Participant FAQs

The Consent Form will ask you if you would like to be approached again in the future by BioGrid Australia for certain options. There are 5 options for you to consider: you may choose yes or no for each level of consent depending on what you think is best for you. These options include consent for BioGrid Australia to contact your doctor to obtain your tumor pathology (histologic) report(s) or rare tumor predisposition report and other medical details to confirm tumor type or rare tumor predisposition type or to contact you to offer you participation in other ethically approved research projects studying your type of disease.

Once your signed consent form has been received by CART-WHEEL at BioGrid Australia, you will receive an automated email confirming this. If a suitable research study or clinical trial becomes available we will contact you.

Consent Option 1:

You will be asked if you give permission for BioGrid Australia to store your medical information as data in the Rare Tumor Database and for it to be used in a re-identifiable (coded) way, for example looking at how many patients with a particular tumor type or rare rumor predisposition we have information for and what are the basic characteristics of those patients.

Consent Option 2:

You will be asked if you give permission for your treating physician to enter, view or edit your data. You may still edit your own data, but if you consent for this option your nominated clinician will also have access to your data. Your data may help your clinician.

Consent Option 3:

You will be asked if you give permission for BioGrid Australia to contact you for an update of your personal information. This is to find out what has happened to you since you last gave us information. Again, this information would be stored and used in a re-identifiable (coded) way as in Option 1.

Consent Option 4:

You will be asked if you give permission for BioGrid Australia to contact your doctor to obtain your tumor pathology (histologic) report(s) or rare tumor disposition report and other medical details to confirm tumor type or rare tumor predisposition type. This is so that the information we store is as accurate as possible.

Consent Option 5:

You will be asked if you give permission for BioGrid Australia to contact you about the possibility of participation in other ethically approved research projects studying your type of disease. Such a study may ask you for more detailed information from you about your case; may inform you about a clinical trial that may be relevant for you; may request a blood sample from you if that is convenient (such a sample may have already been stored in one of the Tissue Banks in Australia or elsewhere); and may request permission to use a small part of any tumor tissue that has been removed in the past and has been examined by a pathologist for the presence of cancer (the tissue samples will only be used by researchers for ethically approved projects, and will only use excess tissue, not required for your pathologist to make your diagnosis).

Identifying information

If you agree to participate in this study, we will record your name, date of birth, address and, if you reside in Australia, part of your Medicare number on the Rare Tumor Database. We will create a unique code for you. Only this unique code will be attached to your clinical information.

Clinical information

We will ask you for clinical data such as your age and where the tumor was in your body when you were first diagnosed with your tumor or tumor predisposition, how the diagnosis was made (eg what type of biopsy or genetic test was performed, what scans you had), who your doctors were at the time, general details about treatment you might have had, whether anyone in your family has had a cancer (as sometimes, but not always, this information is helpful for rare tumors). This information will be kept on a different computer database from your identifying information and identified only by your unique code.

Researchers who have applied to access the BioGrid website (by providing their professional details to BioGrid) will be able to view de-identified information from patients with tumor types or rare tumor predisposition in which they are interested. Only researchers who have approval from a Human Research Ethics Committee (HREC) and BioGrid Australia can request access to tissue samples.

HRECs, which are made up of doctors, lawyers, research scientists, community members and ethicists, ensure that projects are scientifically sound and are conducted according to the National Statement on Ethical Conduct in Research Involving Humans (2007) as issued by the National Health and Medical Research Council of Australia.

Tissue samples may be requested by scientists who are involved in various aspects of cancer research. Your tissue may be helpful for research into understanding the causes and processes that lead to your disease, and/or to develop improved methods for the detection, diagnosis, monitoring and/or treatment of your disease. This might include looking for changes in how cells function or how genes work. Researchers may want to look at differences in the tumor tissue and how they relate to processes leading normal cells to become cancerous, or how differences in the tumor tissue relate to how treatments work, providing better ways to predict the effects of treatment on the cancer cells etc. Researchers may want to study how diseases are passed on in families by comparing the genetic material (proteins and genes) present in both normal and affected cells; this is called genetic research.

Cells obtained from your blood or tissue may also be used to establish cell lines. A cell line consists of cells that are grown and kept for a very long time in the laboratory. Cell lines, therefore, allow the creation of a large supply of material for research. This allows material to be shared with other research groups and enables researchers to compare each other’s results. Only researchers who have obtained special approval can establish cell lines or perform genetic research.

BioGrid Australia is structured so that participant identifying and clinical information are always kept separate. Researchers never receive information that would enable the researchers to know the identity of the people involved in the research. Thus researchers can conduct research while participant privacy is fully protected.

The data will only be available in coded form, your name and other identifying information will not be available to researchers. All data will be stored in a password protected secure computer facility at Melbourne Health. The only people who have access to the codes are two database administrators who do not have access to your health data.

Any information obtained in connection with this project and that can identify you will remain confidential. It will only be disclosed with your permission, except as required by law. Further information on data security of the CART-WHEEL database is available on the website.

For a researcher applying to gain access to the database, the following requirements will be essential:

• The researcher must demonstrate that there are adequate resources, including funding, to complete the project satisfactorily. That will usually mean that there is a research grant, which means in turn that the project has been subject to strict scientific scrutiny. The project must have been examined by appropriately qualified scientists and judged to be of good scientific merit.
• The Human Research Ethics Committee of the researcher’s hospital, university or institution must have approved the project.
• When these requirements are satisfied, a decision as to whether to grant access to the Rare Tumor Database will be made by BioGrid Australia, which is ultimately responsible for the proper maintenance and use of the database.

It is possible that information about the study might be published. However, no information that might identify you will appear in these publications.

