Biomedical research in developing countries is the kind of ethical condundrum we all think about.

On one hand, infectious diseases may cause up to half of all deaths in undeveloped nations(1), so no one needs advanced treatments more. On the other hand, these are human clinical trials of experimental drugs and socio-economic status does not make you a lab monkey in any sort of culture we want to call civilized.

So what is the solution? Americans are primarily distrustful of government, the bigger the worse, so a global body dictating clinical trials would be treated with a lot of skepticism but the perfect solution can't be moving ethical targets determined by various nations, funding sources or institutions as is done now.

Skepticism about bureaucracy and waste also follows the involvement by larger organizations but small charities don't have the infrastructure to manage overseeing clinical trials. Still, wealthier countries spent $80 billion on international aid in 2004 and no one knows what they can show for it. Hardly a great feeling in the fights against AIDS, tuberculosis and malaria.

The World Medical Association’s (WMA) Declaration of Helsinki considers itself the most influential set of ethical guidelines. That's okay, I consider this the greatest site in the world, and I have plenty of people who agree, but the fact remains that ethics are a moving target just like definitions of great science forums.

The largest issue will always be 'informed consent.' Convincing ill people in an undeveloped country to undergo a clinical trial is easy. Explaining that the research is not intended to benefit them personally is not, but consent is consent so ethical guidelines are an internal metric more than a piece of paper written in Finland.

It is fine to give a verbal explanation and a stack of consent papers are great unless the people signing them don't have a formal education. Explaining that a research intervention is not health care is going to be difficult. Explaining a random trial and a genetic study could be bordering on impossible.

It stands to reason that people most likely to get or not get something such as malaria should have genetic testing but how consent is granted is fundamental. As the Declaration of Helsinki gets revised for the first time since 2000, it will be interesting to see if they have anything new to add beyond layers of protocol for overburdened local people. If not, we can always fall back on the EU Clinical Trials and Good Clinical Practice Directives (2001 and 2005) or the UK Medicines for Human Use (Clinical Trials) Regulations (2004, amended 2006) or any number of others.

In other words, there's no shortage of people willing to write documents on ethics. We have to consider why so many people feel those in science need to have them.


(1) World Health Organisation Report on Infectious Diseases (1999)
(2) World Medical Association's Declaration of Helsinki.