Procedures for Faculty

IACUC Procedures for Investigators

All projects (with or without external funding) which involve the use of vertebrate animals must undergo IACUC review and receive approval prior to initiation.

Initial Protocol Review Procedures:

1. All investigators are required to consult with the veterinarian, Dr. Blauwiekel, about the project prior to submitting the project to the IACUC.

2. Investigators must complete the Animal Use Protocol application or an Animal Products Form (if the project does not require live animals.)

3. Upon completion of the proper forms, the application is submitted to the IACUC chairperson and reviewed for completeness. If the forms are complete, the IACUC chair will begin the review process with the full IACUC. Investigators should expect this process to take approximately 30-days.

4. Criteria for review include activities, pain/distress, alternatives, rationale and methods, duplication, surgery, euthanasia, housing/health, qualifications of personnel and any deviation from requirements must be justified.

What to expect after your protocol is submitted:

1. The IACUC will notify investigators and the institution in writing of its decision to approve or withhold approval of those activities related to the care and use of animals, or of modifications required to secure IACUC approval.

2. The IACUC will communicate with the principle investigator through a memorandum outlining the approval status an/or concerns, questions and/or comments of the IACUC. A copy of the memorandum will also be sent to the Institutional Official by the IACUC staff member.

3. The IACUC Chairperson will convey one of the following four decisions in writing to the investigator promptly after the IACUC meeting:

Approval: The investigator may begin the research study upon receipt of the Verification of Approval Form from the IACUC.
Approval Withheld Pending Stipulations/Clarifications: This decision is determined when the protocol is recommended for approval by the IACUC pending the investigator's response to IACUC-directed stipulations/questions and/or revisions. The principle investigator must provide a memorandum responding to the IACUC's recommendations and questions.
Tabled: More substantive issues regarding the protocol must be addressed. Clarifications or requested revisions may have a significant impact on the involved animals. A memorandum is sent to the investigator requesting that these issues be addressed.
Disapproved: Questions regarding scientific merit and use of animals are of such significance that the committee finds approval of the study to be unwarranted. The authority of the IACUC to disapprove a study MAY NOT be overridden.
The IACUC will issue a 30-day and a 60-day reminder from the date of the protocol review for all pending protocol items. At the 90-day mark, the protocol is withdrawn from the committee's consideration.

Protocol Amendment Procedures for Investigators

1. Requests for approval of modifications may be submitted at any time. Completion of an Animal Use Protocol Amendment Form is required. The changes must be approved by the IACUC before any changes can be implemented in the conduct of the protocol. Investigators must consult with the veterinarian prior to submitting their protocol amendment.

2. Amendments to protocols include minor changes such as small increases in animal numbers, minor procedural changes, personnel changes. Major changes include larger increases in numbers, addition of invasive procedures, changes in pain level, change in species, etc.

3. Minor protocol changes require the review of the Veterinarian and the IACUC chairperson. Major changes will require the review of the full IACUC.

4. Procedures for notification to the investigator are the same for protocol amendments as for initial protocol approvals.