Ethics: research involving humans

• Human Ethics Review
• Important - before you apply for ethical review
• Ethical Review based on the level of risk
• Do you already have ethics approval from elsewhere?
  
• Does my teaching and learning project need ethics?
• Accessing UWS student records for research purposes
• Conducting research in NSW state schools (SERAP)
  
• Human Ethics Project Report
• Complaints & Adverse events
• Contacts
  

Human Ethics Review

The University of Western Sydney fosters responsible research, protecting the welfare, dignity and safety of research participants, maintaining the reputation of the University and its researchers, and minimising claims for negligence against individual researchers or the University.

Research involving humans includes, but is not restricted to, the use and/or collection of personal, collective or cultural data from participants or from their records, and may include their oral testimony or observed cultural activities and the testing of responses to conditions devised by researchers as set out in the National Statement on Ethical Conduct in Research Involving Humans 2007 (opens in a new window) (full version). A summary of key aspects of the National Statement is also available.

The University makes provision for the review of all  research that involves human participants being conducted under its auspices. Such review arises from the University’s values, and forms part of its obligations under its funding agreements with the Australian Government, the National Health and Medical Research Council and the Australian Research Council.

For a step by step guide on how to commence human ethics review please see Apply to Human Research Ethics Committee.

2013 HREC Meeting and Submission Closing Dates

Commencing in 2013, applications will be subject to initial review by the Human Ethics Officer (HEO) before being submitted to the HREC for their review and approval. Researchers will be advised of any necessary revisions within 3 business days of their application being received by the HEO. Researchers will then be required to submit their revised NEAF and attachments by the nominated date in order for their application to be reviewed at the next HREC meeting.

Submissions must be received by midnight on the date of closing. Late submissions will not be accepted without the prior consent of the Human Ethics Officer.

Submission deadline	HREC meeting date
25 January 2013	18 February 2013
22 February 2013	18 March 2013
22 March 2013	15 April 2013
26 April 2013	20 May 2013
24 May 2013	17 June 2013
28 June 2013	15 July 2013
26 July 2013	19 August 2013
23 August 2013	16 September 2013
27 September 2013	21 October 2013
25 October 2013	18 November 2013

 

Important - before you apply for ethical review

The National Statement says “Unless proposed research has merit, and the researchers who are to carry out the research have integrity, the involvement of human participants in the research cannot be ethically justifiable.”  UWS HREC does not carry out research merit and integrity review (or scientific review) – it carries out ethical review. Therefore, UWS has a two tier review process:

Tier 1 involves the review of research merit and integrity prior to ethical review (Tier 2).  Most funded research is not required to undertake separate Tier 1 review (check with the Human Ethics Officer if you are not sure).  Higher Degree Research candidates who have completed their Confirmation of Candidature are not required to undertake Tier 1 review.

There are different pathways for lodgement of your ethics application depending on whether you are a student or staff researcher and whether your research is funded or not – details at Apply to HREC.

Tier 1 review of research merit and integrity is undertaken by discipline based Peer Review Committees.

What is a Peer Review Committee at UWS?

Peer Review Committees ensure that the University meets its obligations to ensure the quality of research involving human participants as required under the National Statement for the Ethical Conduct of Human Research 2007. 

If these obligations are not met the University is not allowed to receive public funding for research involving human participants. 

What does the Peer Review Committee do?

A Peer Review Committee undertakes a research merit and integrity review of all unfunded research projects involving human participants arising from Staff, and from Coursework Students, including undergraduate Honours.

The National Statement says that if a project does not have research merit and integrity it cannot be considered ethical research.

The NSW Department of Education and Communities requires that all research occurring in NSW public schools has had the quality of the research projects assessed and approved through an institutional research quality review process.

How does the Peer Review Committee process assist research publications?

The international publication climate is extremely competitive and an increasing number of journals across varied disciplines, including engineering, science, medicine and psychology, require researchers to assent that the research submitted for publication has undergone and received approval from a research quality committee and, where appropriate, a human research ethics committee.

Why does the Peer Review Committee make a Risk assessment of the research?

Research is ethically acceptable only when its potential benefits justify any risks involved in the research. 

The National Statement requires that all research involving humans is assessed for risk to participants and to others.

How is does the Peer Review Committee differ from the UWS Human Research Ethics Committee (HREC)?

HREC is registered with the Australian National Health and Medical Research Council (NHMRC) to undertake ethical review of research involving human participants. UWS HREC does not carry out scientific review or research merit and integrity review – it carries out ethical review. The disciplinary composition of the Peer Review Committees means that they are well placed to carry out review of method and scope and other aspects of research merit. 

