User Guide Human Research Ethics Application System Applicant
Contents
1. 1 Create New Ethics Application Y Create New Ethics Application ti Prior Assessment Instructions Investigator Is primary applicant a student Please select Yes if you are a student if you are a staff member answer No Yes O no Please edit the investigator section by marking the primary applicant as Primary Please click on the name and then select Yes to Primary After making the selection please save it by clicking on the green tick at the right hand side bottom corner Please include all other investigators on this page by using the search function and mark the role as Other Investigator from the drop down box After making the selection please save it by clicking on the green tick at the right hand side bottom corner Search Name ID i Ia More Criteria 10 Given Name surname Full Name Primary Position AOU Organisation Organisation Name 129100 Melanie Batingal Ms Melanie Corpus Batingal No Chief Investigator ORC Di Have you made the necessary changes required by marking the applicant as Primary Please make the changes to avoid any inconvenience and respond with Yes O Yes O No Action Enter the investigator s UniSA staff student ID first name last name or full name in the text box Then click the icon Result A list of students staff members meeting the criteria is displayed Hint if an investigator s name does not appear try searching by surname2. Application Status Draft Workflow State Draft Other Forms NewE1 Form Action Investigator Is primary applicant a student Please select Yes if you are a student if you are a staff member answer No Yes O No Expand Collapse Create New Ethics Application y C WwW ics A icatic Create New Elhics Application Please edit the investigator section by marking the primary applicant as Primary Please click on the name and then select Yes to Primary Investigator gt Investigator After making the selection please save it by clicking on the green tick at the right hand side bottom corner Please include all other investigators on this page by using the search function and mark the role as Other Investigator from the drop down box Prior Assessment After making the selection please save it by clicking on the green tick at the right hand side bottom corner i Instructions Last Updated September 2014 Online Ethics System Applicant User Guide Page d University of South Australia Action Select Principal Supervisor page Application Status Draft Workflow State Draft OtherForms NewE1 Form eS 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
3. 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 As such it is advisable that you complete questions sequentially in order to avoid skipping sections unintentionally Advice and Assistance e fan Applicant requires ethics advice when completing the application form they can contact the Research Ethics Advisor REA for their Division or School A list of REAs and their contact details is available here http w3 unisa edu au res ethics human reas asp e The Research Ethics amp Integrity Team can assist with System troubleshooting and general ethics enquiries email humanethics unisa edu au ph 830 23723 e Please note that students should consult with their Supervisor in the first instance Saving the Application e The answers entered on each page are saved automatically when you click on the green arrows to navigate through the form e The application can also be saved at any time by clicking on the Save icon in the toolbar Step 3 Adding Investigators Navigation Open the Investigator page The person who created the application will automatically be listed as an Investigator but other members of the research team must be added manually Form Action Expand Collapse
4. 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 Updated September 2014 Online Ethics System Applicant User Guide Page 20 University of South Australia Step 16 Responding to Reviewer s Comments During the various stages of review the Application may be returned to you with Comments entered by the reviewer You will receive an automated email notifying you that you are required to make changes to your Application When you log in to the online system you will see that the Application has one of the following Statuses PS Primary Supervisor Update Required ECO Ethics amp Compliance Officer Update Required Approved Subject To Not Approved Resubmit The process of responding to these comments is the same regardless of who wrote the comment A reviewer can enter two types of comments e Action Comments are marked by red flags r they require the Applicant to make changes to their application and mark the item as responded before they can resubmit the Application e General Comments are ma
