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 humanethics@westernsydney.edu.au 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, 53.18 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: help@hrea.gov.au 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.

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.

Core attachments

A number of core attachments in addition to the HREA are needed to complete the application. All applications require a separate Project Description – the template is on the HREA site. 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, 68.34 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. 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 humanethics@westernsydney.edu.au

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 humanethics@westernsydney.edu.au

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 humanethics@westernsydney.edu.au 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

In 2016, 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, 45.65 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 humanethics@westernsydney.edu.au 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, 123.33 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, 83.92 KB) (opens in a new window)

The form should be sent to humanethics@westernsydney.edu.au. 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 (opens in a new window) 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
  • Children
  • Aboriginal and Torres Strait Islander peoples
  • CALD (Culturally and Linguistically Diverse) people
  • 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 involves travel overseas
  • 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

HREC meeting dates and submission deadlines

2017 meeting dates and submission deadlines
Meeting date Submission deadline
20 Feb 2017 25 Jan 2017
20 Mar 2017 22 Feb 2017
12 Apr 2017 15 Mar 2017
15 May 2017 19 Apr 2017
19 Jun 2017 24 May 2017
17 Jul 2017 21 Jun 2017
21 Aug 2017 26 Jul 2017
18 Sep 2017 23 Aug 2017
16 Oct 2017 20 Sep 2017
20 Nov 2017 25 Oct 2017
  • The HREC meets every third Monday of the month in February, March and from May to November. April and December meetings are scheduled to avoid conflict with holiday periods.
  • All applications are subject to initial review by the Human Ethics Officer and you may be required to make changes to the application form and attachments before submission to the HREC.
  • Researchers should check whether their School or Institute has requirements in terms of School/Institute-based approval for the research or the ethics application form. Previously, the schools of Education, Medicine, and Nursing and Midwifery have indicated that such processes exist and these should be undertaken prior to the submission of the ethics application.
  • The Executive meets on Monday each week commencing the third week of January, except on HREC meeting days and to accommodate public holidays.
  • The submission deadline for any meeting is close of business (5pm) on the specified date.
  • This also assumes that all applications have been screened and deemed 'assessment ready' by Human Ethics.

LNR review committee meeting dates and submission deadlines

2017 meeting dates and submission deadlines
Meeting date Submission deadline
17 Jan 2017 11 Jan 2017
24 Jan 2017 18 Jan 2017
31 Jan 2017 24 Jan 2017
7 Feb 2017 1 Feb 2017
14 Feb 2017 8 Feb 2017
21 Feb 2017 15 Feb 2017
28 Feb 2017 22 Feb 2017
7 Mar 2017 1 Mar 2017
14 Mar 2017 8 Mar 2017
21 Mar 2017 15 Mar 2017
28 Mar 2017 22 Mar 2017
4 Apr 2017 29 Mar 2017
11 Apr 2017 5 Apr 2017
26 Apr 2017 19 Apr 2017
2 May 2017 26 Apr 2017
9 May 2017 3 May 2017
16 May 2017 10 May 2017
23 May 2017 17 May 2017
30 May 2017 24 May 2017
6 Jun 2017 31 May 2017
20 Jun 2017 14 Jun 2017
27 Jun 2017 21 Jun 2017
4 Jul 2017 28 Jun 2017
11 Jul 2017 5 Jul 2017
18 Jul 2017 12 Jul 2017
25 Jul 2017 19 Jul 2017
1 Aug 2017 26 Jul 2017
8 Aug 2017 2 Aug 2017
15 Aug 2017 9 Aug 2017
22 Aug 2017 16 Aug 2017
29 Aug 2017 23 Aug 2017
5 Sep 2017 30 Aug 2017
12 Sep 2017 6 Sep 2017
19 Sep 2017 13 Sep 2017
26 Sep 2017 20 Sep 2017
10 Oct 2017 4 Oct 2017
17 Oct 2017 11 Oct 2017
24 Oct 2017 18 Oct 2017
31 Oct 2017 25 Oct 2017
7 Nov 2017 1 Nov 2017
14 Nov 2017 8 Nov 2017
21 Nov 2017 15 Nov 2017
28 Nov 2017 22 Nov 2017
5 Dec 2017 29 Nov 2017
11 Dec 2017 6 Dec 2017
  • Proposals involving not greater than minimal risk (Negligible and Low 1) will be reviewed by the Low and Negligible Risk (LNR) review committee. The LNR meets on Tuesday of each week except on weeks commencing with a Public Holiday.
  • All applications are subject to initial review by the Human Ethics Officer and you may be required to make changes to the application form and attachments before submission to the LNR.
  • Researchers should check whether their School or Institute has requirements in terms of School/Institute-based approval for the research or the ethics application form. Previously, the schools of Education, Medicine, and Nursing and Midwifery have indicated that such processes exist and these should be undertaken prior to the submission of the ethics application.
  • The submission deadline for any meeting is close of business (5pm) on the specified date. This assumes that applications have been screened and deemed 'assessment ready' by Human Ethics.

Executive review committee meeting dates and submission deadlines

2017 meeting dates and submission deadlines
Meeting date Submission deadline
16 Jan 2017 11 Jan 2017
23 Jan 2017 18 Jan 2017
30 Jan 2017 24 Jan 2017
6 Feb 2017 1 Feb 2017
13 Feb 2017 8 Feb 2017
27 Feb 2017 22 Feb 2017
6 Mar 2017 1 Mar 2017
13 Mar 2017 8 Mar 2017
27 Mar 2017 22 Mar 2017
3 Apr 2017 29 Mar 2017
10 Apr 2017 5 Apr 2017
24 Apr 2017 19 Apr 2017
1 May 2017 26 Apr 2017
8 May 2017 3 May 2017
22 May 2017 17 May 2017
29 May 2017 24 May 2017
5 Jun 2017 31 May 2017
26 Jun 2017 21 Jun 2017
3 Jul 2017 28 Jun 2017
10 Jul 2017 5 Jul 2017
24 Jul 2017 19 Jul 2017
31 Jul 2017 26 Jul 2017
7 Aug 2017 2 Aug 2017
14 Aug 2017 9 Aug 2017
28 Aug 2017 23 Aug 2017
4 Sep 2017 30 Aug 2017
11 Sep 2017 6 Sep 2017
25 Sep 2017 20 Sep 2017
9 Oct 2017 4 Oct 2017
23 Oct 2017 18 Oct 2017
30 Oct 2017 25 Oct 2017
6 Nov 2017 1 Nov 2017
13 Nov 2017 8 Nov 2017
27 Nov 2017 22 Nov 2017
4 Dec 2017 29 Nov 2017
18 Dec 2017 13 Dec 2017
  • The Executive committee reviews responses and amendments for projects with a risk rating of Low 2 or High, unless they have been assigned to the HREC.
  • The Executive does not meet the week of the HREC meeting or in weeks with a public holiday.
  • The submission deadline for any meeting is close of business (5pm) on the submission deadline date.