Welcome to the login for NZ Ethics RM

Please log in using the 'Log in' button on the top right-hand corner of this page.


24/05/2023 - Survey of HDEC service users/engagers sent to all in Ethics RM.

ERM users would have received an email from the Ethics team inbox regarding a survey. For more information, please see https://ethics.health.govt.nz/future-of-ethics-review/.


OLDER UPDATES

28/04/2023 - Version 2.0 of ERM user manual available

The Ethics RM manual has been updated following common issues encountered and feedback from users. 
Summary of changes include:

• addition of section on how to change Co-ordinating investigator details
• clarification of minor login error when creating new account
• highlighting the Unlock option if a form is locked due to signatures
• clarification on how to transfer projects within folders
• clarification that a new sub form must be created every time a new post-approval submission is created
• addition of section on sending and receiving correspondences within Ethics RM
• clarification of migrated projects being read-only and what messages may pop up as a result
• addition of FAQ item around not receiving out of scope letter
• addition of FAQ item around changing the title of a study in Ethics RM.

If you have feedback on what can be included in the next update of the manual, please contact ethicsrm@health.govt.nz.

01/04/2023 - High volume of submissions

The HDECs are currently receiving a high volume of submissions. Not all submitted before the agenda-close date may be accommodated on the agenda for that given meeting. The Secretariat will inform you via Ethics RM correspondence if your submission will need to go on the next available one.

The agendas for all remaining meetings for April 2023 are already full. Any applications submitted for next-available will go to the next-available May agenda.

24/03/2023 - Minor Update 1.29b

This is a minor update to relabel the SCOTT form as the SCOTT / GTAC form for clarity. 

Please note that it is not mandatory to update any unsubmitted forms. Doing so will invalidate any signatures and they will need to be reobtained. You may still submit older versions of forms. 

23/03/2023

The HDECs are currently receiving a high volume of submissions. Not all submitted before the agenda-close date may be accommodated on the agenda for that given meeting. The Secretariat will inform you via Ethics RM correspondence if your submission will need to go on the next available one.. 

10/02/2023 - Minor Update 1.29a

Kia ora,

This is a minor update to fix a couple of issues. It is not mandatory to update current forms in order to submit. If you have active signatures on a form please be aware that updating it will invalidate these and they will need to be re-requested.

HDEC Application:

-An issue preventing an out of scope exemption for some observational studies has been fixed. 

HDEC Annual Progress Report:

-The two sections of the progress report have been merged into a single page for ease of use. 

Tissue bank application:

-A miscellaneous document button has been added to allow the upload of other documents to support the application

ERM Update 05/12/2022 - Version 1.29

 

Version 1.29 of the HDEC application form is live. Please note that updating your form will wipe any signatures obtained. This is a non-mandatory update so if your study has been signed off you may still submit without updating.

 

HDEC Application:

• A new section 'Value for Disabled People' has been added to the form.
• Question H5 has been expanded to request more details on the New Zealand based sponsor including which university or Te Whatu Ora locality is sponsoring the study.
• The Sponsor Authorisation section has been revised to include institutional sponsors as well as commercial sponsors. 

Progress Report:

• Question PR24 is no longer mandatory and may be submitted blank if there are no clarifications required.

10.11.2022 - Update to the HDEC Application Form (v1.29) - New Disability Questions and Sponsor Authorisation

 

To align with the National Ethical Standards on disability research a new section on disability will be added to the HDEC form for all studies involving human participants. The new questions are included below and address access, barriers, funding, consultation and comorbidities.

 

The updated form also includes a change to sponsor authorisation and will differentiate between commercial and institutional sponsors.  

 

Version 1.29 of the HDEC application form will go live on Monday 05 December 2022.

 

New Section - Value for Disabled People

 

Introduction

Almost one in four New Zealanders (24% of the population) identified as disabled in 2013, according to the New Zealand Disability Survey. At present, there is a lack of data about disabled people, their lives, and their needs that would allow researchers to meet their obligations to disabled people. Because of this, researchers must recognise the intersectionality of human identity, and that some people identify with multiple ethnicities and social groups, including disabled people. This means that all health research, not just disability research, has potential to involve disabled people.

 

For further guidance on disability research and health research involving disabled people please review Chapter 5 of the National Ethical Standards. 

 

Barriers and Access

Are there any barriers that you can identify within your study which may exclude disabled people from participating?

