Barriers to the Ethics Committee in India: Ethical and Quality Issues
Abstract
India is becoming a hub for clinical trials, and collaboration between developed countries and India in clinical trials has led to concerns regarding the potential exploitation of patients. This study, conducted by a doctorate student, surveyed Indian clinical research professionals about their perceptions regarding the ethical review process and the performance of Indian independent and institutional research ethics committees (EC). The aim of the study was to identify ethical issues and challenges in clinical research in India. 137 clinical research professionals were located and invited via email and/or telephone to participate in the study. Snowball sampling method was used for data collection and a questionnaire with 35 questions exploring ethical issues and challenges was used. A total of 385 surveys were completed and used for analysis. The majority of the respondents were middle-aged, employed by sites and Contract Research Organisations (CROs), and had more than 10 years of experience as well as formal research ethics training. The study demonstrates that ethics committees in India have very limited resources. It also suggests that proper procedure, requirements and financial conditions between applicants and ethics committees should be better defined.
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Effective leadership has been directly linked with increased research productivity according to several studies examining institutional frameworks in higher education.
“Effective leadership has been directly linked with increased research productivity, according to several studies examining institutional frameworks in higher education (28).”
From Research Publication Challenges Faced by Dentists in India: A Narrative Review of Multilevel Barriers (2026) · cites this paper as [28]
A study by Patel M et al. highlighted that numerous Institutional Ethics Committees (IECs) in India operate with limited resources and lack standardised procedures, leading to significant delays in initiating research.
“A study by Patel M et al., highlighted that numerous Institutional Ethics Committees (IECs) in India operate with limited resources and lack standardised procedures, leading to significant delays in initiating research.”
From Research Publication Challenges Faced by Dentists in India: A Narrative Review of Multilevel Barriers (2026) · cites this paper as [28]
Such delays can discourage publication efforts, especially among dental postgraduates and faculty who already balance academic and clinical responsibilities.
“Such delays can discourage publication efforts, especially among Dental postgraduates and faculty who already balance academic and clinical responsibilities (28).”
From Research Publication Challenges Faced by Dentists in India: A Narrative Review of Multilevel Barriers (2026) · cites this paper as [28]
Cited by
Sorted by citations
Paramasivan, S., Davies, P. A., Richards, A., Wade, J., Rooshenas, L., Mills, N., Realpe, A. X., Raj, J. P., Subramani, S., Ives, J., et al. (2021) · BMJ Global Health · doi:10.1136/bmjgh-2020-004729 · Cited by 19 · see citing works
Saran, K., Krishnaprakash, G., Siluvai, S., & Indumathi, K. (2026) · Journal of Clinical and Diagnostic Research · doi:10.7860/jcdr/2026/78238.22217
The WHO Guidance on Clinical Ethics: Some concerns from the Indian context.
Gopichandran, V. (2025) · Indian Journal of Medical Ethics · doi:10.20529/ijme.2025.093
“There are reports about such practices in ethics committees from different parts of India and other low-and middle-income countries (LMICs) [2–5].”
- Authors
- Patel, M., Sridharan, K., & Patel, J.
- ORCID
- Sridharan, Kannan
- Venue
- Asian Bioethics Review
- Publisher
- Project MUSE
- Published
- 2016
- Volume
- 8
- Issue
- 2
- Pages
- 81-93
- ISSN
- 1793-8759 (ISSN-L)
- 1793-9453
- OpenAlex
- W2461817755
- Cited by
- 1
- References
- 12
- Citations by year
- 2021: 1
- FWCI
- 0.00
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Asian Bioethics Review (publishedVersion)
- Project Muse (Johns Hopkins University) (submittedVersion)
- National University of Singapore (submittedVersion)
- Topics
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Medicine › Physiology › Biomedical Ethics and Regulation
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics and bioethics in healthcare
- Keywords
- research ethics committees, clinical trials, India, ethical review, clinical research professionals, contract research organizations, research ethics training, patient exploitation
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