Welcome to the website of the Health and Disability Ethics Committees (HDECs).

 

26.10.2021 - HOLIDAY SHUTDOWN INFORMATION

Last HDEC Meeting for 2021 is the 14th of December 2021

HDEC Shutdown (i.e NO HHDEC reviews/activity) is from the 22nd of December 2021 through to the 9th of January 2022.

First HDEC meeting of 2022 - TBC 

 

22.10.21 – ERM Forms Update

Todays 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 HDEC (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.

 

Hello Researchers,

Some more updates for the HDEC and SCOTT forms:

HDEC Form:

More fixes to the screening section. If you still get no or more than one pathway please email ethicsrm@health.govt.nz

The single line text fields for questions C2, D5, D6.1, D12, D13.2 and D15 have been replaced with multiline text boxes without character limits. Please note if you have answered these questions and not submitted your form your answer will likely disappear. It is recommended to export your application as a PDF before updating so you can copy and paste the answer in again.

HDEC Progress Report Form:

A text box has been added to question PR14 (insubstantial changes/protocol deviations).

HDEC Notification of Conclusion Form:

It is now possible to submit the form without uploading any supporting documents.

SCOTT Form:

Additional options for study categories have been added including not applicable. These are no longer mandatory to answer in order to submit the form.

SCOTT Post-Approval Form:

Miscellaneous / insubstantial documents can now be uploaded.

 

06 September 2021 - URGENT UPDATE
 

The following fixes have been applied

HDEC FORM:

The screening algorithm has been revised and should now allow expedited applications through. If you still encounter more than one review pathway displaying please email ethicsrm@health.govt.nz and an advisor will assist you.

Question S16 on the screening form has been reworded to now clarify that the exemption is only for devices classified as Class I by the TGA. This exemption should only be applied if the study objective is related to the device, not if a class I device is in use at any time.

The character limits on questions D9 and D10 have been removed and should not allow a full answer.

The text boxes for questions C4, C5, C7 and C14 have been expanded. If you have previously answered these questions you may need to rewrite the answer.

A question has been inserted in B3 to ask for an overview of the scientific design of the study. This question will only display for intervention studies with a treatment (e.g. medicine or device).

The CI, sponsor and and locality authorisation text has been inserted.

SCOTT FORM:

The contact section of the form has been rebuilt and should now allow free text for the CI and primary contact person. It is no longer possible to search for users by name.

SCOTT POST APPROVAL FORM:

The mandatory documents preventing submission have now been marked as optional.

If you encounter any issues on any of the forms please email ethicsrm@health.govt.nz.

 

Important update - HDEC and SCOTT changes to submissions

The Ethics Review Manager (ETHICS RM) is now live at the following address: https://nz.forms.ethicalreviewmanager.com/(external link)

ETHICS RM will be offline from 5pm today (3 September 2021) until Monday 6 September 2021 due to data migration. 

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(external link) 

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)

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

Your study documents

The data migration from the current system to the new one happens over two weekends. The first weekend brings all ETHICS RM study data and meta data. You will be able to see all of your study documents from 1 September 2021, however, you cannot open the supporting documents. This is due to the substantial amount of data needing to transfer.

The second weekend starting 4  September 2021 will migrate all supporting documents. From 8 September 2021 you can 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 the title. Going forward, all new provisional approvals will be submitted through ETHICS RM. The Secretariat will upload the documents and send them for review.

For more information about ETHICS RM please see: https://ethics.health.govt.nz/ethics-review-manager/ethics-review-fact-sheet/(external link)

HDEC applications volume and meetings

We have experienced an all-time high of HDEC submissions over the last two months and expect this to continue through until the end of the year. We held an additional meeting on 31 August 2021 and will seek to hold more meetings. Please appreciate that many ethics committee members are busy during Alert Level 3 and 4.

We can assure you we are doing everything we can to hold additional meetings and will keep you updated on what meetings are full.

As at 31 August 2021, August and September full HDEC meetings are nearly 100% full, with 12 applications, the limit in our Standard Operating Procedures.

Once we assess the submissions from 1 September we will update you again on our website and splash page (ETHICS RM home page).

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-only access to studies that have been authorised.

Training and online support

We have held four webinars on ETHICS RM training with an average of 160 participants per session. We will support researchers as they become familiar with the new system. For ETHICS RM queries, please use the ETHICS RM@health.govt.nz inbox.

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, so not all questions can directly 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 will not 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. Please note that all submitted documents will also be available to the form owner in ETHICS RM.

  

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