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Initiation and consultation with the Centres for Health Research

Firstly, in order to understand what you need to know about conducting research in Metro South Health we need to outline some key terms which are used frequently throughout our site and documents:

Terminology

TermDefinition
Human Research Ethics Committee (HREC)

Human Research Ethics Committees (HRECs) play a central role in the Australian system of ethical oversight of research involving humans. HRECs review research proposals involving human participants to ensure that they are ethically acceptable and in accordance with relevant standards and guidelines.

There are more than 200 HRECs in institutions and organisations across Australia. Many other countries have similar systems. In undertaking this role, HRECs are guided by relevant standards. Standards include those in the National Statement on Ethical Conduct in Human Research (2007) ('National Statement') issued by National Health and Medical Research Council (NHMRC). The National Statement sets out the requirements for the composition of a HREC and the relevant ethical principles and values by which research should be designed and conducted by researchers and to which HRECs should refer when reviewing research proposals.

Read more about the Metro South Health Human Research Ethics Committee (HREC)
Ethical clearance

All proposed research projects must consider ethical clearance at the initiating and planning, setup, implementation and maintenance stages. 

Ethical clearance for involvement of human participants in your research must be sought prior to any research work being undertaken, this includes pilot studies and/or focus groups.

Cell lines derived from human tissue are considered human biospecimens. Research involving the use of human cell lines requires ethics approval. Use of cell lines in research is subject to the guidelines provided in the National Statement. The participants in this kind of research are the people from whom the cell lines originated (the person who the biospecimen came from).

In order to receive ethical clearance you must complete a Human Research Ethics Application (HREA) and receive ‘ethical clearance’ from a HREC.

Read more about ethical clearance

Research governance authorisation

Research governance refers to the processes used by institutions to ensure that they are accountable for the research conducted under their auspices. Elements of research governance include: ethical approval, compliance with legislation, regulations, guidelines and codes of practice.

Research governance ensures that all documentation is appropriate for site assessment so that a decision can be made by an organisation to either conduct or not conduct the research.

In order to receive research governance authorisation you must:

  • complete the Site Specific Assessment (SSA);
  • provide relevant supporting documentation and Metro South Health site and department acceptance;

and

  • ensure the submission meets all research governance legislative or authority requirements.

Read more about research governance authorisation

Research project

Also called a research study, a research project is a scientific way to improve or develop new methods of health care in a clinical setting. In an academic or observational setting a research project may target other endeavours. 

In a clinical setting, research projects are typically designed to answer specific questions on how to prevent, diagnose, or treat diseases and disorders.

Many types of research project and studies exist. For example, clinical trials test new medicines or devices.

Read more about setting up a research project

Therapeutic Goods Administration (TGA) Note for Guidance on Good Clinical Practice (GCP)

The Therapeutic Goods Administration (TGA) Note for Guidance on Good Clinical Practice (GCP) as annotated by the TGA is an internationally accepted standard for designing, conducting, recording and reporting of clinical trials.

These guidelines may be overridden by national legal requirements and the requirements of individual regulatory agencies as appropriate, to address matters relevant to local conditions or culture.

Read more about clinical trials

Please see the Quick links, tools, forms and templates page for more information.

The Metro South Health Research Management Compliance Framework aims to ensure that consistent, clear and detailed publically available policies, procedures and supporting documentation, are in place to inform and guide Metro South Health researchers in the pursuit of research excellence. All those who participate in the regulatory steps required for research should familiarise themselves with our processes and practices outlined on our site, and a unified approach among relevant parties is encouraged. Please see the Policies and procedures page for more information.

Communication and research support from Centres for Health Research

Prior to commencing any research concept design or planning, Metro South Health strongly recommends all researchers contact the following teams to seek assistance and support with research project design:

  • Metro South Health HREC Office
  • Metro South Health Research Governance Office
  • Metro South Health PowerTrials Support Team
  • Metro South Health Research Support Coordinator and Grants Administration Office

Both before and after ethical clearance and research governance authorisation, it is essential to ensure good communication between all parties. All parties involved need to establish open lines of communication from the inception and initiation of the research project. If the processes are not discussed and coordinated correctly at the beginning, then the streamlined ethical review and clearance system will not operate to its full potential.

Education

A variety of education sessions are available to researchers in Metro South Health. Furthermore, it is recommended that Good Clinical Practice (GCP) Training is completed.

