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How to submit for 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 for governance submissions.

 

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
  • Mona Vale Hospital
  • Royal North Shore Hospital
  • Ryde Hospital

All applications for site authorisation are submitted using REGIS.

Please note that REGIS is not managed by NSLHD, and we cannot provide technical support beyond basic queries. If you are experiencing difficulty with REGIS website please contact REGIS Help Desk on 1300 073 447.

 

How to submit a Site Specific Assessment (Governance Application)

 

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 within REGIS External Link.

2.  Complete the application using the SSA Submission Checklist, Standard Forms and Method of Payment Form

3.  Create a Word icon 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 of the RGO and gives an explanation on why any items listed on the SSA Submission Checklist have not been provided. The cover letter must be signed by the Principal Investigator.

 

Access Request

 

An Access Request review is required to be completed for all human research projects that require support from a NSW Public Health Organisation (PHO) in the form of access to participants, tissue or data but do not involve the conduct of research at that PHO.

Access request review should be used when the project involves one or more of the following at the PHO:

  • Participant recruitment through posters, leaflets, handouts and letter of invitation but not recruitment through direct contact with potential participants or enrolment (both of which require a Site Specific Assessment);
  • Distribution of surveys and questionnaires through staff of the PHO but not collation and analysis of responses at that PHO (which requires a Site Specific Assessment); and
  • Access to data or tissue held at the PHO but not processing or analysis at that PHO (which requires a Site Specific Assessment).

The Research Governance Officer has the discretion to request that the application is submitted for site specific assessment if they consider that the project involves the conduct of research at a site.

Please note the NSLHD Research Office will accept University ethics approval in lieu of a Health HREC approval for Access Requests.

Please Word icon click here for further information on Access Requests including how to submit an Access Request.

 

Perinatal Research Advisory Group

 

The Perinatal Research Advisory Group oversees all clinical research taking place within the Maternity Services at Royal North Shore Hospital. The group will advise when research can be accommodated in individual clinical areas depending on the resources, time and space required.

For ANY researchers (including any Maternity & Obstetric staff members) wishing to conduct clinical studies within Maternity Services an application is required to be submitted to the Perinatal Research Advisory Group for review prior to Governance submission.

For further information, please email [email protected]

Word icon Click here for application form.

 

Helpful Links and Information

 

Chevron Word icon NSLHD CTN Summary

Chevron PDF icon NSLHD Institution Details

Chevron Medicines Australia External Link

Chevron Standard Clinical Trial Research Agreements External Link

Chevron Indemnity Forms (HREC review only and standard) and Compensation Guidelines External Link