Frequently Asked Questions
1. Do I need to apply for Ethics Approval?
2. Do learning and teaching projects need ethical review?
3. Do Negligible risk projects need ethical review?
4. Does my application need to go through the Peer Review Committee?
5. How long will it take to obtain Ethics Approval?
6. How is the risk level determined?
7. Is my ethics application eligible for review by the Executive?
8. What do I need to submit with my ethics application?
9. I’m a student - who is required to submit my ethics application, my supervisor or myself?
10. How strict are submission closing dates for the Human Research Ethics Committee?
11. I can’t locate the submission closing dates on the webpage for the Executive, what are they?
12. What happens following review by the Human Research Ethics Committee or the Executive?
13. What if my application has already been approved by another University / Research Institution?
14. Will my application be approved straight away?
15. How should I respond to the Committee’s feedback?
16. What happens once I’ve provided the revised application?
17. What if I disagree with the decision of the Human Research Ethics Committee or the Executive?
18. How do I request an amendment or extension of time to an approved protocol?
19. Why am I required to submit progress reports throughout?
1. Do I need to apply for Ethics Approval?
ALL research involving human participants conducted by staff and students of the University of Western Sydney must undergo ethical review by the Human Research Ethics Committee before research can begin in accordance with the National Statement on Ethical Conduct in Human Research (2007) (“the National Statement” (pg 8).2. Do learning and teaching projects need ethical review?
Non-research learning and teaching projects with the sole aim to improve learning and teaching practice in a unit, course or program and where dissemination of the project results will be limited to the relevant staff involved in the teaching do not require ethics approval.
3. Do Negligible risk projects need ethical review?
Yes, except in the following circumstances.
Section 5.1.22 of the National Statement states that:
“Institutions may choose to exempt from ethical review research that:
(a) Is negligible risk...and,
(b) Involves the use of existing collections of data or records that contain only non-identifiable data about human beings”
Negligible risk is defined in the National Statement (Section 2.1.7) as being “where there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience. Where the risk, even if unlikely, is more than inconvenience, the research is not negligible risk”.
4. Does my application need to go through the Peer Review Committee?
All unfunded staff research projects,, undergraduate Honours research projects, and Postgraduate coursework which involves human participants must be submitted to the relevant Peer Review Committee for review of research merit and integrity prior to undergoing ethical review.
There are two Peer Review Committees (PRC): Health & Sciences, and, Humanities & Social Sciences. Once approval has been given by the PRC, the Secretariat of the relevant Committee will forward the application to the Human Ethics Office with an accompanying risk assessment.
5. How long will it take to obtain Ethics Approval?
The HREC recommends that you allow a minimum of four (4) weeks from the time of submission to the Office of Research Services (not to be confused with submission to the PRC) for review and approval of an ethics protocol.
If the application is assessed as being Negligible or Low1 risk, then it will be referred to the Executive. The Executive meets every Monday, except on the weeks the HREC meets or a Public Holiday.
If the application is assessed as being Low2 or High risk, then it will be referred to the next HREC meeting, noting submission closing dates for these meetings are 2 ½ weeks before the date of the meeting.
6. How is the risk level determined?
There are a number of factors taken into consideration when assessing the level of risk of applications.
In general:
High Risk is defined as any research that can cause severe harm to a participant psychologically, physically, socially, economically, cause legal harm or devaluate a person’s self worth.
Low2 Risk is defined as where the foreseeable risk to participants is greater than discomfort or where there are risks to the researcher or the participants are particularly vulnerable.
Low1 Risk is defined as where the only foreseeable risk is one of discomfort
Negligible Risk is defined as where there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience.
