​​​​​Research Governance

Hunter New England Health is committed to the ongoing building of an organisation that lives our values. Our values are integral to the way we do business.

We encourage collaboration, openness and respect in the workplace to create a sense of empowerment for our people to use their knowledge, skills and experience to provide excellence in patient care for every patient, every time.

HNE Health is committed to research and to its proper governance and conduct. It recognises the critical role that research plays in informing clinical practice and promoting the health of the community. It also recognises that the experience of clinicians, patients and the community play in shaping research.

​​National Mutual Acceptance (NMA)
As of 16 July 2018, six NMA jurisdictions are using three different application platforms.  

Where do I create and submit SSAs for NMA studies?

While research applicants proposing studies under NMA will need to work within multiple platforms, the theory behind the process for creating those applications remains the same. Please see the following Links to the MoH website for more information:

HNE Governance Review Process

A Site Specific Assessment Form (SSA) must be submitted for all research being conducted at a site within the HNE Local Health District.

Please note: if your project is being conducted at the Calvary Mater Newcastle and Hunter New England Health sites, a separate SSA's must be completed for the CMN site.

Multi-site research

The Coordinating Investigator must create an SSA form for each site at which the research project is being conducted. The NSW Version of these forms must be filled in online and linked to the relevant HREA Ethics Application. There is online guidance for these forms.

The SSA Form is to be forwarded to the Principal Investigator responsible for the research project at the particular site, to complete and obtain the relevant signatures.

If you are still unsure about what is required, you should seek clarification from the Research Governance Officer responsible for the site.​

Submission requirements for Full HREC Review 

​Multi-Site

(i) For Full HREC Review Submissions (for Research that has been approved by the Hunter New England Human Research Ethics Committee):

  • Original Paper Copy of a completed and appropriately signed Site Specific Assessment Form (please ensure your form has been locked before you have it signed, signed Draft Copies will not be accepted). Note  Electronic Versions will not be processed, as a paper copy is required in order for the Chief Executive to sign on behalf of the Organisation.
  • Requisite number of the Indemnity Agreements as per the sponsors requirements and signed by the sponsor (see Medicines Australia Website);
  • Requisite number of Clinical Trial Agreements as per the sponsors requirements and signed by the sponsor (see Medicines Australia Website) (Please Note: there is a new version of the CTRA dated March 2017, previous versions will not be accepted); 
  • The TGA Clinical Trial Notification (CTN) online submission (see TGA for eCTN guidance):

          -   Sponsored Trials - confirmation of online submission and acceptance  
  •                 -   Investigator Initiated Trials where HNE is the Sponsor - Notification that a draft is ready for authorisation                                        (eCTN  Instructions for Researchers)

  •  Other documents as per the checklist but only if NOT already submitted with the ethics application

(ii) For Governance Only Submissions (for Research has been approved by another Lead Human Research Ethics Committee):

  • Original Paper Copy of a completed and appropriately signed Site Specific Assessment Form (please ensure your form has been locked before you have it signed, (signed Draft Copies will not be accepted).  Note  Electronic Versions will not be processed, as a paper copy is required in order for the Chief Executive to sign on behalf of the Organisation
Electronic copy of the following:
      • The Original HREA
      • The Initial Approval Letter from the Lead HREC
      • All documents listed on the approval letter ensuring the versions numbers and date are the same
      • Any Site Specific Versions of Master documents
      • Approval Letters and associated documentation for any subsequent amendments

​​​(iii) For Low and Negligible Risk Research (LNR) Submissions:

An electronic copy only of the following:

  • A completed and appropriately signed Site Specific Assessment Form; and
  • Copy of other supporting documentation

Single-Site​ (site/s within the HNELHD only)

 

via REGIS https://regis.health.nsw.gov.au/

The Research Ethics and Governance Information System (REGIS) is the portal to help manage ethics and site governance in NSW and ACT Public Health Organisations (PHOs).​

The Site Specific Assessment Form (SSA) will be created from the Project Registration and Generation of the HREA within REGIS. The Applicant must complete the SSA and upload their Site Specific Documentation. The applicant then Submits their SSA to the Head/s of Department for them to indicate their support of the project. Once the HOD/s indicate their support, the applicant must submit their SSA to the Research Governance Office. This is all done electronically through REGIS.

Access Request Form

Please see  https://www.medicalresearch.nsw.gov.au/site-authorisation/ for details about making an access request submission

 

CMN Governance Review Process

The Governance processes for Research conducted at the Calvary Mater Newcastle are managed by the Research Ethics and Governance Office of the Hunter New England Local Health District as well as the Calvary Mater Newcastle Clinical Ethics Committee.

CMN Clinical Ethics Committee

Calvary Mater Newcastle Clinical Ethics Committee is not an officially recognised Human Research and Ethics Committee under the NHMRC guidelines. Any proposed research or clinical trial at Calvary Mater Newcastle must firstly receive the approval of a Lead HREC. Once approved research is then reviewed and approved by Calvary Mater Newcastle's Clinical Ethics Committee.

For more information please go to: https://research.calvarymater.org.au/research/ethics-and-governance/

Calvary Mater Newcastle Submission Requirements (for Research that has been approved by the HNE Human Research Ethics Committee)

​Single Site (HNE & CMN sites only)

via REGIS https://regis.health.nsw.gov.au/

The Research Ethics and Governance Information System (REGIS) is the portal to help manage ethics and site governance in NSW and ACT Public Health Organisations (PHOs).​

The Site Specific Assessment Form (SSA) will be created from the Project Registration and Generation of the HREA within REGIS. The Applicant must complete the SSA and upload their Site Specific Documentation. The applicant then Submits their SSA to the Head/s of Department for them to indicate their support of the project. Once the HOD/s indicate their support, the applicant must submit their SSA to the Research Governance Office. This is all done electronically through REGIS.

Calvary Mater Newcastle Submission Requirements (for Research has been approved by the HNE Human Research Ethics Committee)

​Multi Site

In order for your Governance Submission to be reviewed by the Calvary Mater Newcastle Clinical Ethics Committee, documents must be submitted to the HNE Research Ethics and Governance Office by the submission due date for the corresponding meeting date.

CMN CLINICAL ETHICS COMMITTEE MEETING DATES

 Submission Due Date​Meeting Date
13 February 2019February 2019
13 March 2019March 2019
10 April 2019April 2019
8 May 2019May 2019
12 June 2019June 2019
10 July 2019July 2019
14 August 2019August 2019
11 September 2019September 2019
9 October 2019October 2019
13 November 2019November 2019
Please Note: the CMN Clinical Ethics Committee does not meet in December. Submissions for the January 2020 TBA

 

 We will require the following documentation by the submission due date:

  • Original of a completed and appropriately signed Site Specific Assessment Form (please ensure your form has been locked before you have it signed, signed Draft Copies will not be accepted); and
  • Electronic copy of the following:
      • The Original HREA
      • The Initial Approval Letter from the Lead HREC
      • All documents listed on the approval letter ensuring the versions numbers and date are the same
      • Any Site Specific Versions of Master documents

For Low and Negligible Risk Research (LNR) Submissions: Approval Letters and associated documentation for any subsequent amendments

An electronic copy only of the following:

  • A completed and appropriately signed Site Specific Assessment Form; and
  • Copy of other supporting documentation

Please note: if your project is being conducted at the CMN and HNE sites, 2 separate SSA's must be completed.

For Access Request Form (AR) Submissions:

An electronic copy only of the following:

      • Signed copy of Access Request Form
  • The HREC letter of approval
  • All documents to be distributed through the facilities, locations or services; and
  • Confirmation of support from staff of the relevant facilities, locations or services