DNA, home testing and fuzzy human rights

4 August 2010 by

DNA database impact on human rightsThe Human Genetics Commission have today published new guidance for direct-to-consumer genetic tests, including a recommendation that children should not be genetically tested by their parents unless the test is clinically indicated. The guidelines highlight that the ethical issues surrounding home-testing are still fuzzy and provide an interesting challenge from a perspective of human rights.

Home DNA testing kits are a fast-growing trend. They have already been on sale direct to consumers for three years by companies such as 23andMe and deCODEme, which advertise home-testing as a means of “taking charge of your health” and “filling in your family tree”. DNA paternity testing has been available for years, but it is the health aspects of home testing which have huge and potentially troubling implications in respect of basic rights.

The mapping of the human genome has made it increasingly possible to assess a person’s likelihood of contracting certain diseases in the course of their lifetime. 23andMe provide a veritable shopping list of 163 diseases and conditions which can be tested for, including Type 2 Diabetes, Rheumatoid Arthritis, Psoriasis, Breast Cancer, Colorectal Cancer and Prostate Cancer.

It is quite remarkable that such testing is already available directly to the consumer, but the ethical and human rights implications of the newly available tests are still in flux. It is not inconceivable that if such tests proliferate, they could become widespread in scenarios such as health insurance or even job applications. We are still a long way from the futuristic dystopia painted by the 1997 film Gattacawhere genetically deficient citizens have become a persecuted underclass – but clearly the issue needs careful and early attention from rights groups.

To this end, the HGC, the UK Government’s advisory body on new developments in human genetics, has published a Common Framework of Principles. The guidance aims to ensure that people who choose to buy genetic tests themselves can “have confidence that the companies selling them follow basic principles of consent, data protection, truth in marketing, scientific rigour and balanced interpretation”.

8% risk of cancer

The ability to test oneself for propensity to certain diseases such as cancer and heart disease could  be useful and potentially life-saving. A personalised assessment of the risk of heart disease could, for example, persuade a heavy smoker to give up. However, a number of problems also arise, the most obvious being that too much information which has not been properly contextualised by medical professionals may just end up scaring people unnecessarily. Non-scientists are notoriously bad at interpreting statistics and this is compounded by the somewhat dubious claims made by companies selling the kits as to how well they work. Moreover, testing may cause people to demand pre-emptive or defensive treatment which a doctor would not otherwise have thought clinically necessary, placing additional strain on NHS resources.

More worryingly, parents with access to home-testing kits may decide to test their children, on the basis it is better to know sooner rather than later about potentially life-threatening conditions. The HGC guidance suggests that parents in fact not test their children unless “testing during childhood is clinically indicated“. If it isn’t, then a parent should wait until the child has capacity to consent “according to the applicable law“, which is likely to be when they reach age 18.

This seems sensible, but these standards are voluntary, so it will be up to individual families to decide whether they want to open the Pandora’s box. The Times report this morning that some congressmen in the United States are pressuring the Food and Drug Administration to ban such tests without medical supervision. Rather than recommending such a restriction, the HGC have taken the arguably more democratic route of increasing access to information about the tests and hoping that families will therefore make educated and rational decisions. Given the health implications, if the kits were banned people would probably find a way of sourcing them anyway, so it seems preferable that this activity be carefully regulated rather than needlessly using time and energy to enforce a prohibition.

An issue for the courts?

Home DNA testing is likely to become more of an issue for society, and as such is likely to engage the Human Rights Act at some point soon. In fact, the courts have already been dealing with issues arising from the ethics of DNA testing for a number of years, particularly in relation to use of DNA evidence by the police. The national DNA database, which is now the largest in the world with more than 1 in 10 people’s DNA stored, was a key human rights election issue.

The Coalition Government have pledged to reform the policy of storing innocent people’s DNA for more than 6 years following a critical judgment by the European Court of Human Rights, which found that the UK had violated the Article 8 (privacy and family and family life) rights of innocent people whose DNA it retained despite the fact that they were not convicted of any offence. Reform has to come directly from the government, however, as shown by a recent judgment of the High Court that it would simply decline to follow the European Court’s judgment, preferring instead the contrary decision of the House of Lords (now the Supreme Court).

It is therefore not difficult to imagine the issue of DNA home-testing coming before the courts. If accuracy improves on testing for diseases, it might be argued that a home-test kit should be provided for free on the NHS, or even at schools as this falls under the state’s basic duty to protect life under Article 2 of the European Convention.

From an Article 8 perspective, if, contrary to the HGC recommendations, parents start to test their children’s DNA when there is no specific clinical need, rights groups may seek to judicially review the currently laissez-faire regulation of the tests, arguing that medical professionals should do more to patrol home-testing in order to protect children. It is one thing to tell a child that they are obese; it is quite another to tell them they have a 40% risk of prostate cancer at some abstract point in the future. These issues are by no means straightforward.

The HGC’s approach is correct as it focuses on the provision of accurate public information, which is necessary to allow people to make rational decisions on whether to use the kits. But the government may have to step in with more stringent regulation if this softly softly approach fails to address this still fuzzy ethical issue.

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