The review is initiated when receipt of complete protocol application or amendment, including all required documents, is accepted by the IACUC Administrator. Protocol Approval is required at least every three (3) years. Protocols requiring Institutional Biosafety Committee approval must obtain it prior to IACUC approval. Principal Investigators (PIs) are strongly encouraged to consult with the campus veterinarian during the planning stages and prior to protocol submission, particularly for studies that have significant potential for pain or distress. Experts from within or outside the University community or consultants may be asked to assist in review of protocols that are complex in nature.
The IACUC Chair will receive the accepted protocol from the IACUC Administrator and will recommend one of two review methods: Designated Member Review (DMR) or Full Committee Review (FCR).
Designated Member Review (DMR)
A copy of the written protocol is sent to all IACUC committee members via email. Any member of the committee may request a FCR within 5 business days if they deem it necessary. Following a FCR request, a full committee meeting must convene with a properly constituted quorum. If no requests for FCR are received, the IACUC Chair will appoint one qualified committee member, along with the committee’s veterinarian, to head the review process as the Designated Member Reviewer (DMR).
The DMR has the following options:
- Approve the protocol or amendment if all criteria are met and satisfied
- Request revision(s) to the protocol or amendment if outstanding issues are present in order to secure approval
- Request FCR when further review of the protocol or amendment is warranted
Full Committee Review (FCR)
Full Committee Meetings are schedule monthly according to the above calendar.
The following outcomes of a FCR may occur:
- Approval by majority affirmative vote
- Revisions requested to secure approval
- Defer or table review of protocol if more clarification or outside consultation is needed
- Withhold approval of protocol if it has not adequately addressed all requirements necessary
If the IACUC is unable to approve a protocol, the PI is notified with a detailed report of the requested revisions.
Modifications to an Approved Protocol:
Investigators who desire to make modifications to an approved protocol during the approval period, must submit a modification for approval prior to initiating the change. Modifications include administrative changes such as addition or deletion of research personnel, as well significant changes such as modifications to the study design or objectives, the number of animals or species used, increases in pain or distress, changes to therapeutic or experimental agents or changes in euthanasia methods. Approval of a modification does not change the existing protocol expiration date.
Investigators who plan to submit an animal protocol should email the IACUC Administrator for the protocol application. Applications must be submitted electronically via email to firstname.lastname@example.org. The application must be attached in Word format. The last page of the application (PI assurance statement) is to be signed by the PI and his/her department chair or direct supervisor and submitted separately. You may submit this as a scanned PDF or with an electronic signature.
Upon receipt, the application will be logged and assigned a unique IACUC number. An email confirmation will be sent to the PI and any Co-Investigator(s) listed on the application, along with the tracking number. This number must be included in all future correspondence to the IACUC concerning the project.
Need help? Please contact IACUC staff at email@example.com, (714) 628-2833, or (714) 628-2844.
Training about animal welfare, regulations, and procedures is required for all persons intending to use animals in research, training, or testing. Training includes both fact-based curriculum as well as demonstrating competency with procedures and techniques. The IACUC at Chapman asks for specific documentation of training in the protocol application. And it needs to be appropriate, at minimum, to the animal species, the technique(s), the risks posed by the animal usage, and the demands by regulatory authorities. The IACUC recognizes that training comes from many sources including CITI (see below), AALAS (see below), conferences, training received from experts (e.g., surgical procedures), and experience at other institutions.
The 3Rs principles of reduce, replace, and refine apply directly to training when using animals in research. Training improves both data reproducibility and animal welfare.
Additional information about training can be obtained by contacting the IACUC office at firstname.lastname@example.org.
What is CITI: The Collaborative Institutional Training Initiative (CITI Program) is a leading provider of research education content. CITI Program was established in 2000 to provide training content in many areas related to animal research including Animal Care and Use (ACU) and Biosafety/Biosecurity (BSS), and Conflicts of Interest (COI).
Cost: CITI is free of cost for you. The Office of Research at Chapman pays the subscription fee.
Availability: The courses are available 24/7 on-line. You may log out and return at a later time, but it is suggested that you complete the module you are working on, including the quiz, first. Experience shows that each module takes 10 to 20 minutes.
1. Before you begin: It is recommended that you review the registration process tutorial (version 30 July 2017). Note: CITI may have made changes to its screens, so the PowerPoint "shots" may not match exactly. Navigate through the "General Information" area and become familiar with the site.
2. Registration: Register the first time at https://www.citiprogram.org using any name and password you choose. Select Chapman University as the institution.
3. Using the CITI site: Once registered, provide your user name and password each time you log-on and you will go to the appropriate learner's group. You can change your learner's group should it be necessary. You may also affiliate yourself with other institutions that recognize CITI training.
4. Selecting courses: Select the group in which you must train as defined by the IACUC (for a particular purpose like oncology or wildlife, for the basic Chapman introduction to animal care “101” for investigators (PIs, faculty, students), for the IACUC member, etc.). If you are unsure which group you should choose, please contact your professor, PI, or the Office of Research (as appropriate) for further assistance.
• The groupings and the modules composing them are located here.
• You may take any other modules and repeat modules after you complete (and obtain a passing score) the group of modules in which you originally enrolled. Simply click on "Chapman University Courses," then click on "Add a course or update learner groups" which is on the CITI main menu page. A passing score - set by the Chapman IACUC - is 80% over all of the modules.
5. Course validity: A transcript (completion report) is generated when you complete the required group of modules. Use it to show evidence of training when submitting an animal use protocol, classroom activity, or something else.
• The IACUC has set three (3) years as the length of time for which the training is valid. This is subject to change should there be changes in regulations, campus policies, or research methodology. Investigators may be asked to complete additional training to fulfill requirements for other animal activities.
6. Obtaining, sending, or printing your CITI training report: The CITI Program does not offer certificates. Upon course completion you are issued a completion report, which will be e-mailed to the institution(s) you designated. It is also available to print directly from your account within the CITI software. This report serves as the official document issued by the CITI Program upon completion of a course. Follow this link to view instructions on where to find your CITI report and printing options.
Training in Specific Laboratory Practices
In addition to CITI training, all research/teaching personnel must display proficiency in the performance of the specific procedures described in each animal-use protocol. Evidence of training such as degrees, certifications, hands-on training should be included in the protocol application form. Competence is a measure of knowledge, skills, and aptitudes (KSAs). Be specific to the techniques, manipulations, and animals which are to be used in the protocol.
Many types of hands-on training are available from the vivarium manager and laboratory animal veterinarian. Contact the IACUC office for more information.
Related Training Items and Sources
• Rabbit handling: http://www.nc3rs.org.uk/category.asp?catID=19 (scroll down to the bottom of the NC3Rs page and under "Related resources" click on "AHWLA tutorial" for a short video on rabbit handling)
• The AALAS Learning Library is also a good source of training material. There are both free courses and others needing a paid subscription: http://www.aalaslearninglibrary.org/.
• Digital Resources for Veterinary Trainers: http://www.digires.co.uk/
• Procedures with Care tutorials: http://www.procedureswithcare.org.uk/
• The Journal of Visualized Experiments (JoVE) at http://www.jove.com/ provides unique techniques which may be of interest to particular researchers, although not all of them involve animals.
• Follow this link to hear a podcast about Wildlife Animal Research from AAALAC International.
• Education resources from the Office of Laboratory Animal Welfare (OLAW) at the NIH: http://grants.nih.gov/grants/olaw/educational_resources.htm
- Information to come.
- Information to come.