Frequently Asked Questions

Human Ethics - what are the application types?

There are three main application types for human ethics. For more detailed information please visit the Office of Research Ethics and Integrity page on the Digital Workplace or HiQ. The three applications described below are according to the level of risk: 1. Human Research Ethics Application (HREA) For research where the risks are more serious than discomfort and/or that involve a designated chapter of the National Statement. This application will require the approval of the University Human Research Ethics Committee (UHREC). 2. Human Low-Risk Application For research where the only foreseeable risk is no greater than 'inconvenience' or 'discomfort', as defined in Chapter 2.1 of the National Statement. 3. Human Ethics Exemption Application For research that is of negligible risk as defined in Section 5.1.22 (a) of the National Statement; for research that involves solely the use of existing collections of data/records as per Section 5.1.22 (b) of the National Statement and these datasets must contain only non-identifiable data about human beings as per Section 5.1.22 (b) of the National Statement. SUBFORMS Human Ethics Variation Request Human Ethics Progress/Final Report (HREA) Human Ethics Progress/Final Report (NLR)

Human Research Ethics Application (HREA) information

Further information about the Human Research Ethics Application (HREA) is available on the QUT OREI website and the NHMRC website. OREI - https://qutvirtual4.qut.edu.au/group/research-students/conducting-research/ethics-and-integrity/human-research-ethics/apply-for-approval NHMRC - https://www.nhmrc.gov.au/research-policy/ethics/human-research-ethics-applications-hrea/human-research-ethics-applications-hrea-resources

Animal Ethics - what are the application types?

The main animal ethics applications are described below. For more detailed information please visit the Office of Research Ethics and Integrity page on the Digital Workplace or HiQ. 1. Animal Ethics Application This application is the main form for animal ethics projects where using animals for scientific research purposes enables the researcher to develop new treatments or strategies to improve the understanding of human or animal health, biology and wellbeing and includes the Tissue Use only form and Outside Scope applications. What is an outside scope project? Projects may be considered outside the scope of requiring UAEC review if they satisfy the following requirements: * do not involve legally defined animals, for example using only flies or other insects; and/or * are conducted for a non-scientific purpose such as - diagnosis by a veterinarian within routine veterinary practice or biosecurity inspectors undertaking a disease response; and/or * do not involve using an animal. 2. Standard Operating Procedures (SOP) QUT's Medical Engineering Research Facility (MERF) has a library of lab-animal SOPs for animal procedures (involving mice, rats, rabbits, sheep, pigs) available for use by QUT researchers. Email MERF to request access to their SOP library (merf@qut.edu.au). To access other species and existing project-specific SOPs contact the Animal Ethics Advisory Team for assistance (animalethics@qut.edu.au). SUBFORMS Animal Ethics Variation request form Animal Ethics Progress/ Final Report

What is animal research?

Animal research is scientific work with animals (research and teaching) which must be undertaken in accordance with the Australian Code for the care and use of animals for scientific purposes (the Animal Code). The Animal Code has been embodied in the Animal Care and Protection Act 2001 (the Act), Queensland's animal welfare legislation, and the Australian Code for the Responsible Conduct of Research. The Animal Code places a legal duty of care on people in charge of animals to meet those animals' needs in an appropriate way. The purpose of the Animal Code is to ensure the humane care of animals used for scientific purposes. The Animal Code should be read in conjunction with other guidelines and guidance, as relevant. Australian Code for the care and use of animals for scientific purposes - visit https://www.nhmrc.gov.au/about-us/publications/australian-code-care-and-use-animals-scientific-purposes Animal Care and Protection Act 2001 - visit https://www.business.qld.gov.au/industries/farms-fishing-forestry/agriculture/livestock/animal-welfare/law/animal-care-act The Australian Code for the Responsible Conduct of Research, 2018 - visit https://www.nhmrc.gov.au/about-us/publications/australian-code-responsible-conduct-research-2018

Biosafety - what are the application types?

