IACUC Forms & Templates
Changes to a Protocol
Electronic Institutional Animal Care & Use Committee (eIACUC) Applications
Faculty, researchers and staff can now electronically complete and submit to the Institutional Animal Care and Use Committee (IACUC) protocols online via the Electronic IACUC (eIACUC) system. eIACUC is located within the Division of Research Integrity & Compliance (DRIC) Applications for Research Compliance (ARC) platform.
Starting January 1, 2013 all new IACUC research protocols MUST be submitted through the eIACUC within the ARC platform. We no longer accept any new IACUC protocol submitted on “paper”.
The eIACUC can be accessed at https://arc.research.usf.edu/Prod/
The new system will allow faculty, researchers and staff to submit new animal protocols, and to modify these new protocols. Modifications can be made by submitting protocol change requests, and study team updates. Other online submissions for electronic protocols include annual reviews and three year renewals.
IACUC protocols that were originally approved on paper prior to December 31, 2012, will continue to use paper submissions for procedural changes and amendments.
Prior to submitting your first eIACUC application you must first request an ARC account unless you already have one. This is a simple process:
- Request an ARC Account at https://ARC.research.usf.edu/prod/
- Questions regarding ARC registration can be directed to 974-2880 or RSCHfirstname.lastname@example.org
- Upon completing ARC registration, a new application to the IACUC can be drafted.
Common eIACUC Application Format
A single, common eIACUC application format is used for proposing all study types involving animals, including research, teaching, wildlife in natural settings, murine colonies only, antisera production only, or animal tissue use only.
Applicants will indicate the type of study being proposed to the IACUC under item 3.1.1 of the common eIACUC application.
IACUC Certification of Personnel Required for Protocol Approval
eIACUC applications can be proposed to the IACUC, but will only secure IACUC approval after all personnel contributing to the proposed study have been certified by the IACUC as having adequate knowledge and experience to perform their duties.
VA Merit Applications-ACORP
Principal Investigators developing applications for VA funded Merit Review grants must submit the animal component for their research project to the IACUC using the VA ACORP. The ACORP version 3 is being replaced by ACORP version 4. Please note that beginning May 1, 2013, the USF IACUC will no longer accept and process the previous ACORP version 3.
- Complete ACORP w/ALL Appendices and ACORP Complete Instructions
- ACORP Main Body and ACORP Instructions
- Appendix 1 (Rodent Breeding) and ACORP App. 1 Instructions
- Appendix 2 (Antibody Production) and ACORP App. 2 Instructions
- Appendix 3 (Biosafety) and ACORP App. 3 Instructions
- Appendix 4 (Ante-Mortem Specimen Collection) and ACORP App. 4 Instructions
- Appendix 5 (Surgery) and ACORP App. 5 Instructions
- Appendix 6 (Special Husbandry and Procedures) and ACORP App. 6 Instructions
- Appendix 7 (Use of Patient Care Equipment or Areas for Animal Studies) and ACORP App. 7 Instructions
- Appendix 8 (Use of Explosive Agent(s) within the VMU or in Animals) and ACORP App. 8 Instructions
- Appendix 9 (Departures from "Must" and "Should" Standards in the Guide and ACORP App. 9 Instructions
Assistance in completing an eIACUC smart form
Need Help? There is always a veterinarian available to assist you. If you need help completing an IACUC application, or assistance in incorporating suggested revisions to your draft IACUC application, contact:
- email@example.com telephone 745-4361
- firstname.lastname@example.org telephone 974-4935
- email@example.com telephone 974-3836
There are Help Texts throughout the common eIACUC application providing guidance, suggestions, and template responses (e.g., mouse imaging using MRI, CT/PET/SPECT, ultrasound, bioluminescence, fluorescence) that will assist you with your input.
The following Interactive web-based training videos provide you an intuitive way to familiarize yourself with the eIACUC Application Process:
- How to Navigate and Create a new eIACUC application:
- How to Submit a New eIACUC Application Using the ARC Portal:
How many grants can be used on a single protocol?
- A single IACUC protocol cannot be used to represent the animal use activities of multiple federal or major agency research grants or contracts each with budgets to purchase, maintain, and use animals. Only one protocol per federal or major agency research grant.
How many protocols can be used on a single grant?
- A single research grant or contract may be represented by more than one IACUC-approved protocol.
If an activity involving animals that is described in an IACUC-approved protocol is supported by multiple grants with different titles (e.g., one research grant, one postdoctoral fellowship, and departmental funds), the PI must inform the IACUC by submitting a Request to Amend an Animal Use Protocol form.
If a grant not originally declared in the IACUC application is awarded later during the 3-year approval period of the protocol (i.e., grant not funded during year one of the protocol, but awarded during year two), the PI must inform the IACUC by submitting a Request to Amend an Animal Use Protocol form.
IACUC Protocols with Federal or Major Agency Funding:
Approval of an IACUC protocol application other than an Application to Establish/Maintain a Mouse Colony with proposed support from a federal or major funding agency is contingent on comparable protocol and proposal titles and narratives. IACUC Protocol Applications with Federal or Major Agency Funding must be accompanied by four pages from the grant proposal as described below. These must be uploaded directly into the eIACUC system.
- Face Page of form PHS 398 (or a similar page) that shows that the grant title and name of the Principal Investigator match those of the IACUC protocol application,
- Page 2 form PHS 398 (or a similar page) wherein the project description in abstract form summarizes the scope of work to which the purpose(s) and procedure(s) described in items 7 and 8 on page 2 of the IACUC protocol will contribute,
- First Page of the Research Plan (or a similar page) that includes the Specific Aims of the research. Note that the IACUC protocol must represent an aspect of the broad long-term objectives of the grant proposal.
