Frequently Asked Questions

ERM USER GUIDE

The Monash ERM User Guide can be found by clicking HELP > HELP Or at the following link: https://ethicsapps.monash.edu/Personalisation/DisplayPage/9

CREATING A PROJECT - How do I create an application?

1. In your ERM WorkArea, click "Create Project" on the left hand side of the screen. For student projects, this step should be done by the Monash supervisor. 2. Select the relevant form in the dropdown list. 3. Begin at "Start Here". 4. Use the "Next" button on the left hand side of the screen to navigate to the next section of the application and complete each section sequentially. 5. Click "Submit" to submit your application for review. NOTE: The person that creates the application will be listed as Chief Investigator (CI). The CI must be a Monash University, CSIRO or Dolphin Research Institute staff member, and this role is associated with significant responsibilities as indicated on the Declarations page of the application. If you do not wish to be the CI, you must transfer the project to the appropriate person prior to submission. Please refer to the transfer FAQ below for instructions.

CREATING A PROJECT - Can students submit an ethics application?

No. The Chief Investigator should be the Monash supervisor responsible for the research. The CI should log into ERM, create the project and add the student and other personnel. The CI should 'share' the application with the relevant personnel and set the appropriate permissions to allow them to access the project as required.

CREATING A PROJECT - How do I add an investigator not coming up in the 'search user' field?

New Monash students or staff may need to activate their profile in ERM in order for their names to be found in the 'search user' field. To activate their profile, they need to log in and out of ERM using the link below. This will capture their name and email in the system. You can then add them and share the project with them as required. https://ethicsapps.monash.edu

CREATING A PROJECT - How do I edit the contact details when adding investigators?

The details displayed are synced from Human Resources and aren't editable. If these are incorrect, please contact HR to update your details.

CREATING A PROJECT - How do I add external investigators to my project?

You can list external investigators on your ethics application. For Human Ethics- In A4, select the "External (Non-Monash) Investigator" box. An editable contact block will appear so that you can manually enter their details. For Animal Ethics- In A14, select "yes". An editable contact block will appear so that you can manually enter their details. For Gene Technology- In 2E, select "yes". An editable contact block will appear so that you can manually enter their details. NOTE: External investigators can't log into ERM without a Monash email, so you can't share the project with them. You need to print a PDF of the project and email it to them. NOTE: You cannot add external investigators to the Human Ethics- Other HREC form.

CREATING A PROJECT - Do I need signatures from investigators or head of unit?

Signatures are not required for any of the forms. A declaration is made by the action of submitting the 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. An approval email will be sent to all investigators listed on a project, so they will be aware that a project has been approved.

PROVIDING ACCESS - How do I share an application with Monash collaborators?

1. Click on the project you want to share. 2. Click Roles in the Action Panel. You must have the main form selected in order to see this button 3. Enter the collaborators email address. This must be a Monash email address 4. Click on the drop-down list and select the required role. The selected role will apply to the entire project - that's the main form and all existing and future sub-forms. 5. You can use the green + button to list additional collaborators and assign their role 6. Click ‘Share Role’ to save NOTE: External investigators can't log into ERM without a Monash email, so you can't share the project with them. You need to print a PDF of the project and email it to them. An email will be sent to the collaborator - they will now be able to log in to ERM and view the application in their "Shared" tile.

PROVIDING ACCESS - How do I edit collaborator access?

1. Open the project 2. Click Roles in the Action Panel. You must have the main form selected in order to see this button Collaborators who have been assigned roles will be listed here. 3. Click Remove to remove a specific role that has been assigned to a collaborator, 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. NOTE: You can not edit an existing role, but you can remove roles and re-assign a new role if required.

PROVIDING ACCESS - Why can't investigators see the project in their work area?

When adding new investigators they will not see the project in their work area until you also click the 'Role' button and assign them appropriate access role. The role access options are: Read Only Full access - including the ability to submit Full access - excluding the ability to submit

PROVIDING ACCESS - Why do investigators still receive emails after being removed from a form?

When removing investigators who are no longer involved in the project, you also need to click on the 'Roles' button and edit or remove their access permission. Collaborators can remove access from shared projects themselves by clicking on the Share tile in their Workarea, then clicking 'reject' next to the relevant project.

MANAGING MY PROJECT - How do I correspond with the office?

1. Open the relevant project 2. Click on the "Correspond" action button. 3. Type your message to the ethics office, attach any relevant files, then click Send.

MANAGING MY PROJECT - How do I know if my project is approved?

You will receive an email notification from donotreply@infonetica.net. You can check the status of your project by opening the project and viewing the status under your project tree.

MANAGING MY PROJECT - How do I transfer a project?

Transferring ownership of a project to another Monash investigator changes the Chief Investigator listed within the form. If the transfer is accepted, the new owner holds responsibility of the project outlined in the Declarations page of the relevant form. 1. In your ERM WorkArea, click on the "Transfer" button in the action panel 2. Enter the email address of the person you wish to transfer the project to. Note this must be a Monash email address. Add a message for the new owner if relevant. 3. Select the project from the dropdown list and then click "Transfer". 4. An email will be sent to the new project owner - they will need to open the project, and click "Accept Transfer" in the action panel. 5. If the original project owner still requires access to the project, the new project owner will need to share the project with them. The ethics office will be in touch if an amendment is required.

