Resources
Forms
- Application for Initial and De Novo IACUC Review
- Supplemental Form A: Study Team Training and Qualification Summary
- Supplemental Form B: Principal Investigator Certification (PDF)
- Supplemental Form C: Animal Surgical Procedures
- Supplemental Form D: Use of Biological Materials, Chemicals, Drugs, Hazardous Agents, or Other Substances in Animal Studies
- Supplemental From E: Field Work and Wildlife Studies
- Supplemental Form F: Teaching and Course Activities Involving Live Animals
- IACUC Amendment Form
- IACUC Personnel Only Amendment Form
- IACUC Amendment Attestation Form (PDF)
- IACUC Unexpected/Adverse Event Reporting Form
- Supplier Fish Procurement Form
- Wild Fish Procurement Form
91ÖÆƬ³§ Resources
- Guidance for Completing the Application for Initial and De Novo IACUC Review (PDF)
- Guidance for Field Work and Wildlife Studies (PDF)
- Guidance for Course Instructors (PDF)
- Protocol Review Flow Chart (PDF)
- CITI Training Instructions
- Behavior Core Website
- Zebrafish Education and Research Facility
- Responsible Conduct of Research (RCR) Training
External Resources
Meeting Schedule
The IACUC meets on the third Thursday of every month from 8–10 a.m.
If you are submitting a protocol to be reviewed at a convened IACUC meeting, the complete submission must be received at least 14 days prior to the scheduled meeting date. Submissions arriving after the submission deadlines above will be reviewed at the next scheduled meeting.
For more information about submission reviews and timelines, please refer to the Protocol Review Flowcharts above and the FAQ section below.
FAQ
What I should be aware of before using vertebrate animals in research and teaching at 91ÖÆƬ³§?
No work with vertebrate animals will be conducted on or off campus without an approved protocol on file with the IACUC. This includes grant-funded research projects and teaching activities that seek to use vertebrate animals in the classroom or in the field.
Communication with the IACUC and the director of Animal Care is also required to ensure the proposed species can be housed safely under optimal conditions for maintaining health and security of the animals.
- Current housing systems are designated for maintaining mice, rats, zebrafish, and certain species of fish at the Marine Science Center.
- Any proposal inquiring about the use of species not currently housed on campus must be reviewed by the IACUC to determine whether the facilities are adequate for the proposed species.
- Field studies also require IACUC review and approval to ensure that potentially invasive procedures are humane and personnel are trained to minimize stress on animals in the wild. Species choice may require additional permits if the species is federally or state-listed as endangered or protected.
Who is the IACUC and what regulations does it enforce?
The IACUC is composed of members from the research community on campus, the attending veterinarian, a community member not affiliated with 91ÖÆƬ³§, and a non-scientist. This composition ensures a wide range of viewpoints, both scientific and non-scientific, are involved in the review of all protocols presented to the committee.
The IACUC reports to the Office of Laboratory Animal Welfare (OLAW) and the U.S. Department of Agriculture (USDA), and follows the guidelines established by the Public Health Service to ensure all activities involving animals are approved by the attending veterinarian and the committee.
Who is responsible for overseeing the use of vertebrate animals in research and teaching at 91ÖÆƬ³§?
The IACUC reviews all activities conducted on or off campus involving live vertebrate animals. This includes research and teaching activities that require the use of:
- Laboratory animals housed at 91ÖÆƬ³§ (e.g., mice, rats, zebrafish).
- Vertebrate animals captured or handled in the field (e.g., amphibians, birds, fish, mammals, reptiles).
- Other non-laboratory vertebrate animals brought into the facility for research or teaching.
What are the different levels of IACUC review?
There are four levels of reviews.
Pre-Review
The Compliance Coordinator conducts an initial assessment to ensure the submission is complete and contains all necessary information before a formal IACUC evaluation.
Administrative Review
Managed by the Compliance Coordinator with committee input for minor amendments (e.g., key personnel changes that do not involve a change to the PI), progress reports, and study closures. This process streamlines approvals for straightforward changes.
Designated Member Review (DMR)
Two qualified IACUC members review the protocol. DMR is typically chosen for less complex procedures with minimal impact on animal welfare, but may also be acceptable for more complex protocols (e.g., involving Pain Category D or E procedures) if the PI and IACUC both have prior experience with the procedures and the committee is confident in the procedures being performed.
Full Committee Review (FCR)
Per the federal PHS Policy, any member of the IACUC may request full committee review. Approval can only be granted after the protocol is reviewed at a convened meeting with a quorum of the IACUC and receives approval from the majority of the quorum present. If the IACUC determines that revisions are necessary before approval can be granted, the committee will decide at the convened meeting whether the revisions will be reviewed and approved through a subsequent full committee review (FCR) or via the designated member review (DMR) process.
What types of protocols require Full Committee Review (FCR)?
Protocols may require FCR if they involve:
- A new principal investigator (PI) to the institution.
- Procedures that could compromise animal health, such as Pain Category E procedures, invasive procedures, or experimental treatments.
- Changes in housing, enrichment, or husbandry that deviate from the Guide.
- Satellite locations (off-site animal housing or procedures).
- Switching from non-survival to survival surgery.
- USDA-regulated species.
- Specific procedures such as death as an endpoint, prolonged restraint, food/fluid restriction, singly housed animals, or any exceptions to regulations.
- Protocols that lack sufficient detail or justification.
What is the average processing time from submission to approval for different types of submissions?
