User Guide Human Research Ethics Application and Review
Contents
1. 28 Last saved Friday 21 September 20122012 Online Ethics System Applicant User Guide Updated docx Page 2 of 28 University of South Australia OVERVIEW HUMAN RESEARCH ETHICS APPLICATION AND REVIEW SYSTEM All staff and students at University of South Australia who wish to undertake a research project involving humans including direct collection of data accessing data from databases and or collection of human tissues samples etc must apply for ethics approval from the University of South Australia s Human Research Ethics Committee using the Human Research Ethics Application and Review System the System Researchers must be familiar with the following documents before using the System a the National Statement on Ethical Conduct in Human Research http www nhmrc gov au publications synopses files e72 pdf b the Australian Code for the Responsible Conduct of Research http www nhmrc gov au publications synopses files r39 pdf c related legislation guidelines and codes and University policies and procedures as outlined in the University of South Australia s Framework for the Responsible Conduct of Research http www unisa edu au res ethics integrity default asp Note The images displayed in this user guide were captured using fictitious examples of a human ethics Application and do not contain information or details of actual Applications2. Last saved Friday 21 September 20122012 Online Ethics System Applicant User Guide Updated docx Page 3 of 28 University of South Australia GETTING STARTED Step Logging In Navigation https research unisa edu au RMENet University of South Australia UniSA ResearchMaster Enterprise 5 12 1 Welcome to RMENET at ResearchMaster Welcome to the Research amp Innovation system for tracking processing and administering research management in the University To login enter your username and password in the fields provided and then cick the Log In button I your username has been validated correctly you wil be taken to the RMENET Home page Enter your UniSA network User Name and Password and click the Login button Action Result User is logged into the system with Home page displayed Home Disclaimer Copyright Privacy Australian Technology Network Web accessibility CRICOS Provider no 00121B Contact UniSA Last saved Friday 21 September 20122012 Online Ethics System Applicant User Guide Updated docx Page 4 of 28 ij University of South Australia Step 2 Creating a New Application Navigation Ethics Tab Applications University of South Australia UniSA ResearchMaster Enterprise 5 12 1 HOWE Eth Personnel Applications Home Disclaimer Copyright Privacy Australian Technology Network Web accessibility CRICOS Provider no 00121B Contact UniSA Action Click
3. Repeat this step until all attachments have been reviewed Note There may be more than one page for the uploaded attachments this is indicated by the page counter at the bottom of the attachments table Change page lt 12 gt Displaying page 1 of 2 items 1 to 10 of 13 Change page 1 Go Page size 10 Change Step I Deleting Attachments Navigation In the Application Navigation section click the Attachments page under the Attachment section Additional Attachments Document Description Reference Document Title 1 Reference List testdoc txt x 2 Research Tools or reasons as to why there arent any Action Click the icon against the name of the attachment to be deleted Result A warning message is displayed Message from webpage Jj Are you sure you want to delete this record Action Selecc OK Result Attachment is deleted Last saved Friday 21 September 20122012 Online Ethics System Applicant User Guide Updated docx Page 18 of 28 J University of South Australia Step 12 Adding Page Comments There are two types of comments They are Page comments comments specific to a page within an Application Application comments overall comments about the Application Comments written by the Applicant or another Investigator are visible to all Investigators listed on the Application and whoever reviews the Application Thus they are visible to the Principal Supervisor Ethics and
4. University of South Australia User Guide Human Research Ethics Application and Review System Applicant Role Version Research and Innovation Services For further information or to update this document contact Compliance Officer Research and Innovation Services This is an official document of the University of South Australia for internal use only The document has been prepared by Research and Innovation Services for web use and will be maintained on a regular basis To ensure you have the most recent version it is advised that you access this document from its original location and do not keep local copies The reader should be aware that this document is for the University of South Australia s employees and students information only and nothing contained in this information should be construed as an offer of service by the University of South Australia form part of the terms of any agreement or be legally binding on the University of South Australia Copyright University of South Australia all rights reserved University of South Australia Contents OVERVIEW HUMAN RESEARCH ETHICS APPLICATION AND REVIEW SYSTEM eese 3 GETTING STARTED ione eI OP EIN deiude ame ic uM E 4 DCM Te i NR E TEE m 4 Step MAG Indc 5 Alternate Step 2 Accessing Existing Application s eese eee eeeeeeeeee tenet
