Monash University Procedure. Ethical Research and Approvals Policy. Research, Ethics and Compliance Manger. Academic Quality and Standards

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1 Mnash University Prcedure Prcedure Title Parent Plicy Date Effective Review Date Prcedure Owner Categry Ethical Research and Apprvals: Scientific Activities Invlving Animals Prcedures Ethical Research and Apprvals Plicy 25-Nvember July-2017 Research, Ethics and Cmpliance Manager Academic Quality and Standards Versin Number 1.1 Cntent Enquiries Scpe Purpse Research, Ethics and Cmpliance Manger Applies t all Mnash University staff and students, full time, part time, casual r adjunct, frm Australian Mnash University campuses, wh hst, cnduct, participate in r disseminate the results f research invlving human r animal subjects. Visitrs t an Australian University campus wh participate in research are als cvered by this plicy. T ensure that research cnducted under the auspices f Mnash University cmplies with the Australian Cde f Practice fr the Care and Use f Animals fr Scientific Purpses when using live animals fr research. PROCEDURE STATEMENT 1. Research Gvernance Mnash University staff and students wh use animals in research and teaching activities have a mral bligatin t treat the animals with respect and take int cnsideratin all aspects f the animals welfare when designing and cnducting research activities. Staff and students using animals in research activities must cmply with the requirements set ut in: The Preventin f Cruelty t Animals Act 1986 (Vic); The Preventin f Cruelty t Animals Regulatin 2008 (Vic); Catchment and Land Prtectin Act 1994 (Vic); Catchment and Land Prtectin Regulatins 2002 (Vic); The Australian Cde fr the Care and Use f Animals fr Scientific Purpses 8th Editin 2013; The Cde f Practice fr Husing and Care f Labratry Mice, Rats, Guinea Pigs and Rabbits; The Cde f Practice fr the Use f Animals frm Municipal Punds in Scientific Prcedures 2001; The Australian Cde fr the Respnsible Cnduct f Research (2007); Department f Ecnmic Develpment, Jbs, Transprt and Resurces, Plicy, Prcedures and Guidelines; Mnash University Plicies, Prcedures and Guidelines. 1

2 Mnash University Prcedure Staff and students will achieve the abve by: Familiarising themselves with the cntent f the abve dcuments; Ensuring that all activities invlving the use f animals are subject t review and mnitring by an Animal Ethics Cmmittee respnsible fr reviewing all Mnash University research and teaching activities using animals; Ensuring that n member f staff r student shall use animals fr research and teaching withut the prir written apprval f a Mnash University AEC. Respnsibility Mnash University staff and students Nn-Mnash University persns cnducting activities at Mnash premises 2. Licence(s) The Act requires that all institutes cnducting research and teaching activities invlving the use f animals within Victria hld a Scientific Prcedures Premises Licence (SPPL). Applicatins t btain r mdify a SPPL must be crdinated thrugh the Mnash Animal Ethics Office. Licence nminees shall be either the Dean f a Faculty r their nminee but a licence must nt be btained withut the knwledge f the Animal Ethics Office. The Act requires that all institutes breeding specified animals fr scientific purpses hld a Specified Animals Breeding Licence (SABL). Mnash University will hld nly ne SABL. Only the Directr f Mnash Animal Research Platfrm shall be the licence nminee n any SABL held by Mnash University. Licence nminees must be aware f the research and teaching activities t be cnducted under the licence. This may be achieved by maintaining an awareness f the research and teaching activities cnsidered by the AEC r by nminating a delegate wh will maintain such awareness. Respnsibility Research, Ethics and Cmpliance Manager Mnash Animal Ethics Office Directr, Mnash Animal Research Platfrm Deans r nminee 3. Mnash University Animal Welfare Gvernance The Research, Ethics and Cmpliance Manager will mnitr research activities invlving animals cnducted by Mnash University staff and students r cnducted n Mnash premises by ensuring bth Animal Ethics Cmmittees and Licence Nminees are meeting their respnsibilities as described in the Australian Cde fr the Care and Use f Animals fr Scientific Purpses. The Mnash Animal Ethics Office, will prvide infrmatin sessins t the Mnash research cmmunity n matters relating t animal welfare, and legislative requirements applicable t the use f animals in research and teaching. Such training will be ffered n a biannual basis. Respnsibility Research, Ethics and Cmpliance Manager 2

