Ethics - post approval submission requirements

After your research project has been granted ethics approval and governance authorisation, you'll need to report on your project's progress.

What to report

Please review the FNQ Human Research Ethics Committee (FNQ HREC) Post Approval Submission Requirements (PDF, 175KB) for amendments, progress/final reports, study updates, change of investigators and/or extension of HREC approval.

You’ll need to submit all your reports online using the Ethics Review Manager (ERM).

When you start your project, complete the relevant notification of commencement form from the list below and email it to FNQ_HREC@health.qld.gov.au and/or RGO_Cairns@health.qld.gov.au.

Notification of commencement forms:

Progress reports

You need to submit a progress report annually by 30 April to maintain your ethics approval.

Documents required

You’ll need to:

  1. Submit each document in the ERM against a sub-form
  2. Email one copy of each document to the HREC Coordinator.

It’s a good idea to email your documents to the HREC Coordinator so they know they’re in the system waiting for action. Sometimes documents aren’t submitted properly, and the coordinator won’t be able to access them.

If this happens with your documents, the coordinator will be able to help you submit your documents correctly so they can be processed.

Final report

At the end of the project, you’ll need to submit your final report and any publications.

Documents required

  • Project Final Report — this report is in the ERM
  • Final Report Form (DOCX, 159KB)
  • Any relevant documents, including publications, journal articles and presentations

You’ll need to:

  1. submit each document in ERM against a sub-form
  2. email one copy of each document to the HREC Coordinator.

Safety reports

Any safety issues need to be reported as soon as they happen and include:

You’ll need to submit each document in the ERM.

Amendments

Report any changes to your research project such as:

  • changes to your research protocol
  • change of investigators
  • requests for extensions to your project
  • requests for extensions to your data collection period
  • updated insurance certificates or certificates of currency.

Documents required

Cover letter
You’ll need to include the research title, HREC reference number, brief description of the amendment in lay terms, and a list of all the documents you’ve submitted in the ERM.

Please also include version numbers, page number and document dates in your letter.

HREC Amendments Form
This sub-form is in the ERM. You’ll know if you’ve successfully submitted the amendment if you see a reference number in the footer on the bottom left of the document.

The reference number will look something like this - AM/2022/QCH/12345 (Mar ver 1).

Study change
You’ll need to submit amended study documents – for example study protocol, information sheets, consent forms or data collection tools.

Sometimes there are changes to a project and to multiple documents - for example, the protocol and information sheets.

Make sure any changes are applied consistently to your documents. They need to be an exact match.

If you change any ethically approved study documents, you’ll need to ensure you submit the tracked change version of each document in the ERM system. You’ll also need to submit a clean copy of the updated/new document.

Change of investigators
Submit a resume or CV.

You’ll need to:

  1. submit each document in ERM
  2. email one copy of each document.

How to report

You'll need to submit your forms and reports online by creating a sub-form in the ERM.

Follow the guide on Creating a sub-form (PDF, 200 KB).

Step 1. Prepare your documents

Step 2. Submit your reports using the ERM to the HREC for acknowledgment

Step 3. Email a PDF copy of each document to FNQ_HRECs@health.qld.gov.au

Email: FNQ_HREC@health.qld.gov.au

If the study amendment submission is over 10 pages , one hard copy, of the submission should be posted/dropped off at the FNQ HREC office address listed below.

Office address

FNQ HREC Coordinator
Level 7, William McCormack Place 2
5b Sheridan Street
Cairns QLD 4870

Step 5. When you get approval or acknowledgement from the HREC:

  • Annual and final reports:
    • If the FNQ HREC have received the reports, you don't need to send for CHHHS governance review.
    • If the FNQ HREC have received the reports, you must send for TCHHS governance review.
    • If the reports came from another HHS HREC, you must send for governance review.
  • Amendments and other notifications (for example safety reports):
    • Reports need to be sent for governance review regardless of the location of the offices.
  • If your HREC approval only involves non-Queensland Health site/s, you don’t need Queensland Health Research Governance authorisation.

Last updated: November 2022