The Beacon Volume 2, Issue 1
Dear Investigators and Staff,
The Holiday season is fast approaching. Below, please note the holiday review schedule for significant modifications and the 2018 IACUC deadline and meeting date schedule.
2017 IACUC Review Holiday Schedule
- The holiday recess schedule falls on 12/22/17 – 01/02/18. If your research needs require a significant modification to be approved before the end of the 2017 calendar year, it must be submitted to the IACUC e-mail at email@example.com by the end of the day on Monday, December 18th.
- If you currently have a significant modification that is pending which requires approval prior to the holiday/recess, please respond to questions promptly to facilitate the approval of your modification.
2018 IACUC Meetings and Deadlines
- Investigators are encouraged to submit protocols that are due for 3-year renewal in 2018 early to allow time for pre-review of the protocol by the liaisons and the veterinarians. This will expedite the review and approval of the protocol in the MAPS environment. Should you have any questions, please contact your protocol liaison.
- 2018 Deadline and Meeting Date Schedule
If you have any questions regarding the modification review schedule for the balance of the 2017 calendar year or questions regarding the 2018 schedule, please do not hesitate to call the office at (203) 785-5992.
Thank you and Happy Holidays!
The Office of Animal Research Support (OARS)
- Staffing Changes
- Impact of Workday
- Protocol Modifications
- Policy Updates
- New Animal Research Training Platform
- Maps Update
- Consideration of Alternatives to Potentially Painful or Distressful Procedures
- Expired Drugs
- Make the Most Out of Rodent Basic Principles
On March 20, 2017, Layne Ochman was promoted to a new position as Training Manager, transitioning from her previous role as a Research Support and Safety Specialist. As the Training Manager, Layne focuses on the researcher training program—redesigning how OARS delivers the training requirements set forth by the IACUC so that the program is more efficient and opportunities for training are more available to the research community. One of the first significant initiatives she has undertaken is a shift to the AALAS Learning Library for online training.
On June 12th, Matt Seager became our newest Research Support and Safety Specialist. Matt has nearly 20 years of experience in biomedical research, having spent time in the government, academia, and industry sectors. Most recently at Bristol-Myers Squibb, Matt’s many responsibilities included being a Senior Investigator studying Alzheimer’s Disease and other neuroscience models and as an IACUC member who also performed protocol liaison and post-approval monitoring activities. He will soon assume Layne’s previous group of departments for comparative reviews, start-up meetings, and lab visits.
After 17 years of service to the IACUC and its supporting office, Lisa Corey retired at the end of July. Lisa will remain with OARS as a part-time consultant, continuing in a quality assurance role while we refine our automated reporting tool in MAPS. For all topics that would have routinely been handled by Lisa, please send to firstname.lastname@example.org or call 203-785-5592.
Yale’s transition to Workday for financial transactions will have some impact on how the Office of Sponsored Projects (OSP) manages grants and how the Yale Animal Resource Center (YARC) manages per diem rates and other charges. Faculty members’ department assignments may have been changed with the conversion to Workday, i.e. faculty who have appointments in two different departments, or sections within departments, may now have a different affiliation. From a strictly IACUC-only perspective, this should not a concern but it may have downstream effects on how OSP and YARC interact with protocol-related data. We are aware of this issue and are working to minimize its impact on the research community. If you seem to have a problem that could be related to this issue, please do not hesitate to contact OARS staff at email@example.com or 203-785-5592.
How you submit a protocol modification depends on which protocol application form was used for your protocol approval.
If your protocol was approved via the paper protocol application, then modifications are submitted using the paper modification form found on the Yale OARS/IACUC web section. Both instructions for completing the form and the modification form can be found on the paper applications web page. Alternatively, you can request an electronic copy of the instructions and form by contacting OARS via email at firstname.lastname@example.org, calling the main office line at 203-785-5992 or by contacting your department’s Protocol Liaison.
