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ANIMAL
PROGRAM ORIENTATION
All
new personnel (those with appointments beginning May 1 st
2008 ) 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 and 3 rd Tuesdays)
Orientation will cover: Requirements for conduct of research
involving animals; Introduction to the IACUC; Protocols; Training/Personnel
Qualifications Forms; Occupational Health Program; Web Animal
Ordering; Billing; Animal Facility - access; PPE; appropriate
behavior
Prior to activation of badge access to the animal facility,
a walk through orientation to the animal facility is required.
This will occur only after personnel have completed required
Personnel Qualifications to perform procedures on animals,
Occupational Health Program enrolment, Program Orientation
and are 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 Orientation; begin the enrolment
in the occupational health program; generate their personnel
qualifications form and submit to the IACUC Office (F489).
Please
contact the IACUC Office (303-724-1056) to sign up for orientation
or additional information.
OCTOBER sessions will be:
October 7th: Ed 2 North - Room 2201 - computer labs A/B (9am - 11am)
October 23rd: Ed 2 North - Classroom 2301 - (1pm - 3pm)
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.uchsc.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
The
IACUC is implementing a post approval monitoring (PAM) system
for animal protocols 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, we encourage
the PI to invite the personnel affiliated with the protocol
to participate in the meeting.
Our
specific objectives for this PAM system are:
To cooperatively compare the approved procedures and the day-to-day
work, and direct any discrepancies to our 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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