Help
Ethics Review Manager (ERM) is used at QUT for Animal Ethics, Biosafety, Human Ethics, applications.
Log in to https://ethics-forms.research.qut.edu.au using your QUT SSO(Single Sign-On) Digital Workplace credentials.
External access is granted by the system administrator via email at ethics.sysadmin@qut.edu.au
Please use Google Chrome for a better
| Click this Link to Add ERM to you
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Navigate to the relevant section by keyword search using CTRL+F
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Log into ERM for QUT Staff and Students
For QUT users, you can access ERM from either:
via the Digital Workplace using single sign on (SSO). https://qutvirtual4.qut.edu.au/group/staff/home
Or: to access ERM directly please use the following link to login https://ethics-forms.research.qut.edu.au/
If you are having trouble logging onto the QUT Digital Workplace, please contact QUT IT Support on 07 3138 2000 for them to verify your details and provide you with login credentials.
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Edit Personal Details
N.B. Please be aware that any existing applications submitted for review in ERM are locked from change and will not automatically be updated with any changed or edited user details.
For existing forms to be amended the form will need to be unlocked via your committees variation process.
- Log into ERM - https://ethics-forms.research.qut.edu.au
- Select your name in the top right hand search bar and then select “Personal Details”
- Change the value in the fields as necessary and then scroll down and select “Change Details”
Your updated details will now be populated when adding a new contact on a form.
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Organising the work area
Creating and Deleting Folders
From your Work Area select “Create Folder” and follow the prompts to “Create”
Moving Projects
Move the Project to that new folder by selecting “Move Project” and follow the prompts to successfully move the project
Deleting Projects
Only Projects that have NOT been submitted can be deleted in ERM
Delete a project by selecting "Delete Project" and follow the prompts to successfully delete the project.
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Sharing a Project
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 don’t have to do anything as any previous permission you have given to a user via the Share function will now have the most appropriate role applied.
Please see below for adding/removing existing Roles that have been applied.
Now instead of using the “Share” button
The new “Roles” button is available
| Role Name | Permissions included |
| Read | Read |
| Read (Receive Notifications) | Read, Receive notifications |
| All Permissions (Not Submit) | Read, Write, Share, Create all sub forms, Receive notifications |
| All Permissions (Submit) | Read, Write, Submit, Share, Create all sub forms, Receive notifications |
You can see what permissions a collaborator has under the “Collaborators” tab in your project Timeline.
Sharing/Adding Roles
The following are example screenshots from our test system with no real live data shown
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.
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Responding to Reviewer comments in ERM
"How do I respond to reviewer comments and feedback, and resubmit my application?"
After you have submitted your application, it will go through a review process as it progresses through to approval.
During this process reviewers may make comments or ask questions about your application.
All of these are managed within ERM. There are three ways you can access your reviewer comments in ERM.
Follow the below steps to respond to reviewer comments
a) Open Ethics Review Manager and find the research project that you need to respond to; or
b) Click on the Notifications box in your ‘Work Area’, this will take you to the messages (ERM’s inbox).
Clicking on the message will take you directly to the form (this is useful when you have more than one application in progress)
c) Click on the message, then View Form in the pop-up; or
d) Click on the link provided in the system-generated notification email you receive advising you have
comments to respond to for your application.
e) Once you have completed one of the above (a, b or c) – follow the below steps to respond to comments.
f) From the Actions panel, click the ‘Reviewer Comments’ tile.
g) A panel titled ‘Overall Reviewer Panel Comments’ will open; you are able to view each of the comments that have been
made by the reviewer and which question in the application form the comment relates to.
h) To view the comment, click on the comment under the column titled ‘Comment’ – this takes you to the relevant question in your application.
ERM will outline the question in red to make it clear which question in the form the comment is referring to. Follow the same process for each of the comments. Once all
questions have been answered you can perform a completeness check and resubmit your application.
i) Click on the ‘Submit’ tile in the Actions panel.
j) Your application will be reviewed, and you will be notified when your application is approved
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Signing and Managing Signatures
Overview
The main application forms in ERM require a two step “Sign” then “Submit” process in order successfully submit your application for review and approval.
Also, some sub forms may also require signing before submission.
The “Sign” or “Request Signature” actions for Applicants can be found within a form wherever you see the blue buttons.
Accepting/Declining Signature requests for Supervisors/Chief Investigators is done via the:
- “Signatures” Tile in your Work Area
- Select “View Form” on the right-hand side of the outstanding signature request you need to sign
- then the “Sign” button in the top left-hand corner of the screen when reviewing a form.
