Research
Forms and Documentation
Applications to the Research and Ethics Office
Research applications have specific regulatory and documentation guidelines, namely:
- Applications must be complete, incomplete applications will be returned to the researcher
- Principal Investigators must sign all correspondence
- Applications must be submitted by the closing date (according to meeting timetable)
How to apply
To submit an application, download the appropriate forms and complete. As part of the move towards electronic submission of research applications, you will need to submit an electronic copy of all documentation (to ethics@eyeandear.org.au), plus one original signed application, plus the appropriate copies (see below for number of copies required).
All documentation is to be collated, so that each item of supporting documentation is attached to each copy of the application form. Each copy should be double-sided and stapled/clipped together. Individual items such as indemnity statements, CVs, CTN forms and clinical trial agreements are to be placed with the original, paper application.
If your project is being conducted under the CTN scheme, you will also be asked to submit an electronic version of all documents to ethics@eyeandear.org.au . Any commercial or patentable information should be marked 'commercial-in-confidence'.
Forms and Documentation |
HREC |
AREC |
| Cover Sheet (site specific) & New HREC Application in four modules (Module 1 compulsory) Module 1 , Module 2 , Module 3 , Module 4 or NEAF New AREC Application |
1 original + 15 copies | 1 original + 11 copies |
| New HREC Audit Application (with no PICF - for approval via streamlined process) | 1 Original | |
| Researcher Declaration Form (for all researchers) (HREC) (AREC) |
1 original + CV | 1 original + CV (+11 copies if submitted with new application) |
| Participant Information & Consent Form for Drug or Device Trial / For non-Drug or Device Trial | 1 Original + 15 Copies | |
| Questionnaires / Surveys / Documentation to Patients | 1 original + 15 copies | |
| Investigator's Brochure | 3 copies | |
| Form of Indemnity (Medicines Australia 'Standard' / HREC Review Only) | 2 originals | |
| Certificate of Currency of Insurance |
1 copy | |
| Clinical Trial Research Agreement (Medicines Australia / VMIS 'Standard' Agreement) | 2 originals (at least) | |
| CTN Form | 1 original | |
| Declaration by Head of (Supporting) Department | 1 original (per department) | |
| Fieldwork Notification form | 1 original | |
| Breeding application form | 1 original | |
| Annual Report (HREC) (AREC) | 1 original | 1 original |
| Amendment Form (HREC) (AREC) |
1 original | 1 original |
| Investigator Brochure Revision Form | 1 original + 1 copy (IB) | |
| Adverse Event Reporting Form (Single Incident HREC) (Periodic Event HREC) (AREC) | 1 original | 1 original |
| Self-audit form | 1 original | |
| Final Report (HREC) (AREC) | 1 original | 1 original |