IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To...
Transcript of IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To...
![Page 1: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/1.jpg)
IACUC and IBC PROCESS
![Page 2: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/2.jpg)
Office of Research ServicesResource Center Building Room 206 504-568-4970
• Kenneth Kratz, PhD – Director, Chairman of IRB and IACUC• Staff:
• Nicole Hammill – Pre-award Grants and Contracts• Anissa McDougle– Conflict of Interest, Grants/Contracts• Dyan Melson – IRB• Lynn Arnold – IRB• Kadie Rome – IRB• Rose Castay – IACUC/IBC• Thanh Vu – Student Worker• Thong Pham – Student Worker
• Arnold Zea, Ph.D. – Chairman of IBC
![Page 3: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/3.jpg)
Institutional Animal Care and Use Committee(IACUC)
Purpose
To Protect the Welfare of Animals Used as Subjects in Research
![Page 4: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/4.jpg)
How does the IACUC provide protection?
By ensuring compliance with all federal, state and local laws and regulations governing the use of animals.
• IACUC Policy and Procedure Guidelines• IACUC application – Review and approval by full committee
• Annual reviews, amendments, personnel changes
• Semi-annual Animal Care Facility Inspection • Includes investigators’ laboratory and any other area where live animals are taken.
• Semi-Annual Program Review• Includes IACUC and institutional policies, education and occupation health surveillance
• Review concerns and advise the Institutional Official • Suspend PHS-supported activities if necessary
![Page 5: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/5.jpg)
IACUC Policies and Procedures developed in accordance with the following agencies.
Rules and RegulationsAnimal Welfare Act [7 USC 2131-2159; 7 CFR 2.22,2.80,371.29(g)]
“Guide for the Care and Use of Laboratory Animals” 8th Edition
Public Health Service Policy on Humane Care and Use of Laboratory Animals
Regulatory agencies:U.S. Department of AgricultureOffice of Laboratory Animal Welfare (OLAW)
Third Party AccreditationAssociation of Assessment and Accreditation of Laboratory Animal Care (AAALAC)
![Page 6: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/6.jpg)
IACUC & IBC Web Pages and [email protected] and [email protected]
![Page 7: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/7.jpg)
![Page 8: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/8.jpg)
IACUC Applications & Forms
• IACUC application is required for the use or breeding of live vertebrate animals.
• IACUC Tissue Form is required for animal tissue or materials that will be shared between approved IACUC protocols or for the use of animal tissue or materials that will be taken from an euthanized animal incidental to the original use of the animal.
• IACUC Amendment must be submitted for approval PRIOR to initiating a change to the protocol. Use the Change in Personnel Form when adding personnel.
• IACUC applications are approved annually for up to three years when a renewal application must be submitted to continue the project.
![Page 9: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/9.jpg)
Institutional Biosafety Committee(IBC)
Purpose • To protect individuals and research animals from potential dangers in the
use of or exposure to such things as pathogens, organs or tissues of biological origin, genetic therapy products, transgenic genes, bacteria, viruses, prions and chemicals and toxins that may affect health.
• To assure that the Institution is in compliance with all state and federal regulatory agency bio-safety requirements, e.g. rDNA research as described in the NIH GUIDELINES FOR RESEARCH INVOLVING RECOMBINANT DNA MOLECULES (NIH GUIDELINES)
• To review projects for use of “Select Agents” under the Select Agents Program of DHHS and USDA and/or “Dual use items” under export control regulations of the Department of Commerce
![Page 10: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/10.jpg)
![Page 11: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/11.jpg)
IBC Applications• IBC Oversight is required for research with
• Physical human contact • Physical animal contact • Use of biological materials, pathogens, toxins or rDNA
• IBC Amendment must be submitted for approval PRIOR to initiating a change to the protocol. Use the Change in Personnel Form when adding personnel.
• IBC applications are approved annually for up to five years when a renewal application must be submitted to continue the project.
• Exemption from IBC Oversight if there is NO human or animal contact• Chart review or data collection• Survey or questionnaire by telephone, mail, web or in person but with NO PHYSICAL CONTACT• Special circumstances upon request• If exempted, no annuals or renewals. • If exemption status changes, a full IBC application must be submitted.
