of a non-hazardous experimental substance.

12. Why this works Was a VVC process before the VVC process was cool
Meets the spirit of a VVC process
Minor with vet amendments have a quicker turn-around than our DMR and FCR approval process
The documentation and record keeping process is the same as amendments providing a sense of security
It is familiar, historical, comfortable, and understood

13. What could be refined
Minor with vets go though 4, possible duplicative, levels of review
Administrative
OAWA Vet review
DLAR Vet review
IACUC Chair or Vice Chair Review and final approval
Process could be simplified
Turn-around could be shorter
Not utilizing the flexibility allowed within the regulations

14. Implementing a new process – Things we considered
Worked off our current process – steps to refinement
Looked at what works and what doesn’t
What does the IACUC need to approve to start a new process
Who might be impacted with a change
IACUC Office
Veterinarians
PI’s
IACUC members
What are the areas of concern
Started with a draft policy and went from there ….

15. Troubleshooting areas
Why are we doing this if what we have works and everyone knows how to do it?
Purpose and impact
Potential increase in veterinary workload
Interpreting the new guidance correctly (i.e., will OLAW or USDA do something to us if we interpret it wrong)
Definition of new procedure and at what level is it ‘new’
Genotyping approved: Ear notch to toe clip?
Surgery approved, laparotomy approved, liver biopsy approved …. Does kidney biopsy apply?
Is breeding a procedure
Imaging modality
Biopsy (does the organ matter?), etc.
Crafting guidance to help with decision tree
IACUC Admin
Veterinary
How will we ensure documentation
Should VVC be a part of our established amendment process a new process
How to roll it out
What other items to we need in place before implementation (new policies, SOPs, guidance, forms, etc.)

16. Groups involved in the discussion
IACUC Program Committee
Attending Veterinarian and Veterinary Groups
IACUC Office
Other

17. Where we were going: Policy
Veterinary Verification and Consultation, the following changes will be handled via VVC if the procedure category is already approved in the IACUC animal use protocol and would not change or would decrease the potential for pain or distress. Changes in:
Anesthesia, analgesia, sedation, or experimental substance(s). Includes:
Changes in compound, dose, route, volume, frequency, or duration
Changes in experimental substance(s) if they are fundamentally similar compounds documented in the literature with regard to their safety and toxicity in the same species
Change from pharmaceutical grade to non-pharmaceutical grade compounds
Euthanasia to any method approved in the AVMA Guidelines for the Euthanasia of Animals. Includes:
Acceptable
Acceptable with conditions, when the conditions are met
Duration, frequency, type, or number of procedures performed on an animal. Examples include:
Stock, strain, or genetic modification of the same species
Supportive care
Humane-endpoints
Peri-operative or peri-procedural monitoring
Survival to non-survival surgery
Timing of euthanasia
Sample collection
Identification or genotyping
Animal acquisition or disposition

18. Where we were going: Process and Documentation

19. Let’s Revisit Troubleshooting Areas
Why are we doing this if what we have works and everyone knows how to do it?
Purpose and impact
Potential increase in veterinary workload
Interpreting the new guidance correctly (i.e., will OLAW or USDA do something to us if we interpret it wrong)
Definition of new procedure and at what level is it ‘new’
Genotyping approved: Ear notch to toe clip?
Surgery approved, laparotomy approved, liver biopsy approved …. Does kidney biopsy apply?
Is breeding a procedure
Imaging modality
Biopsy (does the organ matter?), etc.
Crafting guidance to help with decision tree
IACUC Admin
Veterinary
How will we ensure documentation
Should VVC be a part of our established amendment process a new process
How to roll it out
What other items to we need in place before implementation (new policies, SOPs, guidance, forms, etc.)

20. What other facilities are doing
IACUC Admin and CompMed Listserve Question

21. Responses 22 Reply's 18 Institutions using a VVC process
Summary will be provided at the ACLAM Forum

22. Assumptions versus flexibility

23. The IACUC What do they have to approve to start VVC?
Does a list of the proposed activity need to be sent to the membership?
Can they call it to FCR?
Do they need to see it after approval?
Can they call a VVC approved activity back for reconsideration by the IACUC?
How is the IACUC Administration Office involved?

24. Documentation to start
What does the IACUC have to approve?
Policies
SOPs
Guidelines
Formularies
The Veterinarian(s) that will perform the VVC
What is considered “IACUC Approved”
Vote at FCR?
Reviewed with no objections?
Distributed to membership?
How should this be documented (minutes? On the document? In IACUC files?)
Documenting re-review
How is this done? FCR, DMR, ?
Does the IACUC need to re-approve? If so how?
What does OLAW, USDA, and AAALAC Expect? What will they want to see?

25. The Veterinarian IACUC Approved Veterinarian? Attending Veterinarian?
Clinical Veterinarian?
Research Veterinarian?
Subject matter expert?
Non-affiliated Veterinarian?
IACUC Veterinarian?
Other facility veterinarian?

26. Post-approval Monitoring
Should VVC apply?
How to you maintain consistent interpretation and recommendations?
Should VVC receive a routine audit?

27. Documentation to finished
What is needed?
How fast does it need to get into the protocol?
Who should be responsible?
Will online systems restrict the VVC process?

28. Anna Hampton 919-668-6721 Anna.Hampton@Duke.edu