Main application forms: Biosafety work with Genetically Modified Organisms (GMO) application - all QUT research and teaching activities involving a dealing with a GMO require University Biosafety Committee review and approval before the project can begin. In some cases (DNIR/DIR), Office of Gene Technology Regulator (OGTR) approval will be required as part of the process. Biosafety High Risk (Non-GM) biologicals application - all QUT research and teaching activities involving high risk non-GM biologicals require review and approval by the University Biosafety Committee before the project can begin. Visit our website for further information - https://qutvirtual4.qut.edu.au/group/research-students/conducting-research/ethics-and-integrity/biosafety SUBFORMS Biosafety variation request Biosafety GMO progress report Biosafety Non-GM progress report Biosafety Project Personnel List

Biosafety at QUT

The University Biosafety Committee (UBC) is dedicated to providing a safe and healthy work environment and pursues its strategic and operational objectives in a responsible manner, having a duty of care to staff, students, the greater public and the environment. The UBC's primary responsibility is to ensure as far as practicable that potentially hazardous research and teaching is conducted under controlled conditions. Biosafety obligations are a key element to QUT research and teaching activities, with an increasing part of our activities involving genetically modified and high-risk non-Genetically Modified biological material. As such we must ensure that we operate under various interrelated legislation and regulatory guidelines. The UBC requires that approval to carry out work with genetically modified organisms and high-risk biological agents and materials is obtained in advance of initiating the proposed research and/or teaching. Approval is conditional on all staff and students undertaking the appropriate training to conduct such work. Further, the UBC has a monitoring role and may impose fresh conditions if new methodologies emerge for doing the teaching or research or if tighter controls are needed due to recent insights into hazard evaluation.

What is Ethics Review Manager?

The Ethics Review Manager (ERM) is QUT's new system for the submission and review of human ethics, animal ethics and biosafety applications. ERM's implementation replaces the application forms on the Digital Workplace. ERM is accessible on and off campus. ERM allows document attachments, digital signatures, comments, submission, review, edits and resubmission, real time data and progress monitoring, updates and sub-forms.

How do I sign in to ERM?

QUT users can access ERM from the Digital Workplace using single sign on (SSO). Log in to ERM via https://ethics-forms.research.qut.edu.au/. If you wish you can add this to your launchpad on your Digital Workplace home screen. Follow these steps to add the tiles to your launchpad on the Digital Workplace: 1. In the Digital Workplace search bar enter "ethics" and click "search" 2. You will see on the right-hand side of your screen under 'related applications' the first two tiles listed are for the new ERM system (ERM and ERMR). 3. If you are a researcher applicant, click on the "+" sign for ERM (in the top right-hand corner) and this will add the tile to your launchpad. A message will pop up saying 'added to launchpad'. 4. If you are both a reviewer (Research Ethics/Biosafety reviewer, Head of School or Facility Manager) and an applicant, click on the "+" sign for both ERM and ERMR tiles (in the top right-hand corner) and both will be added to your launchpad. 5. Once added to your launchpad ERM will always be accessible from your launchpad by selecting the relevant tile (ERM or ERMR). For external users to QUT or to bypass the QUT Digital Workplace, you can access ERM directly from the link https://ethics-forms.research.qut.edu.au/ - please note that you will need to have requested and be granted an account prior to access. 1. Request access to ERM by emailing: ethics.sysadmin@qut.edu.au 2. Once you have access you can login at: https://ethics-forms.research.qut.edu.au/ There are two sides to ERM: one side is for research applicants (forms view - accessible by using this link - https://ethics-forms.research.qut.edu.au/) If you are a reviewer (Faculty Research Ethics Advisor, Committee Member, Head of School or a Facilities Manager) and are trying to see the reviewer side go to https://ethics-review.research.qut.edu.au/. Chrome is the recommended browser for accessing ERM.

How do I create an ethics application in ERM?

1. Log in to ERM. 2. Click on the 'Create Project' tile in your Actions panel on the left-hand side of your screen. 3. This will open a window where you should enter the project title and select the type of application you need to complete. This is referred to as the "main form" e.g., Animal Ethics Application, Human Low Risk Application, Human Research Ethics Application etc. 4. Click the green 'Create' button. 5. You will be redirected to a new work area where you can access the form.

How do I complete an application in ERM?

