Partnering With Consumers

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.

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

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

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 2024, 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.

Trial participants who wish to provide additional feedback about their clinical trial or about any member of the clinical trials team will be encouraged to email SLHD-ResearchFeedback@health.nsw.gov.au. Such correspondences will be followed up by a member of the Research Governance team for appropriate escalation and resolution of any concerns identified.

This feedback will provide useful data to comply with the requirements of the National Clinical Trials Governance Framework (NCTGF).

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

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

Resources:

ACTA Consumer Involvement & Engagement Toolkit

NHMRC Statement on Consumer Involvement Research

Additional Tools, Resources and Recordings

ACTA Summit 2020 Recording, Sessions 10: Innovations in Clinical Trials Governance and Consumer Engagement

Consumers Health Forum of Australia

Health Consumers NSW