![Page 12: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/12.jpg)
Best way to navigate through the process• Always download forms from the websites for the latest version.• Follow the instructions.• Answer each question completely or enter “N/A” where appropriate.• Email applications/forms to [email protected] or [email protected]• Submit applications for review by the last Monday of the month for the next
committee meeting. IBC Meeting is the 2nd Wednesday and the IACUC Meeting is the 3rd Monday of the month
• Make sure every participant completes all training for activities to be performed.• Need help with forms or have questions, call or email me. • If you have animal care questions, the veterinarians and the animal care technicians
and managers are also available to assist you.• Reply by email when you receive IACUC or IBC annual or expiration notices.
A certain person will nag you until you do!
![Page 13: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/13.jpg)
IACUC Applications and Forms
• Breeding Protocol Application• Research Protocol Application• Amendment Application• Transfer or Use of Animal Tissue or Materials Form• Amendment Form• Change in Personnel Form• Annual Review Form
![Page 14: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/14.jpg)
Transfer or Use of Animal Tissue or Materials Form
When to use• Animal tissue or materials will
be shared between approved IACUC protocols.
• Animal tissue or materials will be taken from an euthanized animal incidental to the original use of the animal
Must be covered by an IBC protocol
![Page 15: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/15.jpg)
Change in Personnel Formuse once protocol is approved except if change in PI
(same form to be used for IBC and IRB)
![Page 16: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/16.jpg)
Change in Personnel FormTraining MUST be completed prior to participation
![Page 17: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/17.jpg)
Breeding Protocol
• One species per protocol
• ONLY genotyping procedure can be listed, all other procedures and manipulations must be describe in the research protocol.
![Page 18: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/18.jpg)
Research Protocol
• Required for all live animal work• Annual review and re-approval required• Maximum approval is 3 years• Submit by last day of the month for
committee review on the 3rd Monday of the next month
• IBC protocol required• Submit associated grant animal section• READ and answer each item
![Page 19: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/19.jpg)
Summary -NON-TECHNICAL [Language understandable to a high school graduate]. 1 Briefly summarize the specific aims and scientific purpose; 2 include how this study may benefit human or animal health or advance the scientific understanding of biological processes. 3 State which species will be used and describe how the animals will be used to achieve your goals. Do not use a g rant abstract. Spell out any abbreviations and explain any technical words that must be used. Do not exceed 400 words. Do not include references to published work in this section or any other section of this application. Do not provide summaries of past accomplishments.
INITIALThe aim of this study is to understand the cellular and circuit mechanisms underlying the establishment and maintenance of tinnitus. Tinnitus is an auditory disease, typically initiated by peripheral hearing damage, that results in a phantom perception of sound. Using a combination of retrograde neural labeling, genetic manipulations, electrophysiological recording and optical stimulation techniques this project will characterize how intrinsic properties of auditory neurons and the short- and long-range connections they make changes with tinnitus. Tinnitus will be induced in mice by prolonged exposure to loud sounds. Hearing performance and behavioral evidence of tinnitus will be assessed by measuring auditory brainstem responses and measuring a mouse’s ability to make fine frequency discriminations. Mice brains will be injected with fluorescent tracers that get taken up by local axon terminals and retrogradely transported back to the neurons that originate the axon projections. Injection suspensions will also include AAV, a viral vector used deliver genes to specific neurons that promote the expression of light sensitive ion channels (ChR2). We will inject AAV in four different brain centers: PFC, NB, VTA and nucleus accumbens. For injection in PFC, NB and VTA we will be recording simultaneously from 3-4 neurons in prepared brain slices to asses synaptic circuit properties in the auditory cortex. The mice will be euthanized and brain slices will be collected for electrophysiological recording and characterization of neuron microcircuit architecture and function. These combined techniques allow for identification and control of auditory neural circuits that are involved in the disease tinnitus. A large body of research has shown that changes in the balance of excitatory and inhibitory neurotransmission at multiple stages in the ascending auditory pathway, accompanies tinnitus. However, how these changes directly relate to the function and coordination of assemblies of neurons is unclear. Furthermore, how extra auditory areas gate or control the auditory system response to tinnitus inducing factors is not well understood. The advance in understanding gained from achieving the goals in this project will help to isolate and identify the role of neuralcircuits and modulatory influences in the induction and maintenance of tinnitus in the auditory system.
