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Knowledge and Practice on Current Regulatory Requirements for Members of Ethics Committee amongst Dental Colleges in India


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1 Dr. D.Y. Patil Dental College and Hospital, Dr. D.Y. Patil Vidyapeeth, Pune, India
     

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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.


Keywords

Ethics, Current Regulatory Requirements, Dental Colleges.
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  • Knowledge and Practice on Current Regulatory Requirements for Members of Ethics Committee amongst Dental Colleges in India

Abstract Views: 259  |  PDF Views: 0

Authors

Vini Mehta
Dr. D.Y. Patil Dental College and Hospital, Dr. D.Y. Patil Vidyapeeth, Pune, India
Sahana Hegde-Shetiya
Dr. D.Y. Patil Dental College and Hospital, Dr. D.Y. Patil Vidyapeeth, Pune, India
Pradnya Kakodkar
Dr. D.Y. Patil Dental College and Hospital, Dr. D.Y. Patil Vidyapeeth, Pune, India
Nitin Gupta
Dr. D.Y. Patil Dental College and Hospital, Dr. D.Y. Patil Vidyapeeth, Pune, India

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.


Keywords


Ethics, Current Regulatory Requirements, Dental Colleges.



DOI: https://doi.org/10.37506/v10%2Fi12%2F2019%2Fijphrd%2F191959