5. User Guide Updated docx Page 9 of 28 J University of South Australia Search amp Add Person Search amp Add Person Found 22 Matching Personnel Please select and add a person form the list below by clicking on the preferred name Preferred Name ID Gender Type Classification School Division Ms Alison 09401965C Female Student Academic Sch Nursing amp Midwifery Division of Health Ballantyne Sciences Dr Andrew Allan 053205 Male Internal Academic Sch Natural amp Built Div of Info Technology Environme Engin Dr Kerry Mallan MALLANK Female External Mr Victor J Callan CALLANV Male External Stephen McFallan MCFALLAN Male External A Prof Judith RIVALLANDJ Male External Rivalland Action Select the investigator from the list Result The details of the selected person will be displayed Given Name Surname Full Name System code of Position held Chief Investigator v Chief Investigator Other Investigator Supervisor Primary O Yes No AOU system code Unaipon School Organisation Organisation Name Action Input appropriate details and click the icon to Save Result Investigator added Last saved Friday 21 September 20122012 Online Ethics System Applicant User Guide Updated docx Page 10 of 28 University of South Australia Step 4 Selecting the Chief Investigator As a default the Applicant is assigned the ro
6. next page in the application Go to the previous page in the application Application Comments Comments that apply to the application overall Reports Reports menu to select and run a report reports include the ability to print the whole application application comments attached documents and review outcomes Page Comments Comments that apply to the current page Help for the page or for the questions Exit the application and return to the Applications home page Last saved Friday 21 September 20122012 Online Ethics System Applicant User Guide Updated docx Page 28 of 28
7. search function and mark the role as Other Investigator fram the drop Gown box Prior Assessment After making the selection please save it Dy cliciong on the green Dck at the right hand side bottom Corner t instructions Action Select Principal Supervisor page under the Principal Supervisor section Result Principal Supervisor page will be displayed Application Status Draft Workflow State Draft Other Forms NewE1 Fara A Principal Supervisor Expand Collapse Only the details of your principal supervisor i e the person responsible for reviewing your application can be included here Please include all other supervisc from the drop down box As you are student candidate please select and add a Principal Supervisor al Create New Ethics Application After making the selection please save it by clicking on the green tick at the right hand side bottom corner Create New Ethics Application Search Name lD Q More Criteria J Investigator f wosia iD Given Name Surname Full Name Primary Position Aou Organisation Organisation Name Supervisor V gat No records to display Prior Assessment Action Enter the principal supervisor s UniSA staff student ID or first name or last name or full name in the text box Then click the icon Result A list of UniSA personnel meeting the criteria is displayed Note The Principal Supervisors can also have a student ID attached to them Make
8. sure you select the Staff record of the Principal Supervisor Search nme AA More Criteria Given Name Surname Full Name Search amp Add Person Found 2 Matching Personnel Please select and add a person form the list below by clicking on the preferred name Preferred Name ID Gender Type Classification School Division Mr Vaneet Vaneet 100111743 Male Student Sch Management Division of Business Mr Vaneet Vaneet 128757 Male Internal General Research and Innovation Servi Research amp International Por Change page lt 1 gt Displaying page 1 of 1 items 1 to 2 of 2 Action Select the Principal Supervisor from the list Result The details of the selected person will be displayed Last saved Friday 21 September 20122012 Online Ethics System Applicant User Guide Updated docx Page 3 of 28 YJ University of South Australia Principal Supervisor Oni Ue d rtad of your principal Supervisor quis Ue PENN nirigenaibie for nimingting pour aepiicabon can Ex inctuded heres PHebR include all oer ie from har Grip dove box s you ae Khada Caer piis ed a Piped JSup rdbe AMT making the sebect on pla te iii HL by clicking dn fer gr sim DER as Die right hand dide bottom corer N ivenHame Sumama Fulhane Primary Puika AGU CegensaBon Organisation tame Supenaor Action Input appropriate details and click the icon to Save Result Principal Supervisor added Step 7 Removing the Principal Superv
9. 122012 Online Ethics System Applicant User Guide Updated docx Page 20 of 28 University of South Australia Step 4 Adding Deleting Application Comments Application level comments can be entered from any page in the form These comments are not linked specifically to any page only to the application as a whole Navigation Go to the any page within the application Action Select the Application Comments icon i from the Toolbar Result Application Comments screen is displayed Repeat steps 8 and 9 within this section to add and delete Application Comments Step 15 Submitting a completed Form application Repeat Step 8 Submitting a completed Form application Last saved Friday 21 September 20122012 Online Ethics System Applicant User Guide Updated docx Page 21 of 28 University of South Australia Step l6 Printing the Application This function allows the Applicant to view the Application as a PDF or HTML file enabling the Applicant to view their answers without navigating the System Navigation Click the Reports icon from the toolbar Action Select the Ethics Application from the Document field and select the either HTML or PDF Select OK Result Document will display in a new screen Project Details Ethics Training have had huma Projext Type Action Document can be printed or saved Note A PDF copy for both Ethics El and Ethics E2 forms of the Application is neces
10. Application changes Emails are also sent to the ECO and the Committee Review Group when their action is required AMENDING AN APPROVED APPLICATION Amendments to an Approved Application cannot be made within the System The process for amendment of an approved application is detailed at http www unisa edu au res ethics human amendments asp TROUBLESHOOTING If you are having trouble logging into the System or completing the form please contact ethics unisa edu au If you require assistance completing the Application please contact your Research Ethics Advisor Last saved Friday 21 September 20122012 Online Ethics System Applicant User Guide Updated docx Page 25 of 28 University of South Australia APPENDIX APPLICATION STATUS Approved The Committee Review Group has reviewed the Application and is satisfied that the project meets the requirements of the National Statement The Application is Approved Approved Subject To The Application has been reviewed by a Committee Review Group and returned to the Applicant with the review outcome Approved Subject To The Applicant is required to make minor changes to the Application before resubmitting it for review An Applicant has started an Application El HREC Chair The Ethics and Compliance Officer has forwarded the Application for review At the time the Application was submitted the System determined that the research project does not pose a foreseeable risk of
