Plans for a national DNA database will be revealed by the Prime Minister this week. This is the same proposal the Tories and Liberal Democrats opposed when presented by the Blair government because they argued it posed a threat to civil liberties. This time it is expected to offer an 'opt-out' clause for those who do not wish their data to be stored; exactly how this would operate isn't yet clear. But does it matter and does it really pose a threat to civil liberties?
When it comes to biology and ethics we tend to have a distorted view of DNA and genetics. This is for two reasons. The first is that it is thought that our genome somehow represents the individual as a code that then gets translated. This is biologically speaking wrong. DNA is a template and part of the machinery for making proteins. It isn't a code in anything like the sense of being a 'blueprint' or 'book of life'. Although these metaphors are used often they are just that, metaphors. It is however a very important bit of biology and it does have the potential for saying something about our health or our potential health; and it is this that poses the greatest problem ethically.
The science of genomics seeks to associate risk of disease or ill health with particular gene mutations or with patterns of expression. The value of the database is precisely that it enhances the potential for finding these associations and potentially developing treatments targeted at those gene mutations. Databases already exist but they lack the breadth of a truly national database.
The ethical argument in favour of a national database is a utilitarian one; that the benefits to be gained will outweigh the small risk that the database might be misused. The database would be anonymised so that names are not associated with it or at least not in a way they could readily be accessed by other than those working on projects requiring a study of cohorts of individuals. The risk is that this could be breached and pose problems if, for example, insurance companies had access to the risk assessments.
Potentially there are other issues that might arise. For example, if it is found that a particular mutation has a significant chance of affecting the health of those individuals who carry it, then should they be informed? This is a problem because many people may not wish to be informed, particularly if there is no cure for the problem. It might affect their lifestyle as a sword of Damocles hanging over them and it might affect their potential for life or health insurance should insurance companies insist on declarations of whether they had been informed. It is also not clear at what level of risk if at all people should be informed.
These are genuine concerns particularly as such mutations are likely to be passed on to their offspring. It would also, therefore, present the individual with a dilemma: whether or not to inform others in the family. These are real issues and if such a database is established then there would have to be assurances that they could be dealt with. One way of dealing with it would be to state at the outset that no individual would be informed of any link; that the database would only be for research purposes and not part of the health care of the individual. Just how this could be expected to hold if the projects using the database become successful is difficult to predict. No doubt there will be strong arguments forthcoming that individuals will have a right to know. Perversely then the very grounds for opposing the database then becomes the grounds for opening access, civil liberties!
Why 'Opt out' consent may not be ethical
Since publishing this post I have considered the need to add a few words about the proposed 'opt out' strategy for consent. An opt out strategy for the data base assumes informed consent to inclusion unless someone specifically indicates they do not wish to be included. Much hangs on its credibility and how it will work. In this case I am dubious about the robustness or efficacy of 'opt out'. It is unclear how this could work in a research context. In a clinical context it can work where it is clear what the consequences might be of either being included or not. In the case of research this is not clear if only because the outcome of the research inevitably remains unclear, at least in the early stages.
The history of ethics in scientific research is fairly recent. Prior to the development of ethical review in research and the development of key principles and how they would be applied, patients and other subjects could be recruited without proper consent. We should be wary of breaching that principle. Proper consent is not simply that they say 'yes' to being included, but that they agree after being informed appropriately of potential outcomes and benefits and potential harms to those in the trial. We may feel that a database offers little or no potential for harm, but this depends of a number of factors: how the information will be protected, how it will be used and what will happen to the information as the studies based on it develop. This last point is clearly an unknown. Without clear safeguards it would be relatively easy to decide the data could be used in ways not envisaged at the outset. If this was done then it would be done without consent of those included in the database, because their positive consent had not been obtained to be included.
Whether such a breach could occur may depend then on the arguments presented. I have no doubt that similar utilitarian arguments will be marshalled in favour. It will be argued that the benefits would outweigh the potential harms and thus justify a breach of the normal principle. Furthermore, it is possible that the clamour for disclosure will come on civil liberties grounds with arguments that individuals have a right to know what information is held about them in relation to the outcome of any research. We need to be vigilant about breaches of the fundamental principle of informed consent.