September 27, 2018
To: Emory University animal users
From: Sam Speck, Chair Emory IACUC, David Martin, Director Emory IACUC Office, Michael E. Zwick, Assistant VP for Research, WHSC, Todd Sherer, Interim VP of Research Administration
Dear Emory Animal Users:
We are reaching out to provide updates regarding the current status of
IACUC protocol submission software. We are in the final stages of phasing out our previous IACUC protocol submission software that did not meet the needs of the Emory research community. We have now implemented a new software solution from Huron that we have termed eIACUC. We believe this solution provides a user-friendly interface to the Emory research community for protocol submission, review, and approval, while also meeting the business needs of Emory University. It is important to emphasize that IACUC protocol submission software products are “boutique software” and, as such, none of these programs will be as
Submission of protocols using Huron eIACUC software. The eIACUC software solution is currently active and in use by numerous investigators. At present over 100 new or 3-year renewal protocols have been approved in eIACUC, as well as numerous amendments. In addition, the IACUC office staff has migrated ~250 approved protocols from the existing system into the new format. All reports indicate that the new solution provides a dramatic improvement from the previous system from a technical standpoint. It runs smoothly on both Macs and PCs, works efficiently with all common web browsers, and can be accessed without error from all locations on campus, as well from home and other off-site locations. It should be noted however that the organization of the protocol form is profoundly different from that used previously. This has resulted in a steep learning curve across the entire research community, which was not unexpected, but has been challenging. One of the major changes is the use of self-contained procedures that are either preapproved by the IACUC (Standard Operating Procedures; SOPs) or written/edited by the research staff (Team Procedures). Currently, eIACUC contains 263 IACUC pre-approved SOPs available for use. These have largely been written by the IACUC office and reviewed by the vet staffs prior to approval by the IACUC. Standard procedures cannot be edited by the research staff and are thus not specifically reviewed by the IACUC during the protocol approval process. Team procedures are fully editable by the research team and thus offer great flexibility to the research community. However, these procedures are subject to protocol review. One nice feature of the eIACUC software solution is that it has a specific, defined process by which Team procedures can be promoted to Standard procedure status.
Current Challenges: A major software change carries with it numerous challenges. Specific to this implementation is the fact that we have been forced to work in three protocol submission and review environments, which has put a great deal of burden on the protocol review process. In addition, the IACUC office has been tasked with the migration of currently approved protocols from the archival systems into eIACUC. This has presented two major challenges: (1) this is a major investment of time and resources, with the average protocol taking about 4 hours to migrate; and (2) migrated protocols are not revised to fit the new format, but rather the approved protocol content is incorporated without editing into the new solution. This is critical to avoid the need for IACUC re-review of all migrated protocols, but also carries with it the reality that subsequent extensive revisions will be required either at the time an amendment or three-year renewal is submitted for review. We wish to emphasize that given this difficult transition, PIs need to plan on 2-3 months from time of initial submission of a new or 3-year renewal protocol and final approval from the IACUC. There are currently 163 approved protocols left to migrate with a deadline of October 31st, 2018 due to contractual obligations with the outgoing vendor. Finally, while the development of SOPs is a critically important piece in the establishment of an efficient protocol submission and approval process, this does take significant time and effort, both for generation of the procedure and subsequent IACUC review.
Goals and Future progress: Clearly, the major advantage of Standard Operating Procedures is that they have been pre-approved by the IACUC, thus greatly streamlining both protocol submission and review/approval. We expect that the administrative burden and time needed for protocol review will decline as we move through this transition. While it is NOT feasible for all team procedures to become SOPs, many of you do perform well-established procedures within the lab, and we encourage you to reach out to the IACUC office if you feel that you have team procedures which you would like to see promoted to an SOP. With respect to SOP generation there are 2 important issues to bear in mind: (1) SOPs should only be generated for those procedures which will be implemented in multiple IACUC protocols, and offer no advantage over Team Procedures if only used in a single IACUC protocol (i.e., SOPs, like IACUC protocols, need to be reviewed by the IACUC every 3 years); and (2) during this transition to the new software, there is limited reviewer time available for reviewing and approving SOPs - thus, any SOPs you would like to submit should be derived from a team procedure that has already undergone IACUC review. Finally, the IACUC is currently reviewing the existing eIACUC form with an eye toward revisions to reduce redundancy/confusion where possible, and to providing additional directions/help text in other cases to achieve greater clarity and efficiency.
