Conducting Research

Updated Libby Spiers 06.08.2024

How do I get involved in research in the Ortho Unit?

  • Want to help out with an existing project? Speak with Prof Tran.
  • Have an idea for a great new research project? Speak with Prof Tran.
  • Collaborators at another institution would like WH to be part of their project? Speak with Prof Tran.
  • You get the idea. Run your idea by Prof Tran and he can direct you regarding who to speak with about existing projects, or can determine the Unit’s capacity to be involved in new projects.
  • Research Co-ordinator, Libby Spiers, can support you with your ethics application if one is required.

I’ve got the all clear from Prof Tran for new research project – what now?

  1. Check out the WH Research Office internet site for low risk, single site projects (eg QA, retrospective data analysis).
  2. Check out the RMH Research and Ethics page for high risk or multi-site projects
  3. Speak with Libby (Research Co-ordinator) if you are not sure what type of ethics application is required
  4. Carry out a literature review on your topic
  5. Write the study protocol using the relevant template from the WH Research Office webpage (or from the RMH ethics webpage if it is a high risk project)
  6. Assemble all your required documents
  7. Run your application past Libby prior to submission
  8. Fill out the application on Ethical Review Manager (you’ll need to create an account) and upload your supporting documents.

WH Clinical Trials Governance Framework

This summary diagram has links to everything related to research at WH – policies, data management platforms, and the WH code of conduct.

Top tips for ethics applications

  • The WH research office webpage clearly sets out everything you need to know/submit for different project applications
  • Always use the research office internet page (not the intranet!). It is much easier to follow.
  • WH ethics committee only considers projects that are considered low risk (eg questionnaires, retrospective data analysis, QA) and are also single site ie WH only.
  • You will need to submit your ethics application to Melbourne Health ethics office, then submit a Site Specific Assessment (SSA) (governance) application to WH Research Office if your project:
    • involves more sites than just WH eg another hospital or surgeon’s private rooms
    • is considered high risk research (research in which there is any possibility of harms greater than discomfort).

Help! Who can assist me with my statistics and analysis?

  • Don’t panic!
  • The Office of Research has just introduced a new consulting service with an experienced biostatistician to help WH researchers with their study design and data analysis for research projects conducted at WH.
  • Please visit their website “Research Support – Biostatistical Consulting Service” for more information regarding this service. You will need to complete a form with details about the project and the assistance that you require.
  • The biostatistician will then get in touch to set up a meeting with you.

Good Clinical Practice (GCP) Training

  • Anyone involved in research at WH will need to have completed this training. Certification usually lasts 3 years (depending on the course) and you’ll need to submit your current certificate with your ethics application.
  • Free, accredited training is available at Global Health Training Centre. This course takes 30-40 mins to complete.
  • What is GCP? The definition of GCP training according to Global Health Training Centre: “Good clinical practice provides a framework of principles which aim to ensure the safety of research participants and the integrity and validity of data. This short course aims to provide the researcher with the basic principles of GCP and how these principles can be applied practically in the research setting. The course is aimed at all those involved in clinical research.”

Where do I store research data and information?

  • All research projects are to have their own folder on SharePoint. Libby can create these.
  • Full copy of all ethics applications need to be in the study file on SharePoint, including amendments, personnel additions and annual reports.
  • Access will be granted to all staff named on ethics as research personnel for that study
  • All projects to have a Training Log, Delegation Log, Adverse Events Log – Libby can provide templates
  • No identifiable data on laptops or Cloud servers – need to be on SharePoint or REDCap only

Past ethics application examples – coming soon!

Quality assurance project

  • Protocol
  • Master re-identifier list

Low risk project

  • Protocol
  • Participant Information and Consent Form

High risk project (MH HREC submission and WH SSA submission)

  • Protocol
  • Participant Information and Consent form
  • VSM

Current Projects

Past Projects