STELLENBOSCH UNIVERSITY

Transcription

1 STELLENBOSCH UNIVERSITY Research Information Management System Instruction Manual REC: Humanities: Ethics Application

2 Contents SECTION 1: NEW APPLICATION... 3 STEP 1: HOW DO I LOG IN?... 3 STEP 2: HOW DO I CREATE A NEW APPLICATION FOR ETHICS REVIEW?... 4 STEP 3: HOW DO I ADD THE E-APPLICATION FORM?... 5 STEP 4: COMPLETING THE E-FORM... 7 Menu tabs... 7 Pages tabs How do I attach documents in the e-form? How do I add my supervisor/ co-investigators? How do I attach my Informed consent forms? How do I attach my data collection instruments? STEP 5: HOW DO I SUBMIT MY APPLICATION? Complete the e-form How to submit the application for review How do I know my application has been submitted? STEP 6: HOW DO I FIND AND CHECK THE STATUS OF MY APPLICATION? SECTION 2: HOW TO MAKE CHANGES TO MY APPLICATION? STAGE 1: CHANGES REQUESTED BY SUPERVISOR/DESC/REC OFFICE STEP 1: Open submission package STEP 2: How to view comments? STEP 3: How do I make changes to my e-form? STEP 4: How do I upload revised attachments to my e-form? STEP 5: How do I upload my response letter? STEP 6: How do I submit my changes? STAGE 2: CHANGES REQUESTED BY REC: HUMANITIES COMMITTEE STEP 1: Notification of Changes Required STEP 2: HOW DO I SUBMIT CHANGES TO REC: HUMANITIES STEP 3: HOW TO ATTACH THE RESPONSE LETTER STEP 4: HOW DO I SUBMIT MY CHANGES TO THE REC: HUMANITIES APPLICATION STATUS: DEFINITIONS InfoEd Instruction Manual: New Application (REC: Humanities) 1

3 FREQUENTLY ASKED QUESTIONS AND IMPORTANT LINKS InfoEd Instruction Manual: New Application (REC: Humanities) 2

4 SECTION 1: NEW APPLICATION STEP 1: HOW DO I LOG IN? If are unable to login, please ensure that you have updated and synchronised your SU username and password via the SU user administration site: If you are still unable to log in, please contact the ethics office or visit the FAQ page on the REC website for troubleshooting instructions: InfoEd Instruction Manual: New Application (REC: Humanities) 3

5 STUDENTS PLEASE NOTE: If you are not a registered student, you will not be able to login or submit an ethics application. Please make sure you are registered before attempting to login or submit an ethics application. If you wish to apply for ethics clearance before you are registered for the degree programme, you must do this in consultation with your department. The department will need to add you to the Information Technology SUNID temporary user database so that you can be issued a username and password by IT. Please note: The SUNID process in not an ethics process. It is a completely separate process and is handled entirely by the relevant department STEP 2: HOW DO I CREATE A NEW APPLICATION FOR ETHICS REVIEW? Once logged in, you will see the InfoEd landing page. To create your ethics application, follow ALL the numbered steps as illustrated below: InfoEd Instruction Manual: New Application (REC: Humanities) 4

6 Your application will be sent to the department linked to your name. An incorrect selection will result in the application being sent to the incorrect department. If you are affiliated with more than one department (i.e. you have an official appointment in more than one division/department OR you are a registered student other than the one you work for), click on the drop down list and scroll for other departments linked to your name. Each time it will list a different department in brackets next to your name. You should select the relevant department. If your name with the additional affiliation is not listed and is applicable for this application, please contact the ethics office before proceeding any further with this application. STEP 3: HOW DO I ADD THE E-APPLICATION FORM? The system has now created a record with a system generated number. Follow the numbered steps below to continue with adding the REC: Ethics application form i.e. REC: Humanities New Application (see instructions below) InfoEd Instruction Manual: New Application (REC: Humanities) 5

7 The system will add the e-form to your Human Protocol Submission and you can click on the form as illustrated below to complete it: Tip: If you are working on your e-form and you want to stop and continue at a later stage, you have to SAVE the e-form information and click exit on your browser. Then click on Done to close the submission. When you are ready to work on the e-form again, go to MY ITEMS and open your record to continue. InfoEd Instruction Manual: New Application (REC: Humanities) 6

