Participant information statement: 1973-78 cohort

One in nine women* have a condition called endometriosis, where tissue similar to the lining of the uterus grows outside the uterus or other organs. You likely know someone who has endometriosis. It can cause very severe period pain, heavy periods, and pain during sex and when going to the toilet. Some people who have endometriosis are so severely affected by the disease that they struggle physically and emotionally with their everyday lives. In our new study, we’re trying to work out why some people develop endometriosis and others don’t.

Very little is known about what causes endometriosis and who might be most at risk of developing it. A person’s genes, their family history, and their health and experiences during childhood and adolescence might tell us a lot about who is most likely to get endometriosis. In GELLES, we’re planning to look at a person’s genes and health across their life to find out more about why endometriosis develops, so that women can be diagnosed earlier and have better treatments.

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 to understand why some people have a certain condition, such as diabetes or asthma, and why others don’t. Understanding a person’s genes may also explain why some people respond to a treatment or experience a side effect, while others do not.

This study is being run by Professor Gita Mishra at the University of Queensland, and the University of Newcastle, and has been funded by the Medical Research Future Fund. The full research team includes:

• Dr Ingrid Rowlands, School of Public Health, The University of Queensland
• Dr Ellen Wessel, School of Public Health, The University of Queensland
• Dr Sally Mortlock, Institute for Molecular Bioscience, The University of Queensland
• Professor Jenny Doust, School of Public Health, The University of Queensland
• Professor Annette Dobson, School of Public Health, The University of Queensland
• Dr Marina Kvaskoff, French National Institute for Health and Medical Research
• Ms Megan Ferguson, School of Public Health, The University of Queensland

All members of the 1973-78 cohort of Women’s Health Australia are being invited to participate in this research. As mentioned above, you don’t need to have endometriosis to participate.

If you agree to participate, you will be asked to:

1. Complete a confidential online survey, which will take approximately 30-60 minutes to complete. The survey includes questions about your health and wellbeing at different points of your life (including medical conditions and pain), your childhood (including questions about your mother’s pregnancy with you, very early childhood, and your relationship with your parents), and your family’s health. It also includes detailed questions about your menstrual cycles, including symptoms you might have experienced during your period.
2. Provide a sample of your saliva for genetic analysis (please refer to sections 8 and 10 for more information). If you consent to providing a saliva sample, you will be mailed a saliva collection kit and instructions. If you already provided a saliva or blood sample as part of the Menarche to PreMenopause substudy (M-PreM) in 2019-2021, and consented to your sample being used in future research, we’ll be able to use your existing sample (but you can tell us if you don’t want your sample to be used for GELLES).

If you choose to participate by completing the online survey, you aren’t obligated to provide a saliva sample. Providing a saliva sample is completely voluntary.

Participation in this research is entirely your choice. Only those people who give their informed consent will be included in GELLES. Your decision will not affect your participation in Women’s Health Australia.

If you do decide to participate and later change your mind, you can withdraw from GELLES at any time without giving a reason, by contacting Women’s Health Australia on 1800 068 081 (freecall) or emailing us at alswh@newcastle.edu.au. You will also have the option to withdraw your data up until data has been provided to researchers for analysis or published.

To thank you for your time spent completing the survey, you will receive a $30 Prezzee Smart eGift Card. The eGift Card can be used online or in-store at 100+ Australian retailers. For more details go to: https://www.prezzee.com.au/store/#gift-cards. Additionally, everyone who completes the survey by 5:00 pm on Monday 31st July, will go into the GELLES 1973-78 cohort prize draw[1], with a chance to win a $1,000 Prezzee Smart eGift Card.

Your contributions will help us to discover more about the possible causes of endometriosis. This is important because health care professionals need ways to diagnose the disease earlier and improve treatment.

There’s a small risk that you may find some of the survey questions uncomfortable to answer. If you start to feel uncomfortable or upset at any time, you can choose to end the survey (with the option to return later, if you want to). You can also choose to skip questions that you are uncomfortable answering. If you are feeling distressed, you may also like to discuss your feelings with someone at Lifeline (13 11 14) or 1800 Respect (1800 737 732).

Would you like to provide a saliva sample? It’s important that you’re aware of the following risks, though the risk of these things happening is very low.

Your genetic information is unique to you (like a fingerprint) and using it can raise some issues for some people. If you provide a saliva sample, it is possible that someone could trace the coded information in a scientific database back to you and your participation in this study. However, they wouldn’t be able to access your survey answers (see more information about how your privacy is protected in section 9).

It is standard practice that we do not contact you about your individual research findings. The genetic results we look at do not provide information about specific diseases or disorders. It is possible that our research may identify new endometriosis diagnostic tools that can be applied to your genetic data. You can decide whether or not you wish to be contacted if this situation arises.

We also do not provide research results about you to your GP or healthcare provider/s, nor will it be recorded in your health records.

