Forms and Guidelines

Application forms for Human Ethics clearance can be accessed via the Research Information Management System (RIMS).

If you require assistance with RIMS, please refer to the RIMS Human Ethics User Guide and RIMS support page or contact a Human Ethics Officer.

Feedback on the eForms is encouraged and welcomed. Please forward your comments to human-ethics@newcastle.edu.au.


Guidelines

Notes for Researchers

Please refer to the Notes for Researchers document (DOC 160 KB) before you begin your application. The notes provide tips on avoiding common problems with applications, guidelines on key ethical considerations and other useful information to assist you in your application.

The Information Statements and Consent Forms - Guidelines (DOC 92 KB) contains background information on information statements and consent forms. Additional question-specific guidelines are provided in the application forms.


Information Statement templates

Consent form templates

Recruitment templates


HREC review

The HREC Review Checklist (PDF 82 KB) shows you what the Human Research Ethics Committee (HREC) looks for when reviewing applications for ethics approval.


Application Forms

Initial Application Form

Initial application forms are used for seeking human ethics approval for a new project.

Applications must undergo a 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 whether it is 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 undergo expedited review.

LevelRiskReviewed by
Level 1 Negligible or no appreciable risks or ethical issues Chair, Deputy Chair or Human Ethics Officer
Level 2 Low risk and ethical issues addressed by research design HREC Panel
Level 3 Potential for significant or unavoidable risk; not eligible for L1 or L2 Full HREC

Response times vary depending on level of review. Please view the Submission Dates and Response Times page for further information.

Only low risk research can be considered by expedited review, as the National Statement on Ethical Conduct in Human Research, 2007 (updated 2018) identifies certain types of research that can only be reviewed by a full HREC.

Which form to use

RIMS has a defined set of initial application forms that are tailored for specific purposes. Each type of initial application will automatically determine the level of review applicable for your application.

The eForm will determine eligibility for expedited review and identify any additional forms you need to complete and submit.

  • Initial: New Project - Submission of a new ethics application. The form will automatically determine the level of review required.
  • Initial: Course Related Ethics Approval - Submission of course related ethics application.
  • Initial: Registration of Test/Procedure - Registration of a new test or procedure.

Initial - HREA Pathway (formally NEAF)

The National Health and Medical Research Council (NHMRC) has streamlined ethics approval by developing the Human Research Ethics Application (HREA) as a replacement for the National Ethics Application Form (NEAF).

The HREA:

HREA applications can be made at the HREA website.

The HREA Resources page offers a range of information for researchers including guides and videos on getting started, how to create an account and how to navigate, copy or share an application. For technical assistance on the HREA system please contact HREA Help on 1800 500 983 / +61 2 6217 9451 or email help@hrea.gov.au.

Once you have completed your HREA and a Project Description, please include them as attachments with your initial eForm submission in RIMS.


Variation

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

You can complete a Variation application by logging into RIMS, opening an existing protocol and completing a Variation submission.