8 If you have closed your application and cannot find the form or have trouble accessing it again DO NOT CREATE A NEW APPLICATION. Please contact the ethics office or InfoEd administrator for assistance. STEP 4: COMPLETING THE E-FORM Once you have opened you application form, please complete all the applicable questions in the e- form. Menu tabs Click to save entered information after completing each section. Save often or unsaved information will be lost. Click Check In/Out to create a snapshot to compare when other versions of the e-form are created. This function allows you to print the e-form from a printer your computer is connected to. Pages tabs By clicking on the Pages tab, the page numbers will display. You can quickly navigate to a certain page, by clicking on the appropriate page number. Note: Another useful feature is that those pages marked with red asterisks (*) show on which pages you still have mandatory questions to complete, in this case on pages 2, 3, and 5. InfoEd Instruction Manual: New Application (REC: Humanities) 7

9 4.1. How do I attach documents in the e-form? Note: Upload icons Once uploaded, the following functions are available for an uploaded document: Click to upload a new version of the original uploaded document. Follow the same steps for uploading a document as described above. This version will then replace the current version. Click to remove the uploaded document How do I add my supervisor/ co-investigators? Note: To add SU-affiliated co-investigators or your supervisors, click on the yellow sign in the right hand corner of section 5.1. InfoEd Instruction Manual: New Application (REC: Humanities) 8

10 Detailed instructions on how to add persons are listed below Note: Please note that you must check the information in the column Name and Surname for every person added. Should you encounter any inaccuracies in the contact information please contact HR for staff members and Student Information for students to have it corrected. We rely solely on this information when sending correspondence and information may not reach you if the contact details are not correct. InfoEd Instruction Manual: New Application (REC: Humanities) 9

11 Note: If you selected a person by mistake, you can make use of the remove button next to the person s name. If you added a row and want to delete the entire row, click the Delete button. Adding your supervisor under section 5.1 does not automatically include your supervisor as a reviewer. Instructions are under STEP 5 of this manual. STUDENTS NOTE: IF YOU ARE A STUDENT YOU MUST ADD YOUR SUPERVISOR TO THE REVIEW PATH. REMEMBER THAT YOU MUST ADD YOUR SUPERVISOR AS A REVIEWER WHEN YOU SUBMIT THE FORM TO ENSURE THAT A COPY OF THE APPLICATION IS SENT TO YOUR SUPERVISOR FOR APPROVAL. Your application will be sent back if the supervisor was not added to the review path. InfoEd Instruction Manual: New Application (REC: Humanities) 10

12 4.3. How do I attach my Informed consent forms? 4.4. How do I attach my data collection instruments? InfoEd Instruction Manual: New Application (REC: Humanities) 11

13 Tip: If you are working on your e-form and you want to stop and continue at a later stage, you have to SAVE the e-form information and click exit on your browser. Then click on Done icon to close the submission. When you are ready to work on the e-form again, go to MY ITEMS and open your record to continue. STEP 5: HOW DO I SUBMIT MY APPLICATION? WARNING!!! - FOLLOW ALL STEPS BELOW TO COMPLETE AND SUBMIT YOUR APPLICATION FORM 5.1. Complete the e-form You must tick the COMPLETE box to prepare your application for review. If there are mandatory questions that are incomplete, the system will allow you to complete these before it prepares the application for review. WARNING: TICKING THE COMPLETE BOX DOES NOT SUBMIT THE APPLICATION FOR REVIEW. YOU MUST CLICK ON SUBMIT ON THE SUBMISSION SCREEN TO SEND THE APPLICATION FOR REVIEW. The system shows you the mandatory questions that must still be answered in a table. You can click on each item to go to that particular question to answer it. Once you have answered the question and saved, that item will be removed from the list. InfoEd Instruction Manual: New Application (REC: Humanities) 12

14 Complete all the outstanding questions, SAVE and tick COMPLETE again How to submit the application for review The e-form window will close and you will be returned to the SUBMISSION SCREEN. The e-form status now shows Completed. WARNING: TICKING THE COMPLETE BOX DOES NOT SUBMIT THE APPLICATION FOR REVIEW. YOU MUST CLICK ON SUBMIT ON THE SUBMISSION SCREEN TO SEND THE APPLICATION FOR REVIEW. InfoEd Instruction Manual: New Application (REC: Humanities) 13

