Business Process Human Research Ethics Application and Review System

Transcription

1 Business Process Human Research Ethics Application and Review System Research and Innovation Services For further information or to update this document contact: Compliance Officer, Research and Innovation Services This is an official document of the University of South Australia for internal use only. The document has been prepared by Research and Innovation Services for web use and will be maintained on a regular basis. To ensure you have the most recent version it is advised that you access this document from its original location and do not keep local copies. The reader should be aware that this document is for the University of South Australia s employees and students information only and nothing contained in this information should be construed as an offer of service by the University of South Australia, form part of the terms of any agreement, or be legally binding on the University of South Australia. Copyright University of South Australia all rights reserved

2 OVERVIEW: ETHICS APPLICATION AND REVIEW SYSTEM... 4 WORKFLOW OF THE ETHICS APPLICATION AND REVIEW SYSTEM... 5 STATUSES OF THE ETHICS APPLICATION AND REVIEW SYSTEM... 9 STEP 1: APPLICANT COMPLETES A DRAFT APPLICATION STEP 2: PRINCIPAL SUPERVISOR REVIEW STEP 3: APPLICANT: PRINCIPAL SUPERVISOR UPDATE REQUIRED STEP 4: PRINCIPAL SUPERVISOR: RE-REVIEW STEP 5: ETHICS AND COMPLIANCE OFFICER REVIEW STEP 6: APPLICANT: ETHICS AND COMPLIANCE OFFICER UPDATE REQUIRED STEP 7: PRINCIPAL SUPERVISOR: REVIEW OF RESPONSE TO ECO UPDATE STEP 8: APPLICANT: PRINCIPAL SUPERVISOR UPDATE REQUIRED (AFTER ECO UPDATE REQUIRED). 29 STEP 9: PRINCIPAL SUPERVISOR: RE-REVIEW (AFTER ECO UPDATE REQUIRED) STEP 10: ETHICS AND COMPLIANCE OFFICER: RE-REVIEW STEP 11: COMMITTEE GROUP (E1/E2/E3) REVIEW STEP 12: APPLICANT: E1/E2/E3 UPDATE REQUIRED STEP 13: PRINCIPAL SUPERVISOR: REVIEW OF RESPONSE TO E1/E2/E3 UPDATE STEP 14: APPLICANT: PRINCIPAL SUPERVISOR UPDATE REQUIRED (AFTER E1/E2/E3 UPDATE) STEP 15: PRINCIPAL SUPERVISOR: RE-REVIEW (AFTER E1/E2/E3 UPDATE REQUIRED) STEP 16: COMMITTEE GROUP REVIEW (E1/E2/E3): RE-REVIEW STEP 17: REVIEW COMPLETED STEP 18: VIEW ACCESS Page 2 of 48

3 GLOSSARY Page 3 of 48

4 OVERVIEW: 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). The System allows researchers to complete and submit human ethics Applications electronically. Applicants navigate their way through the Application by answering a number of questions. Questions appear based on the answers to previous questions. Once the Application is completed, the Applicant submits the Application for review. Upon submission, the System assesses the risk associated with the project (based on the requirements of the National Statement of Ethical Conduct of Human Research, legislation, relevant codes and guidelines and University compliance requirements). The System forwards the completed Application to the required Committee Review Group. The Committee Review Group reviews the Application online and enters their decision. The System notifies the Applicant of the review outcome via . The research activity must not commence until ethics approval is finalised. The System is a dynamic system which enables Applicants to communicate with the Principal Supervisor (for Student Applicants), the Ethics and Compliance Officer, and the Committee Review Group. The System records details of all human research ethics Applications and the outcome of the review. Selected data is recorded in ResearchMaster for administrative and auditing purposes. Researchers must be familiar with both the National Statement on Ethical Conduct in Human Research ( ), the Australian Code for the Responsible Conduct of Research 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 ( 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. Page 4 of 48

5 WORKFLOW OF THE ETHICS APPLICATION AND REVIEW SYSTEM Figure 1 illustrates the various stages of an ethics Application within the System. In brief, there are 5 stages of an ethics Application as a student Applicant progresses through the System, and 4 stages of an ethics Application as a staff Applicant progresses through the System (staff Applicants skip stage 2). However, an Application may be reverted back to a previous stage if the requirements have not been met adequately. Figure 1: Workflow stages of an ethics application Applicant Create New Application Update Required Principal Supervisor Review (Student Applicant Only) Ethics and Compliance Officer Review PS Review ECO Review Committee Review Group E1 Review E2 Review E3 Review Final Outcome Exempt Negligible Approved Not Approved Withdrawn Stage 1: Draft The Draft stage describes two processes. 1. When an Applicant creates a new Ethics Application, the Application is in Draft stage. The status of the Application is Draft and the Applicant can make changes to the Application until they submit the Application for review. 2. A review group may return an Application to the Applicant at any stage of the review process. Once an Application is returned to the Applicant, the Application is reverted to the Draft stage to enable the Applicant to make changes to the Application. However the status of the Application is recorded as either: PS Update Required ECO Update Required Approved Subject to Not Approved: Resubmit After the Applicant submits their Application for review, they are informed that the risk associated with the project requires either E1, E2 or E3 review (See table 1 below) or is exempt or negligible risk. If the System determines the staff Application to be exempt from further review (ie exempt or negligible risk), the Page 5 of 48

