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Topaz navigation V1.2 07/20013 The Hitchhikers guide to Navigating Web Protocol and Review (TOPAZ) Log into Topaz at: https://apps.dar.emory.edu/TOPAZEnterprise/ Note : PIs and staff working directly with TOPAZ are strongly encouraged to attend TOPAZ training. Please contact the IACUC for training schedules at [email protected] The following pages may at first appear daunting! They are Comprehensive, Systematic and Extensive. But they will get you through virtually every aspect of completing your Topaz IACUC protocol. SO Disclaimers DON’T PANIC! : 1. The following document was prepared by active IACUC members BUT does not represent the official view of Emory University, the School of Medicine, the Department of Medicine, the Emory IACUC Office, the IACUC committee, the Division of Animal Resources or any other person real or fictitious, living or deceased. 2. Topaz receives regular updates to improve functionality and to stay abreast of ever changing Federal Regulations and Guidelines. Some of the complex rules and regulations are further open to interpretation. Consequently, accuracy cannot be guaranteed and some information is based on informed opinion only! 3. This is only a guide and individual judgment must be exercised when completing any Animal Protocol. 1 Topaz navigation V1.2 07/20013 Index: A. Iconology B. Topaz explained (Page 3) C. Important Tips and Considerations for completing Topaz Protocols (Page 4) D. Common Non-compliance Issues to be aware of when writing a new IACUC protocol (Page 8) E. New and Three Year Renewal Protocol Preparation using (Topaz): Step-by-Step Guide (Page 10) F. Annual Renewals (Page 53) Adding a new person to an existing approved IACUC protocol (Page 57) 2 A: Topaz Iconology explained Topaz navigation V1.2 07/20013 Click to add a box or row of information, may also bring up a selectable window. “Help” - Additional Information Available (Click on icon) Delete Section Attach a File Expand or contract a section. WARNING: Accidentally clicking this box can lead to sections being obscured and not completed causing a delay in approval. Compulsory Section – Must be completed to Submit protocol Attach an Image File 3 B: Important Tips and Considerations for completing Topaz Protocols: Topaz navigation V1.2 07/20013 Read “The Guide”: NIH Guide for the Care 1. and Use of Laborat Tohrye Abansiimc parlsin“cTiphlee sG guoidveer”ning Federally funded animal research, and upon which many IACUC rules and regulations are based, are contained in the . Anyone performing animal research should have read and be familiar with this document! Significant changes to Topaz have recently been implemented to conform to new guidelines contained in the Eight Edition of the guide released in 2011 and now officially adopted by the IACUC. The Guide is available for download at: Shatvtpe:/o/ftgernan:ts.nih.gov/grants/olaw/Guide-for-the-Care-and-Use-of-Laboratory-Animals.pdf 2. ord proce Ssasvoer :after cowmoprlde tpinrgo ceeascsho srection to avoid loss of information. copy and paste 3. W Use a to compile sentences and paragraphs and into Topaz. This way you maintain a record of the document should a save fail or the computer/network crash unexpectedly. 4. BChe eacwka srpe ethllaint gT:OPAZ requires that Microsoft cShilevcekrl isgphetl blien ignstalled on your computer (browser). ABC 5. Use your Word Processor to before pasting into Topaz. In addition most sections can be spell checked from within Topaz using the “ ” symbol on the formatting bar. Excessive typos and spelling errors annoy reviewers, can obscure information, and may be returned for correction. ProtocolNoncompliance: legally binding agreement ProtocolNoncompliance 6. An approved protocol constitutes a and not following the protocol exactly as written constitutes with potentially serious repercussions. Be specific and precise wherever possible to avoid ambiguity. Avoid making broad statements that are not practical in reality such as “monitoring twice daily for 6 months”, or “injecting an analgesic every 6 hr for 24 hr (will you really come in at 3 AM to inject)! You will be expected to follow everything you write in the protocol to the letter once it is Aapdpdrroevsesdin, sgo t mhea kVee steurrein warhya tC yoonus uprlto:pose is actually realistic and can be done. Veterinary consult comprehensively 7. All protocolsV