11. Compliance Officer and the members of the Committee Review Group Navigation Go to the page where you would like the page comment entered Home test Application Status PS Update Required Workflow State PSUpdate Other Forms Ethics Protocol f Form AG Data storage access disposal m Expand Collapse 9 1 The information which will be stored at the completion of this project is of the following type s Please select all that apply 9 Individually identifiable 3 Create New Ethics Application C Re identifiable Y Create New Ethics Application 7 Non identifiable i Investigator 9 1 1 Give reasons why it is necessary to store information in identifiable or potentially identifiable form coded 1 ti Principal Supervisor ti Prior Assessment ii Project Details 9 2 Where will the data be stored please be specific with the address e g If stored at UniSA please specify which campus and the office room location Resources y Project Funding Y Ownership of Da Data storage access disposal P Action In the Toolbar select the Page Comments icon l gt and click the New Comment link Result Page Comments screen is displayed Page Comments New Comment All v IB Type Author Date Comments Responded Resolved Action Note Ms Melanie Corpus Batingal 27 08 2012 14 16 provide more info re data storage No No Change page lt gt Displaying page 1 of 1 items 1 to 1 of 1 Ac
12. Officer has reviewed the Application and requires the Applicant to provide additional information or amend answers provided Exempt The Applicant has submitted an Application and the System has determined that the research is exempt from further review as the project involves the use of archived data only and the data collected is Last saved Friday 21 September 20122012 Online Ethics System Applicant User Guide Updated docx Page 26 of 28 Negligible Not Approved Not Approved Resubmit PS Review ECO Update PS Review Review Update University of South Australia de identified ie does not contain personally identifiable information and will not reported beyond the University The Applicant has submitted an Application and the System has determined that the research does not require further review as the project is either being e conducted solely for the purpose of internal quality assurance and will not be published or presented externally or conducted solely for the purpose of internal quality assurance but may be published externally however the data was gathered online or in writing the responses were provided voluntarily the respondents were advised of the possibility that the data could be used for such purposes and the anonymity of the respondents is maintained The Committee Review Group has reviewed the Application and is not satisfied that the project meets the requirements of the National State
13. Prim lrsosnqanor Imssligat After making th selection piast save A by cbcking on tha green tick at The moet and ede bonom comer Plana incide all oihar iriastigabsrs on ihia nage by using ihe search function and mark the rola ee Osher investigator fram the drop damn Bex j Prior Bossdsreccamiant Afer making th selection phirasi sant s by dehin on i green Bek ait thi figit hand side boom corner nsirucnana Search Mamet 10 Gen Mame Surname Fuit Mame Primary Posinon ACH Organissti n Organisation Name 15700 Welanie Balingal Mis Uelanie Corpus Batingal Ho Chafinersgalor OEC quired by marking Ihe seplicant as Primary Please make the changes lo avoid any incamvemience and respond with Yas Last saved Friday 21 September 20122012 Online Ethics System Applicant User Guide Updated docx Page 12 of 28 University of South Australia Action Select Yes to question Is the primary applicant a student Result Principal Supervisor section will be accessible Form Expand Collapse Create thew Fthics Application Y Create New Ethics Ay reale New E Please edit the irmestgator secton by marking the primary applicant as Primary Please ch en ebeet Prima ase K OF fe name and the tYes v Investigator hia estigat Antec making the selection please save it by Clicking on the green fick at the right hand side bottom comer Please include all other investigators on thes page by using te
14. ce List and Research Tools or reasons as to why there aren t any are mandatory attachments Note If documents cannot be attached electronically a hard copy of the document s must be forwarded to the Principal Supervisor and once the Principal Supervisor has approved the application these documents must be forwarded to the Ethics and Compliance Officer Neither the Principal Supervisor nor the Ethics and Compliance Officer can submit the Application for review by the next review stage in the workflow until all supporting documents are received It is advised that wherever possible documents are scanned and attached using the Attachments page Also the system can only accept a maximum of ten attachments If there are more than ten documents to upload please combine the additional documents into one zip file Navigation Select the Attachments page under the Attachment section Application Status Draft Workflow State Draft Other Forms Ethics Protocol Form Action Attachments Expand Collapse Note You can upload additional documents by clicking on the Additional Attachments link Types of documents which should be attached include Reference List Bibliograp Research Tools Consent Form Internet Questionnaire Interview Questions Focus Group Questions Details of Observational Aspects Details of Action Research Process Create New Ethics Application Guidelines on how to draft your participant information sheet are ava
