Bureacracy Run Amok

I recently devised a very simple educational study I wanted to do at work. It involved nothing more than giving a class of students some educational study aids, asking them what they thought of it, and seeing how it affected their scores on their tests. It was all completely voluntary, no one was being forced to use the material. The whole time I really needed to spend on the study would be less than a day at work. Sound simple, right?

Before I am allowed to do the study, I had to get it approved by the Institutional Review Board because I was dealing with live human subjects. We wouldn't want anyone to be hurt by the study after all. This is a reasonable requirement for studies that, you know, could actually maybe hurt someone. So ok, I decide to go through the process.

Step one: ask the IRB if I need to have a formal review done. I fill out several pages of forms, which they then decide that I do need a review. Turns out that all the forms were unnecessary as they only thing they care about is if the study deals with people. Why they couldn't just ask that one question or even just put it on their website saying that, I have no idea. But no, I have to fill out a lot of paperwork to get that answer.

Step two: I am told that before I can even submit the proposal, I have to take a course on protecting patient health information. Even though I am not dealing with patients or health information, since the school has a hospital attached, everyone has to have this course. Then I have to take another course on treatment of human subjects in research studies to make sure that I am not mistreating anyone during the study. Ok, for a lot of medical studies this is important. My study? Not so much.

Step three: In the course, I am told that Federal regulations allow educational studies like this to be exempt from review. Makes sense as it involves research on teaching techniques that can't harm anyone and uses no personal information that might be used to harm anyone. Doesn't matter says the IRB. They demand to review everything. So I have to have a pointless review to determine that I need to have my proposal reviewed, during the course of which I am told that it doesn't need to be reviewed, but yes it does? Hello?

Step four: Because my school is attached to a hospital, it has to be reviewed by a clinical studies review board before it can be reviewed. But my study doesn't have anything to do with clinical research, I say. Doesn't matter they say, any research that takes place on campus has to go through them.

Step five: Now I have to get the proposal through their computer system. I fill out several online forms for them. Problem is that the forms are designed through FileMaker Pro, which despite the marketing spiel, was never designed for online use with multiple, simultaneous users and causes it to be buggy as hell. I finally get everything through, with the biggest problem being that the system completely fails if when you submit a revision of your study, you actually call it a revision. But finally, they conclude after much back and forth that my study has no clinical relevance and can be submitted to the IRB for review.

Step six: I can now finally actually submit my proposal to the IRB for review, yay! The IRB has an online form with eleven pages of questions, wherein I have to submit more documents. Several of the questions are highly repetitive. For example, I have to submit a document containing the full proposal, an abstract of the proposal, a lay abstract of the proposal, a scientific abstract of the proposal, and then detailed sections in multiple parts of each part of the proposal that I had to submit as a separate document. Does this sound just a tad bit redundant to you?

Step seven: Because the system is based on FileMaker Pro, the IT guys are not the brightest IT guys ever, and because no one really thought about the set up, it loses my data after it has been successfully submitted and I have to go back to the clinical studies review and have them reapprove my study so I can resubmit to the IRB.

Finally, everything is done and the project is now in review. The original proposal? It was highly detailed, got high marks as a well written and thorough proposal from the clinical review people. It was less than 3 pages, including the survey I planned on giving the students. All the paperwork involved? More than twenty pages and almost a month of time to get through the system for a project that will take less than a day.

I asked one of the administrators why the system was set up the way it was, considering that they have options in the forms that crash the system if they are used. They said they had just copied the system from somewhere else and they probably had a use for it. I wonder if I asked those people if they had simply copied over the system from somewhere else, what would they say?

There are plenty of studies that would require all these hoops. Some studies pose serious potential threats to the test subjects if the researchers are not exactingly careful. My study on the other hand could easily have been reviewed by five minutes on the phone with one of the staff. But no, I have to spend a huge amount of time jumping through bureaucratic hoops.

This is a great example of bureaucracy run amok. Everyone involved agree that the system is terrible. Yet no one is willing to try to fix it. This whole system is set up the way it is because no one who set it up bothered to really think through what they needed. They simply took something designed by someone else for their own particular needs and then tacked on things piecemeal to handle their specific requirements, creating a system that is a headache for everyone involved. The key goal it seems is to protect human subjects by making it so onerous to actually do anything that researchers give up and work on something else. Is this any way to advance human knowledge? I understand making sure the work is done safely, but a little thought can make this process much easier and far less costly. We are spending so much time and money on pointless paperwork that we are not getting work done. Is this really what we want as a society? We are creating excessive obstructions for no other purpose than to give people jobs and to obstruct actual progress in anything important and we are doing it because people are not thinking through what actually needs to be done.