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Submitting a Site Specific Application

There are 2 pathways to obtaining site authorisation in HNELHD, depending on the research activity:

  • Site Specific Application (SSA) - required for each HNELHD site at which the research project has been approved by ethics to be conducted.
  • Access Request - should be submitted instead of and SSA for all human research projects that require support from HNELHD in the form of access to participants, tissue or data but do not involve the conduct of research within HNELHD

Site-Specific review is a key element of research governance, which involves the review of:

  • HREC approval and HREC approved documents,
  • Site Specific Assessment (SSA) form and site specific documents,
  • Regulatory Documents such as research agreements, insurance and indemnity arrangements

All research projects within HNE must undergo review before authorisation can be granted by the HNE Chief Executive/Delegate

The projects must not commence until the applicant has received written notification of documented authorisation from the HNE Research Office.

Site Specific Application

A Site Specific Application is required for each HNELHD site at which the research project has been approved by ethics to be conducted.

How to submit a Site Specific Application:

The Principal Investigator (or anyone with admin/edit access to the project) compiles the Site Specific Assessment as follows:

  1. Complete SSA within REGIS
  2. Complete the application using:
  3. Complete the attached cover letter template addressed to the HNE  Research Governance Officer. The cover letter must be signed by the Principal Investigator and uploaded to REGIS with the SSA.

HNE Head of Department (HOD) authorisation:

  • HODs are automatically allocated within REGIS when selecting the HNE department in your SSA.
  • Ensure you discuss your project with the appropriate HNE Heads of Department (HOD) before submitting your SSA - this may reduce the time taken for your project to be approved.
  • Once the HNE Head of Department (HOD) indicates their support within REGIS, the SSA will automatically be submitted through REGIS to the HNE Research Office for eligibility review.

Access Requests

An access request should be submitted instead of and SSA 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.

For example, access request review should be used if the project involves one or more of the following activities at the PHO:

  • participant recruitment through posters, leaflets, handouts and letter of invitation but not recruitment through direct contact with potential participants or enrolment;
  • distribution of surveys and questionnaires through staff of the PHO, but not collation and analysis of responses at that PHO, and;
  • access to data or tissue held at the PHO, but not processing or analysis at that PHO.

Only one form is required for HNELHD; it is not necessary to complete a form for each individual facility, location or service within HNELHD, however written confirmation of support from each HNE facility, locations or services through which you are seeking access to participants, tissue or data is required to be submitted with your access request.

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.

Click here -  Access Request Form

Please submit all Access Requests to HNE Research Office via: HNELHD-ResearchOffice@health.nsw.gov.au

Please note: Access Request's that are submitted without written confirmation from the HNE facility, location or service will not be accepted.

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