Participating in the study
Can I read the Participant Information Sheet before I agree to take part?
Yes. A copy of the Participant Information Sheet can be found here.
Can I take part if I’m living overseas?
Unfortunately, at this stage, we are unable to collect DNA samples from people living outside Australia. However, we are currently looking into options for people living outside Australia who would like to participate further in the research.
Alternatively, if you are returning to or visiting Australia in the next 12 months or so, you are welcome to undertake the survey then and we can forward a saliva collection kit to your Australian contact address – just contact us 3-4 weeks before you arrive and we can see what we can arrange.
If I give a saliva sample, what will it be used for?
We will use your saliva sample to study the genes that might change the risk of skin cancer, or that affect how skin cancer responds to treatment.
What are the benefits of taking part?
There is no clinical benefit to you from this study, but we hope that this work will contribute to the understanding of how skin cancer develops. In the future, it is likely that genetic studies will:
- Lead to the development of new, effective treatments for skin cancer; and
- Help patients and their doctors predict risk of skin cancer in the future.
Will I find out the findings of the research using my saliva?
The results of research done with your saliva are not likely to be available in the immediate future. This is because research can take a long time and must use samples from many people before the findings are known. We will not be able to give you the individual results from your samples (except in exceptional circumstances, see the Information Sheet for more details:). Everyone who takes part in the QSkin study is sent regular newsletters to let you know in general, how the study is going. You are also welcome to contact the Study Team at any time if you have any questions about the study.
Will the researchers need access to my health records?
Yes, the researchers will ask your permission to access your health records. This is so that they can track who develops skin cancer in the future, without having to contact each participant. By accessing records, researchers can obtain important information about the precise diagnosis made by a pathologist, which is often very difficult for patients to recall but is necessary for the research. Records that may be accessed include:
- Hospital records (including Queensland Health and private)
- Pathology records (public and private)
- Medicare and general practice information; Pharmaceutical Benefits Scheme and Repatriation Pharmaceutical Benefits Scheme (this needs extra permission from you)
- The Queensland Cancer Registry, the Australian Cancer Database, the National Death Index and other health databases, both public and private.
What about my privacy?
The QSkin study is bound by Commonwealth and State privacy legislation, including the Privacy Act 1988 (Commonwealth) and the Information Privacy Act 2009 (Queensland). In addition, the study must adhere to the guidelines of the National Health and Medical Research Council of Australia, Medicare Australia and is also accountable to the QIMR Berghofer Medical Research Institute-Human Research Ethics Committee.
How is the information I give you kept confidential?
Your personal details, questionnaire data, biological samples and genetic information will all be stored in separate databases that sit behind a firewall and are protected by passwords. The only link between your personal details and your other data is your participant identification number. The only people who can linking your personal details to other datasets using this number are members of the QIMR Berghofer data collection research team. Internal access to these databases and samples are strictly compartmentalised - the data collection team can only access your personal and survey information, whereas data analysts can only access your survey information and genetic data, and laboratory staff can only access your biosample and DNA [the latter two groups only have your ID number]. This compartmentalisation protects the confidentiality of participants. When results are published they are done as aggregated data altogether; no individual results are included.
Will my entire DNA/Genome be sequenced?
No. For the QSkin Study we do not plan to do any sequencing. We plan to genotype ~500,000 markers in the genome using a genotyping chip.
Can I access my genetic data?
No. This research is not designed to provide any clinical results to participants. The study does 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.
Will the saliva sample tell you about my ancestry or health?
No. The analysis we conduct on a participant’s saliva sample will not tell us that individual participant’s health status, ancestry or predict health outcomes. We are not looking for these particular genes but rather we are searching for groups of common genes involved in skin cancer from a very large group of people.
Will I get results from the study?
Yes. We will provide all participants with an update of the project's progress and results via the study Newsletters available online on the study website.
Do I have to disclose my participation to my life insurer?
No. In this study you do not need to disclose to Insurers that you have had a genetic test. The current advice is that the genetic research we are doing in QSKIN is not a “genetic test”. The reason this is research and not a test is that your participation in QSKIN is voluntary and your sample is viewed as a ‘donation’ or ‘gift’. Further, in our research, we make no guarantees that we will even use your sample, and we give no undertaking to return information to you (indeed, we state that we will not return information to you). Finally, we are not a NATA-accredited genetic testing service and we make no claims that our genetic assays are valid. This is why our activity is classed as ‘research’ and not a ‘genetic test’.
For further information, refer to this summary article discussing insurance and genetic research, as well as Standard No. 11 of the Financial Services Council policy on genetic testing and research (https://fsc.org.au/resources/standards).
Completing the online survey
The online survey will take approximately 30 to 35 minutes to complete and asks about your general health, lifestyle and well-being.
The survey is designed so that you can complete it over multiple sessions. If you wish to do so, you will need to use the same device and browser, which must have 'Cookies' enabled. The survey remembers where you left off by saving a cookie in your browser. To return to your survey, go to your browsing history and click ‘Online Survey Software’, the cookies knows to load your previous progress.
Some devices have cookies disabled as a default setting, while specific Internet settings such as ‘private browsing’ also disable cookies. You may need to check your device and browser settings if intending to do the survey over multiple sessions.
I have already been diagnosed with melanoma – why don’t you ask about melanoma in the survey?
We do not ask about previous melanomas in our survey because we are able to check for past diagnoses of cancer through linkage with the cancer registries. The other more common skin cancers are not registered with the cancer registry which is why we ask about them specifically in the survey.
I made a mistake, can I go back to change my answer?
Unfortunately, the survey design does not allow for a back button, as this may take you down a different pathway and lead to inconsistent data being recorded in your survey. If you recall which questions you answered incorrectly and can let us know (by calling the study helpline 1800 222 600 or via email: email@example.com) how you wanted to respond, and we can amend your answer at our end, once your survey is submitted. If you only partly completed the survey, please call us and we can send you a personalised link to complete it (please do not start it again from the QSkin webpage).
My diagnosis/medication/circumstances have changed since I completed the survey, should I complete it again so it is now up-to-date?
With thousands of people undertaking the study, many may have their medication, lifestyle or health circumstances change since undertaking the survey. The survey is designed to be a snapshot at a particular point in time for each participant, so we don’t need any updated information from participants. Any change in circumstances does not impact on your DNA or your eligibility to participate in the provision of a saliva sample, so there is no need to complete the survey again.
Providing a saliva sample
I am having trouble producing a saliva sample:
- If you are having trouble producing a sample, please perform the following techniques:
- visualise squeezing a half-lemon;
- don’t wait for 30 mins after eating.
- Please note that any volume is useful, even with bubbles.
- If you are still unable to produce a sample, take a teaspoon of water, vigorously swish it around in your mouth and add that to the tube.
I have provided a saliva sample but the sample is discoloured:
Even if your saliva sample is discoloured in the tube (e.g., lipstick or food scraps or blood), there is still plenty of your DNA in the tube for us to extract and use. Please return it to us and if we need you to provide another sample we will be in contact.
I don’t have a copy of the saliva sample collection instructions:
Please find instructions on how to provide a saliva sample into the tube here.
How will you know that the saliva sample belongs to me?
Although the saliva kit will not be marked with your name, it is marked with a barcode that is unique to you. When your saliva kit arrives back at our sample processing laboratory, the barcode is scanned and we can identify it as belonging to you.