It allowed both therapeutic and non-therapeutic research involving children, provided consent was obtained from the child’s parent or guardian.[1,3] It is worth remembering that with other vulnerable sections of the society, children bore the brunt of ill-effects of human experimentation. meantime Use of thalidomide by pregnant women resulted in severe birth defects. Institutionalized children in the Willowbrook State School were deliberately infected with hepatitis virus as a means of studying the potential to develop a vaccine.[1,4] The continuation of Tuskegee Syphilis study that continued even after penicillin was discovered, resulted in fetal deaths and birth of babies with congenital syphilis.[1,5] These events caused a public outcry and forced the US administration to examine the problems of research abuses and create standards for the protection of individuals participating in research.

The Belmont Report justified research involving children, as it would help find better ways of treating childhood illnesses and promote their healthy development.[6] The Report categorized children as a vulnerable population with diminished autonomy and hence entitled for additional protection from undue influence and coercion. The protective approaches such as requirement of careful scrutiny of pediatric research protocol for the level of risk, entrusting the responsibility of permitting the child to enroll with parents and demanding steps for minimization of risk are some of the protective approaches described in that report.

[1,6] However, GSK-3 over the years; excessive concern about exposing children to selleck chemicals llc molecules about which everything was not known made the society, pharmaceutical companies and regulators not undertake clinical trials in children. This resulted in many drugs being marketed without any worthwhile evidence of their safety and efficacy in children. However, pediatricians were forced to use these drugs just on the basis of data extrapolated from adult studies. This was not a happy situation, as children continued to be exposed to the new molecules without adequate pediatric data and that too without the benefit of intense monitoring that characterizes a clinical trial. In addition, pharmaceutical companies were less keen to conduct specific pediatric trials as these are more challenging and the pediatric market is smaller compared to the adult drug market. Considering the importance of drug trials in children, the US and European countries enacted several legal provisions to encourage, entice or compel pharmaceutical companies to undertake pediatric trials.