5. After approval
5.1 Site inspections
Each facility or program that uses animals must be inspected by the IACUC
at least once every six months. The IACUC may suspend a project that violates
University requirements.
5.2 Continuing review
Each project requires continuing review, typically annual review, although
the IACUC may review projects at other times as well, if circumstances
warrant. The IACUC may ask investigators to revise a project if it determines
that animals may be suffering unnecessarily.
The IACUC provides the investigator with a form that explains what information
needs to be supplied for the continuing review. If the investigator does
not respond to the final notice, the IACUC will classify the study as
"inactive."
A researcher who fails to comply with the continuing review process must
reapply for IACUC approval. If the approval period for a project expires
before the IACUC has reapproved it, the project has "lapsed." The IACUC
must report such lapses to the National Institutes of Health's Office
for Lab Animal Welfare (OLAW). Lapses are extremely difficult to justify
to regulatory and funding agencies and may result in institutional corrective
action.
5.3 Reapplication after three years
Federal regulations allow the IACUC to approve a project for a maximum
of three years. If the research is to continue past this period, the investigator
must submit and obtain IACUC approval of a new Animal Usage Form before
the old one expires. The IACUC notifies the investigator two months before
the expiration date.
5.4 Completing a project
The investigator must notify the IACUC in writing when a project concludes.
The IACUC will reclassify the project as completed.
5.5 Changing research protocols
Any change that affects the animals involved in a project requires
prior IACUC approval. Two kinds of changes are especially common, and
researchers can request IACUC approval for them by writing a letter
to the IACUC referencing the appropriate protocol number.
For other changes that affect the animals in a project, researchers
must request IACUC approval by submitting a written request. If the
change is minor, investigators should send a letter that refers to the
project's protocol number and justifies the new protocol. Substantial
changes, which can include changes in the number of animal subjects,
require submission of a new Animal Usage Form.
5.6 Reporting violations and other problems
Investigators must adhere to the protocol approved by the IACUC. A
departure from that protocol is a violation of IACUC guidelines and
should be reported to the Research Subjects Protection Programs immediately.
General concerns about the welfare of animals used by the University
should also be reported, even if the IACUC has approved the project
in which the animals are used. Federal regulations require the IACUC
to investigate all legitimate concerns.
Office of Animal Welfare
Phone: 612-626-2126
iacuc@umn.edu
5.7 Reporting health-related incidents
If anyone
suffers an injury (such as an animal bite) or is exposed to a hazardous
biological or chemical agent during the course of a project, the supervisor
and if necessary the Department of Environmental
Health and Safety should be contacted immediately.
5.8 Records retention
Investigators should maintain
a file of all documents concerning the use of animals. The principal investigator's
records should be the mirror image of the IACUC's: where the IACUC holds
an original, the principal investigator should hold a copy, and vice versa.
The documents that researchers should have on file include:
- a copy of the original application submitted to the IACUC,
- an original of the IACUC's response,
- a copy of responses to the IACUC's stipulations or requests for
additional information,
- the original notice of final approval,
- a copy of the Certification of Approval sent by the IACUC to any
funding agencies,
- copies or originals of all other correspondence with the IACUC,
- copies of completed continuing review forms and attachments,
- the original notice of renewal of approval and certification, where
applicable, and
- copies of any inspection reports and follow-up action.
The investigator should retain these records for at least three years,
although every discipline has its own retention standards. In some fields,
researchers may need to retain their records for as long as seven years.
These records are subject to inspection by federal authorities. Sanctions
for incomplete or nonexistent records include suspension of funding,
fines, exclusion from future funding, and suspension of laboratory access.
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