University of Hawai‘i
Animal Welfare Program FAQs
When must I complete an IACUC Protocol Form?
An Institutional Animal Care and Use Committee (IACUC) animal use protocol form completion is required whenever live vertebrate animal subjects are involved in research studies, testing projects, and instructional activities. The IACUC is required to determine whether the proposed work is justified scientifically, and will be conducted ethically and humane standards applied. Only when the committee determines that these parameters are satisfactorily met will the IACUC approve the animal use protocol form, and the proposed work be allowed to commence.
What are IACUC Animal Use Protocol Form submission deadlines for IACUC monthly meetings?
Please refer to the IACUC Meetings and Deadlines. IACUC animal use protocol forms are due by noon of a set date for each month of proceeding month’s IACUC scheduled committee meeting.
Who do I contact should I need assistance on accessing the IACUC Animal Use Protocol Form or clarifying protocol questions?
Inquiries for accessing the IACUC Animal Use Protocol Form or clarifying protocol questions requested on the form can be directed to the IACUC Coordinator at 808/956-4552 and email email@example.com.
What is an acceptable IACUC Animal Use Form submission?
Only computer completed and transmitted, electronically signed and dated TOPAZ generated Animal Use Protocol Forms are accepted for submission. Hand-written or incomplete Animal Use Protocol Forms will be returned to the applicant.
How do I get a login for the TOPAZ Protocol Management System?
Who are allowed to submit the IACUC Animal Use Protocol Form?
Who is eligible to be Principal Investigator (PI) on an animal use protocol?
Which web-based TOPAZ form do I use?
Refer to the protocol renewal reminder letter that is sent approximately 2 months before the protocol expires. The reminder letter will indicate whether the protocol is due for an annual renewal or a full renewal (every 3 years).
- For new protocols – Create an Original Protocol in TOPAZ Elements
- For annual renewals – Create Renewal Protocol in TOPAZ Elements
- For full renewals – Create an Original Protocol in TOPAZ Elements, then click save. A toolbar will appear. Click on Copy Answers from Another Protocol
- For personnel amendments only – Create an Amendment Protocol in TOPAZ Elements, then access the Personnel Amendment Form
- For other amendments – Create an Amendment Protocol in TOPAZ Elements
- For significant revisions – Requires Creating an Original Protocol in TOPAZ Elements
*In switching to the new version of TOPAZ called Elements, renewals and amendments can only be created from an Original protocol in Elements. Protocols created in the old version of TOPAZ called Enterprise must use the renewal and amendment forms for Enterprise until the 3 year renewal when an Original request in Elements can be submitted.
What is considered a significant revision?
The following categories are considered significant revisions:
- A change in study objectives
- A switch from non-survival to survival surgery
- A procedure resulting in a greater degree of invasiveness or discomfort to an animal, including a Category E procedure to a previously approved protocol
- Requesting a greater than 25% increase in animal numbers
- Changes that impact personnel safety
- A change in housing location no previously approved by the IACUC
- A change in species that requires new or revised permit conditions, IBC review, or housing in a new location not previously approved by the IACUC
Is the IACUC Animal Use Protocol Form accepted by electronic or physical mail delivery?
Completed and electronically signed IACUC Animal Use Forms are accepted only through the TOPAZ Elements interface. Physical mail delivery is not accepted.
When can I determine the status of an IACUC Animal Use Protocol Form post-IACUC meeting?
An IACUC Animal Use Protocol Form status report is usually sent to the PI within 24-72 hours post-IACUC meeting. Applicants are notified in writing 5-7 business days post-IACUC meeting.
What is the length of time IACUC approval is valid?
IACUC approval is valid for 3 years. Continuance of the IACUC activity is dependent upon renewal and laboratory or site of activity inspection. An IACUC Animal Use Protocol Renewal (Annual or de novo) Form is required to be completed and submitted for renewal to the IACUC for assessment to ensure the activity is renewed and permitted to continue. Contact the IACUC Coordinator at 808/956-4552 for details.
Do I need an IACUC protocol for observing animals in their natural environment without harming or materially altering their behavior?
No. Refer to IACUC Policy 1. Field Studies at https://researchcompliance.hawaii.edu/programs/animal-welfare/aw-policies/.
Submit a written request to the Animal Welfare Program Office for an exemption.
Do I need an IACUC protocol for using vertebrate animal tissues, cell lines, etc?
No. Submit a written request to the Animal Welfare Program Office for an exemption. Include the following information:
- The material that will be used and where it is originally obtained. If it is a commercial vendor, include the company name, address and product stock number.
- Provide a brief description of how the material will be used and the purpose for its use.
I want to add personnel to my protocol but don’t see the individual listed in the TOPAZ Staff list.
Protocol associates are added to the TOPAZ staff list after completing the basic animal welfare training course in CITI (Collaborative Institutional Training Initiative), titled Investigator, Staff and Student Basic Course.
Do students have to be added to teaching and training protocols?
What is Post-Approval Monitoring or PAM?
Post-Approval monitoring is a specific process by which an Animal Welfare Program Office representative or IACUC member and an institutional veterinarian conduct animal use protocol evaluations to ensure that research, testing, or instruction is being conducted according to the approved IACUC animal use protocols. The evaluation process is applied to approved protocols especially those involved in biomedical or neurosciences interests because it is an required expectation of AAALAC Accreditation standards.
What is the Fish Advisory Committee or FAC?
The Fish Advisory Committee was organized in 2013 at the recommendation of the Animal Welfare Program Office and Office of Laboratory Animal Welfare (OLAW) because of the large numbers of aquatic species and programs used for research and testing at the University of Hawaii. The FAC conducts business biannually and concentrates efforts on only aquatic species and the programs that uses them. The FAC work closely with the IACUC, but work independently using a specifically designed checklist for their evaluations. Members of the FAC are appointed to the committee by the Animal Welfare Program Institutional Official for 4 consecutive year terms.
What are the procedures for guests request to attend IACUC meetings?
Non-committee guest that are interested in participation or to attend an IACUC meeting are required to contact the Office of Research Compliance to make a request.
Please provide the information listed below in the contact box with the request for attending the IACUC meeting of interest. The decision to consider and reply to the request may take 48-72 business hours or longer.
- Full name of attendee(s)
- Telephone Number
- Email Address
- Affiliation to the University of Hawaii
- Reason for Attending
How may someone make a request to obtain IACUC meeting minutes?
Upon request, the University will consider pursuant to the Hawaii State Office of Information Practices, the Uniform Information Practices Act (UIPA), HRS Chapter 92F, which requires open access to government records. Federal regulations will also be considered such as the Freedom of Information Act.
Copies of the IACUC meeting minutes will be provided upon request within 10 business days. Information considered confidential, proprietary, or intellectual property may be redacted and will take longer to release. Handling fees and services charges may be applied to the request. Please provide the information below with the request for obtaining copies of IACUC meeting minutes by contacting the Office of Research Compliance.
Please provide the information listed below in the contact box with the request for requested the IACUC meeting minutes of interest. The decision to consider and reply to the request may take 48-72 business hours or longer.
- Telephone Number and Mailing Address
- Email Address
- Affiliation to the University of Hawaii
- Month and Year of IACUC Meeting(s)