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:
- Human Research Ethics Committee (HREC) approval, and
- 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:
- Access Request Review (eg. recruitment through posters, leaflets, handouts and letter of invitation - but not recruitment through direct contact with potential participants or enrolment)
- 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;
- 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