Frequently Asked Questions

How do I create an application?

1. Login to ERM. 2. Click the ‘Create Project’ tile on the left-hand side of the screen, located under the actions bar. 3. From the ‘Main Form’ drop down list, select the relevant form. 4. Enter the 'Project Title' and click the green ‘create’ button. Please note that the system takes a few moments to create a Project ID. 5. Click on the first section of the navigation area to begin. 6. 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. 7. Once all fields of the form are completed, click ‘Submit’ to submit your application for review.

Why am I seeing the message "Note: There is a newer version of the project (Please contact the project owner to update this form)"?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 occasionally release new versions of the forms to fix issues and make improvements that have been identified. Only the project owner of the application can accept the newer versions of the forms. By accepting the update, it ensures that the forms you are completing are the latest release. TIPS 1. When you update a form, all saved information will not be lost 2. Any electronic signatures on 'un-submitted' forms will be lost 3. Updating forms does not affect submitted forms

How do I grant project team members access to my application?

Project team members can be granted access to ethics applications via the roles or share actions available. The differences between roles and sharing are: Roles: assigns pre-defined access to project team members (you can select the pre-defined access you wish to grant i.e. read only, read and write). Once this access is granted on the main ethics application form it automatically cascades to any associated sub-forms. Roles can only be granted on the main ethics application form by the form owner. Share: assigns access permissions you set up and grant. Sharing a main ethics application form does not automatically grant access to other sub-forms and is required to be set up individually for each new sub-form. To grant access to the project via the roles functionality (only available to the form owner): 1. Login to ERM 2. Click on the project you would like to share 3. Click on the roles tile 4. In the collaborator email enter the email address of the person with whom you would like to share the project 5. In the drop-down list available selected the pre-defined permissions you would like to grant 6. Click the green plus icon to add additional people and repeat the above steps 7. Click share role 8. An email will be sent to the collaborator and they will be able to view the item in their work area To grant access to a project via the share functionality: 1. Login to ERM. 2. Click on the project you would like to share. 3. Click on the share tile on the left-hand side of the screen, located under the Actions bar. 4. In collaborator email enter the email address of the person with whom you would like to share the project. 5. Tick the relevant access permissions you would like to grant. 6. Click the green plus icon to add additional people and repeat the above steps. 7. Click share. 8. An email will be sent to the collaborator and they will be able to view the item in their work area. Once access has been granted via the roles or share functionality the permissions can be modified by clicking on the collaborators tab. If I have shared my project already, do I need to use roles? If you have already shared your project, then you do not need to use roles. Consider whether roles or share would work better for the needs of your project team. See what is the difference between roles and sharing for further guidance.

If I have shared my project already, do I need to use roles?

If you have already shared your project, then you do not need to use roles. Consider whether roles or share would work better for the needs of your project team. See what is the difference between roles and sharing for further guidance.

What is the difference between roles and sharing

Project team members can be granted access to ethics applications via the roles or share actions available. The differences between roles and sharing are: Roles: assigns pre-defined access to project team members (you can select the pre-defined access you wish to grant i.e. read only, read and write). Once this access is granted on the main ethics application form it automatically cascades to any associated sub-forms. Roles can only be granted on the main ethics application form by the form owner. Share: assigns access permissions you set up and grant. Sharing a main ethics application form does not automatically grant access to other sub-forms and is required to be set up individually for each new sub-form.

How to I update access permissions?

1. Login to ERM. 2. Click on the project you would like to update. 3. Click on the ‘Collaborators’ tab in the middle of the page. 4. Click the ‘Edit Permissions’ for the appropriate individual and tick/untick the permissions as required. 5. Click ‘Save’.

How do I request a signature?

1) To request a signature, click the ‘request signature’ button available in the declarations section of the form 2) An email notification will be sent to the signee 3) Once the form has been signed you will be notified via email 4) If the signature request has been declined, you will receive an email 5) The form will be automatically submitted upon signing

How do I action a signature request?

