Misconduct in Clinical Research in India: Perception of Clinical Research Professional in India

Abstract

Misconduct in clinical research is an unfortunate reality and widespread. Researchers are expected to conduct research and report results honestly. However, that is not how clinical trials always get done. Good Clinical Practice (GCP) guideline is adopted internationally as a standard operating process for purpose of conducting, recording or reporting clinical trials. However, unavailability of international harmonized framework for misconduct management makes clinical research industry vulnerable to commit misconduct. Most of the cases of misconduct are probably not published. They are not recognized or covered up altogether. Misconduct and fraud can be due to any reasons and of various types. In all circumstances, any misconduct should be handled strictly and related regulations should be at place to prevent occurrences. Very few cases of scientific misconducts have been identified or reported in India. However, there is no evidence that all clinical trials conducted in India meet ethical standards and misconduct does not exist. Rather it is more likely that the scientific misconduct amongst researcher have not been systematically investigated. This article discusses the possible reasons for the occurrence of scientific misconduct and explores options, which can possibly help prevent such instances.

Misconduct in biomedical research: A meta-analysis and systematic review

“…Five studies (Nilstun et al .,[ 10 ] Okonta (2013),[ 11 ] Tijdink et al .,[ 12 ] Hadji et al .,[ 13 ] and Pupovac (2016)[ 14 ]) reported plagiarism (self-reported) and five studies (Titus et al .,[ 15 ] Broom (2010),[ 16 ] Tijdink et al .,[ 12 ] Dhingra and Mishra,[ 17 ] and Pupovac (2016)[ 14 ]) gave quantitative data on nonself-reported plagiarism. Eight studies (Nilstun et al .,[ 10 ] Okonta (2013),[ 11 ] Tijdink et al .,[ 12 ] Camilla (2015),[ 18 ] Hadji et al .,[ 13 ] Pupovac(2016),[ 14 ] Habermann (2010),[ 19 ] and Patel (2017)[ 20 ]) reported fabrication or falsification as the main outcome. Broome et al .…”