The Animal Study Lifecycle
Getting Approval for your Animal Study
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Submit Your Protocol in the ORCA System
Applications for the use of animals in researchResearcha systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. , teaching or testing at UT Health SA are submitted to the IACUC via the Online Research Compliance Assistant (ORCA).
The IACUC may use one of the following two processes when performing a review of your business item:
- -Full Committee Review (FCR) by a convened meeting of the IACUC; OR
- -Designated Member Review (DMR) by one or more IACUC members who are designated reviewerDesignated Revieweran experienced member designated by the Chair to review business items on behalf of the committee. .
The UTHSA IACUC routinely uses Full Committee Review for the following items:
- -New protocols involving USDA covered speciesUSDA Covered SpeciesUSDA regulations pertain to all vertebrates except the following: 1) Birds bred for use in research; 2) Rats of the genus Rattus bred for use in research; 3) Mice of the genus Mus bred for use in research; or 4) Horses not used for research purposes
- -New protocols involving use of unalleviated painful or distressful procedures (i.e., USDA Category E)
- -New protocols involving Deviations or Departures from the Guide for the Care and Use of Laboratory Animals
The UTHSA IACUC may use Designated Member Review to review new protocols that do not meet the criteria for FCR.
Other Committee Approvals
Some researchResearcha systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. protocolProtocolstep-by-step details of how a study will be conducted including objectives, design, procedures, measurements, management and analysis, as well as a discussion of relevant research ethics issues. components will require review and approval by additional committees at UT Health SA or other institutions.
When the study involves Committee approval required Learn more
A researcher who has a conflict of interestConflict of Interestrefers to situations where the individual has the opportunity to influence the Health Science Center's business, administrative, academic, research, clinical, or other decisions in ways that could lead to personal financial gain or advantage or could appear to cause bias in the design, conduct, or reporting of research or educational activities. (COI) related to the research
Conflict of Interest Committee (COIC)
If needed, a COI Management Plan is created by the COIC and forwarded to the designated IACUC for final approval.
Biologic hazards, microbiologic or viral agents, pathogens, cell lines, non- FDA approvedFDA Approvedor cleared refers to FDA having issued premarketing approval (PMA) or cleared the device for marketing via a Premarket Notification 510(k). vaccines, recombinant DNA, or human gene therapy
Institutional Biosafety Committee (IBC)
Radiation exposure, radioactive materials, or radiation generating equipment
Radiation Safety Committee (RSC)
Use of certain hazardous chemicals that pose a significant health riskRiska potential harm described in terms of probability (chance) and magnitude (severity). to employees
Chemical Safety Committee (CSC)
The Institutional Biosafety Committee, Radiation Safety Committee and the Radioactive DrugDrug1) a substance recognized by an official pharmacopoeia or formulary; AND 2) a substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease; AND 3) a substance (other than food) intended to affect the structure or any function of the body; AND 4) a substance intended for use as a component of a medicine but not a Device or a component, part or accessory of a device. Note: biological products are included within this definition and are generally covered by the same laws and regulations, but differences exist regarding their manufacturing processes (chemical process versus biological process). Research Committee are supported by the Environmental Health and Safety Department. Learn more about Environmental Health and Safety Department
Prerequisite Research Training
All personnel involved with the care, treatment and use of laboratory animals must be adequately trained, educated and qualified to perform their duties. Training modules are available through the CITI Program. The DLAR Office offers several training opportunities including vivarium training and specialized training such as surgical techniques and breeding colony management.
Learn more about the Training Requirements for Personnel
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