Locked though signatures/requests
Once a form has been Signed or a Signature request sent, it is locked from any further changes ready for signing and submission.
To unlock the form, invalidate the signature, then make further changes to your application:
- Login to ERM - https://ethics-forms.research.qut.edu.au/
- Select the application from your ERM Work Area
- Select any section in the form to open it
- Select “Unlock” on the top left-hand corner and follow the prompts to invalidate the CI signature and unlock the form.
From there you can:
- Make the changes necessary in the form
- Sign as the Supervisor/Chief Investigator or request a Signature from the Supervisor/Chief Investigator (This locks the form again form any changes ready for submission)
- When signed, the “Submit” button will now allow you to submit the application to/back for review.
You can then expect a system generated email from ERM confirming the successfully submission of your application.
Sign as the Supervisor/Chief Investigator when completing an Application
It’s quick and easy to sign an Application as the Supervisor/Chief Investigator and then submit, here are some steps to walk you through it:
The following are example screenshots from our test system with no real live data shown (example “Human ethics low risk application”, other forms will vary)
- Login to ERM - https://ethics-forms.research.qut.edu.au/
- Select your application from the Work area by clicking on the title
- Navigate to the declaration section of the form
- Select the blue “Sign” button form the signatures section
- Confirm by selecting “Sign” and following the prompts (This locks the form again form any changes ready for submission)
- When signed the “Submit” button will allow you to submit the application to/back for review.
You can then expect a system generated email from ERM confirming the successfully submission of your application.
Request a Signature to the Supervisor/Chief Investigator
It’s quick and easy to Request a signature of the Supervisor/Chief Investigator, here are some steps to walk you through it:
The following are example screenshots from our test system with no real live data shown (example “Human ethics low risk application”, other forms will vary)
- Login to ERM - https://ethics-forms.research.qut.edu.au/
- Select your application from the Work area by clicking on the title
- Navigate to the section of the form
- Select the blue “Request Signature” button form the signatures section
- Search for your Supervisor/Chief Investigator by their QUT email address and enter an optional message for them to receive
(Once you have successfully requested a signature to the CI will receive a system generated email from ERM
confirming the signature request has been sent) - The form will now be locked ready for signing by the requested Supervisor/Chief Investigator
- Once the form is signed by the Supervisor/Chief Investigator (you will then receive another system generated email from ERM confirming the form has been signed and is ready for Submission)
- You will then need to “Submit” the form for Review.
You can then expect a system generated email from ERM confirming the successfully submission of your application.
Accepting/Signing a signature request as the Supervisor/Chief Investigator
For the Supervisor/Chief Investigator to accept the signature request:
- Login to ERM - https://ethics-forms.research.qut.edu.au/
- Select the “Signatures” tile in the top of your work area
- Select “View Form” to the right-hand side of the outstanding signature request you need to sign
- Select the “Sign” option in the top left-hand corner of the screen and follow the prompts to successfully “Accept” signing the form as the Supervisor/Chief Investigator
- Now the “Submit” button will be available to successfully submit the form for review
You can then expect a system generated email from ERM confirming the successful submission of the application.
Rejecting a signature request
For the Supervisor/Chief Investigator to reject the signature request and send it back to the applicant:
- Login to ERM - https://ethics-forms.research.qut.edu.au/
- Select the “Signatures” tile in the top of your work area
- Select “View Form” next to the outstanding signature request you have been requested to sign
- Select the “Reject” option in the Top left-hand corner of the screen and follow the prompts
You can then expect a system generated email from ERM confirming the rejection of the signature request.
Cancelling a signature request
For the applicant to cancel the signature request so they can request a new signature to a different Supervisor/Chief Investigator:
The following are example screenshots from our test system with no real live data shown (example “Human ethics low risk application”, other forms will vary)
- Login into ERM – https://ethics-forms.research.qut.edu.au/
- Select the application from your Work Area
- Select the “Signatures” tab
- Select “Cancel” on the right-hand side of the outstanding signature request and follow the prompts to unlock the form
Once you have successfully cancelled the signature request you will receive a system generated email from ERM confirming cancellation.
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Managing Signatures on a HREA application
The applicant has full control over who signs the form and it is decided by the following:
- What roles they assign to team members in the “Project Team” Section; and
- Whether or not they select “YES” on Q1.9.11 “Does this person have authorisation to sign the application on behalf of all members of the research team?” on the person in the “Project Team” Section
- Indicate which members must sign this application in the “Declaration” section
All signatures are then tracked on the “Declaration - CI/CPI/Lead Investigator” tab.
