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Ethics of Clinical Practice - How to ApplyThe SLHD Ethics Review Committee has two Sub-committees that consider ethical issues relating to clinical practice.
The issues which the Sub-committee is available to review include:
Most proposals for the introduction of new techniques and the use of approved / listed devices in new settings are considered by the Ethics of Clinical Practice Sub-committee once support in principle has been obtained at facility level. See the SLHD Policy Directive SLHD_PD2015_022 "New Interventional Procedures: The Safe Introduction of New Interventional Procedures and Clinical Innovations into Clinical Practice". Where the new intervention has any commercial involvement, a standard protocol and / or a patient outcomes register, or where the device has not been approved / listed for use in Australia, consideration by the Clinical Trials Sub-committee and the Ethics Review Committee will be required as an alternative pathway, ie Study protocol / Registry > Clinical Trials Sub-committee / Ethics Review Committee > notification to the Therapeutic Goods Administration (TGA) under the CTN Scheme. Implementation of a new intervention on the basis of individual patient need using an unapproved device > application via the Ethics Review Committee to the TGA under the SAS or for the clinician to become an Authorised Prescriber of the product.The Sub-committee's Terms of Reference and membership are available elsewhere on this website. The Sub-committee meets monthly, and reports via the SLHD Ethics Review Committee. Meetings are relatively informal. Relevant individuals are often invited to attend meetings to discuss issues or provide expert advice to the Sub-committee. Contact with the Sub-committee can be made through the Executive Officer (Ms Sanaa Thomas) or the Chairman (Dr Rob Loblay, 0417 210 085). 2. Clinical Ethics Advisory Panel
The role of the Panel is an advisory one and the final responsibility for decisions rests with the senior clinician or administrator. As indicated above, the Sub-committee can be contacted 24 hours per day, 7 days per week. |