Frequently Asked Questions

Please note that Governance submissions are not reviewed at meetings and therefore the Ethics submission closing dates do not apply for SSA submissions.

A Site Specific Assessment form (SSA) is used to gain authorisation for research at public health sites within New South Wales. An SSA Form will be created by the same individual that wrote the Human research Ethics Application (HREA) for that research project using the Online Forms website

If you’re coordinating the project and you wrote the ethics application, generate an SSA from the HREA form using the ethics website.  To do this, select the ethics application from your list of projects and then click on the SSA tab. You should then have an option to create a new SSA Form.

Please find more information here

Signatures can be ink signatures with hard copies forwarded to the Research Support Office. Scans of the ink signatures that are forwarded electronically will also be accepted. Signatures can also be electronically generated using the Online Forms website

Please find more information here

This office is currently only accepting local, single site LNR applications via REGIS

Please access the REGIS website here.

IMPORTANT NOTE: All researchers nominated for a site must have a REGIS account before you can complete the SSA.

Please login to REGIS and access the Projects page.

The Project Details page will show a list of the ethics and governance applications associated with the project. You will only be able to access the SSA associated with your site.  

Site applications are indicated with the STE code, i.e. 2018/STE00067 The status: ‘In Progress’ indicates to the SSA can be edited or completed. Please click on the ‘identifier’ to open and edit the application. 

Please read the Quick Reference Guide for researchers completing a Site Specific Application via REGIS.

Please find more information here.

Yes. You must submitted your SSA with support from the relevant Head of Department.
In Regis: Part C of the SSA

  • Select the department from the drop down menu, and the Head of Department’s (HoD’s) email address should appear automatically. You can add further information as required.
  • C1: If you do not see the Department you required, contact the Research Office for the site.
  • C5: Include detailed advice here regarding resources as this will help inform the Head of Department when they review the SSA

If your study is a Clinical Trial of a Drug or Device sponsored by a commercial company or collaborative group, there will be some additional documentation that you’ll need to attach to your SSA submission. 

Please find more information, including CTRA and MTAA templates, here

Australian state and territory Departments of Health have signed a Memorandum of Understanding for mutual acceptance of ethical and scientific review of the multi-centre human research projects undertaken in Public Health Organisations. Currently Australian Capital Territory, New South Wales, Queensland, South Australia, Victoria and Western Australia are participating in National Mutual Acceptance (NMA).

The scope of NMA includes any form of human research as defined in the National Statement on Ethical Conduct in Human Research (NHMRC, 2007) for which an application must be made to a HREC for the purpose of being conducted at a public health organisation.

Please note that QLD, VIC and WA use different research ethics and governance online systems.

The Royal Hospital for Women (RHW) is now a highly active research institution, in all areas of perinatal care. A large number of staff, from midwifery, obstetrics, neonatal nursing and neonatology have contributed to this research activity. Perinatal Academic Group (PAG) was developed at the RHW (November 2011) to review new trial applications, discuss resource implications and oversee a research strategy for the future.

For research conducted in the Royal Hospital for Women Labour Ward, the Perinatal Academic Group will need to provide a letter of approval. Please find the required forms/templates here

Please read the Policy Directive which sets out the fees to be charged by public health organisations for carrying out a research governance review of commercially sponsored research (site specific assessments) and review of commercially sponsored research by their Human Research Ethics Committees (HRECs).
 

  • Submit everything at once with a covering letter itemising the contents of the submission. If any documents are missing or pending, please list these documents on the covering letter. 
  • Electronic submissions will be accepted but not for legal documents requiring original signatures like contracts.
  • Provide relevant contact details. You may need to answer queries regarding this submission. Respond to any queries that are raised.
  • It’s always faster to submit a complete application than submit in multiple stages and then respond to queries later.