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What is involved in a research study can vary depending on what the researchers are investigating.

It may be as simple as allowing researchers to look at your child's medical records or use leftover tissue or blood that is collected from your child as part of their routine medical care.

Involvement in other studies may include:

• Interviews, questionnaires and surveys
• Blood or urine tests
• Imaging studies such as x-rays or MRI scans
• Interventional trials called clinical trials; these types of studies are explained in more detail below
  
  

Clinical trials are research studies that test ways to improve healthcare.�� These stidies help find better ways to treat or prevent disease.��

Clinical trials are conducted only after satisfactory information has been gathered on the quality of the non-clinical (laboratory) safety of the intervention, and an ethics committee has approved the trial.��

Participating in a trial is not the same as receiving regular clinical treatment, so it is important that you read all of the information before deciding to enrol your child in a trial..��

Click this to watch a video about Clinical Trials (avail able in Arabic, Chinese simplified, Chinese traditional, Filipino, Greek, Hindi, Italian, Punjab, Spanish, Vietnamese)��

Further information about how clinical trials work can be found on the

Clinical Trials are used to find innovative ways to prevent, detect, treat or manage various diseases or medical conditions. Clinical trials can involve research into the following:

• new medicines,
• surgical and other medical treatments and procedures
• medical devices
• vaccines
• educational interventions
• diets
• psychological or behavioural counseling

Trials offer the hope of developing better interventions or tests for a particular disease or condition, so that even if a trial does not provide a benefit for an individual, it may provide benefits for others with the disease in the future.

By taking part in a clinical trial, your child can contribute to the advancement of medical knowledge and, in some cases, to improved health for themselves or other children with the same disease or condition.

Clinical trials are part of research and at the heart of all medical advances.������

The goal of clinical trials is to determine of a new test or treatment works and is safe.�� Clinical trials can also look at other aspects of care, such as improving the quality of life for children and young people with chronic illnesses.��

People participate in clinical trials for a number of reasons. Healthy volunteers may participate to help others and to contribute to advancing medical science forward.�� Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trials staff.��

Clinical trials offer hope for many children and young people and an opportunity to help researchers find better treatments for others in the future.��

Are they safe?��

All clinical trials are regulated by Australian laws and codes of conduct to protect�� participants and the integrity of the research information gathered.��

All clinical trials in Australia are required to undergo a thorough review process by an accredited Huma Research and Ethics Committee before commencing. This review process ensures that proposed research conforms to:��

• Australian Commission on safety and Quality in Healthcare :

Clinical trials have many benefits, but they also come with some risk.�� You and your child/ young person are required to be informed of all the potential risk before being enrolled in a trial.��

Potential Benefits��

• Assist in the development of new treatments, therapies and/or diagnostic procedures.��
• A chance to access a new treatment or therapy not yet available to the public.��
• Opportunity to support and contribute to research.��
• Advice and care from top expert clinical leaders in their filed.
• Personalised and enhanced care��
• Specialised treatment monitoring��
  
  

Potential benefits can include:

• Gaining access to new treatments that are not yet available to the public
• Obtaining expert care from world leading researchers

Potential risks can include:

• The��new treatment, intervention or test�� may not work for your child
• There may be unpleasant or serious side effects associated with the new treatment, intervention or test ��
• The need for additional treatment, tests, hospital visits and�� time
  
  

Until recently, children were rarely included in clinical trials and much is still unknown about how children respond to some medications, medical devices and tests. Therefore, clinical trials that are designed to test the effectiveness of��treatments, interventions and tests for children are important to ensure that children, too, can receive appropriate, safe and effective treatment and care.

Aboriginal and Torres Strait Islander Participants��

The RCH has committed to the ��

The Accord’s vision that self-determination in research and traditional ways of knowing, being and doing are prerequisites for creating positive health outcomes from Aboriginal and Torres Strait Islander research��

Wadja Aboriginal family Place��

The RCH provides a culturally sensitive service for Aboriginal and Tores Strait Islander children and their families.�� Visit the Wadja family place webpage for information about support and programmes for Aboriginal and Torres Strait Islander Peoples��

Our commitment to you and your child

As a patient/clinical research participant or their family, you can expect the following:��

• You will only be asked to participate in a research project / clinical trial if it is appropriate for your child.��
• You can be assured that your treatment will not be affected if you decide to NOT take part in a clinical trial.��
• You will receive full information about the trial and the opportunity to ask questions before you enrol��
• You will not be involved until we have received consent in writing (e – signature)��
• You have the right to change your mind and withdraw at any time without your care being affected��

Participation in a clinical trial depends on the type of trial being conducted. All trials specify who they need to recruit to conduct the research.�� This changes for every trial as they need to meet specific requirements as set out in the Ethics application. Trials may need participants relating to particular or combination of:��

• Age group��
• Disease or condition��
• History of disease or condition��
• Stage or progression of disease or condition��
• Previous treatment / medical history��
• Health status��
• Demographics����

Before your child can be enrolled in a clinical trials, they may need to undergo some medical tests to ensure that they are the right person for the trial.�� These tests are also used to create what the researchers refer to as ‘baseline’ data of your child’s condition.�� If / when further tests are done during the trial, they will be compared with your child’s baseline data. ����

All clinical trials in Australia are recorded on the Australian Clinical Trial website where anyone can search by broad health condition or specific condition.��

See the Video tutorial on how to search for current trials being conducted in Australia.��

Speak to you child's treating doctor regarding any potential clinical trials that may be suitable for your child. Also visit the Murdoch Childrens Research Institute ��for details of current research projects and contact details.