3 Mnash University Prcedure Mnash Animal Ethics Office 4. Animal Ethics Cmmittees In accrdance with bth The Act and The Cde each SPPL must nminate r establish an Animal Ethics Cmmittee (AEC) t review all prpsed research and teaching activities using animals. Cmpsitin f the Animal Ethics Cmmittee Members f Mnash University AECs are t be appinted by the Licence Nminee r their delegate. The AEC must cmprise at least five persns, including a separate persn appinted t each f the fllwing categries A t D: A Chairpersn - The Chairpersn shall be appinted by the Licence Nminee; Categry A: - A persn with qualificatins in veterinary science that are recgnized fr registratin as a veterinary surgen in Australia, and with experience relevant t the institutin s activities r the ability t acquire relevant knwledge; Categry B: - A suitably qualified persn with substantial and recent experience in the use f animals fr scientific purpses relevant t the institutins and the business f the AEC. This must include pssessin f a higher degree in research r equivalent experience; Categry C: - A persn with demnstrable cmmitment t, and established experience in, furthering the welfare f animals, wh is nt emplyed by r therwise assciated with the institutin, and wh is nt invlved in the care and use f animals fr scientific purpses; Categry D: - A persn wh is bth independent f the institutin and wh has never been invlved in the use f animals in scientific r teaching activities, either in their emplyment r beynd their undergraduate educatin. The Cmmittee shall have the pwer t c-pt members. All AEC Chairpersns shuld familiarise themselves with Sectin 2.3 f The Cde: Respnsibilities and peratin f AECs. Respnsibility Licence Nminees Chairpersn, AEC Mnash Animal Ethics Office 5. Animals t be cvered by these prcedures Under the Cde and The Preventin f Cruelty t Animals Act 1986 (Vic) the definitin f animal cvers: A live member f a vertebrate species including any fish r amphibian; r reptile, bird r mammal, ther than any human being r any reptile, bird r ther mammal that is belw the nrmal mid-pint f gestatin r incubatin fr the particular class f reptile, bird r mammal; r a live adult decapd crustacean, that is; a lbster; r 3

4 Mnash University Prcedure a crab; r a crayfish; r a live adult cephalpd including; an ctpus; r a squid; r a cuttlefish; r a nautilus; Any animal f a species that is declared by the Minister f Agriculture, by ntice in the Gazette, t be a species f animal fr the purpses f The Preventin f Cruelty t Animals Act 1986 (Vic) and The Cde. The abve species include any mammalian fetus, r any avian r reptilian pre-hatched yung, that is in the last half f its perid f gestatin r develpment, including marsupial puch yung and fully metamrphsed juveniles (Amphibians and Fish) but nt including human beings r ther prenatal, pre-hatched, larval, r ther such develpmental stages f species ther than mammals, birds, and reptiles. 6. Animal use and ethical review Written apprval must be sught fr all research and teaching activities, breeding prgrams, teaching units r training curses invlving animals regardless f where the animals are lcated, where the animals may be hused r used, r f the surce f funding when such activities: Are spnsred by Mnash University; Are cnducted by r under the directin f any emplyee, student, r agent f Mnash University in cnnectin with his r her individual Mnash University respnsibilities; Are cnducted by r under the directin f any emplyee, student, r agent f Mnash University invlving the use f any Mnash University prperty r facility; r Invlve any cllabrating, sub-granting, r sub-cntracting individual r institutin wrking with Mnash University. Nte: When cnsidering an applicatin fr the use f animals in teaching cursewrk the reviewing AEC must cnsider the requirements f the Mnash University Use f Animals in Cursewrk Prgrams Plicy and Prcedures. All animals must be assessed at least daily by the investigatr r nminee t ensure wellbeing f animals in accrdance with the Cde. Applicatins must clearly indicate wh has the primary respnsibility fr assessing wellbeing f animals bth during weekdays and after hurs. Ntificatin t the AEC is required prir t btaining r using bilgical material discarded fllwing the practice f veterinary prcedures by a veterinarian, r fund in the animal s envirnment. Fr tissues and/r rgans scavenged frm Veterinary Clinics, written cnsent f the wner f the animal must be btained. Fr tissues and/r rgans cllected frm dead native wildlife (including rad kills) a wildlife permit frm the Victrian Department f Ecnmic Develpment, Jbs, Transprt and Resurces must be btained. Fr tissues and/r rgans that are imprted frm verseas, written apprval frm Australian Quarantine and Inspectin Service and/r Cnventin n Internatinal Trade in Endangered Species must be btained. Scavenging, which is the use f an entire animal r rgan r tissue frm an animal already killed fr anther purpse, r animals that are killed as part f anther AEC-apprved 4

