IACUC FAQ's
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Meeting Schedule & Deadlines
The IACUC meets twice a year, once in October/November (Fall meeting) and a second time in April/May (Spring meeting). The committee may also meet on an as-needed basis.
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Reviews
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Protocol Reviews
The IACUC evaluates scientific elements proposed in animal study protocols as they relate to the welfare and use of vertebrate animals in research and teaching. The Protocol is a detailed description of the proposed use of research or teaching animals. The IACUC uses guidelines outlined in the Guide for the Care and Use of Laboratory Animals in their evaluation of whether a protocol is approved, requires modifications, or approval is withheld. IACUC members named in protocols or who have other conflicts will recuse themselves from decisions on animal study proposals.
The IACUC utilizes two methods of protocol review, full committee review and designated member review. See OLAW guidance FAQs: https://olaw.nih.gov/guidance/faqs#B
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Full Committee Review (FCR)
The proposal will go to a convened IACUC meeting for discussion. Determination is made to approve, request modifications before approval is granted, or withhold approval. If modifications are requested, the committee may elect to subsequently send the protocol to designated member review.
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Designated Member Review (DMR)
DMR is the most frequently used method of protocol review by the Texas State IACUC. One or more committee members is designated as reviewer and acts on behalf of the full committee to approve or request modifications to secure approval. Designated reviewers may not withhold approval. They may refer any submission to the full committee for review.
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IACUC Process
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IACUC Process
In order to use vertebrate animals in research or teaching, an animal protocol must be completed and reviewed by the Institutional Animal Care and Use Committee (IACUC). No ordering or use of animals may begin prior to receiving written approval of the IACUC.
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Submit a protocol
- New protocols and triennial (de novo) reviews must be submitted in Kuali . A training manual is available here.
- Investigators are encouraged to consult with the Veterinarian for questions regarding protocol design, and the IACUC administrator for questions regarding IACUC submission processes.
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Protocol review timeline
The initial submission will be reviewed administratively for missing information and completion of training and OHS requirements. If substantial information is missing the protocol will be returned to the PI.
Designated member review may be utilized only after all members have been provided the opportunity to call for full-committee review. If any member requests full committee review within 3 days, then that method must be used. If not, the IACUC Chairperson may appoint one or more appropriately qualified IACUC members to serve as the designated reviewer(s). https://olaw.nih.gov/guidance/faqs#615
If the protocol is complete enough to go to the review process, it is assigned to designated member review or to full committee review. Full committee review is rarely utilized. Approved animal protocols are renewed on an annual basis and undergo a de novo review every three years as required by PHS policy.
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Protocol Expiration
When IACUC approval expires the protocol lacks valid approval. Continuation of animal activities in the absence of valid approval is a serious and reportable violation of PHS Policy. Kuali sends reminders of pending protocol expiration. To ensure no interruption of research activities the protocol should be submitted at least two months prior to the expiration date.
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Administrative review
Certain minor changes to protocols can be approved administratively such as change in contact information or addition or removal of personnel (except for the PI). If no other changes are made and if all training and OHP requirements are met, the amendment does not need to go through the standard review process and can be approved immediately.
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Semiannual Inspections
The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy), section IV.B.1.-2., requires the IACUC to review the institution's program for humane care and use of animals and inspect all of the institution's animal facilities at least once every 6 months using the Guide for the Care and Use of Laboratory Animals: Eighth Edition (Guide) as a basis for evaluation.
6 weeks before the scheduled IACUC meeting the committee must inspect all animal housing and use areas. A subcommittee of at least two members will visit each facility and use the OLAW inspection checklist as a basis for their inspection. Any items needing correction will be discussed at the time of inspection, followed by an email notification. If the issue is urgent, the committee may request immediate correction, otherwise a timeline for correction of any outstanding items will be established. A member of the IACUC, or a designee, will follow up to ensure any outstanding items have been corrected within the established timeframe.
A report of all inspection findings is prepared and reviewed during the IACUC meeting as part of the semiannual program review process. The report is then prepared and submitted to the Institutional Official.
Outcomes of review
Once a protocol is reviewed the Investigator receives a determination letter with one of three outcomes:
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Approved
Animal work may begin. Only procedures in the approved protocol may be conducted; an amendment must be submitted for review if any changes are made (including increase in animal numbers). Please mark annual review and de novo submission dates on your calendar to avoid any lapse in approval. Note: no research procedures may be conducted during a lapse of IACUC approval, and federal funds may not be used for housing per diems during this time.
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Modifications needed to secure approval
Additional modifications, justifications, or clarifications are required before final approval may be granted. This information will require review by either IACUC office staff and/or IACUC reviewers. A final approval letter will be sent once the modifications have been reviewed and approved.
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Withhold Approval
Significant information is missing, or federally mandated review criteria have not been met. Reasons for withholding approval will be provided.