Frequently Asked Questions about VVC
OLAW reviewed and approved
1. How can the Veterinary Verification and Consultation (VVC) process be used?
· The VVC process can be used to make significant changes to animal activities that are part of a protocol that was previously reviewed and approved by FCR or DMR. To utilize VVC the IACUC must have an approved policy in place that specifically permits the addition of the significant changes to previously approved protocols.
· The VVC process may not be used to add new procedures to a previously approved protocol.
· The VVC process may not be used to modify existing procedures if the modification increases the opportunity for the animals’ welfare to be compromised or meets any of the other criteria from 1. a. – g. in OLAW’s guidance (Notice Number: NOT-OD-14-126). The guidance defines the modifications listed below as significant changes that must be made using either the FCR or DMR process. The VVC process cannot be used for the following changes.
a. from nonsurvival to survival surgery;
b. resulting in greater pain, distress, or degree of invasiveness;
c. in housing and or use of animals in a location that is not part of the animal program overseen by the IACUC;
d. in species;
e. in study objectives;
f. in Principal Investigator (PI); and
g. that impact personnel safety.
2. To make significant changes to animal activities previously approved by the IACUC means:
· The PI wants to make a significant change to animal activities that are described in a protocol and have been approved by the IACUC using either the FCR or DMR process. The significant change can be approved by the veterinarian using VVC providing the IACUC approved policy is followed and the requirements of VVC are satisfied.
3. What does it mean for the veterinarian to verify?
· Verified means that the veterinarian determines that based on his or her experience and training, the significant change is reasonable for a particular animal or group of animals in a particular situation and meets the parameters of the IACUC reviewed and approved policies.
4. If a PI wishes to add a new procedure to his approved protocol and the procedure he wants to add is one that’s IACUC approved on a separate protocol for the same species, can the significant change be made using the VVC process?
· The VVC cannot be used to add new procedures to a previously approved protocol. For example, if a researcher’s protocol does not include sample collection for genotyping and he/she wishes to add this procedure to the protocol, the VVC process cannot be used even though the genotyping procedure has been IACUC approved as part of other protocols and/or an IACUC SOP. In this scenario, the sample collection would need to be added to the protocol using either the DMR or FCR process.
5. Can the VVC process be used to significantly modify animal use procedures that are part of an IACUC approved protocol?
· The VVC process can be used to make significant modifications to procedures that are already part of a previously IACUC approved protocol providing the required IACUC approved policy is followed and the requirements of VVC are satisfied.
· Scenario: A PI is approved to collect tail snips for genotyping as part of their IACUC approved protocol. Currently he or she is approved to conduct tail snips on mice less than 3 weeks of age. He or she would also like to be able to genotype older animals, and would like to modify his protocol to conduct ear punches since tail snips would be more painful in older animals. The IACUC has previously approved a policy that permits the veterinarian to use VVC to administratively handle changes in genotyping procedures including tail snips, ear punches, and blood collection. The VVC process can be used in this scenario to modify the protocol. Comments:
o Since tail snips are already approved as part of the protocol, the genotyping SOP includes provisions for ear punches on animals older than 3 weeks, and the technique results in less painful procedures, the VVC process can be used. Understanding the IACUC’s policy on VVC review and genotyping, the veterinarian knew he could use VVC to modify the genotyping procedure in the protocol to include a modification of the collection technique that would result in less pain for the animals. The veterinarian is also aware of the investigator’s training and experience with the method.
o Organizations have flexibility to develop their IACUC approved VVC policy. In this particular scenario, the organization’s policy may site an SOP for genotyping rodents. The SOP may list tail snips, ear punches and blood sampling as IACUC approved methods for tissue collection with limitations based on the age of the animals. Consequently the VVC policy empowers the veterinarian to modify sample collection activities within a protocol providing the modification is within the parameters of the SOP.
· The scenario is intended to illustrate the basic concepts behind VVC. The VVC can be used to significantly modify an animal procedure within an IACUC approved protocol providing it doesn’t increase the pain and distress animals will experience. The IACUC must develop a VVC policy that specifically identifies the type of changes that can be made.
6. If an organization has a collection of SOP’s that are IACUC approved animal activities (e.g., blood collection techniques approved for mice, sample collection for genotyping or approved anesthetics and analgesics for mice), can the VVC review process be used to add these procedures to an IACUC approved protocol?
· If the activities being added are not part of the previously approved protocol, then the VVC cannot be used to modify the protocol even if the IACUC has approved SOPs for the procedures being added.
· However if the IACUC approved VVC policy references the SOPs for example, the veterinarian can modify in this case blood and genotype sample collection techniques and anesthetic/analgesic plans providing the changes are within the parameters of the IACUC approved SOPs.
7. Upon modifying a protocol using the VVC process, how much time can lapse before documenting the change in the protocol is required?
· The IACUC at each organization must establish the timeline as part of its VVC policy. The committee may decide that the change may be made immediately, the written verification of VVC handling must be provided to the IACUC office within two working days and the IACUC office has 5 working days to add the change to the protocol. This is just an example. Your IACUC may select different time limits or have different processes.
8. What happens if a veterinarian amends an approved protocol, and that amendment should have been reviewed and approved by the IACUC?
· It's very important to develop a policy that's specific enough to ensure veterinarians can make decisions that support the IACUC’s policy and are in the best interest of the animals. The policy should specifically identify the modifications veterinarians can make. For example, the policy may say the veterinarians can alter sample collection techniques based on the SOP “Collecting Samples for Genotyping in Mice”. The SOP would specifically identify the IACUC approved methods. Consequently as long as the veterinarian is within the parameters of the SOP he or she would know VVC applies.
9. If the VVC process is incorrectly applied (i.e., a change is made to a protocol that should have been reviewed by the IACUC); once the error is discovered would the change be considered non-compliance?
· If the policy is wrongly applied, the conducted procedure would be an unapproved significant change that would have to be reported to OLAW. OLAW would assist and guide the institution to ensure compliance with the PHS Policy.
10. Does a VVC approval of a significant change mean the veterinarian is approving significant changes to an IACUC approved protocol?
· The VVC process allows the veterinarian to consult with the PI then verify that the significant changes being requested are consistent with IACUC VVC policy. The policy should clearly identify the modifications the IACUC has approved to be made using the VVC process. Through the VVC policy, the IACUC authorizes a veterinarian to use their training and professional judgment to determine whether a requested modification is one that the IACUC has approved as a change that can be made using VVC approval.
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