5. 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 available at Guidelines 4c New i pli i a ne i 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 y 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 Non UniSA HREC Additional Attachments Attachments ae 5 Document Description Reference Document Title Soft Copy Hard Copy 4 Reference List O Declaration areas 2 Research Tools or reasons as to why there arent any 3 Participant Information Sheet as applicable Instructions T gt Instructions Consent Form as applicable oO oO d oO Others as applicable Action Click the E icon next to the document type you would like to upload Result Upload File form will appear 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 File Bro
6. Supervisor 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 NamelID Q More Criteria 3 Investigator T ares ID Given Name Surname Full Name Primary Position aou Organisation Organisation Name Supervisor No records to display i Prior Assessment Action Enter the principal supervisor s UniSA staff student ID first name 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 Principal Supervisors may also have a student ID nine digits e g 123456789 or an external ID letters e g SMITHK Ensure you select the Staff record of the Principal Supervisor six digits If the incorrect type of ID is entered then your Supervisor will not be able to review your application Search Namen Ja More Criteria 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 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 your Principal S
7. the Application the Principal Supervisor and the Ethics Reviewers 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 yy Eam Action Data storage access disposal 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 Individually identifiable i Create New Ethics Application C Re identifiable Y Create New Ethics Application C Non identifiable ti Investigator 9 1 1 Give reasons why it is necessary to store information in identifiable or potentially identifiable form coded 4 Principal Supervisor 1 Prior Assessment l 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 1 J Resources v Project Funding a wne hj of D Data storage access disposal P nsurance Action In the Toolbar select the Page Comments icon and click the New Comment link Result Page Comments screen is displayed Page Comments New Comment All a 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 Di
8. 1 Home Personnel Help ae Home Disclaimer Copyright Privacy Australian Technology Network Web accessibility CRICOS Provider no 001218 Contact UniSA Action Click on Create Application Result A new Application is created with an initial status of Draft ResearchMaster Enterprise 5 12 1 Home Ethics Personnel Applications For Review For Assessment Review All Applications Disclaimer Copyright Privacy Australian Technology Network W ResearchMaster Enterprise 5 12 1 Home Ethics PBRF Personnel Reporting SCORE System Administration New Application Application Status Draft Workflow State Draft Other Forms Ethics Protocol T Fonn aio Create New Ethics Application Expand Collapse The following provides brief information on how to complete an online ethics application For more detailed information please r 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 gt Create New Ethics Application providing all the information you need to include If this is the case please include the necessary information as eith
9. AN E A A E A A E A E EA E E E E A T 24 PES Pa TON TATO ce E EE E OE A E EO EE E 24 COMPOR EER NIO aaen ar E E O O E O E O 26 TOOLBAR oenen aia TAA EA ET A E EAE E NA E A 26 OOMTIPIEIN TT PGS acess E E E EEE OEE E EE EE EEA 27 Last Updated September 2014 Online Ethics System Applicant User Guide Page 2 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 The University s Human Research Ethics webpage provides furth
10. Dj Have you made the necessary changes required by marking the applicant as Primary Please make the changes to avoid any inconvenience and respond with Yes O Yes O No Action Click the Full Name of the investigator Result Additional information about the investigator is displayed search NameD eg More Criteria 129100 Melanie Chief Investigator ORC 10 Given Name Surname Full Name Primary Position AOU Organisation Organisation Name 129100 Melanie Batingal Ms Melanie Corpus Batingal No Chief Investigator ORC Di Given Name Surname Full Name System code of Position held Chief Investigator User Person Code Primary Yes O No AOU system code orc Research and Innovation Services Organisation B Organisation Name Action Select Position held as Chief Investigator Select Primary as Yes and click the icon to Save Result Chief Investigator is set Last Updated September 2014 Online Ethics System Applicant User Guide Page 10 d University of South Australia Step 5 Removing an Investigator Navigation Open the Investigator page Investigator Tto OB OMe SoCo a shidan Please poleti Yog d you One o SS F you ond Sha memea Sewer HS Farm gto Expands Collapse a E Yas P Ne j Create New Chics Application Please edil lhe inves ipator section by marking the primary apicar as Primer Fea digk o
