We regularly do research studies on teaching biology to college students. It's an integral part of our mission to develop better teaching tools. When we started doing these studies, we (along with most education researchers) were relatively lax about any regulations involved in conducting such research. We asked (and still do) permission from each student before including them in a study, and assumed if they said 'yes' then everything was OK. After all, these college students are adults who can decide for themselves whether to let us ask them about their biology knowledge.
Later, we started applying for institutional review board ("IRB") approval for our studies from the board at MIT, where we have a lot of collaborations. The IRB hurdle is a federally mandated process meant to protect people from having research conducted on them that could be dangerous to them in some way. It's a noble goal, but a bit irrelevant for most educational research, and that's recognized by an exemption given to many educational studies. The exemption, however, is at the discretion of the review board you apply to. You must fill out forms just to ask for the exemption, so there is inevitably some paperwork involved.
When we had to do this paperwork once, at a single school (MIT in our case) to cover our study, it was an annoyance, but not a major roadblock. In our latest rounds of studies, though, the regulatory hurdles have gone way up. We like to do each of our studies with many students from an array of schools. That gives us statistically meaningful results that apply to a diverse student body. Recently, instead of a single approval from one review board, we have been asked to add approvals from every single school where we recruit a class for a study. So for instance, if we ask professor X at school A to use a new lab we've written and collect pre- and post-tests for us, we first have to go to the IRB at school A, submit a bunch of paperwork, have the professor get trained, get lots of signatures, and then hope all of that goes smoothly so we can do our study. It can take 5-15 hours per school just to fill out the paperwork on our end, not to mention the professor's time and any back and forth with the review board. Needless to say, this is a huge time sink and expense, and also turns off a lot of professors that would otherwise be eager to help us.
A recent commentary in Nature discusses the same problem in medical research, where there are also apparently many studies that have minimal risks for patients yet get stuck on human subjects regulations. They claim that "at least half of institutional review board costs are devoted to evaluating minimal-risk research". So I guess this is a general problem, but in our college biology education subfield, it especially rankles me for another reason. I can see the need for some outsider to review study design just to make sure that there are no hidden aspects that could harm the subjects. But once there is a single review, I feel it is not only wasteful, but also disrespectful to students as adult decision makers to require additional reviews. It's hard to see how studying whether a student is learning some topic in biology adds any substantial risk to that students' life. And these students are adults. They can make their own decisions about participating in a study. Yet the process as it is set up now turns each university into a nanny for its students, who are not allowed to say for themselves whether they are willing to participate, but must first get approval from some bureaucracy. In the land of the free, there's something wrong with that. Research Regulations Don't Respect College Students
Submitted by Eli_Meir on Tue, 03/17/2009 - 23:32.
We regularly do research studies on teaching biology to college students. It's an integral part of our mission to develop better teaching tools. When we started doing these studies, we (along with most education researchers) were relatively lax about any regulations involved in conducting such research. We asked (and still do) permission from each student before including them in a study, and assumed if they said 'yes' then everything was OK. After all, these college students are adults who can decide for themselves whether to let us ask them about their biology knowledge.
Later, we started applying for institutional review board ("IRB") approval for our studies from the board at MIT, where we have a lot of collaborations. The IRB hurdle is a federally mandated process meant to protect people from having research conducted on them that could be dangerous to them in some way. It's a noble goal, but a bit irrelevant for most educational research, and that's recognized by an exemption given to many educational studies. The exemption, however, is at the discretion of the review board you apply to. You must fill out forms just to ask for the exemption, so there is inevitably some paperwork involved.
When we had to do this paperwork once, at a single school (MIT in our case) to cover our study, it was an annoyance, but not a major roadblock. In our latest rounds of studies, though, the regulatory hurdles have gone way up. We like to do each of our studies with many students from an array of schools. That gives us statistically meaningful results that apply to a diverse student body. Recently, instead of a single approval from one review board, we have been asked to add approvals from every single school where we recruit a class for a study. So for instance, if we ask professor X at school A to use a new lab we've written and collect pre- and post-tests for us, we first have to go to the IRB at school A, submit a bunch of paperwork, have the professor get trained, get lots of signatures, and then hope all of that goes smoothly so we can do our study. It can take 5-15 hours per school just to fill out the paperwork on our end, not to mention the professor's time and any back and forth with the review board. Needless to say, this is a huge time sink and expense, and also turns off a lot of professors that would otherwise be eager to help us.
A recent commentary in Nature discusses the same problem in medical research, where there are also apparently many studies that have minimal risks for patients yet get stuck on human subjects regulations. They claim that "at least half of institutional review board costs are devoted to evaluating minimal-risk research". So I guess this is a general problem, but in our college biology education subfield, it especially rankles me for another reason. I can see the need for some outsider to review study design just to make sure that there are no hidden aspects that could harm the subjects. But once there is a single review, I feel it is not only wasteful, but also disrespectful to students as adult decision makers to require additional reviews. It's hard to see how studying whether a student is learning some topic in biology adds any substantial risk to that students' life. And these students are adults. They can make their own decisions about participating in a study. Yet the process as it is set up now turns each university into a nanny for its students, who are not allowed to say for themselves whether they are willing to participate, but must first get approval from some bureaucracy. In the land of the free, there's something wrong with that. 
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