Research Protocol
A research protocol is the foundation of every research project. While the protocol structure and content may vary depending on the research methodology used, all protocols must clearly outline exactly what research is being conducted and how this will be undertaken.
Data management
The protocol details must be clearly aligned to the information provided in the Human Research Ethics Application (HREA) and the Site-Specific-Assessment (SSA) application and should include a plan for data management that demonstrates compliance with legislative requirements for the use of confidential information.
Is my project exempt research or a quality initiative?
It can sometimes be difficult to determine whether a project is a quality initiative or research because they both exist on a continuum of activity. Furthermore, some types of research do not require ethical review, and are considered exempt research. For more information on quality initiatives, exempt research and other types of review and approvals, see below:
Research participants and their data
Participant risk and benefit
The risk for potential harm, discomfort or burden to research participants from the research methods described in the protocol must be justified in the HREA using the principles described in National Statement. This involves the likelihood that a harm or discomfort will occur, and the severity or magnitude of the harm or discomfort, including their consequences, and the potential burden or inconvenience to participants.
Participant consent
The requirement for participants to consent to take part in research is the cornerstone of ethical research practice. A general requirement of the consent process is the provision of a written description of the research and a consent form for the participant to sign.
Protect confidential information
Information that could identify, or potentially be used to re-identify an individual patient, is considered confidential information and is protected by privacy and confidentiality legislation. While Queensland Health employees may have access to patient information for the provision of health care, a lawful authorisation is required to access patient information for the purposes of research.
Legislation, policy and regulatory frameworks
Metro North expects all those who conduct or administer research to comply with the relevant legislation, regulatory guidelines, codes of conduct and policy as they relate to research.
Metro North Research Policy
The Metro North Research Policy is based on the legislative and regulatory frameworks that govern research, and national guidelines such as the National Statement on Ethical Conduct in Human Research and the Australian Code for the Responsible Conduct of Research.
Support services
Statistical support
The Queensland Institute of Medical Research Berghofer (QIMRB) Statistics Unit provides a statistical support and consultancy service for Metro North employees to assist with statistical design, analysis and interpretation of research protocols and findings.
Ethics and Governance Approvals
The framework for ethical review and governance of research is relevant to all stages of the research process, including ethics and governance approvals and post-approval reporting. The following approvals are required to conduct research in Metro North:
- Ethics approval from a Human Research Ethics Committee (HREC).
- Site governance authorisation for each facility where the research will be conducted.
- Notification of commencement, annual reports and final report.
- HREC Amendments and Post-Authorisation Notification (PAN).
Ethics approval is required before site authorisation can be granted. However, Metro North encourages parallel submission of research ethics and governance applications.
Whilst there are some exceptions, almost all research conducted at Metro North must be submitted for ethical approval and governance authorisation before commencing.
Fees
Prior to submitting a research project for ethical and governance approval, a completed and signed fee template must be included.
Good Clinical Practice (GCP)
Principal Investigators (PIs) of clinical trials being conducted in Metro North must provide evidence of accredited GCP certification undertaken within the past three years as a requirement for Site-Specific-Assessment (SSA) authorisation.
Research agreements
A research agreement is required for all research conducted at a Metro North site that also involves any organisation external to Metro North. Early planning for a research agreement with all participating sites will assist with ethical and governance review and support an efficient study start-up.
Ethics and Governance Clinic
Metro North Research runs weekly ethics and governance clinics to provide advice on the ethics and governance requirements of research projects.
Post approval submissions
Understanding the requirements for post approval reporting before commencing a research project is helpful for good project management and efficiency.
Commencement, annual and final reports
All research projects must provide a notification of commencement, ongoing annual and final reporting to ethics and governance once a study is commenced in order to retain ethics and governance approval.