What is Research Governance?
Research Governance is a framework through which institutions are accountable for the scientific quality, ethical acceptability and safety of the research they sponsor or permit. Research Governance, including both ethics and site specific approvals processes, ensures compliance with a broad range of regulations, legislation and codes of good practice to achieve and continuously improve research quality across all aspects of healthcare by:
- Safeguarding the dignity, rights, safety and well-being of participants
- Protecting and promoting the integrity of research and investigators
- Enhancing ethical and scientific quality
- Minimising risk
- Monitoring practice and performance and
- Promoting good practice
- The Research approval and authorisation process
Research Governance consists of two key processes which can be progressed concurrently:
Process 1: Ethics approval
All research within Northern NSW (NNSW) Local Health District (LHD) and/or the Mid North Coast (MNC) LHD involving patients (including health information) and/or health service employees, must be ethically and scientifically reviewed and approved by a Human Research Ethics Committee (HREC) in accordance with the National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research (2007).
Ethics approval can be obtained in the following ways:
- single-site within NNSW or MNC LHDs from the North Coast NSW HREC,
- multiple-sites within NSW from a ‘Certified NSW HREC’, or
- multiple-sites nationwide from a ‘Certified HREC’ under the National Mutual Acceptance scheme.
Process 2: Site specific authorisation
All research to be conducted within NNSW and/or MND LHDs must also have site specific authorisation prior to commencement. Applications for Site Specific Assessment (SSA) must be submitted using the SSA Form via the Research Ethics Governance Information System (REGIS) for all new local and multi-site National Mutual Acceptance (NMA) projects. The REGIS website provides guidance on how to complete the application forms and details the supporting documents required for making an application.
Quality Improvement Activities
There are a number of methods of monitoring and evaluating healthcare with the aim of improving health service delivery. These quality improvement (QI) activities include incident monitoring, root cause analysis, sentinel event monitoring, peer review, morbidity and mortality review and other forms of audit. As there can be difficulty in, and disagreement about, clearly defining ‘research’ versus some QI activities NSW Health provides a guideline to assist health professionals undertaking QI activities to identify when a QI activity may require ethics review by a HREC: Human Research Ethics Committees – Quality Improvement & Ethical Review: A Practice Guide for NSW (GL2007_020).
In some circumstances NNSW and MNC LHDs health professionals may wish to have a project verified as a QI. Some journals may require evidence of an exemption from the requirement for ethical review, and this can be obtained through the QI registration process.