Research without fear

A week ago, my computer connection to the Internet ceased. This was puzzling because my son was still able to log on from his laptop, via the home wireless network based on my computer. Eventually, I traced the problem to the Norton Security software I had installed. With remarkable success, this had prevented any viruses infecting my computer by blocking access to all websites. Computers of course mimic the humans that create them. The Norton approach is found among experts on ‘security’ who argue that the only way to protect our liberties is to lock up without trial people who might possibly be terrorists, give the police free rein to assault and kill peaceful demonstrators, and subject all citizens to permanent CCTV surveillance. A similar destructive enthusiasm is found in the system used in the National Health Service for assessing the ethics of proposals for research.

Just as there are real computer viruses and real terrorists, so there is a true history of unethical research on patients. The most outstanding, described in every book on medical ethics, was the Tuskegee Experiment carried out by the US Department of Public Health, in which 400 poor black people infected with syphilis were monitored from 1932 onwards. Although penicillin was identified as an effective treatment by 1940, none of the subjects of the research were informed or treated, leading to the infection of their spouses and other sexual partners, and their children. The whole ghastly racist experiment only came to an end when a whistleblower informed the New York Times.

This case is a warning that medical scientists are no more ethical than other people, particularly when the subjects of their research are poor and from racial minorities. Bad ethical practice in research still exists, although usually in a less extreme manner than the Tuskegee Experiment. There have been cases of people included in clinical trials without their knowledge, people being denied effective treatments, pointless research inflicted on people, and so on. To prevent these kinds of problems, the National Health Service has set up a complex network of ethical committees to thoroughly assess all applications for research. This is backed by a parallel system of ‘research governance’, which ensures that the recommendations of ethical committees are followed by researchers, that research in insured by its ‘sponsor’, and that the cost implications of the research for the NHS are taken into account.

As governments have attempted to extend the protection of human rights (the 2005 Mental Capacity Act, the 2004 Human Tissue Act, and others), so the work of the ethical committees has become more demanding. Nevertheless, the system has improved greatly in efficiency in the last few years, and the various local ethical committees strenuously seek to protect the public from unethical research. However, there is a problem - the same sort of problem encountered by all who seek to avoid risk and create a world free of fear.

All autonomous or creative human action, whether individual or collective, involves risk and therefore danger. The risk may be very small, but the resulting fear may lead to disproportionate and even harmful precautions. In my village, both the primary and secondary schools are in easy walking distance for most children. But many parents drive their children to school because they perceive the quiet roads of a peaceful village to be dangerous and the pavements crowded with paedophiles. As a result, the roads through the village at the times the schools open and close become crowded with large 4x4 vehicles. This has the effect of making travel more dangerous at these times, even for those children and parents who do walk to school. Disproportionate precautions of this kind are particularly common among those with a professional responsibility to protect the rest of us. After all, it seems common sense to believe that one can not be too safe or too ethical.

In the case of ethical committees, this can result in extreme precautions being evoked for the simplest and least offensive of research projects. One of my masters students (a qualified and very experienced child mental health nurse) proposed to interview a small number of experienced and qualified paediatric nurses about their experiences of managing children who are admitted to accident and emergency following overdoses. The ethical committee expressed concern at the impact of these interviews on the state of mind of the nurses, and eventually insisted that an independent counsellor be made available to alleviate distress. Another student wished to send a questionnaire to fellow therapists about the impact on their career of changes in NHS employment practices. This has required six months of applications, and permission from dozens of separate NHS trusts. I know of many similar cases.

Why do ethical committees need to be involved when members of staff pose a few questions to other members of staff? After all, if we applied the same procedures to any other walk of life, all collective human activity would cease. One reason may be that all these research projects concerned the care of either children or people with an intellectual disability. Both are included in the ever-expanding group deemed ‘vulnerable’, a term that flashes warning lights to some ethical committees.

I raised these problems with a team sent to carry out a routine quality assurance review of our masters programme. I was advised that the solution is to discourage students from carrying out research of the kind that requires ethical committee approval. This is of course the Norton Security solution and ultimate triumph of risk avoidance - the danger of unethical research in healthcare will be completely eliminated by preventing any research from taking place. The cost of doing this is that we continue to treat children and people with an intellectual disability with medications for which have limited evidence of effectiveness, and that we fail to investigate the reality of care they receive behind the bland brochures and policy statements. As a result, their real vulnerability to poor quality health and social care is increased.