New PI FAQ - Office of Animal Welfare

advertisement
Contacts and information for new investigators who use animals in
teaching, research, or testing at the University of Washington.
Contents
Office of Animal Welfare (OAW) at UW
Does your research require an IACUC protocol at the University of Washington?
Who can be the PI of an IACUC protocol at the University of Washington?
What animal work does not require a protocol?
Does your grant or contract require review by the OAW?
How many IACUC protocols do you need?
Timing your IACUC protocol submission
Rodent Health Monitoring Program for rodent imports
Animal Use Training Sessions (AUTS)
Environmental Health and Safety
Office of Sponsored Programs
Department administrators
Human Subjects Division
Department of Comparative Medicine
Veterinary Services
Embryonic Stem Cell Research Oversight
Drug Services
Transferring grants, research animals, and personnel
Prerequisites for IACUC protocol approval
Prerequisites for grant transfer
Prerequisites for animal transfer
2014-12-26 LBI
Page 1
Office of Animal Welfare (OAW) at UW:
http://depts.washington.edu/oawhome/
or request from oawsend@uw.edu
Forms
Calendar (best times to submit protocols)
How the UW approves protocols
Personnel requirements
Grants & Contracts
IACUC policies
Help with writing protocols
Help with animal numbers
Contacts
Find the New Protocol Form (Project Review Form, PRF) and the Environmental Enhancement Checklist
under "IACUC Forms" along with all of our other forms for renewals, addition of personnel, significant
changes, etc.
The OAW website has an IACUC calendar so you can know when the review is likely to happen. It also
has a good description of the process our IACUC uses for reviewing protocols ("Submission & Review").
Under "Personnel Requirements" on the OAW website you will find requirements for being on and
having an IACUC protocol.
The grant review process is explained under "Grants & Contracts" in the OAW site. Reviewers in the
OAW do a side-by-side review of all grants and contracts with the associated IACUC protocols to assure
concordance, and this must be done before a grant is awarded for competing awards and before a grant
is submitted for noncompeting awards (noncompeting renewals). Please be sure to leave our office
sufficient time for this review.
As you write your protocol, please feel free to call on any of the reviewers in our office. We're listed
under "Contacts" on the OAW site. You can reach us by phone at 206-685-7363.
Does your research require an IACUC protocol at the University of Washington?
Submit an IACUC protocol to OAW if you do research, teaching, or testing with live vertebrate animals,
and the activity is not included in any other domestic IACUC protocol. Any "born" or "hatched"
vertebrate organism qualifies as an animal and requires a protocol. "Hatched" means out of the egg or
chorion. If in doubt, contact a reviewer in OAW.
Who can be the PI of an IACUC protocol at the University of Washington?
Typically the PI of a protocol is a member of the faculty or senior professional staff with a strong tie to
the university who is responsible for the conduct of all persons on the protocol. A graduate student or
postdoctoral student cannot be a PI on a protocol. If in doubt please contact OAW before completing
your protocol form.
2014-12-26 LBI
Page 2
What animal work does not require a protocol?
If you receive tissue or blood from animals that were euthanized for completely unrelated reasons (e.g.,
slaughterhouse, or a colleague with an IACUC protocol), we consider this "incidental tissue" that does
not require a protocol. Any animals that were euthanized specifically for your project, or who require
changes in methodology for your project (e.g., larger in vivo blood draw so you can have a sample) must
have a protocol. In many cases changes like this can be added to your colleague's protocol. Studies in
which animals are simply observed without any disturbance at all (e.g., wildlife, zoo) may not require a
protocol. Any intervention that changes the behavior or physiology of the animal may require a
protocol (e.g., changing diet of zoo animal, diving among fish to count them).
Does your grant or contract require review by the OAW?
If your grant or contract or any subcontract involves research, teaching, or testing using live vertebrate
animals at any institution or location in the world you should send a copy of the grant as submitted to
the sponsor to OAW. If some of the live animal work is included on a UW protocol, please identify that
IACUC protocol in section AC-1A of the eGC-1 form. If some of the live animal work is included in an
IACUC protocol at a different institution (i.e., collaborator, subcontract, custom antibodies or custom
transgenic animals), identify that protocol in section AC-1B of the eGC-1 form. Animal work at a foreign
institution needs to be included in section AC-1C of the eGC-1. See additional instructions on form eGC1 section AC-1.
How many IACUC protocols do you need?
