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Ethical clearance

Key messages

  • Ethical review is a mandatory requirement for all human research undertaken within the Metro South Hospital and Health Service (“Metro South Health”). Its purpose is to ensure that health and medical research proposals conform with ethical standards.
  • Generally, Human Research Ethics Committee (HREC) ethical clearance and research governance authorisation must be obtained prior to commencement of any research activity in Queensland.  
  • Please seek guidance from the relevant Research Governance Office if unsure on the site-specific requirements for the research project.
  • Ethical clearance must be obtained in order to finalise research governance authorisation.
  • Human Research Ethics Applications (HREAs) are made via the Online Forms for Research website.
  • Under the National Mutual Acceptance scheme (NMA) most multi-centre research projects in Queensland should have only one ethical and scientific review. Exceptions to this approach have been identified e.g. Aboriginal and Torres Strait Islander (ATSI) and require further discussion with the appropriate Human Research Ethics Committee (HREC) Office.  
  • The Coordinating Principal Investigator (CPI)/Principal Investigator (PI) is ultimately responsible for all elements of the research project; from initial application to final report.

Requirements for the ethical clearance process

There are two requirements for commencement of health and medical research in Queensland, both of these must be addressed in full before a research project can be given ethical clearance and when applicable, research governance authorisation to commence:

Human Research Ethics Committee (HREC) ethical clearance

Reviewing bodyHuman Research Ethics Committee (HREC)
FormHuman Research Ethics Application (HREA)
or Low or Negligible Risk Form (LNR) - only for sites within Queensland

Research governance authorisation

Reviewing bodyResearch Governance Office (RGO)
Form

Site Specific Assessment (SSA)

The Online Forms for Research website must be used to complete the Human Research Ethics Application (HREA) and Site Specific Assessment (SSA) forms. It is strongly recommended that completion of the Human Research Ethics Committee (HREC) - Human Research Ethics Application (HREA) process be conducted at the same time as the research governance authorisation – Site Specific Assessment (SSA) process.  However, research governance authorisation cannot be finalised until ethical clearance has been obtained. Read more about research governance authorisation.

Streamlining ethical review

All human research that takes place in the Department of Health and Hospital and Health Services (HHSs) must be reviewed and approved in accordance with the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research (2007).  Ethical review is a formal process that is followed to ensure patient care or medical research proposals conform to ethical standards.

Multi-centre health and medical research projects in Queensland are usually required to have one ethical and scientific review conducted by a Human Research Ethics Committee (HREC). The National Health and Medical Research Council (NHMRC) certify each Human Research Ethics Committee (HREC). Each site involved with the health and medical research project must conduct its own research governance authorisation process before the research project can commence. The Site Specific Assessment (SSA) form is used for this purpose.

Scope of the streamlined ethical review system

Ethical clearance from a National Health and Medical Research Council (NHMRC) certified Human Research Ethics Committee (HREC) is required if a research project involves research on humans, their biospecimen samples or their data. This includes questionnaires, medical record reviews and the use of databases. Ethical and scientific review of multi-centre research projects applies to any form of human research, as defined in the National Statement on Ethical Conduct in Human Research (2007) (or any replacement of that document published by the National Health and Medical Research Council (NHMRC).

An application must be made to a Human Research Ethics Committee (HREC) for the purpose of conducting research at a public health organisation. This includes negligible, low risk and standard review.

Note: Human Research Ethics Application (HREA) must be created before accessing the Site Specific Assessment (SSA) form.

In order to understand what kind of ethical and scientific clearance is required it is important for you to identify if the research project is considered either single site or multi-centre research, and if there will be  any specific human ethical and scientific review requirements. The below table identifies the processes which are required:

Type

Single Site Research

Multi-centre Research

Specific Human Ethical and Scientific Review Requirements

Description

The research will only be conducted within a single site.

Research will be undertaken in multiple sites/areas.

