Statement on publishing clinical trials in Indian biomedical journals

BACKGROUND: In biomedical journals, authors are expected to report if the study wascarried out in accordance with international and national ethical guidelines and informreaders if approval from ethics committee was obtained and if written informed consentwas taken from the participant or legal guardian. AIMS: To determine the proportion ofresearch manuscripts in two pediatric journals published from India reporting on ethicalclearance, obtaining of informed consent and/or assent. SETTINGS AND DESIGN:Retrospective study for analysis of research articles published. MATERIALS AND METHODS:Research articles published in the issues of Indian Pediatrics and Indian Journal ofPediatrics in 2006 were reviewed for reporting regarding ethical clearance, obtainingwritten informed consent from guardians or parents, and obtaining assent from researchparticipants. STATISTICAL ANALYSIS USED: Descriptive statistics was used. The numberof articles according to their types; the number of research designs employed according totheir types; and the number of research studies mentioning ethical clearance, consent, andassent were expressed as percentages mentioning ethical clearance, consent and assentwere expressed as percentages. RESULTS: Of the 132 manuscripts reporting biomedicalresearch, 39 (29.53%) reported having obtained approval from the ethics committee. Forty-six of the 98 (46.94%) manuscripts reporting on prospective studies indicated that informedconsent was obtained from parents or lawful guardians. Neither ethical approval norinformed consent was mentioned in 45 (34.10%) published articles reporting prospectivestudies. A total of 54/98 (55.1%) studies enrolled children aged 7 years or more and hencewere assessed for reporting of assent; eight (14.81%) reported that children’s assent wasobtained. Only four (7.41%) eligible studies reported ethics committee’s approval, informedconsent, as well as assent. CONCLUSIONS: A significant proportion of research articlespublished in the two pediatric journals did not provide information regarding ethicalapproval, written informed consent, and obtaining of assent.