​​​​​​​​​​​​Research Governance

Research Governance is a framework through which institutions are accountable for the research they authorise to be conducted at their site.  All research must be conducted according to ethical principles, guidelines for responsible research conduct, legislation and regulations.

Click here to access standard forms​  and checklists​ ​(including SSA Low Risk) for governance submissions. 

Click h​ere to jump to low/negligible risk submission information.

Click here to jump to access request information.

Click here to jump to full governance submission information.

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Governance (Site Specific Assessment) Submissions​

Site-Specific Assessment is a key element of research governance, which involves the review of HREC approval, HREC approved documents, Site Specific Assessment (SSA) form, site specific documents, study budget, Clinical Trial Research Agreements (CTRA), insurance and indemnity arrangements.​​

Research Projects undergo site specific assessment before authorisation can be granted by the Chief Executive of the organisation.

The Research Office provides Research Governance review for the following sites:

  • Hornsby Hospital
  • Macquarie Hospital
  • Manly Hospital
  • Mona Vale Hospital
  • Royal North Shore Hospital
  • Ryde Hospital

All applications for site authorisation are submitted using the Online Forms website​ (note that clicking this will take you to the external online forms website). 

Please note that Online Forms is not run by NSLHD, and we cannot provide technical support beyond basic queries. If you are experiencing difficulty with the Online Forms website please contact online forms helpdesk via the website (cont​act​). 


To submit a Low ​Negligible Risk Site Specific Application Project (reviewed by a Lead HREC)

The Principal Investigator at the site compiles the Site Specific Assessment (Low /Negligible Risk pathway) submission by referring to the SSA Low Risk Submission Checklist and Standard Forms.
 
Please note: The process for research governance/SSA remains the same after the launch of the HREA.  The process for submitting an SSA application for LNR review will not change. However, as of 31 August 2017, all applications will be submitted on a NSW “full” SSA form regardless of project risk level.

1. Complete SSA (Low Risk) online available from the O​nline Forms Website​.

2. Complie the submission using the SSA Low Risk Submission Checklist, Standard Forms and Method of Payment form​​.​

3. Create a cover letter addressed to the Research Governance Officer which; lists all documents being submitted including versions and dates, indicates if the application is a STUDENT PROJECT, addresses any study/application specific items that you wish to bring to the attention to the RGO and indicates if the Governance application is being submitted in parallel to NSLHD HREC application, gives an explanation on why any items listed on the SSA Low Risk Submission Checklist have not been provided. The cover letter should be signed by the Principal Investigator.

4. Submit all documents in hard copy to the Research Office as per the SSA Low Risk Submission Checklist. Each document should be printed and stapled.

5. Submit all documents in soft copy to the Research Office email: nslhd-research@health.nsw.gov.au.
 

Submitting a SSA Low Risk Ethics and Governance in parallel (at the same time)

SSA Low Risk applications should be submitted in parallel (at the same time) to the SSA (Low Risk) application when submitting the NLSHD HREC. However it is important to note that the SSA (Low Risk) application is not part of the HREA application.  Please create a separate SSA (Low Risk) application using the instructions available on this page the SSA Low Risk Submission Checklist and Standard Forms.

If you are unsure of the requirements please contact our office.
Incomplete applications will be returned to the applicant.
 

To submit an access request for governance authorisation

A research project that requires support from an entity with NSHLD, (e.g. participant recruitment with no consent, distribution of surveys and questionnaires, access to data) can submit an access request form for authorisation for the activity. 
 
Access Request Form Submission
1. Complete Access Request online available from the Online Forms Website.

2. Compile the submission using the Access Request Checklist.

3. Submit all documents in hard copy and soft copy to the Research Office as per the Access Request Checklist.

To submit a full governance or site specific application

All Governance submissions must include a separate study protocol document approved by the Lead HREC.
 
The Human Research Ethics Application (HREA) (previously NEAF) is not considered a protocol document. Submissions will not be accepted without a HREC approved study protocol document.
 
The Principal Investigator at the site compiles the Site Specific Assessment submission by referring to the SSA Submission Checklist and Standard Forms​.
 
1. Complete SSA online available from the Online Forms Websit​e​.
 
2. Compile the submission using the SSA Submission Checklist, Standard Forms and Method of Payment form​.

3. Create a cover letter addressed to the Research Governance Officer which; lists all documents being submitted including versions and dates, indicates if the application is a STUDENT PROJECT, addresses any study/application specific items that you wish to bring to the attention to the RGO and indicates if the Governance application is being submitted in parallel to NSLHD HREC application, gives an explanation on why any items listed on the SSA Submission Checklist have not been provided. The cover letter should be signed by the Principal Investigator
 
4. Submit all documents in hard copy to the Research Offic​e as per the SSA Submission Checklist. Each document should be printed and stapled.

5.Submit all documents in soft copy to the Research Office email​​ (nslhd-research@health.nsw.gov.au).
 

Submitting Ethics and Governance in Parallel (at the same time)

Governance applications can be submitted in parallel (at the same time) to the Ethics application when submitting the NLSHD HREC. However it is important to note that the Governance application is not part of the Ethics application.  Please create a separate Governance application using the instructions available on this page the SSA Submission Checklist and Standard Forms.

If you are unsure of the requirements please contact our office.
Incomplete applications will be returned to the applicant.