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Apply to Human Research Ethics Committee (HREC)

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Contacts

Contact Miss 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

Levels of Risk and the Ethical Review Process

Under the National Statement on Ethical Conduct in Human Research (NS) guidelines, the Risk level of the research activity determines which Committee may review the project. The types of Risk and which Committee is able to review and issue a protocol is as follows:

High risk - This 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 (NS 2.1).

Under the National Statement, high risk applications must be reviewed by the full Human Research Ethics Committee (HREC). HREC meetings are held on the third Monday of every month. Please observe the deadline dates for submitting your application.

Following submission of your application:

You will receive a confirmation email advising the date of the meeting at which your application will be reviewed.
You will receive a response from the Committee within seven working days of the HREC Meeting.

Low2 risk - This 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 (NS 5.1.6). Under the National Statement, Low2 risk applications will be reviewed by the Human Research Ethics Committee. HREC meetings are held on the third Monday of every month. Please observe the deadline dates for submitting your application.

Following submission of your application:

You will receive a confirmation email advising the date of the meeting at which your application will be reviewed You will receive a response from the Committee within seven working days of the HREC Meeting.

Low1 risk - This is defined as where the only foreseeable risk is one of discomfort (NS 2.1.6). Under the National Statement, Low1 risk applications may undergo expedited review and be considered by the HREC’s Executive Committee. The Executive meets weekly – on Mondays - except on HREC meeting dates and public holidays.

Following submission of your application:

You will receive a confirmation email advising the date of the meeting at which your application will be reviewed You will receive a response from the Committee within seven working days of the HREC Executive Committee meeting.

Negligible risk - This is defined as where there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more that inconvenience. Where the risk, even if unlikely, is more than inconvenience, the research is not negligible risk (NS 2.1.7).

Under the National Statement, Negligible risk applications may be considered by the HREC’s Executive Committee. The Executive meets weekly – on Mondays - except on HREC meeting dates and public holidays.

Following submission of your application:

You will receive a confirmation email advising the date of the meeting at which your application will be reviewed You will receive a response from the Committee within seven working days of the HREC Executive Committee meeting.

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How to apply for human ethics approval

UWS uses the National Ethics Application Form (NEAF) developed by the ARC, NHMRC and AVCC (now Universities Australia). NEAF is a dynamic, interactive web-based software application tool on a secure server. For questions, comments and feedback about NEAF please contact NEAF Assist at neafassist@nhmrc.gov.au or 1800 823 993.

Prior to filling in the National Ethics Application Form both the supervisor and the candidate must establish a NEAF user account and complete the ‘My Details’ section.

Go to NEAF www.neaf.gov.au and create a new user account for both supervisor and candidate.
To populate the details fields, click the blue button – ‘Copy My Details’.
The candidate should initiate a proposal and invite the supervisor to review.

When you invite other NEAF users to read or edit the proposal – beware – no tracked changes so you can’t see what they’ve done – make a copy first.

Principal Supervisor is required to sign off on the application, endorsing the accuracy and quality of the research proposal described in the proposal and the processes put in place to manage ethical issues.

Honours/Masters Coursework and HDR Candidates should ensure they tick ‘student’ in the application. This process will bring up the sections to be completed by the principal and other supervisors.

All applicants must sign the hard copy of the application. UWS does not require Dean of School’s signature.

Who’s who in the National Ethics Application Form (NEAF)

On NEAF	If Honours /Masters Coursework student	If HDR candidate	If UWS Staff
Name on Front Page of Form (contact person)	Supervisor	Supervisor	Applicant (first named Principal Researcher)
Contact Person	Supervisor	Supervisor	Applicant (first named Principal Researcher)
Principal Researcher 1	Student	The candidate will be the principal researcher 1*	Applicant
Principal Researcher 2		If the project is part of a funded grant held by the Supervisor, the Supervisor will be PR2

*The HDR is PR 1 reflecting that their project will be a discrete component of the grant, forming the HDR thesis and will be owned in copyright and IP terms by the candidate, unless a formal agreement has otherwise been made by the University through Legal Counsel.

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Core Attachments

There may be a number of core attachments in addition to the NEAF application form that will be needed to complete your human ethics application. These core attachments may include an information statement and consent form, a questionnaire, and/or interview schedule.

The following guidelines will be of assistance in developing these core attachments:

Compliance with NSW Privacy Legislation (Word, 75Kb)
Consent Form Proforma (General) (PDF, 561Kb)
Consent Form Proforma (Parent or Care-Giver) (PDF, 562)
Dialogue Sheet Proforma (PDF, 560Kb).
Guidelines for Clinical Trials (Word, 70Kb)
Information Sheet Proforma (General) (PDF, 1Mb)
Information Sheet Proforma (Medical) (PDF, 1Mb)
Information Sheet Proforma (Parent or Care-Giver) (PDF, 1Mb)

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Check list for application

If this is an Honours student or HDR candidate project,

The Applicant is the Supervisor, therefore, supervisor must sign that they endorse (ie have read and approve), the application. If it is impossible to sign, then an emailing affirming endorsement should be sent.
The Supervisor is the Applicant and Contact person; the student is the Principal Researcher 1. The Committee will liaise with the Applicant.
Confirmation of candidature documentation - all HDR candidates

All applicants

Ensure you have read the IP policy and the UWS Research Code of Practice which will guide on data storage requirements, including duration of storage (specify in NEAF the room, building and campus of storage).
Consent Forms, Dialogue Sheets - if applicable
Information Sheet/s - if applicable
Questionnaire/Survey Instrument/s, Interview questions - if applicable
All consent forms, participant information sheets and other related material should be developed using the University templates
Contact details must be a UWS email and address or UWS telephone – no private email, address or telephone numbers.
NSW Privacy Legislation compliance - all applicants
Cover sheet to submit external institutions’ HREC approval - if applicable
Academic Registrar approval for access to UWS student records (PDF, 17Kb) – if applicable

For applications seeking ethical review - to be submitted directly to Human Ethics, have you?

