Frequently asked questions:1973-78 cohort

1 in 9 women under the age of 45 in Australia will be diagnosed with endometriosis, a condition which can cause severe period pain, heavy periods, and pain during sex and when going to the toilet. However, very little is known about who might be most at risk of developing endometriosis, and it takes on average 6.5 years for people living with endometriosis to get a diagnosis. Endometriosis can have a major impact on people’s health, with some people so severely affected that they struggle emotionally and physically with their everyday lives.

In the Genetic variants, Early Life exposures, and Longitudinal Endometriosis symptoms Study (GELLES), we want to look at a person’s genes and their health across their life to learn more about endometriosis. We want to find out more about why endometriosis develops, so that people with endometriosis can be diagnosed earlier and have better treatments. To do this, we need women* with endometriosis and women without endometriosis to take part.

*We know that not all people who have periods identify as women. We acknowledge individuals in the transgender community and people who are non-binary.

All participants from the 1973-78 cohort of Women’s Health Australia (also called the Australian Longitudinal Study on Women’s Health) are being invited to participate in this research. You don’t need to have endometriosis to participate.

We know that not all people who have periods identify as women. We acknowledge individuals in the transgender community and people who are non-binary. Participants from the 1989-95 cohort of Women’s Health Australia who identify as transgender or non-binary are welcome to participate in GELLES.

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 experience during your period.
2. Provide a sample of your saliva for genetic analysis. If you consent to providing a saliva sample, you will be mailed a saliva collection kit and instructions.

If you choose to participate by completing the online survey, you are not obligated to provide a saliva sample.

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

To participate, please click on your link to the survey in your invitation email or SMS. 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 you consent to providing a saliva sample, a saliva collection kit will be mailed to you by the GELLES research team. An instruction leaflet will be included within the kit. You can also find the written instructions here or watch a short instruction video here.

If you have any questions, please contact Women’s Health Australia on 1800 068 081 (FREECALL) or email alswh@newcastle.edu.au.

Participant in GELLES is entirely your choice. Whether or not you decide to participate in GELLES will not impact 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 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.

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 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 don’t.

To thank you for your time spent completing the survey, you will receive a $30 Prezzee Smart eGift Card, which 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 with a chance to win a $1,000 Prezzee Smart eGift Card. For more information about the prize draw visit the Prize Draw Details page.

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 the treatment for people with endometriosis.

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 potential 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 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.

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.

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 women before analysis, and findings will only be reported at an aggregate level (i.e., a summary of data from many women). 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.

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, with the aim to better understand genetic differences between 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 women’s 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.

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 from around the world who are approved to study how genes cause a variety of health conditions.

It is standard practice that we do not contact you about your individual research findings. This research is not designed to provide any clinical results to participants. The genetic results we look at do not provide information about specific diseases or disorders. Additionally, this study will not undertake individual analysis of each sample provided, but rather will undertake an overall comparison of genetic markers on all samples provided.

If you have a personal interest in obtaining a genetic test on your DNA, we suggest you consider contacting a genetic testing entity, which can provide such testing. For example, an internet search on ‘DNA testing’ should provide such direction. We recommend that any interpretation of results from a genetic test is done in collaboration with a genetic counsellor.

The analysis we conduct on a person’s saliva sample will not tell us about a person’s health status, ancestry or health outcomes. We will not be looking for these particular genes in our analysis. Rather, the research team will search for groups of common genes involved in health from a very large group of people. This study will not return any diagnostic genetic information to you or your health professional that may have implications for you or your family. This is standard for this type of research.

Analysis of your DNA may include whole genome sequencing (WGS). The GELLES research team will analyse a small number of genetic variants that are likely to be associated with endometriosis. However, whole genome sequencing may be performed in subsequent studies, if approved by an authorised Human Research Ethics Committee.

This study is being run by Professor Gita Mishra at the University of Queensland, and Women’s Health Australia at the University of Newcastle. The full research team includes:

• Dr Ingrid Rowlands, 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

This research is funded by the Medical Research Future Fund.

You can contact the Women’s Health Australia team on 1800 068 081 (FREECALL) or email alswh@newcastle.edu.au.

For questions about the saliva sample or the genetic research in GELLES, you are also able to contact the Human Studies Unit at the Institute for Molecular Bioscience, The University of Queensland on 07 3346 2089 or email hsu-projects@uq.edu.au.

If 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, you can contact the researchers (alswh@newcastle.edu.au). If you would prefer to speak with someone not involved in the research, you can contact the Human Research Ethics Officer at Research & Innovation Services, The University of Newcastle – telephone: 02 4921 6333; email: Human-Ethics@newcastle.edu.au.