Bioequivalence and Bioavailability Forum

Hi M. Vasu,

It is highly impossible that any IRB/IEC disapproves clinical study without valid reason (safety concerns, efficacy etc.); even regulatory authorities (like US FDA, EMEA, ANVISA etc) won't follow this practice. If they are disapproving your clinical study, then they must provide valid reason for disapproval.

In your case there can be two possibilities
1) IRB wants further information/clarification for its approval or
2) Simply disapproving your clinical study without reason.

In first case:
If they provide their views or they want corrections in the proposed clinical study (protocol), just incorporate this extra information, amend your clinical study protocol and resubmit for approval (to same IRB).

In second case:
If they are disapproving your clinical study without providing any reason, then you are having every right to approach another IRB.

"The show must go on"

Regards,
Preet