['Yes/No' question]

 

[If preceding question answered 'YES']

Please describe how these barriers will be addressed and how the study will be made accessible to disabled people so that they have equal opportunities to participate in health research (e.g. supported decision-making, flexibility of timeframes, locality/site access, easy read documents, NZSL interpretation, etc).

[Free text question]

 

[If preceding question answered 'NO']

Please describe how your study is accessible to disabled people and the actions taken to ensure this (e.g. supported decision-making, flexibility of timeframes, locality/site access, easy read documents, NZSL interpretation, etc).

[Free text question]

 

Funding

Please provide details on any funding that may be available to provide accessibility services (separate to any koha or reimbursement as part of standard participation). 

[Free text question]

 

Design/Consultation

Researchers should consider the importance of a disability advisory group or researcher when reviewing the research design for disabling aspects. Please explain whether disabled perspectives were included in the study design for review.

[Free text question]

 

Comorbidities

Will comorbidities from disabilities or impairments be interpreted in the study data?

[Free text question]

 

 

ERM Update 25/03/2022 - Version 1.27

Please note that updating a form will wipe any signatures and these will need to be re-obtained. This is a minor update and is not mandatory. Forms created before 25/03/2022 are still able to be submitted.

HDEC Forms Update:

• An 'administrative section' to import details from the main application has been added to post-approval forms. This will fix the issue some applicants have had with the correct study title and/or CI details not appearing on HDEC approval letters.
• The administrative section in amendment forms may edited in the event of a change of Coordinating Investigator or study title.
• The screening algorithm has been revised and should now allow observational studies that involve tissue to be submitted.
• The COG option on the amendment form will now correctly unlock the form. 

22.10.21 – ETHICS RM Forms Update

This update introduces a new form and a few miscellaneous bug fixes across other forms.

Please note that updating a form to version 1.24 will invalidate any active signatures on it. These will need to be requested again before submission.

 

New sub-form – Additional Signature/Contact Request

• This form has been created for researchers to add additional signature requests and contacts which do not require HDEC approval to a study (e.g. additional investigators, Sponsor representatives or localities).
• If miscellaneous documents are required to be submitted to HDECs (e.g. for regulatory reasons) they can be included in this form.
• Please do not use this form to submit documents that were missed off a main application as they cannot be transferred across. Please contact the HDEC Secretariat if an application is submitted with missing documentation.
• This form can be used for both HDEC and SCOTT submissions.  

Sub-forms

• All sub-forms should now automatically be assigned to the parent committee of the main application by the system. This was an issue that was affecting some HDEC final reports.

HDEC Application Form

• Additional fixes and tweaks to the screening form. If you still encounter issues with two or zero pathways displaying please email ethicsrm@health.govt.nz

HDEC Amendment Form:

• Selecting the submission of non-standard conditions will now correctly display a document upload button.

SCOTT Post-Approval Form

• The SCOTT annual progress form has been corrected to ask for total global numbers of participants only, not numbers for each site in the study.

 

Note on progress reports - we are aware of the issue with progress reports requiring a mandatory non-substantial supporting document and a safety report for cases where they are not relevant. Please add a supporting document stating 'no non substantial amendments' etc. for the time being - we will remove this requirement in due course. 

ETHICS RM enables us to make changes easily, however, they require a 'refresh' for users - so we will wait a few days to check for further bugs and then release an update.

All updates will be listed here. Bug fixes will not invalidate or affect you studies, and any substantive changes will involve a lead in time.

Two ETHICS RM training videos are available:

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 

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

If you encounter any issues issues please email ethicsrm@health.govt.nz 

Your study documents

The data migration from our former IT system (Online Forms) to ETHICS RM happened over two weekends. The first weekend brought all ETHICS RM study data and meta data. The second weekend starting 4 September migrated all supporting documents. 

As of 8 September, you are now able to open all supporting documents.

Provisional approved studies

For studies that are currently provisionally approved before 1 September - you will need to submit your documents via email to HDECS@health.govt.nz with ‘Response to Provisional Approval PRE ETHICS RM’ in title.

Going forward, all new provisional approvals will be submitted through ETHICS RM. The HDECs Secretariat will upload the documents and send them for review.

More information about ETHICS RM is available at: https://ethics.health.govt.nz/ethics-review-manager/ethics-review-fact-sheet/