Comment on “Prevalence of ocular morbidity in school going children in West Uttar Pradesh”

Abstract

Sir, Singh et al. estimated the prevalence of ophthalmic morbidity in schoolchildren in Uttar Pradesh.[1] Children not improving to 6/6 with a pinhole underwent a dilated fundus examination after tropicamide drop instillation. Permission and informed consent were taken from principals of the schools. Consent from the children and parents was not sought. This raises ethical concerns. Although generally safe, the product information[2] for Mydriacyl (tropicamide) suggests that no controlled clinical studies have been performed in children, and hence, the safety and efficacy of the drug's use in children have not been established. In rare cases, tropicamide has been known to cause central nervous system disturbances, which may be dangerous in pediatric patients. Further glare following pupillary dilatation may put a child at risk if traveling home unaccompanied. The UNESCO guidelines[3] are clear that “any preventive, diagnostic, and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned based on adequate information.” If the individual is not of age to give valid consent, then permission must be sought from the parents of the child. “In appropriate cases of research carried out on a group of persons or a community, additional agreement of the legal representatives of the group or community concerned may be sought. In no case should a collective community agreement or the consent of a community leader or other authority substitute for an individual's informed consent.” These are standards that can be achieved in India. Saxena et al.[4] have published their school eye screening where a letter explaining the entire procedure was sent to all the parents along with an informed consent form for the procedure. The institutional review boards have the explicit responsibility to ensure that this happens. Beyond that, scientific journals like IJO must insist on exemplary ethical standards. Only in this way can we ensure ethical research. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.