6 Application bypasses stage 2, 3 and 4 of the workflow and goes to stage 5. Student Applications which are assessed by the System to be exempt or negligible risk still require review by the Principal Supervisor. Stage 2: Principal Supervisor Review This stage is only applicable to student Applications. The student Applicant has completed their Application and submits it for review. The student s Application is forwarded to the Applicant s Principal Supervisor for their initial review. The Principal Supervisor reviews the Application and can either submit the Application to the next review stage or can return the Application to the student Applicant for additional changes i.e. the Application is returned to Draft stage with the status PS Update Required. If the System determines the Application to be exempt from further review (ie exempt or negligible risk), the Application bypasses stage 3 and 4 of the workflow and goes to stage 5. Stage 3: Ethics and Compliance Officer Review The student Applicant s Principal Supervisor has reviewed the Application, submitted it for review and the Application requires E1, E2 or E3 level of review; or the staff Applicant has submitted their Application for review and the Application requires E1, E2 or E3 level of review. The Application is forwarded to the Ethics and Compliance Officer who reviews the Application for completeness. The Ethics and Compliance Officer either submits the Application for review by the relevant Committee Review Group, or returns the Application back to the Applicant to make changes. If the Application is returned to the Applicant, the Application reverts back to Draft stage with the status ECO Update Required. Stage 4: Committee Review Group The Application has been forwarded by the Ethics and Compliance Officer to the required Committee Review Group. The level of review required was assessed by the System based on the Applicant s answers to the Ethics Application form. There are three levels of review and the review group selected is determined by the level of risk associated with the project. These are described in Table 1. Table 1: The interaction between risk level and level of review Risk Level Risk Assessment Review Level System Status E1 Research projects in which there is no foreseeable risk of harm or discomfort, and any foreseeable risk is no more than inconvenience E1 Review: The Chair or Deputy Chair of HREC E1 HREC Chair E2 E3 Research projects in which the only foreseeable risk is one of discomfort All other research projects are more than low risk E2 Review: A panel comprising the Chair or Deputy Chair of HREC and the relevant REA from the discipline. The Chair (or Deputy Chair) may also seek external expert advice as required E3 Review: The full HREC E2 Committee Group Review E3 HREC The Committee Review Group reviews the Application and makes a decision on the Application. Two of the four decision options results in the application being returned to the Applicant for amendments and/or additional information. These statuses are: Approved Subject To Not Approved: Resubmit. The remaining 2 statuses: Approved and Not Approved are final review outcomes (see next stage). Stage 5: Final Outcome There are three processes that result in a final outcome. 1. The Applicant has submitted an Application, and if the Applicant is a student, the Application has also been reviewed and submitted by the Principal Supervisor. The System has determined that the research is exempt from further review. The Application skips stage 3 and 4 of the workflow. These projects fall under one or two outcome categories: Page 6 of 48

7 Exempt Negligible 2. The Application is completed once the Committee Review Group has reviewed the Application and provided the Applicant with one of the following two final review outcomes: Approved Not Approved 3. The Applicant has informed the Ethics and Compliance Officer that they wish to withdraw their Application and the Ethics and Compliance Officer has marked the Application as withdrawn. The Application may be in any stage/status prior to withdrawal. Note: Once an Application receives a final review outcome, no changes can be made to the Application within the System. Figure 2a: Workflow for a student application within the system E1/E2/E3 Update Required ECO Update Required Approved Subject To Not Approved: Resubmit E1 Review PS Update Required (HREC Chair) Draft Principal Supervisor Review Ethics and Compliance Officer Review E2 Review (Panel) Approved Not Approved Withdrawn E3 Review (HREC) Committee Review Group* Exempt Negligible * There are three types of Committee Review Groups. They are E1 Review, E2 Review and E3 Review. Each Application is reviewed by one of these review groups. The System determines which Committee Review Group assesses the Application based on the level of risk associated with the project. This risk assessment is based on the answers provided by the Applicant. Page 7 of 48