1) Once a user has requested a signature an email notification will be sent to the signee 2) Click on the link available in the signature request email 3) Click on ‘view form’ in the list of signature requests to action the item 4) Once the form has been viewed click either ‘sign’ or ‘reject’ in the actions panel to the left-hand side of the screen 5) You will be prompted to re-enter your login credentials to sign or reject the form 6) Once you have signed or rejected the form a green banner will appear on the top of the page advising that the action has been performed successfully 7) The form will be automatically submitted upon signing

How do I submit a progress report, adverse event or other documentation?

Reports are submitted as sub-forms in ERM. To submit a report: 1. Login to ERM. 2. Select the relevant project. 3. Select the ‘Create Sub-form’ 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, followed by the green ‘Create’ button. 5. Click on ‘Start Here’. 6. Complete the questions on the form as required. 7. Click ‘Submit’ from the ‘Actions’ panel on the left-hand side. Please note that the ‘Submit’ button will not be visible if there is a red warning at the top of the page. In this case, contact the project owner 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 import an application I have already done in https://hrea.gov.au/ to ERM?

If you have completed your HREA on hrea.gov.au to completion. The option to 'Generate HREA Document' is available. Click on this and then 'download' your submission, choosing the ‘All application forms and attachments (.zip)’ option. The application and any attachments will be provided to you in a zip file, which will include an XML file. You can import your XML file into the new application you create in ERM. The details on how to do this are within the ERM application form. Please note: the other attachments in the zip file, such as protocol etc. will not automatically be imported to the new application in ERM.

How do I add a UTAS investigator not coming up in the 'search user' field?

New University of Tasmania (UTAS) staff and students will need to activate their ERM profile. This can be done by logging in to ERM. Once activated they can be added to a submission and forms can be shared or transferred.

Why can I not see the application, if I am named on it?

Because the form owner has not shared it with you. Sharing a form enables others to view/edit the same form depending on the level of access they are given. Please contact the form owner and ask them to share the project with you and assign your permissions. The form owner is person who created the form.

How to add an external researcher who isn't appearing in the "search user" field?

If you are a non-University of Tasmania investigator (external), an account will need to be created for you. Please e-mail your full name, your e-mail address and your organisation to online.ethics@utas.edu.au. You can log in to ERM when you have received notification that your account has been created.

Do I need signatures from all investigators or Head of School/Department?

The Chief Investigator/Responsible Investigator is required to sign submissions. In signing, the Chief Investigator/Responsible Investigator is acknowledging that appropriate training, certification and other research governance activities have been completed as required. Signatures of the research team members and Head of School/Department are no longer required. Please note that some forms i.e. safety reporting will allow for a nominated person to sign on behalf of the Chief Investigator/Responsible Investigator.

Do I have to use the new Ethics Research Management System?

All submissions must now be submitted via the Ethics Review Manager (ERM) website. This includes new project submissions and all post approval activity. 1. Please log in to the ERM. 2. Complete the online application. 3. Upload all supporting documentation.

Can a student investigator submit an ethics application?

No. The University of Tasmania (UTAS) supervisor is the Chief Investigator (CI) responsible for the research. The CI should log in to 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 access to the project.

Can I add external investigators to my project and share the application with them?

Yes, you can list external investigators on your ethics application.

Can I create an application if I am not the Chief Investigator?

We recommend that the Chief Investigator/Responsible Investigator create the form in the first instance. After that the Chief Investigator/Responsible Investigator can share the form and manage access permissions i.e. read, write, edit, submit etc. Please note that until a form is shared it will not be visible to other project team members. Please see the FAQ ‘How do I share an application?’

How do I transfer an application?