11. K Result Name is deleted Last Updated September 2014 Online Ethics System Applicant User Guide More Criteria Page 13 d University of South Australia Step 8 Adding Attachments The Attachments section allows you to upload documents to support your Application This includes but is not limited to e A list of key references e The research tools o Questionnaire s o Interview focus group questions or topics e The recruitment material o Participant Information sheet s o Participant Consent form s o Recruitment flyer s letter s o Scripts for recruitment telephone calls e Copies of the approval letters received from organisations involved in the research e A copy of the confirmation of insurance cover from UniSA s Insurance Officer if required e If the application has already been approved by another institution s HREC a copy of the full application and approval letter from the other HREC The Reference List and Research Tools or reasons as to why there aren t any are mandatory attachments 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
12. The following provides brief information on how ta Guide for the Principal Supervisor to assist supe Expand The System allows researchers to complete and i Create New Ethics Application questions appear based on the answers to previc P 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 P Non UniSA HREC you and therefore the review process will be dela ANSWERING QUESTIONS It is important to take time to answer each quest errors 3 Attachments P Attachments Student applicants Please note that you must e Declaration A The research activity must not commence until e gt Declaration Oi agree Instructions gt Instructions 4 Application Content The main section of the screen displays the application questions and responses Workflow State Orat Other Forms Ethics Protocol F Non UniSA HREC Ethics category code apse Human Ethics pplication Primary AOU Application AR e eer ORE Research and Innovation Sensces Please emer an Application Tithe test 11 Has another Human Research Ethics Comenittes other than UniSA reviewed this research project before and does thig Claarance approval accurately Gescnbe the project as R is to be conducted Heo Last Updated September 2014 Online Ethics System Applicant User Guide Page 7 g University of South Australia
13. University of South Australia User Guide Human Research Ethics Application System Applicant Guide Version 2 Research and Innovation Services For further information or assistance please contact the Research Ethics Office e mail humanethics unisa edu au ph 830 23723 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 ccsccsssecsesesssstsesesseeeseees 3 RSET TINS agosto occa teeta enc OEE EA E T E Gen A EEEE E 4 Seea MSI a EE P P A A N ATE AEEA ETE A E E E E P PA E E A 4 Step 2 Creating a New Application cscscssssesscscscssssssscsssssssssssssscssesessesscscesossssaescecucesessssacscacecessesaescecesensee
14. ality 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 Statement 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 or the Application h
15. as been inactive for more than 6 months It is not possible to re activate a withdrawn application Online Ethics System Applicant User Guide Page 25 University of South Australia COMMON TERMS Committee Review Group Refers to one of three review groups that assess human ethics Applications They are El HREC Chair E2 Review Panel E3 Review by full Ethics Committee Ethics and Compliance Officer Human Research Ethics Committee Research Ethics Advisor TOOLBAR gt Next Page Go to the next page in the application eee i 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 a Page Comments Comments that apply to the current page em oP ore paga or or te aietan Exit the application and return to the Applications home page n j Last Updated September 2014 Online Ethics System Applicant User Guide Page 26 University of South Australia COMMENT FLAGS aon A reviewer has entered an action comment on the page p The applicant has responded to the action comment Yellow e The reviewer has resolved the action comment Green BI P There is a general note on the page or application This should be read but no action is required Last Updated September 2014 Online Ethics System Applicant User G
16. e Page 9 d University of South Australia Step 4 Selecting the Chief Investigator As a default the Applicant is assigned the role of Chief Investigator This step is only required if the Applicant is not the Chief Investigator Note there may be more than one Chief Investigator Any person assigned the role of Chief Investigator can view and edit the Application in the Online System Navigation Open the Investigator page Foii pone Investigator 1 Is primary applicant a student Please select Yes if you are a student if you are a staff member answer No yes O No Expand Collapse Create New Ethics Application Create New Ethics Application 2 Please edit the investigator section by marking the primary applicant as Primary Please click on the name and then select Yes to Primary After making the selection please save it by clicking on the green tick at the right hand side bottom corner Please include all other investigators on this page by using the search function and mark the role as Other Investigator from the drop down box i Prior Assessment After making the selection please save it by clicking on the green tick at the right hand side bottom corner Instructions Search NamellD Q More Criteria ID Given Name Surname Full Name Primary Position AOU Organisation Organisation Name 129100 Melanie Batingal Ms Melanie Corpus Batingal No Chief Investigator ORC