The questions and their format are customised for each type of application. Most applications have dynamic questions that reveal additional questions and/or sections based on responses given by you. Fields requesting personnel information will look up QUT/HR/student systems and use autocomplete to fill in the fields. When you open an application in ERM, you will land on a screen that shows some information about the application form - for example, the "Application Status" and "Review Reference". Beneath that information, you will see an overview of the application's content. To commence answering your questions in the application: 1. Click on any item in blue text under "Questions". 2. Navigate through the application by using the Previous and Next buttons. You can also use the "Navigate" action to come back to the application's work area - where you can then navigate to any section. 3. At any stage you are able to save your progress or run a completeness check. 4. Once you have worked through all the questions in the application, you then need to submit your application. Once you click 'submit' a completeness check will be run as part of the submission. This will identify any unanswered mandatory questions, and these will be flagged as needing to be revisited and answered. 5. The completeness check is linked directly to the question in the application. Clicking on the question (blue link) will take you directly to the question to be answered and will be outlined in red. 6. Once all flagged questions have been answered, a message will appear at the top of the page "your form is complete and ready to submit". You can now click on the blue "submit" button. 7. Remember to ensure you SIGN and SUBMIT your application. 8. Once you have submitted your application you will receive confirmation via email (donotreply@infonetica.com) that your application has been successfully submitted. An email will be sent to the nominated email on the application form. 9. On your home page the submitted project will have been assigned a new status e.g., 'AE - new application' with a review reference number e.g. AE2021-0214-0224.

What is the review reference number?

The review reference number is a combination of 4 parts consisting of an application code, year created/submitted, project id and version number. You should think of it as a barcode for your application. For example, AE 2021-0213-0227 is an animal ethics application submitted in 2021 with a project id of 0213 and version number 0227.

How do I know what my application number is for my research project?

After submission you will receive a confirmation email that you have successfully submitted your application. On the home page the submitted project will have a new status (Submitted by applicant) and will have been assigned a review reference number e.g., LR 2021-4351-4719. Your project id (application number) is the four-digit number located in the middle of the 12 numbers, in the example above the project id is 4351. This will be the number (4351) that you use on all your documentation e.g., PICFs etc. for the duration of the project and for searching for the project in ERM if needed. This project id number will not change for the duration of the research project - the only numbers that change is the four digits at the end of the review reference number - these are the version numbers for the project. Each time the project is varied, or a progress report is submitted, the four digits at the end will change but the project id will remain the same.

Do I need to select the "Save" icon before I navigate to the next page of the application?

No. Every time you select the 'previous', 'next', or 'navigate' tiles in the Actions panel, all entered information is automatically saved.

I have completed my application in ERM and have signed it, does that mean it has been submitted?

No, after you have completed your application and clicked the "Sign" button you still need to SUBMIT it. To submit your application, click the 'Submit' tile in your Actions panel on the left-hand side. After your application has been submitted you will receive confirmation via email (donotreply@infonetica.com) that your application has been successfully submitted.

I am trying to add an investigator to my application, why do they not appear in the 'search user' field?

For some fields in ERM, you will only be able to add investigators that have an ERM account and have activated their account in ERM. Users will need to log-on to ERM before you are able to add them. It may be the case that staff and students who are new to QUT have not yet activated their profile in ERM in order for their names to be found in the 'search user' field. To activate their profile, they will need to log in and out of ERM using this link - https://qut.forms.ethicalreviewmanager.com/. This will capture their name and email in the system. You should then be able to add them and share the project with them as required.

Can I still submit the application if there are mandatory questions that I have not yet completed?

No. A completeness check is performed within ERM, and any incomplete sections will be highlighted, and this prevents the application from being submitted. The application will not be submitted until you have responded to all the mandatory questions. Once you have responded to all the mandatory questions a message will appear that says, 'your form is complete and ready to submit.'

Can I upload supporting documents to my application in the system?

Yes. There is a function to 'upload' supporting documents within the application form. This is where you are able to attach all documents in support of the application. Zip folders can be uploaded to ERM.

What is the ERM Work Area?

The ERM work area is the main functional space and first thing you see when you log in to ERM. It is where you can create new human or animal ethics applications and biosafety applications, receive communications and manage your ethics projects. The Work Area includes notification tiles where you receive updates of your applications as they move through the review process. It also includes actions for collaborating and transferring applications to other researchers, if required.

What is the purpose of notification tiles?

