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The Indiana University Policy on Animal Care and Use is as follows:
Fulfillment of Indiana University teaching and research missions requires a variety of approaches, among which is the use of animals. Living animals are used only when there is no valid alternative to their use, or when use may be required by law in a particular experiment or test.
Animals, in order to yield valid results, must be healthy and comfortable. For these reasons, as well as for humaneness, it is the policy of Indiana University that animals required for teaching and research shall be housed, cared for, and used in accordance with the highest standards of comfort and cleanliness, as required by regulations and guidelines of the Animal Welfare Act, the National Institutes of Health, and the Public Health Service.
Federal assurances require that Indiana University provide for the humane care and use of all animals used in research or instruction. Indiana University-Purdue University Indianapolis maintains American Association for Accreditation of Laboratory Animal Care (AAALAC) approved facilities throughout the campus. Each AAALAC approved facility maintains its own federal assurance with the Public Health Service (PHS)/National Institutes of Health (NIH) Office of Laboratory Animal Welfare (OLAW) and has its own United States Department of Agriculture (USDA) registration. The Schools of Dentistry, Medicine, and Science maintain federally-prescribed Institutional Animal Care and Use Committees (IACUCs) which are responsible for the review and approval of protocols describing procedures to be used for research or instruction involving animals. The campus Animal Care Coordinating Committee is responsible for coordinating matters related to animal care and experimentation throughout the campus. School of Medicine faculty should consult with the School of Medicine Director, Laboratory Animal Resource Center (LARC), or the School of Medicine IACUC Chair for assistance in specific matters. Faculty in the Schools of Dentistry and Science should contact the chair of their school's IACUC.
B. RESEARCH REQUIRING REVIEW
IUPUI and federal regulations require that all proposals involving vertebrate
animals in teaching and research activities be reviewed and approved by the
appropriate Institutional Animal Care and Use Committee (IACUC) before such
studies are initiated to determine that the use of animals is appropriate
and that the proposed methods minimize pain and discomfort.
C.
PROTOCOL REVIEW PROCESS
1. Instructions
and Forms for Research Submissions
Animal Care and Use Application Packets include instructions and PI responsibilities
for conducting research. These forms may be obtained from your school as indicated
below:
2.
Committee Reviews
The Schools of Dentistry,
Medicine, and Science each have an IACUC which reviews proposed research from
their respective areas. Please check with your School for deadlines and the
appropriate number of copies to submit.
3.
Committee Actions
The review committee may take one of four actions in regard to proposed research:
a)
Final Approval - The PI may commence the research only after receiving
written approval indicated by a signed copy of the "Animal Care and Use
Application" with a cover letter outlining the additional responsibilities
for conducting research at IUPUI.
b) Provisional Approval - The PI must respond in writing
to provisions requested by the committee and receive
final approval prior to initiating the research.
c) Tabled - Deferred for reconsideration by committee at
a subsequent meeting after PI has responded to modifications requested by
the committee.
d) Denied - The PI will be notified in writing of reasons
for disapproval.
Upon completion of the review, the investigator will receive a response from
the IACUC shortly after the meeting. Any questions raised by the committee
should be responded to in writing promptly in order for the project to be
reviewed at the next committee meeting. However, all provisions must be responded
to within sixty (60) days or the project may be withdrawn from consideration
(provisionally approved or tabled studies). No work may be initiated until
written final approval is received from the IACUC.
4. Requirements
of Funding Agencies
Most funding agencies request that verification of IACUC approval accompany
the application or proposal; however, some agencies may allow the approval
to be submitted within 60 days in the event that IACUC approval is not in
place at the time of submission. Although the time interval for review process
varies for the different committees, often at least four or more weeks must
be allowed to obtain the required review and approval. Therefore, timely submission
of the research application is essential. The IACUC is responsible for determining
that the use of animals is proper and appropriate.
5.
