What does participation in this research project involve?

We will ask you questions on your demographics and medical history to obtain information about your illness. This will be done through an online and secure survey with the provided link sent to you once you consent to participation. The survey is estimated to take 20 minutes and will ask you about your demographic information, autoimmune disease, symptom management and mental health. To study whether your disease is prevalent in families too, we would like to invite some of your blood relatives to participate in this study. If you agree for us to contact your blood relatives, we will ask you to provide their contact details.

What will happen to my responses?

The responses will be marked only with a code number allocated to you for the study that is linked to your identity by a master key to the code. Your name or other identifying information will not be recorded on the survey responses. Due to the exploratory nature of this research, it is unlikely that the data collected on your individual diagnosis will produce any information that will have an effect on your future health or treatment or the future health of your family. However, if this is the case you will be contacted by your doctor, if you choose to be informed of this result, and arrangements will be made for you to receive this information and any counselling that may be required. This information may also be of potential importance to the future health of your blood relatives.
We cannot say exactly what projects your data will be used for in the future, as this project is exploratory. Any future research projects will have to be approved by a Human Research Ethics Committee before your responses and data can be used. However, your responses will always be provided to the researchers in a coded form to ensure your confidentiality. This may include collaborators and researchers interstate and overseas.

What are the possible benefits?

We cannot guarantee or promise that there will be any benefit to you from your participation in this study. However, your participation may help to further medical knowledge and may improve diagnosis and treatment of immune-based diseases in the future.

What are the possible risks?

The potential health risks in this study are low. Psychological risk: Questions relating to mental health and trauma may be triggering and we have labelled questions as such. If you feel triggered, you may stop and remove yourself from the study. Drug use revelation: Symptom management may involve drug use and we will not disclose this information unless formally requested. Questions relating to drug use are optional. Identity risk: Data breaches are unlikely to occur and there are multiple levels of security in place to ensure this does not occur. Disclosure of participation in a research project is not required except in those projects where a personal result has been given.

Do I have to take part in this research project?

Participation in any research project is voluntary. If you do not wish to take part, you don’t have to. If you decide to take part and later change your mind, you are free to withdraw from the project at any stage. Your decision whether to take part or not to take part, or to take part and then withdraw, will not affect your current medical care.

What if I withdraw from this research project?

If you decide to withdraw, please notify a member of the research team before you withdraw. If you do choose to withdraw from the study the investigators will not use information gained from your original responses.

Could this research project be stopped unexpectedly?

The research project could be stopped unexpectedly due to lack of participation or unforeseen circumstances. However, this would not affect you or the information you have provided us.

How will I be informed of the results of this research project?

At the end of this study when the results are known you will be given a written plain English summary of the outcomes of the research upon request.

What else do I need to know?

• What will happen to information about me?
  Any information obtained in connection with this research project that can identify you will remain confidential and will not be disclosed unless required by law. The information collected (data) will be identified using a code number, which will be accessible only to the study team at the Garvan Institute of Medical Research. The key to the code will not be given to other researchers in the future. Data will be recorded in a computer database. Data will be stored on password-protected databases (for electronic records) for a minimum of five years. Although unlikely, any results that impact on your health or future treatment will be added to your medical record. Your data will be stored in a data bank in the Garvan Institute of Medical Research. If you consent for your information to be used in future research, it will be made available to other researchers conducting approved research in research similar to this project only. We intend to publish the results of this research. In any publication, information will be provided in such a way that you cannot be identified.

• Your medical record and any information obtained during the study are subject to inspection, for the purpose of verifying study procedures and the data, by the NSW Health Human Research Ethics Committee or as required by law. How can I access my information?
  In accordance with relevant Australian and/or NSW privacy and other relevant laws, you have the right to access the information collected and stored by the researchers about you. You also have the right to request that any information, with which you disagree, be corrected. Please contact one of the researchers named at the end of this document if you would like to access your information.

• What happens if I am injured as a result of participating in this research project?
  If you suffer an injury as a result of participating in this research project, hospital care and treatment will be provided by the public health service at no extra cost to you if you elect to be treated as a public patient.

• Is this research project approved?
  The ethical aspects of this research project have been approved by the St Vincent’s Hospital Human Research Ethics Committee HREC 2020/ETH02793.

This project will be carried out according to the National Statement on Ethical Conduct in Human Research (2018) produced by the National Health and Medical Research Council of Australia. This statement has been developed to protect the interests of people who agree to participate in human research studies.

Sound good? Take the survey!