5 Mnash University Prcedure prject, des nt require apprval in additin t the riginal written apprval fr the riginal use. Nte: The killing f animals fr the specific purpse f btaining these materials is cnsidered a scientific prcedure and requires prir written apprval frm the AEC. The AEC shuld be infrmed when an investigatr r teacher is "scavenging", especially if this is ccurring n a regular basis. Activities invlving nn-mnash facilities and/r nn-mnash staff When activities are t be cnducted at a lcatin within Victria nt under the jurisdictin f any AEC in Victria, Mnash staff and students must: Submit an animal ethics applicatin and btain written apprval frm a Mnash University AEC befre field activities begin; Ntify the Mnash Animal Ethics Office wh will ntify the DEDJTR Field Wrk Ntificatin Frm; Infrm themselves f any ther apprvals and/r permits frm ther authrities that may be required. When activities are t be cnducted at a lcatin within Victria under the auspices f anther institutin s AEC, Mnash University may r may nt assess prjects depending n the hst institutin s plicy n external investigatrs cnducting experiments n its premises, hwever Mnash University staff must: Advise Mnash University via the AEC f their invlvement by submitting Field Wrk Ntificatin if apprval is btained frm the hst institutin; Prvide full details in writing f the activity and lcatin. The minimum details are thse required by the Mnash AEC Field Wrk Ntificatin Frm; Prvide cnfirmatin f written apprval f the prject by the AEC f the hst institutin if the apprval is btained frm the hst institutin; Terminate their invlvement in the activity if the respnsible investigatr fails t respnd t Mnash AEC cncerns regarding the welfare f the animals. Such terminatin must be cnfirmed in writing t the persn respnsible fr the prject and a cpy sent t the Secretary f the Mnash AEC. When activities are t be cnducted at a lcatin utside f Victria hwever within Australia Under the auspices f anther institutin s AEC Mnash University may r may nt assess prjects depending n the hst institutin s plicy n external investigatrs cnducting experiments n its premises, hwever Mnash University staff must: Advise Mnash University via the AEC f their invlvement by submitting Field Wrk Ntificatin if apprval is btained frm the interstate hst institutin; Cntact Mnash Animal Ethics Office fr interstate licencing requirements Under the auspices f Mnash AEC, Mnash University staff must: Obtain written AEC apprval fr the prject: Cntact Mnash Animal Ethics Office fr interstate licencing requirements; Obtain necessary permits When activities are t be cnducted in anther cuntry; Investigatrs wh plan t use animals in anther cuntry must btain apprval frm Mnash AEC fr such use by submitting a Fieldwrk frm. 5