The National Statement on Ethical Conduct in Human Research specifies that some research, involving particular participant groups, requires review by the Human Research Ethics Committee and therefore, research involving these participant groups is automatically assessed as at least Low2. These participant groups are:
- Women who are pregnant and the human foetus
- 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
- People who may be involved in illegal activities
- Aboriginal and Torres Strait Islander peoples
The UWS HREC has also determined that applications involving the following participant groups should be reviewed by the full Human Research Ethics Committee:
- Children and young people*
- Where the researcher travels overseas to conduct the research with people in other countries (Not to be confused with online surveys where the respondents may be located in another country)
* The term “young people” is not defined in the National Statement as being any particular age group, but rather indicates that there are two types of persons under the age of 18 years, as distinct from infants and young children, they being:
(a) “Young people of developing maturity, who are able to understand the relevant information but whose relative immaturity means that they remain vulnerable. The consent of these young people is required, but is not sufficient to authorise research; and;
(b) “Young people who are mature enough to understand and consent, and are not vulnerable through immaturity in ways that warrant additional consent from a parent or guardian”
7. Is my ethics application eligible for review by the Executive?
Applications that are assessed as being Negligible or Low1 are eligible for review by the Executive, providing an expedited review service. The application will be listed for the next available Executive meeting, noting that there is a limit of 10 applications per Executive. There is no limit to the number of applications reviewed at a full HREC meeting.
You will be advised on the outcome of the risk assessment of your application in one of two ways. If your application has been reviewed by the Peer Review Committee, they will advise you during their review of the outcome of the risk assessment. The risk level will be confirmed in the email issued by the Office of Research Services confirming receipt and registration of your application. If your application does not require Peer Review, then the email noted above will serve as your notification of risk level.
8. What do I need to submit with my ethics application?
On submitting your ethics application the following documents are required:
- The completed NEAF complete with the signatures of all researchers or all members of the Supervisory Panel (noting that the Dean’s signature is NOT required by the University)
- A Participant Information Sheet for each participant group (if applicable)
- A Consent Form for each participant group (if applicable, noting that research projects which involve online or anonymous paper based surveys only do not require a consent form, but rather a statement at the beginning of the survey advising participants that return of the survey implies consent)
- The completed “Compliance with NSW Privacy Legislation” form
- Copies of any questionnaires, interview schedules, research advertisements, or any other documents relevant to the research.
9. I’m a student - who is required to submit my ethics application, my supervisor or myself?
An Ethics Application can be submitted by either your supervisor or yourself, however, your supervisor is considered to be the applicant and is the main contact for the proposal.
To reflect this in the NEAF on the front cover and at Section 2.4, it should be as follows:
Honours / Master Coursework – Supervisor
Masters (Honours) & PhD Candidates – Supervisor
UWS Staff – Applicant (Chief Investigator)
NOTE - In the case that a student emails the application, all signatures must be on the application at the time of submission
10. How strict are submission closing dates for the Human Research Ethics Committee?
Due to the number of applications received and the short time frames between the issuing of the agenda, and HREC meetings, submission deadlines are strict.
11. I can’t locate the submission closing dates on the webpage for the Executive, what are they?
The Executive meets weekly, except on the dates of HREC meetings and in the case of Public Holidays. There are no official closing dates for submissions to these meetings, however, applications must be received no later than close of business the preceding Tuesday, as Agenda items are issued on the morning of the Wednesday.
It should be noted that Executive meetings are also limited to ten (10) applications per meeting. Whilst it is typically a first in best dressed basis, where required, Honours and Masters Coursework research proposals will be prioritised over Higher Degree Research and staff funded/unfunded research projects given the shorter timeframes under which those students operate.
12. What happens following review by the Human Research Ethics Committee or the Executive?
Once your application has been reviewed, the minutes of the meetings are compiled for approval by the Chair. The feedback from the meeting is then sent by email to the researchers within 7 business days of the meeting.
13. What if my application has already been approved by another University / Research Institution?
If you have submitted your application to another Institution, for example, where the Chief Investigator is employed at another University or where the organisation you are researching has their own HREC, then you will only require reciprocal approval from UWS.
In order for your application to be considered for Reciprocal Approval, you will need to submit to the Human Ethics Officer the following:
- Reciprocal Approval Cover Sheet
- Original Ethics Application and amendments submitted to the lead HREC
- Any attachments submitted to the lead HREC
- Letter of Approval from the lead HREC
Reciprocal Approval requests are reviewed by the Chair of the HREC and a response is provided within 7 business days.