Additional review is required by an appropriate reviewing body.

Example

Princess Alexandra Hospital or all Metro South Health facilities.

Princess Alexandra Hospital, Royal Brisbane and Women’s Hospital, Lady Cilento Children’s Hospital and/or interstate under the National Mutual Acceptance (NMA) scheme.

Research project includes Aboriginal and Torres Strait Islander (ATSI) research – the reviewing Human Research Ethics Committee (HREC) will require a letter of support regarding cultural implications.

Process

Liaise with coordinating Human Research Ethics Committee (HREC) Office i.e. Metro South Health Human Research Ethics Committee (HREC) Office.

Liaise with relevant reviewing body and coordinating Human Research Ethics Committees (HREC).

Metro South Health Human Research Ethics Committee (HREC) – certified

Metro South Health operates a Human Research Ethics Committee (HREC) which gives ethical clearance to research projects. The Metro South Health Human Research Ethics Committee (HREC) is able to review and provide ethical clearance for research projects conducted at any public health organisation throughout Australia, with the exception of Tasmania and the Northern Territory. Metro South Health Human Research Ethics Committee (HREC) meetings currently occur monthly (except January) throughout the year. The Metro South Human Research Ethics Committee (HREC) is a National Health and Medical Research Council (NHMRC) certified HREC. Registration No: EC00167. 

Human Research Ethics Application (HREA)

The Human Research Ethics Application (HREA) is a streamlined and contemporary ethics application that uses dynamic content and guidance to assist researchers in considering/ addressing the principles of the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research (2007).

The Human Research Ethics Application (HREA) is a web-based application that enables researchers to complete research ethics proposals for submission to Human Research Ethics Committees (HRECs), and to assist Human Research Ethics Committees (HRECs) to consistently and efficiently assess these proposals. To access the Human Research Ethics Application (HREA) please see the Online Forms for Research website.

The Human Research Ethics Application (HREA) provides reference material and relevant guidelines, Frequently Asked Questions (FAQs), instructional videos and an online help guide. The Human Research Ethics Application (HREA) replaces the former National Ethics Application Form (NEAF).

Metro South Health ethical clearance processes

Assessment of alternative review processes

The Metro South Health Human Research Ethics Committee (HREC) has the discretion to request a review research project based on the level of risk to participants. During the Initiating and planning a research project phase you are encouraged to contact the Metro South Health Human Research Ethics Committee (HREC) Office via telephone or email to discuss your proposed research project and identify whether the research project is suitable for an alternative review, based on the level of risk, other than a full ethical and scientific review process.

Additionally, the Centres for Health Research offers a monthly Drop in Session to provide initial overview of your research project submission with the provision of advice to ensure your submission package is complete and all administrative requirements are completed based on the research projects requirements. View our education opportunities and information regarding our Drop in Sessions.

Once you have determined, with the Metro South Health Human Research Ethics Committee (HREC) Office the level of ethical review required – whether it is Negligible Risk, Low Risk or More than Low Risk (Standard Risk), please follow one of the following processes.

Note: If you are conducting a clinical trial, please view our specific information about clinical trials.

Negligible Risk - if advised by the Metro South Health Human Research Ethics Committee (HREC) Office

Step 1: Application requirements

  1. Complete ECF5 HREC Negligible Risk Application Form (this form must be signed by both the researcher and the Head of Department. In the case where the researcher is the Head of Department, the form must be signed by their line manager)
  2. Collate supporting documentation as required. Please see Ethical and Scientific Review of Human Research Procedure (PR2017/113) (PDF, 413.65 KB) for more information on submission requirements.
  3. Submit one electronic (1) original copy of the completed form and all supporting documentation to the Metro South Health Human Research Ethics Committee (HREC) Office address.

