As human research subjects, children have special needs because of their vulnerabilities. According to World Health Organization, Clinical trials in children are very important because they help researchers discover the best way to treat children. Their body work in very different ways and they often undergo many changes as they grow from infancy towards adolescence and adulthood. Because their bodies work differently, it is important to create child-specific medicines and treatments instead of just modifying adult doses and therapies. Clinical trials in children need to pass rigorous ethical evaluations and meet certain standards before being allowed to recruit patients.

Children under the age of 18 are not permitted to give consent for medical procedures and treatments. Parents are typically the primary decision-makers for their children. In the absence of biological or adoptive parents to give consent, legal guardians (appointed by the court) may have decision-making capabilities. In pediatrics, children who are old enough to understand medical discussions are sometimes asked to give assent for care. Assent means that the child is agreeing to the treatment or procedure. 

Categories of Clinical Research Involving Children That Are Approvable under 21 CFR 50 are Clinical investigations that involve not greater than minimal risk; Clinical investigations that involve greater than minimal risk but present the prospect of direct benefit to individual subjects such that (a) the risk is justified by the anticipated benefit to the subjects and (b) the relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; Clinical investigations involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects’ disorder or condition and (a) the risk represents a minor increase over minimal risk; (b) the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations; and (c) the generalizable knowledge is of vital importance for the understanding or amelioration of the subjects’ disorder or condition; Clinical investigations not otherwise approvable that present an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children as agreed to by the Institutional Review Board and the Commissioner of the FDA after consultation with a panel of experts.

Apart from patient enrolment and retention, there are many other ethical issues encountered by clinical researchers while recruiting children, like small patient population and higher safety risk. Paediatric clinical research has numerous ethical insinuations. World Health Organisation (WHO), the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and European Medicine Agency (EMA) states that “children should not be subjects of clinical trials when the research can be performed in less vulnerable populations, and if the research is necessary, care should be taken to include first the least vulnerable subgroups”. Redundant conduction of trials in children will be considered unethical.

Paediatric Clinical Trials (PCTs) should be conducted following the ‘Belmont principles’, which are beneficence, justice and respect to persons. Additional ethical issues stumble across while conducting PCTs are parents’ informed consent and children’s assent, data protection of minors, biological sample retention, higher discomfort and distress, insurance’s long term liability needed and complications to assess safety. Other problematic consequence is multicentric international studies, these are important to reach an adequate statistical sample. Children also differ vividly with age and maturity from neonates to adolescents and dosing modification is required to counterpart these changes.

It is anticipated that this primitive branch of the clinical research may develop further, and may lead to the successful identification of new treatments and medicines for the paediatric population.