IACUC Specifics (FAQs)

The process proceeding FCR depends on the committee's review and votes. Protocols can be either Approved, Require Modifications, or Withhold Approval. If approval is issued, the Investigator will receive an Approval letter via IRBNet stating the protocol is approved, and their work can commence (provided IBC approval is pending). If the outcome is Modifications are Required, a clarifications letter is sent through IRBNet to the Investigator. The letter details the information required of the Investigator to secure approval. If the outcome is Withhold Approval, the Investigator is notified via IRBNet through a letter. The Investigator would need to submit a new protocol if the committee voted to withhold approval. For additional guidance with general IRBNet navigation, such as submitting a follow-up response, refer to our IRBNet Basics/Pro guidance here.

IACUC application approval time varies depending on the complexity of the protocol, the involvement of other committees, and the responsiveness of the investigator.

Investigators should respond to the IACUC within 90 calendar days of receiving the letter. For additional details on follow-up responses, see the Protocol follow-up Response Guidelines

Any modification (personnel changes, anesthetic change, new procedure, etc.) will require an amendment. Amendments can only happen post-approval of the protocol. Amendment submissions are created as a NEW package. The amendment can be reviewed and approved administratively or by one of the committee review types, DMR or FCR. For additional guidance on How to Create a New Package In IRBNet, refer to our IRBNet Pro section here.

No. Protocols are approved for three (3) years only. The approval date of a modification does not alter the protocol's original approval date.

Yes. Wherever you see a Save and Exit button or Save the form, click on it. You can return at any time to complete the documents. For additional guidance on Accessing an Existing Project, please refer to our IRBNet Basics here.

Yes. Regardless of the status, the investigator will always have access to their protocol submissions.

Yes. PHS policy and the USDA Animal Welfare Act (AWA) mandate reviewing the Institution's animal research program. These inspections ensure animal well-being and compliance with federal regulations and guidelines. Below are a few key details on how semiannual inspections are conducted.

• Inspections are conducted every six (6) months using the IACUC-approved Facility & Laboratory checklists. The inspections are scheduled several weeks in advance.
• Inspection areas include; animal rooms where procedures are conducted on live animals (euthanasia, survival surgery, or other non-lethal methods are performed for research and teaching purposes), animal housing (terrestrial, aquatic), labs where drugs are stored (inspectors must be provided access to locked cabinets, drawers, and storage areas that keep drugs), surgical support rooms/procedure areas, and satellite facilities where animals are housed for more than 24 hours. (USDA species = 12+; Non-USDA species = 24+)
• Investigators and lab personnel are notified at least a month before the inspections. Investigators are provided a date, time, and a copy of the inspection checklist.
• At least two (2) voting members of the IACUC conduct inspections.
• Investigators are emailed inspection results letters within 2-3 days post-inspection. Investigators with minor or significant findings are given ten (10) days to respond with a corrective action plan (CAP) addressing minor and/or significant deficiencies. The IACUC staff will follow up with the investigator’s lab until all deficiencies have been addressed.

For additional details on Semiannual Inspections, please get in touch with the IACUC office.

Yes. A review by the Office of Safety and Environmental Compliance (SEC) is required if your research involves chemotherapeutic agents. Once the SEC does a brief overview of the investigator’s project, a Hazard Acknowledgment Oversite letter from SEC is sent to the investigator. The letter details what agent is being worked with and what safety precautions should be followed. The letter is then attached to your project for IACUC review. For additional guidance on How to Attach Documents In IRBNet, please refer to our IRBNet Basics here.

Yes. If your research involves the use of infectious agents and/or rDNA in animals, a review by the Institutional Biosafety Committee (IBC) is required. To help expedite the review and approval process, reviews between committees should happen simultaneously.

Yes. If your research involves using animals that require special permits (marine mammals, fieldwork specimen collection, etc.), then special permits may be required.

You will notice that there are numerous acronyms used in the field of animal research. Below, is a list of abbreviations with their corresponding definitions. For a more detailed list of acronyms and definitions, please refer to OLAW Glossary and Resources webpage

IACUC: Institutional Animal Care & Use Committee

FCR: Full Committee Review

DMR: Designated Member Review

PHS: Public Health Service

OLAW: Office of Laboratory Animal Welfare

AV: Attending Veterinary

OHP: Occupational Health Care

IO: Institutional Official

Proposal: is the same as protocol or project

PI: Principal Investigator/Investigator/Researcher

USDA: United States Department of Agriculture