Step 2: Negligible Risk determination

 A Negligible Risk research project submitted to Metro South Health Human Research Ethics Committee (HREC) Office takes approximately one week to review. The application will be reviewed by the Metro South Health Human Research Ethics Committee (HREC) Chair/Deputy Chair and a determination is made. This will be forwarded to the applicant by the Metro South Health Human Research Ethics Committee (HREC) Office. If further action/information is required, this will be requested by the Metro South Health Human Research Ethics Committee (HREC) Office.

Step 3: Commence research project/publish

The research project may only proceed upon receipt of advice/confirmation in writing from the Metro South Health Human Research Ethics Committee (HREC) Office.

Low Risk - if advised by the Metro South Health Human Research Ethics Committee (HREC) Office

Step 1: Submission requirements

  1. Complete the ECF4 HREC Checklist for Low and Standard Risk Applications (National Statement Section 2) Form. Please include a full listing of sites covered by the submission. 
  2. Complete the Human Research Ethics Application (HREA) available on the Online Forms for Research website. (Please note this is a different Human Research Ethics Application (HREA) to that used by Universities).
    • If Single Site – research projects conducted within Metro South Health facilities:
      • Also complete the online Site Specific Assessment (SSA) form available on the Online Forms for Research website (to be considered complete, the following must be included on the Site Specific Assessment (SSA): Business Manager/Finance Officer and/or Cost Centre Manager sign-off, research cost centre details, Head of Department sign-off (if any investigator is the Head of Department, please ensure that appropriate line manager signs as Head of Department). Please see research governance authorisation for more information.
    • If Multi-centre Research
      • Ensure application has been booked to the Metro South Health Human Research Ethics Committee (HREC) through the Central Coordinating Service (CCS). The Central Coordinating Service (CCS) will assign a Human Research Ethics Committee (HREC) reference number for the application. Please ensure that the Human Research Ethics Committee (HREC) reference number is included on the above mentioned ECF4 HREC Checklist for Low and Standard Risk Applications (National Statement Section 2) Form and Human Research Ethics Application (HREA) available on the Online Forms for Research website.
      • Submission of the Site Specific Assessment (SSA) form for Metro South Health sites is not mandatory, however it is highly encouraged.
         
  3. Submit the completed Human Research Ethics Application (HREA) available on the Online Forms for Research website  with the following:
    1. Completed Site Specific Assessment (SSA) (if required); and
    2. Any supporting documentation
  4. Obtain a submission code (found in bottom right-hand corner of each page of the Human Research Ethics Application (HREA) and submit the following documents in hard copy to the Metro South Health Human Research Ethics Committee (HREC) Office address:

Reference

Document type

Hard copy requirement

a.

ECF4 HREC Checklist for Low and Standard Risk Applications (National Statement Section 2) Form

  • completed (seek authorisation through the relevant channels of review)
  • clearly articulate on the Form if the research project is single site or multi-centre
  • clearly identify costs - see research fees

1 original copy

b.

Human Research Ethics Application (HREA) – available on the Online Forms for Research website

  • note submission code
  • print and scan from online site

1 copy

c.

Supporting documentation

1 copy

Please note, the original application must be submitted to the Metro South Health Human Research Ethics Committee (HREC) Office in hard copy.  Email/faxed copies will not be processed.

Step 2: Low Risk research determination

The review of Low Risk research projects in Metro South Health takes approximately two (2) weeks. The Metro South Health Human Research Ethics Committee (HREC) Office will advise an outcome to the submission.  If the application is deemed to be more than Low Risk, then the applicant will be advised of the reasons for this determination and directed to proceed with a standard application.  The Metro South Health Human Research Ethics Committee (HREC) will, on certain occasions, accept a right of reply in respect to the decision.

Step 3: Research fee review

There are a number of occasions when researchers will be charged for ethical review. Please review the research fees for the Metro South Health Human Research Ethics Committee (HREC) to determine if your submission attracts a fee. If it does, then please ensure appropriate invoicing details are included in the initial submission.

