aaup new report on irbs and academic freedom

AAUP has released a new report, the first in five years, on restrictions posted by the IRB system on academic freedom. The report is here.  A couple of key points:

  • The list of exemptions to IRB review is too short and, more importantly, contains no guiding principle as to what makes exempt:

What is peculiarly objectionable in that requirement [that interviewing be subject to IRB approval] is that it interferes with freedom of speech. You do not need to get approval from an appropriately chosen Moral Review Board if you want to invite your neighbor to tell you about his or her voting preferences, or about the teaching of evolution, or about anything else, whether your aim is to do research or merely pass the time while waiting for the bus and whether, given that the conversation is public, your neighbor will have been caused a harm by it. It is no more in order to require researchers to obtain IRB approval before inviting their subjects to discuss or report on their views.

  • Even exemptions require approval by the IRB which is overly restrictive.

Research on autonomous adults should be exempt from IRB approval (straightforwardly exempt, with no provisos and no requirement of IRB approval of the exemption) if its methodology either
(a) imposes no more than minimal risk of harm on its subjects, or
(b) consists entirely in speech or writing, freely engaged in, between subject and researcher.

 

 

 

9 Comments

  1. Posted September 7, 2012 at 12:24 pm | Permalink

    I have been fighting this battle on my campus. Lots of research of this character gets classified as exempt BUT you have to fill out all the paperwork describing your project for IRB review to get the exemption because only the IRB has the right to declare that you are exempt from its review. Further the IRB says that if you change your plans (i.e. shift what questions you ask) you are required to fill out the paperwork AGAIN for a “change form” even though you get an exemption letter that says you are “exempt from further review.” It is making me crazy.

    I’m even having to defend research on public documents from excessive review that doesn’t even involve actual human contact!

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  2. Posted September 7, 2012 at 1:04 pm | Permalink

    An IRB issue represents the only time I have truly flipped out as department chair, so I’m sympathetic to the basic premise that IRBs overstep their mandate, especially regarding social science. But the free speech argument doesn’t really work for me. Nobody’s preventing you-the-citizen from talking to your neighbors about whatever, or even calling up random strangers and asking them about whatever. What’s being prevented is you-the-salaried-employee-of-X (or you-the-recipient-of-grant-from-X) from doing these things without approval from your employer in the guise of research. There’s an academic freedom argument I think that can be made about that, but I think the free speech argument doesn’t go far for the capacity for employers to regulate how employees do their jobs.

    (There may be perceptual differences here that come from one’s employer being a private versus public university. I perceive Northwestern as being a complete separate animal from any governmental agency, even if they represent policies as executing government regulation, but I could see where that might feel different at a state university.)

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    • Posted September 10, 2012 at 11:32 am | Permalink

      Jeremy, The “salaried employee” argument seems to me not only wrong but pernicious. Since the employees in this case are university professors, this would suggest that professors acting in their professional capacities have less freedom of speech and inquiry than other citizens, a view completely inconsistent not only with contemporary ideas of academic freedom but the tradition of parrhesia that reaches back to antiquity. We are not simply “employees” following the mandates of our bosses, but professional investigators and thinkers who must be as free as possible from institutional control and direction in order to do our jobs.

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  3. kenkolb
    Posted September 10, 2012 at 8:44 am | Permalink

    Thanks for posting this.

    I’ve been fighting the IRB at my little liberal arts college, and it is a real hassle. The mission creep towards over-regulation is clear. What is so ironic is that I suspect some of the worst cases of IRBs overstepping their bounds are at places like mine. I had relatively no problems with the IRB at UNC for setting up an ethnography/participant-obs at an agency that assists victims of Domestic Violence and Sexual Assault. Of course, I had to go the extra mile in terms of confidentiality protocols and the like, but the process–while cumbersome–was bureaucratic and predictable. At small schools, IRB decisions are much more arbitrary. The people who staff the committee don’t have the resources or training to keep up with best practices in regards to data storage, how to treat inductive research, etc. It is just another committee assignment. As a case in point, for a study that had to go through our IRB as well as the hospital’s IRB, our app cruised through theirs, but got caught up in ours over a bunch of small issues.