15 REMEMBER TO ADD YOUR SUPERVISOR ON THE REVIEWER SCREEN (next screen that will appear) if you are a student (undergraduate, postgraduate or doctoral candidate). WARNING: TICKING THE COMPLETE BOX DOES NOT SUBMIT THE APPLICATION FOR REVIEW. YOU MUST CLICK ON SUBMIT ON THE SUBMISSION SCREEN TO SEND THE APPLICATION FOR REVIEW. InfoEd Instruction Manual: New Application (REC: Humanities) 14

16 5.3. How do I know my application has been submitted? Your application has now been submitted for ethical review. The system shows the routing progress for your application. Please save a copy of this progress report as a print screen or screenshot as proof of submission. InfoEd Instruction Manual: New Application (REC: Humanities) 15

17 Click Done in the top left corner to close the application. Tip: Never close your browser window while working in the system. Doing this will lock your record. Always click on DONE to exit the record. STEP 6: HOW DO I FIND AND CHECK THE STATUS OF MY APPLICATION? You can get access to your record again by going to MY ITEMS. You will then see all your existing applications. You can open the record to make edits to it if it has not yet been submitted. InfoEd Instruction Manual: New Application (REC: Humanities) 16

18 If the application is UNDER REVIEW, you will not be able to edit the application. Contact the person reviewing the application to request that it be sent back to you. InfoEd Instruction Manual: New Application (REC: Humanities) 17

19 Tip: It is important to delete the application attempts that you will not submit to the DESC/REC for review. Please ensure that only the applications that have been submitted for review OR the applications that you plan to submit for review OR the applications that have been approved by the REC are listed under MY ITEMS. NOTE: Contact the ethics office to confirm your applications before deleting them. We cannot restore deleted applications. If you have closed your application and cannot find the form or have trouble accessing it again DO NOT CREATE A NEW APPLICATION. Please contact your ethics office or InfoEd administrator for assistance instead. If the application has been submitted you can view the routing progress of your application. To see a list of application statuses used by the REC: Humanities, skip to the section Application status definition InfoEd Instruction Manual: New Application (REC: Humanities) 18

20 STELLENBOSCH UNIVERSITY Research Information Management System Application Manual REC: HUMANITIES How to submit changes InfoEd Instruction Manual: New Application (REC: Humanities) 19

21 Contents SECTION 2: HOW TO MAKE CHANGES TO MY APPLICATION? STAGE 1: CHANGES REQUESTED BY SUPERVISOR/DESC/REC OFFICE STEP 1: Open submission package STEP 2: How to view comments? STEP 3: How do I make changes to my e-form? STEP 4: How do I upload revised attachments to my e-form? STEP 5: How do I upload my response letter? STEP 6: How do I submit my changes? STAGE 2: CHANGES REQUESTED BY REC: HUMANITIES COMMITTEE STEP 1: Notification of Changes Required STEP 2: HOW DO I SUBMIT CHANGES TO REC: HUMANITIES STEP 3: HOW TO ATTACH THE RESPONSE LETTER STEP 4: HOW DO I SUBMIT MY CHANGES TO THE REC: HUMANITIES APPLICATION STATUS: DEFINITIONS FREQUENTLY ASKED QUESTIONS AND IMPORTANT LINKS InfoEd Instruction Manual: New Application (REC: Humanities) 20

22 SECTION 2: HOW TO MAKE CHANGES TO MY APPLICATION? The following people/ committees may request that you make changes to your e-form or revise your application attachments: STAGE 1 Your Supervisor (if you are a student) Your Departmental Ethics Screening Committee (DESC) REC: Humanities Coordinator STAGE 2 The Research Ethics Commitee: Humanities STAGE 1: CHANGES REQUESTED BY SUPERVISOR/DESC/REC OFFICE REC: Humanities Note 1: The notification is generated by the InfoEd system and lists the Ethics Administrator s name as the sender. If you have enquiries about comments made by your supervisor and/or DESC, please contact the supervisor or DESC Administrator directly for clarification of their comments. Your supervisor, DESC or REC coordinator may request changes on your application. You will receive an notifying you to review the comments made by your supervisor/desc. Please note that InfoEd does not always work properly when you use the internet browser Internet Explorer or Firefox.. We therefore recommend you use Google Chrome STEP 1: Open submission package Click on OPEN SUBMISSION PACKAGE in the to view your supervisor/desc/rec coordinator s comments and to make the required changes InfoEd Instruction Manual: New Application (REC: Humanities) 21