aertee irninitaiarlyly q sueenrt ifeosr a veterinary consultation. Recommendations from yourW ILL need to be addressed before returning your protocol for further review. may sound like “suggestions” but reviewers expect them to be implemented or a convincing scientific rationale and justification provided for why this cannot/should not be done. It is usually best to provide empirical data to support any such objectionnos tor cite convincing published literature to support your arguments. A “gut feeling” that changing the procedure may impact your study, or a lack of familiarity with new techniques usually will suffice. In some cases the IACUC may rDeoq uneostt fae epli lyoot ust aurdey bbeei pnegr pfoerrmseecdu ttoe sdu oprp osirnt gyloeudr o“guutt feeling”. 8. ! Because the veterinary consult and IACUC Reviews serve different functions almost all protocols are returned from the veterinary 4 Topaz navigation V1.2 07/20013 consult for clarifications or modifications, and at least once from IACUC review for clarifications Worh meond aifdicdarteiosnsisn. Dg oth neo vt efeteelr yinoaur ayr ec obnesinuglt p oerr sreecvuiteewd eorr csoinmgmlede notust !d o not be confrontational, rude or belligerent! 9. This will dramatically slow down your approval. Reviewers are volunteers who dedicate considerable amounts of precious time to serving the Emory community. It’s in everyone’s interests to get protocols approved in the minimum amount of time and with the least number of iterations possible. Reviewer and veterinary comments are designed to address specific legal, regulatory, animal welfare, animal and human safety issues, to safeguard the PI and his lab and Emory University from harm and legal actions, and to preserve the good name of the Institution. Without these safeguards, animal research at Emory would not be possible! The underlying reasons for veterinary and reviewer queries may not always be obvious to the applicant, but are seldom frivolous. If unsure about how to address a specific query the IACUC office can usually help interpret the comment or request a clarification from a reviewer (RIeAgCuUlCa@tioenmso Cryh.aenduge o frr Teeqlu: 4en04tl-y7.12-0734). 10. Legal and regulatory requirement change periodically and the IACUC/DAR continually work to refine and improve procedures and techniques for optimal animal welfare and for scientific rigor. Just because you were approved to perform something in a certain way in the past does not mean your protocol will be approved that way in a renewal or a new submission. This can be frustrating but try to be open to new ways of doing things and use strong scientific justifications (not “gut feelings” or hearsay) to justify not making recommended cDhoa nngoets s. i mply cut and paste whole sections from a grant. 11. Reading many pages of superfluous material can slow down the review process. Present the information in a compact, easily understandable and pleasing format for easy assimilation by reviewers who, unlike a study section, are likely NOT experts in your area of research but like grant reviewers, do not want to sTthrueg cgolep yto f uunncdteirosnta. nd what you are doing or why. copy 12. When creating a three-year rSeanveewal or a new protocol you can use the function to transfer all information from a previous approved application. Note that the copy function only becomes active following the first “ ” of the new protocol. The copy function can save tremendous amounts of time in completing a protocol BUT is a frequent source of “remnants” from other studies that are returned for correction during review. Remember to check each section for accuracy and to remove redundant or inappropriate artifacts that may hTahvree bee-eyne acro preiende awcarolss.s from another protocol but are not relevant to the new protocol. Save 13. When creating aN t.Bhr. eDeo-y NeOarT r teincekw tahle y “oTuh nreeeed y teoa crr reeantee aw Nael wbo bxl”a nink Pthreo toorciogli annadl euxspe itrhien gco ppryo ftuonccotli oann dfo dlloo wniontg r tehvei sfier stth “e info”r omf athtieo nne iwn tphreortoec. oTlh tois t braonxs ifse ra tnh e ianrftoirfamcat taionnd fyroomur t phreo otroigcoinla wl pilrlo bteo croelt. urned by the IACUC office requesting all the information to be copied into a New blank protocol! Cage Cards: different It is critical to print new cage cards and update the cards 14.for any existWinhge ann ai mtharlese c-yaerarry irneng eowvaelr p ornottoo ctohle i sn aepwp rporvoetdo cthoel! Protocol number will be to the original protocol. 