6 Mnash University Prcedure The AEC may accept apprval granted by a lcal AEC r its equivalent in that cuntry if it is satisfied that utcmes wuld be equivalent t thse expected thrugh applicatin f the Cde. The AEC must ensure that animal care and use in the ther cuntry is adequately mnitred. The AEC may appint an agent r delegate t cnduct the mnitring and inspectin n its behalf. The prject cmplies with the gverning principles f the cde prvided that such cmpliance des nt breach relevant lcal legislatin The prject is nt cnducted in anther cuntry as a mechanism f aviding cmpliance with the cde. Nn-Mnash staff r students wishing t huse animals and/r cnduct research r teaching at Mnash University premises must ensure the fllwing: Investigatrs frm institutins with a legally cnstituted AEC that are based in Victria; Nn-Mnash staff and students are required t btain apprval frm their hme institutin; Respnsibilities f the hme AEC are t be delegated t a Mnash AEC fr the duratin f the animal husing/scientific prcedures taking place at Mnash University. Investigatrs frm institutins with a legally cnstituted AEC that are nt based in Victria; Nn-Mnash staff and students are required t btain apprval frm their hme institutin; Nn-Mnash staff and students are required t btain a Scientific Prcedures Fieldwrk Licence frm BAW and prvide a cpy f that licence t Mnash University; A Mnash AEC is t be nminated with frmal inter-institutinal agreement fr the duratin f animal husing/scientific prcedures taking place at Mnash University premises in the Scientific Prcedure Field Licence r Scientific Premises Prcedures Licence. Investigatrs frm institutins withut a legally cnstituted AEC that are based r nt based in Victria; Nn-Mnash staff and students are required t btain apprval frm a Mnash AEC; Nn-Mnash staff and students are t btain a Scientific Prcedures Fieldwrk Licence frm EDJTR and prvide a cpy f that Fieldwrk Licence t Mnash University in accrdance with DEDJTR s instructin; A Mnash AEC is t be nminated fr the duratin f animal husing/scientific prcedures taking place at Mnash University premises in the Scientific Prcedure Field Licence r Scientific Premises Prcedures Licence. Cnfirmatin must be prvided that written apprval f the prject by the AEC f the hst institutin has been granted. An applicatin t the AEC respnsible fr the animal facility will be made and permissin t allw animal husing and/r the cnduct f research r teaching at Mnash premises shall be given by that Mnash AEC n a case-by-case basis. In the event that a prpsal is nt submitted in accrdance with and cntaining the infrmatin specified in The Cde, Mnash AEC may in their abslute discretin, decline t act as the 6

7 Mnash University Prcedure delegated and/r nminated AEC in relatin t particular research r teaching activities n Mnash University premises. Investigatrs frm institutins withut a legally cnstituted AEC that are based r nt based in Victria; Nn-Mnash staff and students can nt submit an applicatin in their wn right, applicatin must be submitted by the Mnash staff as a Chief Investigatr. Respnsibility Mnash University staff, adjuncts, students and nn-mnash persns undertaking activities at Mnash premises 7. Research r teaching prpsals and subsequent amendments invlving the use f animals fr ethical review New applicatins and subsequent amendments t apprved prtcls must be submitted t the relevant AEC n the current applicatin and amendment frms as per the guidelines fund n the Mnash Animal Ethics Office website. Only Mnash University staff and adjunct staff may be listed as a Chief Investigatr n Animal Ethics applicatins. Visiting schlars, students and affiliated staff are nt eligible t apply fr animal ethics apprvals. All staff using animals must be listed n the applicatin Cmplete prpsals will be receipted by the AEC secretariat and assigned t the next available meeting f the AEC. Incmplete prpsals will be returned t the investigatr fr their attentin and will nt be cnsidered as having been submitted t the AEC secretariat. Clsing dates fr AEC meetings are available frm the Mnash Animal Ethics Office website. The AEC may require inspectin f the facilities, prcedures and persnnel befre giving written apprval. Investigatrs are ntified f the review utcme in writing fllwing the meeting. Any issues t be addressed are itemised in a letter frm the Cmmittee. Prpsals with n issues will receive written ntificatin f apprval. Prpsals that have issues t be addressed will be apprved nce the issues have been addressed t the satisfactin f the Cmmittee. AEC apprvals are generally issued fr perids f up t three years; hwever apprvals may be issued fr lnger perids if the research prject is funded fr lnger duratin by the external funding agency. Applicatin fr time extensin (maximum fr 12 mnths) must be submitted befre the end date f apprval and can be submitted nly nce Any subsequent mdificatins t the prtcl, changes t the number f animals, species/strains/breeds f animals, prcedures, lcatin f research/husing r fieldwrk site, additin/remval f persnnel r time extensins must be subject t written apprval frm the AEC. Respnsibility Mnash University staff and adjuncts 8. Reprts Annual/Cmpleted Prject Reprts t AEC 7

