Reporting ethical processes in two Indian journals.

BACKGROUND In biomedical journals, authors are expected to report if the study was carried out in accordance with international and national ethical guidelines and inform readers if approval from ethics committee was obtained and if written informed consent was taken from the participant or legal guardian. AIMS To determine the proportion of research manuscripts in two pediatric journals published from India reporting on ethical clearance, 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 of Pediatrics in 2006 were reviewed for reporting regarding ethical clearance, obtaining written informed consent from guardians or parents, and obtaining assent from research participants. STATISTICAL ANALYSIS USED Descriptive statistics was used. The number of articles according to their types; the number of research designs employed according to their types; and the number of research studies mentioning ethical clearance, consent, and assent were expressed as percentages mentioning ethical clearance, consent and assent were expressed as percentages. RESULTS Of the 132 manuscripts reporting biomedical research, 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 informed consent was obtained from parents or lawful guardians. Neither ethical approval nor informed consent was mentioned in 45 (34.10%) published articles reporting prospective studies. A total of 54/98 (55.1%) studies enrolled children aged 7 years or more and hence were assessed for reporting of assent; eight (14.81%) reported that children's assent was obtained. Only four (7.41%) eligible studies reported ethics committee's approval, informed consent, as well as assent. CONCLUSIONS A significant proportion of research articles published in the two pediatric journals did not provide information regarding ethical approval, written informed consent, and obtaining of assent.