1. Click on ‘Home’ to view your Work Area (home page). 2. Click on the ‘Transfer’ tile on the left-hand side of the screen. 3. Enter the email address of the new owner (Chief Investigator) and if required, a message for the new owner. 4. Select the project from the list and then click ‘Transfer’. 5. An email will be sent to the new owner (Chief Investigator). They will need to log in to ERM, click on the project to view it, and then click the tile ‘Accept Transfer’ underneath the Actions panel on the left-hand side of the screen. 6. Once the Chief Investigator accepts the transfer the initial applicant will lose all access to it. As the Project Owner, the Chief Investigator will then need to 'share' the application with them again, giving them the required permissions (read, write, submit, notifications, etc.). NOTE: The transfer button is only visible from your ERM home page (not within the application). Click on the ‘Home’ button, you will then see the ‘Transfer’ button on the left-hand side.

How do I know which meeting my application / amendment is being considered at?

Meeting dates and deadlines for all UTAS ethics committees are available on the UTAS Research Integrity and Ethics Website. You will receive an email to advise you which meeting your submission has been assigned to. You will receive feedback on the outcome of your submission within approximately 7 working days from the meeting.

Will I be notified when applications are approved?

Yes, you will receive an email notification from donotreply@infonetica.net within approximately 7 working days from the committee meeting at which your application was considered. Please note that this email is outgoing only.

Do I need to save my work in ERM?

It is recommended to ‘Save’ your answers in your application as you go to minimise loss of content. However, the system automatically saves new information entered each time you move to a new section, or when you click ‘Next’ or ‘Navigate’ under the Actions panel.

How can I duplicate my application?

Most information can be easily copied to a new application via the following process: 1. Login to ERM. 2. Select the ‘Duplicate Project’ tile on left-hand side of the screen. 3. Select the relevant project from the drop-down list. 4. Enter a new title in the second text field. 5. Click the green ‘Duplicate’ button. 6. Update the new title. 7. You will need to upload any documents/attachments. Please note: legacy data applications may need updating where questions on previous forms are no longer consistent with the new online form.

Do I need to print a copy of my application?

No, the ERM is designed to store all information electronically so applicants and reviewers don’t need to print them. To reduce waste, printing of hard copies is discouraged.

Can I delete my project?

Yes, 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.

If I submit the wrong sub-from i.e report form, what do I do?

If you submit the wrong sub-form, for example: a progress report instead of an extension report. Please contact the Ethics Executive Officer and they can withdraw the form, then you can resubmit the appropriate form. Please note: the withdrawn form will still show in the project tree however it will be archived in ERM.

How do I get help using ERM?

There are a number of support materials, including Frequently Asked Questions, Fact Sheets and Navigation Guides located on the ERM website, www.utas.edu.au/research-admin/research-integrity-and-ethics-unit-rieu/erm, which can also be found on the RIEU home page. Alternatively, you can e-mail online.ethics@utas.edu.au which is managed by the RIEU. Please note that as ERM can be used anywhere (with internet access) at any time of day, the RIEU will not be able to provide moment-in-time support.

How do I contact the office for support?

1. Login to ERM. 2. Click on the relevant project. 3. Click on the ‘Correspond’ tile on the left-hand side of the screen, located under the Actions bar. 4. Enter your message in the free-text box provided. 5. If you wish to upload any files, click ‘Browse’, select the document, and click ‘Open’. 6. Click ‘Send’.

Why am I seeing a yellow exclamation mark in my form?

When a member of the project team is in the same question of a form as another member, a yellow exclamation mark will appear. By hovering over the exclamation mark the name of the other project team member in the form will appear. This helps teams to identify if a form question is being edited/viewed at the same time.

How do I check the status of my submission

1. Login to ERM. 2. Click on the relevant project. 3. Click on the relevant form. 4. Check the 'form status', which appears under the project tree. 5. The 'form status' will reflect the current status of the submission.

How do I insert or upload a photo or image?

Please note that the text boxes available do not accept images. To include an image, diagram or photo please upload it where there is an option to upload documentation or additional information in the form.