![Page 20: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/20.jpg)
Summary -NON-TECHNICAL [Language understandable to a high school graduate]. 1 Briefly summarize the specific aims and scientific purpose; 2 include how this study may benefit human or animal health or advance the scientific understanding of biological processes. 3 State which species will be used and describe how the animals will be used to achieve your goals. Do not use a g rant abstract. Spell out any abbreviations and explain any technical words that must be used. Do not exceed 400 words. Do not include references to published work in this section or any other section of this application. Do not provide summaries of past accomplishments.
REVISED
Tinnitus is an auditory disease, typically initiated by peripheral hearing damage, that results in a phantom perception of sound, such as ringing in the ear. The aim of this study is to understand the cellular and circuit mechanisms underlying the formation and maintenance of tinnitus. We will characterize the fundamental properties of auditory neurons and the short- and long-range connections they make changes with tinnitus.
The brains of mice will be injected with fluorescent tracers. Tinnitus will be induced in mice by prolonged exposure to loud sounds. The presence of tinnitus-like behavior will be assessed by testing the mice’s ability to discriminate sounds that are similar in frequency to the tinnitus perception. Mice will be euthanized to collect brain samples. The neural basis for tinnitus like behavior will be tested by doing electrophysiological recordings of neurons in brain slices and optically stimulating specific auditory pathways that have been transfected with the fluorescent tracers. Retrograde labeling of neurons will be used to identify the role of specific types of projection neurons in the induction and maintenance of tinnitus behavior in mice.
![Page 21: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/21.jpg)
![Page 22: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/22.jpg)
![Page 23: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/23.jpg)
![Page 24: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/24.jpg)
![Page 25: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/25.jpg)
![Page 26: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/26.jpg)
![Page 27: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/27.jpg)
Institutional Biosafety Committee IBC Applications and Forms
• Full Protocol Application and Amendment• Request for IBC Exemption• Change in Personnel Form – same as the IACUC• Annual Review Form
![Page 28: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/28.jpg)
Request for Exemption from IBC Oversight
Use when research does NOT have• human contact• biological, chemical or radiation• rDNA work• Animal tissue or materials will
be taken from an euthanized animal incidental to the original use of the animal
May be associated with an IRB, never with an IACUC
![Page 29: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/29.jpg)
IBC Full Application
• Required for all research not IBC exempted regardless of requiring an IRB or IACUC protocol
• All IACUC and IRB projects require IBC• Annual review and re-approval required• Maximum approval is 5 years• Submit by last day of the month for
committee review on the 2rd Wednesday of the next month
• Submit associated grant• READ and answer each item• Same application is used for amendments
![Page 30: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/30.jpg)
![Page 31: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/31.jpg)
![Page 32: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/32.jpg)
![Page 33: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/33.jpg)
![Page 34: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/34.jpg)
![Page 35: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/35.jpg)
![Page 36: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/36.jpg)
![Page 37: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/37.jpg)
![Page 38: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/38.jpg)
![Page 39: IACUC and IBC PROCESS - LSU Health Sciences …€¦ · IACUC application – Review and ... To protect individuals and research animals from potential dangers in the ... e.g. rDNA](https://reader031.fdocuments.net/reader031/viewer/2022022018/5b8685ce7f8b9a195a8cf6fa/html5/thumbnails/39.jpg)
Got some doubts, cannot figure it out. Call, email or pop in for a visit to avoid project delays.
Rose Castay, IACUC/IBC Coordinator Taylor Kriete, BSOKenneth Kratz, PhD Arnold Zea, PhDLeslie Birke, DVM, DACLAM Jeff Schumacher, DVM
Best to submit applications and forms to [email protected] or [email protected] as multiple people are able process emails from these accounts.