Clinical research
Research is an essential part of the health care system that allows for the discovery and development of new and innovative treatments.
Before any research can be conducted on human beings or using their data or biological samples, the proposed project must undergo an approval process. These processes are known as ethics and governance.
About clinical research
Clinical research facilitates the development of new treatments, procedures and therapies. They are used to prevent, detect, treat or manage diseases and medical conditions. Types of clinical research includes:
- clinical trials
- research Registries
- biobanks.
To ensure the study can be appropriately supported, clinical trials, registries and biobanks must undergo an initial feasibility assessment by the Clinical Trials Management Group (CTMG) prior to submitting for ethical approval.
Site governance approval is required for National Mutual Acceptance (NMA) studies.
The Clinical Trials Support Unit (CTSU) provides secretariat support to the CTCN and can be contacted on 02 5124 3687.
Inter-departmental support
Projects that require inter-departmental support from ACT Pathology, Canberra Health Services (CHS) Pharmacy or Imaging must submit a fully agreed upon quote in support of a stage two Human Research Ethics Committee (HREC) or site governance submission.
Request pathology support by emailing pathologyresearch@act.gov.au.
Using ionising radiation in a research project
ACT Health requires that all research projects that include any level of ionising radiation exposure undergo a notification process to ensure participant safety.
You must complete a radiation safety form if your project includes ionising radiation exposure that is not considered to be additional to that received as standard of care for the clinical management or care of the patient group at the site. This form must be submitted to the Radiation Safety Officer for acknowledgment prior to submission to the Research Ethics and Governance Office.
If your project includes ionising radiation exposure that is considered to be additional to that received as standard of care, you must arrange for a Medical Physicist to complete the radiation safety additional to standard of care form. This form must be submitted to the reviewing HREC and the site governance office.
For more information call 02 5124 5623 or email CHS.DRPhysics@act.gov.au.
Clinical research review process
The Clinical Trials Management Group (CTMG) operates a two-step process:
Stage 1: Initial feasibility assessment
Submit the following for initial feasibility review:
- Feasibility assessment clinical trial or feasibility assessment registry
- Governance clearance sheet for a clinical trial or governance clearance sheet for registry or site governance clearance for general research
- For ACT Health areas only a special purpose account report
- Plain language summary of the trial, registry or biobank which needs to be provided by the principal researcher
- Clinical trial, registry or biobank protocol or protocol synopsis.
Submit all items above to research.governance@act.gov.au.
Stage 2: Final ethics or site governance assessment
Make the ethics or site governance submission and include budget negotiations and preparation.
Find out more about submission requirements.
For more information call the Research Ethics and Governance Office on 02 5124 5659