To change who signs the form the applicant needs to:
- Unlock the form if it is locked through Signature requests
- Remove the person/s from signing by
- Removing them from the “Project Team” Section; or
- Change their Role in the “Project Team” Section; or
- Change “Yes/No” on Q1.9.11 “Does this person have authorisation to sign the application on behalf of all members of the research team?” on the person under the “Project Team” Section: or
- Change “Indicate which members must sign this application” in the “Declaration” section.
- Then get all to sign again on the “Declaration - CI/CPI/Lead Investigator” tab.
- Once all have signed the form can be Submitted.
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Transferring a Project
There are two steps to
transferring a project in the event ownership needs to change in ERM.
- The current Project owner need to send a transfer request to another ERM user
- The requested User then needs to accept the Transfer
Send a project/s transfer request to another user
In the main work Area click on the transfer tile in the actions panel.
A pop-up dialogue box will open where you can enter the user’s email address and then select which project(s) you are transferring.
Accept/Reject a Transfer request
This next section will walk
through options available to you when you are the receiver of a transferred
application.
When someone transfers a project to you, it will appear on your
transfer tile in the main work
area.
Click on the transfer tile to open a list of transfer requests. Click on View project to open it. The project will be read only until it is accepted.
At this point you can either accept or reject the transfer.
Accepting a Transfer
A confirmation pop-up will appear. Click yes to accept the transfer.
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.
Rejecting a Transfer
A confirmation pop-up will appear. Click yes to reject the transfer.
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 by
email that sent the request.
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Updating a Project
n.b. Only Project owners can update a form
For Project Owners
- Select the Project from your QUT ERM login Work Area
- Select the “Update” option from the banner at the top of the page and follow the prompts
or;
For Collaborators that have had the Project shared with them by the Project Owner
- Select the Project from your QUT ERM login Work Area
- If you see this banner you will have to contact the project owner for them to update the project for you.
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Add documents to an unlocked Migrated Form
1. Navigate to the Project in your ERM login by
selecting the project from your Work Area
2. Select “Migration Form” from the Project overview page to open the form
3. Scroll to question 1.1 and select the blue “Upload Document” button and follow the prompts
4. When you are happy with all the changes select
the “Submit” button and follow the prompt to submit your application back to
the
Human ethics Advisory team for processing.
You can expect a system generated email confirming the submission.
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Amend the Title on a HREA form
These are the steps to change the title when you do have the HREA next unlocked for Variation:
1. Navigate to the Project Title in the form – by selecting the “Project Overview” Section
2. Make the change to the text in the text box titled “HREA Full Project Title”
3. Select "Save"
4. The change will now be visible in the Project title for you immediately.
Please be aware that the title change will not be visible immediately to the Reviewer until you then submit the HREA back for Review and Approval.
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Download the Human - Research Ethics Application kit
Select this LINK to download the Human - Research Ethics Application kit
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Submitting an annual/final human progress report
One of the standard conditions of approval is to complete an annual progress report. You will be sent a reminder each year on (or before) the anniversary of your project approval.
To submit a progress report follow the below steps.
1. Open Ethics Review Manager
2. Find and open the approved project that you wish to provide a progress report on.
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 do this.
4. Select 'Create sub‐form', and from the drop‐down list select Human Ethics Progress / Final Report” sub‐ form. Click the ‘Create’ button.
5. Answer the questions.
6. Once you have completed all the questions, you can perform a completeness check and submit your report.
7. Click on the ‘Submit’ tile
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Variations to migrated human ethics projects in ERM
What is a migrated project?
As part of the implementation of Ethics Review Manager (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 to the project to make a variation.
Making a variation is a two step process.
Step 1 - Make a “Variation Request” to unlock your form
a) Open Ethics Review Manager
b) Find and open the approved project that you wish to vary.
c) Check whether you need to update your form. If so, there will be a yellow banner across the top – and you should click “Update”.
d) Select 'Create sub-form', and then select the 'Human Ethics Variation Request' sub-form.
e) Answer the questions.
f) 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.
Step 2 - Submit the varied documents as attachments to your migrated form
a) Open Ethics Review Manager
b) Find and open the migrated project that you wish to vary. It should now be unlocked for editing.
c) Upload your documents to the migrated project in this first question:
d) Submit for review.
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 application for review, or
(b) confirmation of approval, in which case you can commence work
according to the conditions of that approval
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HREA Information (Source: NHMRC)
Further information about the HREA
Further information about the Human Research Ethics Application (HREA) is available on the NHMRC's website.
Human Research Ethics Committees
Human Research Ethics Committee (HRECs) play a central role in the Australian system of ethics oversight of research involving humans. HRECs review research proposals involving human participants to ensure that they are ethically acceptable and in accordance with relevant standards and guidelines.
