Legal control over personal genetic data: how far should we go?

Despite this multifaceted approach, there is no legislation dealing specifically with genetic privacy and non-discrimination and there are a range of sectors in Australia which are not regulated and have no requirements to conform to any privacy or non-discrimination practices. The existing regulations to which I refer applied to about 30 per cent of medical research funded in Australia at the time that I introduced my Bill.

I am of the view that genetic privacy (and genetic discrimination) is best dealt with in a comprehensive privacy scheme. The debate has moved on considerably since I first introduced my bill, though it was never intended to stand without broader privacy issues being addressed. It was instead a contribution to the ongoing debate about privacy and related issues.

My Bill was based on the Boston University School of Public Health’s Genetic Privacy Act introduced into the US congress on 11 March 1997. It establishes, first and foremost, that all samples collected for genetic testing must be undertaken with informed consent.

To facilitate the attainment of informed consent for the collection of a DNA sample, the Bill recognises that counselling should be a key component of any genetic testing for the individual and ensures that counselling will be available. If counselling is not available the Bill ensures that this will be highlighted in every case.

The Bill also includes special provisions for genetic information and samples for research purposes to be regulated with special consideration.

The Bill acts further to outlaw genetic discrimination – as the name implies – except in certain circumstances, such as cases of positive discrimination in the workplace. For example, the use of chromosome screening in certain potentially dangerous workplaces such as a plant that uses potentially carcinogenic chemicals.

It recommends that penalties should be imposed for breaches of privacy and for discrimination and recommends that a body be established for complaints, investigation and enforcement of privacy breeches and discrimination and names the Human Rights and Equal Opportunity Commission under the Privacy Act 1988 and the Disability Discrimination Act 1992 (Cth) as the most appropriate bodies for the job.

Where samples are collected for the purposes of research, the questions of confidentiality and consent are relevant because of the sensitive information which may be made available.

However, specific consent may be inappropriate where samples might be used in research not contemplated at the time the sample was collected and where DNA samples have been collected and stored for other purposes and have relevance to a new research project.

The Privacy Commissioner noted at the time that the Bill "Largely sets out good practice in the research context", however, "the main question is whether incorporation of these standards in a Bill of this kind are desirable at this point in time".

The Bill reflects most of the requirements of the NHMRC then draft Statement on Ethical Conduct in Research Involving Humans and enshrines the DNA sample must be "essential to the research project" and the "the potential benefit of the research project to society outweighs the potential risks to the research subjects" as necessary for the collection of any information.

In any legislative scheme it is necessary to balance the possible legal requirement for specific consent and confidentiality against the public interest for conducting research, and the possible difficulties obtaining specific consent in every circumstance. Though despite the equivocal nature of confidentiality in the public interest, on balance I am of the view that specific consent should be necessary as it would be unethical to diagnose an individual anonymously as they might not be warned to obtain treatment (subject to their not wanting to know), or be able to warn others.