Full Research or Teaching Protocol
Application
PI must submit an application for each activity. Protocols must be approved before
any work can commence, and work must cease if a protocol is determined to be out of
compliance.
Approval Period and post approval monitoring
Approvals are valid for 3 years.
Modifications to Approved Protocols
Significant changes to an approved protocol must be reviewed by IACUC by submitting
an application (above). Significant changes includes changes:
- from nonsurvival to survival surgery
- resulting in greater pain, distress, or degree of invasiveness
- in housing and or use of animals in a location that is not part of the animal program
overseen by the IACUC
- in species
- in study objectives
- in Principal Investigator (PI)
- that impact personnel safety
Observation Only Project
The Animal Welfare Act gives the IACUC responsibility to review activities related
to the care and use of animals and determine that the proposed activities are in accordance
with the regulations. “Field study means a study conducted on free-living wild animals in their natural
habitat. However, this term excludes any study that involves an invasive procedure,
harms, or materially alters the behavior of an animal under study” (9 CFR 1.1). Field studies meeting this definition are exempt from the requirement to have an
approved IACUC protocol (9 CFR 2.31(d)(1)). “Studies with the potential to impact the health or safety of personnel (Guide page 18) or the animal’s biology, behavior, ecology or other species may need IACUC oversight,
even if described as purely observational.” (PHS Policy on Humane Care and Use of Laboratory Animals).
A PI who believes their research or teaching project qualifies as exempt status will
complete the "Request for Review of Observational Study" form and submit to the IACUC for review (iacuc@atu.edu).
IACUC Chair will review, issue decision, and update the committee at the next convened
meeting. If the Chair has questions or wishes to have another reviewer, they will
contact relevant member(s) of the IACUC.
- If the IACUC Chair agrees that the project qualifies as exempt, they will issue a
letter documenting that decision.
- If the IACUC Chair does not agree that the project qualifies as exempt, the PI is
required to submit a "Full Protocol" application for consideration.
Field studies that may qualify for exemption include observation, photography, collection
of feces.
Examples of non-exempt studies (requires full protocol review)
- Field studies that involve capturing and handing (including trapping, banding, darting)
- Procedures where human presence impacts animal behavior (e.g. habitat alteration,
offering food or nesting choices, calling, or baiting)
- Studies using electrofishing as a survey method
The PI in an observation only study is still responsible for:
- Any animal or land-use permits that may be required by federal, state, or local agencies
- Ensuring that all personnel, including students and volunteers, involved in your project
receive proper training appropriate to the nature and scope of the study to ensure
that they health and safety of animals and persons in the field are not compromised
- Notifying the IACUC if a significant change to the project occurs - passive observation
can easily transition into disruption. The PI must recognize when this point is reached,
stop work, and apply for IACUC approval.