Concord Hospital Concord Hospital
The Concord Research Office

Submitting a Proposal

A research proposal is submitted for review using the Research Ethics and Governance Information System (REGIS) website at: https://regis.health.nsw.gov.au/. (First time users of the site must create an account before proceeding).

  1. The first step is to register your project in REGIS. More information is available here.
  2. Once project registration is complete, the Human Research Ethics Application (HREA) must be completed in REGIS. The HREA is used for all research submissions regardless of the level of risk and regardless of whether the research is single-site or multi-site. More information is available here.
  3. Once the ethics application has been submitted, you can commence the Site Specific Assessment Application (NSW SSA) in REGIS. More information on completing an SSA application and obtaining Head of Department support is available here. More information on submitting the SSA application is available here.

When to submit

Low or negligible risk  ethics applications cut-off dates are available here. Please submit the application at least 9 days before the meeting if you'd like it to go to a particular meeting date.  

Greater than low or negligible risk ethics applications must be submitted no later than the HREC's monthly submission dates.

SSA applications may be submitted at any time once the HREA has been submitted.

Please use this submission checklist to assist in submitting Low and Negligible Risk applications.

Please use this submission checklist to assist in submitting Greater Than Low Risk applications.

 Important notes:

  1. The supervisor of a student project should be listed as the Coordinating Investigator, not the student.
  2. During project registration a Co-ordinating Principal Investigator/Researcher must be selected. This is the person with overall responsibility for the research project at all sites. In the HREA this person MUST have the following responses:
    • Q1.9.10 “What is the position of this person on the research project?” must be answered as “Coordinating Principal Investigator”
    • Q1.9.11 “Does this person have authorisation to sign the application on behalf of all members of the research team?” must be answered as “Yes”.
  3. When uploading document files onto REGIS during project registration, keep your electronic filenames as short as possible e.g. Protocol or PISCF. The HREA requires the electronic filename to remain the same even when a new version of the document is uploaded. The filename SHOULD NOT include a version number or date.
  4. Do not include any appendices in the protocol. These should be uploaded as a separate document on REGIS.
  5. Please do not access the HREA from the NHMRC site
  6. Notes on how to complete a HREA form for a medical records project are available here.

NB: Please send a notification email to SLHD-ConcordEthics@health.nsw.gov.au once the application has been submitted on REGIS


SUPPORTING DOCUMENTS

The following supporting documents should be uploaded onto REGIS with your HREA. 

  • Study Protocol
  • Data Collection Form (DCF) (For research involving medical records review) 
  • Research Data Management Plan (For research involving data collection). The form is available here.
  • Privacy Compliance Form (For research requesting a waiver of the usual consent). The form is available here.
  • 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.
  • Once the ethics application has been submitted: Site Specific Assessment (SSA) Form for each site at which the research will be conducted.
  • For all NSW Health Pathology staff or researchers collaborating with NSW Health Pathology staff, services or facilities, additional requirements apply. Please click here for further information. 

Additional documentation for clinical drug or device trials:

  • Clinical Trial Protocol – upload to REGIS 
  • Investigators brochure/product information - upload to REGIS
  • For Clinical Trials involving sites in Victoria, a Victorian Specific Module (VSM) must be completed - upload to REGIS
  • For Clinical Trials involving sites in Western Australia, a Western Australia Specific Module (WASM) must be completed - upload to REGIS 
  • For sponsored trials where the trial will be conducted at CRGH: Medicines Australia Form of Indemnity (Standard) – 3 original paper copies
  • For sponsored trials where Sydney Local Health District HREC – CRGH is the lead HREC: Medicines Australia Form of Indemnity (HREC Review Only) – 3 original paper copies
  • 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 original paper copies
    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.
  • For all NSW Health Pathology staff or researchers collaborating with NSW Health Pathology staff, services or facilities, additional requirements apply. Please click here for further information. 

All original paper copies of contracts should be submitted to our office.


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.