Having cracked the code of the human genome, research scientists are now more eager than ever to experiment, first on animals, then on people, in an effort to treat virtually everything from genetic disorders all the way through to postponing old age. Medical progress based on sound scientific principles is inherently a good thing.

However, before an experimental medical discovery such as gene therapy is put into practice in human beings, it surely must receive societal approval as well as the customary medical approval. Tom Delbanco, a Harvard Medical School professor, sums up the situation thus: "One thing is certain: we are not spending nearly enough time or money considering how society will cope with what scientists are unleashing."

While governments continue to wrestle with the issue of GM foods, research scientists have wasted no time in forging ahead with potentially more controversial feats of medical technology: for example, the production of transgenic animals (intended to provide organs for people); the cloning of farm animals; stem cell technology; and now human gene therapy.

Investigators at the US Food and Drug Administration recently halted a human gene therapy experiment at the University of Pennsylvania following the death of one of the volunteers. A particularly disturbing facet of this tragic episode was the fact that the research institute could not provide the FDA investigators with any proof that the volunteers participating in the fatal study had been adequately warned beforehand of the risks involved. Surely participants in clinical trials deserve better protection?

How does one put this into practice? Protection should be considered at two levels: first, at the level of patients' rights; and second, at the level of citizens' rights. When discussing the issue of patients' rights, two matters spring to mind: first, the composition of research ethics committees, which are responsible for overseeing clinical trials, and which are generally composed of 8-12 members.

Although one or two of the members are non-scientists, there are generally no provisions for allowing representatives of patients' rights or consumer protection organisations to sit on these committees.

The other important matter is that of informed consent: there is still no clear distinction between legal consent and valid consent. The former refers simply to applying one's signature to a document of informed consent. The latter is much harder to define, but is at least equally, if not more important, than the former. This is due largely to the fact that the animal experiments performed before the clinical trial are not predictive with any degree of confidence for human beings.

As a recent example of this, research scientists testing an experimental vaccine for Alzheimer's disease have cautioned that "many experimental treatments that work in animals end up as disappointments in human trials". This is hardly surprising, given that animal experimentation is an a priori methodologically flawed system for the study of human disease.

Hence the call upon the UK government by the organisation Doctors and Lawyers for Responsible Medicine for a judicial inquiry into the questionable scientific validity of animal experimentation in medical research.

When considering citizens' rights, what often comes to mind is the concept of Danish-style citizen-based deliberative "consensus conferences". The idea is not completely foreign to the UK - in fact, two such conferences have already been held there (one on genetically-modified foods, in 1994, and the other, on radioactive waste management, in 1999). The individuals who sit on these citizens' committees are chosen on the basis of standard criteria, as truly representing the public interest.

The committee members interview an officially-recognised panel of experts on the topic under discussion (for example, human gene therapy or human stem cell cloning), and then submit their recommendations to a parliamentary committee, which ideally takes this information into consideration in the ensuing regulatory process.

Of course, there are more draconian options waiting in the wings, but it is anybody's guess as to the likelihood of their being adopted. For example, President Clinton has suggested that research institutes guilty of improperly-conducted clinical trials should be liable to a fine of up to $1 million. The French have taken things one step further, by making scientific error a punishable offence.

Be that as it may, the present situation should not, and cannot be allowed to, persist. It is our society as a whole which should accept or reject, speed up or slow down any novel medical technology, so as to assess potential benefit and risk.

Until such time as we receive better protection in these giddy times of genetic engineering, we will in all likelihood continue to serve as unwilling and inadequately informed human guinea pigs.

Dr Andre Menache is president of Doctors and Lawyers for Responsible Medicine