GV Health is committed to helping find new ways to prevent, diagnose, treat or manage diseases and conditions so that we can provide the best possible evidence-based health care and outcomes for people in our community.
While receiving care at GV Health you may be invited to take part in a research study. In volunteering to participate in and support our research, you will be making a real difference in health care for future generations.
What are clinical research studies?
Clinical research studies play a vital part in telling us more about health conditions, so we can come up with new and better ways to care for people. Clinical research contributes to the advancement medical knowledge and the findings from studies can change the way people are cared for across Australia and the world.
The two primary types of clinical studies are observational and experimental or interventional. In observational studies, researchers observe study participants and record the effects of their current treatment without making any changes or collect information without intervening with anything. Experimental or interventional studies are also called clinical trials. During these studies the enrolled participants may be intervened with drugs, devices, cells and other biological products, surgical procedures, radiologic procedures, behavioural treatments, process-of-care changes, preventive care, etc.
Clinical trials and research undertaken at GV Health reflect the unique health concerns and needs of our community. Conducting this vital research provides opportunities for the local community to access new or better treatments and enables us to continually improve clinical care in order to provide the best possible health services and outcomes for our patients.
What does it involve?
Involvement in clinical research and trials can range from something as simple as completing a questionnaire or giving researchers permission to look at your medical history, to providing blood, urine or other biological samples, or testing a new medicine, device or medical treatment, use of medicine in a different way, or other clinical interventions. The level of involvement depends on what the researchers are investigating. Sometimes researchers may also ask permission to use leftover tissue or blood samples that are collected as part of their routine medical care.
All research must be approved by an ethics committee which is responsible for assessing the ethical principles of research to protect the participants in research.
What is informed consent?
Before agreeing to participate in a clinical trial, it is important for you to understand all the details so that you can decide if participating is right for you. Potential known risks and the benefits, including obligations for yourself and your research team, must be clearly explained to you before you agree. This is called informed consent.
The information you need is usually given to you in a clear, easy-to-read, Patient Information Statement provided by the people conducting the study. This should cover details such as the study’s purpose, duration, required procedures and appointments, and the key contacts.
You will be given the opportunity to ask your study doctor or research team any questions about the study. You should ask about anything that is not clear to you.
After you have received, read and understood all the relevant information, you will be asked to sign a voluntary written informed consent form. This is required to participate in any study.
Can I decline to participate?
Participation in clinical research is completely voluntary. No matter whether or not you decide to participate, you will continue to receive the same high-quality medical care from your treating team.
You also have the right to change your mind at any time. Should you decide to withdraw from a clinical trial or research, you will continue to be treated without prejudice.
How can I get more information?
Please feel free to ask your research team any questions you might have about your participation in clinical research studies. Common questions include:
- What does my participation mean?
- How does my participation help research?
- Will I be treated differently if I do not wish to participate?
- What are the benefits or risks of taking part in this clinical trial?
- Who will have access to my information and how will my information be used?
- If anything goes wrong, how and to what extent I will get support from the research team?
For more information, please contact firstname.lastname@example.org