Submitting a Proposal
The following application forms are available at the “Online Forms” website at: www.ethicsform.org/au. (First time users of the site must create an account before proceeding).
- Human Research Ethics Application (HREA) for both multi-centre, single-site and Low/Negligible Risk research from 1st September 2017. NB: NEAF and LNR forms will still continue to be accepted if an application was created prior to this date.
- Site Specific Application (NSW SSA)
Important note: Low risk ethics applications may be made submitted at any time.
SSA applications may be submitted at any time.
COMPLETING THE ONLINE FORM
- The supervisor of a student project should be listed as the Coordinating Investigator, not the student.
- When the HREA form has been completed you need to click on “Submission Tab” which will generate a “submission code” and also remove the “draft” watermark. The form can then be printed out and signatures obtained before submitting the “hard copy” to the Research Office.
- Completing your forms and uploading your documents on the “Online Forms website” does not result in their submission to the CRGH Research Office. Please submit the required documents in hard copy and pdf as outlined below.
DOCUMENTS TO BE SUBMITTED
For both single and multi-site research, the documents listed below are required. A pdf of each document should be emailed to SLHD-ConcordEthics@health.nsw.gov.au and one paper copy of each document should be provided to the CRGH Research Office.
- HREA form
- Study Protocol
- For research involving medical records review: a Data Collection Form (DCF).
- Participant Information Sheet & Consent Form. A pro-forma is available here. For multi-site research this should be a Master Version from which all sites can prepare their own local version. It should contain a version number and date.
- Separate Participant Information Sheet and Consent Form for genetic sub-studies.
- Site Specific Assessment (SSA) Form – one hard copy with submission code and all signatures. Only the SSA form for Concord Hospital needs to be submitted to the CRGH Research Office. This can be done at any point during the ethics approval process but it may help to expedite matters if it is submitted along with the NEAF/LNR form.
NB: ALL SUBMITTED DOCUMENTS SHOULD BE SINGLE-SIDED AND UNSTAPLED.
Additional documentation for clinical drug or device trials:
- Clinical Trial Protocol – please provide one electronic and 3 paper copies
- Investigators brochure/product information - please provide one electronic and 3 paper copies
- For Clinical Trials involving sites in Victoria, a Victorian Specific Module (VSM) must be completed.
- For sponsored trials where the trial will be conducted at CRGH: Medicines Australia Form of Indemnity (Standard) – 3 originals
- For sponsored trials where Sydney Local Health District HREC – CRGH is the lead HREC: Medicines Australia Form of Indemnity (HREC Review Only) – 3 originals
- Where Sydney Local Health District HREC-CRGH is the reviewing HREC and CRGH is a site for the trial, both Forms of Indemnity are required
You can find the Medicines Australia Forms of Indemnity here. The indemnity documents must name Sydney Local Health District Level 11 KGV Building Missenden Road Camperdown NSW 2050 ABN 17 520 269 052 as the indemnified party.
- For externally sponsored trials only: Medicines Australia Standard Clinical Trial Research Agreement (CTRA) – 2 or more originals
You can find the Medicines Australia standard CTRAs here.
- For externally sponsored trials only: Insurance Certificate: The sponsor should provide evidence that it has appropriate and sufficient insurance to meet its responsibilities under the Medicines Australia Standard Indemnity. Sufficient evidence is a current certificate of insurance which covers the conduct of the relevant clinical trial in Australia and contains insurance cover for a minimum amount of AUD $20 million for any one occurrence and in the annual aggregate. The Insurance Policy must not contain an excess/deductible greater than AUD $25,000 per claim.
GUIDE TO WRITING A RESEARCH PROTOCOL
A Research Protocol is mandatory for all applications to the Ethics Committee. Guidance on writing a Research Protocol is available here.