Here we hope to provide
you with the basics regarding vertebrate animals and their use in
research. All research and teaching
acvities at Universities, nationwide, are subject to certain federal
guidelines as set forth by the Animal Welfare Act (1966, and 1985 most
recent update) and the Guide for the
Care and Use of Laboratory Animals (NRC, 1996). Only mammals,
and only certain mammals at that, are what is known as "covered
species", meaning they have special requirements because they have been
identified in the Animal Welfare Act. But, any vertebrate under
study using Federal funds (or even just equipment purchased with
Federal funds) requires a
protocol as established by The Guide.
The Federal government charged univeristies with creating Institutional
Animal Care and Use Committees and gave them the task of ensuring that
these guidelines are met. Each univeristy should have an IACUC
committee if vertebrates are used in research or teaching activities.
Any research
or teaching activity using vertebrate species should have an IACUC
protocol
in place prior to the initiation of the activity.
Because the
grants
and contracts of MLML are administered by SJSU Foundation, SJSU's
IACUC
reviews and approves MLML animal protocols. For students from
home
campuses other than SJSU, we are working on Memoranda of Understanding
(MOUs)
that would allow SJSU's IACUC to be the body that receives and approves
your
protocol. If SJSU accepts it, then your home campus would be
bound
by the MOU to also accept it and you need only send a copy of the
complete protocol and approval letter to your home campus IACUC for
their records. This will prevent you from having to apply twice,
as several students are faced with presently.
Currently, the MLML representative on the SJSU IACUC is Dr. Lara Ferry-Graham.
Lara tries to make sure that the committee understands the nature
of the animal work conducted at MLML, and to ensure that the
perspective of a field- and lab-based marine animal researcher is
represented in the IACUC's decision making process. You can send
questions to her, or even drafts
of proposals if you would like comments, especially graduate students
who are new to the process.
Where else to turn for help? You can contact Larry Young at
Animal Care at SJSU (408-924-4929 or lyoung@science.sjsu.edu).
He oversees the day to day business of the IACUC and can help to guide
you through the process. Completed
applications are submitted to Larry. He can typically faciliate
electronic submissions, which allows him to send it out to the
committee more quickly. His
extended zip at SJSU is 0100 for
campus mail. Snail mail (which is faster than campus mail most of
the time) is Animal Care, DH-244, San
Jose State University, One
Washington Square, San Jose, CA 95192-0100. FAX
408-924-4840.
Jump straight to the forms for download
FAQs:
Why do we really need an IACUC?
It would be nice if bodies like the IACUC were unnecessary.
Unfortunately, a handful of unethical scientists made that an
impossibility. The public is demanding justification for the use
of animals in
research, and assurance that the studies are truly necessary and the
animals
are well treated. Federal funding agencies have answered that cry
by demanding the same of their applicants. IACUC protocols are
now
simply a part of the grant application, and general research, process.
Why do I need IACUC permission to do my research if I already have a
collecting permit?
The collecting permit, and the like,
ensures only that your taking of the animal does not hurt natural
populations of that animal. IACUC is charged with ensuring that
you take and otherwise use the animal humanely. More
specifically, the USDA has
recently charged the IACUC with ensuring the three "R's" are met
wherever
possible. Reduction in the numbers
of animals used, Refinement of techniques to minimize pain or
distress, or Replacement with non-animal techniques. The
IACUC also works to make sure that the experiments proposed do not
unnecessarily Replicate other experiments, thereby wasting
animal life. If you are working on a vertebrate animal at MLML,
or your work impacts vertebrate animals, you need an approved IACUC
protocol prior to beginning the work. You also need approval if
you are teaching a class that involves vertebrate animals.
Who is the IACUC and how can I be sure that they can really evaluate
MY proposal effectively?
At SJSU the IACUC is a body composed of
largely scientists who use animals in their own research. These
include both laboratory and field biologists, marine and terrestrial,
and we have a safety officer. The IACUC is also required to have
non-scientists and non-university members, as a sort of checks and
balances.
The IACUC is chaired by an member of the committee and is
overseen
by the Institutional Official, which is currently housed in Graduate
Studies
at SJSU. The
committee understands, firsthand, that studies of animals are needed
and your proposal is not going to be unfairly judged just because you
want
to use animals. They do not aim to be
a roadblock between you and your research. Note that there are
many valid reasons for animal research and the committee will readily
recognize those if you take the time to explain and document them.
However, the committee does not and cannot have expertise in every area
of animal research, especially marine animal research. Much of
the deliberation
about proposals occurs at meetings, but if I am not present (which
happens,
due to scheduling conflicts), then simple questions will go unanswered
until
you, the PI, are contacted and respond directly. As an MLML'er,
there
a things you can add to your application that will help ensure that the
time
spent in the review process is not lengthened by having to ask you
silly
questions and then wait for answers that may seem obvious to you.
This
means being sure to include things like the front and back of your
CDF&G
permit, and adding a few extra sentences in your narrative to note the
scope
of your permit(s), the expemption(s) you have been allowed, and what
this
translates into in terms of the numbers and kinds of animals that you
can
take in a collecting session or in a year, where you can legitimately
collect,
how this matches up with your proposed sampling design, and so on.
How will the IACUC find out I am doing animal research if I don't
tell them? What are the consequences of non-compliance?