Emailed – a copy of the NEAF Form and the required attachments to the Human Ethics via humanethics@uws.edu.au; and
Mailed the original signed paper copy of the NEAF with all the required attachments to Human Ethics, Research Services, Building K1, Penrith Campus

For applications seeking research merit and integrity review - to be submitted to the Peer Review Committee, have you?

Emailed – a copy of the NEAF and required attachments to the relevant Peer Review Committee; and
Mailed – the original signed paper copy of the NEAF with all the required to the relevant Peer Review Committee, Executive Officer.

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HREC meeting dates and submission deadlines

2012 Deadlines
Submission deadline	HREC meeting date
3rd February 2012	20th February 2012
2nd March 2012	19th March 2012
28th March 2012	16th April 2012
4th May 2012	21st May 2012
30th May 2012	18th June 2012
29th June 2012	16th July 2012
3rd August 2012	20th August 2012
31st August 2012	17th September 2012
26th September 2012	15th October 2012
2nd November 2012	19th November 2012

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Lodging your application

UWS has a two tier review process: Tier 1 involves the review of research merit and integrity prior to ethical review (Tier 2). 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.

Tier 1 Review of research merit and integrity is obtained as follows:

For HDR students - via a completed Confirmation of Candidature (CoC) – provide evidence with your application
For Staff - if you have a funded research project managed through the Office of Research Services.
Staff with NHMRC Category 5 unfunded application outcome.

NEAF applications dealing with these three types of project should be sent directly to humanethics@uws.edu.au with all relevant attachments (including a copy of the NHMRC notification for unfunded Category 5 projects).

All other applications, including unfunded staff research, undergraduate Honours projects and 3rd year Psychology projects must have research merit and integrity considered by a Peer Review Committee prior to Tier 2 (ethical) review.

For those researchers full details of how to submit for Tier 1 review as are at Peer Review Committee:

1. Staff

Save the NEAF application as a PDF document using the chief investigator's surname to identify the document.
Send soft copy of NEAF and all core attachments to humanethics@uws.edu.au
Forward original signed by all chief investigators either by mail or by hand-delivery to Human Ethics, Research Services, Building K1, Penrith Campus. There is no need to have the head of the academic sign the application.

2. Students

If you are a higher degree research candidate (PhD, Master Honours, Professional Doctorate).

Save the NEAF application as a PDF document using your Supervisor's surname to identify the document.
Send soft copy of NEAF and all core attachments to humanethics@uws.edu.au, including the confirmation of candidature document.
Forward original signed by all chief investigators, including candidate, either by mail or by hand-delivery, to Human Ethics, Research Services, Building K1, Penrith Campus. Supervisor must submit the application.

If you are a postgraduate coursework or 4th year Honours student your supervisor should apply to the Peer Review Committee for research merit and integrity review.

Signatures

All applicants' signatures are required on the original copy of the NEAF that is sent by mail or delivered by hand to the Human Ethics, Research Services, Building K1, Penrith Campus. UWS only requires signatures of all chief investigators not the School Dean.

The NEAF signature page includes space for a number of school/department signatures which are not required at UWS.

It is suggested that applicants retain a physical copy of the signed NEAF, in case the original goes astray in the mail.

NEAF requires that student and higher degree research candidate applications are submitted by the student or HDR candidate's supervisor.

The HREC is unable to review incomplete applications. Please ensure that all questions have been responded to and all support documents are included.

Higher degree candidates must have completed their Confirmation of Candidature before submitting an application.

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The progress of your application

Applicants may submit applications at any time throughout the year, however, applicants should note that Committees are sent papers and agenda well in advance of the meeting date. A closing date is set for receipt of applications for HREC.

The nature of the project and an assessment of the risk of harm to participants will determine if the application undergoes expedited review (weekly) or will be considered by the full Human Research Ethics Committee (monthly).

Applications tabled to either the full HREC or the HREC Executive cannot be accepted – all applications must be submitted through Human Ethics for registration on the University’s research management database and inclusion on the next available HREC or Executive meeting agenda.

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Amendments to approved protocols

From time to time it may be necessary to adjust or amend aspects of an approved human ethics protocol – for example, the addition of new researchers or the discontinuation of some researchers; changes to the recruitment procedure; addition or change to a site or a survey instrument.

How to progress an amendment request:

For time extensions – please complete a Progress Report Form (Word, 48Kb) detailing the work done so far and reasons for the extension. Email to the human ethics officer.
For additional researchers or students listed on the protocol, please provide details as per Section 2 of NEAF. Email to the human ethics officer.
For additional sites – please provide details as per Section 4 of NEAF. Email to the human ethics officer.
For changes to recruitment method, research design or instruments – use please provide summary of changes to the approved protocol and details of requested revised approach. If the protocol has been in operation for more than 10 months please provide a Progress Report Form (Word, 48Kb). Email to the human ethics officer.

Requests for amendments are considered by the Chair and will be responded to within 2 weeks of receipt by Research Services.

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