Clinical trials recruitment

Recruitment into clinical trials is an extremely problematic question with regards to ethics. Generally, participation in a clinical trial is a (minor) risk for the individual, but an enormous (potential) gain to society. In the past, this dilemma was "solved" by force - running clinical trials on prisoners, the mentally disabled, the poor, residents of third world countries and generally any population that was disenfranchised. This unethical behaviour is now widely condemned and has been illegal now for a long time.

So how then are patients recruited for clinical trials? Essentially the safeguard for ethics is the principle of volunteering with informed consent. In certain specific cases patients may volunteer  for the possibility of personal gain, such as a trial of a novel medication for an untreatable disease, but generally the motivation is, and should be, altruism. Clearly this is a vast improvement, but even this solution is not perfect. How do you do pediatric trials? You need the informed consent of the guardian, since the actual participant cannot give it. Can anyone really be "informed" of the risks without sufficient medical training? What about indirect coercion? It is illegal to force an unproven drug onto patients, but what about the case of a patient who does not have access to the normal standard of care? For them the only option might be the unproven drug, and in fact this does occur widely in the US and the developing world where universal health care is not available.

Finally, there is the issue of payment. It may make sense to pay for participation, but in that case the participant is not a volunteer and it opens the door to financial coercion. Yet if only unpaid volunteers are allowed, large demographic groups become under-represented in studies due to the inability to afford time off and transport costs involved in volunteering. To balance these conflicting interests, the ethical and legal rule in clinical trials is that you cannot pay volunteers, not provide a financial reward. You can, however, compensate them for their time and expenses. 

In other words, this is not how to recruit volunteers:

The UZ Leuven ethics committee really should take a walk around campus and look at the clinical trials recruitment flyers pinned up.

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