Research is an essential part of the health care system that allows for the discovery and development of new and innovative treatments. Clinical trials, research registries and biobanks are types of research that facilitate the development of new treatments, procedures and therapies used to prevent, detect, treat or manage diseases and medical conditions.
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.
Governance Approval Process
Clinical trials, registries and biobanks must undergo an initial feasibility assessment by the Clinical Trials Management Group (CTMG) prior to submitting for ethical approval or, in the case of NMA studies, site governance approval. The CTMG terms of reference are available here.
For the purposes of the CTMG a clinical trial is described as: “Clinical research where a therapeutic intervention in human subjects is being evaluated”.
The CTMG operates a two-step process: a feasibility assessment process as follows:
Step 1: Initial Feasibility Assessment
The following items are to be submitted for initial feasibility review:
Please submit all items above to email@example.com
Step 2: Final Ethics and/or Site Governance Assessment
Step 2 of the process is where the researcher proceeds with usual ethics/site governance submission, including budget negotiations and preparation.
Further details on ethics submission requirements.
Budget negotiations and preparations must be conducted with the Clinical Trials Finance Officer (CTFO), call 02 5124 5659 for referral to CTFO. On completion of budget a signed finance summary – provided by the CTFO, is to be included in ethics/site governance submissions.
Once budget negotiations are final, submit the final research agreement and financial summary for review and authorisation to firstname.lastname@example.org.
Full site governance submission requirements.
For any queries please contact the committee secretariat on 02 5124 5659.