- Section F, Item 1 of the Research Plan of format PHS 398 (or a similar page) wherein a description of the proposed use of the animals and the species of animals to be used are identified.
- Any communication/documentation from/with the granting/funding agency indicating a change in the direction of research that would affect how animals are used.
These grant application pages may be submitted to the IACUC electronically via eIACUC.
All vertebrate animal use must first be pre-reviewed by USF veterinarians. In the eIACUC online system once the smart forms are completed electronically they can be submitted directly to the veterinarian from within the system. In addition you can contact veterinarian via e-mail address to CompMed@research.usf.edu, telephone (813) 974-9796, and fax (813) 974-9432. If you need help completing an eIACUC application, or assistance in incorporating suggested revisions to your eIACUC application, contact firstname.lastname@example.org telephone 745-4361 or email@example.com telephone 974-4935.
Colonies of mice and all mice created locally by methods of genetic engineering involving recombinant DNA (rDNA) must first be represented by an IACUC-approved Application to Establish/Maintain a Murine Colony that can be submitted via online eIACUC process.
Vertebrate Animal Section (VAS) for Grant Applications to the NIH
The Office of Laboratory Animal Welfare (OLAW) has developed a new factsheet to assist applicants in completing the Vertebrate Animal Section (VAS) of grant applications, contract proposals and cooperative agreements for submission to the NIH. Here you will find an overview of the requirements for each of the 5 points of the VAS.
Mouse Colony Protocols with Any Source of Funding
An electronic Application to Establish/Maintain a Murine Colony need not be accompanied by a grant proposal regardless of the proposed source of funding.
IACUC Protocols with Other Funding
IACUC protocol applications with other proposed sources of funding need not be accompanied by a grant proposal, but Comparative Medicine will not fill requests for animals or service under a specific IACUC-approved protocol until an association between fiscal support, an IACUC protocol, and an account or purchase order number is assured in writing. A Research Services Agreement and/or a letter on company letterhead indicating a commitment to fund a proposal may be used to document corporate support. A memorandum from the departmental Chairperson or other signature authority on the account may be used to document departmental support of a proposal.
Please address questions to Iacuc@research.usf.edu, telephone (813) 974-7106, fax (813) 974-7091.
Changes to an approved IACUC Protocol
Faculty, researchers and staff must secure approval for any changes prosed to an approved IACAUC protocols prior to implementing any change. Any change proposed to an IACUC-approved protocol must be within the scope of the original hypothesis and/or purpose of animal use.
Appropriate Formats for Proposing Changes to an Approved Protocol
Faculty, researchers and staff should use one of two formats for proposing amendments or revisions to an IACUC-approved protocol.
- If the original application was drafted using the paper IACUC application, use the paper request forms provided below for proposing changes to an IACUC-approved protocol.
- If the original application was drafted using the electronic IACUC (eIACUC) application, use the ARC system described below for proposing changes to an IACUC-approved protocol.
Proposing Changes to an eIACUC Protocol
Faculty, researchers and staff should use the ARC system and eIACUC modification process whenever proposing amendments or revisions to an approved eIACUC protocol.
The "Electronic IACUC (eIACUC) Application Instructional Manual" provides detailed instructions regarding use of the ARC system and processes applicants use when proposing modifications to an existing eIACUC protocol. This manual and other eIACUC Training Resources are viewable at http://www.research.usf.edu/dric/iacuc/training-resources.asp
- How to Prepare and Submit an Amendment Request
Proposing Changes to a Paper IACUC Protocol
Faculty, researchers and staff should use the following documents to propose a modification to an IACUC-approved protocol originally proposed to the IACUC using paper forms. These are either submitted as Amendments or Procedural changes.
Amendments or Procedural changes to a paper IACUC-approved protocol must be submitted to Research Integrity & Compliance at IACUC@research.usf.edu or MDC 35 or fax 974-7091.
Procedural Changes to a Protocol: Minor procedural changes to an IACUC-approved protocol originally proposed using paper forms, including requests for additional animals to be made available to the protocol, are submitted to the IACUC using the form below.
When procedural changes to a protocol involve other-than-minor changes to specific sections of the originally-approved paper IACUC application, use the following documents to extract the appropriate sections and/or appendices. The revised IACUC application section(s) and/or the revised appendix/appendices should be included with the submission of the Request for a Procedural Change to an Animal Use Protocol.
- Application for the Use of Animals in Research
- Application for the Study of Wild Animals In or From Natural Settings
Amendments: Amendments to an IACUC-approved protocol originally proposed using paper forms, including proposing a change in certified personnel, title, or funding source (i.e., other than federal or major agency sources), the addition of another strain of the same species, or the use of conventional therapeutics, drugs, analgesics, or anesthetics are submitted to the IACUC using the form below:
Emergent Mouse Phenotypes: Mouse colony protocols originally proposed using paper forms must be amended using the form linked below whenever aspects of the emergent mouse phenotype, recurring clinical condition(s), or an unanticipated outcome are recognized that were not described in the original IACUC application.
Major Changes Requiring a New IACUC Application: Major changes to IACUC-approved protocols (e.g., a change in scope, hypothesis, specific aims, species, or procedures which exceeds the limits set by IACUC Principles and Procedures of Animal Care and Use ) cannot be amended to an IACUC-approved protocol, but must instead be proposed in a new eIACUC application. Please address questions to CompMed@research.usf.edu, telephone (813) 974-9796, fax (813) 974-9432; IACUC@research.usf.edu, telephone (813) 974-7106, fax (813) 974-7091.
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