In today’s evidence-driven practice, clinical research, including interventional and observational studies, is becoming increasingly relevant. However, the legal and ethical frameworks governing patient participation remain stringent, and non-compliance can lead to serious consequences. Even observational studies , case series, or post-marketing surveillance studies require approval from an Institutional Ethics Committee (IEC) . Many clinicians mistakenly assume that only drug trials fall under regulatory oversight, but data collection without oversight or consent is a violation of both ICMR guidelines and national law .
Equally critical is valid informed consent . Patients must be clearly informed about the study's purpose, their rights, the confidentiality of their data, and the voluntary nature of participation. Digital or blanket consent formats often fail to meet legal standards,…