15. e Expand link Go to this section page Result Action comment icon displayed J Collection Method Y Collection Method vi Participants Relationships Y Consent Y ConsentProcess Action Click the Page Comments icon You should see the Action Notes created by the ECO or Committee Review Group Click the link on the Comments column to view the whole comment Result Action note is displayed 2oliection Method 2274 N Page Comments New Comment 2 L Type Author Date Comments Responded Resolved Click to view whole comment oO Action Note 29 05 2012 15 23 please provide more information on your collectio 0 Change page gt Displaying page 1 of 1 items 1 to 1 of 1 Page Comments New Comment All v L1 Type Author Date Comments Responded Resolved oO Action Note Mrs Angela Berndt 29 05 2012 15 23 please provide more information on your collectio No No Type Response Comments Change page Displaying page 1 of 1 items 1 to 1 of 1 Action Once the comment is read and the action understood select OK Result Action comment will close Complete the required action Last saved Friday 21 September 20122012 Online Ethics System Applicant User Guide Updated docx Page 23 of 28 University of South Australia Action Reopen action comment and check box next to action note Result The P Mark Selected Comments as Responded will be enabled Page Comments New Com
16. e drop damn Bex 3 Prior Aeteeemant After making thi selection please sane 9 by cisci on the green Dok ait tha rigid hand sie baim corner Ingtrucnena Search Hamel uj Gen kami Suara Ful tame Primary Position A rnganisshon Organisation Nami 125700 Welanie Balingal tis Uelanie Corpus Batingal Ho Ctiefinesdigaior RE anges required by marking Ihe ielicamn aa Primary Pleasa make the changes bo avoid any inconvenience aed respond v Action Click the icon against the name of the Investigator to be deleted Result A warning message is displayed Message from webpage j Are you sure you want to delete this record Action Select OK Result Investigator is deleted Step 6 Adding Principal Supervisor If the Applicant is a student then a Principal Supervisor must be identified A Principal Supervisor is not required for a staff member applicant The Principal Supervisor cannot be added with an Investigator role but any other supervisors must be entered with Other Investigator roles Step 3 Adding Investigators Navigation Select the Investigator page under the nvestigator section investigator Expand Collapse amp pnmary applica a student Plaasa SORE wes you ara Mamot d Cs Yes f C Hs Crete Hew Ethics Application J riait irs Emi nplizjlian i saa scis ipM 2 Pease edit Une eestor Section by marking Ine primarg appiscaemt as Aimar Pree hok onse nare acid then esled Yeo 1o
17. e tete neneonetetenenes 6 Hic es uude wel 7 Step Navigating the Application cssssssscssessssssscsseccssscssscssesesesesescesesesesssccesesesesesescsccesesescacsceseseesacaceceeeaesescaesceeeseneeees 7 Step 2 Answering Questions in the Application eere eee esee eeeee tete teet totns enenenenete tots ene sesets tn en enne 9 Step 3 Adding VEST SALONS cocco riore oreet eese onec eat eerie et eFatck ttn oe seb ere x ed nave eere Cep edes Fou dese tasas e do buend rane ca era n Ced rape c 9 Step 4 Selecting the Chief Investigator eere eee esee eee ene tete ttr en enata tatnen en en epe seen ssepe pene se ene n spen eae ss saos I Step 5 Removing an Investigator eee ee eee esee eee ee tete enero teta tn en en esteso totns esee sete tne n ene ne ases ene n esos essa setae 2 Step 6 Adding Principal Supervisor 1 5 0 rrtbEr tbscstecsccznccntaconscatdenacostesenesetdeeacaetsaatasessbensdhanecnatbsatcenteaenctadiastenseanietastes 2 Step 7 Removing the Principal SUPeErviSO cssscscececsssssscececsssesssssscssecsssssscscecssessesscscecesessesscssscucesessssacscecessesecscscesores 14 Step 8 Submitting a completed Form application esesesesssssceceseecsescscececeseecsesceceseseseseceeesesesesesceceeeeeseeesesceeseeees I5 Step 9 Adding Attachments seesseeosseseosesseseressoseosessesesre
18. ecessary information as ether a separe document and add i1 s an atLachirsent function available on the He had menu avadabhe bu tha Aitechmenia Saetisn or ag m pags comanant Plenga reler in tha Ligar Guides Hye are umeua hya tn usa these funetinns Pipase ensure you onbe requested informare in the sections avaitable on the creans left hand menu Iestigabses Attachments etc Submitted applications that d not contain the required ifcemarion wall Be retumied te yOu and therefore Ie resa process vill ba delayed Kaler te iha Usar Guided if you aa urreure how 16 use Ehasa functions ANSWERING QUESTIONS IL te impeetant to take bene fo anger each question carefully and fully belore presressing io the next quasbien By dang sa you wil minimiss ihe reguesi er more detada from ihe reviewers andor prevent parential system ans Sludent apphzanbs Please mote thal you mut emad your superasor a copy of all atlachenents meluded imn your apblcstion The research actraty must not commence unti ethics approval ig finalised af agrea Last saved Friday 21 September 20122012 Online Ethics System Applicant User Guide Updated docx Page 7 of 28 Y University of South Australia There are four components to the application Information Area Located at the top of the screen the Information Area displays the Application Title Status Current Workflow State and the Current Ethics Form ResearchMaster Enterprise 5 12 1 Home Ethics PBRF Pers