23 InfoEd Instruction Manual: New Application (REC: Humanities) 22

24 STEP 2: How to view comments? You can view comments in two places: 1. Click on SHOW ROUTE on the SUBMISSION SCREEN 2. View the YELLOW ICONS throughout the e-form to view comments InfoEd Instruction Manual: New Application (REC: Humanities) 23

25 STEP 3: How do I make changes to my e-form? On the e-form untick the Complete box to activate the form for edits 1. Scroll to all the places where you see the yellow icon. Wherever you see this icon, click on it to view comments. 2. You will need to make the required changes, by either adding additional information or making changes to existing information/documentation. DO NOT TICK COMPLETE UNLESS YOU ARE DONE WITH ALL THE CHANGES. Only untick COMPLETE once. Every time you untick Complete and then tick Complete again InfoEd creates a new version of your application form. If you are unable to finish all the changes requested rather click on Save. You can then return to your application at a later stage to finish the required changes without a new version being created. 3. To make changes to questions on the e-form type in your changes in the relevant text box, or change your selection to drop down lists or tick boxes as required. InfoEd Instruction Manual: New Application (REC: Humanities) 24

26 Remember to click (in the Menu tabs on the left hand) often. If you do not SAVE often, the information will be lost in the event of system timeout. Tip: If you are working on your e-form and you want to stop and continue at a later stage, you have to SAVE the e-form information and click exit on your browser. Then click on the Done icon to close the submission. When you are ready to work on the e-form again, go to MY ITEMS and open your record to continue. InfoEd Instruction Manual: New Application (REC: Humanities) 25

27 STEP 4: How do I upload revised attachments to my e-form? If changes are requested on any attachments, make sure that you attach the documentation in the applicable attachment box. Please read through the critical warning below for important guidelines on attaching revisions to documents on the e-form. e.g. DO NOT ATTACH YOUR REVISED PROPOSAL UNDER THE SECTION ADDITIONAL DOCUMENTS PLEASE ATTACH IT IN THE ATTACHMENT BOX FOR THE RESEARCH PROPOSAL. Please respond to ALL the points raised about attached documents You must HIGHLIGHT (in colour) the changes made or use the MICROSOFT TRACK CHANGES function to indicate ALL corrections / amendments on ALL ATTACHMENTS you make changes to, You must attach a RESPONSE LETTER responding to all of the reviewer s comments, referencing the page numbers/sections where these changes have been made. Motivation(s) for any changes that were requested but have not been made should also be included in the response letter. The above must be done in order to allow for rapid scrutiny and appraisal of your resubmission. FOR INSTRUCTIONS ON HOW TO UPLOAD ATTACHMENTS, PLEASE SEE INSTRUCTIONS IN STEP 4.1 OF THE USER MANUAL: HOW DO I ATTACH DOCUMENTS IN THE e-form. When adding attachments in the e-form, please do not use password protection, limit editing or use any other security access controls on documents as this often causes problems in the system and may prevent reviewers from being able to access the document(s). InfoEd will automatically make the document read-only once it has been submitted, so no further security needs to be setup on the document. STEP 5: How do I upload my response letter? The response letter to the supervisor or DESC must be added under section 15 of the e-form. Specify in Section 15, that the document is a response to the supervisor/desc or REC under DOCUMENT NAME section E.g. Response to Supervisor) Your response letter should include the following if applicable: Your response to all comments made by the reviewer, with references to the specific sections/attachments where the changes were made InfoEd Instruction Manual: New Application (REC: Humanities) 26

28 Use section 16 Additional Information to add any additional information e.g. motivate any changes requested but not changed or provide further information for any concerns raised by reviewers. STEP 6: How do I submit my changes? Once you have made all the changes tick Complete. SEE INSTRUCTIONS UNDER STEP 5 OF THIS MANUAL: HOW DO I SUBMIT MY APPLICATION? InfoEd Instruction Manual: New Application (REC: Humanities) 27

29 STAGE 2: CHANGES REQUESTED BY REC: HUMANITIES COMMITTEE STEP 1: Notification of Changes Required The Research Ethics Committee: Humanities will request changes through a feedback letter in PDFformat. The comments made the REC: Humanities Committee will be listed in the attached PDF letter NOT IN THE E-FORM. Make sure you attend to all the items listed in the letter. InfoEd Instruction Manual: New Application (REC: Humanities) 28

