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.
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, The Royal Children's Hospital Melbourne on
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 Consumer Involvement Pack – How to get involved in Health and Medical Research
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.