You will notice that when you log into ERM there will be four (4) notification tiles visible in the work area. Notifications are also accessible through the drop-down menu in the personal details section in the far right of the top menu (black bar) . Unread notifications will appear as red numbers on the corresponding tiles. When all notifications have been read and actioned the number shown on the tile resets to zero. If all numbers are 0 it means you have nothing outstanding. The four tiles you will see are: 1. Notifications - all system generated notifications will appear here. In the notifications panel you can search through your notifications and sort your messages by short message title, attachments, project short title and date received. 2. Signatures - any applications/forms that require your signature are viewable here 3. Transfers - any applications/forms that are transferred to you will appear here. 4. Shared - any applications/forms that have been shared with you will appear here.

Why can't I view my application or projects in ERM?

You will only be able to view applications/projects in ERM that you have created or that have been 'shared' with you as a collaborator on a project. The applicant (form owner) will need to share the application with you in order for you to be able to view the application and see the project's status.

Why am I seeing the message "Note: There is a newer version of the project. (Please contact the project owner to update this form)"?

New versions of forms will become available after system updates or errors have been identified and corrected. If you are not the owner of the form and you wish to make an update to the form you will need to contact the form owner and request that they "update" the form before you can make the changes.

Are students able to submit an ethics application?

Yes. HDR students and occasionally Masters or Honours students will be required to submit an ethics application. This can be done through ERM however, they will require a signature from their Supervisor before the application can be submitted through ERM.

What is the purpose of the 'Create Folder' tile in the Actions panel?

You may want to create folders to keep your application and associated documents together and organised. To create folders: 1. Click on the 'create folder' tile under the Actions panel on the left-hand side. 2. A pop-up box will appear. Write a name for the folder and click the green 'Create' button. 3. Drag an application from your project list to place it into the folder. 4. If you need to, you are able to move a project to another folder or back to the project list from the action panel inside the folder. 5. PLEASE NOTE: Once a project is moved into the folder IT IS NOT visible in the main project list, only in the folder project list. NB: You will only be able to delete a folder if there are NO projects in the folder.

How do I find out the status of my application?

First you will need to open up your application. Below your project title is a series of menu items from left to right (these menu items are in bold text) that include: Action Required - this will be 'yes' or 'no' Status - e.g., HE - Under Faculty Review; HE - UHREC Chair Review; HE - SREA Q's Response etc. Review Reference - e.g., LR - 2021-0617-1167 Application Type - e.g., Low Risk Date Modified - e.g., 29/07/2021 11.20am The status of your application will indicate which stage of the review process your application is currently at.

What if I already have ethics approval from another institution?

For Human Ethics: If your project has been approved by another NHMRC-registered (National Health and Medical Research Council) Human Research Ethics Committee (HREC), you'll need to apply for an Administrative Review to register the project with us. Email humanethics@qut.edu.au for further information or advice. For Animal Ethics: If you have already gained approval from another registered Animal Ethics Committee (AEC) you may not need to submit an animal ethics application on QUT forms. Instead, you may only need to submit an administrative review application. Email animalethics@qut.edu.au for further information or advice.

What is the purpose of the 'Refresh' button under the Actions panel?

Periodically, system forms will be updated with new questions or new information, refreshing your form will ensure you are submitting the most recent version. Each time you access ERM YOU WILL need to refresh the form.

How can I print my application form and/or view it as a PDF?

Select the 'print' icon under the Actions panel on the left-hand side of your screen. This icon allows you to print the application or save it is a PDF version. It also provides the option to print comments made by reviewers with the application.

Does ERM have a spell check feature?

Yes, ERM has a spell check feature.

Do I need to use the Contacts tab?

No, you do not, however you may find this feature useful as it may provide a shortcut during the application process. 1. Click on 'Contacts' in the black menu bar at the top of your page. 2. This will take you to a new page where you can search for or manually enter a new contact. 3. When you enter contacts manually into the form, it gives you the option to add that person to your contacts. If you do this it means that the next time you look up that person in 'contacts' it will automatically populate all their details. 4. Use the search bar to search for internal contacts or click on new contact to manually enter the information. You will likely need to manually enter the information for contacts external to QUT. 5. Clicking on a new contact will open a pop-up window containing a form where you can fill in the contact's details. None of the fields are mandatory. 6. Once completed, click SAVE.

Why am I not receiving email notifications from the system?

Emails may go to your spam or clutter mailboxes. It is a good idea to set these notification emails "as not spam" that way they should then be sent to your inbox.

When I try to login, I get an error message - what should I do?

