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The IRB response

That was fast. I wasn’t expecting to hear anything back from the IRB so quickly, but here we are and I have a bit of work to do. Technically we didn’t get the IRB reviewed yet, it’s only been “pre-reviewed,” but pre-review helps speed things up when the IRB meet next (in about a month) to look over the application. Since we were asked to make some modifications, this should help bring our IRB application up to standard before the IRB actually review it.

Once again here we are another day and some actual progress. For those who are completely confused, the IRB is the review board that provides feedback to experiments you want to do. The goal of the IRB is to make sure you remain ethical! The catch of course is that we’re all human and ethics is a fuzzy thing, but it’s the best system we have even if it’s a flawed one. I wrote more about the IRB process here for anyone needing to get up to speed.

There are several steps to the IRB application process, from pre-submission all the way to actual acceptance. For awhile there I was at the pre-submission phase. This is the phase where the people who run the IRB find out that I’m in the process of applying. Once I write all the documentation and get approval from school-PI and the department head I can submit the application (which I did about a week or so ago).

From there it goes into the pre-review stage. As I mentioned this is so that people who are not the IRB, but know what the IRB want, can review the documents and make sure we aren’t wasting the time of the IRB or our own time. This is where we are now, so the IRB doesn’t even know I exist quite yet. That’s okay though because now I can make sure my application has the best shot it can to get approved once they meet, which as I noted above is not very often!

Now I’m in the “clarification requested” phase, which means they are waiting for me to edit my documents per the feedback I got and resubmit. It feels a lot like journal submission in a way. You submit something you think is good, they come back and tell you it’s crap, then you repeat the process until they agree it doesn’t suck as much. Even the stuff I was asked to change feels very “journal paper” feedback. Mostly clarifying certain things or rewording things to better fit their expectations.

I should be able to get this stuff addressed in the next day or two, then with the blessing of school-PI I can resubmit and repeat this process until they are happy. I would assume that this will be a one and done type deal, but you never know. After they approve it though it goes on the schedule for the next IRB meeting.

Since we’re here let’s take a peek at the upcoming steps. After pre-review the IRB gets to review it. They can ask for changes or they can send it off to the next phase. You would think the next phase is completed review or something like that and I wouldn’t blame you because I thought the same thing, but there is another step involved even though “technically” it is approved. While this step happens after approval it’s listed as before approval so I’m going in order.

The next phase is the post-review, which is a bit confusing, but there is a second review that is done and even here they can ask for modifications. This doesn’t occur right away though, the post review is to verify that the procedures we outlined are being followed so technically the IRB is approved and we can start the experiment. Post-reviews happen at the IRB request so we won’t know if or when that happens, but as long as we’re following the procedures we outlined everything should be clear. Basically this is just to ensure that we’re doing what we said we would be, because while the IRB trusts us it would be silly not to double check.

I’ve got about a dozen or so things to do this weekend, so that will be fun and now I can toss this into the pile of things that need to happen soon. While the IRB won’t be meeting for this particular application for another month, having it ready to go when they meet is of the highest priority right now. I cannot miss this next deadline or I will be behind schedule.

The race is on!

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