Ethics review fact sheet
The online platform upgrade
The Ethics Review Manager (ETHICS RM) is being rolled out to:
- streamline the process for submitting, reviewing and managing ethics applications
- meet Ministry strategic goals
- manage increased demand for research
- and reflect the updated NEAC Ethical Standards.
|20/07/2021 – 6/08/2021||ETHICS RM Training via webinars and online sessions|
|10/08/2021||Final date to create a new application form (HDEC) using Online Forms (available until 5.00pm).|
|21/08/2021||Final date to submit an application form, further information response or post-approval report using Online Forms (available until 5.00pm).|
|21/08/2021 – 1 September 2021||No items can be submitted to HDEC|
|1 September 2021||ETHICS RM starts!|
Content migration across to ETHICS RM
All existing studies, including application forms, supporting documents and post approval items will be converted to PDF and migrated from the Ministry’s current Research Ethics Database to ETHICS RM.
For ongoing studies, you will be able to continue to submit post approval forms under the same study after the data migration.
Applications that have not been submitted from Online Forms by 21 August 2021 and validated by HDEC by 25 August 2021 will not be migrated. You can still access these non-submitted forms on Online Forms until the end of November 2021.
An important note regarding studies that are provisionally approved during the transition
ETHICS RM cannot accept responses to studies that are in the provisional approval status during the transition. For responses to provisional approvals during this period, HDEC will accept an email process. Please contact HDEC if you find your study is provisionally approved during this period.
Then, once the study is migrated to ETHICS RM we will review the Committee decision and update the study status in ERM.
What is ETHICS RM used for?
ETHICS RM is an information management system for completion, submission and storage of documentation.
- ETHICS RM will have new application forms that reflect the updated NEAC Standards and provide forms that are proportional to the risk level of the activity.
- Full application form
- Expedited application form
- Establishing a Tissue Bank form
- Do I need HDEC review form
- Updated Post Approval Forms
- These forms have been developed by a working group and tested with researchers and research offices.
- Once the forms are complete the HDEC will share the forms prior to ERM going live.
- ETHICS RM has improved data reporting, supporting the monitoring functions of the Health Research Council Ethics Committee and National Ethics Advisory Committee and provides important data to feed into the Health Research Strategy.
- ETHICS RM makes completing ethics applications easier and managing studies more efficient.
Will the ETHICS RM change HDEC processes?
No, the ETHICS RM is built to reflect the current standard operating procedures, the terms of reference and NEAC Standards. ETHICS RM can also be changed to reflect future changes to HDEC processes.
Information regarding the HDEC Standard Operating Procedures and Terms of Reference changes will be provided on this website in due course.
Is ETHICS RM training available?
Yes, training sessions via webinars will be available in July and August 2021. Dates and registration will be provided on this website.
Demonstration videos that show you how to complete each function in ETHICS RM will be made available at on this website.
Will I need to create a new ETHICS RM account?
Existing account holders (users who have submitted forms) on the Online Forms system will automatically have an ETHICS RM account created. Your new ETHICS RM account will have the same login details as your old Online Forms account (and your password can be reset if you’ve forgotten it).
When ETHICS RM goes live, your existing, account registered email address, will receive an email that includes updated terms and conditions, and an activation code, that will trigger and unlock your existing account into ETHICS RM.
For users who have only authorised forms, for example through the locality review process or to peer review an application for a colleague, as these accounts do not have responsibility for a form the account will be migrated, but only with read access to studies that have been authorised.
I’m planning to submit an application using Online Forms soon – what will happen to it?
Applications submitted using Online Forms before 21 August 2021 will be processed using the current system. If the application is not validated in the current system by 25 August, processing will be completed in ETHICS RM after 1 September 2021.
I’m planning to submit an application soon after 1 September 2021, what should I do to prepare my application?
You can prepare supporting documents and start your new application in ETHICS RM from 1 September 2021.
I’ve started an application in Online Forms but won’t be submitting it anytime soon – will it be lost?
You can print the form or save as a PDF if you want to keep your work, however the application form is changing to reflect the NEAC ethics standards, so not all questions will be directly able to be copy pasted to the new form.
What about the old applications in Online Forms?
Online Forms will remain live until the end of November 2021, but only as an archive (you won’t be able to create/submit new applications, but you can refer back to old ones). You can download past application forms and supporting documents and save them to a local drive. Note that all submitted documents will also be available to the form owner in ETHICS RM.
I’m due to submit an annual report in September – should I use ETHICS RM for that?
ETHICS RM will be used to fill in and submit all post approval report forms, including annual reports, amendments etc. Guidance on how to do this will be provided closer to the ETHICS RM launch.
What if I need to report something urgently during the changeover period?
To report an urgent item between 21–30 August 2021 please contact HDEC directly at email@example.com