ARIES Human Ethics User Guide
Contents
1. Protocol title 1a x a a a a a a a a Ethics programme type Xxx Chief Investigator Protocol number 200x xxx Approval date Anticipated end date Expiry date XX xXx xXxx x Submission date Current clearance status Xxxxxx Review level Review Xxx System ID XXXXX RRA RAR AM Primary investigator Department of Physics Faculty of Science ANU Paley Name KAKKAAKARAK Co investigator University of Queensland AAKAAAAAAAA Co investigator University of Queensland You should select any external investigators as well as internal ANU based investigators Expedited Protocol Entry When you have finished adding your Investigators click on the High Risk One tab The next three tabs have questions that need to be considered Page 5 ARIES User Guide Human Ethics Module a 3 If your answers are all No click on the High Risk Two tab Monitoring Yariation Project Details Documents Progress steps Header Investigators Departments gh R High Risk Two Questions Protocol title The implications of chemical spills for the general populace Ethics programme type Staff Chief Investigator Aarons Hank Protocol number 2007 2142 Approval date Anticipated end date Expiry date Submission date 09 06 2007 Current clearance status Draft Review level Expedited Ethical Review E1 System ID 2142 If Monitoring Yariation Project D2. area where data collection will be conducted es This screen contains a considerable amount of data In order to prevent you from being timed out of your ARIES session the system automatically saves every five minutes and consequently prevents the data loss This saving can be slightly disconcerting but it is preferable to the alternative of data loss Documents In addition to the basic data entry for protocols investigators are able to upload documents against each protocol For example the Information Sheet and Consent Form required for each protocol will be stored in the Documents tab Click on the Documents tab and then the button This will bring up a screen where you name the document you are uploading and then browse and select the document from your hard drive Document description File to upload pdf doc Browse The documents uploaded to the documents tab must be uniquely named The following convention can be used Year_ProtocolNo _Surname_document description 1 e 2007_123_Smith_InformationSheet If you delete a document both the replacement document name AND the document name in Aries will need to be given a new name i e 2007_123 Smith_InformationSheetl Page 14 ARIES User Guide Human Ethics Module Once you have named and selected your document click the sp Add button The page at http caswebacep anu edu au says X A IMPORTANT After you click lt OK gt your File will st
3. Existing Records e Create a New Protocol y LOCU Create a New Facility List Existing Records e List Existing Facilities ERA E Home Page ERS Screen ERA Re port Wizard Once a menu option has been selected the user will be taken into the system From here the user can navigate through the different modules using the tabs that appear at the top of the screen Page 1 ARIES User Guide Human Ethics Module Alternatively the user can select the Gi Home J button to return to the Home Menu to select the desired menu Human Ethics module The Human Ethics section has three menu options Human Ethics Ae Home Page Create a New Protocol List Existing Records Home Page takes the user to a menu strictly displaying Human Ethics menu options with links and quick guides Create a New Protocol commences the process of creating a new protocol List Existing Records takes the user to a summary screen of protocols from the users department The user will only be able to access protocols that they have created or they are listed on as an investigator Clicking on the He button will also take you to the same links Once a menu option has been selected the user will be taken into the system Contracts Grants Publications Animal Web Tools Creating a Protocol To add a new protocol from the main screen click HF Create A training message will be
4. entered the data in the Header screen click the tab labelled investigators You now choose the relevant investigators by selecting the sp Add button searching on their names and selecting them Protocol title Ethics programme type Chief Investigator Protocol number Approval date Anticipated end date Expiry date Submission date Current clearance status Review level System ID Institution Institution Please remember to complete the Header and Investigator s tab before exiting ARIES otherwise your application will NOT BE VISIBLE when you log back into the system If this does happen you will need to contact us to rectify the problem on 6125 3427 or human ethics officer anu edu au Throughout ARIES searches will work with at least two characters anywhere in the word you are seeking So for example if you are looking for the name Cardew Smith you could type card or dew and it would be retrieved Surname or Staff ID surname Search options Contains gt If an ANU staff member or student is not on the list contact our office on 6125 3427 or human ethics officer anu edu au Please do not just add them as an external investigator In selecting investigators you will almost always click yes to Add their Department Automatically add a department _ WOULD YOU LIKE TO ADD THE IN ESTIGATOR DEPARTMENT No fi Yes Investigator name Investigator department Department of Chemistr