8 Figure 2b: Workflow for a staff application within the system E1/E2/E3 Update Required Approved Subject To Not Approved: Resubmit ECO Update Required E1 Review (HREC Chair) Draft Ethics and Compliance Officer Review E2 Review (Committee Group Review) Approved Not Approved Withdrawn E3 Review (HREC) Committee Review Group* Exempt Negligible * There are three types of Committee Review Groups. They are E1 Review, E2 Review and E3 Review. Each Application is reviewed by one of these review groups. The System determines which Committee Review Group assesses the Application based on the level of risk associated with the project. This risk assessment is based on the answers provided by the Applicant. Page 8 of 48

9 STATUSES OF THE ETHICS APPLICATION AND REVIEW SYSTEM The following table illustrates the various statuses of an ethics Application within the System. There are a number of statuses and each status requires action from one of the following: The Applicant The Principal Supervisor (PS) The Ethics and Compliance Officer (ECO) The Committee Review Group o E1 Review Group o E2 Review Group o E3 Review Group Table 2: The statuses of an ethics Application and the person responsible for actioning the Application. Status Description Action required from Draft An Applicant has started an Application. Applicant PS Review An Applicant has completed an Application and Principal Supervisor submitted the Application for PS Review. PS Update Required The Principal Supervisor has reviewed the Application and requires the Applicant to provide additional information or amendments to the answers provided. Applicant Exempt Negligible ECO Review An Applicant has submitted an Application (for student Applicants, the Application has then been reviewed and submitted by the Principal Supervisor). 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. An Applicant has submitted an Application (for student Applicants, the Application has then been reviewed and submitted by the Principal Supervisor). The System has determined that the research does not require further review as the project is either being conducted solely for the purpose of internal quality assurance and will not be published or presented externally conducted solely for the purpose of internal quality assurance but may be published externally however: o o o 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 o the anonymity of the respondents is maintained. An Applicant has completed an Application (for student Applicants, the Application has then been reviewed and submitted by the Principal Supervisor). The Application is forwarded to the No further action is required. The Applicant can commence their research. No further action is required. The Applicant can commence their research. Ethics and Compliance Officer Page 9 of 48

10 ECO Update Required PS Review ECO Update E1 HREC Chair E2 Committee Group Review E3 HREC Approved Subject To Not Approved: Resubmit Approved Ethics and Compliance Officer for review. The Ethics and Compliance Officer has reviewed the Application and requires the Applicant to provide additional information or amend the answers provided. The Applicant has responded to updates required from the Ethics and Compliance Officer and resubmitted the Application to the Principal Supervisor. The Principal Supervisor is required to review the changes made before actioning. 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 E1 level of review. The Application is forwarded to the Chair or Deputy Chair of HREC for E1 Review. The Chair or Deputy Chair of HREC reviews the Application. 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 panel reviews the Application. 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 posed more than low risk. The Applicant was thus notified that the risk associated with the project requires E3 level of review. The HREC reviews the Application at their next monthly meeting. The Committee Review Group has reviewed the Application and requires the Applicant to make minor changes to the Application. The Committee Review Group review group has reviewed the Application and requires the Applicant to make significant changes to the Application. The Committee Review Group has reviewed the Application and is satisfied that the project meets the requirements of the National Statement. The Application is approved. Applicant Principal Supervisor E1 Reviewer (Chair or Deputy Chair of HREC) E2 Reviewers (members of the E2 panel) E3 Reviewers (members of HREC) Applicant Applicant No further action is required. The Applicant can commence their research. Page 10 of 48

11 Not Approved Withdrawn 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 Applicant has advised the Ethics and Compliance Officer that the research will not proceed and the Ethics and Compliance Officer has marked the Application as withdrawn. No further action is required. The Applicant cannot commence their research. No further action is required. The Applicant cannot commence / continue the research. Page 11 of 48

12 STEP 1: APPLICANT COMPLETES A DRAFT APPLICATION There are 3 steps involved in completing an ethics Application. It is important that these steps are carried out before an Applicant submits their Application. Person responsible: Applicant (Staff or Student) Create New Application Application Details Page Comments Investigators Application Overview Attachments Supervisor* Print Cover Sheet Application Completed Summary Comments * This tab is only visible to Student Applicants. Instructions on how to complete each of the 3 steps are detailed under the relevant headings. 1.1 Create New Application An Applicant must create a new Application for every human research ethics project they are undertaking. All Univeristy staff and students listed as an investigator on a research project involving humans must have ethics approval for that project before commencing the research. New Applications must also be submitted whenever the scope of an Application changes significantly. A new ethics Application is created once the Applicant has confirmed that they are wanting to undertake a research project involving human. 1.2 Application Overview There are a number of tabs within the Application. These are Application Details Investigators Attachments Supervisor (visible only to Student Applicants) Print Cover Sheet Summary Comments Page 12 of 48