17. e attached documents or adding your own page comment in response Once you have done so mark the Action Note s as Responded as follows Action Reopen the Page Comments screen and check the box next to the Action Note Result The Mark Selected Comments as Responded ink at the top of the comments table will be enabled Page Commenhs change page a Dipig page 1 of 1 derma DiS 1 of 4 Action Select IP Mark Selected Comments as Responded Result Warning message Message from webpage j 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 to indicating that the action note for that page has been responded to Collection Method Collection Method vi Participants Relationships Consent Consent Process Note An Application can only be resubmitted once all Action items have been responded to and all flags have turned yellow An Application cannot be resubmitted if there is a red flag against any section Re submitting the Application Once all action items and general comments have been responded to the Application can be resubmitted ref Step 15 Last Updated September 2014 Online Ethics System Applicant User Guide Page 22 University of South Australia EMAIL NOTIFICATIONS Emails will be sent to all the Applicant Principal Supervi
18. e minor changes to the Application before resubmitting it for review An Applicant has started an Application It has not yet been submitted 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 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 El Applications within 10 working days of submission E2 Committee Group Review 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 The review panel reviews E2 Applications within 10 working days of submission E3 HREC The Ethics and Compliance Officer has forwarded the Application for review At the time the Application was submitted the System determined that th
19. e research project poses more than low risk The Applicant was thus notified that the risk associated with the project requires E3 level of review HREC reviews E3 Applications at the next monthly meeting ECO Review An Applicant has completed an Application and has submitted it to the Ethics and Compliance Officer who conducts an initial check for completeness and consistency ECO Update Required The Ethics and Compliance Officer has reviewed the Application and requires the Applicant to provide additional information or amend answers provided Last Updated September 2014 Online Ethics System Applicant User Guide Page 24 Negligible Not Approved Not Approved Resubmit PS Review ECO Update PS Review Review Update Last Updated September 2014 University of South Australia 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 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 qu
20. er a separa the Attachments Section or as a page comment Please refer to the User Guides if you are unsure how to use these functions Prior Assessment Please ensure 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 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 Updated September 2014 Online Ethics System Applicant User Guide Page 5 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 El hics 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 Applications available 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 ication Title Status Primary Investigator Process Stage emplate Name Applica
21. er information on the ethics application and review process http w3 unisa edu au res ethics human 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 Applications Last Updated September 2014 Online Ethics System Applicant User Guide Page 3 University of South Australia GETTING STARTED Step Logging In Navigation https research unisa edu au RMENet University of South Australia Uver Narve EE o o TS PET Win ResearchMaster Enterprise 5 12 1 Welcome to RMENET at ResearchMaster weicome to the Research amp Innovation system for tracking processing and adnunstering research management in the University To begin enter your userre and password in the feds provided and then cick the Log In button T your username hae been vakdated comectly you wil be taken to the RMENET Hone page eD accessit LRDOUS Provider ne 01216 Contact Unga unma Maree Vie Action Enter your UniSA network User Name and Password and click the Login button Result User is logged into the system and the Home page is displayed Page 4 Last Updated September 2014 Online Ethics System Applicant User Guide d University of South Australia Step 2 Creating a New Application Navigation Ethics Tab gt Applications University of South Australia UniSA ResearchMaster Enterprise 5 12
