Developing your research question

Every research project begins with a clear and well-defined research question.

Before developing a project, researchers should:

  • Review existing literature to identify gaps in knowledge.
  • Consider whether the project addresses a clinical need, service priority or research gap.
  • Discuss ideas with supervisors, mentors, department leaders and collaborators to ensure alignment with local strategic priorities.
  • Assess whether the project is feasible within available resources and timeframes.

Metro South Health libraries (internal link) can assist with literature searching, reference management and evidence reviews.

Researchers are encouraged to engage Metro South Research early when planning a project. Early consultation can help identify approval requirements, study risk level and relevant support services.

Planning to publish your findings?

Consider ethics and governance requirements early. Journals and conferences may require evidence of ethical review or ethical oversight, including for some quality improvement activities.

Is my project research, exempt research or quality improvement?

Not all projects require Human Research Ethics Committee (HREC) review. Activities may be:

  • Human research requiring ethics and governance approval
  • Exempt research (which may still require research governance review)
  • Quality improvement activities
  • Clinical audits
  • Evaluation activities

Determining the correct pathway early can save significant time and effort.

If you are unsure whether your project is research, quality improvement, audit or evaluation, seek advice from Metro South Research before commencing.

See Exemptions from Human Research Ethics Committee (HREC) review and use the Research or quality initiative decision tool to determine the appropriate pathway.

Research protocol and study documentation

A research protocol is the foundation of every research project. The protocol should clearly describe:

  • Research question and objectives
  • Study design and methodology
  • Inclusion and exclusion criteria
  • Recruitment strategy
  • Data collection methods
  • Statistical analysis
  • Ethical considerations
  • Data management arrangements
  • Study timelines

The protocol must align with information submitted through the Human Research Ethics Application (HREA) and Site Specific Assessment (SSA).

Researchers should identify, assess and manage risks associated with the conduct of the project, including participant, operational, regulatory and data management risks.

Designing your study

Consumer engagement and involvement

Researchers should consider opportunities for consumer involvement throughout project design, conduct and translation. Early engagement can improve the relevance, quality and impact of research.

Funding opportunities may be available to support consumer engagement and involvement activities.

See How to partner with consumers in research including the IMPACT Initiative, consumer engagement resources and available funding opportunities.

Participant risk and benefit

Researchers must assess and justify potential risks, burdens and benefits to participants.

Risk assessment should consider:

  • Likelihood of harm occurring
  • Severity of potential harm
  • Participant burden or inconvenience
  • Measures to minimise risk

Protocol templates

Metro South Health provides templates and resources to support protocol development, including:

Research participants and consent

Consent mechanisms

Waiver of consent

Where researchers intend to access existing information without obtaining participant consent, justification must be provided in accordance with the National Statement on Ethical Conduct in Human Research.

Informed consent

Researchers must ensure participants are provided with sufficient information to make an informed decision about participation.

Participant information and consent materials

Depending on the project, participant information may be provided through:

  • Participant Information and Consent Forms (PICFs)
  • Participant Information Statements
  • Assent Forms
  • Other approved participant-facing materials

Researchers should use approved templates wherever appropriate.

Recruitment of participants

Researchers must ensure recruitment methods are ethical, appropriate and consistent with approved study procedures.

All recruitment materials and processes should support informed and voluntary participation.

Supporting study documents

Depending on the nature of the project, additional study documents may be required, including:

  • Recruitment and advertising materials
  • Participant-facing materials
  • Surveys and questionnaires
  • Data collection tools
  • Investigator CVs
  • Training records and certifications

Data, privacy and confidentiality

Data management and confidentiality

Research data must be collected, stored, managed and disposed of in accordance with legislative, ethical and organisational requirements.

Researchers should consider:

  • Data sources
  • Data collection methods
  • Data variables
  • Participant population and sample size
  • Storage arrangements
  • Retention and disposal requirements
  • Privacy and confidentiality obligations

Data management plans

Researchers should develop a Data Management Plan (DMP) outlining how research data will be collected, stored, accessed, retained and disposed of.

See the Data management plan template.

Protecting confidential information

Information that may directly or indirectly identify an individual is considered confidential information and must be appropriately protected.

Access to patient information for research purposes requires lawful authorisation and appropriate approvals.

Researchers should also consider:

  • Data source (for example ieMR, registries or departmental databases)
  • Whether data is identifiable, re-identifiable or non-identifiable
  • Data retention requirements
  • Secure storage arrangements for electronic and hard-copy records

Researchers planning to use existing clinical or administrative data should engage relevant data custodians early. See Research data and privacy.

Clinical trials

Additional documentation and review processes may apply to clinical trials, including:

  • Investigator Brochures
  • Radiation Safety Assessments
  • Pharmacy Reviews
  • Laboratory Assessments
  • Contracts and indemnities

See the clinical trial page for further information.

Partnerships, funding and support

Research partnerships and collaborations

Research projects may involve collaboration with universities, research institutes, other Hospital and Health Services, commercial sponsors and community organisations.

Effective communication between investigators, departments, collaborators and research support offices is important throughout the research lifecycle.

Early planning should identify:

  • Roles and responsibilities
  • Research agreements and contractual requirements
  • Intellectual property considerations
  • Sponsor requirements
  • Ethics and governance responsibilities
  • Applicable fees

See research agreements for further information.

Research funding and budgets

Many projects require resources beyond existing clinical or departmental funding.

Researchers should consider both direct and indirect costs, including infrastructure, staffing, equipment, specialist services, publication and administrative expenses.

Researchers should identify and plan for:

  • Research administration fees
  • Staffing costs
  • Equipment and consumables
  • Statistical support
  • Data management systems
  • Publication costs
  • Travel and conference expenses
  • Participant reimbursement costs
  • Submission and review fees

Research budgets should be developed before ethics and governance submission.

Metro South Research Finance can provide research finance assistance.

Grants support

Metro South Research provides support for:

Ethics, governance and compliance

Ethics approval

Ethics review assesses whether research is ethically acceptable and complies with national standards.

Ethics approval is obtained through submission of a Human Research Ethics Application (HREA) to an appropriately registered and certified Human Research Ethics Committee (HREC).

See the list of certified HRECs.

Site Specific Assessment (SSA) authorisation

Research governance review confirms that the site has the resources, capability and approvals required to conduct the project safely and appropriately.

SSA applications involving one or more Metro South Health sites should be submitted in Ethics Review Manager (ERM) to the Metro South Health Research Governance Office.

See the Apply for research governance authorisation page for further information.

Aboriginal and Torres Strait Islander research

Research involving Aboriginal and Torres Strait Islander peoples, communities, data or biological materials may require additional consultation, review and approval processes.

Researchers are encouraged to seek advice early during project planning.

See Aboriginal and Torres Strait Islander Research health research guidance.

Research integrity

Research conducted at Metro South Health must comply with the Australian Code for the Responsible Conduct of Research and Metro South Health research integrity requirements.

Learn more about research integrity.

Compliance

Researchers must comply with relevant legislation, national guidelines, Queensland Health requirements and Metro South Health research policies throughout the lifecycle of the project.

Need help?

For information on research development, ethics and governance, grants, research finance, clinical trials, contracts and consumer engagement services, visit support for researchers.

Metro South Research can provide advice at any stage of your research project, from developing a research idea through to ethics, governance and post-approval requirements.

Contact Metro South Research for support with planning, approvals, funding and research administration.

Last updated:   November 2026

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