13 These tabs can be completed in any order and are available from the left hand menu. All tabs must be completed before an Applicant can submit their Application for review Application Details Application Details contains the Ethics Application form. The Ethics Application form is structured as follows: High level order Ethics Application Form Section Page Low level order Question The Ethics Application form is made up of a number of sections. Each section may contain one or more pages. Each page contains a number of questions. The number of questions an Applicant is required to complete is dependent on the nature of the research and the potential risk to participants. How the Applicant answers each question therefore affects whether other questions appear. Questions in the Application form are hidden until the Applicant answers a particular question. Based on the answer(s) provided, new questions may appear. These new questions may appear on the same page or a different page. For example, the Applicant may answer Yes to question 1. By providing this response, questions 2, 3 and 4 are displayed. These questions request additional information from the Applicant as a result of the response provided to question 1. If the Applicant changes the response of question 1 from Yes to No then questions 2, 3 and 4 will be hidden. New questions however may appear as a result of the Applicant answering No to question 1. Page 13 of 48

14 Question 1 Yes No Question 2 Question 5 Question 3 Question 4 All questions that appear in the Application form are mandatory and therefore must be completed before the Applicant submits their Application Page Comments An Applicant may enter comments on any page of the ethics Application form. These comments can be viewed by other investigators, the student s Principal Supervisor (for Student Applications only), the Ethics and Compliance Officer and the Committee Review Group Investigators The Applicant must complete the Investigator s tab before submitting their Application. This tab allows the Applicant to list all investigators involved in the project, whether they are internal or external investigators. If an investigator is unable to add an investigator, they are asked to research.information@unisa.edu.au and provide details of the person to add. They will be notified via was the new investigators name has been added to the system. The Applicant must also indicate which investigator is the primary role, and which is the primary contact : Primary role: is the principal investigator for the project. Primary contact: is the person who has the responsibility to submit the ethics Application and respond to review outcomes (if updates are required) These roles are automatically assigned to the Applicant when they create a new Application. These roles do not need to be assigned to the same person. Only the person listed as the primary contact can change the primary contact and/or primary person role Attachments The Applicant must complete the Attachments tab before submitting their Application. This tab allows the Applicant to add electronic copies of all supporting material for their supervisor (for student Applications), the Ethics and Compliance Officer and members of the Committee Review Group to review. These include (where applicable): A copy of the HREC Application submitted and approved by another institution s HREC (i.e. other than UniSA HREC). Copies of the approval letters received from organisations involved in the research and/or where the data will be collected from. The research tools: o Questionnaire(s). o Interview schedule(s). o Focus group / interview topic(s). The recruitment material: o Recruitment flyer / letter(s) o Participant Information sheet(s) Page 14 of 48

15 o Participant Consent form(s) A copy of the confirmation of insurance cover from UniSA s Insurance Officer Supervisor (Student Applicants only) The student Applicant must complete the Supervisor tab before submitting their Application. This tab allows the student Applicant to list their supervisor for the project (if not automatically selected). Once an Application is submitted, the Application will be forwarded to the supervisor listed in this tab for them to review. Thus it is vital that the correct person is included in this tab Print Cover Sheet The Applicant must complete the Print Cover Sheet tab before submitting their Application. This tab allows the Applicant to indicate which documents were unable to be attached in the Attachments tab and will instead be posted to the Ethics and Compliance Officer and the Principal Supervisor (for Student Applicants) once the Application is submitted (along with a print-out of the cover sheet) Summary Comments An Applicant may enter overall comments in the summary comments tab. These comments can be viewed by other investigators, the Student Applicant s Supervisor, the Ethics and Compliance Officer and the Committee Review Group. 1.3 Application Completed The Application is complete once the Applicant has answered all questions in the Application Details tab and included the required information in the other tabs. The Application can then be submitted for review by selecting Application Completed from the Application Overview screen. Once an Application has been submitted, the Applicant is informed of the risk associated with their project based on the answers provided on the Ethics Application form. There are 5 risk outcomes: Exempt Negligible E1 E2 E3 If the risk outcome is Exempt or Negligible, and the Applicant is a staff member, the Applicant is advised they can commence their research. No further review is required. The Application progresses to Step 17. If the risk outcome is Exempt or Negligible, and the Applicant is a student, the Application progresses to Step 2. Applications with the risk outcomes E1, E2 or E3 require further ethical review. Student Applications requiring E1, E2 or E3 review progress to Step 2. Staff Applications requiring E1, E2 or E3 review progress to Step 4. Risk outcome Description Review required. Next stage Exempt The Applicant has submitted an Application and the system has determined that the research is exempt from further review as the project involves the use of archived data only and the data collected is de-identified (i.e. does not contain personally identifiable information) and will not reported beyond the University Further review is not required. The research project can commence. Negligible 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 Further review is not required. The research project can commence. Page 15 of 48

