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29 March 2006

Comments

jack katz

It's critical that the law academic community realize that, in complying with the IRB system, they are supporting a censorship agency that is increasingly suppressing research at the behest of third parties and independent of any effects on research subjects.
If I remember the British phrase correctly, it's "I'm alright, Jack." Yes, you can work out relations for your projects with the IRB, in most instances. In doing so you're supporting a system that is blocking research and penalizing researchers whose work offends a variety of interests--employers opposed to unions, academics eager to suppress student or colleague's research they regard as wrong headed, conservative religious groups, "creation science," the university's irrational fears of law suits, as promoted by university legal counsel's offices, etc.

There are several empirical issues that should but do not yet inform these debates.
1: What evidence is there that IRBs make a beneficial difference for subjects of social and humanistic research?
2. If universities collectively resisted the prior restraint posture of IRBs, at least for non biomedical research, would the federal government shut down the nation's funding of biomedical research? The U of Chicago just opted out of IRB review for non funded research, as Richard Shweder has detailed in a recent/current essay. In fact the U of Chi isn't losing its federal funding for biomedical work.
3. How is IRB censorsihp power being exploited by third parties, who, led by academics who understand how IRBs work, increasingly appreciate how they can harass their substantive opponents?
4. How can you actually comply with the IRB requirement that you get pre-authorization, whether as an exemption or through expedited or full review, for your work? If often you cannot, support for the current prior approval system means that you are exposing yourself to attack by your substantive opponents. This vulnerability will not be lost to law academics when they are brought more fully within IRB oversight.

Laura Beth Nielsen

I didn't mean to say that a university would lose federal funding for a few interviews with elites. They could lose it if a few interviews with elites somehow went awry, harming individuals, and there was no IRB approval. And, let's face it, the risk of that is very low.

It's also worth seeing your institution's policy on pilot research which is, what I think you are describing. The standards are often lower as you do background or pilot research leading up to the real research. (and, they cannot prevent you from talking to people at cocktail parties or calling your friends to chat about something -- we are talking about research rules here).

That said, I have interviewed a lot of lawyers and they put themselves at risk all the time. I could tell you stories that you would not believe! (Here's one -- I am interviewing Ps drawn from a national random sample of federal employment discrimination cases filed in federal courts over a 15 year period. We track down Ps, interview them, and, with their permission, speak to their lawyer about the case. I called a lawyer to make an appointment to talk about a case. On my cold call, he said, "OK, interview me now over the phone." I said, "Don't you want to check with Joe Blow (the P) to make sure you can?" "Nah, go ahead." He proceeded to tell me everything about the case including confidential stuff. I did have Joe Blow's permission, but he did not know that. He is the only lawyer who did not check with the client before talking to us and he is a named partner in a very large elite law firm.

Part of the point of going through IRB is to come up with a warning (verbal or written) that they hear prior to the interview which reminds them of this. You don't always know, going into an interview, where it will go and what might be revealed (thank goodness! this is, for me, the fun of research).

The point is that the risks are not always perfectly forseeable and so you need to go through a process where someone helps you think about what you might be missing and what you are going to do if various issues arise. For example, what am I going to do if a lawyer reveals malpractice to me? his own or someone else's? Nothing, of course. I cannot. But what if there is a lawsuit and my notes are subpoenaed? Am I going to turn them over? Go to jail? (This happens -- that would actually make a good entry here by some of those who have faced thisdecision -- not me luckily).Doesn't the subject have the right to know how I plan to keep the information confidential?

I know it is all remote, but these human subjects are taking time from their lives to help out our research. I believe they are due our utmost care -- even the ones who are likely to be able to take care of themselves. They make mistakes too and our job is to have systems in place that protect them in the event that occurs.

It's frustrating to me that legal academics resist this so much. I see the relationship between researcher and subject like I see the fiduciary relationship between lawyer and client. I know empricial research already takes longer and costs more money than other kinds of legal scholarship and this just makes it take longer, but we do have this obligation.

This is not to say that these systems are great -- they could certainly be improved dramatically, but I don't think legal academics should just decide they can place themselves outside the processes required by law and their employer.

William Ford

Let’s assume a law professor talks with a few lawyers at a law firm as part of a research project, but he does so without the permission of the IRB to conduct this “gray area” human subjects research. Laura Beth Nielsen is, I think, suggesting the risks are too great for this sort of thing to continue: the university’s federal funding could be lost. But what would happen if the responsible authority tried to cut off federal funding to a university over something like this, elite interviews that don’t seriously put anyone at risk? Wouldn’t the present system be exposed as absurd? Would IRBs want to expose themselves in this way -- and risk having some of their power taken away?

Laura Beth Nielsen

I didn't mean law professors wouldn't shout (I'm way too smart to make that claim!) and perhaps even louder.