IACUC must conduct semi-annual inspections of the sites that it
is charged with overseeing. At MLML, the Aquarium Room and the
Sea Lion facility (SLEWTHS) are inspected at this time. Note that
the IACUC itself is also is subject to both internal and external
review
every six months which includes unannounced inspections of the IACUC
records and checks of compliance by the USDA. If the USDA officer
finds missing pieces then SJSU will be cited for them. MLML too
can be cited in this way by the USDA for violations. The
point of the IACUC inspection is to avoid and prevent citations. If
citations are not corrected by the time noted, facilities can (and have
been at SJSU) shut down. At this point, federal funding to all
researchers within the facility (i.e., MLML as a whole) is also in
jeopardy. Federal agencies like NSF and NIH require compliance
with IACUC. For these agencies, you have to have an IACUC
application in place to even proceed with a grant application.
SJSU Foundation is now routinely screening all grant applications
for any federal funding source and will not allow you to use your
money, once awarded, until an approved IACUC protocol is in place.
More practically, if you are a graduate student, you may be
required to omit any work from your thesis or subsequent publications
that was collected prior to IACUC approval, and you can be denied
graduation by Graduate Studies if IACUC approval was never granted.
Note that if you are a student from a home campus other than
SJSU, you are still bound by SJSU rules because of the source of funds
and equipment. Again, this is why we are so actively pursueing
the MOUs with the other campuses. Once your SJSU IACUC
application is approved, you should be sure to route a copy to your
home campus IACUC so that your graduation is not hindered in any way by
this process.
What if I am getting dead samples from some other source and am not
killing the animals myself?
IACUC has a "short form" for this. It is a simple one-page
form. If you are collecting dead or stranded animals, or animals
that are part of a commercial fishing operation, for example, the form
is straight forward. Just provide the sources or locations and
copies
of any necessary permits. If you are using animals collected by
another
research institution or individual, you should provide assurance that
there
is IACUC approval in place at that institution by providing the PI
name,
protocol number and dates that it is valid at the very least. If
the
animals come from a study by Fish and Game or some "exempt" agency,
you'd
just need to explain that to the committee and provide assurances that
the
animals are/were being killed as humanely as possible. If it is
simply
the use of animal parts, like an otolith archive, then it should be
fairly
easy to explain. In general, using animals taken as part of
another
study is a great way to extend their scientific value, which IACUC
fully
supports.
Do I need to submit a protocol for each grant?
The answer to this is "it depends". If the grants are very
similar in nature (i.e., the same study in two locations), then you may
be able to combine them under one IACUC protocol. If they are
very different, then you are likely going to need different protocols
to adequately explain the different techniques to be employed.
This can be to your advantage. For example, if one protocol
expires, then you (hopefully) still have the second in place which
prevents your research program from shutting down entirely.
How long are proposals good for?
You can define the time limit of your study up to a maximum of three
years. Each year you will be asked to provide an annual report to
keep your protocol in good standing. You will be sent a reminder
from
the IACUC for this report.
Forms for download (word docs):
Standard Protocol application
Pain and Distress Guidelines
Short-form for tissue only
Short-form for observational studies
(recommended, not required unless you are entering an area that
requires special permits or permission)
Short-form for invertebrate studies
(recommended, not required)
Sample Protocol Narratives and Annual Reports (word and pdf docs):
NOTE: We provide these to give you some example of
well-received protocols. Each of these still may have had minor
issues needing clarification prior to acceptance. Please keep in
mind that every project is different, and the composition of the IACUC
changes over time, so new and valid questions
may arise in
response to your application even if you follow these templates exactly.
Marine Ichthyology Classroom Protocol (PIs: Cailliet, Ferry-Graham)
Functional Morphology of Prey
Capture in Marine Fishes and Elasmobranchs (PI: Ferry-Graham)
Aspects
of Reproduction in the Eelpouts, Family Zoarcidae (PI:
Ferry-Graham)
Embryology, reproductive biology, and age
and growth of Pacific sharks, skates, and rays (PI: Cailliet, Flammang)
Diving and Hematology of the
Common Murre in Monterey Bay (PIs: Harvey, Nevins)
Annual Report - Diving and
Hematology of the Common Murre in Monterey Bay (PIs: Harvey, Nevins)
Other sources of useful information:
A more complete description of the role
of the IACUC as set forth by the USDA can be found here: http://www.nal.usda.gov/awic/pubs/IACUC/iacuc.html
Association for Assessment and Accreditation of Laboratory Animal Care
International:
http://www.aaalac.org/
NIH Animal Care: http://oacu.od.nih.gov/
Office of Laboratory Animal Welfare: http://grants.nih.gov/grants/olaw/
USDA and Animal Welfare Act: http://www.aphis.usda.gov/ac/
USDA policies: http://www.aphis.usda.gov/ac/polmanpdf.html
(accepted practices of euthanasia: http://www.nal.usda.gov/awic/pubs/noawicpubs/avmaeuth.htm)
Animal Alternatives: http://altweb.jhsph.edu/
Department of the Interior - Endangered Species Act: http://endangered.fws.gov/
International Regulations for Animal Importation and Use: http://www.cites.org/
CA Fish and Game: http://www.dfg.ca.gov/index.html
Use of Controlled Substances: http://www.usdoj.gov/dea/
Fishes: http://www.nal.usda.gov/awic/pubs/Fishwelfare/iacuc.htm#euth
Marine Mammals: http://www.nmfs.noaa.gov/prot_res/laws/MMPA/MMPA.html
Migratory Birds: http://migratorybirds.fws.gov/intrnltr/treatlaw.html
Also remember to check the website(s) of the scientific societies to
which
you belong for guidelines on animal use, you can provide this
information
as evidence for standard acceptable treatment, care, and use:
Mammal Society: http://www.mammalsociety.org/
(Mammal studies)
Society for the Study of Reptiles and Amphibians: http://www.ssarherps.org/
(Amphibians
and Reptile studies)
American Society of Ichthyologists and Herpetologists: http://www.asih.org/ (Fish studies)
Page created and maintained by Lara Ferry-Graham
last update 24 April 2006