IACUC News In Depth

REDERIVATION PROJECT & FACILITY CLEAN UP IN RC1

Communication from Jori Leszczynski, DVM, DACLAM - University Veterinarian &

Director, Clinical and Academic Programs Office of Laboratory Animal Resources:

After many discussions with the groups that must coordinate to make this project happen, we have set a timeline for the cryopreservation and rederivation of lines, as well as the date at which all animal work must end in RC1 to allow for decontamination to occur.

Therefore, the deadline that has been set for all unique and approved lines to be cryopreserved is December 31, 2009 .  Please make sure you are in communication with the transgenic core if you have lines that need to be cryopreserved and have everything arranged prior to that date.  The Transgenic Core's e-mail is makeamouse@ucdenver.edu

With that deadline in mind, RC1 will be scheduled for COMPLETE closure for decontamination on March 31, 2010 . All animal studies MUST stop at RC1 at this point.   The facility will be depopulated and shut down for approximately 4 weeks while the decontamination process is completed.  After the decontamination process has been completed, imaging, irradiation, ABSL2/3, surgical, and non-rodent studies will resume in RC1.   At the same time, sentinel testing of the rodent areas will start and continue for an additional 8 weeks.  Rodent breeding colonies will NOT be moved into RC1 until sentinel testing has been completed, which will take approximately 8 additional weeks (12 total weeks of closure).

Therefore, please DO NOT start any study at RC1 that will finish after March 31, 2010 .  If you need to start a long term study, please arrange to start those studies in RC2.

I will be planning multiple information sessions to discuss the move over the coming year and will make every effort to vary the times to capture as many as possible. 

In addition, to date, all colonies in RC2 remain disease free and I want to thank all of the users that have migrated for following the established SOPs.

ANIMAL PROGRAM ORIENTATION

All new personnel are required to attend a session prior to being named on protocols/conducting procedures on animals.

•  Orientation will be in a classroom setting offered twice per month (1st Tuesday morning and 3 rd Thursday afternoon)

•  Orientation will cover: Requirements for conduct of research involving animals; Introduction to the IACUC; Protocols; Training/Personnel Qualifications Forms; Occupational Health Program.

• Orientation for animal facility issues is also required; please be aware that the facility orientation for RC2 vivarium access is a more extensive process than that for RC1.

• The didactic portion of the RC2 orientation will follow directly after the Animal Program Orientation; this portion will cover: Web Animal Ordering; Billing; Animal Facility - access; PPE; appropriate behavior; infection control.

•  Prior to activation of badge access to the animal facility personnel must have completed required Personnel Qualifications to perform procedures on animals, Occupational Health Program enrolment, Program Orientation and be named as an associate on a valid protocol.

•  If space permits any researcher can attend.

PIs are advised to begin the process for themselves/new employees/students as soon as it is identified that they will conduct research involving animals: sign up for the Animal Program Orientation; begin the enrolment in the occupational health program; generate personnel qualifications forms and submit to the IACUC Office (F489). 

Please consider the timelines needed to complete all steps including the facility orientation/walkthrough sessions and plan schedules accordingly.

Please contact the IACUC Office (303-724-1056) to sign up for orientation or additional information.

September/October  sessions will be:

October 22 (Thursday) ~ Education 2 North Bldg – rm 1103 (1pm to 4pm)

November 3 (Tuesday) ~ Education 1 Bldg – rm 3500 (9am to 12pm)

November 19 (Thursday) ~ Education 2 North Bldg – rm 1103 (1pm to 4pm)

ONLINE IACUC PROTOCOL SUBMISSION

Protocol applications are to be submitted online. Please note the following steps to be completed prior to submission:

•  Please allow adequate time for the online application process; submission deadlines cannot be extended. 

•  Personnel to be named as associates on a protocol must be identified in a master 'drop down' list in order for you to select associates during the protocol application process. Thus, personnel must be entered into the system to enable this option. At present the Personnel Qualifications (PQ) form will still be used to provide information about personnel; one form for each person (Principal Investigator [PI] included) named on the protocol must be submitted to the IACUC Office, before you attempt to enter a protocol online; please allow adequate time (at least 24 hours) for the PQ data for new people to be entered into the system; please submit one updated PQ form for all other personnel so that the IACUC can review their qualifications in concert with the newly submitted protocol. Please contact the IACUC Office if you have questions on this.

•  A password is required to allow access to the website; please contact 303-724- 1056 to obtain the password; anyone who will access the protocol (during development, during the review process or after approval) will need a password; the PI (even if someone else enters the data) will need a password to effect the final step in the submission.

•  The URL to be used for protocol submission is http://nimbus2.ucdenver.edu/protocols/

•  Once you enter a valid user name and password, any existing protocols on which you are associated will be listed. On the top left a box called "MY DASHBOARD" will be visible. Please click on that and choose the "Protocols for Animals" option. Navigate to "Protocols" and choose the "Create Protocol Requests" icon. Choose "Create an Original Request" [You will only be able to use the "create from an existing request" after you have a protocol approved through this online mechanism]. Please consult the printed help manual provided at the TOPAZ training sessions or contact the IACUC Office for more help.

•  Hazardous material information questionnaires will also still be in use initially, and can attached to the web based application [Please contact the IACUC Office if you encounter difficulties] or sent to the IACUC Office (e-mail attachment is acceptable).

TIPS

•  Please provide PQ forms for new personnel before entering a protocol.

•  Please provide PQ forms for all personnel named on protocols - prior to submission is preferred.

•  Please save your application frequently to avoid losing entered data as you become          familiar with the new application.

•  Please remember that only the PI can complete section J - the regulatory assurances - and make the final submission.

•  The IACUC Office will develop more detailed written instructions as use of the online system progresses but the form itself contains built in help features (click on the ? ) and help is also available by calling 303-724-1056.

POST APPROVAL MONITORING PROGRAM

Post approval monitoring (PAM) for animal protocols is aimed at improving the communication between animal researchers and the IACUC, and, preparing our animal program for the inspections performed by the USDA (United States Department of Agriculture), PHS (Public Health Service i.e. NIH funded research) and AAALAC (Association for Assessment and Accreditation of Laboratory Animal Care). Maintaining effective communication between the IACUC and animal researchers will help to keep our program AAALAC accredited, PHS and USDA approved and ensure the success of all animal research performed at our Institution.

The PAM process involves a brief meeting between the IACUC Research Monitor (designated with this responsibility by the IACUC) and the Principal Investigator of randomly selected protocols. During the meeting, the monitor will gather information about the work related to the protocol, as well as address questions or concerns about the program that the PI might have; because junior faculty, trainees and professional research assistants are often the ones performing the procedures, the PI is encouraged to invite the personnel affiliated with the protocol to participate in the meeting.

Specific objectives for this PAM system are:

•  To cooperatively compare the approved procedures and the day-to-day work, and direct any discrepancies to the amendment process so that the protocol will comply with PHS and USDA regulations.

•  To communicate to the researchers any changes in the PHS and USDA regulations, as well as the IACUC policies that must evolve to keep our program in compliance with them.

•  To communicate to the IACUC any ongoing problems with animal husbandry, facility operations, and program personnel related to the work that is approved in the protocol, so that the Committee can address the issues or facilitate a resolution.

A checklist will be distributed in advance of the visit so that the PI and affiliated personnel are aware of the issues that will be discussed. We believe that this monitoring will not only satisfy the requirements of our outside regulatory agencies, but will also help the IACUC to proactively solve problems and resolve issues before they adversely impact the important research conducted at our University.

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