Step 4: Ensure research governance authorisation prior to commencement of research

The research project may only proceed upon receipt of approval from the Metro South Health Chief Executive Officer or delegate. See research governance authorisation for more information.

More than Low Risk (Standard Risk)

Step 1: Review closing dates

Researchers are required to submit their research applications to the Metro South Health Human Research Ethics Committee (HREC) Office by the appropriate closing date.  For Metro South Health Human Research Ethics Committee (HREC) Application Standard Risk submission deadlines and Meeting Dates please access the following ECF4 HREC Checklist for Low and Standard Risk Applications (National Statement Section 2) Form. Remember - the submission deadline is always 12pm/noon.   

Step 2: Submit Standard Risk application

  1. Complete the online Human Research Ethics Application (HREA) available on the Online Forms for Research website (**Please note this is a different Human Research Ethics Application (HREA) than that  used by Universities**).
  2. Upload the completed Human Research Ethics Application (HREA) online with the following:
    1. Completed Site Specific Assessment (SSA) (if required); and
    2. All supporting documentation.
  3. Obtain submission code (found at the bottom right hand corner of the Human Research Ethics Application (HREA) pages) and print out completed Human Research Ethics Application (HREA).  

Please note, the original application must be submitted to the Metro South Health Human Research Ethics Committee (HREC) Office in hard copy.  Email/faxed copies will not be processed. 

Reference

Document type

Hard copy requirement

a.

ECF4 HREC Checklist for Low and Standard Risk Applications (National Statement Section 2) Form

  • completed (seek authorisation through the relevant channels of review)
  • clearly articulate on the Form if the research project is single site or multi-centre and list the individual sites if more than one
  • clearly identify fees - see research fees

1 original and 4 collated copies

b.

Human Research Ethics Application (HREA) available on the Online Forms for Research internet site

  • printed and scanned from online site -  note submission code found in bottom right hand corner of form

1 original and 4 copies

c.

Research Protocol and Participant Information and Consent From (PICF)

1 original and 4 copies

d.

Questionnaires/Surveys (e.g. Survey Monkey)

1 original and 4 copies

e.

Participant Diary

1 original and 4 copies

f.

Advertising Material (e.g. Brochure, Leaflet)

1 original and 4 copies

g.

Data Collection Form

1 original and 4 copies

h.

CV of Principal Investigator(s)

1 copy

i.

Other Supporting Documentation

1 original and 4 copies

j.

For research using radiological procedures that are performed specifically for research:

  • independent assessment report or verification by a medical physicist (or radiation safety officer) of the total effective dose and relevant organ doses for those radiological procedures that are performed specifically for the Research Protocol.

1 original and 4 copies

Step 4: Metro South Health Human Research Ethics Committee (HREC) review/determination

The evaluation of More than Low Risk (Standard Risk) application in Metro South Health takes approximately four (4) weeks. The Metro South Health Human Research Ethics Committee (HREC) Office will advise an outcome to the submission in a formal letter from the Committee.  If further information is requested, to make a final determination, this must be supplied to the Metro South Health Human Research Ethics Committee (HREC) Office by no later than three meetings/four calendar months. Failure to provide this information will result in the application being withdrawn by the Metro South Health Human Research Ethics Committee (HREC) Office, with a new application required to reinstate the research project.

Step 5: Research fee review

There are a number of occasions when researchers will be charged for ethical review. Please review the following research fees for the Metro South Health Human Research Ethics Committee (HREC) to determine if your submission attracts a fee. If it does, then please ensure appropriate invoicing details are included in the initial submission.

Step 5: Ensure research governance authorisation prior to commencement of research

The research project may only proceed upon receipt of approval from the Metro South Health Chief Executive Officer or delegate. See research governance authorisation for more information.