The University of Washington allows multiple grants to be included in one IACUC protocol as long as the
goals of the protocol are written broadly enough to encompass all grants. We encourage investigators
to maintain a single protocol that includes all grants in order to reduce the amount of paperwork you
have to do for annual renewals, new personnel, and so on. There are other good reasons not to
maintain multiple protocols, and you should contact a reviewer to discuss the issue if you think that it is
important to have more than one protocol. If you are transferring multiple grants, it is ok for you to
divide the protocol into sections as if there were multiple protocols, but we will still refer to it by one
protocol number.
Timing your IACUC protocol submission
Check the calendar for IACUC submission deadlines:
http://depts.washington.edu/oawhome/review-calendar/
Submit the protocol as soon as the science is complete to oawsend@uw.edu.
It is OK to submit your IACUC protocol even though you have not yet completed animal training, or
obtained all room assignments, or approvals from other offices such as OH, EH&S, or ESCRO. All of
these details must be completed before final approval, but parallel review is fine for these items.
Submit EH&S and ESCRO documents early in the process to prevent delays.
If you are transferring a grant that depends on your new UW protocol, be sure to allow time in OAW for
a side-by-side review of the grant and protocol before the protocol must be submitted to the
committee. Submit a copy of the grant along with the protocol. See Transferring grants, research
animals, and personnel below.
Consult a reviewer in OAW if you are uncertain about anything (see Contacts at the OAW website).
2014-12-26 LBI
Page 3
Rodent Health Monitoring Program for rodent imports:
https://depts.washington.edu/compmed/animal/import.html
UW NetId required
Animal Use Training Sessions (AUTS):
http://depts.washington.edu/auts/index.html
auts@uw.edu
Training requirements
Online courses
In-Person Courses
Certifications
Forms
Animal use manuals for mouse, rat, rabbit, pig
Access to animal facilities
Some training or certification is required before a protocol is approved or before personnel can be
added to a protocol.
Some other training or certification may be required before performing a procedure on live animals
without supervision.
Senior personnel on a protocol who will supervise research but never personally handle animals may be
exempt from some hands-on species specific handling classes, but they may still be required to take
online species specific training. Contact a reviewer or AUTS to find out.
Animal procedures that follow the guidelines in our lab manuals will seldom elicit comments or
corrections from the IACUC or vet staff.
Environmental Health and Safety:
http://www.ehs.washington.edu/
Occupational Health review is required for all protocols including animals, and all protocol personnel
must enroll in the Occupational Health Program by completing the Animal Use Medical Screening Form.
The form and instructions can be found at Animal Use Medical Screening (AUMS).
If your project involves administration of bio-hazardous agents, submit an application for Biological Use
Authorization (BUA) to EH&S as early as possible in the process. Projects involving viruses, pathogens,
or recombinant DNA will likely have to be reviewed by the Institutional Biosafety Committee (IBC) in a
monthly meeting, and the IACUC will not be able to approve your protocol until after it has been
approved by the IBC and your BUA is issued by the biosafety officers. Forms and instructions can be
found at UW EH&S - Biological Use Authorization.
Please note that any animal work referred to in your BUA must match the animal work that is submitted
in your IACUC protocol. Biosafety officers in EH&S compare the BUA and IACUC protocol to ensure that
the IBC does not approve a hazard for animal work that is not proposed in your IACUC protocol. For
example, if your IACUC protocol proposes the use of Adeno-associated viral vectors for administering
2014-12-26 LBI
Page 4
genes to animals, be sure to list these and no other vectors, such as lentiviruses, in the animal-use
section of your BUA.
Guide for New PIs working with biohazards:
http://www.ehs.washington.edu/manuals/piguide.pdf
Direct line to biosafety officers:
ehsbio@uw.edu
Office of Sponsored Programs:
http://www.washington.edu/research/osp/
Information about obtaining or transferring grants or contracts to the University of Washington.
System to Administer Grants Electronically (SAGE, requires UW NetId):
https://ucs.admin.washington.edu/era/uwnetid/sage/list.aspx
Department administrators are too numerous to list here, but your department's administrators
should be in contact with you already. They will help you create a form called "eGC-1" that is essential
for having any grant or contract funded at, or transferred to, the University of Washington. The eGC-1 is
created using SAGE (see immediately above). They will also help you get a UW NetId.
