Application Forms and Guidelines

These are the only forms to be used to apply for human ethics approval from the University of Newcastle. All staff, students, and external researchers wanting to conduct human research at the University, use these forms. Applications on old forms will not be accepted.

Research Ethics Advisors (REAs) have been appointed in Faculties to assist researchers, both staff and students, to design ethically acceptable human research and assist them through the ethics approval process. Enquiries should be directed to them in the first instance.

The HREC Register of Approved Tests and Procedures is now available. For tests and procedures listed in the Register it is not necessary for researchers to provide copies with an application to the HREC for ethics approval.

The following Initial and Variation forms are to be used for applications to the University of Newcastle Human Research Ethics Committee (HREC).

There is no longer an application form specifically for Renewal of Approval. This has now been incorporated into the HREC Annual Progress Report form.

The application forms and guidelines undergo continuous refinement. Each time they are amended the form identification numbers will change. Download the appropriate form each time you are required to submit an application. Applications submitted on outdated forms will not be accepted.

Feedback on the forms is encouraged and welcomed. Please forward your comments to Human Research Ethics.

Guidelines

Notes for Researchers:

Please refer to the Notes for Researchers before you begin your application. They provide tips on avoiding common problems with applications, guidelines on key ethical considerations and other useful information to assist you in your application. Additional question-specific guidelines are provided in the application forms.

What the HREC looks for:

The HREC Review Checklist shows you what the HREC looks for when reviewing applications for ethics approval.

Information Statements and Consent Forms for research participants:

* Guidelines

* Information Statement - sample content

* Consent Form - sample content

Application Forms

Initial approval

Variation to approved project

Getting help with your application. Research Ethics Advisors (REAs) have been appointed in Faculties to assist researchers, both staff and students, to design ethically acceptable human research and assist them through the ethics approval process. They are the first source of assistance.

Initial

The Initial application forms are used for seeking human ethics approval for a new project. Applications must undergo peer review prior to submission.

The University of Newcastle HREC applies a hierarchical level of review to applications for ethics approval. This reflects the ethical issues and possible risks to research participants presented by the research protocol. Risk is the potential for harm - physical, psychological, social, economic, or legal - or the potential to cause people to think they have been treated disrespectfully. There are 3 levels - two of which are dealt with by expedited review.

Level	Risk to participants:	Reviewed by:
L1	Negligible or no appreciable risks or ethical issues	Chair or Deputy Chair
L2	Low risk and ethical issues addressed by research design	HREC Panel
L3	Potential for significant or unavoidable risk; not eligible for L1 or L2	Full HREC

Response times vary depending on level of review.

Only low risk research can be considered by expedited review. The National Statement on Ethical Conduct in Human Research identifies certain types of research that can only be reviewed by a full HREC.

There are 2 application forms for applying for Initial human ethics approval:

1. Initial Application - Expedited Review - used for L1 and L2 applications

2. The NEAF - National Ethics Application Form developed by the governing body for human research ethics committees in Australia - used for L3 applications.

Which form to use:

Start with the Initial Application - Expedited Review form.

Questions in Part A of the form will determine eligibility for expedited review and the form you need to complete and submit. Alternatively, if you know your research will be ineligible for expedited review you can go direct to the NEAF pathway.

Initial - Expedited Review		Initial - NEAF pathway
Application form (Includes How to submit)	Word	NEAF - How to submit an application	Word
		NEAF Supplement and peer review declaration	Word
		NEAF Quick Reference Map	PDF
		NEAF Application form **	Go to

** Please note: The first time you access NEAF you will need to register as a user. If you do not receive an email from NEAF within 24 hours with confirmation of your registration and your password please contact Neaf Assist on 1800 823 993 or neafassist@nhmrc.gov.au

If you continue to encounter problems please contact staff in the Human Research Ethics office on :

492 18999; 492 15151 or 492 16333 or Human-Ethics@newcastle.edu.au

Variation

The Variation application is used for requesting approval for proposed variations or amendments to research projects which have an existing human ethics approval.

Document

Variation Application