Regulatory guidelines have been made stringent to safeguard human rights, integrity, safety and welfare. Aim and Objective: The present study was designed to elucidate the knowledge and practice of current regulatory requirements for the members of ethics committee (EC), amongst dental colleges in India. Materials and Method: A cross sectional survey was conducted amongst the ethics committee members of various post graduate dental colleges representing North, South, East, West and Central zones.
A validated closed questionnaire was framed in accordance with the Schedule Y of Drugs and Cosmetic Rules 1945 and Indian‑GCP guidelines, which was sent through an e‑survey using Google forms. Results: The response rate was found to be 40%. Less than 50% participants correctly answered about guidelines of biomedical research, composition of EC, serious adverse effect and vulnerable population.…
