National authorities define certain populations as vulnerable and therefore unable to provide informed consent, such as those without the necessary cognitive, psychological, or social maturity to understand these benefits and risks.
[2] According to the relevant Code of Federal Regulations (45 CFR 46, Subpart d), investigators wishing to conduct clinical trials in children in the United States are required to seek the permission of both parents and patients.
[4][failed verification] Unless a waiver is granted, the European Medicines Agency mandates that drug companies prepare Pediatric Investigation Plans (PIPs) and conduct clinical trials that will ensure their products are safe and effective in children.
[7] Additionally, it should conform to their intellectual capacity to understand the reason for the research and the risks therein, and the family should be given sufficient time and information to consider the pros and cons of their involvement.
This means being tailored to the child’s age, social environment, psychological and intellectual maturity, hence specialist companies have arisen to serve the need of providing specialized pediatric study information.
In late 2000, the Washington Post broke the story of a 10-year-old girl who died during a meningitis clinical study conducted in Kano, Nigeria, by the drug giant Pfizer.
The Post also alleged other such corporation-sponsored experiments “in Africa, Asia, Eastern Europe, and Latin America” that were “poorly regulated,” “dominated by private interests” and “far too often betray” their promises to research subjects and consumers.