There are approximately 200 HRECs in institutions and organisations across Australia. Many other countries have similar systems.
In undertaking this role, HRECs are guided by relevant standards. Standards include those in the National Statement on Ethical Conduct in Human Research (the National Statement) issued by NHMRC.
The National Statement sets out the requirements for the composition of an HREC and the relevant ethical principles and values by which research should be designed and conducted and to which HRECs should refer when reviewing research proposals. It also identifies requirements and responsibilities for:
- Institutions/organisations in establishing HRECs
- researchers in submitting research proposals to HRECs
- HRECs in considering and reaching decisions regarding these proposals and in monitoring the conduct of approved research.
In some circumstances HRECs charge fees for considering research application.
Further information on HRECs is available on NHMRC's website.
National Statement on Ethical Conduct in Human Research
The latest version of the National Statement on Ethical Conduct in Human Research (the National Statement) is available on NHMRC's website.
The National Statement consists of a series of guidelines made in accordance with the National Health and Medical Research Council Act 1992. It is intended for use by:
- any researcher conducting research with human participants;
- any member of an ethics review body reviewing that research;
- those involved in research governance; and
- potential research participants.
The National Statement is developed jointly by the National Health and Medical Research Council, the Australian Research Council and Universities Australia. It replaced the 1999 National Statement on Ethical Conduct in Research Involving Humans.
Compliance with the National Statement is a prerequisite for receipt of NHMRC funding.
Privacy Act Definition of Personal, Sensitive and Health Information
- Personal information is defined in the Privacy Act 1988 (Cth) as information or an opinion about an identified individual, or an individual who is reasonably identifiable:
- Whether the information or opinion is true or not; and
- Whether the information or opinion is recorded in a material form or not.
- Sensitive information is defined in the Privacy Act 1988 as:
- information or an opinion about an individual’s:
- racial or ethnic origin; or
- political opinions; or
- membership of a political association; or
- religious beliefs or affiliations; or
- philosophical beliefs; or
- membership of a professional or trade association; or
- membership of a trade union; or
- sexual orientation or practices; or
- criminal record; that is also personal information; or
- health information about an individual; or
- genetic information about an individual that is not otherwise health information; or
- biometric information that is to be used for the purpose of automated biometric verification or biometric identification; or
- biometric templates
- information or an opinion about an individual’s:
- Health information is defined in the Privacy Act 1988 as:
- information or an opinion about:
- the health, including an illness, disability or injury, (at any time) of an individual; or
- an individual’s expressed wishes about the future provision of health services to the individual; or
- a health service provided, or to be provided, to an individual; that is also personal information;
- other personal information collected to provide, or in providing, a health service to an individual;
- other personal information collected in connection with the donation, or intended donation, by an individual of his or her body parts, organs or body substances;
- genetic information about an individual in a form that is, or could be, predictive of the health of the individual or a genetic relative of the individual.
- information or an opinion about:
Project Description
Institutions and third-party providers are encouraged to use the text below if they are developing a Project Descriptions template.
Please note that:
- Inclusion of a Project Description is a mandatory component of a submission using the HREA.
- The purpose of a project description is to provide the scientific and academic background and context of a research project.
- The section headings below represent a sample structure for a project description with presentation of information about a research project that meets the needs of an ethics review body.
- Not all headings or sub-headings below are relevant for each research project.
- Submissions of clinical trial proposals may use alternative protocol templates, such as the SPIRIT statement.
- Researchers may choose to submit an existing document (such as a protocol or project description that has already been developed) instead of developing a new document.
- If researchers choose to submit an existing document instead of using the templates provided, they may need to provide indications to the ethics review body of where in the submitted document the content corresponding to the relevant fields in the template are located.
- There is no need to duplicate information included in the HREA in the Project Description or vice versa.
- Language that is understandable to non-technical reviewers should be used.
Researchers are strongly encouraged to address the following headings in their Project Description. Each dot point provides an example of the information that researchers might want to include, if relevant to their project.
Title
- Acronym (if appropriate)
- Version number
Project Team Roles & Responsibilities
- Names, affiliations, positions and responsibilities of investigators and other key project team members (as required in addition to that outlined in the HREA).
- Identification of research sites or collaborating/contributing services or individuals not otherwise included in the HREA.
Resources
- Resources necessary for the project to be conducted.
- Funding/support being sought or secured.
