RPA RPA
Research Ethics and Governance Office

Partnering with Consumers

The Australian Commission on Safety and Quality in Health Care (the Commission) has introduced standards for the conduct of clinical trials in Australia, called The National Clinical Trials Governance Framework.

Under Standard 2 “Partnering with Consumers”;

To create an organisation in which there are mutually beneficial outcomes by having:

  • Consumers as partners in planning, design, delivery, measurement and evaluation of systems to deliver clinical trial     services
  • Trial participants and patients as partners in their own care, to the extent that they choose.

Consumer Engagement Plans: The Sydney Local Health District HREC is encouraging investigators to take steps towards involving consumer involvement in clinical trial planning, as described above, and to demonstrate this has occurred through evidence of team meeting notes and details added to the Protocol (under a new section). Alternatively, researchers can complete the SLHD Consumer Engagement Plan.

The Committee will review progress of the plan upon review of your first annual progress report and/or when subsequent amendments to the Protocol/Participant Information Statement have been submitted.

Patient Reported Experience Measures (PREMs): To ensure clinical trial participants have the opportunity to provide direct, comprehensive and timely feedback about their experiences specific to clinical trials, a Clinical Trial PREMs questionnaire has been developed by the SLHD Research Support team. Effective 17 September, all clinical trials studies conducted in the SLHD will now require a new statement, and a QR Code, to be added to the local Participant Information Statement prior to authorisation. Refer here for further information and instructions on how to include the PREMs survey in the documents.

Resources to assist researchers can be found in the sub-menus (on the left) 

SLHD staff members can find additional resources on the SLHD Research Intranet page and are invited to attend the monthly Clinical Trials Drop-in Clinic or Governance Drop-in Clinic to seek further advice or assistance.