5 VA funded studies: Topaz navigation V1.2 07/20013 15. ACORP prior When VA funded studies are performed wholly or in part at Emory though partial or full off site waivers there is a requirement for a preapproved VA Animal Protocol ( ) to submitting an Emory IACUC protocol. The Emory IACUC office is in the process of developing a significantly shorter streamlined Topaz form to address Emory IACUC specific questions not covered in the VA ACORP without generating tremendous redundancy and thus minimizing PI burden. Please consult the IACUC office BEFORE beginning a new Topaz protocol iDnovDol vfuinngd VeAd fsutunddeieds o: r VA sponsored research. prior 16. When DoD funded studies are performed wholly or in part at Emory a pArLeTaBppIBro:AveLdT DBoIBD Animmaaln Pdraottoorcyol is required to submitting an Emory IACUC protocol. 17. is a database for Alternatives search. ALTBIB can be found here: hAtdtpv:e/r/steo xenveetn.ntlsm: .nih.gov/altbib.html 18. Fully document any possible complications of procedures and reagents administered to avoid having to file an adverse event report to the IACUC should animals become sAinckti obro ddiye .P roduction using Commercial Sources: 19. Be aware that even if you are using a commercial company to generate polyclonal or monoclonal antibodies for your studies you are still required to have an approved Emory IACUC protocol for the production of the antibodies if animals are used by the commercial source. This does not apply to antibodies freely available fBrroimng cionmg mAnerimciaall ss oounrtcoe sE, monolryy u Pnriqoupee artnyt:ibody production specifically contracted by you! 20. Any animals brought onto Emory property for any reason whatsoever (even if just temporarily for a short imaging procedure) must be covered by aAnl la spipterosv uesde Edm foorr ya nIAimCUaCls p mroutsotc oble. approved: 21. Animal procedures may not be performed outside of DAR/Yerkes Facilities without pre-approval and in spection of those sites by the IACUC. S tate explicitly in the protocol every site (including the building and room number) where animal aTcrtiavnitsipeso wrtiilnl gb ea npeimrfoarlsmed including surgeries, imaging, etc. 22. : Transporting animals between labs and housing, building and campuses is strictly regulated and must be done in accordance with IACUC policies. While it is encouraged to use DAR resources for the transportation of animals it IS permissible for lab members to transport animals themselves. However, this MUST be done in accordance with the Transportation policy AND MUST BE Specifically APPROVED in the IACUC protocol. There is currently no section to request this approval so be sure to place a statement explaininMga tkhee snuereed tyoo tur arnesapdo trht ea npiomliaclys,! f rom where to where and how it will be accomplished (using DAR resources AND/OR by the lab) and state specifically that the IACUC policies will be adhered to. Modifications to approved protocols: marking 23. D espite the instructions in Topaz suggesting that this is unnecessary, using a colored font and/or otherwise changes (e.g. “Protocol Modification 1 (03/03/13)”) greatly facilitates Revieweven though reviewers have access to comparison software. Change colors or mark clearly for subsequent modifications, but do not attempt to change previously colored font back to black, as ALL changes will show up as modified text and create confusion and delays. 6 Topaz navigation V1.2 07/20013 24.Do not make changes OTHER than those specifically described in your modification as all changes are logged. Even fixing an irrelevant typo will be flagged during review as a change in the approved protocol. search for Alternatives 25.When making changes to procedures do not forget to update the to painful/stressful procedures, if applicable. Reviewers are required to check for this. 26.Ignorance of IACUC/DAR regulations is not an acceptable excuse! If in doubt check with the IACUC office, or the DAR/Yerkes veterinary staff, as appropriate. They are knowledgeable and h elpful! 