Background
- Literature review
- Rationale/justification (i.e. how the research will fill any gaps, contribute to the field of research or contribute to existing or improved practice)
- Research questions/aims/objectives/hypothesis
- Expected outcomes
Project Design
- Research project setting (physical sites, online forums and alternatives)
- Methodological approach
- Rationale for choices of method/s (tied to project aims/objectives)
- Rationale for the choice of any control arm
- Participants
- Description and number
- Inclusion and exclusion criteria
- Sample size and statistical or power issues
- Participant recruitment strategies and timeframes (as required in addition to that outlined in the HREA).
- Approach/es to provision of information to participants and/or consent (as required in addition to that outlined in the HREA).
- If necessary, the type, timing and context of consent sought from different participant groups, and any arrangements to confirm or re-negotiate that consent.
- If necessary, details of who will be confirming or re-negotiating consent with participants and the process/es that will be undertaken.
- Research Activities:
- What you are going to do
- Participant commitment
- Project duration
- Participant follow-up
- Data Collection/Gathering:
- What information are you going to collect/gather? (As required in addition to that outlined in the HREA).
- Data collection/gathering techniques: How will you collect/gather the information?
- Impact of and response to participant withdrawal.
- Data Management:
- How will you store, provide access to, disclose, use/re-use, transfer, destroy or archive the information that you collect/gather? (as required in addition to that outlined in the HREA).
- Include a data management plan in accordance with National Statement 3.1.45 and 3.1.56
- Data Analysis:
- How will you measure, manipulate and/or analyse the information that you collect/gather?
- Matching and sampling strategies
- Accounting for potential bias, confounding factors and missing information
- Statistical power calculation
- Data Linkage:
- What linkages are planned or anticipated?
- Outcome measures
- For research involving an investigational drug or device as part of a clinical trial:
- What is/are the drug(s) and/or device(s)
- Approved name
- Trade name (if any)
- Manufacturer
- Supplier of drug/device (e.g. manufacturer/pharmacy)
- Approved therapeutic indication, dosage/duration in Australia
- Believed mode of action
- Dosage regimen
- Mode of excretion
- Known adverse events
- Known contra-indications or warnings
- If arrangements have been made for a hospital or other Pharmacy Department to receive or dispense the drugs involved in this project, explain how the drugs will be received and dispensed for the purposes of the research project.
Results, Outcomes and Future Plans
- Plans for return of results or findings of research to participants
- Include an ethically defensible plan in accordance with National Statement 3.1.65, 3.2.15 or 3.3.36–3.3.61, as appropriate.
- Plans for dissemination and publication of project outcomes.
- Other potential uses of the data at the end of the project.
- Project closure processes.
- Plans for sharing and/or future use of data and/or follow-up research.
- Anticipated secondary use of data.
Targeted, Likely/Foreseeable and Incidental Participant Recruitment
Participation of members of defined populations in research occurs as a consequence of recruiting them as a research cohort or as individuals whose participation can be anticipated as being likely or foreseeable. For example, a research project may target people who have a specific disease, disability or impairment or who are migrants from a particular country or it may, because of the setting and nature of the research, be likely to include individuals from these groups.
It is also possible that individuals from a defined population will be recruited into a research project without in any way being targeted by virtue of their being present in the general population from which the participants are being recruited. This is often referred to as ‘incidental’ recruitment.
This distinction is important, as the purpose of considering the ethical implications of recruiting members of defined populations, whether they are considered to be ‘vulnerable populations’ or not, is to address those implications as they relate to the likely or foreseeable recruitment of these individuals, not as they relate to the incidental recruitment of these individuals.
Researchers should use common sense and a ‘project-specific’ approach in applying this principle: if it is foreseeable that a portion of the projected participants in a specific research project will be eligible for recruitment as a result of a defined population being specifically targeted or as a result of demographic or other factors, then those ethical considerations that are specific to that group should be addressed. Whereas, if this is not the case, then the fact that it is conceivably possible that individuals who are members of a group will be recruited, but the project is not directed toward that group and the numbers of these individuals will be small, then the ethical considerations that are specific to that group may not need to be addressed.
In Australia, the issue of intended, likely, foreseeable or incidental recruitment is of particular importance when considering the inclusion of Aboriginal and Torres Strait Islander people and communities in research. The ethics committees that are established to perform review of research that targets or is likely to involve Aboriginal and Torres Strait Islander people and communities have valuable guidance on when and how to apply the guidelines that are appropriate to this research, including definitions that may be useful for researchers.
Researchers and ethics review bodies are jointly responsible for assessing whether recruitment is likely and foreseeable or incidental. Incorrectly designating the recruitment of a specific population as incidental may result in a deficient ethics application, which may be returned to the researcher by the ethics review body for appropriate modification.