16 E1 E2 E3 conducted solely for the purpose of internal quality assurance and will not be published or presented externally conducted solely for the purpose of internal quality assurance but may be published externally however: o the data was gathered on-line or in writing o the responses were provided voluntarily o the respondents were advised of the possibility that the data could be used for such purposes o the anonymity of the respondents is maintained. The Applicant has submitted an Application and the system has 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 has submitted an Application and the system has determined that the research project poses only one potential foreseeable risk, that of discomfort. The Applicant has submitted an Application and the system has determined that the research project poses more than low risk The Application will be reviewed by the Chair of HREC (E1 Review) The Application will be reviewed by a panel (E2 Review) The Application will be reviewed by the full HREC (E3 Review) The Application is forwarded to the Ethics and Compliance Officer (for staff Applications) or the Principal Supervisor (for student Applications) The Application is forwarded to the Ethics and Compliance Officer (for staff Applications) or the Principal Supervisor (for student Applications) The Application is forwarded to the Ethics and Compliance Officer (for staff Applications) or the Principal Supervisor (for student Applications) Page 16 of 48

17 STEP 2: PRINCIPAL SUPERVISOR REVIEW Whenever a student Applicant completes an ethics Application and submits the Application for review, the Application is forwarded to the Student s named Principal Supervisor. The Supervisor is required to review all Applications submitted by their Student(s). Under the Australian Code for the Responsible Conduct of Research, Supervisors are responsible for the research undertaken by their students. Therefore it is important that the Principal Supervisor checks the accuracy of their student s Application. The Principal Supervisor has a week to review and action the Application (i.e. to submit the Application for review or return the Application to the Applicant for update). Person responsible: Principal Supervisor Status: PS Review Open Application Application Details Page Comments Investigators Review Application Attachments Supervisor Review Outcome* Summary Comments Enter PS Comments* Submit Application Revert Application * If the Principal Supervisor has entered page and/or summary comments for the Applicant, then the Application must be returned to the Applicant (i.e. Revert Application) 2.1 OPENING AN APPLICATION AT PS REVIEW The Principal Supervisor selects an Application that has the status PS Review. If there are more than one Application requiring their review, select the Application with the shorter due date. 2.2 VIEWING AN APPLICATION AT PS REVIEW The Principal Supervisor must review all components of a completed Application (i.e. all tabs) that has been submitted for their review Application Details The Application Details tab includes all questions that the Applicant was required to answer and comprise the Ethics Application form. The Ethics Application form is structured as follows: Page 17 of 48

18 Ethics Application Form Section Page Question The completed Ethics Application is made up of a number of sections. Each section may contain one or more page. Each page contains a number of questions that was answered by the Applicant. The number of questions an Applicant was required to complete was dependent on the nature of the research and the potential risk posed to participants. The Principal Supervisor must view the answers provided for accuracy Page Comments An Applicant may have entered comments on any page of the ethics Application form. These comments must be viewed by the Principal Supervisor to clarify any questions/queries/concerns the Applicant may have raised Enter Comments The Principal Supervisor may write a comment on any page of the ethics Application form. The Principal Supervisor can enter 2 types of comments. They are: Action comments: This comment type is used when the Principal Supervisor is reviewing their student s answer and would like them to provide more information, change their answer, or reconsider their response etc. General comments: This comment type is used when the Principal Supervisor is reviewing their student s answer and would like to make a comment. The comment does not require a response and/or change to the content of the Application. Therefore the Application can be submitted for review by the Principal Supervisor (if only general comments have been written). These comments can be directed at either the Student Applicant, the Ethics and Compliance Officer or the Committee Review Group. If the Principal Supervisor enters an action comment, the Application must be returned to the Applicant for the required changes to be made. The Principal Supervisor may return an Application to the Applicant if they have only entered general comments. If an Application is returned to the Applicant, the Application progresses to Step 3. If no comments are entered (at both the page and summary comment level see 2.5)), or only general comments are entered, and the Principal Supervisor is satisfied that the Application correctly reflects the research the Student will be undertaking, the Application progresses to Step 4. Page 18 of 48

