FM10.{25-27,29} | Research Ethics & Ethics Committees — Summary & Reflection

KEY TAKEAWAYS

Clinical research requires independent ethical oversight because its goal (generalisable knowledge) may conflict with the individual participant's interests. India's primary reference is the ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (2017) — NOT the Belmont Report (US). Key principles include essentiality, voluntariness, non-maleficence, beneficence, justice, and privacy. IEC constitution: minimum 7 members — chairperson (independent), scientists, clinician, social scientist, legal expert, ethicist, and community representative. IEC functions: protocol approval, ICF review, ongoing monitoring, SAE review, end-of-study oversight. CTRI registration must be prospective (before first enrolment). CDSCO regulates clinical trials under the New Drugs and Clinical Trials Rules 2019. SAEs must be reported within 24 hours (life-threatening). Vulnerable populations (children, pregnant women, mentally ill, prisoners) need enhanced protections. Protocol amendments require fresh IEC approval, not merely notification.

REFLECT

As a junior doctor, you are approached to be a sub-investigator in a pharmaceutical-sponsored clinical trial at your institution. Before agreeing, what questions would you ask about the trial's ethical standing — IEC approval, CTRI registration, consent process, and conflict of interest management? If you were asked to enrol a participant who is semi-literate and economically dependent on the hospital's charity ward, how would you ensure the voluntariness of their consent? Reflect on the power differential between researcher and participant, and how the ethical framework protects against its abuse.