5. save your work frequently ARIES is a system where the data is contained in a series of tabs Fields which must have data contain an asterisk You may save your protocol and exit Aries ONLY AFTER YOU HAVE Se Tab You completed filling out the information under the Header and then have the option to return to the application at any time whilst your application is still in draft and make changes and or submit it Monitoring i ariation Project Details i Documents Notes Progress steps Investigators Departments y High Risk One High Risk Two jf Questions Cancel Save Submit Print Form Created by Record number New Protocol type Expedited Ethical Review E1 Protocol number Auto generated Date entered 07 09 2007 Ethics program type staff Requested start date ss Requested end date Protocol title Enter data against all fields in the screen and ensure that you choose the appropriate Ethics program type Dates are entered in the form dd m yy though they will store and display as dd mm yyyy You may enter in this full form if you choose e Remember ethics approval from ANU will last for only 5 years After this time you can apply for a year extension If you require longer than this period you will then need to submit a new application prior to your current application expiring Page 3 ARIES User Guide Human Ethics Module After you have
6. the participant Select Yes against the questions that apply to your protocol and then click the button This will take you to further questions relating to the questions answered Yes If all boxes are selected No the system will take you directly to Project Details Protocol title 1x k a a aa a Ethics programme type Xxx Chief Investigator Protocol number 200 xX X Approval date Anticipated end date Expiry date XXxx Submission date Current clearance status Xxxxx Review level Review XXX System ID XXXxX Information it Children or Young People Dependent or Unequal Relationship Deception Edit When you select the button the system will take you to further questions relating to the initial question For example when you select the button against Children or Young People the below questions will appear Page 8 ARIES User Guide Human Ethics Module Protocol title 1 a a a a a a a a Ethics programme type xxx Chief Investigator Protocol number 200x Xxx Approval date Anticipated end date Expiry date X X XXxXxX Submission date Current clearance status Xxxxx Review level Review xxx System ID AXXXX Help Answer Question __ lt gt y B No Will appropriate parental guardian consent be sought or is the child or young person capable of consenting without parental guardian consent F No gt Is the child or young person capable of consenting i
7. Australian S National University Research Integrity amp Compliance ARIES Research Management System Human Ethics User Guide Human Ethics Manager T 6215 3427 E human ethics officer anu edu au W http researchservices anu edu au ori human index php ARIES User Guide Human Ethics Module Using the Human Ethics module of ARIES Aries 1s accessed on the web using Mozilla Firefox Internet Explorer or Safari or Google Chrome The URL for Aries is https researchservices anu edu au ore aries Log into ARIES using your HORUS id and password If you get a message saying that your password and ID are correct but you don t have a profile you will need to fill in a new user form You will find this link above where you log in https aries anu edu au content ASP AN Ulogin asp Navigating the System Home Menu ARIES opens to a Home Menu displaying the various modules of ARIES This includes Human Ethics Animal Ethics Contracts Grants Publications and ERA vail address u1234567 anu edu au Skip Navigation Logout Publications Contracts Reporting Grants ee eee anii Home Page Home P ae al eee are Publications wizard Create a New Record Create a New Record Aek EMchaa DAAE er RVEHAA Dace Reporting Engine List Existing Records List Existing Records Global Reporting Animal Ethics Human Ethics Ag Home Page Create a New Protocol Home Page List
8. Current clearance status XXXxXx System ID XXXXxX Approval date Anticipated end date Submission date Review level Review XXX Report name External reporting services Action Expedited approval form Full Approval form To print your application click the Print Form button on the Header tab Select the magnifying glass that relates to the Review Level of your application The continue button will take you back to the Header tab Don t press the continue button unless you want to be taken back to the Header Tab Submitting If you are satisfied that the application is now complete go to the Header screen and click the Submit button Remember You may save your application and exit ARIES at any time after you have entered the names of investigators and then return to it and make changes and or submit it You may also print the form at any time and work on the hard copy Monitoring j Variation Project Details j Documents j Notes Investigators Departments High Risk One HighRiskTwo Questions Created by Record number Protocol type Protocol number Date entered KI KRKK Ethical Review 200OX XKX 07 07 2008 Ethics program type Staff Requested start date o 1 08 2008 Requested end date fo 1 08 2013 KALKKI Protocol title You should now sign the form and get it signed by your supervisor if appropriate Once your application has