If your protocol was approved in MAPS, then modifications will be created and processed via MAPS. There is a Quick Guide on how to submit a modification via MAPS on the Yale OARS/IACUC web section. You can also contact your Protocol Liaison for assistance.
What to include in your MAPS modification form:
- Include both a description AND justification in the modification form using the Other Info text box at the bottom of the page.
- Make additions/changes to the protocol by using Edit IACUC Protocol function on the left side of the protocol homepage.
Although MAPS has the option to add personnel and funding via the Add Personnel and Add Funding functionalities respectively, it is unnecessary to do so. Once a Personnel Qualification Form (PQF) has been approved, OARS will add the new personnel administratively to the protocol Study Staff page and the PQF will be linked to the protocol via the Personnel tab on the protocol homepage. Similarly, once congruency has been established via PI request for congruency, OARS will add the funding source to the Funding Details page.
The IACUC Committee has reviewed and approved revisions to three policies, Animal Acquisition, Regulated Food and/or Fluid in Rodents, and Transportation of Animal (intra).
The following are the key points and any changes that were made within each policy:
Policy 4409 Animal Acquisition
This policy describes the process by which all animals must be acquired. It discusses all procurement requirements, including those for vendors, transfers between Yale protocols, and transfers between Yale and other institutions. It also includes a brief section on considerations if you are performing field collection.
The changes made to this policy were limited to general wordsmithing and more clearly stated requirements.
Policy 4438 Regulated Food and/or Fluid in Rodents
This policy defines the requirements and justifications necessary if a study plans to deviate from the normal food and water husbandry practices for rodents. An IACUC protocol that requires food/fluid regulation in rodents should address several specific topics, including monitoring, consideration of positive reward training, etc.
There were several changes to this policy:
- Restructuring of the procedures for fasting, food/fluid regulation, and maintenance for better clarity.
- For fasting, the duration is now defined based on weight of the animal.
- Fasting duration should be set to avoid any physiological stress. This is especially important when considering the effects stress may have on the outcome of the study, as stress may have unforeseen consequences on the validity of the data.
- Food/fluid regulation describes in more detail the issues that need to be addressed in an IACUC protocol for approval.
- Level and/or pattern of regulation required
- Potential adverse consequences, including clinical endpoints
- Methods for assessing health and well-being
Policy 4443 Transportation of Animals (Intra)
This policy discusses all procedures that are necessary for transferring and relocating animals on Yale’s campus.
The changes made were mainly restructuring of the document for improved clarity. The following are key points included in this policy:
- General transportation of rodents: types of approved containers/carriers and how to properly transport one or multiple containers/carriers at one time
- Indoor transportation of non-hazardous rodents and their cages
- Outdoor transportation of non-hazardous rodents and their cages
- Animals exposed to hazardous agents or species harboring zoonotic agents
- Cross-campus transportation
- Transportation and relocation of all other species
- When the PI can transport and when YARC must transport
If you have questions about any IACUC or OARS policies or procedures, please contact Alli Czarnecki (Policy Manager; email@example.com).
In order to provide more standard and efficient training opportunities, we will soon begin using the American Association for Laboratory Animal Science (AALAS) Learning Library (ALL).
The ALL is an online training resource that includes a library of over 100 online courses, including modules on regulations, species-specific biomethodology, research procedures, bioethics and occupational health and safety. The initial rollout is scheduled for September 2017, with only “Working with the IACUC,” which will replace the current course, “Regulatory Training for Animal Care and Use.” Additional courses will be added to the curriculum as we refine the overall training program to provide improved training opportunities in such a way as not to increase regulatory burden to PIs and their staff.
There are two major benefits to the research community in using the ALL for training courses:
- Courses are transferable between institutions that use the ALL, so there may be fewer requirements for research staff who already have an up-to-date transcript from another institution
- Once registered, the entire library is open to you, which may enhance how training is delivered in the laboratories
The ALL will also provide several advantages:
- AALAS routinely updates courses to maintain the most current information regarding regulations and animal care and use, allowing OARS to focus time and effort on other program improvements
- More flexibility in online scheduling of courses offered at Yale.
