Information for participants

Skin Health Study

The Skin Health Study is a new part of the 45 and Up Study that focuses on skin cancer and aims to improve our understanding of how sun, lifestyle and viruses can together cause this disease. It is a study of the common skin cancers, basal cell carcinoma (BCC) and squamous cell carcinoma (SCC).
Australia has very high rates of skin cancer. We know that most skin cancers are caused by exposure to the sun. What we don’t know much about is why some people get them and others don’t, even with the same sun exposure.

Who is doing the Study?

The research is being conducted by Cancer Council NSW, The University of Sydney, and the Australian National University. Scientists at the German Cancer Research Center are providing special expertise in viruses that can cause cancer. Researchers at Cancer Council NSW are coordinating the Study. The 45 and Up Study is assisting the researchers by inviting potential participants. None of your details have been given to the Skin Health Study. The 45 and Up Study will only give your details to the Skin Health Study if you agree to participate by signing the Consent Form. The National Health and Medical Research Council of Australia has awarded a grant for the study.

Who is being asked to join the Skin Health Study?

People being asked to participate in the Skin Health Study joined the 45 and Up Study in 2008 by completing a questionnaire about health and lifestyle. We are now asking two groups of people from that study to join the Skin Health Study based on the information provided:
• People who have recently been diagnosed for the first time with a basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin
• People who have not had skin cancer. The researchers will compare these two groups for their sun
sensitivity, sun exposure and other lifestyle characteristics, number of moles, and the presence of human papillomaviruses (HPVs) on their skin. HPVs are very common viruses, with four out of five people having them at some stage of their lives. We want to see if they contribute to causing skin cancer.

How to join the Skin Health Study

If you are invited to participate in the Skin Health Study you will receive a letter in the mail. To join the study, sign and return the Consent Form in the enclosed reply paid envelope. People who said they have had a skin cancer may also receive a Skin Cancer Record; if you have received one, please fill it in and return it with the completed Consent Form.

Currently, participation in the Skin Health Study is by invitation only, so we are not able to accept requests to volunteer.

What information does the Skin Health Study ask for?

If you agree to participate in the Skin Health Study we will ask you to do the following:
• Complete a consent form
• Complete a 30 minute questionnaire asking about your hair and eye colour, freckling and moles on your skin, sun sensitivity, places you’ve lived, your sun exposure, your general health, and other lifestyle aspects.
• Give a blood sample and sample of your skin cells.To give the blood and skin samples, you will be asked to go to a pathology collection centre in your area between Monday and Thursday. You will be mailed a pathology request form and sample kit to take with you. At the collection centre, a trained
person will take a 30ml blood sample and will swab a small area of your skin to pick up loose skin cells for testing. The swab causes no discomfort and has no harmful effects. The Study will pay for collecting the blood and skin cells. You do not pay.

What tests will the Skin Health Study do on my samples?

The blood and skin sample will be used:
• To test for past exposure to HPVs and other infectious agents possibly related to HPV infection or skin cancer (e.g. Merkel cell polyomavirus, human herpesviruses and others still to be identified)
• For future testing of DNA for changes in genes that may influence the activity of vitamin D or the risk of having a BCC or an SCC.

Will I get the results of the tests done on my samples?

We will not send you your results for any of the tests we do. Knowing them would not benefit your health in any way. The blood and skin cells will be securely stored for laboratory testing which may be up to four years away; they will be tested under research conditions and not for diagnostic purposes. We can send you a summary of the overall results of the study when they are complete.

How will the 45 and Up Study use my blood sample and questionnaire data?

As well as being used by the Skin Health Study, a portion of your blood sample, your DNA, and the information from your questionnaire will be used by the 45 and Up Study. The 45 and Up Study will store your blood sample securely and allow it to be analysed as needed over the next decades for approved health research.

You are one of over 250,000 people in NSW aged 45 and over who agreed to have their health followed over time by the 45 and Up Study. All information collected in studies that are part of the 45 and Up Study, including the Skin Health Study, is used for ongoing research into the health of Australians in mid to later life.

Your blood sample will be used by researchers to look at a very wide range of factors able to be measured in blood, such as cholesterol, antibodies, and blood sugars. Research may also include investigation of genetic factors, such as the structure and function of certain genes, and how they relate to a range of illnesses and other conditions. No results from your blood sample or other tests will be given to you or your doctor.

Information you provide in the Skin Health Study will be combined with the information that you have previously given to the 45 and Up Study, including information from your health and other records that you allowed the 45 and Up Study to access (see www.45andUp.org.au or call 1300 45 11 45 for more information).

Additional skin cancer research

We may wish to contact you again, in the future, to provide information on any changes to your skin health. In particular, we may contact you to see whether or not you have developed a skin cancer since completing the Participant Questionnaire. We will only contact you for the purposes of skin cancer research, and your participation would be completely voluntary. We will also ensure that we limit the number of times we contact you, so we do not over-burden you.

What about my privacy?

All information and blood samples provided to the 45 and Up Study and the Skin Health Study are bound by Commonwealth and State privacy legislation and guidelines, including the Health Records and Information Privacy Act and the NSW Health Privacy Manual. The commitment of both studies to providing a high standard in handling personal information includes:

• Working with the University of NSW Human Research Ethics Committee and Cancer Council NSW Ethics Committee, which are responsible for overseeing the conduct of the 45 and Up Study and the Skin Health Study respectively

• Ensuring information is used for health research and the purposes described in this leaflet only

• Ensuring your identifying information, such as name and address, is removed and stored separately as soon as possible

• Ensuring information is not released in a way that would allow an individual or household to be identified, except as is compelled by law.

What if I don’t agree to participate in the Skin Health Study?

Participation in the Skin Health Study is entirely voluntary; you do not have to take part. If you don’t take part, there will be no disadvantage to you. If you do take part, you can withdraw at any time without having to give a reason. You may choose todecline this invitation and still remain in the 45 and Up Study.

For more information about the Skin Health Study:

Call The 45 and Up Study Infoline on 1300 45 11 45

To view the Skin Health Study Information for Participants leaflet, click here.

Concerns and complaints

The Skin Health Study has been approved by the Cancer Council NSW Ethics Committee. If you have any concerns or complaints about it, or the way it is being conducted, you may contact the Committee:
Mail: The Secretary
Cancer Council NSW Ethics committee
PO Box 572,Kings Cross NSW 1340
Tel: (02) 9334 1708