Managing Your Research

Amendments that qualify for administrative review may be reviewed by the IACUC Administrator or any member of the IACUC, if necessary. The following items may be approved via administrative review:

• Administrative changes (changing titles, contact information, etc.)
• Changes in delegation of the provision of care or husbandry
• Changes in funding source
• Changes in housing or facility
• Addition or removal of personnel
• Removal of a species, agents or experimental procedures from a protocol
• Addition of animals that do not exceed 10% of the original study numbers (reviewed by the IACUC Chair)

Certain amendments qualify for expedited review. This means the amendment needs to be reviewed only by the IACUC Chair or the IACUC Veterinarian. Typically, an amendment undergoing expedited review will be reviewed within five business days. 

Amendments qualifying for expedited review must include one of the following amendments:

• Addition of animals that exceeds 10% of original approval numbers
• Changes or additions of veterinary therapeutic drugs
• Addition of drugs to induce a transgene expression
• Changes or additions to anesthesia monitoring methods
• Change in tissue collection method for genotyping
• Changes or additions to environmental enrichment methods
• Addition of non-invasive procedures similar to ones currently approved in the protocol
• Changes or additions to identification methods
• Changes in blood draw techniques
• Changes or additions to sterilization/disinfection methods
• Changes in experimental drug route or dose of an approved drug
• Changes or additions to supportive care (i.e. supplemental heat, IV fluids, etc.)
• Changes in non-standard diets or addition/deletion of supplements
• Changes or additions to the anesthetics or analgesic regimen
• Changes in strain, sex, source or age of animals
• Changes or additions to the euthanasia methods which are AVMA acceptable
• Changes in surgery length
• Changes to wound closure type, technique or removal date
• Increasing the number of collections for tissue or fluid collections currently listed in the protocol
  

Any amendment that contains both minor and major amendments must first be voted on by IACUC members to determine the review type (designated member or full convened review). IACUC members have five (5) business days to vote to determine the review type. If the amendment is assigned to a designated reviewer, the reviewer has ten business days to conduct the review and provide feedback. If the amendment requires a full convened review, a meeting will be scheduled to conduct the review. 

Any amendment that includes major amendments must first be voted on by IACUC members to determine the review type (designated member or full convened review). IACUC members have five (5) business days to vote to determine a review type. If the amendment is assigned to a designated reviewer, the reviewer has ten (10) business days to conduct the review and provide feedback. If the amendment requires a full convened review, a meeting will be scheduled to conduct the review. 

Annual reports are due for the first two (2) years, for all IACUC approved studies, by the annual anniversary date of the study. After which, the researcher may:

• Submit a three (3) year renewal, or 
• Close the study

To submit an annual report, the Principal Investigator must follow these instructions.

As a reminder:

• If a wildlife permit is required and it has expired, an updated wildlife permit must be submitted with the annual report.
• All personnel must complete the Animal Contact Assessment annually. The Animal Contact Assessment form must be current at the time of the annual report.
• CITI training for all research personnel must be current at the time of the annual report.

The following steps will be taken if the PI does not submit the annual report:

1. The IACUC Administrator will contact the researcher to notify the researcher that the annual report is late (30 days after due date).

2. After another 30 days, if the annual report has not been submitted to the IACUC Administrator, the IACUC Administrator will contact the researcher and copy the Chair of the IACUC, and the Chair of the department or immediate supervisor, on the email (60 days after due date).

3. After another 30 days, if the annual report has not be submitted to the IACUC Administrator, the IACUC Administrator will contact the researcher and copy the Chair of the IACUC, the Chair of the department or immediate supervisor, and the Dean of the college on the email (90 days after due date).

4. After another 30 days, if the annual report has not be submitted to the IACUC Administrator, the IACUC Administrator will contact the researcher and copy the Chair of the IACUC, the Chair of the department or immediate supervisor, the Dean of the college, and the Vice Provost for Graduate Education, Research and Outreach on the email (120 days after due date).

5. After another 30 days, if the annual report has not been submitted to the IACUC Administrator, the research study will be placed on an administrative hold until the report has been submitted.