Important article. Something that concerns me about IRB protocols at my uni and I imagine elsewhere is the handling of collected data.
The ideal proposal says it will be in a locked cabinet in a locked office to which only the PI has access, securely encrypted on any computers, and destroyed after 5 to 7 years. The idea that there could be value in making data accessible to checking, follow up, future study, challenge by other researchers, or even history is completely absent. The operative assumption is that all data should be handled like personal confidential medical records.
As an academic and former IRB member, I can say that the flip side of this problem is just as bad. My institution’s IRB would reflexively approve garbage research (I would be outvoted) as long as the proposal pointed toward an approved outcome. One study invited first-year students to visit the university library and search for signs of white supremacy. Of course, there were no objective criteria for these assessments. Attempts to point out glaring methodological flaws were pointless when the committee (as many are) is drawn from across the institution. Those familiar with science, much less human subjects research, were often outnumbered.
Well but IRBs are not there to assess that. It is not a committee to say which research is worth doing and creep in that direction is something to be resisted even if it means biting back criticism of silly studies.
Like HHS, our institution operates with a supposed “sound science” standard, especially when it comes to projecting false impressions on vulnerable students.
Totally agree with Kathleen here. In general, the role of the IRB is limited to ensuring against unforeclosed and undue risks to participants. I have never heard of one with a mandate to ensure sound science. What college is this? And can you post any links where it states some version of "The purpose of the IRB is ensure sound science"?
Sadly, I have seen this type of manipulation both in IRB's and professional societies. Professional society Codes of Conduct are simply tools for those in power to retaliate and oppress those whose opinions they fear or dislike. The more I see of the situation, the more I am coming to the conclusion that academics are incapable of self governance in any form and funding agencies should seriously consider cutting off all of academia from the spigot of societal support until that changes.
Important article. Something that concerns me about IRB protocols at my uni and I imagine elsewhere is the handling of collected data.
The ideal proposal says it will be in a locked cabinet in a locked office to which only the PI has access, securely encrypted on any computers, and destroyed after 5 to 7 years. The idea that there could be value in making data accessible to checking, follow up, future study, challenge by other researchers, or even history is completely absent. The operative assumption is that all data should be handled like personal confidential medical records.
As an academic and former IRB member, I can say that the flip side of this problem is just as bad. My institution’s IRB would reflexively approve garbage research (I would be outvoted) as long as the proposal pointed toward an approved outcome. One study invited first-year students to visit the university library and search for signs of white supremacy. Of course, there were no objective criteria for these assessments. Attempts to point out glaring methodological flaws were pointless when the committee (as many are) is drawn from across the institution. Those familiar with science, much less human subjects research, were often outnumbered.
Well but IRBs are not there to assess that. It is not a committee to say which research is worth doing and creep in that direction is something to be resisted even if it means biting back criticism of silly studies.
Like HHS, our institution operates with a supposed “sound science” standard, especially when it comes to projecting false impressions on vulnerable students.
I think the oversight of IRB should be as limited as possible. Richard Schweder has a great piece on this:
https://www.chronicle.com/article/long-sought-research-deregulation-is-upon-us-dont-squander-the-moment/
Totally agree with Kathleen here. In general, the role of the IRB is limited to ensuring against unforeclosed and undue risks to participants. I have never heard of one with a mandate to ensure sound science. What college is this? And can you post any links where it states some version of "The purpose of the IRB is ensure sound science"?
45 CFR 46.111(a)(1)(I)
Sadly, I have seen this type of manipulation both in IRB's and professional societies. Professional society Codes of Conduct are simply tools for those in power to retaliate and oppress those whose opinions they fear or dislike. The more I see of the situation, the more I am coming to the conclusion that academics are incapable of self governance in any form and funding agencies should seriously consider cutting off all of academia from the spigot of societal support until that changes.