Processing times vary by submission type, assigned review level, and submission complexity. Please remember that the average times provided below include time for pre-review, voting, and committee review as applicable to the submission type.
| Submission Type | Average Processing Time |
|---|---|
| Initial protocols | DMR: 6 weeks FCR: 8 weeks |
| De Novos | DMR: 4–5 weeks FCR: 8 weeks |
| Admin amendments (personnel only) | ~5 days (if training is complete) |
| Amendments (procedural, species, animal numbers, etc.) | DMR: 3–4 weeks FCR: 5–6 weeks |
| Study progress reports and study closures | ~5 days |
| Adverse events | ~1–2 weeks (depending on severity) |
Time estimates are in calendar days, including weekends and holidays. Please refer to the IACUC Protocol Review Flowcharts for visual representation and more details.
What factors can affect the processing timeline?
Processing times may be impacted by:
- High submission volume, leading to extended processing periods.
- Quality of submission, including missing information or lack of justification.
- Lag in response time from the Principal Investigator (PI) to requested revisions or clarifications.
- Committee member availability and the volunteer status of IACUC members.
Please be aware that a single protocol submission may go through multiple rounds of review depending on the quality and completeness of the initial submission and subsequent revisions.
If the IACUC identifies missing information, unclear descriptions, or issues that require clarification or modification, the protocol will be returned to the Principal Investigator (PI) for revisions.
Each time the protocol is sent back for clarification and resubmitted, a new review cycle begins, and this can extend the total review time.
How far in advance should I submit to the IACUC for review?
We encourage all investigators to carefully consider the average processing timelines outlined in the table above when planning to submit protocols, amendments, or other IACUC submissions.
For example, new projects that are expected to undergo Designated Member Review (DMR) should be submitted at least 6 weeks before the intended project start date to allow sufficient time for review and approval.
Submitting your protocol well in advance of your desired start date will help avoid delays and ensure compliance with institutional and regulatory requirements.
We also encourage the PI to communicate with IACUC before submission, particularly for a new PI, involving new procedures, and with special deadlines (e.g., for funding release). The pre-communication usually helps improve the quality/completeness of the initial submission, and therefore accelerates the review/approval process.
What happens during Pre-Review?
The Pre-Review process ensures that all necessary information is present before formal evaluation. The compliance coordinator checks for:
- Completeness of the submission package
- Adherence to guidelines
- Missing or unclear information
If issues are found, the PI will be contacted for revisions before the protocol moves forward.
What type of changes can be approved via administrative review?
Administrative Reviews handle:
- An addition of animals to the protocol that does not exceed 10% of the originally approved number of animals for that species.
- Addition or removal of personnel other than the PI
- Progress reports
- Study closures
This process streamlines approvals for straightforward changes.
What are some tips to ensure a smooth IACUC approval process?
Submit early
Allow sufficient time for review by submitting your application well in advance of your project start date.
Follow submission guidelines
Ensure all required documents are complete and adhere to IACUC’s specific submission instructions and applicable IACUC guidance.
Provide clear, detailed protocols
Be thorough in describing research methods, including animal care, procedures, and any potential risks.
Address previous feedback
If applicable, incorporate feedback from prior reviews to avoid delays and ensure compliance.
Check for compliance with regulations
Ensure that all procedures comply with relevant regulations, including the Animal Welfare Act and PHS Policy. Consult with the Attending Veterinarian as needed.
Consult with the IACUC office
Reach out for clarification or guidance on the submission process before submitting and whenever needed during the review process to avoid common mistakes.
Ensure proper training and certifications
Verify that all personnel involved in the study are properly trained and meet IACUC requirements.
Provide all relevant and required permits
Ensure that any required federal, state, or local permits for your research or teaching activities are obtained and submitted along with your protocol. This may include — but is not limited to — USDA registrations, APHIS permits, Fish and Wildlife Service permits (e.g., for endangered species or migratory birds), state collection or import permits, or marine mammal research authorizations.
What should the PI do if their permit lapses?
If a permit lapses, the PI should take the following actions immediately:
Cease all activities involving wild animals
The PI should stop any research or teaching activities involving wild animals until the permit is renewed or reinstated.
Contact the relevant permitting authority
The PI should contact the issuing agency (e.g., U.S. Fish and Wildlife Service, a state wildlife agency, or local regulatory body) to understand the steps for renewing or reinstating the permit.
Submit for renewal or amendment
If the permit has expired, the PI will need to apply for a renewal or possibly an amendment to the original permit if there have been changes in the scope of the activities. This process may involve submitting additional paperwork or undergoing a review by regulatory agencies.
Notify institutional oversight committees
If the research or teaching activity involves IACUC-approved procedures, the PI should inform the IACUC that permits have lapsed. They may be able to assist or advise on the next steps.
What actions should the PI take when an adverse event occurs?
The applicable animal facility manager should be notified as soon as possible to help assess the situation and determine the necessary next steps.
Who reviews adverse events, and how long does it take?
Adverse events are reviewed by the IACUC Adverse Event Subcommittee, which determines:
- If no action is needed
- If more information is required
- If specific actions should be taken
- If a Full Committee Review (FCR) is necessary
Average processing times typically range from one to two weeks, depending on the severity.
Can students serve as the Principal Investigator (PI) on an IACUC protocol?
No, students cannot serve as the PI on an IACUC protocol. Only qualified faculty or professional staff members with the appropriate institutional authority and oversight responsibilities may serve as a PI. Students may be listed as co-investigators or key personnel under the supervision of an eligible PI.
Who can I contact if I have questions about my protocol submission?
For assistance, protocol guidance, or to schedule a pre-submission consultation, contact the 91ÖÆƬ³§ IACUC at iacuc@une.edu.
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