    I have a lot more to say on this issue (unwarranted fear of lawsuits, stifling academic freedom), but I just get too worked up to talk/write about it.

    I just wish OHRP would get around to making those changes to the common rule already. They closed public comment in Oct of last year. How long will it take?

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  4. Posted September 10, 2012 at 1:50 pm | Permalink

    An irony of timing – I just got back a response from our IRB asking for changes to a protocol for my semiannual telephone poll of NC voters. Note the “semiannual” – essentially the same poll, with the same protocol, is submitted twice a year. And twice a year, like clockwork, the ethics cops at the IRB take a break from deciding whether or not radioactive isotopes can be administered to prison populations to cure restless-leg syndrome to dream up some fancy new way in which participating in an automated telephone poll might cause harm.

    Last year, it was that people needed an email address to contact if they had questions about their rights as “subjects.” This year — it was that if they were to take advantage of said email address, then we would have their email address, which could cause a breach of confidentiality.

    These people are nuts. Grr.

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    • Posted September 10, 2012 at 4:44 pm | Permalink

      Ah but only if the email address was associated with their responses, which it wouldn’t be if they just emailed you or the IRB to complain, and if they do this, they are voluntarily disclosing their identifying information which is, after all, the only way the can complain. If they call you on the telephone or write you a letter they are also breaching their confidentiality. In short, a push-back seems in order.

      Being on the IRB has not made me any less furious about process, but it has made me aware that some of the lunacy arises from people getting confused about how to think about things or forgetting the details of a particular project.

      Also consider external pressure. Our IRB has taken to requiring “recruitment scripts” and has gotten paranoid about snowball sampling, even on the most benign topics in the most non-threatening contexts possible. This turns out to be because the federal reviewers hassled and grilled the local IRB about recruitment procedures and threatened to hold up federal approval over it.

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      • Posted September 10, 2012 at 8:24 pm | Permalink

        Of course, I will push back, and they will let me run the survey. But there’s no good reason for IRB to have any authority to review this survey at all, and the whole thing bugs me. Grr.

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      • Posted September 10, 2012 at 8:51 pm | Permalink

        We agree, as I griped in my first response. I bugs me no end that you have to be reviewed to be “exempt” from review. Surveys ought not to need any review unless they are of minors or are eliciting threatening information with people’s names attached.

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  5. dan hoyt
    Posted September 12, 2012 at 7:01 am | Permalink

    I spent (wasted) a few years trying to address IRB issues on our campus. A few observations from this experience:

    OHRP provide a considerable degree of flexibility on how university IRBs implement regulations, as well as consistent and well documented.

    However, fear of implications for federal funding being withheld has lead most institutions to be overly conservative. This is characterized as errors on the side of caution. But, in reality it is likely producing just the opposite of the notion of protection of research subjects. Overly complex and legalistic language in consent forms can often result in research subjects not understanding to what they are consenting.

    In my view, the current over-regulation is contrary to the Belmont Report principle of Beneficence. The notion here is that there is an equal chance to participate in, and benefit from, research. It is presumably one of the cornerstones of the IRB process. However, over-the-top and unnecessary consent processes are likely to reduce participation of minority participants who have life time experiences that make them less trusting of assurances from authorities. Our current implementation of these regulations may be resulting in systematically under representation of minority populations in our research.

    One of the most disturbing trends is the push to ‘certification’ of university human subject protection programs. An entire industry has been constructed by organizations like AAHRPP that evaluate and certify university IRB processes. If any of your campuses has gone through this accreditation process, you will have noticed a proliferation of checklists, forms, and a excessive obsession with documentation. The intent is to implement a system that minimizes a university running into issues with federal regulations – at the expense of wasted time on the part of researchers, and no appreciable increase in protection of human subjects (who often did not require protection in the first place).

    Finally, there is a part of the process where we can make a difference, but it comes at a cost that many academic researchers find too high. You can impact the process by having more active researchers serving on IRBs. The IRB process involves active discussion and deliberation, and having the board populated by active researchers – rather than non-productive colleagues who are looking for a service role – makes a big difference in how the rules are implemented locally.

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  1. [...] Perrin nails it: Twice a year, like clockwork, the ethics cops at the IRB [institutional review board, the group on [...]

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