In accordance with relevant Australian and/or Victorian 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 below if you would like to access your information.

Since this database can help research, which by its very nature, is experimental and can take many years your data will be kept indefinitely unless you choose to notify the researchers that you wish to withdraw your data from the project.

Once you are logged into the Questionnaire, select 'My Consent details' in the top right of your screen. Select the 'Add Consent' button. You will see a number of screens which contain the same information as our regular consent form. You are encouraged to read this information.

To indicate which of the five consent options are appropriate for you, there are boxes to tick on the screen. You are also asked to enter the details of your treating clinician if giving permission for them to edit your information and the name of any other research project you are taking part in. Once you click the ‘Submit’ button on the last screen, you are considered to have provided your consent.

Once you click the ‘Submit’ button on the final screen, the consent process is completed and you are unable to make any changes. The details are locked to provide a legal record of your consent.

If you want to change any of the details of your consent, you can click on the ‘Re-consent’ button. This will take you through the consent module again and the new details you provide will become the ‘Active’ consent version. All versions of consent you provide remain listed in the ‘My Consent details’ section of your CART-Wheel account.

If you wish, you can also withdraw your consent using the ‘Withdraw Consent’ button.

Online consent is an option for you, but you can still print out a regular consent form, sign it and send it back to us via email or post. We are happy to receive your consent in the way that suits you best.

No. 

You can exit out of the consent module at any time. Your consent will be shown as ‘In progress’ and you can come back and complete when it suits you. You may wish to discuss some aspect of the CART-Wheel project with a friend, family or a health professional and you are encouraged to do this.

You can return to where you left by clicking the ‘Complete’ button. While ‘In progress’ you are able to change or edit any details. For example, you can add the phone number of your treating clinician or tick one of the consent option boxes. 

After you click the ‘Submit’ button on the final screen, the process is complete and you will not be able to make any changes or edits.

We have consulted with the ethics committee which oversees this research project (the Melbourne Health Human Research Ethics Committee) and been given approval to accept consent provided through this online function.

You may have already given legal consent online for other purposes. For example, when agreeing to the terms and conditions of the use of a website or a phone application.

If you are not comfortable with giving your consent in this way, you are able to print our regular consent form, sign it and send it to us via email or post.

If you change your mind about any of the details you provided when you gave consent, you can go through the consent process again and this new information will become your ‘Active’ consent. All versions of consent you provide remain listed in the ‘My Consent details’ section of your CART-Wheel account.

Some participants in CART-Wheel gave their consent a number of years ago using an earlier version of our consent form. They may wish to re-consent to give permission to their treating clinician to access and edit their information. This consent option was added to more recent versions of our consent form.

To withdraw your consent for any of your information to be used for research purposes, click on the ‘Withdraw Consent’ button. Note that your consent changes from ‘Active’ to ‘Withdrawn’ from the current date.

You are able to re-consent at any time by clicking on the ‘Re-consent’ button and adding new consent details.

The questionnaire includes 21 questions (sections). Not all of these questions may apply to you.

Depending on how much information you can provide, it will take about 30 to 60 minutes. You do not have to answer all questions in one session. After your registration you can login, start the questionnaire and save your information at anytime. You can login again at a later time to continue the questionnaire or edit your details.

Yes, with your permission (controlled by access to your login details). 

This may be a friend, relative or one of your treating doctors. The way in which the questionnaire has been structured is such that the questions are all directed at the patient i.e. ‘When were you diagnosed with your tumor?’. If the person is filling out the questionnaire on the patient’s behalf this person should interpret them as if he or she was the patient and answer accordingly. For more information go to Patient Proxy.

You do not have to answer all questions in one session. 

After your registration you can login, start the questionnaire and save your information at anytime. You can login again at a later time to continue the questionnaire or edit your details.

Yes. 

You can navigate backward and forward through the questionnaire as much as you like.

You have two options to do so:

1. Use the "Summary" Link in the top right corner to get an overview of which questions you have already answered and navigate back to the question for viewing or editing using the provided "Edit" buttons.
2. Alternatively you can use the "Progress menu bar" on top of the page which shows the numbers of the questions as links and a little pop up window on mouse over to which question the link will take you.

If you make a mistake you can go back to the question and edit your answers.

The summary screen gives you a good overview of which questions you have already answered and also provides you with "Edit" buttons that will take you back to the question for viewing or editing. Alternatively you can use the "Progress menu bar" on top of the page which shows the numbers of the questions as links and a little pop up window on mouse over where the link will take you.

Yes. 

The summary page also has links in the top right corner "Print" to print the summary straight away or "Save" to save your summary as a Word-file to your computer.

No. 

You can navigate backward and forward through the questionnaire as much as you like.

You have two options to do so:

1. Use the "Summary" Link in the top right corner to get an overview of which questions you have already answered and navigate back to the question for viewing or editing using the provided "Edit" buttons.
2. Alternatively you can use the "Progress menu bar" on top of the page which shows the numbers of the questions as links and a little pop up window on mouse over to which question the link will take you.

Yes. 

You can show it to anyone who you think might be helpful for you.

Yes.

Please send an email with your questions to contact@cart-wheel.org

If you don’t know the answer, please simply leave the field empty or select "I don’t know" or "Other" if that option is provided.

No. 

You can answer the questions you know and come back at a later time when you have more information. If you don’t know the answer, you can leave the field blank.

If your contact details change please login to CART-WHEEL and go to section 2 "Contact Details", edit your information and go back to the summary screen to see the details changed correctly.

With your registration and the username/email and password you have chosen you can come back to the questionnaire anytime and as often as you like to view and edit your details.