8 Mnash University Prcedure All investigatrs receiving written apprval frm the AEC fr research r teaching activities, breeding prgrams, teaching units r training curses must submit annual prgress reprts and a cmpleted prject reprt within six mnths f cmpletin f the prject. These inlcude thse discntinued, nt cmmenced r cmpleted. The AEC reserves the right nt t apprve new applicatins in the event f nn-cmpliance in relatin t reprting requirements n past apprved applicatins. Annual Animal Use Return t DEDJTR Chief Investigatrs are required t submit annual animal use reprts n the Animal Use Return Frm prvided by DEDJTR as stipulated under The Act fr prjects cnducted in Victria. Investigatrs will be ntified via the Mnash Animal Ethics Office when returns are due and prvided with the latest frms fr cmpletin. Cmplete frms must be returned t the AEC by the specified due date. Annual Animal Us Return t Interstate Regulatrs Where prjects are cnducted in states ther than Victria, Animal Use Returns must be submitted t the relevant State Regulatr. Investigatrs will be ntified via the AEO when returns are due and prvided with the latest frms fr cmpletin. Cmplete frms must be returned t the AEC by the specified due date. Respnsibility Mnash University staff and adjuncts 9. Respnsibilities f chief investigatrs The Chief Investigatr is the nminated fficer t liaise with the AEC and is respnsible fr ensuring the fllwing: The Chief Investigatr (CI) and any named c-investigatrs are familiar with Sectin 3 f The Cde; The CI must accept primary respnsibility fr wrk undertaken including the selectin f an apprpriate animal species, the chice f the number f animals, the nature f the prcedures and all matters related t the mnitring and cntinuing welfare f the animals and their ultimate dispsal, accrding t the principles utlined in this prcedure. The AEC will nly liaise with the CI and nt with ther c-wrkers r students wrking under the CI s supervisin. In the absence f the CI, the AEC will liaise with the nminated c-wrker wh acts n behalf f the CI; It is the respnsibility f the CI t btain written apprval frm the Mnash AEC befre beginning a prgram f research prjects, breeding prgrams, teaching units r training curses that uses any animal (as defined in Sectin 5 f The Cde); The CI must ensure that adequate recrds f animal use, prcedures and mnitring are kept and that such recrds are kept when students/staff leave and fr seven years after the cmpletin date; The CI must cntinually recnsider the value f specific animal prcedures t the verall aim f the study befre carrying ut each series f tests r prcedures n animals. In the event f an audit the CI will be required t demnstrate evidence that such a review has been cnducted; If a suitable alternative t animal experimentatin becmes available, the CI must cnsider the alternative prcedure in view f the requirement t minimise the number f animals used; It is the respnsibility f the CI t request apprval frm the AEC t mdify apprved animal ethics prtcl. Any changes require written apprval frm the AEC and requests fr 8

9 Mnash University Prcedure changes will be cnsidered at ne f the scheduled meetings f the AEC; therefre prjects shuld be planned well befre the actual starting date; The CI must ensure that all staff and students, including technicians, and cllabratrs are named n the applicatin and prperly trained t carry ut specific animal prcedures. It is acceptable fr the CI t train staff and students in specific techniques. It is expected that the CI will prvide clse persnal supervisin until such time that cmplete cmpetence has been attained in activities; Respnsibility The CI must reprt t the AEC any adverse events assciated with an apprved prtcl as sn as pssible after the incident using the Mnash Incident/Nn- Cmpliance Reprt Frm. Mnash University staff and adjuncts 10. Infrmatin Sessin The Cde requires that Mnash University ensures that staff, adjuncts and students are aware f their respnsibilities under The Cde thrugh the prvisin f educatinal prgrams, cntinuing training and wrkshps. Therefre Mnash University requires that: Respnsibility All new Mnash staff and students using live animals cmplete the infrmatin sessin titles Animal Use in Research and Teaching run by the Animal Ethics Office at the first available sessin; Investigatrs must have successfully cmpleted the relevant training t be named n an animal ethics applicatin. Mnash University staff, adjuncts and students 11. Cmpliance The University Animal Welfare Officer, the AEC r its appinted representative shall have the right at any time, and withut ntice, t inspect the facilities in which the animals are hused and/r inspect the labratries in which experimental wrk ccurs, the prcedures used and the cnditin f the animals. Where there is cncern they shall be required t investigate and t take apprpriate actin. All members f the University r ther persns may bring t the attentin f the AEC any cncern regarding cmpliance with The Act, Regulatins and The Cde. The AEC shall be respnsible fr ensuring cmpliance with The Act, Regulatins, Cde and is authrised t require a University member t either mdify (as directed by the Cmmittee) r t suspend/withdraw their research r teaching prgram invlving live animal usage. Respnsibility Mnash University staff, adjuncts and students Animal Welfare Officer AEC members 12. Nn-Cmpliance Nn-cmpliance ccurs where there is a specific actin r missin that cnstitutes a breach f the Cde by any party r persn invlved in the care and use f animals including investigatrs, animal 9