Human Subjects Division
http://www.washington.edu/research/hsd/
Department of Comparative Medicine
http://depts.washington.edu/compmed/
Animal housing and procedure locations and assignments
Animal quarantine
Animal purchases and billings
Training
Transgenic Resources and other services
Attending Veterinarian: Dr. Thea Brabb thea@uw.edu
Associate Attending Veterinarian: Dr. Molly Lucas mklucas@uw.edu
Rodent health monitoring and imports: Dr. Susan Dowling sdowling@uw.edu
Veterinary Services
https://depts.washington.edu/compmed/veterinary/index.html
UW NetId required
Veterinary care and protocol review
Vet services review help: vsreview@uw.edu
Embryonic Stem Cell Research Oversight
http://www.washington.edu/research/?page=escro
ESCRO approval must be secured prior to IACUC approval for all protocols that include the
administration of embryonic or induced pluripotent human stem cells to animals.
2014-12-26 LBI
Page 5
Drug Services
http://depts.washington.edu/drugsvcs/home/
Obtain research pharmaceuticals
Information on licensing
Transferring grants, research animals, and personnel
See our website for a description of the grant review process in the OAW:
http://depts.washington.edu/oawhome/grants-contracts/
Transfers of grants, animals, and personnel must happen in a particular sequence in order to comply
with the laws and regulations regarding such transfers, and that sequence may not be the most
convenient one for you or parallel your priorities. We can help you through this. Needs vary, so the
best plan is for you to contact an OAW reviewer early in the process to discuss your specific needs. Our
reviewers are experienced in transferring grants, contracts, research animals, and personnel and they
can help you find an optimal sequence that is within the regulations.
For example, your priority may be to get your animals transferred so they can begin their time in
quarantine. However, before you can transfer them you need to have a way to pay per diem
costs, and that may require that you transfer your grant first. Before you can transfer your
grant, you have to have an approved IACUC protocol that includes all experiments proposed in
your grant, and your grant and protocol will have to be reviewed for concordance before
approval of either the grant transfer or the protocol. Furthermore, all animals arriving at the
University of Washington must be transferred to an approved IACUC protocol that includes the
rationale and procedures of the experiments that will use them. If your research involves
potentially bio-hazardous agents such as pathogenic organisms, recombinant DNA, or viral
vectors, this use may require prior approval by the Institutional Biosafety Committee (IBC)
before your IACUC protocol can be approved, and that committee meets only once per month.
The IACUC can't give contingent approval of the IACUC protocol before your BUA is approved or
other requirements are met -- the laws and regulations exclude contingent approval.
Certain short-cuts that seem reasonable may not be possible within the regulations. Your
approved IACUC protocol must include all experiments for all years of your grant before the
grant can be transferred. A simple protocol that includes only a small subset of the experiments
is not sufficient to transfer the grant. However, a small "starter" protocol may be possible if you
have alternative funding, such as startup money from your department or school. In that case,
we can work with you to get your animals and personnel transferred while you write a
"significant change" to your protocol that adds all of the remaining experiments. The grant can
then be transferred after you arrive at UW and set up your lab.
We can defer some of your hands-on training until you are actually here to take it, but the
training must be scheduled before you can order new animals.
Provide OAW a copy of your grant as it was submitted to the sponsor (i.e., all form pages) so our grant
reviewers can do a side-by-side comparison of the grant and your new protocol. Reviewers will make
sure that all experiments that are described in the grant are included in the new protocol. There are
two exceptions to this for a grant transfer: (1) Omit experiments that have already been completed.
2014-12-26 LBI
Page 6
Attach a note that states what experiments have already been completed so our grant reviewers don't
have to ask why you omitted them from the protocol. (2) Include experiments as you now intend to do
them rather than the way they were written in the grant. Attach a note that explains that you have
purposely decided to make a change. Any discrepancies between the grant and the protocol will be
reported to the sponsor in the approval letter.
It is important to have this side-by-side review completed in our office BEFORE we send your protocol
for review by the IACUC. Our reviewers often find confusions or errors that need to be cleaned up
before the protocol is submitted. If the grant review isn't done until AFTER the protocol is approved,
you may have to get a significant change approved to clear up the errors before we can transfer the
grant.
Prerequisites for IACUC protocol approval:
IBC/Biosafety approval
ESCRO approval
Occupational Health review and recommendations
Training of key personnel
Approval of all animal use rooms (if outside the vivarium)
IACUC and veterinary review of the protocol
Prerequisites for grant transfer:
Approved IACUC protocol that includes all proposed experiments for all years of the grant
Review for concordance between grant and protocol(s) by OAW
Approval of form eGC-1 by all reviewers and OSP
Prerequisites for animal transfer:
Approved IACUC protocol that includes a rationale and at least some experiments for the
animals being transferred
Consultation with Comparative Medicine regarding health reports and quarantine
2014-12-26 LBI
Page 7
Download