Concord Hospital Concord Hospital
The Concord Research Office

Partnering With Consumers

Partnering with Consumers

The Australian Commission on Safety and Quality in Health Care (the Commission) is introducing standards for the conduct of clinical trials in Australia, called The National Clinical Trials Governance Framework which will be implemented early 2022.

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). The Committee will not delay ethical approval and acknowledges this requires planning and preparation however, the Committee expects researchers to develop a plan with definite timelines to meet this requirement in 2022.

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.

Resources:

ACTA Consumer Involvement & Engagement Toolkit

NHMRC Statement on Consumer Involvement Research

Addiitonal 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