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Frequently asked questions (FAQ)

What documents are needed for a valid Standard Risk application versus a Low Risk application?

Standard Risk Ethics Research: 1 Original, plus 5 copies of the following

  • National Ethics Application Form (NEAF)
  • Research Protocol
  • Resumes for Principal Investigators (ONLY 1 COPY)
  • Any supporting documentation for your particular study such as Participant Information, Consent Forms, Questionnaires, Interview Questions, Data Collection Worksheets, Advertisement material etc.

Low Risk Ethics Research: 1 copy of original documents of the following

  • Low or Negligible Risk Research Form (LNR)
  • Research Protocol
  • Resumes for Principal Investigators
  • Site Specific Assessment
  • Metro South Research Contracts Form
  • Any supporting documentation for your particular study such as participant information, consent forms, questionnaires, interview questions, data collection templates etc.

All documentation must be uploaded onto Queensland Health Online Forms to be submitted electronically and in hard copy as outlined above. Both forms of submission must be completed in order for an application to be valid.

How do I submit my forms online and generate a submission code?

All new ethics applications need to be submitted through the Online Forms site.

You will need to create an account if you don’t already have one. Upon login, complete sections of the NEAF/LNR, then click on the ‘Submission’ tab, click on ‘Save’ and then click on ‘Generate Code’ button.

If when you print out your project, it has the word ‘DRAFT’ printed across each page and the submission code is missing from the bottom-right corner of each page; then this means the submission was not successful. You will need to ensure that it is submitted properly with the submission code provided in the bottom-right hand corner.  If you have further technical difficulties, online IT support can be contacted here:

  • Telephone: +61 2 903 78 404 (available from 10am to 4pm AEDT Mon to Fri)
    *Callers will hear on hold music while they are being connected to a Helpdesk analyst.
  • E-mail: helpdesk@infonetica.net

Can I use the new Human Research Ethics Application (HREA)?

Whilst the NHMRC released the new HREA late last year, the online platform used by Queensland Health HRECs (Online Forms) has not been updated with the new form yet. This update is due to take place sometime later this year. Until the new form is added to the Online Forms platform, ethics applications will still need to be submitted using either the NEAF or LNR until further notice. Communications will be sent out to research contacts once the HREA is up and available on Online Forms. There will be a period of transition between the different forms.

How do I make an amendment to my study?

To amend an existing study, you will need to complete an AMSF49 Metro South Amendment Form (XLS, 629.5 KB) and submit it to the MS Research Ethics and Governance Office (MS REGO), along with the appropriate supporting documentation.

Further details on what constitutes an amendment and the documentation required, can be found in the ‘Post Approvals’ presentation here: https://www.tri.edu.au/chr30

How do I know if my project idea is eligible for Exemption from formal ethical review?

The MS REGO has created an exemption form (XLS, 655.5 KB) and process to fulfil two different purposes:

  1. The first is for projects that do not meet the definition of research, such as routine service evaluation against existing standards or a case report, but contain information that may be relevant for publication.  In such instances, a letter from an ethical committee is often requested by peer-reviewed journals. The Exemption Form facilitates the generation of this letter which states that the application is exempt from formal ethical review due to the nature of the project.
  2. The second is for projects that meet the conditions of research that can be exempted from review:
    1. It is negligible risk research which is defined as “…no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience” (National Statement, 2.1.7).
    2. Involves the use of existing collections of data or records that contain only non-identifiable data about human beings (National Statement, 5.1.22). This means that at the point of access, the data already exists in a database with all identifiers stripped out. If the research requires direct access to a patient’s medical record or other identifiable source, then this means it is not eligible for exemption and must be submitted on the Low or Negligible Risk Form (LNR).

NB: If your intention is to ‘do research’ in any form other than as negligible risk, then appropriate ethical review is required.

How long does the Ethics/Research Governance review process take?

A Low and Negligible Risk Application is reviewed throughout the month by a sub-panel of the Metro South HREC and therefore these do not need to be submitted by the submission deadline for the MS HREC meetings. Generally, it may take up to 3 weeks from a valid submission until authorisation to commence is received.  This is highly dependent on any contractual requirements or approvals required from other regulatory agencies.

A Standard Risk Application must wait until the HREC meets on the first Tuesday in the month; for initial review. Any subsequent reviews or changes are generally dealt with by the Chair of the HREC out of session and therefore do not need to wait for the next meeting Generally, a Standard Risk application that is well written has an average 25 business days to go through ethical review and approval. 

It is strongly encouraged that the Site Specific Application and associated documents are submitted in parallel with the HREC submission to facilitate parallel review and timely authorisation of your study. Upon receipt of a valid submission including partially executed contracts and signatures from PI, Head Of Department and Finance Manager, expect to receive your authorisation letter within 1 week.

Do I need to submit my Low Risk Research Application by the submission deadline each month?

No, the submission deadline only applies to Standard Risk applications. The Low Risk applications are reviewed by a sub-panel of the Metro South HREC which contains two rotating committee members and a Chair. The panel reviews the applications out of session, throughout the month.

Do I need to get the signatures of all researchers on the NEAF/HREA/LNR?

Yes, all investigators named on an application need to sign the signature page. It also needs to be signed by an appropriate Head of Department or University Supervisor as indicated. These signatures can be in an electronic format via the Online Forms website or as a scanned copy.

How do I respond to HREC queries letter following a committee meeting?

After the monthly HREC meeting has taken place, (usually the following week) the Principal investigator will receive a letter from the Committee with queries or concerns to be addressed in order to proceed to approval. When responding to this letter, please consider the following:

  • Include a cover letter which addresses each of the points raised in the HREC letter.
  • Forward any updated documents such as a protocol or participant information and consent form with tracked changes and version control.
  • When responding to questions regarding the NEAF, do not update the NEAF document. Address the points in the letter, and make any changes in the study protocol as appropriate. The protocol is the ‘living document’ for your study and any subsequent changes or updates to the study need to be reflected in this document.
  • Please send the letter and any relevant documentation to the Metro South HREC Office in hard copy via post or drop-off to TRI reception. We do not accept email copies of the response to a request for further information/clarification.

The submitted documents are reviewed by the Chair of the HREC out of session.

What style of language do I use for my application e.g. what is lay language?

The Metro South HREC contains members of varying backgrounds and skill sets. When writing your application and associated documentation, please keep in mind that the person reviewing your application may not have a background in science or clinical care.

Therefore, it is recommended to use lay language in your application and avoid the use of jargon that may be confusing to a reviewer. This is particularly relevant for any participant documentation as they need to be able to easily understand what is needed of them in the study to give informed consent. It is recommended that you write to a grade 8 reading level, which means that someone 12 or 13 years old could easily understand the document.

Please also ensure you use correct grammar, punctuation and accurate spelling as it makes it easier for the reviewer to read your application and grasp its meaning. This will greatly assist in getting your application through the review process.

Is there a fee associated with Ethical/Governance review and when do I need to pay it?

A fee may be applicable to your submission depending on your circumstances. A fee is always applied to commercial studies where there is a named Sponsor in the application and they are invoiced directly; so please ensure you include the relevant invoicing details on the MSF31 Submission Checklist Form (XLS, 655 KB).

For non-commercial studies, a fee may still be applicable depending on whether you are from Queensland Health or an external party.

For details on the fee structure, please refer to our Fee Structure. Should you have any further questions about whether a fee is applicable to you please call our office to discuss.

Last updated 7 June 2017
Last reviewed 7 June 2017

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