30 Please note you must login and open the record to be able to make any changes. STEP 2: HOW DO I SUBMIT CHANGES TO REC: HUMANITIES Once you have logged onto InfoEd follow these steps InfoEd Instruction Manual: New Application (REC: Humanities) 29

31 InfoEd Instruction Manual: New Application (REC: Humanities) 30

32 If you selected the wrong option go back to the submission page and next to the wrong one click on Delete. After refreshing the webpage, the response link will appear again and repeat steps 1-4 as illustrated above. InfoEd Instruction Manual: New Application (REC: Humanities) 31

33 Follow the instructions under STEP 3 of this manual: HOW DO I MAKE CHANGES TO MY APPLICATION FORM. DO NOT TICK COMPLETE UNLESS YOU ARE DONE WITH ALL THE CHANGES Only untick Complete once. Every time you untick Complete and then tick it Complete again InfoEd creates a new version of your application form. If you are unable to finish all the changes requested rather click on Save. You can then return to your application at a later stage to finish the required changes without a new version being created. REMEMBER TO SAVE AFTER EVERY CHANGE STEP 3: HOW TO ATTACH THE RESPONSE LETTER Follow STEP 3: HOW TO ATTACH THE RESPONSE LETTER under STAGE 1 to add the response letter. Remember to indicate under the section Document Name that it is a letter in Response to REC: Humanities. STEP 4: HOW DO I SUBMIT MY CHANGES TO THE REC: HUMANITIES When you have completed all the requested changes tick Complete and then Click on Save 1. On the SUBMISSION SCREEN, click on Submit 2. Follow instructions under STEP 5 on HOW DO I SUBMIT MY APPLICATION InfoEd Instruction Manual: New Application (REC: Humanities) 32

34 APPLICATION STATUS: DEFINITIONS Acknowledged This status is used for submissions other than new applications, i.e. serious adverse events, protocol deviations, etc. These submissions are acknowledged by the committee via expedited review. Approved The application and all attachments have been approved. Approved with stipulations The application has been approved and data collection may commence, but the approval is subject to some stipulations. Respond to these stipulations within 6 months or the approval expires. Complete A final progress report was submitted and the ethical clearance process is complete. Deferred The application must be re-submitted and reviewed by the full committee at the next scheduled REC meeting. Exempt The researcher will only access and use data that is available in the public domain and will not have direct/ indirect interaction with human participants (i.e. literature study). Ethics clearance is not required and the researcher may commence with data collection. Expired The approval period or request for modifications/deferral has expired. A new application must be submitted for review. Modifications required Significant changes need to be made to the application and must be resubmitted for approval. The submission will expire in 6 months if no response is received Not Human Subjects Research An application was submitted to DESC/ REC for ethics review, but does not involve human InfoEd Instruction Manual: New Application (REC: Humanities) 33

35 subjects or data. The researcher may need to submit an application to the REC: ACU or REC: BEE if the project involves the use of animals or environmental issues. REC external review Referred to convened REC Referred to other ethics committee Rejected/disapproved Schd Exped. Review Schd Full Review Suspended Terminated Under Development The application has been sent to an external expert for review in cases where the committee does not have the necessary expertise to decide on the ethical aspects of the study. An application was reviewed via expedited procedures by the DESC or REC but after careful review, it is decided that it should rather be scheduled for a full committee review. The application was submitted to the REC: Humanities but should actually be reviewed by the Health Research Ethics Committee or vice versa. The application for ethics approval is rejected completely due to noncompliance with minimum ethics considerations. The application is processed for expedited review. The application is scheduled to be reviewed by the full ethics committee and cannot be reviewed via expedited procedures. The study has been suspended, for whatever reason, either by the committee or by the researcher. It could continue if circumstances change, with the approval of the ethics committee. The study has been terminated permanently either by the REC, or by the sponsor or researcher. The application has not yet been submitted InfoEd Instruction Manual: New Application (REC: Humanities) 34

36 Under Review The application is currently under review by the supervisor or the DESC/FESC. FREQUENTLY ASKED QUESTIONS AND IMPORTANT LINKS InfoEd FAQs page: REC: Humanities webpage: Division for Research Development webpage: REC Application webpage: Health Research Ethics Committee: REC: Animal Care and Use: REC: Biosafety and Environmental Ethics: InfoEd Instruction Manual: New Application (REC: Humanities) 35