I'm sorry, Dr. X

Dear Dr. X,

I am sorry it has taken over 5 weeks for you to receive your letter from the IRB. What's more, your response, whenever you actually respond to it--because investigators such as yourself take a long time to respond but like to blame the entire time it takes for your study to be reviewed on the IRB--will have to go back to the full IRB. Lucky you.

We needed a consultant for your study because it was so obscure and strange in design. You won't like to hear this either but federal regulations require us to seek out expertise when none are available on the Board for your line of research.

But I hope you take my advice and simply answer the questions, give in and agree with the IRB on the minor issues raised, and did I say answer the questions? Most investigators (often study coordinators) DO NOT answer the questions. The result? More delays.

These sorts of delays are easily but erroneously blamed on the IRB. Still, the IRB is such an easy target and the temptation so great that it is understandable. However, it's a shared blame and one which can be fixed given a re-prioritization of the powers-that-be to resourcing, education, and collaboration. In time, I believe this will occur.... It must, actually, for the sake of advancement of science in the long run.

This is a letter I could never write in real life. And so I write this make believe letter here on this make-believe blog.

Busy is as busy does

I have not been able to write recently for the simple reason that the IRB has been as busy as ever. We lost a number of high level staff in the last six months and while always a struggle, it represents an opportunity to bring new energy and personnel with expertise in both applied research and human subjects protection.

The learning curve for anyone coming into a new organization in this field is quite steep regardless of one's prior experience. The work we do can be nuanced and difficult. There are multiple agencies which oversee an IRB at an academic research institution and sorting, interpreting, and coordinating all of the laws, regulations, and guiding documents is a formidable task.

I share this because it is not just enough to have the right number of staff to enable an IRB to function. Trained staff is important. So for those who loathe the time it takes for studies to be reviewed and approved by your IRB, among the many questions which could be asked, "How many trained staff are there?" should be one of them.