Partnering with Consumers and Consumer Plans

The Sydney Local Health District is committed to working with consumers to improve healthcare services together. This is further supported by the following frameworks and strategic plans:

·       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:

o   Consumers as partners in planning, design, delivery, measurement and evaluation of systems to deliver clinical trial services

o   Trial participants and patients as partners in their own care, to the extent that they choose.

·       The NHMRC National Statement on Ethical Conduct in Human Research (2025) supports consumer and community involvement across all types and levels of health and medical research, and advises that under section 5.1.4 that:

o   Each institution should be satisfied that the human research for which it is responsible adequately takes account of consumer and community perspectives, with reference, where relevant, to NHMRC’s Statement on Consumer and Community Involvement in Health and Medical Research.

·       The Sydney Local Health District has launched the Consumer and Community Participation Strategic Plan 2025-29.The Consumer and Community Participation Strategic Plan provides a blueprint for the way Sydney Local Health District will work in partnership with our consumers and communities. It outlines our integrated approach to investing in and developing our relationships with our communities.

Consumer Engagement Plan

The Sydney Local Health District Research Ethics & Governance Office requires investigators to take steps towards involving consumer involvement in clinical trial or research planning, as described above, and to demonstrate this has occurred through a range of documentation evidence such as team meeting notes, planning days, advisory panel meeting minutes. Details of the consumer engagement plan should be added to the Protocol, please refer to our preferred Protocol templates. Alternatively, researchers can complete the SLHD Consumer Engagement Plan Template. The Consumer Engagement Plan Progress Report can be used to provide an update on the progress of engaging with consumers throughout the study.

The Committee and the Research Ethics & Governance Office will review progress of the plan upon review of your final report and/or when an ethics extension amendment has been submitted if the study is continuing after ethics approval has expired.

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

Clinical Trials Specific 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 below. 

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