22. hy there arent any Action Click on the Document Title Result The attachment will open in a new window Action Check the attachment and close the new window once you have finished 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 tems 1 to 10 of 13 Change page 1 Go Pagesize 10 Change Step 10 Deleting Attachments Navigation Open the Attachments page Additional Attachments Document Description Reference Document Title op Hard Copy 1 Reference List testdoc txt A x 2 Research Tools or reasons as to why there C arent any Action Click the iJ icon against the name of the attachment 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 Attachment is deleted Last Updated September 2014 Online Ethics System Applicant User Guide Page l6 g University of South Australia Step Il 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 If necessary Applicants can add comments to provide further information to the Reviewers Comments written by the Applicant are visible to all other Investigators listed on
23. leted in the same way as Page Comments Last Updated September 2014 Online Ethics System Applicant User Guide Page 18 g University of South Australia Step 14 Viewing a PDF Copy of the Application This function allows the Applicant to generate a PDF or HTML copy of the Application enabling them to view all of their answers in a single document and print or save a copy Note Attachments are not included in the PDF and must be opened separately Navigation Click the Reports icon on the toolbar The following screen will open Printer Friendly Version Print View Snapshot Document Ethics Application Option Action Select Ethics Application and either HTML or PDF Note A summary of all comments on the application can also be generated by selecting Comments Report Click OK Result Document will display in a new screen Note if the window does not open check your Browser Settings to ensure that Pop Ups are enabled Application ID 0000025646 Application Title Test Staff Application Date of Submission N A Primary Investigator Dr Sue Briggs Project Details Ethics Training 3 1 Have you had human ethics training in the last 24 months Please do not include training you have attended regarding how to use the online ethics system O Yes No Project Type 4 1 Main type of research e g staff PhD Course Approval O PhD Honours Masters by Course work Ma
24. n Te name and than select Yeg to Primar Aher moking the selection please sive A by ciching on the green Lick of the tighi herd ade botiom comer iak Pjese inchide all other ivastigators on is page by using th search funchon and mark the pHi as Other Invistigabor trem the drop diwn B3 j Pela Ae eae Jitter making the selection pease aaro H by Clicking on the green tick ai the righi hand side botom comer z insiruc bons Search Miell i Moen Criteria in Giankama Suman Teil Hare Primary Position AQU Organisation Organisation Nara 120000 LUelanie Hatags ls Uallais Capus fatingal Ms Chfinesagator ORC E Mave you made Ihe necessary changes required by marking Ihe aoeecanl as Primar Please make Ie changes lo artid any inconvenience a53 respond wih Tes CI yas EI Hig Action Click the iJ icon against the name of the Investigator 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 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 staff applications Note The Principal Supervisor cannot also be an Investigator Navigation Open the Investigator page Action Select Yes to question 1 Is the primary applicant a student Result Principal Supervisor section will be accessible
25. only Search Nam emf al More Criteria Given Name Surname Full Name Last Updated September 2014 Online Ethics System Applicant User Guide Page 8 d 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 Select their Position and indicate whether they are the Primary Applicant Click the icon to Save Result Investigator added Last Updated September 2014 Online Ethics System Applicant User Guid
26. rked by blue flags P they do not necessarily require a response but should be viewed Navigation Select the relevant Application from the My Applications list In this example the application has the status ECO Update Required Applications rie Carnet Primary invesakgator Process Sage ECO Update Pecquined Or Sue Driggs EGO Reve Action Check the sections pages which have the action comment icon F next to them Hint use the Expand link Go to this section page a Collection Method Collection Method v Participants Relationships Consent Consent Process Action Click the Page Comments icon You should see the Action Notes created by the Supervisor ECO or Ethics Reviewer Click the blue text under the Comments column to view the whole comment Result Action note is displayed colHection Method g Click here to view the whole comment 37 1 Data collected Page Comments New Comment L Type Author Date p Sponded Resolved g Action Note 29 05 2012 15 23 please provide more information on your collectio No No Change page Displaying page 1 of 1 items 1 to 1 of 1 Last Updated September 2014 Online Ethics System Applicant User Guide Page 21 University of South Australia Action Once the comment is read and the action understood select OK Amend the Application as necessary by making changes to your answers within the Application revising th
