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 Help page.
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.
The HREC Review Checklist (PDF 82 KB) shows you what the Human Research Ethics Committee (HREC) looks for when reviewing applications for ethics approval.
Example Applications
- Example Application for Research involving Aboriginal participants (More than Low Risk Research)*
- Example Application for Negligible Risk Research*
- Exemplar Application to use commercially available cell lines (Negligible Risk Research)
*The redacted application has been shared with the permission of the Chief Investigator.
Templates
- Participant Information Statement - Template (DOC 102 KB)
- Participant Information Statement for Anonymous Surveys/Questionnaires - Template (DOC 47 KB)
- Consent Form - sample content (DOC 76 KB)
- Recruitment flyer template (PPT 64 KB)
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.
| LEVEL | EXAMPLES OF RISK | REVIEWED BY |
|---|---|---|
| Negligible Risk Research | Research in which there is no foreseeable risk of harm or discomfort; and any foreseeable risk is no more than inconvenience. E.g. minor survey or interview on a benign topic, giving up time. | Chair, Deputy Chair or Human Ethics Officer |
| Low Risk Research | Research in which the only foreseeable risk is one of discomfort. E.g. minor side effects, discomfort associated with blood tests, emotional discomfort induced by an interview or survey, management of relationships involving a power imbalance, embarrassment, management of incidental findings or observations, risks to confidentiality and privacy. | HREC Panel |
| More than Low Risk Research | Research in which there is potential for harm. E.g. physical, psychological, social, economic or legal harms. The risk can be associated with the activities of participation (e.g. novel interventions or trials, exposure to ionising radiation) or the potential vulnerability of the research population (e.g. Aboriginal & Torres Strait Islander peoples, people with a cognitive impairment, intellectual disability or mental illness, women who are pregnant) as defined by the National Statement on Ethical Conduct in Human Research. | Full HREC |
Response times vary depending on level of review. Please view the Submission Dates and Response Times page for further information.
Only low or negligible 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: Registration Ext HREC Approval - Registration of Hunter New England Human Research Ethics Committee approvals or approvals from other registered HRECs, as stated in the Collaborative Research and Ethics Approval Guideline). Note that projects involving University of Newcastle staff or students as research participants must be reviewed by the University of Newcastle's HREC.
- 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:
- is a concise application to facilitate efficient and effective ethics review for research involving humans; and
- assists researchers to consider the ethical principles of the National Statement on Ethical Conduct in Human Research, 2007 (updated 2018) in relation to their research, rather than focus on requirements for approval.
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.