Preparing and Submitting a Governance Application (SSA)
Preparing Site Specific Assessment (SSA) applications
SSA applications should be prepared for all sites where research is proposed to be undertaken. SSA applications form a key part of research governance and allows public health organisations to determine, among several governance requirements, the suitability of the investigators to undertake and the proposed site to host the research, including considerations of any resource requirements. Please contact the relevant LHD Research Governance Officer/s well in advance to the submission of your application. The submission of an incomplete application will delay the authorisation process.
All research to be conducted within NNSW and/or MND LHDs must have site specific authorisation prior to commencement. Applications for SSA must be submitted using the SSA form via the Research Ethics Governance Information System (REGIS). The REGIS website provides guidance on how to complete the application forms and details the supporting documents required for making an application. Once completed in REGIS, the SSA is submitted and assessed for eligibility by the Research Governance Officer, which will then manage the subsequent authorisation process.
When preparing your SSA in REGIS – please ensure:
- All information relates to the relevant site (Facility and/or Local Health District).
- Applications need to be clear regard to the resources relating to participation by the LHD in the project eg:
- Number in each of the participant groups (as discussed with the relevant LHD Manager)
- Task/s ie: what is the expected participation eg: complete online survey, participate in focus group etc
- Timeframe – how long is each task expected to take to complete (travel time to and from a venue should be included in the timeframes)
- Once completed in REGIS, the SSA is submitted and assessed for eligibility by the Research Governance Officer, which will then manage the subsequent authorisation process.
Access Request (AR) applications
An AR review, instead of SSA, should be completed for all human research projects that require support from the NNSW and/or MNCLHDs in the form of access to participants, tissue or data but do not involve the actual conduct of research at a NNSW and/or MNCLHD site.
Applications for AR review must be submitted using the AR form. The form is available from the Site Authorisation Page on the Office for Health and Medical Research website and includes detailed information on the supporting documentation required.
Only one AR per Research Governance Officer is required for each research project, even if the project requires access to several facilities, locations or services covered by that Research Governance Officer. ARs will be accepted in electronic format – including scanned copies of the signature pages. Submit by email to the relevant Research Governance Officer.
Research Governance Fees
When the NSW System for Single Ethical and Scientific Review of Multicentre research was introduced in 2007, the then NSW Department of Health specified a fee schedule. This fee schedule is outlined in clauses 1-5 of the policy PD2008_030 HREC and Research Governance: Fee Policy for Review of Commercially Sponsored Research. Revenue from these fees is to be used in accordance with the policy clause that states:
Revenue raised through the application of this policy must be used by Public Health Organisations to support their HREC and their research governance functions (including salaries, administrative support and training).
Prior to 1 August 2021, the only fees levied within the Northern NSW Local Health District have been in accordance with the aforementioned policy directive. There have been no increases in these fees since 2007.
The following fee structure is effective from 1 August 2021:
Site Specific Assessment | Type of Sponsorship | Fee (inc. GST) |
---|---|---|
Initial review | Commercially Sponsored Research including Clinical Research Organisations.
Collaborative group studies with commercial sponsorship >$50K to NNSWLHD. |
$5500
$3740 |
Major Amendments
|
Commercially Sponsored Research including Clinical Research Organisations. | $550 |
Minor Amendments requiring site acknowledgement only | N/A | Nil |
Exemptions | Students with limited funding.
Internal NNSWLHD projects. Collaborative Organisations e.g. Universities with <$50K in sponsorship to the NNSWLHD. Not for Profit Research Organisations with <$50K in sponsorship to the NNSWLHD. |
Nil |
Further Information:
- Process for engaging NSW Health Pathology for research purposes
- NC NSW HREC resources and forms
- NSW Health Office of Health and Medical Research on Access Requests
- Research Ethics and Governance contact details