IRB ≠ Protection: When Ethics Boards Become Bureaucratic Fences

They’re supposed to safeguard participants. But what if they’re just safeguarding paperwork?

You’re in the middle of a trial start-up. Timeline’s tight. Site’s prepped. Sponsor’s ready.

Then the IRB swoops in.

Weeks pass.

You’re answering questions like:
→ Why didn’t you specify the font size on the subject information sheet?
→ Can you clarify how ‘mild headache’ is defined?

The urgency? Gone.
The momentum? Dead.
The patient enrollment? Still pending.

A…