Information about Ethics approval

Information about Ethics approval

Click on the sub-meny JCU HREC for information about JCU reciprocal acknowledgement of ethics approvals from other organisations.

Ethics application must be done for all human research prior to starting up data collection. There are different Human Research Ethics Committee (HREC) and at least one must evaluate your project. The committees in Australia follow the National Statement on Ethical Conduct in Human Research (first published in 2007 and revised several times).

Where should I send my application? - which HREC?

You should send your application to all organisations that will be involved having an HREC. The most common ones in northern Queensland are Queensland Health and James Cook University. However, some private organisations delivering health care also have their own HREC.

Queensland Health participates in the NHMRC single ethics review process. This means, that for many multi-centre research studies where there is a Queensland Health site, you will only be required to submit your HREC application to one Queensland Health HREC. However, there are some exclusions e.g. where Aboriginal and or Torres Strait Islander people are specifically targeted as research participants. If you have a single site study, submit your HREC application to the local site HREC. If you are unsure where or how to submit your HREC application please contact any Queensland Health HREC Coordinator for advice.

If you are a student or staff at JCU then you always need to make an application to JCU HREC. If you need to submit to both a Queensland Health HREC and JCU HREC then submit firstly to the Queensland Health HREC. After their approval send the application with their approval to JCU HREC for reciprocal approval.

If you engage a single school you will need approval from the principal. In case you engage more than one government run school then you also need approval through a separate Education Queensland ethics process.

Clinical audit

An activity where the primary purpose is to monitor or improve the quality of service delivered by an individual or an organisation is a Quality assurance (=Audit) activity. They only use descriptive statistics, does not calculate p-values and are usually not published in peer-rewieved scientific jopurnals. You could apply for doing a clinical audit if you fulfill these requirements. However, often you find something interesting worth publishing and then you can't. Therefore, we recommend that you always do a low risk application instead. More information: Science Network TV about different types of projects. Please also have a look at:
pdf document 2014 NHMRC Ethical considerations in Quality Assurance.pdf (167 kB)

Case reports

For a case report you should obtain patient's consent (unless this is impossible because the patient is dead). You should also subject this to the relevant ethics committee for review. They usually accept a simple letter and the decision is done by the chair so it is usually a quick process. Contact the relevant ethics committee and ask for their routines regarding presentation of case reports. You will find a template for this here :
word document NSLHD_HREC_Letter_Template and consent_Case Report.docx (32 kB) (Please ask if your HREC have different routines before using this template)

Letter of support

A letter of support should be signed by participating clinics / sites and be part of the ethics application. You will find a template for this here:
word document Template for a letter of Support.docx (37 kB)

How do I submit my application?

All Queensland Health HREC, JCU HREC and several other government health organisations use a cloud based application system. You will find this on line system at Australian Online Forms for Research. Once the application is complete it ends up in a database labelled AU RED. Apart from this form every HREC usually also requires some additional forms.

information Ethics application online can be found at  www.hrea.gov.au and ethicsform.org/au. Which one is best to use?

Answer: You can use both but if your application is to be evaluated by a HREC belonging to the Departments of Health in Queensland, NSW, Victoria and South Australia then you will save yourself a lot of work if you choose Australian Online Forms for Research on ethicsform.org/au.

The Human Research Ethics Application (HREA) replaced the old National Ethics Application Form (NEAF). HREA is owned by the NHMRC and is used around Australia for ethics applications. However, the Departments of Health in Queensland, NSW, Victoria and South Australia have purchased an ethics database called "AU RED" from a company called "Infonetica". Infonetica has permission to replicate the HREA in their system. 

The advantage of using  Australian Online Forms for Research is that their system can create an SSA where parts of the information is populated automatically from the HREA.

So in summary, there is only one version of the HREA available. It is available from two different websites. Only one format is technically compatible with the AU RED database.

Low risk application

If you tick no to all the below questions then you may choose a low risk application. Does the study include any of the ten following types of research and/or participants?

  • New interventions and therapies, including clinical and non-clinical trials
  • Introduction of new treatment modalities
  • Human genetics
  • Human stem cells
  • Women who are pregnant and the human foetus
  • People who are highly dependent on medical care who may be unable to give consent
  • People with a cognitive impairment
  • People with an intellectual disability or a mental illness
  • Research specifically targeting Aboriginal or Torres Strait Islanders
  • People who may be involved in illegal activities

In the online system the low risk application is labelled LNR QLD. A low risk application not requesting a waiver of consent (see below) is decided by the chair of the HREC. It is not discussed in the committee itself. Even if you tick no to all the above questions there will always be a small chance that your low risk application is not considered being of low risk.

