Participant Information Sheet

1. Introduction

You and your child are invited to participate in this research project, which is called the ‘Eating Disorders Genetics Initiative’, or EDGI.

We are seeking children aged 13 years of age or older who have experienced an eating disorder at any time in their life, and their parents, to participate.

This Participant Information Sheet/Consent Form tells you about the research project.  It explains what is involved in the study to help you decide if you want your child to take part.

Please read this information carefully.  Ask questions about anything that you don’t understand or want to know more about. Before deciding whether or not to take part, you might want to talk about it with your child, a relative, friend or your doctor.

If you decide you want to take part in the research project, you will be asked to provide your consent online.  You will be able to save an electronic copy of this Participant Information Sheet and Consent Form to keep.

2. What is genetic epidemiological research?

Genes are made of DNA – the chemical structure carrying your genetic information that determines many human characteristics such as the colour of your eyes or hair.  Researchers study genes in order to understand why some people have a certain condition such as Anorexia Nervosa and why some people do not.  Understanding a person’s genes may also explain why some people respond to a treatment while others don’t, or why some people experience side effects and others do not.

3. What is the purpose of this research?

Anorexia Nervosa (AN) is a severe mental illness causing significant disability and burden, afflicting 3% of females and 0.3% of males.  Bulimia Nervosa (BN) and Binge Eating Disorder (BED) are more common than AN and carry substantial morbidity and profoundly impact quality of life.  Researchers so far have only scratched the surface in understanding the causes of eating disorders.   EDGI researchers propose to use genetics to understand the biology of Eating Disorders and, in turn, the pathways and systems that influence these complex diseases.

We are seeking 3,500 participants who have experienced an eating disorder at some time in their life to help us reach this goal.  We are recruiting children 13 and over as adolescence and early adulthood are the typical ages of onset for some eating disorders. Eating Disorders in adolescents have serious medical and psychological consequences and adolescents have increased potential for long-term complications. Including adolescents will increase the breadth and utility of our findings.

This research has been funded by a grant from the National Institute of Health (NIH), USA.

4. What does participation in this research involve?

There are 3 parts to this study.  We encourage you to involve your child in each one as much as possible:

• In the first part of this study, you will be asked to complete an online consent form.  We will then ask you for your contact details so we can contact you about the study;

• After giving your consent, your child will be asked to complete an online questionnaire about their eating disorders and other health information;

• Depending on your responses to the core online questionnaire, your child may be asked to donate a saliva sample.  We will extract the DNA from your child’s sample to investigate genetic risk factors for Eating Disorders.   To collect your child’s sample, we will send you a specialised collection kit.  The collection kit is easy to use and the sample can be collected in your own home at your convenience.  We will also send you a consent form that asks for yours and your child’s permission to use the sample. You will be asked to return this sample and consent form via Australia Post to our laboratory, at no cost to you.

Completing the online questionnaire will take approximately 45 minutes, but may take less time.  For your convenience, the survey is designed so that you can start a module and return to it later where you left off.

There are no additional costs associated with participating in this research project, nor is there any payment.

5. Does my child have to take part in this research project?

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

6. What are the possible benefits of taking part?

This study is unlikely to be of any immediate and specific benefit to you or your child.  Extensive research is required to find answers to the questions we are studying. However, future medical or scientific discoveries may come from the research in which you participate.  These may help improve the available treatments and outcomes for people suffering from eating disorder.

7. What are the possible risks and disadvantages of taking part?

You, or your child, may feel that some of the questions we ask in the questionnaire are stressful or upsetting.  Before starting, we will provide parents with an outline of the questions that will be asked in the questionnaire, so you can discuss completing the questionnaire with your child. More information on the questions can be provided if required, including a copy of the questionnaire.  If you or you child do not wish to answer a question, you may skip it and go to the next question, or you may stop immediately.  If your responses to questions in the online questionnaire indicate that your child may be at significant risk of serious harm, you or you child will be provided with advice on how to seek appropriate counselling, support or formal health care.

8. What will happen to information about me and my child?

All personal and questionnaire data collected and information linked for the study remains confidential in accordance with the National Health and Medical Research Council (NHMRC) ethical guidelines and the Privacy Act.  Your child’s personal details, questionnaire data and genetic data will all be stored separately.  The only link between your child’s personal details and your child’s other data is your child’s participant identification number.  Linking your child’s personal details and other data using this number is restricted to members of the QIMR Berghofer research team. All information about you and your child will be stored securely, with access restricted to members of the research team.

