| Autor: |
Mehta, Vini, Hegde-Shetiya, Sahana, Kakodkar, Pradnya, Gupta, Nitin |
| Předmět: |
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| Zdroj: |
Indian Journal of Public Health Research & Development; Dec2019, Vol. 10 Issue 12, p282-287, 6p |
| Abstrakt: |
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. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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