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If you are new to submitting projects to the IACUC, the below steps will help guide you through the process of developing and submitting your animal subjects research activity.

1. Overview
2. Training
3. Preparing Your Protocol
4. The Review Process
5. Important Information Following Approval

1. Overview

This website will provide helpful tutorials, resources, and submission materials to guide you towards obtaining IACUC Approval for your project.

Summary of Things to Know In Preparation for IACUC Protocol Submission, Review and Approval:

  1. IACUC Core training must be completed and any other trainings as required by the Project PI or the IACUC.

  2. Occupational Health and Safety training must be completed.

  3. Proof of Tetanus Vaccination (or the appropriate signed declination form) must be forwarded to the Radford University Environmental Health and Safety Office unless you are an enrolled student and have already provided proof of tetanus vaccination upon enrollment.

    1.  Proof of rabies vaccination is only required when the research activity requires the handling of bats and certain other mammals.
  4. IACUC protocol documents must be completed and submitted to the IACUC.

Please review the Links page for additional information pertaining to the care and use of animals used in teaching and research. This includes links to federal regulations and agencies that oversee the protection and ethical treatment of animals used in teaching and research, as well as links regarding the care and use of specific species in teaching and research.

2. Training

Plan Ahead

Before any research can be approved and conducted, a researcher must:

  1. Complete the appropriate CITI Program IACUC Core Training and any other trainings as required by the Project PI or the IACUC.
  2. Read the Occupational Health and Safety Program Training Materials and read and sign the Occupational Health and Safety Agreement (OSHA) Form.

Below are several resources to help locate and complete the appropriate IACUC Training modules on the CITI Training Program and provides information about the Radford University Health and Safety Program, which includes the OSHA Training Materials that must be signed by the researcher.

*Students- Please see the IACUC Student Training Webpage*

IACUC Core Training Module on the CITI Training Program

  1. Access the CITI Core Training Program at CITIProgram.org.

  2. Complete the Working with the IACUC training module in the CITI Training Program.

  3. Complete any additional trainings as assigned by the Project PI or the IACUC.

  4. For assistance in locating the correct module, please the training pages on this website - IACUC Training (for faculty and staff) and IACUC Training for Students.

Health and Safety Program

The Radford University Occupational Health and Safety Training Program outlines the potential risks that are involved in working with animals in research. The training materials also describe safety measures that faculty and students can take to ensure that all research personnel and animals are protected.

  1. Read the 15 page Occupational Health and Safety Training Document [PDF].

  2. Read and sign the OSHA Agreement Form within this document.

  3. Submit all signed OSHA Agreement Forms for a given protocol to the IACUC Office.

 

3. Preparing Your Protocol

Once you have completed your IACUC Core CITI Training and have signed the OSHA Agreement Form, it's time to create your protocol.

All of the required documentation for completing an IACUC submission can be found on our Submission Forms page. All protocols require the following documents:

  • Main Submission Form
  • PI Assurance Form, to be signed by the PI and senior department representative
  • In addition, as directed in the Main Submission Form, please download and complete the appropriate appendices for your protocol in order to provide specific information regarding the methodology of your study.

Once all documentation has been completed and signed:

  1. Please forward the OSHA agreement forms to the IACUC Office, either in person or via campus mail.
  2. Please forward the original, signed PI Assurance form to the IACUC Office.
  3. Once you have finished creating your protocol, please email all submission documents in Word format to irb-iacuc@radford.edu.
  4. Upon approval, an Approval Letter cannot be generated until all documents are on file at the IACUC Office.

 

4. The review Process

Administrative Pre-Review

  1. Your submission will first be pre-reviewed by the IACUC Office.

    1. You will be contacted if we find anything missing from your submission or if we have suggestions in improving the clarity of particular aspects of your proposal for the IACUC.

Veterinary Pre-Review

  1. Once the protocol passes the pre-review stage, your protocol will be sent to a veterinarian on the IACUC for review.

  2. The veterinarian will be examining your protocol for specific animal handling and use issues to ensure that their well-being is properly maintained.

    1. You will be contacted by the Research Compliance Office if the veterinarian has any comments about the specifics of your methodology for the care and use of your requested animals.

IACUC Review

  1. Once the protocol has passed the veterinary pre-review stage, your protocol will be sent to the IACUC for a complete review of your entire protocol. This can be conducted in one of two ways:

    1. Designated Member Review (DMR) - Upon electronic routing of your submission to the entire IACUC, the Committee will designate one member of the IACUC to review your document thoroughly.

    2. Full Committee Review (FCR) - The Committee will meet, discuss, and vote on your protocol.
  2. Be able to correspond with the Research Compliance Office to address any comments that may be sent to you during the Pre-Review, Veterinary Review, and/or IACUC Review stages.

 

5. Important Information Following Approval

Even after obtaining approval, there are still important considerations to be aware of for your protocols.

Personnel and Training Amendments

At the beginning of each semester of the fiscal year, the IACUC Office will send reminders to all of the PIs on active protocols to amend all new and incoming personnel onto their current protocols. Any new personnel (including students) must be trained and amended onto a protocol  before they may work with animals or their unfixed tissues.

  1. Personnel can be amended onto a protocol through the completion of a Personnel and Training Report (PTR). Reminders will be sent at the start of each semester.

    1. The PTR form can be located on the Submission Forms webpage. A separate PTR should be completed for each protocol.

    2. List all new staff and students to be amended onto each protocol for the semester. Each new investigator must complete the IACUC Core CITI Training module(s), read the Occupational Health and Safety Training Matierals, and read and sign the OSHA Agreement form.
  2. Please forward the PTR and signed OSHA Agreement Form to the IACUC Office, either in person or via campus mail.

Amendments/Modifications

  1. Any changes made to an approved IACUC protocol must be reviewed in the form of a protocol amendment prior to implementation. The Protocol Amendment Form can be found on the Submission Forms webpage.

  2. The PI must also provide a revised Main Submission form, with all revisions clearly indicated. Any information that should be deleted must also be clearly indicated, but not deleted.

  3. Please submit both forms to the IACUC Office for review and processing. Requested changes may not be implemented until a modfications approval letter has been generated by the IACUC Office.

Annual Review of Protocols

All IACUC protocols are approved for 3 years. However, federal regulations and Radford University policy requires the submission of an Annual Protocol Review (APR) form for each active protocol, to be submitted and reviewed no less than annually.

  1. The IACUC Office will contact the PI for completion of the required documentation prior to the anniversary date of the approval for each protocol.

  2. Reminders will also be sent; however, the PI is expected to complete and submit the Annual Protocol Review on or before the anniversary date of the protocol.

  3. Please forward the completed Annual Protocol Review form to the IACUC Office, either in person or via campus mail by the protocol's anniversary date.

  4. If you have completed your study early and wish to close the protocol, please indicate this on your Annual Protocol Review Form or in your correspondence with the IACUC Office.

Expirations, Continuations, and Closures of Submissions

  1. All IACUC protocols are approved for 3 years. Once a protocol has reached its expiration date, no animals may be held, housed, used, or manipulated on this protocol after this date. However, data or tissue manipulation may occur after this date.

    1. The IACUC Office will provide the PI with expiration reminders prior to and on the date of protocol expiration.
  2. On or before the expiration date, a 3rd Annual Protocol Review Form is required. Upon receipt of this form, the protocol is considered closed. Please forward this form to the IACUC Office either in person or via campus mail.

  3. If you wish to continue your study, you must submit a new IACUC protocol in addition to the Annual Protocol Review Form. Please complete the new submission sufficiently early to allow for IACUC review to avoid lapses in approval periods.