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How to apply for human ethics review
Most research involving human participants carried out by staff or students at Western Sydney University must undergo ethical review, and most researchers will submit their application to the Western Sydney University ethics committees. The following information relates to that process. Researchers who will be submitting their ethics application to other ethics review entities need to liaise directly with those entities e.g. other University HRECs or Local Health District HRECs.
At Western Sydney, new applications are reviewed by either the Human Research Ethics Committee (HREC) or its Low and Negligible Risk (LNR) review committee.
Researchers are advised not to wait until the submission deadline to submit their application as a screening process is undertaken by the Human Ethics Officers before an application is assigned to a meeting.
Researchers carrying out consultancy or short term contract research should contact firstname.lastname@example.org for advice regarding review within a limited time frame.
For an overview of the application process, see Guidance for Researchers New to Human Ethics Review (PDF, 50.45 KB) (opens in a new window)
Creating an application
Western Sydney University uses the national Human Research Ethics Application (HREA) (opens in a new window)
HREA is a dynamic, interactive web-based software application tool on a secure server. The University does not have any control over HREA functionality. For technical assistance on the HREA system, please contact HREA Help via email: email@example.com or by calling 02 6217 9902.
Prior to filling in the HREA form, applicants must establish an HREA user account.
The NHMRC has released 'how to' videos (opens in a new window) about the new application system.
The University has also developed a HREA FAQ (PDF, 62.72 KB) (opens in a new window) document.
Higher Degree Candidates: Your principal supervisor is the applicant but you are the principal researcher. Your principal supervisor must endorse the accuracy and quality of the proposed research and of the completed HREA.
A copy of the Confirmation of Candidature (PhD CoC) or Presentation of Proposal (MRes PoP) must be included with the application.
A number of core attachments are needed in addition to the HREA to complete the application.
All applications require a separate Project Description using the Western Sydney-specific Project Description template (DOCX, 52.71 KB) (opens in a new window). See Guidance on Completing the Project Description (PDF, 126.28 KB) (opens in a new window) for more information.
Most applications will also require participant information sheets and consent forms. See Guidance on Choosing the Most Appropriate Participant Information Sheet and Consent form (PDF, 80.35 KB) (opens in a new window) for further information.
Copies of the research data collection tools must also be supplied e.g. questionnaires, interview schedules etc. Other attachments such as agreements from 3rd parties may also be required.
The HREC requires applicants to use the templates provided at Research Forms unless otherwise arranged with the Human Ethics Officer.
Finalising your application for submission
Upload all documents as per the HREA instructions - see the NHMRC User Guides (opens in a new window) for further information.
The website will create a file of the combined documents that can then be emailed to firstname.lastname@example.org
Do not give attachments long file names. If there are a lot of attachments, and/or if the attachments make more sense if read in a particular order, please number them. If there are a lot of attachments the University email system may not send them in one email, therefore you may need to spread them over a few emails.
Ensure you keep a copy of the application download, including the omni file, and a copy of the email(s) you send to email@example.com
Lodging your application
Applications may be submitted at any time throughout the year, however, applicants should note that meeting agendas are set and papers sent to the HREC well in advance of the meeting date.
For meeting dates and submission deadlines see below.
All named researchers are required to sign the application. Electronic signatures may be inserted or the signature page can be printed out, signed, scanned and included as an attachment. Please note: Some Schools require the Dean to sign off on the application while others require that a School research committee approve the project prior to submission. Researchers need to determine what is required by their School.
All applications must be submitted through the Human Ethics Officer at firstname.lastname@example.org for registration on the University's research management database and inclusion on the next available meeting agenda. Once the application is accepted as ready to be reviewed, the ethics database will auto-generate an email to the CI or Principal Supervisor confirming the date of the meeting the application has been assigned to.
The approval process
The majority of new applications were approved after a second review. Some require a number of review/response cycles.
