Ethics education in biomedical research in India is frequently limited to regulatory compliance, with inadequate emphasis on ethical reasoning, contextual vulnerability, and deliberative review processes. As part of the Silver Jubilee of the Institutional Ethics Committee of St John’s Medical College Hospital, a one-day preconference workshop titled “Responsible Researchers and Reviewers: Ethics of Good Clinical Practice” was conducted during the 13th International Conference of Ethics Education. The workshop employed case-based, interdisciplinary discussions focusing on vulnerability, ethics committee accreditation, and ethical review of diverse study designs. Key gaps identified included difficulties in operationalising vulnerability, managing surrogate consent in critical care research, inconsistent ethics committee monitoring practices, and limited faculty preparedness for ethics pedagogy. The discussions revealed a need to move beyond knowledge transmission towards reflective, skills-based ethics education.
Keywords: research ethics, ethics committees, ethics education
Ethical conduct in biomedical research is foundational to public trust, participant protection, and scientific integrity. In India, despite robust regulatory frameworks — including the Indian Council of Medical Research (ICMR) National Ethical Guidelines and mandatory ethics committee oversight — ethics education often remains fragmented and procedural. Training programmes frequently emphasise regulatory requirements rather than cultivating ethical reasoning, reflexivity, and context-sensitive decision-making among researchers and reviewers. This gap becomes particularly pronounced in complex research contexts such as paediatric studies, adolescent health, critical care research, and multi-centric trials.
Against this background, the Institutional Ethics Committee (IEC) of St John’s Medical College Hospital organised a focused workshop to critically examine the ethical responsibilities of researchers and reviewers, with an emphasis on Good Clinical Practice (GCP), vulnerability, and ethics committee (EC) processes.
The workshop adopted an interactive, discussion-driven pedagogic model, deliberately moving away from didactic lectures toward case-based ethical deliberation. Participants included faculty members, postgraduate students, researchers, and ethics committee members from diverse institutional settings. Ethical principles were consistently examined through real-world scenarios rather than abstract normative frameworks. Ethics committee members participated as facilitators, reinforcing the notion of ECs as educational stakeholders rather than solely as regulatory authorities.
Historical milestones such as the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report were revisited, not as static doctrines but as evolving responses to ethical failures. Participants acknowledged that regulatory familiarity does not necessarily translate into ethical sensitivity, particularly when dealing with uncertainty, competing interests, or power asymmetries. A recurring concern was the tendency to equate ethics with documentation.
Accreditation was perceived as a mechanism to improve transparency, consistency, and accountability in EC processes, particularly in documentation, conflict-of-interest management, and study monitoring. However, participants expressed concerns about resource constraints, especially in smaller institutions, and the risk of accreditation becoming a checklist exercise rather than a driver of ethical culture.
Case-based discussions on neonates, adolescents, women, and critically ill adults revealed a persistent ambiguity in defining and operationalising vulnerability. Participants struggled to balance protection with access to potential benefits, particularly in neonatal and paediatric research. Parental consent may be influenced by stress, therapeutic misconception, and power differentials [1]. Adolescent research raises tensions between emerging autonomy, confidentiality, and parental authority [2]. In critical care research, surrogate consent, deferred consent, and post-trial access were identified as ethically complex and inadequately addressed in routine training [3].
Panel discussions emphasised that ethics review does not end with the approval of protocols. The challenges identified included delayed reporting, inconsistent monitoring, and limited training in serious adverse event causality assessment.
Despite high baseline knowledge among participants, the discussions revealed gaps in applied ethical reasoning, particularly in translating principles into practice. It was noted that limited formal training in ethics pedagogy resulted in reliance on personal experience rather than structured teaching frameworks. The workshop was limited by its single-day duration, which constrained the depth of discussion and follow-up. Participant representation, though interdisciplinary, may not reflect the diversity of institutions nationally.
At the institutional level, ethics education should be integrated longitudinally into undergraduate, postgraduate, and faculty development programmes with ethics committees as educational hubs. Accreditation frameworks should prioritise ethical culture and deliberative capacity over procedural compliance.
This workshop highlighted that strengthening ethics in clinical research requires moving beyond regulatory literacy toward sustained, context-sensitive ethical engagement. Case-based, interdisciplinary learning offers a valuable pedagogic approach but must be embedded within institutional and national strategies for ethics capacity building. The reflections presented here underscore the need for longitudinal training, faculty development, and policy support to nurture ethically responsible researchers and reviewers.