The error message you will get states 'Login unsuccessful: you have exceeded the number of log in attempts and your account has been locked temporarily'. You will need to wait 15 minutes and try again. If the error continues, contact the OREI Business Analyst at ethics.sysadmin@qut.edu.au for assistance.

Is it possible to review all my active projects on a summary page in the system?

You can view them all as a list when you are in ERM. If you wish to know the status of each application/project you have, you will need to individually select each of your applications/projects to view the status of the application/project by clicking on the project title. The status of the application/project will be reflected in the application's home screen e.g., HE - Approved.

Are current Standing Operating Procedures (SOPs) accessible in ERM?

No - please contact the relevant ethics team in OREI.

What is the purpose of the 'Project Tree' under the Actions Panel?

The project tree allows you to see all forms associated with a project. It also provides you with a view of all submitted documents, any transfers that have occurred and the history of the project.

Do I need signatures from investigators on the project application?

No. A declaration is made by the action of submitting a project. The Chief Investigator will retain ultimate responsibility for all submissions. A receipt email will be sent to all investigators listed on a project, so they will be aware that a submission has been made and will also be able to track the progress of that submission.

Can the templates in ERM (e.g., Participant Information and Consent Forms etc.) be downloaded from the system?

Yes they can. All the templates can be accessed via ERM through the Templates section in the Help panel at the top right of the screen. Look through the list, select the template you wish to download and select the download button.

How do I unlock my form if I mistakenly locked it by signing the form?

You can unlock your application form and add any additional documentation or amend content by completing the following steps: 1. Log in to ERM 2. Open the application form in ERM you need to unlock 3. You should see under the title of the form e.g. Human Ethics Low Risk Application (LR), there are two columns - one is titled Section and the other is titled Questions. Under 'Questions' - click on the blue text titled 'Research title, aims, questions and methods'. This will take you to the first section of the application form. 4. You will see at the top of the page the note - 'This form has been locked through signatures/requests'. 5. On the Actions panel on the left-hand side you have an 'Unlock' tile - click on this and it will unlock the application form for you and allow you to make the necessary changes to your application and add any additional documentation as required. 6. PLEASE NOTE - when you unlock the application form it will invalidate (nullify) all previous signatures so you will need to SIGN and SUBMIT the form again.

Can I copy/paste special characters into ERM multiline text boxes?

No. Unfortunately ERM is unable to handle special characters in multiline text boxes. We recommend these not be used for text boxes in ERM.

Can I make changes to my application if it comes back to me from a reviewer and it was not a reviewer comment?

Yes. You are able to make changes to your application when it comes back to you with reviewer comments. There is nothing stopping you making changes in panels that do not contain reviewer comments. Reviewers will see these changes clearly marked as changes. If for some reason this is not a viable option, you can upload an explanation as supplementary material, or as a revision to a protocol. See question 7.2 - Are there any other documents to attach in support of your application (e.g., a protocol/project description or evidence of prior peer review)? Finally an email could be ok. If it's relevant to the review of the application, though, then the reviewer should upload it to the documents tab. In that case, one of the first two options is still preferable, since everything relevant to the review of the application should be contained in the application (and attachments).

How do I respond to reviewer comments and feedback, and resubmit my application?

After you submit your project, it will go through the review workflow. The approval workflow will vary, depending on the application type. During the review process, reviewers are able to make comments, ask questions or make change requests. All of these are managed within ERM in the notifications section. 1. Click on the message, then view form in the pop-up, then click on the 'Panel Comments' tile in the Actions panel on the left-hand side. Once you click on this tile it will open a section which outlines all the commentary from the reviewer. 2. Click on the comment to open the question that the comment is related to. ERM will outline the question in red to make it clear which question in the form the comment is referring to. 3. Respond to comments by making changes in the form. If questions require additional information, you can add this under your original text and when it goes back to the reviewer for further review it will appear as highlighted text, so they are able to clearly identify what text has been added. 4. Once you have responded to all comments you can perform a new completeness check and resubmit your application to progress along the review workflow to approval. When you upload a newer version of a document to your form, please also delete the superseded version.

What is the difference between sharing and transferring an application?

The difference between sharing and transferring is whether or not you retain ownership of the application. 1. Sharing is where you share with other users and RETAIN OWNERSHIP/ADMIN RIGHTS to the application. 2. Transferring is where you RELINQUISH ONWERSHIP/ADMIN RIGHTS to another user. The application will no longer be accessible to you once it is transferred.

