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RPO News

RPO would like to congratulate Abbey Dattilio for being selected as a recipient of the 2023 President’s Our Common Ground Award! The award recognizes University of Vermont staff members who exemplify the qualities of �պ�����’s Our Common Ground, the statement of aspirations and shared values of our community: Respect, Integrity, Innovation, Openness, Justice, and Responsibility. Congratulations, Abbey! This award is well deserved!

Research Protections Office Metrics Project

RPO has been updating and creating new metrics for the IRB, IACUC and IBC committees.  Metrics are currently in development for measuring RPO Regulatory Analyst, researcher and member workloads, timelines, and establishing reasonable expectations.

One of the items we detected across all boards was a delay in researcher responses to Committee requests for clarifications. RPO takes advantage of the �պ�����Click automated reminder system to alert researchers of outstanding clarification requests for each of its committee modules.  Additionally, when protocols are about to expire or responses become progressively delayed, the RPO Analysts are reaching out to the researcher personally for the outstanding item.  Despite these efforts, delays continue.  Unfortunately, response delays result in research approval delays.

To that end the Committees approved a policy that outlines criteria by which each of the Committees will discard protocols or amendments in the approval process that have not received responses to clarifications or modifications.  

Dilution and Storage of Buprenorphine and Ketamine

Some substances require mixing with a diluent to reach an appropriate working concentration. Buprenorphine and ketamine are controlled substances that are commonly diluted and stored here at �պ�����. Upon inspections of laboratories, we have found these diluted substances stored in refrigerators, often in a secondary lock box that has been installed in a refrigerator that is not part of the DEA registered location.  The DEA requires that all controlled substances be stored in their registered locations.  This also applies to diluted controlled substances. Storing substances outside of the registered location (i.e., the lock box location that has been approved by the DEA) is a violation of the Code of Federal Regulations and �պ����� policy. If cited by the DEA, this may result in revocation of your registration. 

We realize this poses an issue for substances that require refrigeration to maintain stability and efficacy after dilution. In the case of Buprenorphine and ketamine, there is a long-held misconception that once diluted, they must be stored in the refrigerator. In fact, these substances remain stable for long after the 28-day expiration date at room temperature. Please see these article references:

Please store your diluted ketamine and buprenorphine in your DEA approved registered lock box and not in a refrigerator. If you have substances that do need to be refrigerated upon dilution, discuss this with a DEA Diversion Officer so they can advise you on how to register additional storage locations.

General Guidance for diluted substances:

• Diluted substances are considered expired after 28 days, in keeping with USP (United States Pharmacopeia) standards and �պ����� Policy.
• Mix in sterile, glass containers using aseptic technique. 
• Store at room temperature (if appropriate) for no more than 28 days.
• When possible, only mix what you need for the day to avoid additional record keeping and waste.

Animal Overages

The IACUC works in collaboration with OACM to track animal usage per protocol. We have seen an uptick in instances where usage has exceeded approved numbers and requires an urgent amendment to get the protocol back in good standing. Upon investigation into the matter, it has become clear that the overages are primarily due to protocols approved prior to the October 2021 update to IACUC policy 15.32 Guidelines for Counting Animals Used in Breeding Protocols.  This policy was updated and notice provided to researchers on October 18, 2021 to revise their protocols to include a “cull experiment”.  The purpose of a cull experiment is to account for animals culled due to genotype that do not count towards the allotment of experimental animals but need to be tracked and documented since this policy update. Animal tracking utilizing the new VOS system is extremely accurate. Overages are identified in real-time and OACM contacts the IACUC when an overage occurs. The animals in overage are marked and are not allowed to be used until the overage is corrected with an approved amendment to the protocol. PIs  are allotted one week from the time of the overage to submit an amendment to avoid a noncompliance Concern.

RPO has identified nearly 40 protocols that include a breeding component but do not currently have a cull experiment. We are reaching out to individual PIs to assess the need for a cull experiment and work with the PI to incorporate one if needed. As you are reviewing and updating your protocols, please note that these additional numbers should not impact your justification (e.g., power calculation, literature reference) for requested animal numbers needed for experimental groups.

�պ�����Click Update

All modules are preparing for an upgrade to version 10 in the next year.  V10 provides you with opportunities to personalize your Dashboard. This new feature will be a welcome addition to assist researchers with managing workload.

From your Dashboard, you will see:

• My Inbox: Items that require you to take action.
• My Reviews: Items assigned to you to review if you are a reviewer. These are a subset of the items in My Inbox.
• Recently Viewed:
  • Recent: The last several items you viewed. Scroll through this list to find an item you worked on recently.
  • Pinned: You can pin the items in the Recently Viewed section for quick and easy access. This is where those pinned items are listed.

Personalize Table: You can alter the tables displayed on the dashboard by using the Personalize Table gear icon.

Reminder About Triennial Review

Despite several notices, triennial reviews continue to be submitted with too little time for processing and review by the Committee. Please submit your triennial reviews at least 6 weeks prior to the protocol expiration date. This gives staff and reviewers ample time to assist you with any required edits to the protocol that are necessary for approval.

RPO has created some resources to help you with your submission:

• The How to Submit an Annual or Triennial Review guide can be found on the �պ�����Click-IACUC User Guide page.
• The educational session materials regarding Triennial Reviews hosted throughout April and May 2023 can be found on our educational resource page.

The above-mentioned materials describe the required and permittable edits that may be made during this type of review.

Policy Updates

The below policies were updated with non-substantive edits.

11.0 Reporting Requirements       
15.6 Euthanasia Methods
15.8 Care of Animals During an Emergency or Disaster
15.20 Survival Surgery
15.25 Breeding and Weaning