9. art to upload Depending on the size of your file this process may take several minutes Please wait For the system to confirm the file has been Uploaded The system will then take some time in uploading the document depending on the file size and will alert you with the above message Once the file 1s successfully uploaded it will be listed on the documents tab of the protocol as shown below Protocol title XXX xXXxXxXxxXXKX Ethics programme type xxx Chief Investigator Protocol number 200x xxx Approval date Anticipated end date Expiry date X XXxx Submission date Current clearance status Xxxxx Review level Review Xxx System ID XXXXX 4p ada Document File Size File Name 137614 Printing Applications PLEASE NOTE Submitting your application will lock your application and you will not be able to edit your application online As the paper form needs to be identical to the electronic form it 1s advisable that you print your application BEFORE submitting so that you are able to edit your protocol if you notice an error that needs editing after printing If you have submitted and wish to edit your protocol please contact our office on 6125 3427 or human ethics officer anu edu au and we will put your application back to draft format Page 15 ARIES User Guide Human Ethics Module Protocol title XXXXXXXxXXXXXX Ethics programme type Xxx Chief Investigator Protocol number 200x xxx Expiry date XX XXXx
10. been signed you are ready to submit your hard copy application to Research Integrity amp Compliance An email will be sent to you once you submit advising how many copies to bring to our office Bldg10b Page 16 ARIES User Guide Human Ethics Module Submitting the protocol has three effects e It locks the protocol and prevents further data entry e It sends a message to the Ethics Office that a new application has been submitted online You will then receive an ARIES email advising you what to do next e t allows the final printing of your protocol Additional Tips Selecting the Submit button will take you to the opening summary screen If you have saved your data and want to return to edit the protocol the easiest way to get back to your protocol is to click the Edit my last record button on the main screen Additionally if you would like to print your protocol after submission you will need to re open your protocol by selecting the pencil button Log Out At the conclusion of your work in the system please terminate your session to guarantee that unauthorized users do not use your profile Ensure your session is terminated by selecting the _ Logout button Page 17
11. displayed If you haven t already attended a training session please contact the ORI Otherwise click the Create button again to start a new application SA ANU ARIES build 485 Development Filter records hy Institution Anu Filter records by Faculty School Centre Faculty of Science gt Filter records by ee RET i Filter records by Review level an z Filter records by status ALL RECORDS Filter records by Meeting ALL RECORDS Additional Filters ALL RECORDS Refresh list Edit my last record fdit 2607 2142 Expedited Ethical Draft The impheations of chemical spills for the general populace Aarons Hank Faculty of Science AEN Revie wei Page 2 ARIES User Guide Human Ethics Module The next screen will ask you to click on your level of review You will then choose the option which best suits your sense of the risk of the protocol where Expedited Ethical Review is low or negligible and Full Ethical Review is high Unless you know that your research is HIGH RISK choose the Expedited Review option As the system is designed to assess the risk level from the answers yes or no that you give if it does prove to be High Risk your data will be transferred over to a Full Review application without you losing any of the information you have entered Protocol Data Entry For security and privacy reasons ARIES automatically times out after 20 minutes of inactivity Please
12. etails Clinical Trials f Documents Progress steps EEEE EEEE Investigators Departments High Risk Two Questions Protocol title The implications of chemical spills for the general populace Ethics programme type Staff Chief Investigator Aarons Hank Protocol number 2007 2142 Approval date Anticipated end date Expiry date Submission date 09 06 2007 Current clearance status Draft Review level Expedited Ethical Review E1 System ID 2142 Each question in Aries has an information bubble and an external link that takes you to the National Statement where you can view information about the question Page 6 ARIES User Guide Human Ethics Module Monitoring j Yariation Project Details Documents Notes Progress steps gt Header Investigators Departments igh Risk One High Risk Two Questions Protocol title The implications of chemical spills for the general populace Ethics programme type Staff Chief Investigator Aarons Hank Protocol number 2007 2142 Approval date Anticipated end date Expiry date Submission date 09 06 2007 Current clearance status Draft Review level Expedited Ethical Review E1 System ID 2142 Does this research involve the intentional recruitment or issues involving Aboriginal and Torres Strait Islander Peoples Cleared by another HREC listed procedure or renewal application ves Provide details pee University 2006 207 Save Once this layer of question
