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Ethics

Research Ethics and Governance

All research studies undertaken with St John Ambulance (Western Australia) are required to comply with the National Health and Medical Research Council – National Statement on Ethical Conduct in Human Research (2007) and have ethics approval from either a Western Australian university or Western Australian hospital (and in some cases both) Human Research Ethics Committee.

In addition, all studies are reviewed, approved and monitored by the St John Ambulance (Western Australia) Research Advisory Group.

St John Ambulance (WA) Research Governance

Introduction

St John Ambulance has been involved in numerous clinical research studies and encourages research within the discipline of pre-hospital care. With the increasing focus on issues relating to clinical governance within St John, it is also important that the approval and conduct of clinical research be encompassed within the broader clinical governance framework. Accordingly this document outlines the process for facilitating, co-ordinating, reviewing, approving and monitoring clinical research undertaken within St John Ambulance.

Research Advisory Group

A Research Advisory Group (RAG) has been established to review and provide advice on research being proposed or undertaken within St John Ambulance. The group will consist of the following members:

  • SJA (WA) Ambulance Service Director (Mr Len Fiori)
  • SJA (WA) Manager of Clinical Governance ( Mr Joe Cuthbertson)
  • SJA (WA) Manager of Training (Mrs Debbie Walley)
  • SJA (WA) Clinical Support Paramedic (yet to be appointed)
  • SJA (WA) nominated representative / paramedic from the Union (yet to be appointed)
  • consumer/community representative (Mr Brian Stafford)
  • specialist with extensive knowledge experience in research and evidence based medicine (Professor Judith Finn).

The specific role of this group will be to:

  • facilitate and encourage research being undertaken within St John Ambulance
  • receive and review proposals to undertake research
  • provide feedback as to the applicability and impact of such research for St John Ambulance
  • monitor the progress and outcomes of research
  • inform the wider community of the planned and current research being undertaken within St John Ambulance (WA) Detailed below are the approved operating and monitoring procedures for undertaking research in St John Ambulance with immediate effect.

Operating Procedure

a) Approving research

  • All research conducted within SJA requires approval of the Research Advisory Group and endorsement of the Ambulance Service Directors. This includes any research being undertaken as part of an undergraduate or postgraduate education program.
  • A research proposal (electronic copy) is forwarded to the Chair of the Research Advisory Group at research@ambulance.net.au.

The proposal should address the following headings:

  • study title
  • details of the study investigator(s) – name, qualifications, position, institution
  • background to the research being proposed
  • aims and objectives
  • methods
  • data management, storage and security
  • funding
  • significance of the project
  • expected outcomes
  • timelines
  • human research ethics approvals obtained or being sought.

The proposal will be reviewed by the RAG (and the MPC if a change is clinical practice is proposed) and a recommendation made as to whether the project should be approved.

Additional information may be requested from the applicant to assist in making this decision.

If the proposal is approved by the RAG, the recommendation will be submitted to the Directors for their endorsement. The applicant is then notified as to whether the project has been approved and any conditions associated with such approval.

b) Monitoring research project

All projects approved will be entered into a research database and include the following data items:

  • title of the project
  • name and contact details of the Chief Investigator and other investigators
  • project start date
  • project end data
  • organisation providing ethics approval
  • date annual report received
  • date final report received
  • any additional notes.

An annual report will be provided by the Chief Investigator briefly outlining the project’s progress to date, listing any publications and/or presentations as well as any issues that have arisen during the course of the project. This report is required every 12 months during the course of the project.

At the completion of the project a final report is required outlining the findings of the study, a list all publications and presentations, provisions for research data storage / security and requirements for ongoing access to the research data.

A consolidated report of research projects and their current status will be provided to the Directors annually.

Any adverse event occurring during the research must be reported immediately to the Chair of the Research Advisory Group.

Approval to undertake research may be suspended or revoked on advice of the Research Advisory Group.

Summary

The purpose of Research Governance is to ensure that research within SJA is conducted in an appropriate manner consistent with the requirements of the National Health and Medical Research Council. As such there needs to be process which co-ordinates, reviews and monitors the research being undertaken.

Further Information can be obtained from the Chair of the Research Advisory Group at research@ambulance.net.au.