Clinical trials

Find information about clinical trials in Tasmania including governance and information for participants and healthcare professionals.

National Clinical Trials Governance Framework

The Australian Commission on Safety and Quality in Healthcare (the Commission) has developed the National Clinical Trials Governance Framework (the Framework) on behalf of all jurisdictions in collaboration with the Australian Government Department of Health. The Framework builds on the National Model Clinical Governance Framework and the National Safety and Quality Health Service (NSQHS) Standards.

The Framework is aligned with the NSQHS Standards, especially the Clinical Governance Standard (Standard 1) and the Partnering with Consumers Standard (Standard 2). It outlines:

• roles and functions for identified positions relating to clinical trial service provision within a health service organisation
• actions against which health service organisations with a clinical trial service will be assessed for accreditation
• suggested strategies health services may implement to meet the actions within the NSQHS Standards
• examples of evidence a health service organisation may provide that demonstrate they have met the actions within the NSQHS Standards for clinical trial service provision.

Reporting a safety event

To report a Safety Event, download the Research Governance Safety Event form.

Where to get more information

• Visit the NSQHS website
• Download the National Clinical Trials Governance Framework FAQs and fact sheets

Information for participants

Evidence shows that where consumers are involved in the design of research and data collection tools—such as surveys or questionnaires—the tools are better received by the participants. There is also evidence that involving consumers is helpful in improving the dissemination of research findings to the community. For example, involving consumers in setting research agendas or identifying research priorities places consumer needs at the centre of cancer research. Involving consumers in research:

• ensures that issues important to consumers are identified and prioritised
• supports the dissemination of research results
• helps to translate research findings into clinical practice and implemented within health service delivery
• protects against money and resources being wasted on research that has little or no benefit or impact for consumers.

Consumer guide to clinical trials

Download the Australian Clinical Trials and Consumer Health Forum of Australia Consumer Guide to Clinical Trials Fact Sheet.

Australian Charter of Healthcare Rights

The Australian Charter of Healthcare Rights describes what consumers, or someone they care for, can expect when receiving health care, this includes clinical trials. Learn more on their website.

Informed consent

• Everyone taking part in a clinical trial must give ‘informed consent’ or have a parent or guardian or other legally authorised person give consent using a Participant Information and Consent Form (PICF).
• Informed consent means that potential participants are given information about the key facts of a clinical trial before deciding whether to take part (or not).
• Informed consent also means that participants are provided with information on new developments throughout the trial.
• You cannot be entered a trial if you don't want to be.
• If you are asked to take part, you are free to say yes or no at any time. There should be no pressure on you to enter a trial.
• If you are under 18, a parent or guardian must give legal consent and you must give your permission as well.

If you have concern about a clinical trial

• Call 000 if there is a serious or imminent risk to human health or life.
• If you feel the trial is not proceeding as expected (for example, the care or treatment was not as anticipated) or you have another concern, you should raise it in one of the following ways: