Applied Clinical Research, Clinical Trials and Regulatory Affairs

Satish Chandra
Tawam Hospital
Al Ain
UAE

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A Comprehensive Analysis of Reasons for Neglected Status of Institutional Ethics Committees (IECs) in Health Research Institutes of Punjab, India

Author(s): Ramandeep Kaur, Vikas Gupta, Ajay Francis Christopher, Parveen Bansal.

Graphical Abstract:


Abstract:

Background: Institutional Ethics Committees (IECs) in India are in their infancy stage which has significant implications in context to oversight of the protection of human participants. The critical and first step to support the protection of research participants and improve the scientific quality of health research is to understand how these IECs currently function.

Objective: Authors assessed the functioning of IECs to understand the neglected status of IECs in health research institutes providing the graduate/postgraduate education under the jurisdiction of Baba Farid University of Health Sciences (BFUHS), Faridkot (A state govt. funded autonomous body).

Method: A cross sectional study was done to assess the general information about IECs, training level, activity levels, application process and review procedures of IECs in health research institutions of Punjab, India. A structured self-administered questionnaire was developed and used for compilation of all the information.

Results: In this study authors obtained response from 56% health research institutes of Punjab. Data revealed significant shortcomings in the existence of formal IECs (54%), non accreditated Drug Controller General of India (DCGI) status (86%), inadequate training level (85%), non allocation of dedicated budget for IECs (92%), poor documentation and standard operating procedures (75%), poor competence and exposure of IECs to review varied research proposal etc. Most of IECs review quantitative studies (67%) as well as most of IECs do not operate actively (irregular meeting in 74%).

Conclusion: This study indicates very poor status of IECs in health research institutes of Punjab that need urgent attention of regulatory authorities. Therefore, authors suggest that the IECs must be registered with DCGI for the improvement in structure and functioning of IECs.

Keywords: IEC, training, lack of budget, review process, bioethics, DCGI.

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Article Details

VOLUME: 4
ISSUE: 1
Year: 2017
Page: [77 - 82]
Pages: 6
DOI: 10.2174/2213476X03666160603101300
Price: $58