Abstract
Introduction: 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. 16.3% of the participants had registered EC and only 28.7% applied universal ethical principles.
Conclusion: Despite the presence of ethics committee in the dental institute, the knowledge and practice regarding current regulatory requirements was found to be insufficient for proper functioning.