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

We often release new versions of our forms to keep up to date with changes to National/State guidelines and regulations, and to fix issues that have been identified. Please contact the project owner of your application so that they can accept the newer version of the form.

MANAGING MY PROJECT - How do I edit a form that is 'Locked for Review'

Approved applications need to be unlocked to allow amendments to be made. Click on the "Correspond" button on the left hand side panel to send us a correspondence message requesting to amend the project.

MANAGING MY PROJECT - How do I submit a progress report, adverse event report, or incident report?

Reports are submitted as sub-forms in ERM. To submit a report: 1. Open the relevant project 2. Click "Create Sub-form" in the Actions panel on the left hand side. Note if you cannot see this button you have 'Read Only' access and do not have permission to create-subforms for this project. 3. Select the relevant form 4. Click "Start Here" 5. Complete the questions on the form as required. 6. Click "Submit"

MANAGING MY PROJECT - How do I delete my project?

You can delete a project if you have not submitted it. Once submitted, you can no longer delete the project, but you can withdraw it from review if the research is no longer going ahead.

MANAGING MY PROJECT - How do I duplicate my project?

Only the Project Owner can use the duplicate function. 1. In your ERM WorkArea, click "Duplicate Project" on left hand side of the screen. 2. Select the relevant project from the dropdown list. 3. Enter a new title in the second text field. 4. Click the green ‘Duplicate’ button. NOTE: Document attachments, and animal ethics animal numbers are not duplicated - these will need to be entered manually. Older Animal Ethics forms with previous versions of the incident report form cannot be duplicated.

MANAGING MY PROJECT - How do I cancel an amendment I have already submitted?

Send a correspondence message to inform the Committee Secretary why the amendment is no longer required. Ensure you detail whether you wish to cancel the review of the amendment because you want to make further changes to the same amendment, or whether the amendment is no longer required.

When are the Human Ethics meetings?

A list of the human ethics meeting dates is at this link below: https://www.intranet.monash/researchadmin/start/ethics/human/submission-dates

Is there an online human research ethics training module?

Yes, the Human Research Ethics online module is now available through MyDevelopment. This course is essential for all staff and students undertaking human research and can be accessed at the link below. https://monash.csod.com/ui/lms-learning-details/app/course/4358b34b-53c5-454e-aa91-9767674bcb02

How do I register a project approved by another human ethics committee?

Monash University researchers who have obtained ethical approval for a project from another Human Research Ethics Committee (HREC) are required to register their project with MUHREC if the research involves any of the following: -Funds being administered by Monash University -Students undertaking research or placement for their degree at the other institution (e.g. a hospital) -The project will contribute to their research output such as publications, conference presentations These projects will not be subject to a full review with MUHREC, but will be checked for governance matters that may need to be flagged to other areas of the university. 1. Login to Infonetica ERM. 2. Select the "Create Project" tile on left hand side of the screen. (For student projects, this step should be done by the Monash supervisor). 3. Select the "Human Ethics - Other HREC" form. 4. Begin at "Start Here". 5. Use the "Next" button on the left hand side of the screen to navigate to the next section of the application and complete each section sequentially. 6. Click "Submit" to forward your application for review.

How do I submit an amendment to a human ethics project created in ERM?

1. Login to ERM and open the relevant project 2. Click on the "Correspond" tile on the left hand side panel. This tile is only visible on projects that are under review or have been approved or amended. 3. Enter a message requesting to amend the project including a brief description of the amendments that you wish to make. Click send. 4. You will receive notification when your project is unlocked by the office, enabling you to modify the relevant sections of your project. 5. Open the Amendment Details page on your unlocked form and complete the amendment justification. 6. Follow the instructions on this page to make the required changes to the relevant sections of the form. 7. Changes to documents should be done using track changes or highlights. Revised documents should be uploaded in the relevant sections of the form with a new date and version. 8. Click "Submit" to forward your amendment(s) to the office for review. NOTE: The "Submit" button will not be visible if there is a red warning at the top of the page. In this case, contact the Chief Investigator and ask them to click the blue "update" link and accept the latest version of the form. Once updated, the "submit" button will become visible.

How do I submit an amendment to a project that has been migrated into ERM?