19. harm or discomfort and any foreseeable risk is no more than inconvenience The Applicant was thus notified that the risk associated with the project requires El level of review The Application is forwarded to the Chair or Deputy Chair or HREC for El review The Chair or Deputy Chair of HREC review EI Applications The Ethics and Compliance Officer has forwarded the Application for review At the time the Application was submitted the System determined that the research project poses only one potential foreseeable risk that of discomfort The Applicant was thus notified that the risk associated with the project requires E2 level of review The Application is forwarded to a panel comprising 2 members The Chair or Deputy Chair of HREC and the Applicant s Research Ethics Advisor E2 Committee Group Review The review panel reviews E2 Applications E3 HREC The Ethics and Compliance Officer has forwarded the Application for review At the time the Application was submitted the System determined that the research project poses more than low risk The Applicant was thus notified that the risk associated with the project requires E3 level of review The HREC reviews E3 Applications at the next monthly meeting ECO Review An Applicant has completed an Application and submitted the Application for review The Application is forwarded to the Ethics and Compliance Officer for review ECO Update Required The Ethics and Compliance
20. iew process will be dela ANSWERING QUESTIONS It is important to take time to answer each quest errors Attachments P Attachments Student applicants Please note that you must e Declaration A The research activity must not commence until e gt Declaration C agree Instructions P Instructions 4 Application Content The main section of the screen displays the application questions and responses Note AOU is the Applicant s Originating Unit which refers to the applicant s own school Vorkfiow State Draft Other Forms fthics Protocol Non UniSA HREC apte Ettecs category code Human Ethics w pplication Primary AOU Applicatior ORE Research and leecvation Sereces Please eter an Apphcation Tt teat 11 Has another Human Research Ethics Committee other than UniSA rewewed thes research project before and does thes clearance approva accurately descnbe the propect as i is to be conducted O Yes O No Last saved Friday 21 September 20122012 Online Ethics System Applicant User Guide Updated docx Page 8 of 28 J University of South Australia Step 2 Answering Questions in the Application Questions within the Application require answers in different formats Yes No numerical and text responses The Applicant can answer questions in any order However some questions are dependent on the answer provided to an earlier question If you change the answer to one question this may cause new questions to a
21. ilable at Guidelines 4c New i nli A A a Create New Ethics Application A model consent form is available at Model Consent Form Please ensure all irrelevant information is deleted as there are numerous notes to the researcher included in the m form Investigator v Investigator The system only accepts a maximum of ten 10 attachments If you have more than ten documents to upload please combine the additional documents into one zip file Prior Assessment Y Non UniSA HREC Additional Attachments Attachments Eus z Document Description Reference Document Title Soft Copy Hard Copy j 1 Reference List go 2j Declaration ere 2 Research Tools or reasons as to why there arent any 3 Participant Information Sheet as applicable Instructions L1 O gt Instructions Consent Form as applicable Others as applicable Action Click the B icon next to the document type you would like to upload Result Upload File form will appear Last saved Friday 21 September 20122012 Online Ethics System Applicant User Guide Updated docx Page 16 of 28 Last saved Friday 21 September 20122012 Online Ethics System Applicant User Guide Updated docx iJ University of South Australia Upload File To upload a file click Browse to find the file When you have found the correct file click OK to upload it If you decide not to upload a file at this time click Cancel Fle C
22. ine Ethics System Applicant User Guide Updated docx Page 6 of 28 University of South Australia THE ETHICS APPLICATION Step I Navigating the Application Navigation An application is created or opened see Getting Started New Application Application Status Drak Workhow State Brat Fiir Acton Expands Collapse a zi Creare Mew Ethics Application b Create New Pihics Application ti Prior Assessment j Putachimaents 5 Declaration lnetrcthong il ulis Other Formia Ethics Protocol Create Hew Ethics Application The foliereang peades bof information on how bo complete an onbre gihecs dpplicaien For more detailed information please refer to the Uee Gandes aexlable at the UniSA website Please note that lhe ex aloo a User Guida ier tha Principal Supaniaee ta aasiat supeeannrs erik tha nagawi af studant applicatema The Weer Guten alae detail tha pemcexg ta fies ahold yeu ba required Ta respond En re swarg commania The System Movs researchers 10 complete and submit human grhics applicabons electronically Applicants navigate their way through the application by anawenng a number of questions Sections pages and ce quasteens appear besed on the arewers to previous questions tharefera it ig 333552 ikm you completa quastieng sequentially in onder bs moid skipping questions uniniaetionally Ad times werd kma may prevent you tu providing al the migematon you need to melude E This r ihe case please include the n
23. isor Navigation Select the Principal Supervisor page under the Principal Supervisor section search Name lD f CR More Criteria 12875 Vaneet Vaneet Mr Vaneet Vaneet Mao Superisor ORC Action Click the icon against the name of the Principal Supervisor to be deleted Result A warning message is displayed Message from webpage 2 J Are you sure you want to delete this record Action Select OK Result Principal Supervisor is deleted Last saved Friday 21 September 20122012 Online Ethics System Applicant User Guide Updated docx Page 14 of 28 University of South Australia Step 8 Submitting a completed Form application The Ethics application can only be submitted when all mandatory questions in the form have been answered This is true if the appears next to each item on the Application navigation Hint use Expand link to check all items Navigation Select Action tab Submit Action Click the Submit button Result Warning message is displayed Message from webpage E J Are you sure Action Click OK Result If the form is complete the Applicant is informed of the level of the risk associated with the project If the form is incomplete an error message will appear informing the Applicant that their form cannot be submitted This will display above the Application title Return to the Form tab to determine what needs to be completed The Application has been submitted and the Applicati