- Development of more focused, person-specific training programs
- Access to personal transcripts including ability to print individual transcripts and certificates of completion
- Courses can be used for continuing education credit
OARS will provide updates and course offerings to the research community over the coming months, including how to register (please be patient!). TMS will continue to use your Net ID to register and track your training. Contact Layne Ochman (Training Manager) with any questions.
As the number of approved protocols within MAPS increases, the number of suggestions for improvement from the research community also increases. We appreciate this kind of feedback, as it helps us make steady progress to improve the application’s user-friendliness. In the remaining months of 2017, we plan on making several enhancements.
The first update is expected to be completed in September. This update will include:
- Significantly improved views for the research community and the reviewers. There is redundancy that leads to confusion for all users—PI and reviewers alike. The new view will be based on panels within the main window; the left panel will be a table of contents that links to specific sections of the protocol and the right panel will be the content of the protocol.
From the reviewer perspective, less redundancy should translate into shorter review times and fewer questions, as protocol content will be presented in a more comprehensive manner.& From the PI/lab perspective, there will be the ability to print the entire protocol as a PDF, as well as the ability to print experiments only or building blocks only. This improvement should significantly reduce the size of the printed protocol, as well.
- Greater consistency and defining of values in drop down menus. For example, swine was used in a few drop-down menus and pigs was used in others.
The second update, which is targeted to be released in October or November, includes the following enhancements:
- Significant change in how “drugs” are managed. The new improvement eliminates the building block concept for drugs. It will instead provide a single table to enter and display all relevant drug information without having to “click” through several screens. Once implemented, all drug information will be included on one screen. While the information requested has not changed, the time to enter that information will be reduced.
- Moving Special Instructions out of experiments. By “promoting” SIs to protocol-level information, the unnecessary duplication of recreating the same SI across multiple experiments will be eliminated. For example, 10 experiments with special diets currently would require 10 SIs; this process turns into a complicated situation for YARC, the PI and the IACUC. This enhancement will help ease some of the administrative burden placed on the PI.
- Adding functional hyperlinks to policies. Hyperlinks were broken when “It’s Your Yale” was released.
The third set of enhancements currently targeted for winter release, will include the following:
- Combine colony maintenance information into the Species building block. Currently, breeding and genotyping/identification are separate procedure building blocks. By including this information into the species building block, the number of “clicks” to enter the colony maintenance information will be significantly reduced.
- Simplify and clarify monitoring plans.Monitoring plans are currently included in both procedures and experiments, leading to a great deal of confusion of where the details should actually be captured. What information needs to be included in the monitoring plan will be made much clearer than it is today. Procedure monitoring details will include only intraprocedural monitoring (e.g. depth of anesthesia) and the immediate post-procedure time period (e.g. seconds for an injection but up to two weeks for survival surgery). Essentially, procedure monitoring takes place until the animal has “recovered” from the procedure. Monitoring animals at the experiment-level for a disease model may include monitoring for weeks or even years. For example, if tumors were surgically implanted, the monitoring plan details would be captured at the procedure level and include up to suture removal. The monitoring plan to observe tumor growth would be detailed in the experiment, up until euthanasia.
If you have suggestions on how we can further refine the MAPS application and improve user experience, please do not hesitate to contact Troy Hallman communicate your suggestions with your Protocol Liaison.
USDA Inspection. During May 15-18th, 2017, the United States Department of Agriculture conducted its federally required annual inspection of Yale’s animal facilities and laboratories. We received two citations.
An IACUC protocol included a painful procedure but did not contain a written narrative description of the methods and sources used to determine that alternatives were not available for that procedure.
How can we avoid a repeat citation in the future?
- When considering whether a procedure is painful or distressful, think about all parts of that procedure. For example, an imaging procedure alone is likely not painful or distressful but it may also include a cutdown for vascular access, which is painful.
- At the July 2017 IACUC meeting, the Committee was retrained on evaluating searches for alternatives as part of the protocol review process.