27. scucecesesensees 5 Alternate Step 2 Accessing Existing Application S cccsessssssecscecessssssssssecesesesscecesesesssccesesesesescsceseseseeeacscacceneeeseseses 6 EAE ETHICS APPLICA HON een eC eee ee ee ee eee ee eee eee 7 Step Navigating the ADDIICATION sccscacescesccevssesstscscanscsescencecedcesnsveucdcbesasetatindeiatcvesetedcus eucssuatessieeateesucvadeotaeustectisestansteuetesiadateect 7 Step 2 Answering Questions in the Application ss ssesossessssessesssseseessesessesessessosessesesseseosessosessesessesressoressesessesesseseesesse 8 Step 3 Adding InvestigatorsS eeesseseeeesseeeoressosessesresessessoresresesressosessosesseseoresreesoseeresssseseoseerosesreseosessoseeresreseeseseoseeseseeressesess 8 Step 4 Selecting the Chief Investigator csssscscsssssssssscsssssssssnsscscssessssssscasesessnsssacacesssesessasseacecessnsacacacessssasacacacessees 10 Step 5 Removing an Investigator sseeeseeseesesressoresresesseseeseoresresessessssessosesreseereseoressoseosesseseeressoseesostesesesreseostsroseeseereseesess Step 6 Adding Principal SUDEMVISOM scsssasuscsssscveseszecasaeseseaszesencscscessesenessctssssascascacesaasisesoasnscendsomteneentnniaaemnientuedensdneeieen I Step 7 Removing the Principal Supervisor e seesseeessessesessesessessosessesreseoressoresresesseseoressosessessssesressoseeresseressoresseseereseesess 13 Step 8 Adding PAC CAC INNIS soe cessctc sec cas cestcetponteci
28. sor if applicable and Investigators listed on the Application whenever the status of the Application changes Emails are also sent to the ECO and the Committee Review Group when their action is required The Applicant cannot commence their research until they receive an email notifying them that final approval has been granted AMENDING AN APPROVED APPLICATION Amendment requests are submitted and reviewed outside of the Online System The application process is outlined here 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 the Research Ethics amp Integrity Team email humanethics unisa edu au ph 830 23723 If you require ethics advice or guidance please contact the relevant Research Ethics Advisor see http w3 unisa edu au res ethics human reas asp Last Updated September 2014 Online Ethics System Applicant User Guide Page 23 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 Applicant is free to commence the research as outlined in the Application 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 mak
29. splaying page 1 of 1 items 1 to 1 of 1 Action Type your comment into the text box then click the Save icon to save the comment or the Cancel icon A to delete it Repeat these steps to enter page comments throughout the application as needed Last Updated September 2014 Online Ethics System Applicant User Guide Page I7 University of South Australia Step 12 Deleting Page Comments Navigation Go to the page where you would like the page comment deleted Action In the Toolbar select the Page Comments icon Result Page Comments screen is displayed Page Comments New Comment E 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 lt gt 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 _ SS Message from webpage Eg y D J Delete this comment Cancel Action Click OK Result Page comment is deleted Step 13 Adding Deleting Application Comments Application level 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 from the Toolbar Result Application Comments screen is displayed Follow steps and 2 above Application Comments are added and de
30. sters by Research Professional Doctorate Undergraduate Graduate Diploma Graduate Certificate O Staff other Action Document can be printed or saved Last Updated September 2014 Online Ethics System Applicant User Guide Page 19 University of South Australia Step I5 Submitting a completed Application The Ethics application can only be submitted when all mandatory questions in the form have been answered This is true if a green tick appears next to each item in the Navigation section A yellow arrow or red exclamation point will appear against unanswered sections Resources t Ownership of Data P Insurance Hint use the Expand link to check all items Form Action Navigation To Submit the completed application select the Action tab Submit Action Click the Submit button Result Warning message is displayed Message from webpage x agy Are you sure Action Click OK Result If the form is complete the Application is submitted to the next stage of review and 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 Application Status and Workflow State changes to one of the
