Policy Matter

ICMR issues national ethics guidelines for biomedical research involving children

The Indian Council of Medical Research (ICMR) has issued the national ethics guidelines for biomedical research involving children.

The guidelines cover the ethical and legal issues that researchers need to consider when carrying out biomedical research in neonates and children. It is aimed to set out general principles that can be applied in most situations rather than to cover each and every ICMR-biomedical-researchsituation. These guidelines need to be used in conjunction with the other existing ICMR guidelines. These guidelines are meant for use by researchers, ethical committees and other involved stakeholders.

Biomedical research involving children is needed for the benefit of the future generations of humanity. It leads to advances in medical care which can potentially improve the health and quality of life of children. There are numerous opportunities to develop interventions to promote health, and prevent and treat diseases that affect children. This can only be achieved through experimentation. Research and innovation is therefore the core of the endeavour to generate and translate knowledge into clinical care.

In India, there is an additional challenge of applying universal ethical principles to biomedical research in the multicultural Indian society with a wide diversity of health-care systems of considerably varying standards. Medical research involving children is essential for advancing child health. In most situations, research with adults cannot simply be generalised or extrapolated to infants, children, and adolescents and, research involving children is essential if children are to share fully in the benefits derived from advances in biomedical sciences.

The biomedical research is necessary in children because the disease may affect only children and newborns, e.g. hyaline membrane disease, birth asphyxia, neonatal hyperbilirubinemia, extrahepatic biliary atresia, infantile spasms, infantile tremor syndrome, Kawasaki disease, etc. Such diseases have no close parallels in adults, therefore it is necessary to carry out research with children to advance the knowledge in these diseases. Additionally, even if the same disease affects both children and adults, the pathophysiological processes and responses to treatment in children may differ from those in adults.

Diseases such as nephrotic syndrome, hypertension and rheumatoid arthritis, for instance affect both adults and children, but the pathophysiological basis is very different in both. The physiology of children is different from that of adults, and the pharmacokinetics of many drugs will vary with the age of the child. For example, children metabolise many drugs much more rapidly as compared to adults, hence the dose of the drug per kg of body weight that needs to be given, is much higher in children as compared to adults. The absorption of drugs also varies with age

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