24. le of Chief Investigator This step is only required if the Applicant is not the Chief Investigator Navigation Select the Investigator page under the nvestigator section Investigator amp primary applica student Pleasa select es d you n See dt Action Dolapee ia Yes C Ne Cristi Now Ethics Appiucatin Crbale Mine Emits Application y 5 2 Piease edm Unc immet spon By marking The primary appiscan a Primary Pisae click on fes narri aevd then baled Vea do Primer lriosngasor aliaa Invealigat Afer making the election pease eae H by Chcking on Tha green Deck a31 th molt hand sse bontom comer Pinaasa incide all oihar iriastigabsrs an ihia page by using ihe search function and mark the rola ee Other investigation from the drop dan Bex 3 Prior Aebeeemant After making thi selection plas sane 9 by clscinag on tfi green Dok at tha rigid hand sie aciem corner zIngtrucuena Search Haenel ID Givenfaee Surname Full lame Primary Position A Organisation Organisation Name 125700 Welanie Balingal tis Uelanie Corpus Batingal Ho Chiners galor OEC rares Peruri Dy mating the dice aa Prmar Pleass make the che eet lo wold any incarenience and respond wih Y Action Click the Full Name of the investigator Result Additional information about the investigator is displayed Search Name lD e Mare Criteria ID 128100 Melanie Batingal Ms Melanie Corpus Batingal Chief Investigat
25. ment nor that it can meet the requirements of the National Statement if changes are made The Application is Not Approved and cannot be resubmitted The Committee Review Group has reviewed the Application and is not satisfied that the project meets the requirements of the National Statement however it could meet requirements after significant changes are made The review outcome is Not Approved Resubmit The Applicant is required to make significant changes to the Application before resubmitting it for review An Applicant has completed an Application and submitted the Application for PS Review Supervisor to review changes made by the Applicant in response to the Ethics and Compliance Officer s ECO comments Supervisor to review changes made by the Applicant in response to the Review Group s during El E2 or E3 review comments The Ethics and Compliance Officer has marked the Application as withdrawn because the Applicant has advised them that the research will not proceed COMMON TERMS Committee Review Group Refers to one of three review groups that assess human ethics Applications They are El HREC Chair E2 Committee Group Review E3 HREC Last saved Friday 21 September 20122012 Online Ethics System Applicant User Guide Updated docx Page 27 of 28 J University of South Australia Ethics and Compliance Gificer HREC Human Research Ethics Committee TOOLBAR CELL CNN Go to the
26. ment P Mark Selected Comments as Responded a Type Author Date Comments Type Response Comments Change page lt gt Displaying page 1 of 1 items 1 to 1 of 1 Action Select Mark Selected Comments as Responded Result Warning message Message from webpage 2 Jj Mark selected comments as responded Action Select OK Result The value of the Responded column for this Action Note will change from No to Yes The marker for the page will also change from F to indicating that the action note for that page has been responded to Collection Method Y Collection Method vi Participants Relationships Consent Y Consent Process Note An Application can only be resubmitted once all Action items Page Comments and Application Comments have been responded to and therefore contain the symbol An Application cannot be resubmitted if there is a symbol on the Application navigation Form tab area Submitting the Application Once all action items and general comments have been responded to the Application can be resubmitted Refer to the Submitting a Completed Form Application for the steps Last saved Friday 21 September 20122012 Online Ethics System Applicant User Guide Updated docx Page 24 of 28 University of South Australia EMAIL NOTIFICATIONS Emails will be sent to all the Applicant Principal Supervisor if applicable and Investigators listed on the Application whenever the status of the
27. on Create Application Result A new Application is created with an initial status of Draft ResearchMaster Enterprise 5 12 1 Home Ethics Personnel Applications iL Create Application For Review For Assessment Review All Applications Disclaimer Copyright Privacy Australian Technology Network W ResearchMaster Enterprise 5 12 1 Home Ethics PBRF Personnel Reporting System Administration New Application Application Status Draft Workflow State Draft Other Forms Ethics Protocol Fai Adion Create New Ethics Application The following provides brief information on how to complete an online ethics application For more detailed information please n Expand Collapse 2 T f 2 capil s Guide for the Principal Supervisor to assist supervisors with the review of student applications The User Guides also detail the The System allows researchers to complete and submit human ethics applications electronically Applicants navigate their way i Create New Ethics Application questions appear based on the answers to previous questions therefore it is advisable that you complete questions sequentially P Create New Ethics Application providing all the information you need to include If this is the case please include the necessary information as either a separa the Attachments Section or as a page comment Please refer to the User Guides if you are unsure how to use these function Prior Assessment Please ensu
