Ethical Malpractice in Randomised Controlled Trials in India: An Appraisal and Improvement Proposal

Abstract

Over the past two decades, numerous randomised trials exploring the efficacy of cervical cancer screening in intervention and control groups have been conducted across India. The trials have attracted both scrutiny and regulatory action for their failure to adhere to the ethical standards expected of the clinical research community (Baggchi, 2014). Exploration of the ethical malpractice in the Tamil Nadu cervical cancer trial, and examination of the context in which the trial was conducted form a basis for consideration of how research practitioners can act as exemplars and enablers of ethical research. An improvement plan is proposed for individual research practitioners working on clinical trials; incorporating educational and professional development requirements, evidencing of key research skills with the aim of issuing a standardised framework for the job role to contribute to quality assurance processes and ensure safe and ethical research practice.