What has happened to my existing applications / previous submissions (prior to January 2020)?

Applications already submitted to the ethics office prior to 31 January 2020, and those that already have ethics approval will come across into ERM as a Minimal Data Form (MDF). The MDF will not reflect the application that was reviewed and approved by the Ethics Committee as it will not show the actual application answers and information. However, it will be used as an anchor to submit items such as amendments, annual reports, adverse events etc. Please note that you will not be able to change any details on the MDF.

How do I submit my revised application/form and responses to the Ethics Committee feedback?

Applications submitted but not approved by 31 January 2020 were on paper-based forms, therefore only basic information about the project and investigators has been copied over into the system. This information sits in a Migrated Data Form (MDF) for your project and is visible to you. The MDF is used as an anchor to add the revised application and ongoing sub-forms. As of 12 February 2020 you are able access ERM. 1. Login to ERM and search for the relevant project by using the title or the ethics reference number. 2. Click on the ‘Project title’ which will take you to the main MDF. 3. Click on the action ‘Create Sub-form’ which is located on the left-hand side. 4. From the drop-down menu select the form titled ‘Human/Animal Ethics Revision – Provisional’. 5. Click on the section ‘Start Here – Introduction’ which is highlighted in blue. 6. Complete the form. 7. Click on the action ‘Submit’ which is located on the left-hand side. 8. You will receive a response via email and via the ‘Notifications’ action on the home page.

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

Applications approved prior to ERM were on paper-based forms, therefore only basic information about the project and investigators has been copied over into the system. This information sits in a Migrated Data Form (MDF) for your project and is visible to you. To submit an Amendment to a migrated approved application: 1. Login into ERM and open the relevant project. 2. Click on the ‘Create Sub-form’ tile on the left-hand side of the screen and select ‘Animal or Human Ethics Amendment - Provisional’ form. 3. Answer all questions and upload any relevant documentation using tracked changes, underline or bold to identify any changes made. This will avoid any delays in assessment. 4. Click ‘Submit’ to forward your amendment(s) to the ethics office for review. Please note that the ‘Submit’ button will not be visible if there is a red warning at the top of the page. In this case, contact the Responsible 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.

What important information should I be familiar with?

Applicants must be familiar with the Australian Code for the care and use of animals for scientific purposes (“the Code” 8th edition, 2013 NHMRC). It is recommended that the Code be accessed directly from the NHMRC website to view the most recent version. The RIEU website contains further information on local Animal Ethics requirements.

How do I submit a revised application, amendment, report or UAE?

To submit revisions for an ERM submission please: 1) Login to ERM 2) Click on the project you want to submit revisions for in your ERM work area 3) Click on the form you wish to revise 4) The form status will indicate that revisions are required and you will see 'reviewer comments' available in the left hand side of the screen under 'actions'. The form will be unlocked for editing. 5) By clicking on 'reviewer comments' you can view and navigate to the AEC's queries and/or requests for clarification. 6) Update the sections in line with the requests (the changes are tracked for the reviewers, but, this is not visible to applicants) 7) Once all revision requirements have been addressed please 'sign' and 'submit'

How do I submit an amendment for a project created in ERM ?

1. Login to ERM and open the relevant project. 2. Click on the ‘Create Sub-form’ tile on the left-hand side of the screen. 3. Select the ‘Ethics Amendment Request’. This will send a notification to the ethics office and they will unlock your application so you may make changes. 4. You will receive notification when your project is unlocked by the office. Please note that requests to unlock your form will only occur within standard business hours of 9am-5pm Monday to Friday. 5. Go to Section 1 of your application and click on ‘Start here - Introduction & Acknowledgements’. 6. Select ‘Amendment (for approved application)’. This will open the 'Modification' section of the application, enabling you to modify the relevant sections of your project. 7. Changes to any uploaded documents should be done using track changes. 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 ethics office for review. Please note that the ‘Submit’ button will not be visible if there is a red warning at the top of the page. In this case, contact the Responsible 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.

