1. What is the purpose of the study?
2. Who is conducting the study?
3. What does participation in the study involve?
4. What will the researchers do with my blood and tissue samples?
5. How will my privacy be protected?
6. Will I find out the results of the research using your blood?
7. Who do I contact if I have more questions or a complaint about the study?
8. Can I withdraw from the study once it has started?
What is the purpose of the study?
The purpose of the study is to better understand what causes of cancer, and possibly what factors may protect a person from getting cancer. We will do this by collecting information from participants with and without cancer, and comparing their lifestyle, cultural and genetic information. The only way to get proper answers to such a complicated disease is to get detailed information from people from a variety of backgrounds and see which factors may lead to cancer.
Who is conducting the study?
This study is being conducted by the Cancer Epidemiology Research Unit (CERU) at the Cancer Council NSW (CCNSW) by the researchers listed below:
| Name | Position | Department |
| A/Prof Freddy Sitas | Director | CCNSW Cancer Epidemiology Research Division |
| Prof Dianne O’Connell | Senior Epidemiologist | CCNSW Cancer Epidemiology Research Division |
| A/Prof Karen Canfell | Research Fellow | CCNSW Cancer Epidemiology Research Division |
| Prof Michael Barton | Research Director | Collaboration for Cancer Outcomes, Research and Evaluation Liverpool Health Service |
| Prof Emily Banks | NHMRC Senior Research Fellow | National Centre for Epidemiology and Population Health, Australian National University |
What does participation in the study involve?
Participation involves completing a consent form and questionnaire. You will also be asked to provide a small blood sample, which is optional. In the consent form we ask your permission to access information about you that is held by other organizations (see table on next page). If you have cancer, we also request a tissue sample held by your pathologist. With these resources and by linking them to certain databases, we will be able to gain a greater understanding of factors contributing to your health.
i. Consent Form
The first thing to do is to complete the study consent form. This document gives us permission to access and use your information on the CLEAR study.
So that we can make the most use of your information, we intend to store and use it on the study indefinitely unless you contact us (see page 4) to have it deleted and not used in future research.
ii. Questionnaire
After completing the consent form, you will need to fill in the questionnaire which typically takes about 30 – 40 minutes. The questionnaire asks about medical history, lifestyle, diet, family and use of medications. When you’ve finished the questionnaire, simply return it along with the consent form. You can use the postage paid, pre-addressed envelope provided.
iii. Blood and Tissue Samples (Optional)
Collection
Whether or not you have cancer, we ask that you provide a small blood sample (less than 2 tablespoons). You may experience some mild discomfort and minor bruising or swelling at the site where the blood sample is collected. If you agree to provide a blood sample, we’ll send you a form which you can take to your local pathology collection centre at a time convenient to you.
Tissue samples are collected only from participants with cancer. If you agree to let us collect your tissue sample, just indicate this on the consent form. You won’t need to have another sample taken. Instead, we will contact the facility where your surgery was done, and ask them for a tissue sample.
Tissues will be stored until all of the tissue has been used in analysis. For some analyses only a very small amount of tissue is required, and therefore the overall storage time will depend on this and several other factors including the timing of specific analyses. It is possible that some of the tissue sample will be stored for several decades
Testing
Tissue and blood samples can be tested for different things, including some genetic markers, viruses, bacteria and other factors. Some of the test results won’t mean anything yet – that’s why the researchers are studying them, to see whether they are important or not.
We will not tell you the results of tests done on your blood sample (even if the results do not seem to be normal). This is because outside of a normal clinical setting this kind of feedback is of questionable value and may even be harmful (for example, causing undue alarm). Your blood sample will generally not be analysed immediately following collection. Instead, over the next decades your sample will be stored securely and then analysed as needed for approved health research as part of the NSW CLEAR Study. In the event that a notifiable disease (for example a highly infectious disease) is detected you will be informed of the results as required by the Public Health Act 1991.
iv. Data Linkage (standard)
An important aspect of the study is observing your health over time with your permission we will access and link information from your questionnaire with a number of other sources as listed in the table below for information about your past, current and future health.
The information from these health datasets will only be linked with the information from the NSW CLEAR study if you consent to this, and after specific ethical committee approvals for access and linkage to each of the datasets has been obtained.
What will the researchers do with my blood and tissue samples?
Tissue and blood samples can be tested for different things, including some genetic markers, viruses, bacteria and other factors. Some of the test results won’t mean anything yet – that’s why the researchers are studying them, to see whether they are important or not.
We will not tell you the results of tests done on your blood sample (even if the results do not seem to be normal). This is because outside of a normal clinical setting this kind of feedback is of questionable value and may even be harmful (for example, causing undue alarm). Your blood sample will generally not be analysed immediately following collection. Instead, over the next decades your sample will be stored securely and then analysed as needed for approved health research as part of the NSW CLEAR Study. In the event that a notifiable disease (for example a highly infectious disease) is detected you will be informed of the results as required by the Public Health Act 1991.
How will my privacy be protected?
Your privacy is carefully protected at all times. All information and blood samples provided to the 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.
Our commitment to providing a high standard in handling personal information includes:
- Working with St Vincent’s Human Research Ethics Committee which is responsible for overseeing the conduct of the Study and NSW Population Health Research Services Ethics Committeefor granting access to data.
- Ensuring information is used for health research and the purposes described in this information sheet only
- Ensuring your identifying information, such as name and address, is removed and stored separately upon initial processing and thereafter.
- Data linkages will be conducted under strict privacy and confidentiality processes, as set forth by Population & Health Research Services Ethics Committee.
- Ensuring information is not released in a way that would allow an individual or household to be identified, except as is compelled by law.
Will I find out the results of the research using your blood?
Tissue and blood samples can be tested for different things, including some genetic markers, viruses, bacteria and other factors. Some of the test results won’t mean anything yet – that’s why the researchers are studying them, to see whether they are important or not.
We will not tell you the results of tests done on your blood sample (even if the results do not seem to be normal). This is because outside of a normal clinical setting this kind of feedback is of questionable value and may even be harmful (for example, causing undue alarm). Your blood sample will generally not be analysed immediately following collection. Instead, over the next decades your sample will be stored securely and then analysed as needed for approved health research as part of the NSW CLEAR Study. In the event that a notifiable disease (for example a highly infectious disease) is detected you will be informed of the results as required by the Public Health Act 1991.
Who do I contact if I have more questions or a complaint about the study?
If you have a complaint or would like to speak to someone who is not involved in the CLEAR study please contact the Executive Officer at St Vincent’s Hospital Human Research Ethics Committee (HREC), on (02) 8382 2075 and let them know its about study #07/072.
Can I withdraw from the study once it has started?
You may withdraw from the study at any time. If you have agreed to participate and have completed the questionnaire, you can still change your mind later. Just contact us on 1800 500 894 or via email clear@nswcc.org.au.
Associate Professor Freddy Sitas
