As you Asking for the Information About the National Ethical Guidelines for Biomedical Research Involving Children of the Indian Council of Medical Research the Information the Guideline is given below

Biomedical and health research includes basic, applied and operational research studies designed primarily to increase scientific knowledge about diseases and conditions (physical or socio-behavioural), their detection, cause and strategies for health promotion, prevention, or amelioration of disease and rehabilitation.

Why is biomedical research necessary in children?
Some of the reasons why biomedical research may be necessary in children are as follow:

1. The disease may affect only children, for example, hyaline membrane disease, birth asphyxia, neonatal hyperbilirubinemia, extrahepatic biliary atresia, infantile spasms, infantile tremor syndrome, Kawasaki disease, etc. Such diseases have no adult counterparts and therefore, it is necessary to carry out research in children to advance our knowledge of these diseases.

The physiology of children is different from that of adults, and the pharmacokinetics of many drugs is age-dependent based on the maturation of the drug metabolism pathways. For example, children metabolize many drugs much more rapidly as compared to adults; hence, the dosage of the drug (per kg of body weight) that needs to be given is much higher in children.

The adverse effects of many drugs may also be different in children as compared to adults. For instance, tetracyclines cause teeth discoloration in young children and aspirin use is associated with Reye’s syndrome in children.


Challenges of biomedical research involving children
1. Diseases in children may be rare, and there may not be sufficient numbers of affected patients to answer the research questions. This may lead to difficulties in having adequately statistically powered studies to evaluate an effective treatment. For this reason, large multicentric studies lasting many years may be needed, which are not always feasible.

To overcome this difficulty studies in children often benefit from and require alternative and innovative study designs that incorporate multiple regions, high number of study sites relative to the number of patients to be enrolled, and realistic timelines to allow them to be feasible and to collect relevant data specific to the population being studied.

2. It is usually difficult to find funding for research in children. As the market for paediatric drugs and treatments is quite small compared to the adult ones, pharmaceutical companies do not find it sufficiently remunerative to fund research in children.

The ethical concerns regarding research involving children, which include lack of autonomy and inherent vulnerability, make it more difficult to perform research in children and obtain appropriate informed consent.

4. Research in children is not just about performing research on individual patients. As parents and families are involved, there is a need to take account of familial and socio-cultural concerns while planning the research


National Ethical Guidelines for Biomedical Research Involving Children of the Indian Council of Medical Research






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