How do I share my application?

ERM has transitioned from the “Share” to the “Roles" button for granting access/permissions to a fellow researcher, team member or collaborator. The benefit of “Roles” over “Share” is permissions are applied to the whole project and not just individual forms. This means when you give a role to a new collaborator they will be able to see new and old and new subforms for the whole project. You can see what permissions a collaborator has under the “Collaborators” tab in your project Timeline. Adding Roles 1. Open the project you wish to share by select the title from your QUT ERM login Work Area 2. Select “Roles” from the action panel on the top left-hand side 3. Enter the collaborator's email address. Please be aware that if you receive a message “Collaborator email address is not valid” first check your spelling as the email address may not match the user; or the user may not have a QUT ERM login generated yet. By asking the QUT staff member to log into ERM via the Digital work place their ERM account will be automatically created via their QUT login credentials. 4. Select the required role from the dropdown list. The selected role will apply to the entire project - that's the main form and all existing and future sub-forms. 5. Use the green “+” button to list additional collaborators and assign their role 6. Click “Share Role” to save. Every time a role is shared the person sharing the roles and the person the role is applied to will receive a system generated email informing them of the change Removing Roles You cannot edit an existing role, but you can remove roles and re-assign a new role if required. 1. Click “Roles” to view all collaborators who have been assigned roles on the selected project. You must have the main form selected in order to see this button. 2. Click “Remove” to remove a specific role that has been assigned to a collaborator 3. Select “Close” and your changes will be saved 4. or, if the collaborator has multiple roles and is therefore listed multiple times, you can click “Remove All Permissions” for this person. If a collaborator is listed multiple times, the role with the highest level of access will apply.

How do I transfer an application to another Investigator?

1. Log in to ERM. 2. Click on the 'Transfer' tile in the Actions panel on the left-hand side. This button is only visible from your ERM homepage (not within the application). 3. A pop-up dialogue box will open where you can enter the email address of the new owner (Chief Investigator of the project) and add a message for the new owner if relevant. 4. Select the project(s) you are transferring from the list and then click 'Transfer'. NB: Changes to the project team will require a variation to be submitted and must be approved before the project can be transferred to a new owner.

How do I accept a transfer?

1. Log in to ERM. 2. When someone transfers a project to you, it will appear on your 'Transfer' tile in the main work area of ERM. 3. Click on the 'Transfer' tile to open a list of transfer requests. 4. Click on 'View Project' to open it. The project will remain read only until it is accepted. 5. At this point you are able to either accept or reject the transfer. 6. To accept a transfer, click "accept transfer", a confirmation pop-up will appear - 'Are you sure that you want to perform this action'. 7. Click "yes" to accept the transfer. 8. When you accept a project via transfer, it will appear in your project list. There will also be a transfer accepted status noted. If someone is accepting a transfer from you, that project will still appear in your list with a transfer accepted status, but you will not be able to open the project.

How do I reject a transfer?

1. Log in to ERM. 2. When someone transfers a project to you, it will appear on your 'Transfer' tile in the main work area of ERM. 3. Click on the 'Transfer' tile to open a list of transfer requests. 4. Click on 'View project' to open it. The project will remain read only until it is accepted. 5. To reject a transfer, click 'Reject transfer', a confirmation pop-up will appear - 'Are you sure that you want to perform this action'. 6. Click 'Yes' to reject the transfer. 7. When you reject the transfer, you will not be able to view the project (unless you are a collaborator on the project). This action will also notify the person that sent you the request.

How do I edit the access permissions for collaborators?

The steps below will help you view and edit the assigned permissions: 1. Click on "Work Area" to view your Homepage. 2. Select the project you want to share by the search or click on the project you want from the list on the page. 2. Click the "Collaborators" button on the left-hand side or the "Collaborators" tab in the middle of the page. 3. Click the "Edit" button for the relevant individual and change their permissions as required.

Why would I need to duplicate a project?

Sometimes a new project will be similar to another project that you have previously prepared. In this instance you can duplicate a project in ERM and then edit it. 1. Log in to ERM. 2. Click on 'duplicate project' from the Actions Panel on the left-hand side. 3. In the pop-up, select from the drop-down menu the project you want to duplicate and in the text box enter the title of the new duplicated project. You also have the option to duplicate the sub-forms. You will need to upload all documents and/or attachments for this project as the documents/attachments will not be duplicated. 3. Click on the green 'duplicate' button. 4. The new duplicated project will appear in your project list.

