1. Foster Children for HIV Experiment The controversial HIV experiments on children surfaced when the early report by Liam Scheff was published in the New York Post and the New York Press, which caught much public attention. The report also formed the basis of the BBC film named “Guinea Pig Kids” (1,2), and triggered an official investigation by the federal Office of Human Research Protection (OHRP) in the United States (3). The basis of such controversy revolved around the issue where children in foster homes were exploited as subjects to test new HIV drugs. These foster children were mostly poor or from a minority, and they all tested positive for HIV. From the perspective of medical research, these groups of children were the perfect example of vulnerable subjects (4). The experiment was funded by the National Institute of Health and involved multiple research centres in the country. U.S. legislation required the appointment of independent advocates for any foster child who was enrolled in these studies that posed more than minimal risk and without definite evidence of direct benefits to these children. However, reports indicated that many of these children were denied any such advocates, and were subjected to high risk early phase trial without their consent (3,5). State officials defended the decision where foster children were recruited en masse by stating there was a need to provide these children with the life-saving medicines which otherwise would be impossible for them to access. Furthermore, they also declared that the policy to provide blanket permission to enrol children was no longer applicable after the incident (5). 2. UK patients enrolled in trials without consent The British Medical Journal (BMJ) once ran a news article titled “GP suspended for enrolling patients in drug trial without consent” in 2003. The article featured Dr Robert Macindoe Adams, a GP based in Hertfordshire who had failed to obtain appropriate informed consent from 12 of his patients before enrolling them into clinical trials involving drugs for depression and hypertension. Further investigation from the General Medical Council (GMC) revealed that Dr Adams failed to provide sufficient information to ten of these patients in order for them to provide informed consent. Moreover, Dr Adam was reported to have failed to inform the other two patients that they were being recruited into a clinical trial at all (6). Informed consent forms the ethics cornerstone of any clinical trials involving human subjects. All potential participants must be appropriately and fully given all information pertaining to the trial before their agreement can be sought to participate the study. Dr Adams was found guilty of serious professional misconduct and received 12 months of suspension from the GMC (7). 3. Unregulated clinical trials in India In the past decade, India has become a favourite destination to conduct clinical trials given the large population of treatment-naïve patients and relatively low cost. However, recent reports of unethical conduct of many trials had led to uproars in the Indian medical research community. Human right group Swasthya Adhikar Manch (SAM) had filed a petition to the country's Supreme Court alleging multi-national pharmaceutical companies were exploiting the poor patients in India to conduct clinical trials, which often were poorly run and did not adhere to ethical guidelines. In response, the Indian Supreme Court was reported to have castigated the Union government "for being negligent in curbing illegal clinical trials despite the deaths of at least 2,374 persons who had undergone the dubious testing for unregistered drugs between 2007 and 2012." (8) Currently, tighter controls over the conduct of clinical trials have been introduced in India in hopes of better regulating the sector. Source
