IRBs and Mission Creep?

I’ve written several times in the past about the intersection of IRBs and the legal academy. (Blogging; Caselaw Research; Zach Schrag interview) Consider this an update in that series.

My university (Temple) has an interesting set of new IRB guidelines. Essentially, Temple’s IRB (for all subjects) is now requiring department head sign-off for all protocols:

“In addition to the PI, every individual listed on the approval route on an IRB submission is required to approve the submission before it can reach the IRB for review. The electronic approval takes the place of a hard copy signature. Department Heads and all research personnel are required to approval Initial Submissions. Individuals can also be manually added to the approval route. Everyone listed on the approval route must view and approve the submission in order for it to reach the IRB. Please see the instructions for Providing Approval in eRA on the IRB’s website.”

When I inquired as to why this regulation was required, I was told that department heads knew the financial health & needs of the institution, and would therefore be able to tell if particular projects’ execution was financially possible.  Because department heads are best positioned to know if research is too expensive (and consequently that human subjects wouldn’t be cared for), IRB review will be denied if they refuse to sign the application. The IRB acknowledged that the regulation was not required by HHS regulations or the common rule, but was essentially a way to improve the quality of the University’s research.

To me this is a deeply problematic requirement. Academic freedom is a slogan which almost always signifies rent seeking. But here, there are significant risks that the IRB could be used as a way to cloak gamesmanship inside of departments.  Imagine that you are on the outs from your boss. She or he can now simply refuse you the right to do research by stating that the department can’t support it.  The IRB enforces that refusal, with its full array of punitive sanctions. What avenue of relief could you possibly have, apart from an incredibly cumbersome university grievance process, or a First Amendment lawsuit against the University?

Ultimately I dropped my objections to the regulation and got sign-off, in large part because I trust the powers that be.  Also, who wants to poke the bear?  But I thought I’d throw it out there to see whether any of you have seen similar regulations, and whether (or not) they’ve been challenged successfully.

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