28. on Status and Workflow State changes to one of the following a If the Application is considered Exempt or Negligible the Applicant is informed that no additional review is required and they can commence their research b Ifthe Application does not meet the conditions for Exempt or Negligible then that Application changes from Draft to ECO Review for a staff application or Draft to PS Review for a student application The Applicant will also be informed of the risk associated with their research El E2 or E3 Last saved Friday 21 September 20122012 Online Ethics System Applicant User Guide Updated docx Page 15 of 28 J University of South Australia Step 9 Adding Attachments The purpose of the Attachments page of the Application is to enable the Applicant to attach documents to support their Application This includes but is not limited to A copy of the HREC Application submitted and approved by another institution s HREC i e other than UniSA HREC Copies of the approval letters received from organisations involved in the research and or where the data will be collected from The research tools O Questionnaire s O Interview schedule s O Focus group interview topic s The recruitment material O Recruitment flyer letter s O Participant Information sheet s O Participant Consent form s Acopy of the confirmation of insurance cover from UniSA s Insurance Officer The Referen
29. onnel Reporting SCORE System Administration New Application Application Status Draft Workflow State Draft Other Farms Ethics Protocol Ens Action Create New Ethics Application Expand Collapse The following provides brief information on how to complete an online ethics appl 2 Toolbar Located in the top right corner of the application the Toolbar provides actions available to view and review the application Icon descriptions can be found in the Toolbar table at the appendix e 9 GF wl i o Ga 3 Application Navigation Located on the left side of the application the Navigation section provides access to sections within the application Form tab and available actions Actions tab The Form tab shows the Sections and Pages within the Sections providing Expand and Collapse links to view the whole structure The Action tab contains the action s ie Submit available for the current workflow state Eone Kion Create New Ethics Application Expand Collapse The following provides brief information on how to Guide for the Principal Supervisor to assist supe The System allows researchers to complete and 3i Create New Ethics Application questions appear based on the answers to previc gt Create New Ethics Application providing all the information you need to include the Attachments Section or as a page commer Prior Assessment Please ensure you enter requested information ir gt Non UniSA HREC you and therefore the rev
30. or ORC iD Given Name Surname Full Name Primary Position AOU Organisation Organisation Name 129100 Melanie Batingal Ms Melanie Corpus Batingal No ChiefInvestigator ORC t3 Given Name Surname Full Name System code of Position held Chief Investigator User Person Code Primary Yes O No AOU system code Research and Innovation Services Organisation Organisation Name Action Select System code of Position held as Chief Investigator Select Primary as Yes and click the amp icon to Save Result Chief Investigator is set Last saved Friday 21 September 20122012 Online Ethics System Applicant User Guide Updated docx Page of 28 YJ University of South Australia Step 5 Removing an Investigator Navigation Select the Investigator page under the nvestigator section Investigator amp pimai applicant student Plaas sel Yes dyol am a sfadent if rou aio Sa ee eee Tho AGIHHI Collapse fer Yag C Ws Cristi iw Ethics Applica T ee 2 Pease edit Un iris tirgator section By marking The primarg applscant as 7Priman lade dk on fes name ded then ssled Tes la Primer mpanga Imesligat After making the selection peast eame i Er cbcking on tha green Hok 31 ihe ng hand side boltom comer Paasa incide all oihar iriastigabsrs an this page by using ihe search function and mark the rola ee Osher Insestigater from th
31. ppear and previously answered questions to disappear This may result in pages that have been marked completed no longer being marked completed Note Answers are saved automatically If you exit a page or navigate to another page the answers entered up to that point will be saved automatically Step 3 Adding Investigators Navigation Select the Investigator page under the nvestigator section Fem Investigator Expands Collapse 1 is pamary apphcant a student Create New Ethics Application Please ensure thot you mark the Primary Contact usually the Chiel Investigator lor this protocol as Primary Please click on the name and select Yes to Primary field You can also search and add other investigators from this section select Other Investigator as their role from the dropdown box t Prior Assessment To save your changes click the green tick at the right bottom corner of the form t Instructions Search Named ID Given Name Surmame Full Name Primary Position AOU Organisation Organisation Name 129100 Melanie Batinga Action Enter the investigator s UniSA staff student ID or first name or last name or full name in the text box Then click the GL icon Result A list of staff members meeting the criteria is displayed Search Name lD eN More Criteria Given Name Surname Full Name i siti Organisation Organisation Name Last saved Friday 21 September 20122012 Online Ethics System Applicant