The researchers will store your child’s other personal, questionnaire and genetic information indefinitely at QIMR Berghofer Medical Research Institute.  This information may continue to be valuable to researchers many years into the future, and may be considered for use in future, related projects.  Before any future work proceeds it will be subject to approval by the relevant ethics committees.

Your child’s genetic information and some of your child’s questionnaire information (BUT not your child’s name or personal details) may eventually be put into an international genetics data repository.  Information in the database will be available only to researchers from around the world who are approved to study how genes cause a variety of health conditions. These scientists will not know your child’s name or other personal information we learn about you or your child.

Results of this research project may be presented in scientific papers in medical literature, or in public talks, but your child’s identity will not be revealed.  The data collected as part of this study will be combined at analysis with the data from many other people, and as such there will be no way of identifying you or your child as a participant.

In accordance with relevant Australian privacy and other relevant laws, you have the right to request access to the information about you and your child that is collected and stored by the research team. You also have the right to request that any information with which you disagree be corrected.  Please inform the research team member named at the end of this document if you would like to access your information.

In consenting to this project, you permit the research team collecting and using personal, questionnaire and genetic information about you and your child as described above.

9. What will happen to my child's biological sample?

We will use your child’s biological sample to extract one or more samples of DNA.  The research team will then look for differences and similarities between participants’ DNA samples.  This information can help us understand why some people have a certain eating disorder and some people do not.

Your child’s biological sample and samples of DNA will be stored securely at QIMR Berghofer Medical Research Institute along with samples from many other people.  They will be re-identifiable, which means that they will be stored with a barcode label, and can be identified as your child’s even though their personal details are stored separately.  Linking your child’s personal details with your child’s biological sample or DNA using the barcode is restricted to members of the QIMR Berghofer research team.

We may send part of your child’s DNA sample to another laboratory (which may be overseas) for genetic processing and analysis.  This is called genotyping.  If this occurs, your child’s part sample will only be labelled with a number, and transported along with samples from many other people.  No information about your child will be sent to or accessible by the other laboratory.  Any sample remaining after genetic processing or analysis by another laboratory will be destroyed.

We will store the remainder of your child’s DNA sample indefinitely.   We may send a small portion of your child’s DNA to a scientific research repository established by the National Institutes of Mental Health (NIMH) in the USA for indefinite storage.  If this occurs, your child’s part sample will only be labelled with a unique number, a number not used in any other phase of the study, and transported along with samples from many other people.  No information about you or your child will be sent or accessible by this repository.  Your child’s sample will be used for future research on psychiatric disorders, related medical conditions and/or other health conditions.  Access to the repository is strictly limited and all applications will be reviewed by the NIMH review panel.  QIMR Berghofer will store any remaining DNA samples for use in future research studies that may or may not be related to the original research project.  The purpose of storing these types of samples is to answer questions in the future, so we expect to keep your samples for a long time.

Consent to use your child’s biological sample as described in this information sheet will be collected when the sample is provided. Both parent and child are required to sign this form.

10. Will I be given the results of the research project?

This research is not intended for the purpose of treating any health problems your child may have.  Participation in this research study does not take the place of visits to a doctor or other health professionals.

Yours and your child’s information will be used for research purposes and you will not be given any clinical results from this study. Your child’s information will be analysed in combination with information from other participants in this study.  The nature of the research means that the data is de-identified prior to analysis, and only results of a global (not individual) nature will be produced.  It will therefore not be possible to provide any individual results from the study.

11. Who has reviewed the research project?

All research in Australia involving humans is reviewed by an independent group of people called a Human Research Ethics Committee (HREC).  The ethical aspects of this research project have been approved by the HREC of the QIMR Berghofer Medical Research Institute (QIMRB-HREC).

This project will be carried out 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.

12. What if I don't want to participate or what if I change my mind later and want to withdraw from the study?

Participation is voluntary and you can choose not to participate. If you do choose to participate you can withdraw from the study at any time, at any stage, or for any reason for some, part, or all of the research.  You can withdraw your consent by contacting the Project Coordinator by phone 1800 257 179 (freecall) or email edgi@qimrberghofer.edu.au.  These contact details will be listed on your correspondence with the project team.

13. Further information and who to contact

The person you may need to contact will depend on the nature of your query.

If you want any further information concerning this project, you can contact the project coordinator:

If you have any complaints about any aspect of the project, the way it is being conducted or any questions about being a research participant in general, then you may contact:

If you do not want to participate, thank you for your time.  You are not required to respond in any way.  You may close the browser window to exit.