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|Year : 2014 | Volume
| Issue : 1 | Page : 51
Commentary on projects not initiated by investigators: A retrospective analysis of the queries raised by the institutional ethics committees of a teaching hospital
Independent Consultant and Teacher (Bioethics and Public Health), Editor, Indian Journal of Medical Ethics, Mumbai, Maharashtra, India
|Date of Web Publication||14-Mar-2014|
Independent Consultant and Teacher (Bioethics and Public Health), Editor, Indian Journal of Medical Ethics, Mumbai, Maharashtra
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Jesani A. Commentary on projects not initiated by investigators: A retrospective analysis of the queries raised by the institutional ethics committees of a teaching hospital. J Postgrad Med 2014;60:51
|How to cite this URL:|
Jesani A. Commentary on projects not initiated by investigators: A retrospective analysis of the queries raised by the institutional ethics committees of a teaching hospital. J Postgrad Med [serial online] 2014 [cited 2020 Jan 25];60:51. Available from: http://www.jpgmonline.com/text.asp?2014/60/1/51/128810
Increasing drug research by the pharmaceutical industry and mandatory review of research by students and faculty of the institution has increased the number of research projects reviewed by the Institutional Ethics Committees (IECs). Such a high and increasing load necessarily raises question about the quality of ethics review. One of the ways to constantly improve the quality of review is to audit the review process and its outcomes. The paper by Kuyare and colleagues analyzing 6 years of data of two IECs at a tertiary referral center is thus commendable.  The importance of the subject lies not just in providing clues to what is happening to the queries raised by the IECs (and thus help in improving their own work to follow up queries) but also in raising some important policy issues regarding the way ethics regulation mechanism in the country is designed and functioning. The paper, however, has not reflected adequately on the latter.
There are three worrying aspects of this study. The first is the shortcomings of the research protocols submitted both by faculty and postgraduate students of a premier institute in the country. Medical education in India tends to focus primarily on achieving excellence in clinical practice. Attention to training in science and ethics (barring a few institutes) remains grossly inadequate. Most institutions in India do provide training in research methodology and good clinical practice, but the paper shows that having them as add on in the medical curriculum alone may not be enough and provides evidence for reorienting medical education in general.
Second is the ethics regulatory mechanism for the multicentric studies in the country. First, while reviewing such protocols, the ECs do not communicate with each other. They cannot and may not unless a system for such communication is established and made a mandatory part of the standard operating procedures of all ECs in the country. At the moment, investigators and sponsors are only required to disclose to ECs the names and approvals from other sites, but not queries. Having a central EC for such studies perhaps would be useful, but that would not diminish the role and responsibilities of the local ECs. With the mandatory registration of the ECs in place now, the next policy initiative ought to be to create such a system.
The third issue, understated in the paper, relates to what is well known as the "ethics committee shopping" [EC shopping]. , While this will be impossible for students and faculty of an institute, it is less difficult for sponsors. Some data from the paper seem to point in that direction. Interestingly, as many as 61% (14/23) of the studies not initiated at these institutions after June 15, 2009, when the registration of clinical trials on the CTRI was made mandatory, were initiated at other sites. Such abandonment is unlikely to be routine or accidental. While "EC shopping" is often talked about, there is little systematic research to produce evidence for it. The researchers have illustrated the issue by using one placebo-controlled study rejected by the IECs. However, there is an opportunity to follow up 94 multicentric studies not initiated at the institute that may provide interesting leads on the conscious or normative EC shopping. An acknowledgment of such a phenomenon is necessary to initiate policy and system changes for the future.
| :: References|| |
|1.||Kuyare SS, Marathe PA, Shetty YC, Kamat SK, Katkar JV, Thatte UM. Projects not initiated by investigators: A retrospective analysis of the queries raised by the institutional ethics committees of a teaching hospital. J Postgrad Med 2014;60:46-50. |
|2.||Kass NE, Hyder AA, Ajuwon A, Appiah-Poku J, Barsdorf N, Elsayed DE, et al. The structure and function of research ethics committees in Africa: A case study. Plos Med 2007;4:e3. |
|3.||Goldfarb N. Can you handle the truth? IEC aappeals. J Clin Res Best Pract 2011;7:1-3. |