Is human subjects review sometimes contrary to academic freedom?

BlogHer Original Post

Ah, the life of a humanities professor. . . reading great stuff, teaching engaged students, writing books, eating bon-bons. . .and submitting research proposals to the institutional review board (IRB).

Wait. . . What was that last bit?

An institutional review board

...is a group that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the alleged aim to protect the rights and welfare of the subjects. In the United States, Food and Drug Administration (FDA) and HHS regulations have empowered IRBs to approve, require modifications in (to secure approval), or disapprove research. An IRB performs critical oversight functions for research conducted on human subjects that are scientific, ethical, and regulatory.

So say you're going to do a study of a new drug--you send a proposal to the IRB. If you're going to undertake an ethnography with a sensitive population, you submit your research proposal. And if you're going to pick up the phone to ask adults about their jobs as part of your research, you--you guessed it--submit to the IRB.

Wait a minute. . . Are those kinds of research all really subject to institutional review? I mean, sticking people with needles and asking them to ingest experimental substances is one thing, but interviewing people for a book on regional history is quite another. Why do both fall under the IRB (AKA "human subjects review")?

That's something that many humanities scholars are wondering. If I wanted to tape record someone talking about her life, then make an exact transcript and store it in an archive, do I need to pass human subjects review? Institutional review boards frequently say yes, I do. But the American Historical Association and other parties in the humanities and social sciences are calling for certain exceptions to IRB review.

Profgrrrrl wrote a post a year ago on the IRB, in which she elaborated her few dissatisfactions with the review:

I have my fair share of complaints about the process, the biggies being:

* It can cause timing problems -- sometimes research opportunities present themselves and you know they are minimal/no risk things, but you still have to go through IRB. Even just to do an oral history or conduct an interview.
* The IRB doesn't always fully understand how to deal with social science research or non-experimental design research.
* The need to change wording on items sometimes arises -- changes that pose no risk whatsoever -- and technically those instances require that you file an amendment before making the changes. Time, again, time.

But, she continues, the IRB does have its place, even in the social sciences:

However, there are many good things about the process. Obviously protecting participants and not putting them at risk is the biggie, the raison d'etre for the IRB, but there are other reasons why I think it is important for us as researchers to engage in this process. For one, it makes us *plan* in advance. I have to submit an interview protocol, samples of my surveys, etc. for approval. I have to know how I will contact my participants and what I will say to them. I can't do it off-the-cuff. Having a blueprint to follow is important to my research, even in the most naturalistic of studies, and so I consider the IRB process is merely an articulation of that blueprint, an excuse to plan. Also, it makes us consider the true purpose of the research. There can be a temptation to collect data at any instance possible because, well, you can. I've seen people try do do this ("I'll figure out what I'm doing with it later ..."). Requiring IRB approval slows down kneejerk data collection reactions and probably cuts down on frivolous data collection. I think this is a good thing. If someone really wants that data, they can apply to the IRB for approval. And if not, then they won't bother to do it. Finally, and very importantly, it makes us consider what impact our work will have on our participants -- even if the impact is so minor as taking up 5 min of their time, cutting into something else they might have been doing, making them feel as if they are under the microscope, or making them see the world in a different way as a result of the questions they ask.

Check out the comments of her post for some good discussion.

A couple of weeks ago, the American Historical Association asked that oral history projects be exempt from institutional review. This makes sense to me, as if you're just the medium for another person's message--just reporting what they say--that doesn't seem to me to be terribly invasive, as long as the person knows what's happening to the recording you're making. (Zachary Schrag has a very interesting and informative post on the history of exclusions of oral history projects from IRB review, and Linda Shopes has prepared a bibliography on historians and the IRB.)

That said, by asking for an exclusion for oral history, the AHA may in some ways be damaging the professional reputation of oral historians. Is the AHA asking for IRBs to no longer classify oral history as research, for example? Does that means historians who undertake oral history are not really researchers? What if I find an unpublished transcript of an oral history recording in an archive, and I quote it in my research, but I analyze, interpret, and reflect upon what the recorded person said. Does my research need IRB review? Maybe, maybe not. But when I was writing my dissertation, I did interview women scientists about their jobs--mostly via e-mail, once by phone--and for those 5-6 interviews, I needed to fill out a lot of IRB forms and wait a month for a group of medical doctors and research scientists to approve my research plan. Honestly, I felt a little bit as if my academic freedom could be in jeopardy. The IRB technically has the power to tell me I can't undertake my project. What if (putting on my conspiracy theory hat here) the scientists on the review committee didn't want to see research undertaken or published on the poor treatment of women in their disciplines? They could, in theory, fail to approve my project.

