In normal circumstances the Institutional Ethics Committee (IEC) should be involved because it is not only the ethical issues in the protocol but also during the conduct of the study IEC has responsibilities to the enrolled subjects. All serious adverse events are reported to IEC and also there is role in deciding compensation as well as prevention of injuries to the patient from conduct of study. In the absence of IEC an independent ethics committee may be approached. However, it should be in a position to take up the responsibilities of Ethics Committee during the conduct of study, which may not be possible for an overseas ethics committee. Even for multi centric trials with same protocol which have ethical clearance from other Ethics Committees the clearance of IEC is required.

In present case however the study involves only analysis of retrospective data. No patients are being enrolled and there is no ongoing trial/study. Only important ethical issue is that the identity of study subjects is not revealed. It is possible to accept the argument that in the absence of IEC the ethical clearance was sought from the Ethics Committee of institution to which two of the investigators belonged. This is an exception and should not be used as an easy way out.