The bottom line is that the IACUC is working hard to implement the new protocol software and move existing protocols into the new system. We also aim over the next 1-2 years to expand the number of SOPs that are available to investigators – with the ultimate goal of simplifying and speeding up protocol submission and review. We appreciate that these changes are disruptive for everyone, but hope that in the long run, we will end up with a much better protocol review process.
Please see the following important reminder
- PHASE-OUT OF ENTERPRISE AND ELEMENTS SOFTWARE: The use of both Enterprise and Elements for protocol processing and approval will be discontinued by October 31st, 2018. In order to meet this objective, no new protocol amendments will be accepted in either system as of September 1st, 2018. This is absolutely necessary to allow for the time required for protocol approval from these systems as well as their decommission by the October 31st target date.
- AMENDMENTS TO ENTERPRISE AND ELEMENTS PROTOCOLS: If you have a protocol(s) in the existing systems that have not been migrated AND you feel you will need to submit an amendment soon, please contact the IACUC office immediately. We will prioritize your migration into the new solution in order to prevent any unnecessary loss of time.
- AMENDMENTS AND MIGRATIONS AFTER SEPTEMBER 1st. If your protocol has not been migrated after September 1st, and you find you need to submit a protocol amendment, please see the following guidance:
- Personnel amendments: Contact the IACUC office. We will work with you to submit the amendment to add your staff directly into eIACUC so as not to hold up approvals and to allow your staff to get to work as quickly as possible;
- All other amendments: Contact the IACUC office. We will migrate your protocol within 2 business days and then release it to you for subsequent submission of the new amendment into the eIACUC solution.
Thanks to all, and please feel free to contact us if you have questions or concerns, or need assistance.
"The Animal Examiner - News from the IACUC"
Iissue 01 Topics
- Top Three Noncompliances
- Upcoming IACUC Events
- Veterinary Drug Procurement
- Animal Model Resources
- Tips for Swifter Review
- Download February 2013, Volume 02, Issue 01: pdf, 106 kb
Iissue 03 Topics
- Top Three Noncompliances
- Upcoming IACUC Events
- A Change in Annual Reviews Processing
- Implementing the New Guide – Rodent Surgery
- Tip for Swifter Review
- Download July 10, 2012, Volume 01, Issue 03: pdf, 48 kb
Iissue 02 Topics
- Top Three Noncompliances
- WLAW and WWAL Week is Here - April 21-29
- Introducing the Animal Research Classifieds (ARC)
- Tip for Swifter Review - Ask a Vet
- Download April 19, 2012, Volume 01, Issue 02: pdf, 54 kb
Iissue 01 Topics
- IACUC to Divide and Conquer
- Compliance Reminders
- Upcoming Site Inspections
- TOPAZ Web P&R Maintenance
- IACUC Office Welcomes a New Employee
- Tip for a Swifter Review: Amendment Strategy
- Download March 15, 2012, Volume 01, Issue 01: pdf, 54 kb
The New "Guide" and Changes to Mouse Housing Requirements
According to the new 8th edition of the “Guide for the Care and Use of Laboratory Animals.” Based on Table 3.2 on page 57 of the new “Guide”, adult mice (>25 grams body weight) have a recommended minimum 15 square inches of space per animal. The average adult mouse will weigh approximately 30 grams. Using this minimum, cages currently in use will only allow 5 adult mice per cage.
Emory University’s PHS Assurance states that we will adhere to the “Guide” and PHS Policy. The IACUC must conduct at least one of its semiannual inspections incorporating the new “Guide” before December 31, 2012. The IACUC has already conducted one site inspection of all facilities and did not cite any cages with more than 5 adult mice/cage. With this implementation timeframe in mind, any mouse cages containing more than 5 adult mice found after May 1st will be reported to the IACUC. Any cages found with more than 5 adult mice found on the next semiannual site inspection will be documented as a deficiency and reported to our Institutional Official, Dr. David Wynes, Vice President for Research Administration, in the semiannual report as required by the Animal Welfare Act.
Please don’t blame the IACUC. Following the new revised “Guide” is federally mandated by our regulatory bodies and expected by our accreditation agency. Please note that the IACUC has revised its policy to comply with the new “Guide”. Please see Mouse Overcrowded Cage Policy.
TOPAZ Web P&R - Routine System Maintenance
Due to the number of changes made on a daily basis to this system, regular system maintenance is scheduled nightly. Beginning immediately, system maintenance will occur between
Message from the IACUC Chair
Dr. Sam Speck - It has been a year since I last wrote to you regarding laboratory animal use at Emory. In this