M-PreM@home participant information
You have been a participant in the Australian Longitudinal Study on Women’s Health (also known as Women’s Health Australia) since 1996 – thank you! We have collected valuable data about Australian women and now we want to find out how we can improve and personalise healthcare.
You expressed an interest in a new substudy of Women’s Health Australia: the Menarche-to-PreMenopause (M-PreM) substudy. You will be asked to do a small number of measurements and provide a saliva sample, which will be used for genetic research.
Before you decide whether or not you wish to participate in this substudy, it is important for you to understand why the research is being done and what it will involve. Please take the time to read the following information carefully and discuss it with others if you wish.
Participation in this research is voluntary. If you don’t wish to take part, you don’t have to. Your participation in Women’s Health Australia is not affected by whether or not you decide to take part in the M-PreM Substudy.
Genes are made up 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 diabetes and asthma, and why others do not. Understanding a person’s genes may also explain why some people respond to a treatment or experience a side effect, while others do not.
Women are at greater risk of poor health than men as they age. These conditions include heart disease, diabetes, asthma, muscle weakness, and cognitive impairment. This could be due to one or a combination of factors in a woman’s life. Therefore, the purpose of this research project is to examine how reproductive (e.g. age at menarche or first period), sociodemographic (e.g. education level, where you live), lifestyle, and genetic factors influence risk of poor health in women.
This substudy is being run by Professor Gita Mishra at the University of Queensland and the University of Newcastle, and has been funded by the National Health and Medical Research Council.
In your most recent survey, you indicated that you were interested in the M-PreM Substudy. This substudy is not suitable for you if you: are pregnant, are postmenopausal, or have been diagnosed with a reproductive cancer.
Participation in this substudy is voluntary. It is completely up to you whether or not you wish to participate and it will not affect your relationship with Women’s Health Australia. You can leave the substudy at any time without giving a reason and without consequences of any kind.
You can also specifically withdraw your biological samples at any time without consequences of any kind. If you do withdraw your biological samples, you can choose to destroy all stored samples and/or unpublished data that has been obtained from using the samples. Note that data that are already deposited in an international data repository or published will not be withdrawn and destroyed.
If you agree to take part, you will be posted a package containing a questionnaire, saliva collection kit, measuring tape, physical activity monitor, and a sleep diary. You can request this package by calling Women’s Health Australia.
|You will be asked questions about when you last had something to eat or drink, your menstrual cycle status, respiratory symptoms, and recent use of medications and health behaviours that affect your lung function.|
|Saliva collection||You will be asked to provide 2ml of saliva, which will be used to extract DNA for genetic analysis.|
|Body size measurement||Your height, weight, and waist, hip, arm, and thigh circumference will be measured.|
|Physical activity monitor and sleep diary||You will be asked to wear a small physical activity monitor (4.5cm x 2.5cm) on your thigh and complete a sleep diary for 8 days. You will be provided instructions on what to do and how to return the device at the end of the 8 days.|
|Menstrual cycle diary||If you have been diagnosed or treated for polycystic ovary syndrome, you will be asked to complete a menstrual diary for 3 months.|
Research results from this substudy are unlikely to be of any immediate and specific benefit to you. The data from this substudy will be analysed and future medical discoveries may result from your participation. This will help improve and personalise medical treatment and care for women overall. We will, however, send you the results of your physical activity and sleep pattern. If you are concerned about any of these results, we encourage you to seek advice from your GP.
- You may feel uncomfortable with a particular measurement/test. If you do not wish to answer a question or do a test or measurement, you may skip it.
- It may be possible to trace your genetic sequence back to you, however, this is very unlikely because your genetic data and personal information will be kept in physically separate and secure locations.
- It is also possible that the genetic analysis may reveal information that is important for your healthcare. You can decide whether or not you wish to be contacted if this situation arises.
- All personal, questionnaire and genetic information collected for the substudy remains confidential in accordance with the National Health and Medical Research Council (NHMRC) ethical guidelines and the Australian Privacy Act 1988.
- Your personal details, questionnaire data and genetic data will all be stored separately.
- The data you provide in this substudy will be linked to the questionnaire data collected by Women’s Health Australia in previous and future surveys
- The only link between your personal details and your other data is your participant ID number. Linking your personal details and other data using this number is restricted to authorised members of the Women’s Health Australia research team at the University of Newcastle.
- All other questionnaire and genetic information data about you will be de-identified (i.e. will not contain identifying information, such as your name, address, and date of birth) and stored securely at the University Queensland.
- Your information will be stored indefinitely at these two sites.
- This information may continue to be valuable to researchers many years into the future, and may be considered for use in future projects. These projects will require approval by the relevant ethics committees before they begin.
- Your genetic information (not your biological sample), sleep patterns, physical activity data, and some of your questionnaire information (but not your name, address or date of birth) may eventually be put into an international data repository. Information in the repository will only be available to researchers from around the world who are approved to study how genes, sleep, or physical activity cause a variety of health conditions.
- Your data will be combined with the data from many other women before analysis so there will be no way of identifying you as a participant. Results of this research project may be presented in scientific or public articles and talks, but your identity will not be revealed.
We will use your saliva sample to extract your DNA and analyse a small number of genes which are likely to be associated with determining the age when your period starts, other reproductive characteristics, and the development of heart and metabolic diseases. The analysis of these genes cannot be used for diagnosis right now. However during the course of this research project, we may discover new information that is important for your healthcare. You will be asked whether you wish to receive the results (this may require you to have the test repeated in a clinical laboratory). If you agree, we may contact you if such a situation arises.
You will not receive any payment for your participation.
The results of the research project may be presented in scientific or public articles and talks. We will not report the substudy results in any way that could identify you. Only grouped and summarised results will be reported. We will not publish any information that could identify any particular person.
Your DNA will be stored indefinitely for future research projects, as part of Women’s Health Australia in collaboration with Professor Gita Mishra, that may or may not be related to this project. All future projects will require approval by the Human Research Ethics Committee with oversight of Women’s Health Australia. The DNA that you provide (but not your personal details) may be made available to other researchers working with Professor Mishra to study different health conditions, some of whom may have commercial interests. If you consent to participate, you will be donating your saliva freely for these purposes and waive any claim to commercial rights arising from this work. Your DNA will be stored securely at the University of Queensland Institute for Molecular Biosciences. Your DNA sample will be stored in tubes with a barcode label containing your project ID number (not the Women’s Health Australia participant number you receive on emails and letters). This means that your samples may be re-identifiable, however the likelihood of this happening is very low. You can have the samples destroyed at any time by contacting the Women’s Health Australia.
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 Metro South Health and Health Service HREC.
If you want any further information concerning this project, you can contact Women’s Health Australia on 1800 068 081 (Freecall) or email firstname.lastname@example.org. 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 the Metro South Health and Health Service Human Research Ethics Committee (EC00167) (approval number HREC/2019/QMS/52052):
- Contact Person: MSH HREC Coordinator
- Phone: 07 3443 8049
- Email: MSH-Ethics@health.qld.gov.au
If you are interested in participating in the M-PreM Substudy, please contact Women’s Health Australia on 1800 068 081 (Freecall) or email email@example.com to request a package or to get more information.