Research question/s

Research may be initiated from a variety of different areas:

  • You – as the researcher
  • Your team or line manager
  • Clinical data or metrics
  • Principal Investigator/Trial Coordinator
  • Metro South Health (sponsor)
  • Other Hospital and Health Services
  • Universities
  • Commercial sponsors
    • **pharmaceutical companies**
  • International sponsors
    • *Note: must have an Australian sponsor associated with an ABN and address**
  • Private industry

The Public Health Act 2005 (Qld) defines research as the systematic investigation for the purpose of adding to knowledge about human health and well-being and includes:

  • biomedical studies
  • clinical and applied studies
  • epidemiological studies
  • valuation and planning studies
  • monitoring and surveillance studies

Establishing a research question requires rigorous review of literature to ensure there is an unmet need. Conducting a search of the literature will help to determine the current knowledge on the topic of interest. This can also assist in clarifying a research question and identifying the tools and resources needed to conduct the research. Metro South Health libraries; Princess Alexandra Hospital, QEII Hospital, Logan Hospital and Redland Hospital, can offer training and support in conducting a literature search and using referencing software. The literature review should evaluate and analyse previous research, demonstrating where the proposed research fits into the current body of knowledge.  

The research question, when appropriately written, will guide you and assist in the construction of a logical argument. The research question should be a clear, focused question that summarises the issue that you will investigate.

Research question steps

StepRecommended approach
Clinical area and/or research topic

Researchers should begin by identifying a broader subject of interest that lends itself to investigation. 

For example, a researcher may be interested in lung cancer.
Undertake preliminary research

Find out what research has already been done and what literature already exists. 

  • How much research has been done on the topic?
  • What types of research projects have already occurred? 
  • Is there a unique area that is yet to be investigated or is there a particular question that may be worth replicating?
Develop a research question

Narrow the topic by asking open-ended "how" and "why" questions. 

For example, a researcher may want to consider the factors that are contributing to lung cancer or the success rate of early detection programs.

Create a list of potential questions for consideration and choose one which is of interest and provides an opportunity for exploration
Evaluate the question
  • Is the research question one that is of interest to the researcher and potentially to others? 
  • Is it a new issue or problem that needs to be solved or is it attempting to shed light on previously researched topic?
  • Is the research question researchable?  
  • Consider the available timeframe and the required resources.
  • Is the methodology to conduct the research feasible?
  • Is the research question measureable and will the process produce data that can be supported or contradicted?
  • Is the research question too broad or too narrow?

Adapted from the Centre for Innovation in Research and Teaching

Once you have conceptualised and developed a research idea or question it is important to link with a research mentor, a research expert in the field and/or the Metro South Health HREC Office to discuss further. It’s also vital you discuss the research project idea with key stakeholder departments and that approval is received from your Division/Department before progressing further.

If you are unsure if your work activity or project pertains to research it is recommended to contact the Metro South Health HREC Office to discuss further.

Research mentor and clinical team

Some of the best clinical research questions are those which stem from a clinical need or a limitation identified by a Metro South Health facility or service.  It is recommended for discussions regarding the research question to occur with colleagues, supervisions/line managers, key stakeholder departments and Divisional/Department heads to determine whether it is a clinical priority and can be supported by the Division/Department. Early in the process the research mentor and trainee should create an agreement delineating the amount of time they will devote to each other, ownership of data and so forth, so as to maintain a healthy working environment.

A research mentor and/or clinical team may be able to provide you with assistance:

  • in developing and refining a research idea and question
  • providing direction to key research literature related to the research question
  • developing the most appropriate research plan and methodology to answer the research question

Researchers should also consider aligning the research idea/question with the Division/ Department’s strategic plan or Key Performance Indicators (KPIs).

Support may also be provided by discipline specific areas such as:

Collaborations

External researchers regularly seek assistance from Metro South Health employees for the inclusion of Metro South Health as an additional site for a larger research project. This may involve Metro South Health employees as Associate Investigators (AIs) or simply as a site contact to facilitate recruitment or data extraction.

If you are contacted by someone who is interested in collaboration for a research project it is important to identify:

  • if it is a collaboration (eg between two or more Hospital and Health Services - also called multi-centre research)
  • if it is sponsor driven (eg by a commercial sponsor)
  • if it is a Metro South Health sponsored research project (eg Metro South Health Research Support Scheme (RSS))
  • if any Metro South Health Intellectual Property (IP) will be utilised
  • required legal contracts between collaborators/partnerships
  • if Metro South Health HREC fees will be applicable

Investigator initiated collaboration

Consideration must be given to collaborations before planning and designing the research project and before seeking ethical clearance.

Collaborative research projects with a pre-existing HREC ethical clearance from another Committee may not require an ethics application due to pre-existing reciprocal arrangements.

Last updated 5 June 2018
Last reviewed 17 May 2018