Ethics RM fact sheet

The online platform upgrade

The Ethics Review Manager (ETHICS RM) is now live and was launched to:

• streamline the process for submitting, reviewing and managing ethics applications
• meet Ministry of Health strategic goals
• manage increased demand for research
• reflect the updated NEAC Ethical Standards.

An Ethics RM user's manual is available.

Timeline

Tuesday 10 August 2021

Tuesday 10 August was the last day that you were able to create a new HDEC application form via Online Forms. 

Saturday 21 August 2021

Saturday 21 August was the last day you could submit a new application or post approval form.

Anything not submitted did not transfer to ETHICS RM; however, a copy was retained on Online Forms until the end of September 2021.

Two ETHICS RM training videos are available.

1. In the first part of this introduction to ETHICS RM, we provide step-by-step guidance on account creation and login, creating, submitting, recalling applications and the main work area screen: https://youtu.be/0QdYTCioDUo(external link)(external link) 
2. In the second part of this introduction to ETHICS RM, we provide step-by-step guidance on sharing, transferring form to colleagues and system 'roles', creating post-approval items and existing applications from Online Forms: https://youtu.be/SxxOQVz0HMk(external link)

1 September 2021

ETHICS RM went live and you can now submit new applications, and post approval forms on your migrated applications.

Submission dates

* Process for urgent submissions

To report an urgent item between 21–30 August 2021 please contact HDEC directly at hdecs@health.govt.nz

An urgent item is an item that meets the following definition:

Urgent safety measures

• It may sometimes be necessary for investigators to take urgent safety measures in order to protect participants in an intervention study from a significant, immediate hazard to their health or safety. If this occurs the applicant must notify the HDEC immediately and in any case within seven calendar days of taking any such measures. 
• Notifications of urgent safety measures are considered to be a type of amendment, and applicants should submit them as such to the HDEC for review. 

Temporary halts

• Where a study is halted temporarily (for example for reasons of participant safety), applicants must notify the HDEC of this as soon as possible but in any case, within seven calendar days. 
• Temporary halts are considered to be a type of amendment, and applicants should submit them as such to the HDEC for review. Similarly, the recommencement of a study following a temporary halt is considered to be a type of amendment. If a study that has been temporarily halted concludes or is terminated early, applicants should notify the HDEC in the normal way (see below).

We request that substantial amendments are held until 1 September to submit, rather than submitted by email. If you are uncertain please contact HDECS@health.govt.nz

Applications that are provisionally approved during the transition

If your study has a provisional approval status during the migration of data, your response will need to be emailed to HDECS@health.govt.nz

The HDECs Secretariat will upload the documents to ETHICS RM on your behalf and send them for review.

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 of Health's 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.

Important note for 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, the HDECs will accept an email process. Please contact the HDECs Secretariat if you find your study is provisionally approved during this period.

Once the study is migrated to ETHICS RM we will review the Committee's decision and update the study status in ETHICS RM.

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 ETHICS RM going live.
• ETHICS RM has improved data reporting, supporting the monitoring functions of the Health Research Council Ethics Committee and NEAC and provides important data to feed into the Health Research Strategy.
• ETHICS RM makes completing ethics applications easier and managing studies more efficient.

Will ETHICS RM change HDEC processes?

No, 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 HDECs Standard Operating Procedures and Terms of Reference changes will be provided on this website in due course.

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 have forgotten it).

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’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.