Since India is expected to develop into an international hub for clinical research, the editorial on ethics of research in children has not come a day sooner(1). The Ethics committees (EC) and Institutional Review Boards (IRB) have the onerous responsibility to ensure that children, who constitute a vulnerable population, are not used as a commodity in clinical research in absence of explicit national guidelines for pediatric research and in the milieu of abject poverty.

It is the responsibility of EC/IRB to take care that the participation is without coercion or inducement. The American Academy of Pediatrics expects that, assent is obtained from children over the age of 7 years in pediatric practice(2). There have been arguments favoring a much higher cut-off age of 14 years for pediatric research trials(3). Several guidelines state that assent should be obtained where children have sufficient understanding and intelligence to understand what is proposed(4) and that this ability could be determined taking into consideration the child’s age, maturity and psychological state. Most parents act in the best interests of their children on most occasions. However, given the magnitude of poverty prevalent in the country, it is possible that amount provided as compensation for participation could act as inducement and influence parental judgment regarding enrolling the child. EC/IRB should formulate local guidelines concerning these issues, share their expertise and collaborate with each other and form a consortium so that national guidelines concerning pediatric research could be evolved.

Obtaining assent from the child and permission from parents is not equivalent to obtaining consent from an adult participant. Hence, EC/IRB have additional responsibilities while dealing with these studies by probing the potential risks and benefits of a trial in children and adolescents. EC/IRB could seek assistance from persons with experience of dealing with sick children so as to develop specific expertise in evaluating pediatric trials. They should also monitor the process of obtaining assent to ensure that develop-mentally appropriate information is being provided to children before requesting their assent, that their dissent is respected and that their participation is entirely voluntary. Going beyond their usual role, the EC/IRB should also take up the mantle of an educator, informing researchers about the ethical standards to be followed while conducting pediatric trials. Only with such affirmative actions would the EC/IRB be able to fulfill their mandated role of safeguarding the interests of children and adolescents participating in research trials.

S.B. Bavdekar,
Department of Pediatrics,
Seth G.S. Medical College and
KEM Hospital, Mumbai 400 012, India.
E-mail: [email protected]  

1. Krishna A. The ethics of research in Children. Indian Pediatrics 2005; 42: 419-423.

2. Committee on Bioethics. American Academy of Pediatrics. Informed Consent, Parental Permission and Assent in Pediatric Practice. Pediatrics 1995; 95: 314-317.

3. Wendler D, Shah S. Should children decide whether they are enrolled in nonbeneficial research? Am J Bioethics 2003; 3:1-7.

4. Royal College of Paediatrics and Child Health: Ethics Advisory Committee. Guidelines for the ethical conduct of medical research involving children. Arch Dis Child 2000; 82: 177- 182.