Information for participants and community

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Information for participants and community

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As a clinical trials participant, your safety and comfort are our highest priorities. We are committed to keeping you informed throughout the entire clinical trial experience, so you can make informed decisions about the management of your health.

This includes:

  • An informed consent process, where all relevant information is provided to you prior to making a decision.
  • The opportunity for an in-depth discussion with your health provider (for example, GP or specialist) as well as the medical researchers undertaking the trial, before you commence the trial.
  • The ability to leave a clinical trial at any time, with no obligation to remain in a trial if you no longer wish to participate.
  • The ability to discuss results from any tests performed.
  • A summary of the results at the completion of the trial.

Common questions about clinical trials

Who should I speak to about whether clinical trials are right for me?

Before deciding whether or not to take part, you might want to talk about it with a relative, friend or your local doctor. Ask questions about anything that you do not understand or want to know more about. A participant information sheet or consent form will be provided to you and tells you about the research project. It explains the tests and treatments involved. Knowing what is involved will help you decide if you want to take part in the research. Participation in research is voluntary. If you do not wish to take part, you do not have to. You will receive the best possible care whether or not you take part.

How do I know these trials are properly conducted and approved?

All research in Australia involving humans is reviewed by an independent group of people called a Human Research Ethics Committee (HREC). Projects carried out by USC will be conducted according to the National Statement on Ethical Conduct in Human Research (2007). This statement has been developed to protect the interests of people who agree to participate in human research studies.

What is placebo and what happens if I get the placebo?

A placebo is a medication with no active ingredients or a procedure without any medical benefit. It looks like the real thing but it is not. This research project has been designed to make sure the researchers interpret the results in a fair and appropriate way and avoids study doctors or participants jumping to conclusions.

What are the benefits to me in participation?

We cannot guarantee or promise that you will receive any benefits from clinical research. For further information please read the Consumer Guide to Clinical Trials.

Are trials safe? People often say trials are guinea pig experiments?

Medical treatments often cause side effects. You may have none, some or all of the effects listed for a specific clinical trial, and they may be mild, moderate or severe. If you have any of these side effects, or are worried about them, talk with your study doctor. Your study doctor will also be looking out for side effects.

What if something goes wrong?

If you suffer any injuries or complications as a result of the research project, you should contact the study team as soon as possible and you will be assisted with arranging appropriate medical treatment. If you are eligible for Medicare, you can receive any medical treatment required to treat the injury or complication, free of charge, as a public patient in any Australian public hospital.

Do I pay to participate or will I get paid?

There are no additional costs associated with participating in a research project, nor will you be paid. All medication, tests and medical care required as part of the research project will be provided to you free of charge. You may be reimbursed for any reasonable travel, parking, meals and other expenses associated with the research project visit.

What If I change my mind about participation?

Participation in any research project is voluntary. If you do not wish to take part, you do not have to. If you decide to take part and later change your mind, you are free to withdraw from the project at any stage.

This information has been made available with permission from the Consumer Health Forum of Australia.

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