Joondalup Family Health Study (JFHS)

Frequently Asked Questions - Ethical, Legal and Social Issues

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1. What will the study data be used for?

The JFHS study data will be used to look at how genetics, environment and behaviour affects health and disease. At the same time we hope to find better treatments for disease and ways to prevent them before they occur. We are particularly focused on common chronic diseases that affect many of our community such as asthma and obesity.

2. Who will have access to the study data?

As the JFHS is a medical research project only medical researchers will be permitted to access the Study data. The JFHS will be bound by the Commonwealth Privacy Act which severely restricts access by any other group such as employers, insurers, courts or the police.

The JFHS will not release any data unless:

The participant has given permission to the JFHS to release it, or
The JFHS is required to by law (for example, court order or if a contagious disease is found), or
Emergency situations where JFHS data is needed to stop a serious or imminent threat to someone's life, health or safety.

3. What about drug companies or other commercial users?

The JFHS resource belongs to the Joondalup community. Raw data or samples will not leave WA and will not be sold to third parties under any circumstances.

However one of the key aims of the JFHS is to find better treatment options for diseases like asthma and osteoporosis. Drug companies, as the actual producers of important medicines, have an important role in the community. However, their involvement with the JFHS will be heavily regulated.

Data would be analysed 'in house' and only given to industry at the population, not individual, level.

Industry collaborators would be charged a fee and would share intellectual property with JFHS. All funds generated in this manner would be put back into supporting the JFHS resource and community / education outreach activities in Joondalup.

4. How is this access controlled?

Medical researchers wishing to access JFHS data will sign a confidentially agreement, which is legally binding and states how the data can and cannot be used, according to the participant's consent.

Researchers will require clearance from the JFHS Science Advisory Committee and the Ethical Oversight Committee (see governance structure for further information). They must also show approval and monitoring by their own research institutions' ethics committee.

Penalties for non-compliance may include:

permanent exclusion from future data access
withdrawal of ethics approval
project termination
conduct reported to host institution

5. How will the study be governed?

The JFHS team is committed to setting the international best-practice standard for safeguarding participants' data.

In addition to legal protection, the study will be subject to an internal and external governance structure with a high degree of control and transparency.

The Joondalup Family Health Study will have three key governing bodies:

1. Scientific Oversight Committee

Every research project that wishes to use JFHS data will be scientifically evaluated by the JFHS SOC. Eminent senior researchers and health professionals will evaulate the scientific validity of proposed projects and confirm that the health objective is acceptable to the greater community.

2. Ethics Oversight Committee

All research using JFHS will then require approval and be monitored by the JFHS EOC. Joondalup community representatives, lawyers, social workers, doctors and health researchers will monitor research to ensure that data is used in accordance with participants' consent and advise on issues of data protection, legislative changes and medical research standards.

3. JFHS Board

The JFHS Board of Trustees will be an independent body of prominent leaders from within the WA business, academic, health and medical research communities. The Board will authorise overall decision-making regarding use of the JFHS resource.

6. How can you guarantee my information will be kept confidential?

Rigorous confidentiality and privacy protection protocols are already in place for medical research projects in WA, providing an excellent model for the JFHS.

The JFHS is voluntarily opting to be bound by the Federal Privacy Act 1988 (Cth) ("the Act") and its 10 National Privacy Principles ("NPP"). The Act makes it illegal to release any medical research information to third parties, except under very strict conditions. The NPPs determine how the JFHS must use, secure and disclose study participants' personal information.

Secondly, WA plans to introduce a State Privacy Act later in 2006. The JFHS team strongly supports this initative, and will also meet the standards required by this Act.

Safeguards will be further strengthened by recommendations newly-adopted by the Federal Government to address genetic privacy concerns. Already, the JFHS will be prohibited under the Privacy Act from making unauthorized releases of information. With these reforms however, Australia is set to become the world leader in the legal protections for genetic privacy. Recommendations adopted include making it expressly illegal for employers to unlawfully discriminate against people on the basis of their genetic makeup, and making non-consensual genetic testing a criminal offence. The Federal Government has already established a National Human Genetics Advisory Committee as part of this reform, which will monitor and regulate the use of genetic tests in the life insurance industry.