19 2.2.2 Investigators This tab will include a list of all investigators involved in the project. There are two roles related to an Investigator. They are: Primary role: is the principal investigator for the project. Primary contact: is the person who has the responsibility to submit the ethics Application and respond to review outcomes (if updates are required) These roles are not necessarily assigned to the same person. The Primary contact will be the principal supervisor s student which is why the Application requires review by the listed Principal Supervisor Attachments This tab includes details of any documents that have been attached to the Application. These may include (where applicable): A copy of the HREC Application submitted and approved by another institution s HREC (i.e. other than UniSA HREC). Copies of the approval letters received from organisations involved in the research and/or where the data will be collected from. The research tools: o Questionnaire(s). o Interview schedule(s). o Focus group / interview topic(s). The recruitment material: o Recruitment flyer / letter(s) o Participant Information sheet(s) o Participant Consent form(s) A copy of the confirmation of insurance cover from UniSA s Insurance Officer. The Principal Supervisor must review all documents attached to determine whether the Application meets ethical requirements Supervisor The Supervisor tab does not need to be viewed by the Principal Supervisor as it will include their details only. This tab is completed by the Student Applicant in order to indicate who their Principal Supervisor is and therefore who the Application is to be reviewed by at PS Review stage Summary Comments A student Applicant may enter overall comments on the summary comments tab. These comments must be viewed by the Principal Supervisor to clarify any questions/queries/concerns the Applicant may have raised Enter Comments The Principal Supervisor may write overall comments on the summary comments tab. The Principal Supervisor can write 2 types of comments. They are: Action comments: This comment type is used when the Principal Supervisor is reviewing the student s Application and would like them to make considerable changes to the Application. General comments: This comment type is used when the Principal Supervisor is reviewing their student s Application and would like to make an overall comment on the Application. This comment type does not require a response by the Applicant. Therefore the Application can be submitted for review by the Principal Supervisor (if only general comments have been written). If the Principal Supervisor enters an action comment, the Application must be returned to the Applicant for the required changes to be made. The Principal Supervisor may return an Application to the Applicant if they have only entered general comments. If an Application is returned to the Applicant, the Application progresses to Step 3. Page 19 of 48

20 If no action comments are entered (at both the page and summary comment level see also ), or only general comments are entered, and the Principal Supervisor is satisfied that the Application correctly reflects the research the Student will be undertaking, the Application can be submitted for review (The Application progresses to Step 5 or Step 17). 2.3 REVIEW OUTCOME The Principal Supervisor must action the Application once they have reviewed the whole Application. The Principal Supervisor has two actions available. They are Submit Application Revert Application The Principal Supervisor selects Submit Application if they are satisfied with the answers the Applicant has provided and believes it accurately reflects the research project they wish to undertake. The Application progresses to Step 5 (for E1/E2/E3 risk outcomes) or Step 17 (for exempt/negligible risk outcomes) The Principal Supervisor selects Revert Application if they are not satisfied with the answers the Applicant has provided and/or does not believe the Application accurately reflects the research project they wish to undertake. The Principal Supervisor must have entered action and or general comments for the Applicant in order for them to make the required changes to the Application and thus to meet the requirements for the Principal Supervisor to submit the Application for review. Applications that are reverted to the Applicant progress to Step 3. Page 20 of 48

21 STEP 3: APPLICANT: PRINCIPAL SUPERVISOR UPDATE REQUIRED When the outcome of the Principal Supervisor Review is to revert the Application to the Applicant, the status of the Application is PS Update Required. The Student Applicant must respond to the action/general comments entered by the Principal Supervisor. 3.1 VIEWING COMMENTS The Principal Supervisor may have written comments on any page of the ethics Application form (Application Details) or made overall comments using the Summary Comments tab. The Principal Supervisor may have written 2 types of comments. They are: Action comments: This comment type requires the Applicant to respond to the comment the Principal Supervisor entered. For instance, the Principal Supervisor may require the Applicant to provide more information, change their answer, or reconsider their response etc. General comments: This comment type does not necessarily require a response, however should be viewed before the Applicant resubmits the Application Responding to action comments Any action item the Principal Supervisor has entered at either the page or summary comment level must be viewed by the Applicant. The Applicant must then change the Application as requested by the Principal Supervisor and/or enter a comment indicating what change has been made or why this change is not needed. Once the Applicant has taken the desired action, they must mark the item as Responded. 3.2 RESUBMITTING THE APPLICATION Once the Applicant has marked all action comments entered by the Principal Supervisor as Responded, the Applicant can submit the Application by selecting Application Completed from the Application Overview screen. The Application then progresses to Step 4. Page 21 of 48