To find clinical trials around Australia, click on this link

For most* research involving children��under the age of 18, a parent or guardian has to give legal consent for the child to be part of the research.

Informed consent means that the parent/guardian is given information about the key facts of the clinical trial before deciding whether or not their child will take part. Where possible your child should be included in the discussion and decision making process.

Your child cannot be entered into a trial if you don't want them to be. You are free to say yes or no at any time. There should be no pressure placed on you to enter your child in a trial.

*any child who has been deemed a mature minor may be able to give their own consent. The research team will make this decision based on ethically approved criteria.

For a list of potential questions to ask the research team, there are a number of suggestions on the website.

The Consumers Health Forum (CHF) have developed a factsheet about clinical trials - ��-��that will also provide useful information.

You can stop your child's participation in a trial at any time. You can choose to remove your child from the trial at any time without giving a reason and without it affecting the care that your child receives.

If you do withdraw your child from a clinical trial, the relationship between you and your child's doctor will not be affected.�� It is important to discuss your decision with the research team so that they can advise you about any special requirements about leaving the trial and what will happen to information about your child that has been collected to date.

• Your will be upheld – Access, safety, Respect, partnership, Information Privacy and opportunity to provide feedback��

If you would like further information about clinical trials in general please visit the

If you would like further information about clinical trials at the RCH Campus please speak to your child's treating doctor.

If you have any concerns and/or complaints about the research project your child is participating in, the way it is being conducted or your child's rights as a research participant, and would like to speak to someone independent of the project, please contact the Director, Research Ethics & Governance, ������Ƶ on

• telephone: (03) 9345 5044
• email: rch.ethics@rch.org.au
• or contact the RCH Consumer Liaison Officer (CLO)��– Feedback (translated material)

Consumer Involvement��

Consumer and community involvement is where patients, carers, and other people who use health care services, actively work with researchers and research organisations to help shape decisions about health research priorities, policy and practice.��

To learn more about Consumer Involvement in Clinical Research visit the Australian Clinical Trials Alliance ��

Informed consent��

For most* research involving children under the age of 18, a parent or guardian has to give legal consent for the child to be part of the research.��

Informed consent means that the parent/guardian is given information about the key facts of the clinical trial before deciding whether or not their child will take part. Where possible your child should be included in the discussion and decision making process.��

More information about Consent Processes can be found on the RCH Consent page (translated materials available)��

*any child who has been deemed a mature minor may be able to give their own consent. The research team will make this decision based on ethically approved criteria.��

Privacy��

All clinical trials are conducted in accordance with the Victorian Health Records Act Privacy Principles.�� Your child’s information is kept confidential and will not be identifiable in any publications of the trial results.�� Your consent to share your information with any other organisation is obtained before information is released.��

Glossary of Common Terms��

Clinical Research -��Clinical research is medical research that involves people to test new treatments and therapies.��

Clinical Trial -��A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.��

Healthy Volunteer -��A Healthy volunteer is a person with no known significant health problems who participates in clinical research to test a new drug, device, or intervention.��

Inclusion/Exclusion Criteria -��Inclusion/Exclusion Criteria are factors that allow someone to participate in a clinical trial are inclusion criteria. Those that exclude or not allow participation are exclusion criteria.��

Informed Consent -��Informed consent explains risks and potential benefits about a clinical trial before someone decides whether to participate.��

Patient Volunteer -��A patient volunteer has a known health problem and participates in research to better understand, diagnose, treat, or cure that disease or condition.��

Phases of Clinical Trials -��Clinical trials are conducted in “phases.” The trials at each phase have a different purpose and help researchers answer different questions.��

• Phase I trials — An experimental drug or treatment in a small group of people (20–80) for the first time. The purpose is to evaluate its safety and identify side effects.��
• Phase II trials — The experimental drug or treatment is administered to a larger group of people (100–300) to determine its effectiveness and to further evaluate its safety.��
• Phase III trials — The experimental drug or treatment is administered to large groups of people (1,000–3,000) to confirm its effectiveness, monitor side effects, compare it with standard or equivalent treatments.��
• Phase IV trials — After a drug is licensed and approved by the FDA researchers track its safety, seeking more information about its risks, benefits, and optimal use.��

Placebo -��A placebo is a pill or liquid that looks like the new treatment but does not have any treatment value from active ingredients.��

Protocol -��A Protocol is a carefully designed plan to safeguard the participants’ health and answer specific research questions.��

Principal Investigator - A Principal Investigator is a doctor who leads the clinical research team and, along with the other members of the research team, regularly monitors study participants’ health to determine the study’s safety and effectiveness.��

Randomization -��Randomization is the process by which two or more alternative treatments are assigned to volunteers by chance rather than by choice.��

Single- or Double-Blind Studies -��Single- or double-blind studies (also called single- or double-masked studies) are studies in which the participants do not know which medicine is being used, so they can describe what happens without bias. In single-blind ("single-masked") studies, you are not told what is being given, but the research team knows. In a double-blind study, neither you nor the research team are told what you are given; only the pharmacist knows. Members of the research team are not told which participants are receiving which treatment, in order to reduce bias. If medically necessary, however, it is always possible to find out which treatment you are receiving.��