A condition of reciprocal approval is that a copy of all reports, amendments and approvals submitted to the lead HREC are also submitted to UWS .
14. Will my application be approved straight away?
Currently, approximately 15% of applications are approved as submitted.
There are a number of factors which can prevent your ethics application from being approved on initial review. One of the most common factors being inexperience by the researcher in submitting ethics applications. HDR candidates and Honours students must have the application reviewed in detail by their supervisor, prior to submission to the HREC, as the Supervisor is formally the applicant. Supervisors will have experience in completing NEAFs and an understanding of what is required by the HREC.
On the Office of Research Services website, there is also a list of “Helpful Hints”, listing those sections of the NEAF where students and researchers make common errors. Guidance is given on how to best address these questions. The Human Ethics Officer is also available to answer any further questions you may have relating to your ethics application.
15. How should I respond to the Committee’s feedback?
The feedback from the Committee will advise of what revisions are required to the protocol. Where the Committee says ‘for noting’, this is not something that must be changed but should be acknowledged by the applicant.
Changes should be done on the NEAF.
The revised NEAF, any revised Attachments and a Summary of the changes made should be returned to the Human Ethics Officer.
Use track changes on your advice letter to create the Summary.
16. What happens once I’ve provided the revised application?
On return of the revised NEAF and / or Attachments the application will then follow one of three courses of action:
a) Return to HREC / Executive for further review – This happens on rare occasions and only where the NEAF was not at an acceptable standard to be considered for ethical review in the initial instance, or where there are legal or medical issues which require further review.
b) Return to Chair for review – The application is returned to the Chair of the Committee (via the Human Ethics Officer). The Chair will review and either then approve or request further revisions. Approximately two thirds of the applications reviewed require further review by the Chair after initial review by the Executive or the HREC.
c) Approval by Human Ethics Officer – Upon return of the revised NEAF and/or attachments, the application is approved by the HEO
(NOTE – Researchers are generally not advised of what actions follow resubmission unless the application requires re-review by the HREC due to tight deadlines for submission)
For all applications being returned for further review, the following is required:
- A letter addressing the revisions requested by the Committee
- A copy of the revised NEAF
- A copy of any revised Attachments (including Participant Information Sheet and Consent Forms where required)
You will be notified of the outcome of your revised application within 7 business days of receipt by the Human Ethics Office.
17. What if I disagree with the decision of the Human Research Ethics Committee or the Executive?
It is a rare that an application is declined. In fact, in the period 1 January 2011 – 30 June 2012, no ethics applications were declined.
If a researcher, however, disagrees with the feedback provided by the Committee, or feels that the Committee has misinterpreted a section of the NEAF, the researcher will need to submit information by email outlining their position on the issue at hand. More often than not, this will then be resubmitted to the Chair for review and determination
18. How do I request an amendment or extension of time to an approved protocol?
Variations to Approved Protocols
When a researcher is requesting an amendment to an approved protocol, for any reason including an extension of time, an email should be sent to humanethics@uws.edu.au with a completed HREC Amendment Request form (PDF, 1664.76 KB) outlining the variation and the reason for why it is being requested.
If the request is for additional research staff to be added to the approved protocol, the details of the additional staff, consistent with Section 2 of the NEAF are to be provided.
19. Why am I required to submit progress reports throughout?
The National Statement on Ethical Conduct in Human Research states that:
5.5.5 At regular periods – reflecting the degree of risk, and at least annually and at the completion of the project – researchers, should provide reports to the relevant review body/ies and institution/s, including information on:
(a) Progress to date, or outcome in the case of completed research;
(b) Maintenance and security of records;
(c) Compliance with the approved proposal; and
(d) Compliance with any conditions of approval.
The University requires annual progress reports on the anniversary of your approval date. For example, if your protocol approval dates are from 1 July 2012 until 30 April 2015, you will receive an auto-generated reminder to submit a progress report on the 1 July each year, with a request for a final report on the 30 April 2015. If a report is not submitted within a month of receiving a request, a reminder will be sent out to the researcher.
