The National Statement on the Ethical Conduct of Research
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) (the National Statement).
This webpage is designed to assist you with the submission of an ethics application, the National Statement (referenced above) should be considered by all researchers prior to submitting an ethics application as it provides detailed information on ethical considerations when planning and conducting human research. Further information available on this page include:
- How to submit a NEW ethics application
- The Human Research Ethics Application (HREA)
- Supporting documentation for ethics applications
- Aboriginal Health and Medical Research Council approval requirements
- Decisions regarding NEW ethics applications
- Post-ethics approval submissions
- Final reports
Submitting a NEW ethics application
Submitting a new ethics applications to the North Coast NSW Human Research Ethics Committee (NCNSW HREC) requires the following elements:
- A Human Research Ethics Application (HREA) completed in the Research Ethics Governance Information System (REGIS); and
- All supporting documents – each with a document footer including the document title (e.g. protocol), version number and date in the footer of each page
Ethics applications must be completed in REGIS. Information on how to create, complete and submit ethics applications and upload supporting documentation in REGIS is available through a suite of REGIS Quick Reference Guides.
Please note, only complete applications will be accepted for review. Incomplete applications will be returned to the submitting investigator in REGIS for revision and resubmission once complete. Applications should be submitted in REGIS on or before the submission deadline for the intended meeting.
Human Research Ethics Application – HREA
From 31 August 2017, the HREA replaced the National Ethics Application Form (NEAF), which was available in Online Forms. This same HREA is available in REGIS, the new system for generating and completing ethics applications. All new ethics applications to the North Coast NSW Human Research Ethics Committee (NCNSW HREC), regardless of study risk level, should be generated using the HREA within REGIS.
Supporting documentation for ethics applications
All supporting documents must have a document footer including the document title (e.g. protocol), version number and date in the footer of each page.
A new ethics application should consist of at least the following:
- A competed HREA submitted via REGIS
- Protocol or Research Proposal/Plan
Further documentation as required such as:
- Applicable Brochures / Manuals / Product Information
- Participant Information Statement/Sheet/s
- Participant Consent Form/s
- Data Collection Tool/s
- Advertisements/Flyers etc
- Surveys / Questionnaires / Interview Schedules / Semi-structured Interview/Focus Group Questions
- Other relevant information – as/if required
The health and wellbeing of Aboriginal people and communities
Approval from the Aboriginal Health and Medical Research Council (AH&MRC) Ethics Committee is required where a research project involves research in, or concerning, NSW and any one of the following applies:
- The experience of Aboriginal people is an explicit focus of all or part of the research
- Data collection is explicitly directed at Aboriginal people
- Aboriginal peoples, as a group, are to be examined in the results
- The information has an impact on one or more Aboriginal communities or
- Aboriginal health funds are a source of funding
Decisions regarding new ethics application
Formal correspondence regarding the NCNSW HREC decision will be emailed to the project Co-ordinating Investigator or Principal Investigator. Please note that projects cannot commence until research authorisation has been issued by the relevant site/s.
Post ethics approval submissions
Post-ethics approval applications, including amendments, safety reporting and progress reporting, are to be submitted in REGIS. Please refer to the REGIS Quick Reference Guides for information on how to submit post-ethics approval applications.
Examples of other submissions include:
- Amendments to a previously approved project
- Annual Progress and/or Completion Reports
- SAE/SUSARs (local only)
- Protocol violations
- Updates e.g. publications
Statement on the position of the North Coast NSW Human Research Ethics Committee on the use of research study findings to inform clinical practice, policy and/or procedure change
Last updated: 08/02/2021
The North Coast NSW Human Research Ethics Committee (NCNSW HREC) and its Executive Committee, which considers low or negligible risk (LNR) applications, provide ethical and scientific review of proposed research activity. These committees do not provide approval nor endorse clinical or policy/procedure changes as a result of any particular research activity.
Researchers who wish to use the results of their research to influence clinical or policy/procedure changes are encouraged to seek advice from their respective Clinical Governance teams and/or relevant Service Managers and Executive. Researchers should consider the statistical power of their research design and study findings and then consider if a threshold has been reached which would indicate, with confidence, that change is warranted. It is encouraged that decisions about the care of individual patients are based on the best available evidence from systematic research in combination with clinical expertise in accordance with the principles of evidence-based practice.
There are various processes through which clinical practice changes can be progressed:
- Clinical policy. Both NNSWLHD and MNCLHD have clinical policy frameworks for the development and approval of clinical policy documents, including clinical policies, guidelines and protocols. These clinical policy documents underpin standardised evidence-based clinical practice throughout each LHD. It would be expected that any LHD-wide initiative to a change to clinical practice throughout the LHD would be supported by some form of clinical policy document as a mechanism to ‘get everyone playing from the same sheet of music’.
- Clinical practice improvement. Other keys to the success of LHD-wide clinical practice improvement initiatives include executive sponsorship, governance oversight, leadership, stakeholder engagement, education and training – all being components of evidence-based clinical practice improvement.
- Have you heard of Big Ideas? NNSWLHD have a Change and Innovation Network under development. This is a structured process to encourage and deal with ideas – to drive innovative initiatives with the blessing of the organisation and having ability to take them to scale.
- MNCLHD has recently adjusted the scope of a Governing Board Subcommittee, now known as the MNCLHD Research, Innovation and Health Service Development Committee. This provides a forum through which research and innovation can be considered and where possible, contribute to health service design and development.
- New technology and services. Where there is proposed introduction of new technology, with or without a research component, development should be in alignment with the NSW Framework for New Health Technologies and Specialised Services (GL2018_023).
- The MNCLHD Clinical Governance Unit is currently revising the District procedure relating to this framework.
- The District procedure for NNSWLHD is Introduction of New Clinical Services, Procedures and Other Interventions (NC-NNSW-POL-6829-13). The Clinical Operations Directorate oversees these processes.
- Clinical products. Both NNSWLHD and MNCLHD have procedures for Clinical Product Management – Trial and Evaluation. Rather than being research projects, these are processes for bringing registered medical devices (including consumables) into use across the LHDs, similar to the way additions to a formulary is used for medicines. Clinical Product Managers oversee these processes.
Researchers should also aware of the relevant committees within NNSWLHD and MNCLHD who may be able to provide governance oversight in relation to proposed changes in clinical practice policy / procedure emerging from research activity.
- The North Coast NSW Human Research Ethics Committee
- NCNSW HREC Submission deadlines and meeting dates
- NCNSW HREC Resources and forms
- NSW Health Office of Health and Medical Research Ethics and Governance
- Aboriginal Health and Medical Research Council (AH&MRC) Ethics Committee
- Research Ethics and Governance contact details