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Children’s nod would be compulsory for making them part of any clinical trials, say guidelines
Children’s assent would be compulsory to make them part of any clinical trial in the country, according to the recently-released new draft guidelines published by Indian Council of Medical Research (ICMR), an arm of the Union Ministry of Health and Family Welfare.
The ICMR released the guidelines in the form of a 23-page document titled “National Ethics Guidelines for Bio-Medical Research involving Children”.
The guidelines say that the authority to allow a child’s participation in research rests with the parents or guardians because children usually lack the requisite legal and intellectual capacity. “However, with respect for children’s emerging maturity and independence, investigators must seek to involve children in discussions about research and obtain their assent for participation,” it says.
The guidelines use different terms to describe permission of the child and the guardian. While the child’s permission is termed “assent”, the guardian’s permission is termed as “consent”.
The guidelines further state that for children between 7 (84 months and above) to 12 years of age, oral assent must be obtained in the presence of the parent/ legally acceptable representative. For children between 13 and 18 years of age, written assent must be obtained. If a child turns 13 during the course of the study, then written assent must be obtained. In cases of verbal assent, the parent’s counter-signature must be obtained to certify that the child’s verbal assent has been taken.
The guidelines further propose the establishment of a Data Monitoring Committee (DMC), which should have members with appropriate expertise in the evaluation of clinical studies in children.
Because children are less likely to challenge records about themselves, there is an additional duty of the investigator in protecting children’s data and ensuring confidentiality. “All documents of a research involving children should be archived for a duration that takes into account the potential need for long-term review of data. This primarily pertains to long-term safety,” the guidelines add.
The guidelines stipulate that there are certain situations when an ethics committee can waive off taking children’s assent. These situations include the prospect of the research directly benefitting the child and the child being differently-abled.
The ICMR has asked for comments by November 15.
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