- The Cushing/Whitney Medical Library has set up an informative tutorial to help the research community develop search strategies and perform literature searches for alternatives to painful/distressful animal research procedures (Searching for Alternatives to Painful Procedures Used on Research Animals).
- The Cushing/Whitney Medical Library also offers instructor-led courses on conducting appropriate searches for alternatives, among other research animal use-related topics. (Library Classes & Workshops).
- Please do not hesitate to contact your Department’s assigned librarian in YSM or FAS for guidance and assistance in conducting a painful procedures alternatives search. If you have any questions about this specific topic or any other protocol-related topics, please do not hesitate to contact your Department’s protocol liaison.
Expired medications were found in an investigator’s laboratory space and were ready for use (not labeled as “Expired – Do Not Use”). The USDA inspects expiration dates on food and supplies (sterile surgical equipment, etc.), as well.
How can we avoid a repeat citation in the future?
- Consolidate all animal-related drugs into one or two (if using controlled drugs) laboratory locations. Storing drugs in a central location makes it easier to survey the inventory.
- Create an expiration date tracking system. This could be as simple as routine checks of the entire inventory (e.g. monthly). Many labs keep an inventory log in a spreadsheet, with built-in reminders of when a drug is approaching its expiration date.
VCS uses a sticker system to track expiration dates. A round, colored sticker is placed on the drug container (not obscuring the expiration date). The color of the sticker represents the year of expiration, e.g. yellow = 2017, green = 2018, etc. The month of the expiration is then written in permanent marker on the sticker, e.g. “8” for August, “9” for September. This method makes surveying the entire inventory very efficient, as you will only need to scan for containers with an “8” on a green sticker for those drugs expiring in August 2017.
Expired compounds (drugs, food, and supplies) are consistently identified as one of the top three deficiencies found during IACUC semi-annual self-assessments of vivaria, PI-managed facilities and laboratories. The reason checking drug inventories during IACUC inspections and post-approval monitoring activities (lab audits, comparative reviews, procedure monitoring, etc.) is so heavily emphasized is in hopes to prevent external reviewers from finding such easily avoided issues.
If you have any questions about this specific topic or any other post-approval requirements, please do not hesitate to contact your Department’s specialist.
The most popular instructor-led course preparing research staff to work with laboratory animals is Basic Principles in Handling, Collection and Injection Techniques in the Animal Handlers Working with Rodents section. Here are a few tips to help you get the most of this training and get you working on your IACUC protocol more quickly.
- Before you may participate in Basic Principles and work with rodents (or any species, for that matter), researchers should at least be in the process of being added to an approved IACUC protocol.
- When submitting the minor modification to add you to the protocol (paper protocols only), also include a description of your qualifications on the Personal Qualifications Form. For protocols approved prior to August 2016, please complete the PQF form which can be downloaded from the IACUC web site. Completed forms, including the cover page, must be submitted to firstname.lastname@example.org. For MAPS protocols, only the Personnel Qualification Form needs to be submitted. The Add Personnel function is no longer necessary to complete (see Protocol Modifications: Paper Application Form vs MAPS Protocol article).
Update: All PQFs must be submitted in MAPS, regardless of whether the protocol is still “on paper” or already in MAPS.
- In order to be added to a protocol, you must also complete “Regulatory Training for Animal Care and Use” and “Medical Surveillance Program for Animal Handlers” in the Training Management System (TMS), as well as be cleared by Employee Health to work with rodents.
Taking the Course
- Log into TMS and schedule yourself for the training laboratory “Rodent: Basic Principles in Handling, Collection and Injection Techniques”.
- Discuss your experience and comfort-level with the course instructors so that they may gear the training experience to match your needs.
- Remember that you are taking this course to learn new techniques or to reinforce the skills that you may already have. We encourage you to participate fully and not skip anything. Even if you will not collect blood or euthanize animals in your laboratory, still learn the techniques in the lab so that you can develop new skills.
- You can retake this course as often as you’d like to improve your skills in rodent handling and basic procedures.