Will I be notified when my application/s are approved?

Yes. You will receive both a system notification and an email notification from (donotreply@infonetica.net) when your application has been approved. Please note that this email is outgoing only. An approval email will be sent to all investigators listed on a project to make them aware that the project has been approved. All standard conditions of approval and/or specific conditions of approval will be outlined in the email, or attached as a letter to the email that you receive. It is important that you save this email and/or attachment somewhere safe. Your application approval status will be reflected in the application's home screen.

Can I delete/withdraw my application in ERM?

Yes, you can only delete your project if you haven't SUBMITTED the application form in ERM. Follow the below steps to DELETE your application form: 1. In the Actions Panel on the left-hand side - click the 'Delete Project' tile. 2. Select the project you wish to delete from the drop down list and click the green 'Delete' button. 3. You will then be prompted with the question 'Are you sure you want to remove this item? - select Yes 4. A message will then appear at the top of your screen indicating the project has been successfully removed. You are only able to WITHDRAW your application if you have submitted your application through ERM and it hasn't been progressed through the workflow. Follow the below steps to withdraw your application: 1. Log in to ERM 2. Select the project you wish to withdraw 3. From the Actions panel on the left-hand side select the 'Withdraw Project' tile 4. Follow the prompts to withdraw the application. 5. You will be prompted with the question 'Are you sure you want to remove this item? - select 'Yes' 6. You will see a message appear at the top of your screen advising that it has been successfully withdrawn. APPROVED projects CANNONT be withdrawn or deleted. Please contact the OREI team for assistance.

Which Committee will review my human research ethics application?

This is only relevant for human ethics applications, and it will depend on whether your research is no more than low risk or greater than low risk. If it is more than low risk, it will be reviewed by the nominated Faculty of the Chief Investigator. If your research is more than low risk, it will be reviewed by the University Human Research Ethics Committee (UHREC). Please consult the cut off time times on the OREI website for the UHREC to ensure your application is reviewed at the next available meeting.

How do I access my approval letter in the system?

You are not able to access this approval letter in the system. Instead, it is sent via an email that is generated by ERM (donotreply@infonetica.net) to your QUT email address or the email address nominated on the application. This email will outline your approval and any conditions attached to that approval. It is important that you store this email in a secure place.

Do I delete superseded versions of documents when I resubmit an ethics application or variation?

Yes, when you upload a newer version of a document to your form, please also delete the superseded version.

What is a sub-form?

A sub-form is any form that becomes part of an ethics application and relate to post approval documentation. Research projects that continue over extended periods of time will potentially consist of the original ethics application, variations, annual progress/final reports and/or unexpected/adverse event/s notifications. In ERM these additional forms will be known as sub-forms and they will be dependent upon the main form that has been created.

Unexpected Events

The Unexpected Event Form is a dynamic form that you can use for Human or Animal unexpected Events. For Human: An unexpected event is any event that has a negative impact on participants, researchers or the reputation of the Queensland University of Technology. The National Statement on Ethical Conduct in Human Research provides specific definitions for device and drug-related adverse events as well as serious adverse events. For Animal: According to the Code, the UAEC is required to take appropriate action in response to unexpected adverse events to ensure that: Animal wellbeing is not compromised, the issue is addressed promptly and that activities that have the potential to adversely affect animal wellbeing cease immediately.

Administrative Reviews - Human and Animal

Human Research Ethics An administrative review application is required to be submitted if you've previously received approval for your project from another registered Human Research Ethics Committee. Animal Research Ethics An administrative review application is required to be submitted if you've previously received approval for your project from another registered Animal Ethics Committee. On both of these occasions the OREI will review your application to ensure the project meets university governance requirements.

Request for Variation

A Request for Variation form will be used to assess your intent to amend an approved project, and will assist in determining if the current project application may be unlocked for your proposed changes to be made and reviewed, OR if a completely new application is warranted. Note: Any changes/variations to a project must be approved before any implementation is to occur.

How do I make a variation to a new project I have created in ERM (not a migrated project)?