Do I need to report an Unexpected Adverse Event (UAE)?

Yes, the University of Tasmania Veterinarian is to be promptly notified of any unexpected adverse events. 1. Log into ERM and select the project you are required to report the UAE against 2. Select the "Create Sub-form" from the "Actions" panel on the left hand side. You must have permission to "Create all sub forms" to see this button 3. Choose the sub-form 'AEC Adverse Event" 4. Complete all sections and click submit. If the adverse events were detailed in the application expected as part of the project, and approved by the AEC, they do not need to be reported unless the rate of occurrence exceeds that which was expected.

Can I conduct research 'outside' of UTAS?

Yes, you will be required to submit an AEC Notification of External Research in ERM. 1. Log into ERM 3. Choose the sub-form 'AEC Notification of External Research" 4. Complete all sections and click submit.

Can an approved research project be suspended or withdrawn?

Yes, the University of Tasmania may suspend or withdraw approval for animal research where it is reasonable to believe that continuation of the research project may compromise animal welfare.

Do I need to report animal usuage numbers?

Yes, animal usage numbers are collected in compliance with Section 35 of the Animal Welfare Act 1993 which requires each licensed instituation to provide an annual report to the Tasmanian State Government on the animals used in research. In accordance with the Act, the report is to contain the numbers and types of animals used and the types of animal research carried out. The reporting of animals is based on the calendar year (1 Jan - 31 Dec) and numbers will be required to be submitted annually. UTAS also reports to other Commonwealth, state and territory bodies on animal ethics- related matters, as required

Can I request an extension for my project?

Yes, but only twice per application. Extensions are granted for one-year periods only, from the anniversary of the original ethics approval date. 1. Log into ERM and select the project you wish to extend. 2. Select the "Create Sub-form" from the "Actions" panel on the left hand side. You must have permission to "Create all sub forms" to see this button 3. Choose the sub-form 'AEC Extension Report" 4. Complete all sections and click submit.

Do I need approval for conducting procedures on or with animals?

It is a legal requirement that in the case of certain surgical procedures, researchers MUST be assessed as competent by the University Veterinarian. This is in accordance with the Tasmanian Veterinary Surgeons Act 2012. It is the responsibility of researchers to contact the University Veterinarian Team to arrange for an assessment at University.Veterinarian@utas.edu.au

Can animals be rehomed at the conclusion of the approved project?

Yes, this would need to be processed and approved by the Animal Ethics Committee

How do I complete Animal Ethics Training?

Animal Ethics Training is done through ANZCCART ComPass. https://anzccart.adelaide.edu.au/compass This free online course covers the Australian Code and NZ Guide and welfare issues relating to animal use in research and teaching. Successful completion of the Phase one of the course and its quiz fulfills the mandated basic training needs of researchers and teachers using animals as well as members of Animal Ethics Committees (AEC) in Australia and NZ Once completed, please submit the training certificate via ERM. This is done by 'creating a project' and selecting 'AEC Training Certificate', 'save' the details and 'submit' for noting.

Can I submit a project already approved by another ethics committee?

Yes. The Tasmania Human Ethics Committee (HREC) Tasmania Network does not presently participate in the National Mutual Acceptance Scheme, however, UTAS provides a prior approval application pathway in accordance with the National Statement on Ethical Conduct in Human Research 2007 (updated 2018). This minimises the unnecessary duplication of ethical review. 1. Login to ERM. 2. Select the ‘Create Project’ tile on left-hand side of the screen. 3. Enter ‘Project Title’ details. 4. Select the ‘Human Ethics Prior Approval’ form. 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 project created in ERM?