Metro South Health Human Research Ethics Committee (HREC) – ethical clearance

You will be formally notified of Metro South Health Human Research Ethics Committee (HREC) ethical clearance; by letter from the Metro South Health Human Research Ethics Committee (HREC) Chair.  This letter will be sent via email to the Principal Investigator (PI) and nominated contact person as well as the Metro South Health Research Governance Office and Metro South Health PowerTrials Support Team.  

Metro South Health Human Research Ethics Committee (HREC) operates within the 60 (stop clock) days benchmark as set by the National Health and Medical Research Council (NHMRC).  Registration of the Metro South Health Human Research Ethics Committee (HREC) clearance of the research is documented within AU-RED.

Ongoing management of ethical clearance

Researchers are responsible for management of their research project/s.

Frequently asked questions

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

All new Low Risk and Standard Risk ethics applications need to be submitted through the Online Forms for Research site.

  • You will need to create an account if you do not already have one
  • Upon login, select ‘My Project’ and then ‘Create New Project’
  • Select Queensland and then ‘HREA’
  • Once completed click on the ‘Submission’ tab, click on ‘Save’ and then click on ‘Generate Code’ button

If when you print out your research project submission, 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 is not finalised. You will need to ensure that it is submitted properly with the submission code provided in the bottom, right- hand corner.  For any further technical difficulties, online IT support can be contacted by clicking the ‘Contact Us’ tab.

What is the difference between a National Ethics Application Form (NEAF) and the new Human Research Ethics Application (HREA)?

The National Ethical Application Form (NEAF) has been replaced by the Human Research Ethics Application (HREA).  Information about HREA is available here and from the HREA website.

What is the difference between a National Ethics Application Form (NEAF) and the new Human Research Ethics Application (HREA)?

The National Ethical Application Form (NEAF) has been replaced by the Human Research Ethics Application (HREA).  Information about HREA is available here and from the HREA website.

How do I make an amendment to my research project?

To amend an existing research project, you will need to complete an ECF6 Amendment Form and submit it to the Metro South Health Human Research Ethics Committee (HREC) and Metro South Health Research Governance Offices along with the appropriate supporting documentation.  An emailed version of your submission is appropriate if there are less than three attachments and each attachment is less than 20 pages.  For larger submissions, please provide one hard copy to the Metro South Health Human Research Ethics Committee (HREC) Office.

Further details on what constitutes an amendment and the documentation required, can be found in the Maintain and manage your research project page.

How do I know if my research project is eligible for Negligible Risk review in Metro South Health?

The Negligible Risk process serves for applications where the potential level of risk is ‘less than an inconvenience (National Statement 2.1.7).  The ECF5 HREC Negligible Risk Application Form serves a dual purpose:

  1. It may be appropriate for activities which 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 a Human Research Ethics Committee (HREC) is often requested by peer-reviewed journals. The ECF5 HREC Negligible Risk Application Form facilitates the generation of this letter.
  2. Its second purpose is to facilitate research projects that meet the conditions of research where a proposed activity is minimally invasive and less than an inconvenience.  It 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 online Human Research Ethics Application (HREA).

How long does the ethical clearance process take?

A Low Risk Human Research Application (HREA) is reviewed, electronically, throughout the month by members of the Metro South Health Human Research Ethics Committee (HREC) and therefore these do not need to be submitted by the submission deadline for the Metro South Health Human Research Ethics Committee (HREC) meetings. From receipt of the application to final ethical clearance can take approximately two weeks. This is dependent on the availability of the Metro South Health Human Research Ethics Committee (HREC) members to review, given their involvement is voluntary and they may have competing priorities. A More Than Low Risk (Standard Risk) Human Research Application (HREA) will not have a final determination until the Metro South Health Human Research Ethics Committee (HREC) meets on the first Tuesday in the month. Any subsequent re-reviews are undertaken by the Chair; often in consultation with other Metro South Health Human Research Ethics Committee (HREC) members.  

