If you are seeking ethical approval from a certified HREC other than the RCH, as part of the National Mutual Acceptance (NMA) scheme, you need to submit a
Governance Only ‘Site Specific Assessment (SSA)’ Application.
There are no closing dates for SSA applications – they can be submitted for review at any time.
ERM number
Your research project must have a single unique identification number for use across the Parkville Precinct and the Melbourne Children’s Campus. This is called an ERM Project ID. ERM will generate this five digit number when you create your project in ERM. You will find this number at
the top right hand corner of your screen on ERM. Ex. 55555. See
How to get a project reference number.
You need this number to communicate with REG and for all internal communications, as well as all supporting service departments on campus. Please quote this number in all email and other correspondence
You also need to
pre-register your study prior to submission. You can do this by completing the
pre-registration form.
Include your ERM Project ID in this form.
RCH HREC fee payment
Your RCH HREC Submission Fees are payable in full when you submit your project or amendment. Use the RCH HREC Fee Payment Form
for payment remittance advice - proof of payment.
You can pay the fee by credit card, electric funds transfer and internal cost centre transfer. All credit card payments will incur a 1.5 per cent surcharge fee. We can no longer accept American Express (AMEX) credit card payments.
If payment does not accompany the initial submission or amendment the Ethics review process will not be able to start until it has been received.
To determine whether fees are applicable to the review of your submission, please review the schedule of RCH HREC Submission Fees. You do not need to submit this form if no fee applies.
Submission process
The following documents are required when submitting an SSA application for governance authorisation (as applicable):
| Document |
Number of Copies |
|
RCH REG Application Coversheet
|
One electronic copy
|
|
HREC Approval letter listing:
- All ethically approved documents - see the handy hints on this page
- RCH or MCRI as an approved site |
One electronic copy |
| Protocol - see
templates and guidance |
One electronic copy |
|
Human Research Ethics Application (HREA) |
One electronic copy signed by the PI |
|
Victorian Specific Module (VSM) |
One electronic copy |
Site Specific Assessment (SSA) Form Wet ink signatures can be obtained on the below declaration forms: Head of Department Declaration Supporting Department Declaration Form (please also refer to below) |
One electronic copy signed by:
- Associate investigators (RCH/MCRI only)
- Head of Department, and
- Supporting Departments |
|
Supporting Department Declarations completed via the MCC Department and Ethics Research Platform if applicable This Platform allows you to request support from the following Departments: - MCRU
- Medical Imaging
- Pathology/Lab services
- Endocrinology
- Audiology
|
One electronic copy of the signed approval - PDF |
| Master Participant Information Statement and Consent Form tracked to site specific - see the handy hints on this page |
One electronic copy |
| Master Parent/Guardian Information Statement and Consent Form tracked to site specific - see the handy hints on this page |
One electronic copy |
| Master Child Information Sheet tracked to site specific - see the handy hints on this page |
One electronic copy |
| Investigators Brochure or Product Information |
One electronic copy |
| Other documents for participants such as flyers, letters, contact forms, advertisements, questionnaires, diaries etc |
One electronic copy |
Site budget
|
One electronic copy
|
| Research Agreement |
One electronic copy |
| Form of Indemnity (if commercially sponsored) |
One electronic copy |
| Insurance Certificate (if commercially sponsored) |
One electronic copy |
You need to submit electronic documents as separate documents. Each file name should capture the name of the document, as well as the version number and date.
Handy hints
- Approval Certificate: Please ensure documents listed on the approval certificates are submitted to the RGO with the same file name (and/or footer) to ensure ease of review. Inconsistent naming will delay approval times.
- Please take the master approved document and track changes to make it specific for this site i.e. 'site-specific'. In this case it is only necessary to submit one file, as the RGO can hide tracked changes to view the "Master" and accept tracked changes to view the 'clean site-specific'.
- Please keep the version and date consistent with the master approved version i.e. if the Master is version 1 dated 12/01/19, the site specific should also be version 1 dated 12/01/19.
- Ensure site specific governance documents include appropriate version controls i.e. document footers should include version controls e.g.'RCH Site Specific PICF, Version 1 dated 01 March 2016 (based on Master PICF, Version 1 dated 01 March 2016)'
- Ensure that all site specific information has been inserted and that no prompts remain in the information statement and consent forms.
- Common omissions within the SSA form include site specific recruitment numbers and strategies.
- Ensure you use your ERM number on all documents and correspondence.
Please ensure that you submit a Governance Only SSA Application as soon as possible, preferably in parallel with the ethics submission. This is critical for applications where a non-standard agreement is used as legal review will be required, which may incur delays.