1. Login to ERM and open the relevant project. 2. Click on the ‘Create Sub-form’ tile in the action menu (on the left-hand side of the screen). 3. Select the ‘Ethics Amendment Request’ from the drop down list, click 'create' and then click on the 'submit' tile in the action menu. This will send a notification to the ethics office and they will unlock your application so you may make changes. 4. You will receive notification when your project is unlocked by the office. Please note that requests to unlock your form will only occur within standard business hours of 9am-5pm Monday to Friday. 5. Go to Section 1 of your application and click on ‘Start here - Select New Application or Amendment’. 6. Select ‘Amendment (for approved application)’. This will open ‘Section 2 - Amendment Details’ of the application, enabling you to modify the relevant sections of your project. 7. Changes to documents should be done using track changes. Revised documents (both tracked and clean versions) 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 ethics office for review. Please note that 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?

Applications approved prior to ERM were on paper-based forms, therefore only basic information about the project and investigators has been copied over into the system. This information sits in a Migrated Data Form (MDF) for your project and is visible to you. To submit an Amendment to a migrated approved application: 1. Login into ERM and open the relevant project. 2. Click on the ‘Create Sub-form’ tile on the left-hand side of the screen and select ‘Human Ethics Amendment - Provisional’ form. 3. Answer all questions and upload any relevant documentation using tracked changes, underline or bold to identify any changes made. This will avoid any delays in assessment. 4. Click ‘Submit’ to forward your amendment(s) to the ethics office for review. Please note that 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 a revised application, amendment, report or SAE?

To submit revisions for an ERM submission please: 1) Login to ERM 2) Click on the project you want to submit revisions for in your ERM work area 3) Click on the form you wish to revise 4) The form status will indicate that revisions are required and you will see 'reviewer comments' available in the left hand side of the screen under 'actions'. The form will be unlocked for editing. 5) By clicking on 'reviewer comments' you can view and navigate to the queries and/or requests for clarification. 6) Update the sections in line with the requests (the changes are tracked for the reviewers, but, this is not visible to applicants) 7) Once all revision requirements have been addressed please 'sign' and 'submit'

When are the Committee meeting and submission dates?

The HREC meet weekly, except between mid-December and mid-January. There are no deadlines for submission. Please note that if your application requires resubmission back to the committee for review, you will be advised of a deadline date.

What level of review will my application require?

Applications that fall under the remit of the guidelines approved under Section 95 and/or Section 95A of the Privacy Act 1988, will require review by the nominated Human Research Ethics Committee (HREC) at the next available meeting. Applications that request a 'Waiver of Consent' to use personal information in medical research, or personal health information, will require review by the nominated HREC at the next available meeting. For a Prior Approval application: As your application already has approval from an NHMRC registered Australian HREC, it will now proceed directly to the Chair of the nominated Human Research Ethics Committee (HREC) for consideration. Information regarding Social Sciences HREC applications only: For a Minimal Risk application: Your application will now be reviewed out of session by the Chair of the Social Sciences Human Research Ethics Committee (SSHREC). For a Full application: Your application will now be reviewed by the Social Sciences Human Research Ethics Committee (SSHREC) at the next available meeting. Information regarding Health and Medical HREC applications only: For a Low Risk application: Your application will now be reviewed out of session by the Chair of the Tasmanian Scientific Research Advisory Committee (TSRAC) and, once endorsed, will proceed to the Chair of the Health and Medical Human Research Ethics Committee (HMHREC) for final approval. For a General Medical application: Your application will now be considered by the Tasmanian Scientific Research Advisory Committee (TSRAC) unless you have also applied for exemption from TSRAC review. Once endorsed, it will proceed to the Health and Medical Human Research Ethics Committee (HMHREC) for final approval. For a Clinical Trial application: Your application will now be considered by the Tasmanian Scientific Research Advisory Committee (TSRAC) unless you have also applied for exemption from TSRAC review. Once endorsed, it will proceed to the Health and Medical Human Research Ethics Committee (HMHREC) for final approval. Clinical Trials with UTAS as a site and/or sponsor will also require a Clinical Trials Governance application to be submitted. Information can be found here: http://www.utas.edu.au/research-admin/research-integrity-and-ethics-unit-rieu/clinical-trial-governance or contact clinical.trials@utas.edu.au for further information.

