Genetics and Human Behaviour: The Ethical Context
Monitoring the provision of genetic tests and interventions
13.49 If genetic tests and corresponding genetic, medical or environmental interventions relevant to traits in the normal range are developed, it is important to consider how such tests and interventions may be made available. Genetic tests for variants that influence behaviour in the normal range might be thought of as comparable to personality or IQ tests, rather than genetic tests that are used to diagnose or predict the onset of a serious disease such as cancer. Similarly, interventions might be seen as comparable to vitamin supplements or cosmetic surgery. In both cases, therefore, if the comparisons are a guide, it may turn out that individuals are left to make decisions about whether to make use of tests or interventions without the involvement of health professionals.
13.50 This has important implications for the regulation and monitoring of tests and interventions. Without appropriate safeguards, consumers may be at risk of exploitation through misleading marketing practices. This is particularly likely in novel areas of science, where most people will not be well placed to make informed judgements. In the case of genetic tests, there is currently no specific legislation in place that would provide a regulatory mechanism for assessing the efficacy or reliability of a test. This applies even to genetic tests for diseases, as well as to the hypothetical tests for genetic influences on behavioural traits that are the focus of this Report. In 1997, the Advisory Committee on Genetic Testing (ACGT), a non-statutory committee that reported to the Department of Health, produced a Code of Practice and Guidance on Human Genetic Testing Services Supplied Direct to the Public.(30) The code of practice was a voluntary one, and suppliers of genetic tests were expected to submit their proposed tests to the ACGT for consideration before introducing them to the public. The ACGT noted that it would be necessary to review how successful the voluntary system proved to be, and to consider recommending ‘a more rigorous statutory regime’ if necessary.
13.51 The remit of this code of practice was restricted to tests for genetic disorders, and did not include tests for traits in the normal range. Some of the code’s requirements are pertinent, including the need for verifiable external quality assurance and control of laboratories conducting the tests and the importance of protecting the confidentiality of the data obtained. However, we consider that the issues raised by tests for behavioural traits and other traits that exhibit normal variation require specific attention. The questions addressed by these tests include very sensitive areas of personal and family vulnerability, and there is considerable potential for exploitation of the anxieties and aspirations of members of the public in an area where the science is not well understood. This danger is particularly important since both tests and interventions might be applied to children without their consent. Thus, we take the view that it is not adequate in this area to rely on the same mechanisms that apply to non-genetic or non-medical enhancements, such as recourse to the Advertising Standard Authority or the Office of Fair Trading, to prevent misleading claims being made and ineffective tests from being sold.
13.52 The ACGT was subsumed in 2001 by the Human Genetics Commission (HGC), which currently has responsibility for administering the code of practice. The HGC issued a public consultation document on the supply of genetic tests direct to the public in July 2002.(31) This summarises the current situation and poses a number of specific questions covering issues such as consent to testing, storage and use of samples, and confidentiality of data. It notes that tests in the field of behavioural genetics are likely to be particularly controversial.
13.53 On the presumption that tests for genetic influences on behavioural traits in the normal range, of varying quality and predictive power, will become available, we welcome the consideration by the HGC of genetic tests supplied directly to the public. We encourage the HGC to give thorough consideration to the issues raised by genetic tests for behavioural and personality traits. We recommend that both the public and private provision of such tests, if they are developed, should be stringently monitored and regulated as necessary.
13.54 In addition to genetic tests, interventions may be developed, whether medical, genetic or environmental, on the basis of information about genetic variants. The HGC consultation document recognises that some genetic tests may be accompanied by a corresponding intervention that is recommended, depending on the test results. How should such interventions be regulated? It is useful here to consider the types of intervention separately. In the case of genetic interventions, we have already noted (paragraph 13.31) that the use of gene therapy will be regulated by the GTAC.
13.55 Medical interventions such as pharmacological substances will not necessarily be classified as medicines. While some would be subject to the existing regulation in place for medicines, others might be classified as foodstuffs or herbal remedies. Those which are not classified as medicines are unlikely to be harmful, but there is a risk that they will be promoted on the basis of unreliable, or even non-existent scientific evidence, and that consumers will be misled. Similarly, environmental interventions, such as changes in lifestyle or surroundings, may be promoted on the basis of genetic information about an individual. As noted above, we do not consider that there are currently any public bodies constituted in such a way as to monitor the provision of such interventions effectively and ensure that they are appropriate and of sufficiently high quality. We recommend, therefore, that those charged with the monitoring and regulation of genetic tests for behavioural traits in the normal range should also be responsible for ensuring appropriate monitoring of the provision of interventions based on such genetic information, which fall outside the scope of other regulatory bodies.
13.56 We note the difficulties for monitoring and regulation raised by the sale of existing testsand interventions on the internet, and encourage the efforts of the Office of Fair Trading and consumer protection agencies such as the National Consumer Council and the Consumers’ Association in developing codes of practice and strategies, such as kite-marks for assisting consumers.
Footnotes30 Advisory Committee on Genetic Testing. (September 1997). Code of Practice and Guidance on Human Genetic Testing Services Supplied Direct to the Public. London: Health Departments of the United Kingdom.
31 Human Genetics Commission. Consultation on Genetic Testing Services supplied Direct to the Public. http://www.hgc.gov.uk/testingconsultation/index.htm (16 Jul 2002).