OBJECTIVES: To assess the existence, structure, and functioning of Institutional Ethics Committees (IECs) in dental teaching institutions in Kerala. METHODOLOGY: A cross-sectional questionnaire-based survey was conducted by personally approaching Heads of Institutions/Ethics Committee (EC) in-charge of all dental colleges (23) in Kerala. The validated questionnaire consisted of two parts. The first part pertained to details of institutions, and the second part assessed the structure and functioning of the IEC. The data obtained was tabulated and analyzed using descriptive statistics. RESULTS: Of the participating 17 colleges, 13 colleges had a functioning IEC. Only four of these IECs were accredited to a central agency. Only one among the 12 colleges completely adhered to recommended structure. Regarding the functioning of IECs, 69% of the IECs had neither a separate application form for ethical review of proposals nor a proforma for its evaluation. On average, more than ten proposals were reviewed in a single EC meeting in 54% of the colleges. Nearly 40% of the IECs had no representation of a lay person. CONCLUSION: The absence of IEC in four colleges and non-accreditation to a central agency was a matter of concern. Enforced accreditation is the need of the hour to ensure ethical protection to human participants.
OBJECTIVES: To assess the existence, structure, and functioning of Institutional Ethics Committees (IECs) in dental teaching institutions in Kerala. METHODOLOGY: A cross-sectional questionnaire-based survey was conducted by personally approaching Heads of Institutions/Ethics Committee (EC) in-charge of all dental colleges (23) in Kerala. The validated questionnaire consisted of two parts. The first part pertained to details of institutions, and the second part assessed the structure and functioning of the IEC. The data obtained was tabulated and analyzed using descriptive statistics. RESULTS: Of the participating 17 colleges, 13 colleges had a functioning IEC. Only four of these IECs were accredited to a central agency. Only one among the 12 colleges completely adhered to recommended structure. Regarding the functioning of IECs, 69% of the IECs had neither a separate application form for ethical review of proposals nor a proforma for its evaluation. On average, more than ten proposals were reviewed in a single EC meeting in 54% of the colleges. Nearly 40% of the IECs had no representation of a lay person. CONCLUSION: The absence of IEC in four colleges and non-accreditation to a central agency was a matter of concern. Enforced accreditation is the need of the hour to ensure ethical protection to humanparticipants.
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Keywords:
Dental teaching institutions; India; human subjects regulation and oversight; institutional ethics committee; legal and regulatory issues in research; research in developing countries