31. tion Date Lo HUMAN 0000029214 Draft Draft Ethics Protocol N A ECO review Last Updated September 2014 Online Ethics System Applicant User Guide Page 6 oJ University of South Australia THE ETHICS APPLICATION Step I Navigating the Application There are four components to the application Information Area Located at the top of the screen the Information Area displays the Application Title Status and Current Workflow State ResearchMaster Enterprise 5 12 1 Home Ethics PERF Personnel Reporting SCORE System Administration New Application Application Status Draft Workflow State Draft Other Forms Ethics Protocol Form Action Create New Ethics Application Expand Collapse The following provides brief information on how to complete an online ethics appl 2 Toolbar Located at the top right hand corner of the application the Toolbar provides actions available to view and comment on the application Icon descriptions can be found in the Toolbar table appendix WOONOs 3 Navigation Panel Located on the left hand side of the application the Navigation section provides access to sections within the application Form tab and available actions Action tab The Form tab shows the Section Headings and Pages The Expand and Collapse links can be used to view the whole form The Action tab lists the action s available e g Submit Withdraw Eim Acticin Create New Ethics Application Collapse
32. ts xasacesaceate sauce sceastedaia sascsacesuscdabacseanedeecuaactesanecstecsesundaucdcanioestecicBestaeseteteentace 14 Step 9 Viewing Attachments sssississsreinisniidorioridonioiidriperd oriee iente a PENTSA RENEE NEA ENE eTii eine l6 Step 10 Deleting Attachments scenes E cee vacate teases l6 Step I l Adding Page CoMMe nte cccscssssssscesscsssscscssssssssessscscessssnsesscecesessesscscncesessecseacscececeneasscscecesensacscuceceneesacsescsceseres I7 Step F2 Deleting Page C OMMENtS vavescniananaanenaaciannncunnaincannacnensaununndaannaaunuedentcn 18 Step 13 Adding Deleting Application Comments se seessseessessssessesessesesseosessesesseseoressesesresessessosessesessesressoressesesreseesess 18 Step 14 Viewing a PDF Copy of the Application se seeseseosseesssessesessesesseosessesesseseosessesessesessessosessesessessessoressesesseseesess 19 Step 15 Submitting a completed Application 0 0 cssssssssssesececsssssscscecesecesescscesesesesescececesesesescsceseceseeeseacececeseeeseacseeeeees 20 Step 16 Responding to Reviewer s COMmMments sseesseessesessessosesseserseoreseoressesessessoressosesreseesessoseoseeresssressoressessereseesees 21 EVE IN TS HONS orriari annar i E E EE OTE O EENE OEE EENE 23 AMENDING AN APPROVED APPLICA TION oercssssiinnossieniripseriters coiden iaspsctvacnsacendossostns avencievensestacveesdaecwenpecereees 23 TROUBLE SOO TUNG resio se ana E E E E E E EE E T E EA 23 PPT IN e OA A es cnt T
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34. upervisor from the list Last Updated September 2014 Online Ethics System Applicant User Guide Page 12 d University of South Australia Principal Supervisor Only the details of your principal supervisor i e the person responsible for reviewing your application can be included here Please include all other su from the drop down box As you are student candidate please select and add a Principal Supervisor After making the selection please save it by clicking on the green tick at the right hand side bottom corner 1D Given Name Surname Full Name Primary Position Aou Organisation Organisation Name Supervisor Given Name Surname Full Name System code of Position held Supervisor vi User Person Code Primary O Yes No AOU system code Research and Innovation Services Organisation Organisation Name Supervisor person code Action Check the details and click the icon to Save Result Principal Supervisor added Step 7 Removing the Principal Supervisor Navigation Select the Principal Supervisor page Organisation Organisation Name 128757 Vaneet Vaneet Mr Vaneet Vaneet No supervisor 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 O
35. wse Description optional Maximum length 50 characters Last Updated September 2014 Online Ethics System Applicant User Guide Page 14 Last Updated September 2014 University of South Australia Action Click the Browse button to 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 d Action To add further documents when all existing rows are full click the Add New Document link at the top of the Attachments table Add New Document 1 Reference List Action Enter a Document Description for example Recruitment Flyer in the text box displayed Click to save the new document type Result A new document type is added and an attachment can be uploaded by clicking on the a icon as described above 3 Participant Information Sheet as applicable Consent Form as applicable Others as applicable Online Ethics System Applicant User Guide Page I5 University of South Australia Step 9 Viewing Attachments Navigation Open the Attachments page Additional Attachments Document Description Reference Document Title 1 Reference List testdoc txt x 2 Research Tools or reasons as to w
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