Hazardous Chemicals
If the research involves infectious materials or any chemicals, contact Environmental
Health & Safety at 274-2005.
6.
Radiation and/or Radioactivity
If the study involves the use of radiation and/or radioactivity, IACUC approval
may be contingent upon approval from the appropriate radiation committee.
Further information and sample risk statements for radiation exposure may
be obtained from the Radiation Safety office at 274-4797.
D.
RESPONSIBILITIES OF THE INVESTIGATOR
1. Amendments and Continuing Reviews
Any change in an approved protocol must be submitted via an amendment form
by the principal investigator. The investigator must receive written approval
by the IACUC prior to the initiation of the change.
A status report must be filed with the IACUC on at least an annual basis.
Each school will generate these reports for your completion. This form must
be completed even if the study was never initiated or was terminated for any
reason since the last review.
2.
File Maintenance
It is important for investigator to keep copies of all research-related documents
submitted to the committees. For audit purposes, these documents must be kept
for at least three (3) years after terminating the study.
3.
Training/Experience Documentation
Federal law requires that all personnel be trained prior
to initiating projects with animals. The appropriate Animal Care and Use Committee
chair or veterinarian should be contacted for assistance in meeting the training
requirements.
E.
RESEARCH CONDUCTED AT OTHER CAMPUSES OR INSTITUTIONS
1. Proposal Routing and Protocol Review Procedures
Research studies are normally reviewed on a campus specific basis, with the
exception of the School of Medicine. All School of Medicine protocols, including
the Regional Centers for Medical Education, will be reviewed by the School
of Medicine IACUC. Campus specific is defined as the campus where the faculty
applicant is located. Other variables may require that a decision to modify
their normal procedure be made by the campus research administration offices
representing the campuses involved (see Appendix G).
2.
Research Conducted at Other Campuses or Institutions
If it is anticipated that a research project may involve faculty, animals,
facilities, and other resources which are located on more than one campus
or at another institution, the review board which is located on the same campus
or institution as the principal investigator is responsible for the review.
The investigator is responsible for being certain that the review board(s)
on the other involved campus(es) is provided the documentation it requires
for review and informational purposes. If no objections/questions are raised
by the other campus review board(s), the originating campus will be considered
as having given the project approval. It will also be responsible for continuing
reviews of the project.
In cases where the principal investigator's appointment is on more than one
of the involved campuses, the campus where the greatest portion of the appointment
is located will be the responsible campus. In the event the appointment is
divided 50-50 between two participating campuses, the originating unit's dean
will determine the responsible campus, with that same campus being the responsible
campus for all future similar projects under the same principal investigator's
direction.
F. ANIMAL HOUSING
Federal, State, Department of Agriculture, and American Association for Accreditation
of Laboratory Animal Care (AAALAC) regulations prohibit housing animals in
any area which is not approved for that purpose. Violations of these regulations
could bring serious sanctions to the institution and they will be reported
to the IACUC, which is responsible for monitoring and enforcing these regulations.
Violations of these regulations could lead to withdrawal of approval to conduct
animal research.
G. PURCHASE OF ANIMALS
Animals may only be purchased for use in an approved protocol and may only
be purchased, or otherwise obtained through the animal resource center within
each school. If special arrangements are required by the nature of the research,
they must be approved by the animal resource center and by the appropriate
IACUC. These rules apply regardless of the source of funding.
H. TRANSFER OF ANIMALS TO A NEW PROTOCOL OR INVESTIGATOR
Regulatory agencies require that the staff of the research animal resource
center be able to identify the experimental protocol to which each animal
is assigned. In addition, in order to prepare reports required by the Department
of Agriculture, it is necessary that the staff of the animal resource center
be aware of the specific use of all animals. Therefore, the principal investigator
must notify the animal resource center if animals will be transferred for
use by a different investigator or to a different protocol from that for which
they were originally ordered prior to the transfer. Animals
may only be transferred for use in an approved protocol. These regulations
apply regardless of the source of funding.