10 Mnash University Prcedure careers, the AEC, gvernance fficials, and external parties. Nn-cmpliance may als invlve breaches f relevant state r territry legislatin(s). Incident and cmplaint alleging nn-cmpliance may cme frm an internal r external surce. Cmplaints can be made verbally r in writing (preferred). Written cmplaints shuld be submitted using Incident /Nn-Cmpliance Reprt Frm. The cmplainant can remain annymus. The cncern shuld be reprted t AWO r the Chairpersn f the AEC. In the event f the AWO r the Chairpersn are nt being available, cmplaints can be reprted t the Research, Ethics and Cmpliance, Manager r the respective Licence Nminee. The AWO r the Chairpersn are respnsible fr determining whether; the alleged incident r cmplaint shuld be investigated fr nn- cmpliance; the activities need t cease immediately until the incidence/nn-cmpliance is reviewed by the AEC, and whether immediate actin is required t alleviate any animal suffering r distress. The welfare f the animals is always the pririty where nn-cmpliance has the ptential t adversely affect animal wellbeing; If immediate actin is required t be taken by the AWO r the Chairpersn, the Chief Investigatr, the respective Licence Nminee, Head f Schl/Dean f Faculty and Manager, Research Ethics & Cmpliance will be advised in writing; In the event f the AWO r the Chairpersn are nt being available, cmplaints can be reprted t the Research, Ethics and Cmpliance, Manager r the respective Licence Nminee. In all instances f Minr nn-cmpliance, the fllwing actins will ccur: The Chief Investigatr and the Manager Research Ethics & Cmpliance are infrmed in writing; The allegatin, assessment and recmmended actins are reprted in the AEC minutes; If there is a repeat f the same incident, depending f the severity f the nncmpliance, it may be dealt with as a majr nn-cmpliance; and The incidence f nn-cmpliance is recrded against the prject. In all instances f Majr nn-cmpliance, the fllwing actins will ccur: The Chief Investigatr, respective Licence Nminee, Head f the Schl/Dean f the Faculty and Research, Ethics and Cmpliance, Manager are infrmed in writing; Cnsideratin will be given t the need t suspend apprval fr the activity. Cnsideratin fr the time-frame fr suspensin f the apprval will be dependent n the nature f the nn-cmpliance; The welfare f the animals will always be a pririty where nn-cmpliance has the ptential t adversely affect animal wellbeing. If necessary apprpriate actin must be taken t alleviate any animal suffering r distress (if nt already implemented); The allegatin, assessment and recmmended actins are reprted in the AEC minutes; and The incidence f nn-cmpliance is recrded against the prject. Depending n the degree f nn-cmpliance the AEC may: cautin the Chief Investigatr/prject staff member; suspend r withdraw apprval fr a specific activity within a prject; suspend r withdraw apprval fr the prject; Investigate ther prjects invlving the staff member r Chief Investigatr; recmmend disciplinary actin t the Licence Nminee and line manager/s; Research, Ethics and Cmpliance, Manager may reprt t statutry authrity and/r funding agency. The AEC shall be respnsible fr ensuring cmpliance with The Act, Regulatins, Cde and is authrised t require a University member t either mdify (as directed by the Cmmittee) r t stp their research r teaching research prgram invlving live animal usage 10

