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Is human subjects review sometimes contrary to academic freedom?

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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

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joanegood 5 pts

I have a small educational service and we frequently would like to do some user testing on different approaches to education. I wanted a professor to get feedback from using a new course that we were developing by trying it with some real students . Unfortunately, he explained that due to the IRB requirements, it made alot more sense for me to have my own test group and for him to learn about the results second hand.

http://www.Time4Learning.com

Kim Pearson 5 pts

In our case, the IRB process, while tedious, is helpful because it is forcing us to be very clear about goals, methods and assessment processes. Our project involves children, so there is a necessarily a higher level of caution. But implementing IRB guidelines consistently is a challenge. My journalism students are exempt from IRB reviews, for example. Does that make sense when oral history researchers have to get approval? Well, from a practical standpoint it does, but that makes it even more critical that journalism professors and advisors stress ethics as part of our teaching and mentoring.
Kim
BlogHer Contributing Editor ( http://www.blogher.com/blog/kim-pearson )|Professor Kim ( http://professorkim.blogspot.com )|

holly_jahangiri 5 pts

Just this morning, driving in on the way to work. No, I wasn't.

But as an author, reading this, I did wonder (as you brought up towards the end), "Why are institutionally affiliated academics required to undergo review, but not authors, marketers, and anyone else conducting research outside the confines of a university?"

One hopes it lends credibility to your study and ensures that it will not come back to haunt the academic institution or taint it in the eyes of peers and prospective donors and students. (Oh, sure, noble to think it's all about the risks to human subjects, but if that were truly of primary concern, then I think we'd all have to get approval from some government entity before we could talk to our neighbors over the fence.) And journalists certainly operate without much concern for their human subjects. I once took part in a study and was surprised at the procedural and contact information I was given concerning any questions or concerns I might have before, during, and after the study was conducted. I think, in addition to the planning it forces (Profgrrrrl's comments), it leads to greater trust and openness from study subjects. It's not just the researcher's reputation on the line; it's the institution's.

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Holly Jahangiri
http://jahangiri.us/blog