7. How exactly will the information be coded?

Study health information collected for the JFHS will have all individual identifying details removed and replaced by a code prior to storage, analysis and reporting by scientific researchers. Researchers using JFHS data will only ever work with coded information.

There will be occasionally be situations where identifying info will need to be matched to a study code number. For example:

When participants return for follow-up, to match new data with previously collected information
If participants choose to withdraw and wish to have their information removed from the system
If researchers find a significant health finding for a particular participant and the participant wishes to be informed of this

Coding/decoding will be made possible by an electronic decryption key kept under the highest security conditions. This key will be stored on a network-isolated, encrypted and password-protected computer housed in a secured server room. The server room is protected by internal and external closed circuit television and access-card security.

Only a limited number of personnel will be permitted access to the key - they will be required to sign an enforceable confidentiality agreement and obtain special clearance from the JFHS Ethics Oversight Committee.

A similar protocol has existed for the past 40 years for the Busselton Health Study.

8. What happens if it is discovered I have an illness?

Study participants may choose to receive notification of any test results that indicate a potentially significant health issue. Where appropriate, up-to-date support information can be provided through the JFHS to participants and/or their GPs about management of specific conditions identified as a result of being in the Study.

Genetic feedback will not be given to participants, as the results will not provide a useful assessment of disease risk for that person. The JFHS will not be testing for single-gene diseases like cystic fibrosis, but aims to assess the overall interplay between different genes, the environment and lifestyle factors for complicated illnesses like cancer. The disease risk attributable to each factor will be small, and we do not yet know exactly how these elements all interact, so releasing genetic information would not be clinically meaningful, or useful to the individual.

9. How would a detected illness affect my health insurance?

Participation in the JFHS will have no impact on an individual's health insurance policy. Health insurance companies such as HBF or Medibank Private must charge the same premium and provide the same coverage regardless of their members' health. Furthermore, health feedback from the study would not have to be disclosed to health insurance companies.

10. What about life insurance?

People applying for life insurance policies have a special obligation to disclose all relevant information. Application forms may ask questions about previous or potential illnesses and medical tests - if participants have chosen to receive medical feedback from the JFHS then they must reveal this information on such forms. However, as genetic feedback will not be given to participants they will not be obliged to give any genetic information from the JFHS.

The Australian government has established a Human Genetics Advisory Committee to oversee regulation of genetic testing and assess which genetic tests are relevant to the life insurance industry.

11. How long will the study go for and for how long will my consent be valid?

We hope to continue the JFHS for as long as possible, in order to collect a large amount of data over several generations. Participants will be asked for their informed consent at the onset of the study and at each subsequent follow-up visit. Consent would extend for the study duration, unless the participant chooses to change their consent preferences or withdraw from the study, either of which may be done at any time.

12. Can I withdraw from the study at any time?

Yes. Anyone who volunteers to be part of the JFHS may withdraw at any time. This can be done by first contacting the JFHS on 1800 783 110 (freecall).

13. What happens to my data if I withdraw?

Participants who want to withdraw from the study have two options regarding their data. They can:

Allow the JFHS to use the data collected to date, but not be contacted for any future follow-ups.
Withdraw all data collected by the JFHS and not be contacted for any future follow-ups.

If the data is part of a research study that has already been conducted, however, it would not be possible to withdraw it. In any case, participants' names or other identifying information would not have been disclosed.

Under Commonwealth privacy laws, researchers will not be allowed to use research data from participants who have withdrawn their consent.

14. Will I have a say in what sort of health issues will be studied?

Yes. The JFHS team is very keen to maintain an ongoing dialogue with the community, via the Community Engagement Program and community representation on JFHS oversight committees.

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