India for the first time in its history has released comprehensive guidance related to the ethical specifics of biomedical research in neonates and children.
The pragmatic guidelines from the Indian Council of Medical Research (ICMR) set out general principles that can be applied in most situations to cover the ethical and legal issues that researchers need to consider when carrying out such biomedical research.
First and foremost, the guidance calls for research involving children to take into consideration the unique physiology, anatomy, psychology, pharmacology, social situation and special needs of children and their families.
And in general, the drugs intended for the children's and neonates' research should be tested for safety, pharmacokinetics, and at least initial indications of efficacy in adults before being tested in children.
"It may often be appropriate to defer pediatric testing until adult testing has reached Phase III or beyond, when substantial data are available on the safety and efficacy of a drug in adults," the guidelines say.
Interventions intended to provide therapeutic benefit should be at least as advantageous to the individual child as any available alternative interventions.
"The risk presented by interventions not intended to benefit the individual child participant should be low when compared to the importance of the knowledge that is to be gained," the guidelines add.
ICMR notes the sensitivity around research involving children, noting that children usually lack the capacity to provide informed consent and the authority to allow a child’s participation in research "rests with parents or guardians, who must provide their permission. However, with respect for children’s emerging maturity and independence and investigators must seek to involve children in discussions about research and obtain their assent to participation."
In children between the ages of seven and 12 years, oral assent must be obtained in the presence of a parent or legal guardian, while for children between the ages of 13 and 18, written assent must be obtained.
In addition to informed consent, the guidelines also deal with safeguard systems, such as institutional ethics committees and data monitoring committees, compensation for participants (which "should not influence parents’ or children’s decisions to participate in research"), as well as other special situations, including Internet- and school-based research in children, and neonate and adolescent research.
The guidelines, which follow the release of the third iteration of the "Ethical Guidelines for Biomedical Research on Humans" from 2006, were developed in line with the Institute of Medicine's pediatric research guidelines in the US, the Medical Research Council guidelines in the UK, EU guidance and through discussions with experts in bioethics in India.
India's National Ethics Guidelines for Biomedical Research involving Children