11 Mnash University Prcedure Respnsibility Mnash University staff, adjuncts and students The Chairpersn Animal Welfare Officer Mnash Animal Ethics Office Research, Ethics and Cmpliance, Manager AEC members 13. Appeals A Chief Investigatr wishing t appeal an AEC decisin must d s in writing t the AEC Chairpersn within 14 days after being advised f the AEC decisin. The AEC Chairpersn is respnsible fr adding the appeal t the agenda f the next scheduled AEC meeting where the AEC will review the appeal. The AEC Chairpersn will infrm the Chief Investigatr in writing f the utcme f the AEC review f the appeal within 14 days frm the AEC meeting. If staff, adjunct r student finds the utcme unsatisfactry the cmplaint must be referred in writing t the Research, Ethics and Cmpliance, Manager within 28 days f the AEC decisin fr review f the due prcess. The Research, Ethics and Cmpliance, Manager will advise the AEC, the investigatr and the SPPL Nminee f the utcme f the review f due prcess. If the Research, Ethics and Cmpliance, Manager finds fault with the prcess fr an AEC decisin, the AEC may be requested t re-review the applicatin in light f any finding and with due prcess. If the matter is nt reslved, a written request fr interventin may be made t the Vice Prvst (Research) by either the cmplainant r the Research, Ethics and Cmpliance, Manager within 28 days f the AEC s final decisin. The written request must include the basis n which the request fr interventin is being made. The Vice Prvst (Research) must review the cmplainant s applicatin and then attempt t reslve the cmplaint thrugh further negtiatin r mediatin, r may advise the cmplainant in writing that the cmplaint is cnsidered t be lacking in substance, r frivlus and/r vexatius, and that n further cnsideratin r interventin is t be cnducted. A cmplaint case will be cnsidered clsed upn receipt by the Vice Prvst (Research) f a written withdrawal f the cmplaint by the cmplainant, r when the Vice Prvst (Research) determines that there is nthing further that can be dne in rder t settle the cmplaint. Decisins f the Vice Prvst (Research) may be appealed by the cmplainant in writing t the Vice-Chancellr. An appeal must be made within 28 days f receipt f the decisin f the Vice Prvst (Research). An appeal must be in writing and include the grunds fr the appeal. It will nt be sufficient fr a cmplainant t ask fr a re-cnsideratin f the riginal cmplaint. The cmplainant must prvide sme reasns why they cnsider the decisin t be incrrect r unfair. Respnsibility The decisin f the Vice-Chancellr is cnsidered t be final Chairpersn, AEC Mnash Animal Ethics Office Research, Ethics and Cmpliance, Manager Head, Academic Unit 11

12 Mnash University Prcedure Vice Prvst (Research) Vice-Chancellr 14. Miscnduct r Breach f the Cde Where University emplyees fail t btain written ethical apprval when such apprval is required r where they act cntrary t the decisin f an AEC, the matter may amunt t miscnduct and be dealt with under the University s Prcedures fr Investigating Cmplaints f Research Miscnduct. Where a student has engaged in an unethical activity, the matter shuld be dealt with by the student s examiner r supervisr, and where necessary, referred t the head f the schl. Respnsibility Vice Prvst (Research) Research, Ethics and Cmpliance, Manager Heads f academic/administrative units Research supervisrs and managers Mnash University staff and students Respnsibility fr implementatin Status Apprval Bdy Definitins Vice Prvst (Research) Mnash Research Cmmittee (MRC) Mnash Animal Ethics Office Departmental/Schl Animal Ethics Cmmittees Mnash Research Office Heads f academic/administrative units and cntrlled entities Research supervisrs and managers Research staff All Students Review Name: Academic Bard Meeting: Date: Agenda item: AEC: Animal Ethics Cmmittee The Act : Preventin f Cruelty t Animals Act 1986 N 46 (Vic) The Regulatins: Preventin f Cruelty t Animals Regulatins 2008 N. 162(Vic) The Amendment: Animals Legislatin Amendment (Animal Care) Bill 2007 N 65 (Vic) The Cde: Australian Cde fr the Care and Use f Animals fr Scientific Purpses, 8th Editin

13 Mnash University Prcedure DEDJTR: Department f Ecnmic Develpment, Jbs, Transprt and Resurces SPPL: Scientific Prcedures Premises Licence SABL: Specified Animals Breeding Licence Legislatin Mandating Cmpliance Queries may be addressed t Risk and Cmpliance at: riskandcmpliance@mnash.edu. Related Plicies Related Dcuments Use f Animals in Cursewrk Prgrams Plicy and Prcedures Incident/Nn-Cmpliance Reprt Frm 13