Research specifically targeting Aboriginal or Torres Strait Islanders is often ambiguous. There are three different situations:

  • The main focus of the study is to investigate ethnicity (Aboriginal or Torres Strait Islanders) related to some phenomenon. In this case a full NEAF should be done.
  • Being Aboriginal or Torres Strait Islanders is one of many variables registered but its importance is also of interest to evaluate. This importance is presented in some way (using odds ratios or something else). It is considered hot stuff to point out that one ethnic group differs from another. Thus, In this situation a full NEAF is likely to be the best pathway.
  • Being Aboriginal or Torres Strait Islanders is one of many variables registered and this variable is just used as a confounding factor adjusting the true outcome so ethnicity does not distort the phenomenon you are looking for. In this situation a value (odds ratio or similar) is not presented for the variable being Aboriginal or Torres Strait Islander. The Cairns The FNQ HREC has decided that these situations should be treated as above because you will get a measure of the influence of ethnicity and once you have that it is difficult to ignore it.

It should be mentioned that analysing ethnicity provides sensitive information. The sensitivity is not directly linked to Aboriginal or Torres Strait Islander ethnicity, just the fact that ethnicity of any kind is being analysed.

Human Research Etchics Application (HREA)

HREA is the full ethics application for projects not being of low risk. Go to the website containing the forms. If you are new to the system start by creating a login. Follow instructions. Start by choosing state (QLD) and then type of form. Although the application ends up in a database you will need to print 16 hard copies of it and send in to the HREC.

Involving Aboriginal or Torres Strait Islander people

Involving Aboriginal or Torres Strait Islander people pose a risk for cultural clashes. Registering ethnicity as one variable to be analysed is enough to make special considerations even if ethnicity is not the main focus of the study. If ethnicity is involved to any extent it means that you have to describe to the HREC how you have considered the core values and ethics in Aboriginal and Torres Strait Islander research:

  • Spirit and Integrity
  • Reciprocity
  • Respect
  • Equality
  • Survival and Protection
  • Responsibility

Please read more about this on NHMRCs Guidelines for Ethical Conduct in Aboriginal and Torres Strait Islander Health Research. We also recommend you to look at a video with Cleveland Fagan (Chief Executive Officer for Apunipima Cape York Health Council) taking about Apunipima's view on research.

Asking HREC to grant waiver of consent

Normally research involving humans should ask each participant for consent and ask them to sign a consent form (see below). However, in some research, often retrospective chart reviews or use of databases, this may be impractical. A HREC can grant a waiver of the need for personal consent. In the low risk application (and the full NEAF) is a question if you ask HREC to waive personal consent. If you say yes you are asked to supply an explanation for why. When you try to motivate this it may be of value to refer to the Australian national statement on ethical conduct in human research. An example of writing may be:

According to the national statement on ethical conduct in human research paragraph 2.3.9 and 2.3.10 we ask the HREC to grant waiver of consent for this study. This research carries no more than low risk (section 2.3.10a), the research has a clear benefit (paragraph 1.1) justifying the risk of harm associated with not seeking consent (paragraph 2.3.10b), it is very impracticable to obtain consent due to the quantity (paragraph 2.3.10.c), it is reasonable to believe that participants would have consented (given that the principal investigator is a senior medical students and as such have advanced access to patient files and notes and has signed confidentiality agreements and deeds) (paragraph 2.3.10.d), patients individual privacy will be protected by only extracting de-identified data and to let the code key remain safely locked at the clinic (paragraph 2.3.10.e + 2.3.10.f), in case results from the research will have significance for the participants welfare these patients will be contacted (paragraph 2.3.10.g), results from this project will not be commercially exploit (paragraph 2.3.10.h) and finally to our understanding the waiver is not prohibited by State, federal or international law (paragraph 2.3.10.i). According to paragraph 2.3.12 the College of Medicine and Dentistry at James Cook University has a list and a summary description of research projects for which consent has been waived under paragraph 2.3.9 and 2.3.10 publicly available. This public list with short descriptions are found at: http://au.researchweb.org/is/jcu/ (click on “Search”).

For the latter to work (getting your project listed on the public list) you also need to ensure it is registered in the SMD project database (requires that you first log in).

Number of hard copies to submit

RiskWaiver of consentSet of documentsDecision made by
Low riskNo1Chair
Low riskYesEqual to members in committeeFull committee
Not low risk (Full NEAF)NoEqual to members in committeeFull committee
Not low risk (Full NEAF)YesEqual to members in committeeFull committee

The number of hard copies you need to submit to the full committee may vary between different ethics committees.

Data retention

The minimum recommended period for retention of research data related to Human research in Australia is 5 years from the date of last publication.

For studies asking for individual consent the signed consent forms for any research project that has been granted ethics approval should be retained for 15 years. It would be reasonable to retain all data for that project for the same time period to avoid having multiple disposal dates for the same project.

All data from a clinical trial must be retained for 15 years from completion of the trial and 10 years after the last patient service provision or medico-legal action.

For areas such as gene therapy, research data must be retained permanently (eg patient records).

Public Health Application (PHA) (specific to Queensland Helth)

If anyone is accessing charts/medical records, in a Queensland Health facility, to do any type of audit which is research, be it for a Low Risk or a NEAF submission, and they do not have written patient consent from each patient then they must apply for a PHA approval. PHA is applied for by the researcher, with an Ethics Committee approval letter. The PHA application must be signed by specific staff (data custodians) stating that the requested data can be retrieved. The PHA application signed by the data custodians must be submitted to Health and Medical Research at Queensland Health in Brisbane. Once the PHA is approved the approval letter of the PHA must be presented with the Site Specific Application (see below).