Researchers should allow at least 4-6 weeks whenever possible for the process from assignment to a meeting to final approval.
Responding to review
The request for more information will set out the queries or suggestions on which the committee needs clarification. Some of these will be related to specific application questions and they will be numbered to correspond to the application form. Others may be general comments. For guidance on how to present your response see Guidance on Receiving and Responding to Ethics Committee Assessor Comments (PDF, 78.25 KB) (opens in a new window)
The response process
Once received, the response will be screened by the ethics staff and if ready for review by the committee, it will be assigned to the next available review. High risk and Low 2 review may be delegated to the HREC Executive or the Chair or, infrequently, be required to go back to the full HREC. Responses for LNR applications are reviewed weekly by members of the LNR committee.
You are welcome to discuss the process and/or the committee's comments you receive with the Human Ethics Officers. Please contact them at email@example.com or via telephone.
If you disagree with the decision of the ethics committee
You are invited to discuss the review comments with the Human Ethics Officers in the first instance. If this doesn't resolve the issue the Ethics Officer will follow the complaints protocol which requires consultation with, and decision by the HREC Chair. See Guidance on Complaints (PDF, 58.62 KB) (opens in a new window) for further information.
Researchers are requested not to speak directly with individual committee members because members are bound by confidentiality agreements and may only discuss an application outside of the meeting with the express permission of the committee. Following the complaints protocol also assists ethics staff and the committees to track and monitor complaints and their resolution.
Amendments to approved protocols
It may be necessary to adjust or amend aspects of an approved human ethics protocol – for example, the addition or discontinuation of some researchers; changes to the recruitment procedure; addition or change to a site or a data collection tool. All amendment requests should be submitted using the Amendment Request form (DOCX, 56.58 KB) (opens in a new window)
The form should be sent to firstname.lastname@example.org. Supporting documents may also be required, e.g. a new data collection tool.
Amendment requests that change the recruitment methods, research design, instruments etc. are assigned for review in the same way as applications.
Levels of risk
Under the National Statement on Ethical Conduct in Human Research (opens in a new window), the risk level of the research activity determines which committee may review the project.
High risk and Low 2 risk applications must be reviewed by the full Human Research Ethics Committee (HREC), whereas Low 1 risk and negligible risk applications are reviewed by the Low and Negligible Risk (LNR) review committee.
Assessing the risk level
Section 2.1 of the National Statement provides an overview to guide the assessment of risk to determine which ethics committee will review the application.
This section states the following with regards to low risk and negligible risk research:
- "The expression 'low risk research' describes research in which the only foreseeable risk is one of discomfort. Research in which the risk for participants is more serious than discomfort is not low risk."
- "The expression 'negligible risk research' describes research in which there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience."
If the project has any of the following characteristics, the application must go to the HREC (monthly meeting):
- Interventions and therapies, including clinical and non-clinical trials, and innovations
- Collection of samples such as blood, bodily fluids, etc.
- Physical screening or physical exertion
- Aboriginal and Torres Strait Islander peoples
- Human genetics or human stem cells
- Women who are pregnant and the human fetus
- People highly dependent on medical care who may be unable to give consent
- People with a cognitive impairment, an intellectual disability, or a mental illness
- Topics that may cause distress to participants due to past traumatic experiences
- Limited disclosure involving active concealment and/or planned deception
- Study or exposure of illegal activity, or research that is likely to discover illegal activity
- Research that could jeopardise a participant's employment
- Research that poses a risk to the physical or emotional safety or welfare of a Western Sydney University researcher
- Research which seeks a waiver of consent for the use of health information
- Research intending to use 'opt out' as a consent approach
Following review of the risk categories, the HREC has determined that research conducted overseas and/or which involves Culturally and Linguistically Diverse Peoples does not automatically have to go to the HREC. A case by case decision will be made based on the National Statement (above) and the requirement to effectively manage risk around the physical or emotional safety or welfare of a Western Sydney University researcher.