Participants in this, or any related studies, cannot claim ownership rights to any medical or scientific product that results from research with their saliva sample.

[1] Prize draw: run 26th April 2023 – 31st July 2023, drawn 2nd August 2023. Winner randomly drawn from a ballot box will be informed via email. For prize draw terms and conditions, see: https://alswh.org.au/gelles/information-for-participants/prize-draw-details/

Survey data: The survey data collected in this study will be linked with the other data held by Women’s Health Australia. As with your regular Women’s Health Australia data, your GELLES data will be securely stored and may be made available for future research. All researchers who wish to use Women’s Health Australia data, including GELLES data, will need to apply to the Australian Longitudinal Study on Women’s Health (ALSWH) Data Access Committee and agree to their terms and conditions for use of the data. Researchers may also need to obtain ethical approval for their project from a Human Research Ethics Committee.

Genetic data: Your saliva sample will be used to extract your DNA and generate genetic information, which may include sequencing your genome. The study will analyse a small number of genetic variants that are likely to be associated with endometriosis. This study aims to use genetics to better understand the genetic differences in women* with and without endometriosis.

Your genetic data will be linked with your survey data and other survey and linked health data held by Women’s Health Australia.

Data from all participants will be pooled and analysed to examine issues related to health and endometriosis. The findings from this study may be reported in publications in scientific journals and in conference presentations and seminars. A summary of results will also be made available in the annual participant newsletter for Women’s Health Australia. Individual participants will not be identified in any reports, publications, or presentations arising from this study.

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. You will be asked whether you consent to the storage and use of your saliva sample/DNA for future research projects (see section 10).

Your genetic data (but not your saliva sample) and some of your survey data (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 who are approved to study how genes cause a variety of health conditions.

Your privacy is our number one concern. We have processes and systems in place to protect your privacy:

• All personal, survey, and genetic information collected for GELLES remains confidential in accordance with the National Health and Medical Research Council (NHMRC) ethical guidelines and the Australian 1988 Privacy Act.
• Your survey data will be collected using REDCap (an online survey host), with all data securely stored on servers at the Hunter Medical Research Institute in Newcastle, NSW.
• Your personal details, survey data, and genetic data will all be stored separately.
• 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 GELLES survey and genetic data about you will be de-identified (i.e., will not contain identifying information, such as your name, address, or date of birth) and stored securely at the University of Queensland.
• Your data will be combined with the data from many other participants before analysis, and findings will only be reported at an aggregate level (i.e., a summary of data from many participants). Individual participants will not be identified in any way.
• Results from this research may be presented in published scientific articles and talks, but your identity will not be revealed.

Your saliva sample and extracted DNA sample will be stored securely at the University of Queensland’s Institute for Molecular Biosciences indefinitely. Your saliva and DNA samples will be stored in tubes with a barcode label containing a unique barcode number, your project ID number (not the Women’s Health Australia participant number that you receive in emails and letters), your first and last initial, and the date at which you initially commenced the survey. This means that your samples may be re-identifiable; however, the likelihood of this happening is very low.

If you consent to the storage and use of your saliva sample/DNA sample for future research, the saliva and resulting DNA data that you provide (but not your personal details) may be made available to future research projects as part of Women’s Health Australia in collaboration with Professor Gita Mishra. These projects may or may not be related to GELLES. All future projects will require approval from Human Research Ethics Committees, with oversight from Women’s Health Australia. If you provide consent for future research projects, you will not be contacted to provide consent for these projects.

It is possible that some of this research may have commercial interests. If you consent to your saliva/DNA sample being stored and used in future research, you will be donating your sample freely for these purposes and waive any claim to commercial rights arising from this work. Participants in this, or any related studies, cannot claim ownership rights to any medical or scientific product that results from research with their saliva sample. Research results about you as an individual will not be available to you or your GP, nor will it be recorded in your health records.

You can have your sample and/or unpublished data obtained from your sample destroyed at any time by contacting Women’s Health Australia. Please note that data that has already been published or deposited in an international data repository cannot be withdrawn or destroyed.

Please make sure you have read this information statement and that you understand its contents before you consent to participate.

To participate, please click on the link for the survey in your invitation email. Before you begin the survey, you will be asked whether you consent to participate in GELLES and whether you consent to providing a saliva sample.

If there is anything you do not understand, or if you have questions, please contact Women’s Health Australia on 1800 068 081 (freecall) or email alswh@newcastle.edu.au.

Should you have concerns about your rights as a participant in this research, or you have a complaint about the manner in which the research is conducted, it may be given to the researcher, or, if an independent person is preferred, to the Human Research Ethics Officer, Research & Innovation Services, The University of Newcastle, University Drive, Callaghan NSW 2308, Australia, telephone (02) 4921 6333, email Human-Ethics@newcastle.edu.au.