What empirical research has been undertaken on the ethics of clinical research in India? A systematic scoping review and narrative synthesis

Sangeetha Paramasivan*, Philippa Davies, Alison C Richards, Julia Wade, Leila Rooshenas, Nicola J Mills, Alba X Realpe Rojas, Jeffrey Raj, Supriya Subramani, Jonathan C S Ives, Richard Huxtable, Jane M Blazeby, Jenny L Donovan

*Corresponding author for this work

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The post-2005 rise in clinical trials and clinical research conducted in India was accompanied by frequent reports of unethical practices, leading to a series of regulatory changes. We conducted a systematic scoping review to obtain an overview of empirical research pertaining to the ethics of clinical trials/research in India.


Our search strategy combined terms related to ethics/bioethics, informed consent, clinical trials/research and India, across nine databases, up to November 2019. Peer-reviewed research exploring ethical aspects of clinical trials/research in India with any stakeholder groups was included. We developed an evidence map, undertook a narrative synthesis and identified research gaps. A consultation exercise with stakeholders in India helped contextualise the review and identify additional research priorities.


Titles/Abstracts of 9699 articles were screened, full text of 282 obtained and 80 were included. Research on the ethics of clinical trials/research covered a wide range of topics, often conducted with little to no funding. Studies predominantly examined what lay (patients/public) and professional participants (eg, healthcare staff/students/faculty) know about topics such as research ethics or understand from the information given to obtain their consent for research participation. Easily accessible groups, namely ethics committee members and healthcare students were frequently researched. Research gaps included developing a better understanding of the recruitment-informed consent process, including the doctor-patient interaction, in multiple contexts and exploring issues of equity and justice in clinical trials/research.


The review demonstrates that while a wide range of topics have been studied in India, the focus is largely on assessing knowledge levels across different population groups. This is a useful starting point, but fundamental questions remain unanswered about informed consent processes and broader issues of inequity that pervade the clinical trials/research landscape. A priority-setting exercise and appropriate funding mechanisms to support researchers in India would help improve the clinical trials/research ecosystem.
Original languageEnglish
Article numbere004729
Number of pages19
JournalBMJ Global Health
Issue number5
Publication statusPublished - 18 May 2021

Bibliographical note

Funding Information:
Funding This study was funded in part by the MRC ConDuCT-II (Medical Research Council, Collaboration and innovation for Difficult and Complex randomised controlled Trials In Invasive procedures) Hub for Trials Methodology Research (MR/ K025643/1) and support from the Royal College of Surgeons of England Bristol Surgical Trials Centre. JMB, JI and RH are part funded by the National Institute for Health Research (NIHR) Bristol Biomedical Research Centre at University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol. JLD and JMB are NIHR Senior Investigators. PD and ARi were supported by the NIHR Applied Research Collaboration West (NIHR ARC West) at University Hospitals Bristol NHS Foundation Trust.

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  • ConDuCT-II

    Blazeby, J.


    Project: Research

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