How do I assess the level of risk?

We have guidance notes available in ERM to assist you in assessing the level of risk for your research. Under the 'Help Tab' select ‘Templates’. Download the document ‘Human Ethics - How to Assess the Level of Risk’.

Do I have to submit a Protocol/Project Description with a low risk application?

Yes, it is mandatory to submit a Protocol/Project Description for all human ethics application submissions. We provide a great Protocol/Project Description template in ERM that can be used for all human ethics applications. Under the 'Help Tab' select ‘Templates’. Download the document ‘Human Ethics – Protocol/Project Description Template’.

How do I submit a protocol deviation?

1. Login to ERM. 2. Select the relevant project. 3. Select the ‘Create Sub-form’ 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 Human Ethics Protocol Deviation Form – Provisional, followed by the green ‘Create’ button. 5. Click on ‘Start Here’. 6. Complete the questions on the form as required. 7. Click ‘Submit’ from the ‘Actions’ panel on the left-hand side.

Why isn’t my HREA submitting when I have signed the form?

We only accept electronic signatures for the HREA. If you have selected ‘upload other evidence’ or ‘wet ink sign after printing’ you will be prevented from submitting the form. Please update the selection to ‘electronic signature’ and ‘sign’ or ‘request signature’ to progress the application. Once the form has been electronically signed it will automatically submit. We are in consultation with the vendor to update this section of the HREA so only ‘electronic signature’ is available as an option.

How do I know if I am doing a Clinical Trial?

What is a Clinical Trial? A clinical trial is a research investigation in which people volunteer to test new treatments, interventions or tests as a means to prevent, detect, treat or manage various diseases or medical conditions. Some investigations look at how people respond to a new intervention* and what side effects might occur. This helps to determine if a new intervention works, if it is safe, and if it is better than the interventions that are already available. A clinical trial might also compare existing interventions, test new ways to use or combine existing interventions or observe how people respond to other factors that might affect their health (such as dietary changes). The World Health Organization (WHO) definition for a clinical trial is: 'any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes'. Clinical trial interventions include but are not restricted to: experimental drugs; cells and other biological products; vaccines; medical devices; surgical and other medical treatments and procedures; psychotherapeutic and behavioural therapies; health service changes; preventive care strategies; and educational interventions. Researchers may also conduct clinical trials to evaluate diagnostic or screening tests and new ways to detect and treat disease. *The word 'intervention' is used to refer to interventions, treatments and tests throughout this website. For assistance determining whether your research project is a clinical trial, please refer to the 'What is a clinical trial' decision aid provided in 'Templates' under the 'Help Tab'. For more information please go here: to https://universitytasmania.sharepoint.com/:u:/r/sites/research-division/SitePages/Clinical-Trial-Governance.aspx?csf=1&web=1&e=wR7PXz#frequently-asked-questions

How do I apply for Clinical Trial Authorisation at the University of Tasmania?

If your project is a clinical trial, the next step is to determine what role the University of Tasmania is playing. A clinical trial sponsor is defined as the organisation that takes responsibility for the initiation, management and/or financing of a clinical trial. The University of Tasmania can play one of four roles in a clinical trial: - Human Research Ethics Committee review only - Clinical Trial Sponsor - Clinical Trial Site - Clinical Trial Sponsor and Site For more information please refer to the University of Tasmania, Clinical Trial Governance webpage. https://universitytasmania.sharepoint.com/sites/research-division/SitePages/Clinical-Trial-Authorisation-Process.aspx Email: Clinical.Trials@utas.edu.au

What form(s) do I use for Clinical Trial Safety Reporting?

Please refer to - Human Ethics Safety Reporting for Clinical Trials & Form Use, located within 'Templates' under the 'Help Tab'.