IACUC Compliance

The Institutional Animal Care and Use Committee (IACUC) oversees research involving live vertebrate animals. AcaTrove's IACUC module helps researchers create detailed animal use protocols, manage veterinary reviews, and maintain compliance throughout the life of a study.

Creating an IACUC Protocol

1. Navigate to /compliance and click + New Protocol, then select IACUC.
2. Complete the required sections:

Study Overview

• Protocol title and principal investigator.
• Research objectives and scientific justification for using animals.
• Lay summary explaining the study's purpose in non-technical language.
• Funding source and grant details.

Species and Numbers

• Species used (common name and scientific name).
• Number of animals requested with statistical justification for the sample size.
• Source of animals (commercial vendor, breeding colony, field capture).
• Housing requirements and special environmental conditions.

Procedures

• Detailed description of all procedures performed on animals.
• USDA pain and distress category for each procedure (Category B through E).
• Anesthesia and analgesia protocols, including drugs, dosages, and routes of administration.
• Surgical procedures, if any, with pre-operative, intra-operative, and post-operative care details.
• Humane endpoints and criteria for euthanasia.
• Euthanasia method (must conform to AVMA guidelines).

IACUC protocol form with species and procedure sections

Alternatives Search

• Documentation of a literature search for alternatives to animal use (replacement, reduction, refinement -- the 3Rs).
• Databases searched, keywords used, date range, and results.
• Justification for why alternatives are not feasible.

Personnel

• List all personnel involved in animal procedures.
• Training and qualifications for each person (species-specific training, CITI certification, etc.).
• Occupational health enrollment status.

Hazardous Materials

• Any biological, chemical, or radiological hazards used in conjunction with the animals.
• Safety precautions and institutional safety committee approvals.

Species section with pain classification and animal numbers

Submission and Review

Submit the completed protocol by clicking Submit for Review. The IACUC review process includes:

1. Pre-review -- The IACUC office checks the submission for completeness and requests clarifications if sections are missing or unclear.
2. Veterinary Review -- The attending veterinarian reviews all procedures, anesthesia and analgesia plans, and humane endpoints.
3. Committee Review -- The full committee or a designated reviewer evaluates the protocol. Possible outcomes:
   • Approved -- The study may begin.
   • Minor Modifications Required -- Small changes needed; can be verified by the IACUC chair.
   • Major Modifications Required -- Substantive changes needed; protocol returns for full committee review after revision.
   • Not Approved -- The protocol cannot proceed as submitted.

Responding to IACUC Feedback

When modifications are required:

1. Open the protocol from your compliance dashboard.
2. Review comments from the veterinarian and committee members.
3. Revise the relevant sections and provide written responses to each concern.
4. Click Resubmit.

Annual Reviews and Renewals

IACUC protocols require annual continuing review and a full renewal every three years:

• Annual Review -- Report animal usage numbers, adverse events, and any protocol deviations. AcaTrove sends reminders 90 days before the annual review is due.
• Triennial Renewal -- Submit a new protocol application or a comprehensive renewal. The full committee reviews the renewal.

Amendments

To add new procedures, species, or personnel to an approved protocol:

1. Open the protocol and click File Amendment.
2. Specify the changes and provide justification.
3. Submit for review. Minor amendments may receive expedited review; major amendments require full committee review.

Reporting Adverse Events

If an unexpected adverse event occurs during the study (animal illness, unanticipated pain, procedural complication):

1. Click Report Adverse Event on the protocol page.
2. Describe the event, its impact on the animals, and the corrective action taken.
3. The report is routed immediately to the IACUC chair and attending veterinarian.

Adverse events must be reported within 24 hours of discovery.

Tips

• Complete the alternatives search thoroughly -- IACUC committees scrutinize this section closely.
• Ensure all listed personnel have current training before submitting the protocol.
• Use precise dosage and timing information for anesthesia and analgesia to expedite veterinary review.
• Link the IACUC protocol to its corresponding project so lab members can see the compliance status.