IACUC and IBC PROCESS

Transcription

1 IACUC and IBC PROCESS

2 Office of Research Services Resource Center Building Room 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

3 Institutional Animal Care and Use Committee (IACUC) Purpose To Protect the Welfare of Animals Used as Subjects in Research

4 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

5 IACUC Policies and Procedures developed in accordance with the following agencies. Rules and Regulations Animal Welfare Act [7 USC ; 7 CFR 2.22,2.80,371.29(g)] Guide for the Care and Use of Laboratory Animals 8 th Edition Public Health Service Policy on Humane Care and Use of Laboratory Animals Regulatory agencies: U.S. Department of Agriculture Office of Laboratory Animal Welfare (OLAW) Third Party Accreditation Association of Assessment and Accreditation of Laboratory Animal Care (AAALAC)

6 IACUC & IBC Web Pages and and

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8 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.

9 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

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11 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.

12 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. applications/forms to or Submit applications for review by the last Monday of the month for the next committee meeting. IBC Meeting is the 2 nd Wednesday and the IACUC Meeting is the 3 rd 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 me. If you have animal care questions, the veterinarians and the animal care technicians and managers are also available to assist you. Reply by when you receive IACUC or IBC annual or expiration notices. A certain person will nag you until you do!

13 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

14 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

15 Change in Personnel Form use once protocol is approved except if change in PI (same form to be used for IBC and IRB)

16 Change in Personnel Form Training MUST be completed prior to participation

17 Breeding Protocol One species per protocol ONLY genotyping procedure can be listed, all other procedures and manipulations must be describe in the research protocol.

18 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 3 rd Monday of the next month IBC protocol required Submit associated grant animal section READ and answer each item

19 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 grant 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. INITIAL The 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 neural circuits and modulatory influences in the induction and maintenance of tinnitus in the auditory system.

20 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 grant 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.

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27 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

28 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

29 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 2 rd Wednesday of the next month Submit associated grant READ and answer each item Same application is used for amendments

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39 Got some doubts, cannot figure it out. Call, or pop in for a visit to avoid project delays. Rose Castay, IACUC/IBC Coordinator Kenneth Kratz, PhD Leslie Birke, DVM, DACLAM Taylor Kriete, BSO Arnold Zea, PhD Jeff Schumacher, DVM Best to submit applications and forms to IACUCoffice@lsuhsc.edu or IBCoffice@lsuhsc.edu as multiple people are able process s from these accounts.