How much oversight is too much?
A recent article in the May 14 issue of the New England Journal of Medicine, titled, 'Globalized Clinical Trials and Informed Consent', expressed concern that the increasing globalisation of clinical research trials calls for more effective ethical and legal rules to protect both research subjects and scientific integrity. It notes that the situation observed more than a decade ago that research was being conducted in developing countries without concern for adherence to the international ethical principles for human-subjects research contained in the 1947 Nuremberg Code and the 1964 Declaration of Helsinki, has not improved.
The article goes on to cite Pfizer's medical experiments in at the Kano Infectious Diseases Hospital, Nigeria where in 1996, they conducted a study involving 200 sick children, over a two-week period, after which the Pfizer team abruptly left. After the story broke in 2000 and press coverage detailed how researchers monitored the slow death of a 10-year old girl, families of the children filed a suit alleging that the pharma company did not take the informed consent of either the children or their guardians.
More such experiments were uncovered in other lesser developed countries which were ‘poorly regulated’ and ‘dominated by private interests’ studies, that ‘far too often betray’ their promises to research subjects and consumers. Similar examples exist in
These situations only show that regulatory oversight needs to be tightened in clinical research. However, there are cases where strict laws can keep affordable medication out of reach of needy patients.