32. re you enter requested information in the sections available on the screen s left hand menu Investigators Attachm you and therefore the review process will be delayed Refer to the User Guides if you are unsure how to use these functions Attachments ANSWERING QUESTIONS It is important to take time to answer each question carefully and fully before progressing to the next question By doing so yo errors Last saved Friday 21 September 20122012 Online Ethics System Applicant User Guide Updated docx Page 5 of 28 rj University of South Australia Alternate Step 2 Accessing Existing Application s Navigation Ethics Tab Applications University of South Australia UniSA ResearchMaster Enterprise 5 12 1 Home Ethics Personnel Applications Home Disclaimer Copyright Privacy Australian Technology Network Web accessibility CRICOS Provider no 00121B Contact UniSA Action Click on My Applications or All Applications Result Available applications are displayed Note Applications are grouped according to their status Applications can be completed progressively and do not have to be completed in one sitting Applications Create Application My Applications Approved Type lication ID lication Title Status Primary Investigator Process Stage emplate Name Application Date LI I HUMAN 0000029214 New Application Draft Draft Ethics Protocol N A ECO review Last saved Friday 21 September 20122012 Onl
33. reuse Description optional Maximum length 50 characters Action Search for the file provide a description optional and click the OK button to upload the file Result the name of the uploaded file will appear under the Reference Document Title column of the Attachments table Additional Attachments Document Description Reference Document Title soft Copy Hard Copy Participant Information Sheet F Action Add an additional document description Click Additional Attachments link at the top right part of the Attachments table and enter a Document Description name in the text box displayed Click the to save the new document type Result A new document type is added and an attachment can be added 3 Participant Information Sheet as applicable Consent Form as applicable Others as applicable Sample Document Description Page 7 of 28 UJ University of South Australia Step 10 Viewing Attachments Navigation In the Application Navigation section click the Attachments page under the Attachment section Additional Attachments Document Description Reference Document Title tc Hard Copy 1 Reference List testdoc txt 2 Research Tools or reasons as to why there C arent any Action For soft copies click on the Document Title Result The attachment will open in a new window Action View the attachment and close the new window once you have finished
34. sary to get the complete details Step 7 Responding to Reviewer s Comments Once the Application has been submitted for review the Application may be returned to the Applicant with Page Comments and or Application Comments entered by the reviewer This means that the Applicant is required to make changes to the Application The Application will therefore be returned to the Applicant with one of the following status e ECO Update Required e PS Update Required for student applications e Approved Subject To e Not Approved Resubmit The process of responding to these comments is the same regardless of who wrote the comment Last saved Friday 21 September 20122012 Online Ethics System Applicant User Guide Updated docx Page 22 of 28 YJ University of South Australia A reviewer can enter two types of comments e General Comments e Action Comments Action Comments require the Applicant to respond to the comment and mark the item as responded before they can resubmit the Application General Comments do not require a response but should be viewed Navigation Select the relevant Application from the My Applications list For this example the application has the status ECO Update Required Applications h Crese Applicaion Liy Agglicatons brat Primary investigator O Update Required am zou FOr Rogen Dr Sua Driggs Action Check the sections pages which have the action comment icon next to them Hint Use th
35. ssosesresesreseosessosesresessessesseseesosesresessessosesrosteresesressessoressessereseesess l6 Step I0 Viewing ZAGETEBISIBHES cesis tenir Sess URDU IM DI IM I8 Step 1 T Deleting ACCA CHIN SINS uci eoi tot opi Eeird ood HEREIN Ieqebi te Fre PP Ig etus e sebv Rees g ese b Iw iE SUI URR HDI SISSE NESA C DI Sr Ei I8 Step 12 Adding Page CoMMe mte ccsssssssscscsssssssssscecsssssseesscssesessssssscecesessesscsccesensasseacscscecesesssescncesensacsescecensesacsescscncores 19 Step 13 Deleting Page COorrmelitsioe acte ai aeia dco Aaa a eia 20 Step 14 Adding Deleting Application COMMENTS cssssssssecssesstsscesecescscecscecscesesesescecesesesescscseesesesescsescececeseessesceeeeees 2l Step 15 Submitting a completed Form application esee e eeesesee eese tenente enean ne o tnnts 21 Step le Ite i mate c P 22 Step 17 Responding to Reviewer s Comments eee eee eeeeeeee teen te teen enti note tn tots tnis eese sets enini nes tnnis 22 EMAIL NOTIFICA HONS core 25 AMENDING AN APPROVED APPUCA TION iieri pei ich sutras Ee ERE Reb oc E Ev aaeain 25 TROUBLE SAIO AOIN C e E E E E TE ae eee 25 APP EPID A rera E E AEA E TOERIEN E OAE OEA E EES 26 AEFPLICATKON TATH ieena e ena E E EEE TEE N E er 26 COON TERM Il D 27 FO OLDAR
36. tion Select the New Comment Result Comments box is provided Last saved Friday 21 September 20122012 Online Ethics System Applicant User Guide Updated docx Page 19 of 28 J University of South Australia Page Comments New Comment All v Iu Type Author Comments Responded Resolved Type Response Comments Action Note Ms Melanie Corpus Batingal 27 08 2012 14 16 provide more info re data storage No Change page lt gt Displaying page 1 of 1 items 1 to 1 of 1 Action Select the Save icon to save the comment or Cancel icon to cancel the comment Result Record is saved cancelled Action Repeat these steps to enter page comments through the application Result Comments are added successfully Step 13 Deleting Page Comments Navigation Go to the page where you would like the page comment deleted from Action In the Toolbar select the Page Comments icon ag Result Page Comments screen is displayed Page Comments F New Comment All Type Author Date Comments Responded Resolved g General Note Dr Sue Briggs 29 05 2012 13 47 test comment N A N A Change page Displaying page 1 of 1 items 1 to 1 of 1 Action Click the Delete icon next to the comment you wish to delete Result Warning message is displayed Message from webpage Ed 3 Delete this comment Action Click OK Result Page comment is deleted Last saved Friday 21 September 20
Download Pdf Manuals
Related Search