Roberta S. Gold seems to agree with me to some extent in her post "None of Anybody's Goddamned Business?"

Looking back at much of my research, I find the notion of a review board's responsibility to protect vulnerable subjects from my probing questions almost laughable. The subjects were veteran grassroots activists, many with decades of experience talking to the press. I was a rookie with a new tape recorder from Radio Shack. I was putty in their hands. When I posed questions they didn't like, they smiled and steered onto a different topic so deftly that I didn't realize what had happened until twenty minutes later. Or they told me why I was asking the wrong question. I recall a civil rights historian's remark that one does not so much interview SNCC veterans as get schooled by them; something like that could be said of talking to seasoned housing activists, too.

[....]

Through all these sessions, I felt the tug of two ethical impulses. One was not to cause pain. I suppose that impulse, actually, had both ethical and self-serving dimensions. On the ethical side, I genuinely liked and admired these women. I appreciated their generosity (several had me into their homes and treated me with something of a grandmotherly air); who but a schmuck would pay them back by opening old wounds? On the self-serving side, I also didn't want to alienate them and thus make them unwilling to talk further.

The second impulse was a sense of responsibility to the historical record, and to the way future generations would understand the past.

Through her research, however, Gold began to understand that IRBs may have their place in the gathering of oral histories:

But that just raises the question how we define and measure harm? And risk?
When I'd filled out my school's human subjects waiver form, I had checked the "minimal psychological risk" line in good faith (the human subjects worker who walked me through the form offered the example of questions about a subject's sexual history and health to illustrate psychologically risky ones, and I was pretty sure I would not be asking tenant organizers if they'd ever had gonorrhea). I did not understand until I actually got into the project, and the interviews themselves, how emotionally difficult topics might come up even in a study of people's activity in the public sphere. This was no doubt in part because I was a rookie at oral and CP history. But it also reflected a certain unforseeability that is inherent in open-ended human conversation. Oral history is a venture into uncharted territory, not a controlled laboratory experiment.

She raises a good question: If even the historian conducting the project may have difficulty foreseeing the emotional turmoil summoned by discussions of a particular historical event or practice, then can we count on IRB members--usually stacked with medical doctors and scientists--to intuit and flag these potential problems? Read Gold's entire post to get a sense of her deep reflection on human subjects review and oral history practice.

I understand why IRBs are in place. Tuskegee syphilis study, anyone? But there aren't bright lines between what's right and what's not, especially considering cultural differences and disagreements over what constitutes "harm" or "benefit" to a research subject. For more on this subject, see Janet Stemwedel's piping-hot post on research on the psychology of abandoned children in Romania. An excerpt:

Nelson et al. are saying that their research passes ethical muster because it conforms to Romanian ethical norms and to the ethical norms recognized by IRBs at American universities; because it seeks to answer an important scientific question that was not yet answered and whose answer is expected to produce real societal benefits, especially for the population of whom the research subjects are a part; because it exposes the research subjects to no significant additional harm relative to what their situation would be if they were not participants in the study; and because the involvement of the Romanian child protection authorities in monitoring the research and moving kids out of it if considerations of their welfare warrant it gives the kids something like an advocate without a bias in favor of continuing the research.

And I understand on some level why all research involving living people needs to undergo human subjects review: It's hard to draw lines between research that poses high, low, or no risk to the subject. And where do we draw the line between journalism and research? Why are institutionally affiliated academics required to undergo review, but not authors, marketers, and anyone else conducting research outside the confines of a university?

What are your thoughts? When a scholar interviews someone, should she be required to submit her proposal in advance for approval by an IRB? Can we create any hard-and-fast rules for exemption from human subjects review, or should all academics be required to present their work for IRB approval?

When she's not undertaking high-risk, medically invasive studies on sensitive populations, Leslie Madsen-Brooks helps university faculty improve their teaching. She blogs at The Clutter Museum, Museum Blogging, and The Multicultural Toy Box.

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