Please note that the PHA approval letter, not the PHA application, must be submitted as an attachment to the SSA application.

Research contract (specific to Queensland Health)

A research contract is not necessary for JCU medical students once they have signed the student Deed poll (for the clinical placements). However, a copy of the signed Deed poll must be submitted as a attachment to the SSA application (se below).

Site Specific Assessment(SSA) (specific to Queensland Health)

SSA focuses on if the resources and costs for the research are covered. An SSA needs to be done if the research in any way involves a Queensland Health facility. However, if you are only doing a retrospective chart review and your application is low risk then an SSA might not be needed (HREC will advice this in their decision). Usually one SSA is needed for each site. The website containing the forms can create the SSA for you.

When you write your SSA you must click on the submit button before printing and getting signatures (otherwise the form will have a water mark Draft. Once submitted the lower right corner will show a submission code.

Finance authorisation in the SSA must be signed by the chief finance officer or delegate in the health care organisation.

In the section Study budget at site declare where your money comes from. In the section Site Finance management state costs including in-kind support from Queensland health staff. The latter consists of staff time converted to an estimated cost in AUD.

When you finally submit the SSA application to the research governance officer ensure all documents are uploaded in the AURED database. Also send a hard copy of all documents (one copy is enough) to the research governance officer.

Multi site research projects

Multi-site research projects involving Queensland Health are managed by a lead ethics committee. A list of existing committees are found at the list of Queensland Health HREC. You have to contact any of them yourself and ask if they accept reviewing your project. If none accepts contact the office of health and medical research in Brisbane.

Patient information sheet

If your study involves humans, not only as a retrospective chart review, then these participants must be clearly informed. A patient information sheet should contain:

  1. Logotype for the responsible organisation. More than one logotype may be adequate.
  2. An easy to understand title.
  3. The formal research title.
  4. Short introduction explaining:
    • Short description of the topic. The information should not use terminology that may be difficult to understand.
    • The rationale for doing this research project.
    • What is expected to be achieved by this project. What questions can it answer.
    • Describe who is organizing this project.
    • Describe who is funding this project.
    • That a request for a decision to participate or not will be made and if the person participates a request to sign a consent form.
    Clearly describe what participation in the project involve. What is expected of the person if he / she enrolls. What will happen if the person decides to participate. Clearly describe demands, what is required of participants.
  5. Describe possible inconveniences and risks with participation.
  6. Describe if participation results in possible benefits (medical, financial or others).
  7. Describe that participation is voluntarily and that not participating will not affect any routine treatment.
  8. Describe how collected information concerning participants will be treated regarding storage, privacy, confidentiality and disclosure of information. If physical samples are taken describe how will they be stored.
  9. Information that if the person enrolls then he or she can later at any time decide to withdraw participation without being required to state any reason. If the patient withdraw participation it will not influence the health care provided to the patient.
  10. A statement that future information such as publications made in this project will be made available for those who wish to have it.
  11. Describe who has reviewed and approved the ethical aspects of this project (which HREC approved). Provide contact details to that HREC.
  12. Name, e-mail and phone number to the person (persons) that can provide further information or answer questions.

All information sheets and consent forms should be labelled with a version (number or date).

Consent form

A consent form should be attached to the patient information sheet as a separate sheet. If the person is under 18 years old then a parent / guardian must also consent. After written consent keep the consent form. The patient should keep the information sheet and a copy of the consent form. A consent form should contain:

  • Logotype for the responsible organisation. More than one logotype may be adequate.
  • An easy to understand title (preferably the same as on the information sheet).
  • The formal research title.
  • A declaration that the person may say no by not signing the consent form
  • A declaration "By signing this consent form I declare that I accept to participate and that I have understood the following:
    • The purpose, methods, risks and inconveniences of the study as described in the information sheet.
    • That I may not personally directly benefit from participating in the study.
    • That my participation is voluntary and I can withdraw at any time.
    • I have been given information and the opportunity to ask questions.
    • That the information specified in the information sheet concerning me may be stored in a research database for the purpose of this study.
    • That any publication of the results will conceal my identity.
    • I have been given a copy of the participant information sheet and consent form to keep.
    Participants printed name, participants signature and date of participants signature
  • Printed name of witness of participants signature, witness signature and date of witness signature
  • If relevant also name, signature and date for interpreter
  • Printed name, signature and date for signature of investigator or co investigator giving the information.

Follow up by the ethics committee

The ethics committe requires you to submit an annual report. Other follow ups during the process:

 HREC Queensland healthHREC JCU
Notification of commencing data collection (=commencing research)X 
Annual reportXX
End of data collection X
End of project (no more writing and editing of publications or other presentationsX 

Example of previous ethics applications

Examples are shown below if you are logged in (they are otherwise hidden).

Information about Ethics approval, from James Cook University