Pre-approval planning2024-10-08T23:41:00+00:00

Pre-approval planning

Careful planning before submitting any project for ethics and governance approval helps to navigate the process and get research up and running sooner. 

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    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.

    External Researchers

    Research that involves access to a Metro North facility by an external researcher must comply with the Metro North external researchers policy.  

    Legislation, policy and guidelines

    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.

    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.

    REDCap

    Research Electronic Data Capture (REDCap) is a secure, online platform for the capture of research data. Queensland Health REDCap is jointly provided by the Office of Research and Innovation (ORI) and eHealth Qld, with local support for research projects provided by Metro North Research.

    Grants

    Some research projects are managed without the need for additional funds. However, many projects require funding to cover staffing, consumable or other project costs. Early planning for project budget and expenditure is important.

    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.

    Ethics Approval

    Human Research Ethics Committee (HREC) review is the first step in the research approval process, required for all human research conducted within Metro North.

    Research Governance

    Following ethics approval, institutional research governance/SSA approval must be granted before research can commence 

    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.

    HREC Amendments 

    For research projects approved by a Metro North HREC, approval is required for any amendments to the protocol, PICFs or any study materials approved by the HREC.

    Post authorisation notification

    Any changes to a research project that affect site authorisation must be submitted as a post authorisation notification (PAN) via ERM to the Metro North Research Governance Office for review.

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