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 ETHICS FORUM-RESEARCH ARTICLE
Year : 2014  |  Volume : 60  |  Issue : 1  |  Page : 46-50

Projects not initiated by investigators: A retrospective analysis of the queries raised by the institutional ethics committees of a teaching hospital


1 Department of Microbiology, Seth GS Medical College, Acharya Donde Marg, Parel, Mumbai, Maharashtra, India
2 Department Pharmacology and Therapeutics, Seth GS Medical College, Acharya Donde Marg, Parel, Mumbai, Maharashtra, India
3 Institutional Ethics Committee, Seth GS Medical College, Acharya Donde Marg, Parel, Mumbai, Maharashtra, India
4 Department of Clinical Pharmacology, Seth GS Medical College, Acharya Donde Marg, Parel, Mumbai, Maharashtra, India

Correspondence Address:
P A Marathe
Department Pharmacology and Therapeutics, Seth GS Medical College, Acharya Donde Marg, Parel, Mumbai, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0022-3859.128808

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Background: Some investigators on receiving queries from Institutional Ethics Committee (IEC), either leave the queries unanswered or withdraw their studies. The present study was conducted to assess the queries raised by two IECs after reviewing studies that were not initiated and to identify reasons for the same. Clinical Trials Registry-India (CTRI) website was checked to review approval status of these studies at other sites. Materials and Methods: A retrospective analysis of studies (submitted between January 2006 and December 2011) not initiated by investigators on receiving queries from IECs were identified. The nature of of these studies: whether sponsored (pharmaceutical industry (pharma)/government/investigator initiated), single-centre/multi-centric, and queries raised were analyzed. Status of multi-centric trials; not initiated at our site was checked at CTRI. Data was analyzed using descriptive statistics. Results: A total of 219/2075 (11%) studies were not initiated. The proportions in pharma sponsored, investigator initiated, and government sponsored were 33%. 7.4%, and 8%, respectively. Out of a total of 1676 queries, the maximum queries were related to ethics (42%) and the least were administrative (7%). The largest proportion of queries in the pharma studies was ethical (47%), whereas majority were scientific queries (45.5%) for the investigator initiated studies. Twenty-one of the 94 multi-centric studies not initiated at our site were found registered at the CTRI and were ongoing or completed at 2-55 sites. Conclusion: Inability of investigators to defend studies due to lack of good clinical research practice (GCP) and research methodology training or unwillingness of sponsors to comply with local IEC requirements could be potential reasons for studies remaining uninitiated. Continued GCP training of investigators and IEC members and development of uniform ethical review standards across IECs are strongly recommended.






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Online since 12th February '04
2004 - Journal of Postgraduate Medicine
Official Publication of the Staff Society of the Seth GS Medical College and KEM Hospital, Mumbai, India
Published by Wolters Kluwer - Medknow