Procedures for Submission and Approval of Animal Use Protocols

This link will automatically download the IACUC Protocol Form (Mac only) to your desktop. This is only a Mac compatible option. This program allows you to complete the form and save it on your computer.

This link will open the IACUC Protocol Form in PDF Format for PC or Mac users. This pdf is best viewed using Acrobat Reader 4.0.(click to download).  Note: You will not be able to save your completed form with the free Acrobat Reader 4.0. Saving the form on your computer requires that you have a registered copy of Adobe Acrobat (not the free Acrobat Reader) installed which is available from General Stores.

This link will open the IACUC Protocol Form in MS Word Format (doc) for PC or Mac users.  If the document opens in Quick View, Click the Microsoft Word Icon to save to your hard drive.
 

General: This page provides instructions for submitting animal use protocols to the Institutional Animal Care and Use Committee (IACUC). Reference materials for these procedures include the UT Memphis Lab Animal Care and Use Handbook, the USDA regulations relevant to the Animal Welfare Act , and the Public Health Service Policy on Humane Care and Use of Laboratory Animals, and the NIH Guide for the Care and Use of Laboratory Animals.

New Submissions

A. Timing:

1. Allow at least one month for processing protocols. According to federal law, all IACUC members must have the opportunity to review every protocol prior to approval. This process takes time.
2. NIH grants
• New grants can be submitted with review of the animal protocol in process.
• Noncompetitive renewals must have a currently active approval when submitted, with the approval date occurring within the past year.
• The IACUC meets once per month. The cut off date for receipt of materials to be reviewed at a given meeting is the first Monday of every month. Contact the Medical Research Protocol Coordinator for specific deadlines.(448-3904)

1. Obtain a protocol form by clicking on the icon above. This will down load the form onto your computer.
2. Fill in the form completely. Incomplete forms will be returned without review.
3. Use only the space provided, unless otherwise requested. Do not attach additional materials (e.g. reprints, grants, etc.).
4. The protocol director must sign the form.
5. The completed form must be typed.
6. Avoid the use of jargon and abbreviations. If the committee does not understand what you are saying, the protocol will take longer to process.
7. An investigator assurance of training form is part of the protocol.
8. When completing the protocol form, refer to the IACUC guidelines on relevant issues of animal use to insure compliance. These guidelines include the following topics and are printed in detail in the Lab Animal Care and Use Handbook.
• Surgery from which the animal recovers consciousness.
1. Non-rodent mammalian species.
2. Rodent species.
3. Multiple survival surgery.
4. Postsurgical care.
• Use of paralytic agents.
• Use of ether.
• Immunization of research animals and injection of complete Freund's adjuvant.
• Physical restraint of unanesthetized animals.
• Lethal or toxic challenge.
• Experimentation involving pain.
• Blood collection.
• Tumor induction.
• Food/water restriction or deprivation.
• Acute toxicity testing.
• Euthanasia.
• Ascites collection.

1. The protocol is logged in and assigned a protocol number. A protocol file is initiated based on the number and cross-indexed to the protocol director.
2. A handbook will be mailed out to all new protocol directors.
3. The protocol is reviewed for completeness and legibility. If incomplete or illegible, problems will be indicated and the protocol returned to the project director. No further action will be taken until the protocol has been returned. Processing will proceed only when a complete and typed protocol is received.

1. The pain and distress category of the protocol (class 1-5) is determined based on preliminary review.
2. All class 1, 2 and 3 protocols are sent out as a list to all IACUC members, asking each member whether they request full committee review. No further action can occur until all committee members reply.
3. Class 1 and 2: if full committee review is not requested, one member of the committee will review the protocol.
4. Class 3 and 4 protocols are reviewed by the IACUC chairman, a veterinarian and 1 other committee members.
• Class 3: if full committee review is not requested, one member of the committee (usually the veterinarian) will process reviewers' comments.
• Class 4: full committee review required.
5. Class 5: must be reviewed by all committee members and discussed at the meeting.
6. Following veterinary and/or IACUC review:
• If necessary, the Medical Research Protocol Coordinator will summarize committee concerns in a letter to the protocol director. Generally, the letter will request clarifications or denote restrictions.
• A response to this letter must be received within 30 days to maintain progress on the approval process.
• If a response is not received in 30 days, a memo will be issued stating that the protocol will be inactivated in 7 days.
7. After investigator reply, the corresponding member (usually the veterinarian) will review the response and take necessary action (respond to investigator or return the protocol to committee if necessary).
8. If no problems remain, an approval letter will be issued.
9. Remember your protocol number. This is essential information for ordering animals on a given approved protocol.

A. Annual reviews

1. Each protocol must be reviewed annually to satisfy the requirements of funding agencies, the Public Health Service, and the Animal Welfare Act.
• First and second annual reviews involve completing a form that asks if the protocol continues as submitted, continues with changes (to be specified), or is inactive.
• Third annual reviews require that the protocol be rewritten and resubmitted as if it were a new protocol.
2. The Medical Research Protocol Coordinator will notify you when annual renewals are due.
• A response to the annual renewal notice is required within 30 days.
• If a response is not received within 30 days, a second memo will be issued stating that the protocol will be inactivated in 7 days.
3. Whe response is received, the following actions will occur.
• First and second annual reviews.
1. If the protocol is to continue unchanged, one committee member will review and probably approve the protocol.
2. If the protocol is to continue with changes specified on the form, a committee member will review.
• If necessary, the review will draft a letter requesting clarifications or denoting restrictions, or refer the revisions to the committee for review.
• After investigator reply, a committee member will review and take necessary action (respond to the investigator or return protocol to the committee, if necessary).
• If no problems remain, an approval letter will be issued.
3. If the protocol is inactive, it will be withdrawn from the active files and archived. Inactive protocols can be reactivated, if necessary, at a later date.
• Third annual reviews.
1. These protocols will be handled exactly like new protocols, as described above, except that they will not receive a new number.
2. Do not delay in resubmitting third annual reviews, or your protocol may be inactivated.
B. Protocol revisions
1. Initially reviewed by a committee member.
2. If necessary, the reviewer will draft a letter requesting clarifications or denoting restrictions, or refer revisions to committee for review.
3. After investigator reply, a committee member will review and take necessary action (respond to investigator, or return protocol to committee, if necessary).
4. If no problems remain, an approval letter will be issued.


back to top