Friday, September 29
I do social-science-y type research, for which I need to file a human subjects protocol with my Institutional Review Board before I'm allowed to go ahead with my research. My project should be "exempt" from review given pertinent federal regulations, but at my institution you have to file an exempt protocol and let them review your application before they agree that you are, in fact exempt.*

Even though my research has nothing to do with health or experiments and mostly involves asking professional people questions about things that happen as a normal result of their work, I have to file a RIDICULOUSLY long and complicated protocol form. The protocol is submitted through a web application, which won't let you move forward or submit your protocol until you have answered every single question.

So, pretend my research was about interviewing members of congress about their past votes.** In filing my exempt protocol, I would have to answer questions about***:

-what I plan to do in case one of my research "subjects" needs medical, psychiatric, or other professional treatment as a result of the research

-whether there are other treatments that would be better for the "subject" than the one I am giving

-what I'm going to do with x-rays and lab specimens after I'm done with them

-why I'm excluding minors from my study

and, my favorite,
-whether my institution could make any money off a patent from this research.

The whole protocol form for "exempt" projects is over 10 pages in length of these irrelevant questions.

Now, don't get me wrong, I'm all for review boards in general and I think that protecting human subjects is a really important and vital thing in research communities. It's just that the actual risks to the "subjects" of my research are not addressed at all by these questions, and that the IRB makes people who do social science jump through all the same questions as the drug-testing people, and doesn't let us skip any questions. I would really like to see a protocol review that gets at more pertinent questions, like:

-Are there at least 3 other people, besides yourself, who are likely to care about the outcome of your research?

-How are you going to ensure that your research does not turn into a massive waste of government and/or funder money?

-Please explain what protections you have in place to prevent the oppression of graduate research assistants.

Oh wait. I would probably have to answer "no" to the first question, and except for the fact that the sums involved are miniscule, would have no answer for the second. So maybe I don't want those questions on there after all. Bring on the disposal of biohazard material questions instead!


* This leads to very silly who's-on-first conversations that go:
A: did you file your protocol with the IRB?
B: no, we're exempt
A: but you have to file an exempt protocol before you can be exempt and start your research
B: but if we're exempt, doesn't it mean we don't have to file a protocol?
A: no, you're exempt, so you file a protocol and wait until you get Exempt Approval
B: if they call it "approval", in what sense is it exempt from review?
A: Well, you're not exempt until they say you are exempt.

** All research fields and disciplines have been made up to protect the privacy of the a.secret society.

***The actual wording of these questions is hilarious, but unfortunately I don't want to reveal what institution I'm at, so I'm paraphrasing.


strawberries said...

is it bad that i usually don't give out the information sheet but explain it instead?

even though i say that i give it out? when you work with the ppl i work with, the last thing they want to see is an official looking paper. b/c then there is no reason to trust you...

by the way, this is all hypotheical and not really true, and please don't tell on me.

Orange Ina said...

I think we could start a whole separate blog about IRB issues. I'm thinking that you're not at my institution if your exempt forms only add up to about 10 pages. OUCH. Yeah, that's my plight. I think ours is more around 15-20. On the one hand, I can see how they would want to check about exemption to some extent, but you're absolutely right to ridicule the issues associated with exemption being linked to an elaborate process of approval.

One point about your proposed alternate questions. While I can see how they can be seen as funny, if you want to hear the absolutely ridiculous IRB twist on them, here ya go. An IRB that considers itself qualified to determine the scientific value of whatever project to which they have no professional ties and so can actually deny you the right to run a project because they happen to think that it's not worth subjects' time. This hasn't happened to me, but the mere idea that I have to justify in fifty thousand ways why my project matters to people who don't have PhDs in my field really annoys me.

fraud, in denim said...

I have had my share of similar IRB frustrations. In fact, the best project I ever formulated (in my humble opinion) died on an IRB conference table. Luckily, that was my old insitution and my new one seems a bit more laid back.

There's evidence, though, that I suffer PTSD from those previous experiences: the other day, when I learned that I had cleared my most recent IRB hurdle, I was happier than learning a recent manuscript was accepted for publication. That's really, really sad.

Turquoise Stuff said...

Fraud, your comment sums up very well the MAJOR problems with IRB. I mean, c'mon, this is nuts! (And I can't believe they killed your project.)

thistle said...

strawberries: It's no worse than throwing away audio tapes after you promised the IRB you'd keep them in a locked drawer for 3 years under the protection of a rabid rottweiler and then erase them and bury the erased tapes under a land-fill (hypothetically).

orange ina: A scholar in my field wrote a book chapter where she said that her IRB told her what and how she could teach her qualitative methods class. I totally agree that IRBs should not be in charge of determining what is important/ worth it research and what isn't.

fraud: OMG, we totally need an IRB PTSD support group.

Turquoise Stuff said...

you promised the IRB you'd keep them in a locked drawer for 3 years under the protection of a rabid rottweiler and then erase them and bury the erased tapes under a land-fill

This made me laugh out loud, thanks! (You know, in that this-is-too-real sad sort of way.)