Applying for a variation is a two step process. Step 1 - Make a request to submit a variation To make a request to submit a variation: i) Open Ethics Review Manager ii) Find and open the approved project that you wish to vary iii) Select 'Create sub-form' from the Actions panel and then select the appropriate variation form e.g., 'Human Ethics Variation Request' sub-form iv) Answer the questions provided. v) Select 'Submit'. If your request is successful, you'll receive confirmation by email that your approved project is unlocked for editing, and you can progress to Step 2, below. If your proposed changes are major, you may be asked to submit a new application, rather than vary an existing approval. Step 2 - Make your proposed changes and submit them for review To make your proposed changes. i) Open Ethics Review Manager ii) Find the approved project that you wish to vary. It should now be unlocked for editing. iii) Make your proposed changes to the application form. iv) Make any changes to your supporting documents in tracked changes, and upload them to the relevant sections of the form. v) Select 'Submit'. When you upload a newer version of a document to your form, please also delete the superseded version.

How do I submit a progress report, final report, or an unexpected/adverse event for my research project?

These reports are known as sub-forms in ERM. Follow these steps to submit your form: 1. Log in to ERM. 2. Select the relevant project you wish to provide a report on. 3. Select the 'Create Sub-Form' tile from the Actions panel on the left-hand side. (You must have permission to create all sub-forms to see this button). 4. Choose the relevant form (progress/final report, unexpected/adverse event) followed by the green "create" button. 5. Complete the form. 6. Share the sub-form will all investigators listed on the main form (if required). 7. Click 'Submit' from the Actions panel on the left-hand side.

How do I submit a variation to a project that has been migrated to ERM?

What is a migrated project? As part of the implementation of ERM, records of all existing approvals were migrated to ERM. These are called "migrated projects". They will be used for the ongoing management of those approvals - e.g. variations and progress reports. The Chief Investigator of each project has access to the migrated project and can "share" access with their colleagues. You will need access and the appropriate permissions for the project to make a variation. MAKING A VARIATION REQUEST IS A TWO STEP PROCESS Make a "variation request" to unlock your form 1. Open Ethics Review Manager (ERM). 2. Find and open the approved project that you wish to vary. 3. Check whether you need to update your form. If so, there will be a yellow banner across the top - and you should click "Update". The form owner may need to to this. 4. Select 'Create sub-form' from the Actions panel on the left-hand side, and then select the relevant "Ethics Variation Request" sub-form. 5. Answer the questions. 6. Click the 'Submit' tile in the Actions Panel on the left-hand side. If your request is successful, you will receive confirmation by email that your approved project is unlocked for editing, and you can progress to Step 2, below. Submit the varied documents as attachments to your migrated form. 1. Open Ethics Review Manager (ERM) 2. Find and open the migrated project that you wish to vary. It should now be unlocked for editing. 3. Upload your documents to the migrated project in this first question: "1.1 - if you are submitting a variation to this migrated project, upload a zip file containing all of your approved documents, and then separately a copy of each of the documents you wish to vary with tracked changes. (More than one document can be uploaded) 4. Click the blue "upload document" button to upload your documents. 5. If you are making changes to the research team, make these changes in the "personnel" section of the migrated form. 6. Click 'Submit' in the Actions Panel on the left hand side. When you upload a newer version of a document to your form, please also delete the superseded version. Once your application has been reviewed, you'll receive a system-generated email from ERM. this email will be either: (a) feedback from your reviewers, in which case you'll need to respond in ERM and resubmit your migrated form for review, or (b) confirmation of approval, in which case you can commence work according to the conditions of that approval.

How do I cancel a variation?

You can cancel a variation by contacting OREI and asking them to cancel it for you.

When are email notification reminders generated for annual progress/final reports?

Annual Progress report reminder email notifications will be issued as below: * Human Ethics Progress Reports will be sent one month prior to the end date of your project. For example, if your project approval expires on 20 April 2023, you will be sent a reminder email on 20 March 2022 and again on 20 March 2023. If your project end date has been extended, the reminder will be sent one month before the new expiry date. * Biosafety Progress Report Emails will be sent on the anniversary of the start date (date of approval) and a final email reminder will be sent 3 months prior to the clearance expiry date. * Animal Ethics annual Progress Report reminder emails will be sent on 31 December each year for the life of the project.

Who should fill out the application?

Your supervisor is the Chief Investigator and as such should start the application form for you. They will need to share the application with you as a collaborator and provide you with all the viewing and editing rights to the application.