Old applications were on paper based forms, so responses to the specific questions were not migrated into ERM. Only basic information about the project and investigators was migrated. Therefore, you will need to populate mandatory fields (most fields are mandatory) within the online form before submitting amendments. We understand that this may be a burden for some but there was no technical solution available to avoid this and we apologise in advance. 1. Login to ERM and open the relevant project. 2. Click on the "Correspond" tile on the left hand side panel. 3. Enter a message requesting to amend the project in the free text box including a description of the amendments that you wish to make. Click send. 4. You will receive notification when your project is unlocked by the office, enabling you to modify the relevant sections of your project. 5. Answer all check box/radio button questions. 6. Include text in all mandatory text fields. Remember a response is required for all mandatory questions before you can submit the form. The text can be as follows: - Relevant text copied from your existing copy (PDF or word form) of the project. This is the preferred option as you will have a complete version of the project for future reference and further amendments. This is particularly important for ongoing clinical trials and longitudinal projects. - Add standard text e.g. “Refer to legacy project no. #####”. This is the quicker option but it will make future amendments more difficult to assess by reviewers. 7. Ensure that you complete the Amendment Details page to provide justification for the changes you wish to make. This will assist in the review process as all the updates you make to the fields/questions will be recorded as changes to the migrated project. 8. Changes to supporting documents should be done using track changes to avoid delays in assessment. Revised documents should be uploaded in the relevant sections of the form with a new date and version. 9. Click "Submit" to forward your amendment(s) to the office for review. NOTE: The "Submit" button will not be visible if there is a red warning at the top of the page. In this case, contact the Chief Investigator and ask them to click the blue "update" link and accept the latest version of the form. Once updated, the "submit" button will become visible.

Where can I find resources to help me prepare my ERM application?

Information for preparing your application in ERM can be found at: https://www.intranet.monash/research-ethics-integrity/animal-ethics/application-process/new-applications Guidance specific to the animal ethics application form can be found at: https://www.intranet.monash/research-ethics-integrity/animal-ethics/application-process/new-applications/applying-for-animal-ethics-approval

How do I request a copy of my approval certificate?

An approval certificate can be requested by sending an ERM correspondence message on the relevant project. An approval certificate will be generated and forward to you.

When are the AEC Meetings?

Meeting dates can be found here: https://www.intranet.monash/research-ethics-integrity/animal-ethics/aec-meeting-dates

How do I submit an amendment?

1. Log into ERM and select the project you wish to submit an amendment for. 2. Click the ‘Correspond’ button to send a message to the office requesting that the project is unlocked for an amendment. Include a brief summary of the amendments you wish to make. When your project is unlocked, you will receive an email from donotreply@infonetica.net with instructions to submit the amendment. 3. Click on Section A: Amendment Details. Complete this page as well as the relevant sections of the form you wish to make changes to. Changes should be made directly to text fields. Changes to documents should be made using track changes and uploaded in the relevant sections of the form with a new date and version. Delete any previous versions. 4. Once you have amended all relevant sections of the form, click submit.

How do I request a time extension?

Applications for time extension (maximum for 12 months) must be submitted before the end date of approval and can be submitted only once unless there are extenuating circumstances. 1. Log into ERM and select the project you wish to extend. 2. Click the ‘Correspond’ button to send a message to the office requesting that the project is unlocked for a time extension. When your project is unlocked, you will receive an email from donotreply@infonetica.net with instructions to submit the amendment. 3. Complete Section A: Amendment Details. Ensure you describe why the time extension is necessary and any animal welfare impacts. 4. Once you have amended all relevant sections of the form, click submit.

Where can I find resources to help me prepare my ERM application?

Information including flowcharts to determine Dealing Type, and an example application can be found at: https://www.intranet.monash/research-ethics-integrity/gene-technology/gt-at-monashuni/gt-projects

How do I obtain a copy of my approval certificate?

When your Gene Technology Project has been approved by the IBC, you will receive an email informing as such - The approval certificate will be attached to this email. Alternatively, log into ERM, access the relevant Project, and under the “History” tab within the project, look for the description “Notification received: Your application has been approved” and click “Download” to download the approval certificate. If you do not see this option under the “History” tab, ensure that you are on the ‘Approved’ submission of the form rather than older submissions that required changes to be made, by clicking on the “Submission” tab and selecting the ‘Approved’ submission. Then, access the “History” tab again. If the above two options do not work, contact the MUIBC Secretary on gene.technology@monash.edu.

When are the MUIBC meetings?

The MUIBC meets quarterly to discuss matters pertaining to gene technology and the OGTR. Applications are not reviewed at these meetings and are instead, reviewed on a rolling basis, entirely through ERM. This means that you need not wait till a meeting is held for your application to be reviewed.

How long will it take to obtain approval from the MUIBC?

All Gene Technology Project applications are assessed by the Monash University IBC on a rolling basis. The review period is generally 2 weeks*, starting from the point the application is assigned to the MUIBC for review. Should there be no further information required for assessment, approval will be granted within or directly after the 2 week review period. *Note that IBC members are predominantly academics who volunteer their time, so during busy periods (e.g. grant-writing season) or during common periods of annual leave (e.g. school holidays, Christmas holidays), the review period may be longer than 2 weeks.

How do I submit an amendment?

Refer to https://www.intranet.monash/research-ethics-integrity/gene-technology/gt-at-monashuni/gt-projects/gt-projectsamd

How do I request for a time extension to address MUIBC comments?

If an extension is required, please contact the MUIBC Secretary on gene.technology@monash.edu.

Is there an online gene technology training module?

Yes, the Biosafety 2 online training module that covers Gene Technology and Biosecurity topics is now available through myDevelopment. This course is essential for all staff and students undertaking research utilising gene technology or working within OGTR-certified facilities and can be accessed via the HR & employment tab in your my.Monash portal.