13. l buttons that present themselves and keep answering until you get a green tick w instead of a red cross You will not be able to submit your protocol within ARIES until each Question has a green tick Protocol title xxx x a aaa Ethics programme type Xxx Chief Investigator Protocol number 200x xxx Approval date Anticipated end date Expiry date SX xXxX Xxxx Submission date Current clearance status XXxXxx Review level Review Xxx System ID XXXXX Next Information Edit Question ov Edit Children and young people A Edit Aboriginal or Torres Strait Islander Peoples Once you have addressed the above you have entered all the information relating to the risk assessment of the protocol Project Details Now click on the tab You must enter something in the text type questions You cannot submit your protocol until these sections contain some text Page 13 ARIES User Guide Human Ethics Module Protocol title Ethics programme type Staff Chief Investigator Protocol number 2008 Approval date Anticipated end date Expiry date Submission date Current clearance status Draft Review level Expedited Ethical Review E1 System ID 2614 Description of Project Describe the research project in terms easily understood by a lay reader using simple and non technical language Eas Location of Data Collection Australia Yes gt Overseas No gt Provide country
14. n their own right Yes gt Is the research in the best interests and or welfare of the child or young person Research would not ordinarily qualify for expedited review if it should be characterised as being contrary to the best interests and or welfare of the child or young person These questions capture which risks are associated with the protocol If you answer Yes to each question you have identified that the protocol method has negated the associated risks If AT LEAST ONE question remains as No the system will take you to the below screen Protocol title XXXXXxXxXXxXXXX Ethics programme type xxx Chief Investigator Protocol number 200x xxx Approval date Anticipated end date Expiry date XX xXxxXx Submission date Current clearance status Xxxx Review level Review XXX System ID AXXXX Children or Young People Are the risks easily negated minimised or managed No In 200 words of less provide and outline of the measures which will be taken to address the risks This screen provides you with the opportunity to explain how the risks will be negated If you are able to negate the risks you need to select Yes and provide an explanation and then select the asx button This will return you to the question summary screen and will have a green tick w against the question You need to continue this process until all buttons have a green tick 4 However if you are unable to negate
15. nce you will need to click on the Full Ethical Review link and the system will transfer the data you have already entered in your Expedited Review application to a Full Review application You will then need to complete the Full Review protocol application Page 10 ARIES User Guide Human Ethics Module Protocol title XXXXxXXxXxXXXXX Ethics programme type Xxx Chief Investigator Protocol number 200 Xxx Approval date Anticipated end date Expiry date XX x XXXX Submission date Current clearance status Xxxx Review level Review xxx System ID XXXxX Next Information Edit Question A Edit Children or Young People A 4 Edit Dependent or Unequal Relationship 4 Edit Deception Remember that you must click all Edit buttons that present themselves and keep answering until you get a green tick instead of a red cross You will not be able to submit your protocol within ARIES until each Question has a green tick Depending on your answers in the three questions tabs your protocol will now be E1 if you have answered all questions as no or if your protocol has been previously approved by another HREC E2 if you have answered yes to any question on the questions tab but your subsequent answers make it clear that the risks have been minimized You will have had your protocol converted to Full if you have answered yes to any of the questions in the three tabs and you do not have prior ap
16. proval or if you have not been able to demonstrate that you can minimize risk For further instructions please refer to the Full review system on the next page Page 11 ARIES User Guide Human Ethics Module Full Protocol Entry When you have finished adding your Investigators click on the Questions tab This will show additional risk assessment questions to be considered No Healthy members of the community T Mo University students No Employees or officers of a specific company or organisation T No Members of a specific community group club or association T No Clients of a service provider T Yes Children and young people Mo Members of a socially disadvantaged group T Mo People who belong to a group T Mo People who may be involved in illegal activities Mo People whose primary language is other than English E Mo People in other countries Aboriginal or Torres Strait Islander Peoples 5 a i Peonle in a denendent or uneanal relationshin If the questions here are all answered No then you should probably be using the Expedited Review rather than Full Review Contact the Ethics Office ext 53427or ext 53931 and we will be able to reset your protocol at this level without losing any of the data you have entered If you do answer Yes to any of the questions then click the button This will bring you to a summary