You are right about university counsel and the type of mistakes they are likely to make. Indeed, the kind of mistakes they do make as I have seen in my own experience.

But still, am I crazy to think that university lawyers would see the value of academic research by lawyers (they are, after all, working as lawyers for a university)? Maybe. But I sure hope not.

Ron Wright

Two quick responses to the comments from William, Laura Beth, and Jeremy.
First, the main thrust of my post (I hoped) was to predict what will happen when legal scholars start to tangle with a cumbersome IRB process. On this descriptive level, the fact that IRB members mean well, or that the process generally allows research to go forward after churning up a stack of papers, will not stop legal academics from protesting this process more loudly than most researchers.
Second, about the "lawyers on most every IRB at any majory university": in every place I know about, a lawyer on the IRB comes from the university counsel's office, and is not an active legal scholar from the law school. University counsel, in my opinion, is more likely to recognize Type 1 errors than Type 2 errors by the IRB.

Laura Beth Nielsen

The stakes for the universities are too high for IRB's to "hope legal academics remain in a gray area." Losing all federal funding -- which is the potential downside of someone at a university conducting research that is not IRB-approved -- would devastate most universities. Think about all the federal funding in pouring into the hard sciences including medicine and what would happen to your institution if that funding ceased.

I think everyone who is going to conduct research on people should seek IRB approval as a check that they are not going to harm anyone (we can make mistakes in our assessments of such matters) as an issue of morality, but if that won't work, how about obligation to one's institution?

Also, Bill and Jeremy are right -- yes it is a lot of work, but you eventually get approved and along with that comes the university's protection should someone sue you over the consequences of the research (this can vary somewhat, but in general, you are getting a sort of indemnification that may be useful to you at some point).

Also, there are lawyers on most every IRB at any major university. After all, IRB is an issue of complying with federal regulations, so there typically will be someone on the panel familiar with legal scholarship who would be able to speak on behalf of our work.

It's not so bad -- just a condition of doing the work in my opinion.

William Henderson

I appreciate Ron's initial comments on lawyers and IRBs--from a distant, IRB look like they have the potential to overreach. But I generally agree with Jeremy. IRB approval should not be basis for lawyer rebellion.

I have worked through the IRB process at three different institutions. Although I was unhappy with the amount of work a good IRB protocol entailed, the process did force me to articulate solid parameters for protecting the privacy of the research subjects. Absence the IRB rules, my subjects would probably be worse off.

Finally, most of the people reading IRB applications are university professors who don't want to stifle research. The learning curve for IRB's is fairly steep, but my overall experiences have been positive.

Jeremy A. Blumenthal

A number of thoughts on the IRB issue:

First, I’m less cynical about IRB’s than others seem to be. That may be because I’ve not had work “rejected” by an IRB (even questionnaires asking subjects about past criminal activities), and almost all research I’ve done falls into exempt or expedited - i.e., relatively or entirely innocuous - categories. And I think that is the case for much of the empirical research that might be conducted by legal academics - mock jury experiments; interviews; archival research; models of judge or jury behavior; negotiation; etc.

Second, I will set aside the First Amendment issue of whether the regulatory regime is constitutional. And I will give IRB’s as an institution the benefit of the doubt as to political motives. With those caveats, the issue seems to rest on whether the empirical research we conduct _might_ have the potential to cause psychological, emotional, physical, or legal harm to a research subject, which seems a perfectly reasonable concern. Perhaps it does not, in which case there is no reason an IRB should not approve it, and the harm to the researcher is mostly time and effort in paperwork and waiting for approval. Perhaps it may - in which case I think it makes sense for a researcher to acknowledge the possibility and articulate why the benefits of the research outweigh that risk.

Third, I certainly understand the possibility of finding new data as a study proceeds, or coming across unexpected information that can be incorporated into a developing study. But (a) I imagine we can reasonably foresee some such events; (b) if not, there’s the potential to inform the IRB of a change/amendment in the protocol; (c) (cynicism creeping in) a well-crafted or broadly-enough worded initial IRB proposal should be able to cover such circumstances.

Finally, we’ve been focusing on the IRB’s and their rights and responsibilities. But as empirical legal research develops - finally! hooray! - we also should consider researchers’ ethical obligations in designing studies, conducting research, coding and analyzing data, storing data, making them available for replication purposes (see Michael Heise’s 3/22 post), and presenting data. For instance, as a psychologist also I have ethical obligations relating to all those issues, under the American Psychological Association’s Ethical Guidelines. I don’t know what analogous guidelines might be in political science or other fields. But what of law professors conducting empirical research (i.e., if I only had the J.D.)? Do we as university professors, for instance, have such FORMAL ethical obligations or guidelines as regards empirical research? As law professors? Simply as people studying other people? I don’t know whence they would arise.

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