Bioequivalence and Bioavailability Forum

Hi M. Vasu,

❝ If the IRB disapproves clinical study, can the sponsor approach another IRB? Kindly coat with applicable guidelines?

To be honest I don't know the answer to your question, so the following is a kind of common-sense-attempt...

1. I guess most of us have asked mum for an ice cream only to hear her say no, and then with success asking dad the same without mentioning that mum said no. Yummm! But the entire thing may backfire if or when mum and dad communicate. Good bye to ice creams for a bit of time in the future.

2. Imagine we ask dlabes' random number generator (in essence a good looking female of younger vintage) to roll a dice 20 times and sum the score of each roll. We want the sum to be at least 107. I bet the random number generator will not succeed in the first attemp. So we ask her to roll another 20. And she fails. And so forth. Stupid random number generator?? Well, sooner or later she will succeed, that's for sure.

If your IRB saw something they didn't like then perhaps it's because there is a real problem or it could be that there is no problem and they are just a bunch of silly people. At any rate, regulators (at least in principle, in Europe) do want to know about it AFAIK when you apply for a clinical trial in case an IEC/IRB has given thumbs down (H3 on the form). So although you may not be breaking any laws -I have no idea if this is the case- I think it would be a step in the wrong direction to roll that dice again, and even though I am not a regulator I would think it could backfire on you if mum and dad start talking to each other.


Come on, there must be others out there who have a much more qualified opinion about this interesting issue?!

EM.