It is strongly recommended that the Site Specific Assessment (SSA) form, (and associated documents), are submitted in tandem with the Metro South Human Research Ethics Committee (HREC) submission to facilitate parallel review and timely authorisation of a research project. Upon receipt of a valid submission including partially executed contracts and signatures from Principal Investigator (PI), Head of Department and Finance/Business Manager, clinicians and researchers can expect to receive an authorisation letter within one week.

Do I need to submit my Negligible Risk Application Form or Low Risk Human Research Ethics Application (HREA) by the submission deadline each month?

No, the submission deadline only applies to More Than Low Risk (Standard Risk) Human Research Application (HREA).  The Negligible Risk and Low Risk Human Research Ethics Applications (HREAs) are reviewed by members of the Metro South Human Research Ethics Committee (HREC) rostered from the main Committee to review electronically, on a monthly basis. 

Do I need to get the signatures of all Coordinating Principal Investigators (CPIs)/Principal Investigators (PIs) on the Negligible Risk, Low Risk or Human Research Ethics Application (HREA)?

Yes, all investigators named on an application need to sign the signature page on the relevant form. It also needs to be signed by an appropriate Head of Department. Please note, the ECF5 HREC Negligible Risk Application Form can only be submitted by Metro South Health employees and are not available to University students.   These signatures can be in an electronic format via the Online Forms for Research  site or as a scanned copy.

How do I respond to Metro South Health Human Research Ethics Committee (HREC) queries letter following a Committee meeting?

Following the monthly Metro South Human Research Ethics Committee (HREC) meeting, (and usually the following week) the Principal Investigator (PI) will receive a letter from the Metro South Health Human Research Ethics Committee (HREC) with queries or concerns to be addressed in order to proceed to ethical clearance.  In responding, please consider the following:

  • Inclusion of a cover letter which addresses each of the points raised in the Metro South Health Human Research Ethics Committee (HREC) letter.
  • Provision of any updated documents such as a Research Protocol or Participant Information and Consent Form (PICF) with tracked changes and version control.
  • When responding to questions regarding the Human Research Ethics Application (HREA), do not update the Human Research Ethics Application (HREA) document. Address the points in the cover letter, and make any changes in the Research Protocol as appropriate. The Research Protocol is the ‘living document’ for your research project and any subsequent changes or updates to the research project need to be reflected in this document.
  • Please send the letter and any relevant documentation to the Metro South Health Human Research Ethics Committee (HREC) Office in hard copy via post or drop-off to the Translational Research Institute (TRI) reception. The Metro South Health Human Research Ethics Committee (HREC) Office does not accept email copies of the response to a request for further information/clarification.
  • A response to Metro South Health Human Research Ethics Committee (HREC) comments is required within three months and four meetings. 

The submitted documents are reviewed by the Chair of the Metro South Health Human Research Ethics Committee (HREC); often in consultation with other Metro South Health Human Research Ethics Committee (HREC) members out of session.

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

The Metro South Human Research Ethics Committee (HREC) comprises members of varying backgrounds and skill sets. When writing an application and associated documentation, please keep in mind that the person reviewing the application may not have a background in science or clinical care.

Therefore, lay language is recommended in an application and avoidance 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 research project to give informed consent. It is recommended that clinicians and researchers write to a Grade 8 reading level, which means that someone 12 or 13 years old could easily understand the document.

Please also review all submission documentation for grammar, punctuation and accurate spelling. This will greatly assist in getting an application through the review process.

Is there a research fee associated with ethical clearance and research governance authorisation and when do I need to pay it?

A research fee may be applicable to an application depending on individual circumstances. A fee is always applied to commercial research projects where there is a named sponsor in the application and they are invoiced directly; so please ensure the relevant invoicing details are included.

For non-commercial studies, a fee may still be applicable depending on whether the clinician or researcher is from Metro South Health, Queensland Health or an external party.

Should a clinician or researcher have any further questions about whether a fee is applicable please contact us discuss further.

Last updated 18 May 2018
Last reviewed 17 May 2018

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