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Research Governance Overview

On 1 July 2007, the NSW Department of Health introduced a new process where every research project to be conducted in the New South Wales Public Health System requires both:

  1. Human Research Ethics Committee (HREC) approval, and 
  2. Research Governance approval for each site at which the research is to be conducted (ie site authorisation) 

Why is Research Governance Relevant

Research governance can be defined as a framework for effective oversight of research, such that it meets appropriate standards of quality, safety, privacy, risk management, financial management and ethical acceptability in the Public Health Organisation. It provides a framework for the Local Health District, hospital/facilities, managers and researchers in a shared responsibility and accountability for the conduct of research.

The Research Governance Officer (RGO) is responsible for assessing the suitability of a project to be conducted at a particular site and making a recommendation to the Nepean Blue Mountains Local Health District Chief Executive (or delegate). The Chief Executive (or delegate) may or may not authorise a study to be conducted at their site.

Research Governance authorisation and the Local Health District (LHD) responsibilities are outlined in the following NSW Health policy directive: PD2010_056: Research - Authorisation to Commence Human Research in NSW Public Health Organisations.

Types of Applications to be lodged with the RGO

There are 3 types of applications that can be submitted to the RGO for approval and this depends on the type of research study to be conducted:

  1. Access Request Review (eg. recruitment through posters, leaflets, handouts and letter of invitation - but not recruitment through direct contact with potential participants or enrolment)
  2. Low and Negligible Risk Site Specific Applications (LNR SSAs) and associated with an LNR Ethics Application - (eg. managing and analysing data, tissue and responses from surveys and questionnaires collected for or from research) or;  
  3. Site Specific Assessment (SSA) and associated with a NEAF Ethics Application - (eg. clinial studies, sponsored drug trials)

 Important: These forms are only relevant for research undertaken within the NSW Health Public Health System




Tuesday, 26 August 2014 11:14:11 AM