22 STEP 4: PRINCIPAL SUPERVISOR: RE-REVIEW The Principal Supervisor is required to re-review an Application after the Application is resubmitted to them (due to PS Update Required). The Principal Supervisor must mark any responded action comments as Resolved. 4.1 VIEWING COMMENTS The Principal Supervisor must review the Applicant s responses to the action comments and general comments entered during Step 2. After the Principal Supervisor has viewed the response and/or the changes made to the Application, the Principal Supervisor must either: Mark the action item as Resolved. Enter a new action item for the Applicant to make further changes (as per Step and ) 4.2 REVIEW OUTCOME The Principal Supervisor must then action the Application once they have re-reviewed the comments and/or Application. The Principal Supervisor has two actions available. They are Submit Application Revert Application The Principal Supervisor selects Submit Application if they are satisfied with the responses the Applicant has provided and has marked all action items as Resolved'. The Application progresses to Step 5 (for E1/E2/E3 risk outcomes) or Step 17 (for exempt/negligible risk outcomes). The Principal Supervisor selects Revert Application if they are not satisfied with the responses the Applicant has provided. The Principal Supervisor must have entered new action and or general comments for the Applicant in order for them to make the required changes to the Application and thus meet the requirements for the Principal Supervisor to submit the Application for review. If the Application is reverted, the Application is returned to Step 3. Page 22 of 48

23 STEP 5: ETHICS AND COMPLIANCE OFFICER REVIEW An Application progresses to Step 4 when: A Principal Supervisor is satisfied that the Application completed by their student correctly reflects their intended research; or A staff Applicant completes and submits an Application. The Ethics and Compliance Officer is required to review all Applications for completeness. The Ethics and Compliance Officer must review and action the Application within a few days of receipt. The reason for this expedience is that the Committee Review Group only has 10 working days from the date the Applicant submitted the Application (or from the date the Principal Supervisor submitted their student s Application for review) to action the Application. However, this is provided the Application requires either E1/E2 Level of Review. Applications requiring E3 Level of Review are different as members of this E3 Committee Review Group (UniSA HREC) meet monthly to discuss the E3 Applications. In order for the Application to be assessed at the next full HREC meeting, the Staff Applicant or Principal Supervisor (for Student Applicants) must have submitted the Application before the HREC submission deadline. The Ethics and Compliance Officer must review the E3 Application and provide the action response that allows the Application to be submitted for review. If the Application is incomplete, the Application will be returned to the Applicant and will not be included in the upcoming E3 meeting. Person responsible: Ethics and Compliance Officer Status: ECO Review Open Application Application Details Page Comments Investigators Review Application Attachments Supervisor Review Outcome* Summary Comments Enter ECO Comments* Submit Application Revert Application * If the Ethics and Compliance Officer has entered page and/or summary comments for the Applicant, then the Application must be returned to the Applicant (i.e. Revert Application) Page 23 of 48

24 5.1 OPENING AN APPLICATION AT ECO REVIEW The Ethics and Compliance Officer selects an Application that has the status ECO Review. If there are more than one Application requiring their review, the Ethics and Compliance Officer selects the Application with the shorter due date. 5.2 VEIWING AN APPLICATION AT ECO REVIEW The Ethics and Compliance Officer must review the Application that has been submitted for completeness Application Details The Application Details tab includes the Ethics Application form. The Ethics Application form is structured as follows: Ethics Application Form Sections Pages Questions The completed Ethics Application is made up of a number of sections. Each section may contain one or more pages. Each page contains a number of questions that was answered by the Applicant. The number of questions an Applicant was required to complete was dependent on the nature of the research and the potential risk posed to participants. The Ethics and Compliance Officer may view the answers provided Page Comments Comments may have been entered on any page of the ethics Application form. These comments must be viewed by the Ethics and Compliance Officer in case their response is required Enter Comments The Ethics and Compliance Officer may write a comment on any page of the ethics Application form. The Ethics and Compliance Officer can write 3 types of comments. They are: Action comments: This comment type is used when the Ethics and Compliance Officer is reviewing an applicant s answer and would like them to provide more information, change their answer, or reconsider their response etc. General comments: This comment type is used when the Ethics and Compliance Officer is reviewing an applicant s answer and would like to make a comment. The comment does not require a response and/or change to the content of the Application. Therefore the Application Page 24 of 48