Authors: Savitha D (corresponding author — savitha.d@stjohns.in), Professor and Head, Department of Physiology, Member Secretary, Institutional Ethics Committee, St John’s Medical College and Hospital, Bengaluru, INDIA; Mathangi Krishnakumar (mathangi.krishnakumar@stjohns.in), Associate Professor, Department of Anaesthesiology and SICU, Member, Institutional Ethics Committee, St John’s Medical College and Hospital, Bengaluru, INDIA; Prem Pais (pais.prem@gmail.com), Emeritus Professor, St John’s Research Institute; Member, Institutional Ethics Committee, St John’s Medical College and Hospital, Bengaluru, INDIA; Jagdish Chinnappa (jagchin@gmail.com), Consultant Paediatrician, Manipal Hospitals; Member, Institutional Ethics Committee, St John’s Medical College and Hospital, Bengaluru, INDIA; Johnson Pradeep (johnson.pr@stjohns.in), Professor and Head, Department of Psychiatry; Member, Institutional Ethics Committee, St John’s Medical College and Hospital, Bengaluru, INDIA; Jyothi Idiculla (jyothi_idiculla@yahoo.co.in), Consultant Physician, Manipal Hospitals; Member, Institutional Ethics Committee, St John’s Medical College and Hospital, Bengaluru, INDIA; Manjulika Vaz (manjulikavaz@sjri.res.in), Associate Professor, Division of Health and Humanities, St John’s Research Institute; Member, Institutional Ethics Committee, St John’s Medical College and Hospital, Bengaluru, INDIA; Nisha CK (nishack@stjohns.in), Professor and Head, Department of Psychiatry Nursing, St John’s College of Nursing; Member, Institutional Ethics Committee, St John’s Medical College and Hospital, Bengaluru, INDIA; Kavitha Rajarathna (kavitharajarathna@gmail.com), Professor, Department of Pharmacology, Bangalore Medical College and Research Institute; Member, Institutional Ethics Committee, St John’s Medical College and Hospital, Bengaluru, INDIA; Nancy Angeline (nancy.ag@stjohns.in), Assistant Professor, Department of Community Health; Member, Institutional Ethics Committee, St John’s Medical College and Hospital, Bengaluru, INDIA; Mary Joseph (taurgo@gmail.com), Consultant Ophthalmologist, Manipal Hospitals; Member, Institutional Ethics Committee, St John’s Medical College and Hospitals, Bengaluru, INDIA; Jayanthi Savio (jayanthisjmc@gmail.com), Professor and Head, Department of Microbiology; Member, Institutional Ethics Committee, St John’s Medical College, Bengaluru, INDIA; Karuna Ramesh Kumar (karunark@gmail.com), Consultant Pathologist and Member, Institutional Ethics Committee, Rainbow Hospital; Chairperson, Institutional Ethics Committee, St John’s Medical College, Bengaluru, INDIA.
Conflict of Interest: None declared
Funding: Declared (ICMJE COI disclosure available online only)
Acknowledgments: We thank all the participants of the workshop and the management of St John’s National Academy of Health Sciences and International Association of Ethics Education. We thank the Manipal Hospitals, Bengaluru for financial support. We thank our IEC members Fr Christopher Vimal Raj, Mr Anil D’Souza, Mrs Shobha Manmohan, Ms Martha Jayashree and Ms Kalpana Subramanya. We thank Dr Priya Pais and team and Dr Nachiket Shankar and team for their support with the workshop arrangements. We thank the IEC Secretarial staff Ms Mary Bridget, Ms Geraldine Sharmila and Mr Rishu Pradeep for their untiring assistance.
To cite: Savitha D, Krishnakumar M, Pais P, Chinnappa J, Pradeep J, Idiculla J, et al. Indian J Med Ethics. Responsible researchers and reviewers: Ethics of Good Clinical Practice silver jubilee workshop report. Published online first on June 10, 2026. DOI: 10.20529/IJME.2026.035
Submission received: August 8, 2025
Submission accepted: May 27, 2026
Manuscript Editor: Sunu Thomas
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©Indian Journal of Medical Ethics 2026: Open Access and Distributed under the Creative Commons license (CC BY-NC-ND 4.0), which permits only noncommercial
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