Reports of site monitoring visits by institutional ethics committees in an Indian tertiary care hospital: A retrospective analysis

Can an ethics code help to achieve equity in international research collaborations? Implementing the global code of conduct for research in resource-poor settings in India and Pakistan

“…However, on site monitoring is difficult to implement, not least because ‘on-site monitoring adds yet another resource-related issue to already stretched research ethics committees’ (Shafiq et al, 2021: 51). Further, while this type of evaluation can undoubtedly yield benefits, for instance, by helping to ensure that good clinical practice standards are maintained (Shetty et al, 2019) and safeguarding public trust in research (Ochieng et al, 2013), ‘the focus is very likely to be on completing reports rather than critical reflection, engaged discussion, and an increased sensitivity towards all aspects of relevance to ethical judgement’ (Dawson et al, 2019: 3).…”

An analysis of deficiencies in the ethics committee data of certain interventional trials registered with the Clinical Trials Registry–India

“…Since we encountered a study where a given site was approved by three generically named ECs, IEC I, II and III, in principle other IECs may not have been unique for a given institution. There is also an earlier report of hospitals with multiple ECs [19]. Accordingly, it is important that the ECs be listed in an unambiguous manner.…”

“…It is important to have accurate data pertaining to which ECs are linked to a given trial that has taken place, or is ongoing, in the country. An EC itself may be over-burdened with trial-related work [19], or physician members of the EC in their individual capacity may have high clinical burdens. Accurate EC data will help determine the frequency with which particular ECs supervise studies, and can quantify the load on each EC, or its physician members, at a given time.…”

Assessing completion reports for compliance with institutional ethics committee-approved protocols: An observational study

“…A thorough literature search revealed original research studies in the area of protocol deviation/non-compliance. However, the methods or study designs used by these researchers to identify protocol non-compliance are different, for example, a review of published clinical trials ( 9), studies of monitoring reports (10,11), or a review of deviations submitted to IECs (5,12) and so on. A study conducted by Jones et al, who evaluated 45 monitoring reports found that end point deviations (38%) and informed consent document (ICD) deviations (17%) were common (10), and Shetty et al identified ICD-related violations in 8 of the 12 sites monitored by them (11).…”

“…However, the methods or study designs used by these researchers to identify protocol non-compliance are different, for example, a review of published clinical trials ( 9), studies of monitoring reports (10,11), or a review of deviations submitted to IECs (5,12) and so on. A study conducted by Jones et al, who evaluated 45 monitoring reports found that end point deviations (38%) and informed consent document (ICD) deviations (17%) were common (10), and Shetty et al identified ICD-related violations in 8 of the 12 sites monitored by them (11). Whereas a study conducted by Jalgaonkar et al, which evaluated protocol deviation reports submitted to the IEC, reported that of the total deviations reported, the majority were procedurerelated deviations (68%) (12).…”