17. s have been answered click B save This same process is followed for the High Risk Two tab When you have finished with each tab click on the next tab header Please note that the button will NOT take you on to the next tab You must click on each of High Risk One High Risk Two and Questions tabs even if you do not answer yes to any of the questions This is to ensure that you have considered all questions Once you have considered the High Risk One and High Risk Two tabs click on Questions tab Page 7 ARIES User Guide Human Ethics Module Protocol title Kxxx Ethics programme type Xxx Chief Investigator Protocol number 200x xXxx Approval date Anticipated end date Expiry date XX XX XXxx Submission date Current clearance status xxxxx Review level Review Xxx System ID XXXXX Help Answer Question p No gt Third Party Identification p ves Children or Young People F ves Dependent or Unequal Relationship No Membership of a Group or Related Issues No Physical Harm No gt Psychological Harm includes Devaluation of Personal Worth R No Social Harm No Economic Harm p No gt Legal Harm F No Covert Observation Yes Deception B No Sensitive Personal Information Bp No Overseas Research Help Answer Question p No Collection use or disclosure of personal information WITHOUT the consent of
18. screen of further questions relating to the questions to which you answered Yes Protocol title XXXXXXxXXXXXXX Ethics programme type XXX Chief Investigator Protocol number 200 xxx Approval date Anticipated end date Expiry date XXxXx Submission date Current clearance status Xxxxx Review level Review XXX System ID XXXXxX Aboriginal or Torres Strait Islander Peoples Page 12 ARIES User Guide Human Ethics Module Click the P Edit button against each question in turn and you will be taken to a new range of questions For example if you clicked Yes to the question relating to Aboriginal or Torres Strait Islander Peoples then the screen below displays g What role have Aboriginal or Torres Strait Islander peoples played in the development and implementation of the research proposal Describe their role Does the research team include Aboriginal or Torres Strait Islander people No Does this proposal involve health research involving Aboriginal and Torres Strait Islander peoples MHo In undertaking research that involves the intentional recruitment of Aboriginal and Torres Strait Islander peoples or issues of significance to Aboriginal or Torres Strait Islander Peoples ensure your answers reflect considerations outlined in Chapter 4 7 of the NATIONAL STATEMENT in particular Research Merit amp Integrity Justice Beneficence Respect D g You must click al
19. the risks you need to select No and then click the save button The system will take you to a further screen to check if the protocol has approval from another HREC Page 9 ARIES User Guide Human Ethics Module Protocol title XXXXxxXXxXxXXRX Ethics programme type xxx Chief Investigator Protocol number 200 xxx Approval date Anticipated end date Expiry date XX xx XXXX Submission date Current clearance status X xxx Review level Review XXX System ID XXXXX Back Children or Young People Cleared by another HREC listed procedure or renewal application No Provide details ee If your answer is yes you need to provide details of the other HREC approval ie protocol number and HREC name You will also need to upload the approval document under the Documents tab If at this stage you have no approval from another HREC select the B save button The system has assessed the scope of your research and identified that it is not low risk and expedited review is inappropriate The system will alert you that your protocol requires FULL Review Protocol title 3i i a a a a a a a Ethics programme type Xxx Chief Investigator Protocol number 200 x Approval date Anticipated end date Expiry date X XX Xxxx Submission date Current clearance status XXxXx Review level Review xxx System ID AXXXX Click below for the level of review you require Full Ethical Review In this insta
20. y Investigator Faculty School Centre Faculty of Science For Postgraduate and Undergraduate protocols you must select at least one person with the role of supervisor Please note that the supervisor must be at ANU Internal If your supervisor or co investigator is not on ARIES let us know and we will add them for you Page 4 ARIES User Guide Human Ethics Module Protocol title XX XXxXxXXxXxxXX Ethics programme type Xxx Chief Investigator Protocol number 200x xxx Approval date Anticipated end date Expiry date XX XXXx Submission date Current clearance status Xxxxxx Review level Review Xxx System ID XXXXX Investigator name Duck Donald Role on protocol gt Preferred contact number Experience Expertise Qualifications As well as your research background outline your experience with your methodology for the present proposal If you are conducting your research overseas outline your experience in that country and the language to be used Citing your qualifications is not sufficient It is recommended that researchers supply at least 1 2 paragraphs when answering the Experience Expertise Qualifications question 1 e PhD Candidate is not sufficient for committee members to evaluate your qualifications and experience in relation to what you propose to do Monitoring Variation Project Details Documents Notes Ss 4 2 aya lt y Y ea Header Departments High Risk One High Risk Two Questions
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