25 can be forwarded for review (if only general comments have been written). These comments can be directed at either the Student Applicant or the Committee Review Group (and can be viewed by both the Student or members of the Committee Review Group). General comments (confidential): This comment type is used when the Ethics and Compliance Officer is reviewing an Applicant s answer and would like to make a comment directed at the Committee Review Group only. The Applicant can not view this comment. If the Ethics and Compliance Officer enters an action comment, the Application must be returned to the Applicant for the required changes to be made. The Ethics and Compliance Officer may return an Application to the Applicant if they have only entered general comments. If an Application is returned to the Applicant, the Application progresses to Step 6. If no comments are entered (at both the page and summary comment level see 5.2.5)), or only general comments are entered, and the Ethics and Compliance Officer is satisfied that the Application is complete the Application progresses to Step Investigators This tab lists all investigators involved in the project. There are two roles related to an Investigator. They are: Primary role: is the principal Investigator for the project. Primary contact: is the person who has the responsibility to submit the ethics Application and respond to review outcomes (if updates are required) These roles are not necessarily assigned to the same person Attachments The Attachments tab includes details of any documents that have been attached to the Application. These may include (where applicable): A copy of the HREC Application submitted and approved by another institution s HREC (i.e. other than UniSA HREC). Copies of the approval letters received from organisations involved in the research and/or where the data will be collected from. The research tools: o Questionnaire(s). o Interview schedule(s). o Focus group / interview topic(s). The recruitment material: o Recruitment flyer / letter(s) o Participant Information sheet(s) o Participant Consent form(s) A copy of the confirmation of insurance cover from UniSA s Insurance Officer. The Ethics and Compliance Officer must view these documents for completeness Supervisor The Supervisor tab details who the student s Application was reviewed by at PS Review (Student Applicants only) during Step Summary Comments Overall comments may have been entered on the Summary Comments tab. These comments must be viewed by the Ethics and Compliance Officer to clarify any questions/queries/concerns the Applicant (or Applicant s Supervisor) may have raised Enter Comments The Ethics and Compliance Officer may write overall comments on the Summary Comments tab. The Ethics and Compliance Officer can write 3 types of comments. They are: Page 25 of 48

26 Action comments: This comment type is used when the Ethics and Compliance Officer is reviewing an applicant s answer and would like them to provide more information, change their answer, or reconsider their response etc. General comments: This comment type is used when the Ethics and Compliance Officer is reviewing an applicant s answer and would like to make a comment. The comment does not require a response and/or change to the content of the Application. Therefore the Application can be forwarded for review (if only general comments have been written). These comments can be directed at either the Student Applicant or the Committee Review Group(and can be viewed by both the Student or members of the Committee Review Group). General comments (confidential): This comment type is used when the Ethics and Compliance Officer is reviewing an applicant s answer and would like to make a comment directed at the Committee Review Group only. The Applicant can not view this comment. If the Ethics and Compliance Officer enters an action comment, the Application must be returned to the Applicant for the required changes to be made. The Ethics and Compliance Officer may return an Application to the Applicant if they have only entered general comments. If an Application is returned to the Applicant, the Application progresses to Step 6. If no comments are entered (at both the page and summary comment level see 5.2.5)), or only general comments are entered, and the Ethics and Compliance Officer is satisfied that the Application is complete the Application progresses to Step REVIEW OUTCOME The Ethics and Compliance Officer must action the Application once they have reviewed the whole Application. The Ethics and Compliance Officer has two actions available. They are Submit Application Revert Application The Ethics and Compliance Officer selects Submit Application if they are satisfied the Application is complete. The Application progresses to Step 6. The Ethics and Compliance Officer selects Revert Application if they are not satisfied with the completeness of the Application. The Ethics and Compliance Officer must have entered action and or general comments to enable the Applicant to make the required changes to the Application and thus meet the requirements for the Ethics and Compliance Officer to submit the Application for review. Page 26 of 48

27 STEP 6: APPLICANT: ETHICS AND COMPLIANCE OFFICER UPDATE REQUIRED When the outcome of the Ethics and Compliance Officer is to revert the Application to the Applicant, the status of the Application is ECO Update Required. The Applicant must respond to the action and/or general comments entered by the Ethics and Compliance Officer. 6.1 VIEWING COMMENTS The Ethics and Compliance Officer may have written comments on any page of the ethics Application form (Application Details) or made overall comments using the Summary Comments tab. The Ethics and Compliance Officer may have written 2 types of comments. They are: Action comments: This comment type requires the Applicant to respond to the comment the Ethics and Compliance Officer entered. For instance, the Ethics and Compliance Officer may require the Applicant to provide more information, change their answer, or reconsider their response etc. General comments: This comment type does not necessarily require a response, however should be viewed before the Applicant resubmits the Application Responding to action comments Any action item the Ethics and Compliance Officer has entered at either the page or summary comment level must be viewed by the Applicant. The Applicant should then change the Application as required by the Ethics and Compliance Officer and/or enter a comment indicating what change has been made or why this change is not needed (based on the aims of the study and/or the National Statement). Once the Applicant has taken the desired action, they must mark the item as Responded. 6.2 RESUBMITTING THE APPLICATION Once the Applicant has marked all action comments entered by the Ethics and Compliance Officer as Responded, the Applicant can resubmit the Application by selecting Application Completed from the Application Overview screen. The Application then progresses to Step 7 for Student Applicants or Step 10 for Staff Applicants. Page 27 of 48