7 C. Common Non-compliance Issues to be aware of when writing a new IACUC protocol. Topaz navigation V1.2 07/20013 When submitting or revising an IACUC protocol it is important to be aware of the repercussions (oAf dParpotteodc ofrlo nmo:n h-tctopm:/p/wliawnwce.ia acnudc. etom coorny.setdruu/cpto yloicuiers P/drootcoucmoel nints a/ nwoanyc otmhaptl imaninceim.pdizf e)s any chance of a minor or major non-compliance from occurring. Note: See the following document for detailed explanations of the point system for infractions, repercussions or various infractions and corrective actions that may be assessed: http://www.iacuc.emory.edu/policies/documents/noncompliance.pdf NB: The definitions of “Serious” and “Minor” do not necessarily reflect the severity or seriousness of the infraction, but refer rather to the category of the infraction. Almost all infractions will have consequences and should be avoided at all costs. Repeat violations will always have exacerbated consequences. Serious Non-Compliance Issues: directly resulting in animal distress or suffering serious” Deficiencies or infractions are considered “ issues. directly results in animal distress If an occurrence of non-compliance , the IACUC Chair and/or v Eextearminpalreys sotaf fsfe mriaoyu isn atenrirmupatl awlle alfnairmea al nwdo/rokr i mhummedaina tsealfye ptye nisdsinuge sa: review. • • Performing a procedure in such a manner that animals endure distress, pain, or suffering that is not addressed in the approved protocol • Acquiring animals for research without IACUC approval and/or knowledge of the animal resources program. • Not performing, or inadequately applying a physical means, to assure death when euthanatizing a•nimals. • Not following aseptic technique as described in the protocol when performing survival surgery • Failure to monitor animals adequately following an invasive procedure • Extreme cage overcrowding (as defined in IACUC policy) Not administering analgesics as required in the approved IACUC protocol • Not following safety procedures such that personnel are unknowingly exposed to hazards (e.g. • dangerous chemicals, radioactivity, biohazards) Interfering with the veterinary staff and/or failing to adhere with veterinary-mandated instructions M Cinoonrd uacntiimnga al nwimelafal-rreel, aItAeCdU aCct pivoiltiiceys ,b aenydo nrde gthuela etxopriyr agtuioidne dlaintee se sitsasbuleisshed by the IACUC non-compliance issues that do not directly result in animal pain or distress minor animal welfare minor or m:a jor regulatory issues WExiathm rpelsepse:ct to . This is s•ubdivided further into issues and/or . • • Housing animals in a laboratory or other site without approval Allowing new personnel to work with animals before completing IACUC requirements • Insufficient records of monitoring animals (disease condition, PI care, survival surgery, post- procedure care) Personnel ignorant of protocol content 8 • Topaz navigation V1.2 07/20013 • • Performing unapproved procedure without causing pain or distress • Failure to adhere to IACUC expired drug policy without specific exemption • Controlled substances not secured properly or dispensing logs not kept • Failure to respond to the IACUC by designated deadlines • Failure to participate/cooperate in the semi-annual inspection and/or review process • Not participating in the Occupational Health and Safety Program where it is mandatory Improperly labeled bottles or secondary containers • Relocating a laboratory without properly notifying the IACUC; research conducted in unapproved • areas • Improper waste disposal practices • Exceeding the number of animals approved on the study (e.g., breeding colonies) • Overcrowded animal enclosure(s) Improper laboratory or animal facility attire • Cage cards not containing required information (e .g. date of surgery, chemical administration, tumor inoculation, etc.) • Failure to maintain cleanliness, hygiene and up keep of lab space where animal work is done Failure to follow established IACUC policy. 9 D. New and Three Year Renewal Protocol Preparation using (Topaz): Step-by-Step Guide. Topaz navigation V1.2 07/20013 Throughout the Topaz protocol clicking on the blue “i” button will bring up additional information on completing the relevant box. However, be aware that some of this information can be out of date as regulation changLe opge riniotdoi cTaollpya. z at: https://apps.dar.emory.edu/TOPAZEnterprise/ Start Page “ 1. Click on the “ (Left Top of Window). Animal Protocols 2. Click on “ ” 2. Click “Create Original Protocol” 3. The following Box will Appear. 10
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