There are two Peer Review Committees:

• Health and Science (covering health, biomedical, public health and psychology)
• Humanities and Social Science (covering education, studies in human society, language, communication and cultural research and business)
  

The Chair of the Humanities and Social Science is Assoc. Pro Vice Chancellor, Professor Deborah Stevenson, (02) 9685 9641, ext 9641, d.stevenson@uws.edu.au

The Chair of the Health and Science is Assoc. Pro Vice Chancellor, Professor Debbie Sweeney, (02) 4736 0995, ext 2995, d.sweeney@uws.edu.au

Ethical Review based on the level of risk

The National Statement lists particular types of research that require HREC review regardless of whether they may otherwise be considered low risk. There are additional categories of research that the University of Western Sydney HREC will not consider as low risk.

Full Review List:

• 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 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
• 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 University of Western Sydney student researcher
  

Do you have external ethics approval?

If you have received ethics approval from any NHMRC registered Human Research Ethics Committee, for example, from another university or a NSW Local Health District Human Research Ethics Committee, UWS is normally  able to provide reciprocal approval for UWS researchers and students. 

In order to be considered for reciprocal UWS approval, please submit all documentation related to the approval to humanethics@uws.edu.au including:

• The original application to the approving / administering HREC
• The approval letter from the approving / administering HREC
• Any amendments approved by the approving / administering HREC
• Any other correspondence including previous progress reports
• HREC Reciprocal Approval Cover Sheet (PDF, 1.62Mb)
  

Note: this process does not refer to the NSW Department of Education and Communities (SERAP) Approval (see State Education Research Approvals Process).

Does my teaching and learning project need ethical review?

All research, including learning and teaching research for publication, conducted by UWS staff or students involving human participants, whether funded or unfunded, must undergo ethical review before the project commences.

To assess whether or not a learning and teaching project will require ethical review, please self-assess using the Guidelines on research learning and teaching projects (Word, 181Kb). For further information, please contact the Human Ethics Officer.

Note: Research that is replicated annually or involves a coherent program with a suite of closely related studies over an extended period of time may be eligible for 5 year HREC approval, obviating the need for iterative applications - see guidelines on applying for program of research ethics approval (PDF, 25Kb).

Accessing UWS student records

If you intend to use UWS student records for your research please note the following information and process.

Student records are protected under Privacy Legislation and their use must conform to NSW Privacy Legislation (Word, 75Kb).

All use of student results or any other information that forms part of the student’s record requires:

• a full ethics protocol
• approval from the Academic Registrar to access and use the data

Researchers will seek in principle approval from the Academic Registrar prior to applying for ethical review.

With in principle approval in place, please commence the normal human ethics application process. 

An ethics approval protocol number will be required by the Academic Registrar before access to the student records will be available.

All student records must be de-identified by someone other than the researcher prior to release to the researcher, therefore, there are human resource implications for the Academic Registrar’s Office in conducting this process.

• Flow chart of this process (PDF, 56Kb).
  

Note: UWS SFU and SFT surveys advise students that if they submit the survey they are consenting to the data being used for research purposes, therefore, further ethical review is not required.

Conducting research in NSW state schools

The New South Wales Department of Education and Communities (DEC) compels researchers to have  the quality of their research projects endorsed and to  comply with the National Statement of Human Ethics before the department issues permission for the research to proceed in the school (State Education Research Approvals Process - SERAP).

Human Ethics Project Report

Researchers are required to provide a brief report outlining the implementation of a human ethics protocol at the completion of any project that received ethics. Prior to the completion of the research project, any unforeseen events, adverse or otherwise, or significant variations to the research protocol which might affect continued ethical acceptability of the project should be reported immediately to the UWS Human Research Ethics Committee (HREC) by email to Ms Jill Shute the Human Ethics Officer - humanethics@uws.edu.au.

Include the following in your email:

• Project title
• HREC approval number
• A description of the event or incident
• A description of the steps take to resolve the issue. 
  

Projects that are approved for longer than one year are required to provide progress reports annually to the Human Ethics Officer.

For progress and final reports please use the HREC Ethics Protocol Report Form (PDF, 1.6Mb).

Please supply the original (only) to Human Ethics, Research Services, Building K1, Penrith Campus or humanethics@uws.edu.au.

Complaints & Adverse events

Researchers - if an Adverse event occurs in your research, stop gathering data, secure the existing data, and where appropriate, make the research site safe and advise the Human Ethics Officer immediately.

If any person has a complaint about the conduct of research projects approved by the UWS Human Research Ethics Committee (HREC) please contact - humanethics@uws.edu.au.

For more information on how complaints are reviewed by the University see Complaints Guidelines (Word, 115Kb).

Contacts

Contact Ms Jill Shute the Human Ethics Officer via Telephone: (02) 4736 0229 or e-mail: humanethics@uws.edu.au.

The postal address is:

Jill Shute
Office of Research Services
Kingswood Campus, Building K
Locked Bag 1797
Penrith NSW 2751
Australia

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