Adventures in Ethics and Science

I haven’t mentioned it here before, but I’m currently working on a project to launch an online dialogue at my university (using a weblog, of course) to engage different members of the campus community with the question of what they think the college experience here ought to be, and how we can make that happen. The project team has a bunch of great people on it, and we thought we had anticipated all the “stake holders” at the university from whom we ought to seek “buy-in”.

As we were poised to execute the project, we discovered that we had forgotten one:

The Institutional Review Board.

Yes indeedy, the IRB. See, because we’ll be inviting students, as well as faculty, staff, and administrators, to participate by contributing blog posts and commenting on blog posts, we need to go through the whole rigamarole of getting the dialogue approved as “research with human subjects”. I do not know that we would be expected to do this if we were just inviting interested parties to show up and participate in a two-hour discussion in a room somewhere on campus. (Frankly, having committed the question to words, I fear that I may receive an affirmative answer.)

Well, if this is what must be done, we’ll do it. I already have my piece of paper on file indicating I passed the online human subjects training quiz (which has much more to do with biomedical research than social science research, let alone … having a dialogue). I know how to complete the paperwork for the IRB (having done it before).

But I think I’ll reread this post on “educating” your IRB before I write up our “protocol”. I have to at least try to pull the bureaucratic machinery in the direction of common sense.

Wish me luck!

Comments

#1 Orac
April 27, 2007

I wrote about ridiculous levels of IRB overreach into stuff like this before. I just wish that IRBs would spend more time looking at dubious drug trials and questionable CAM trials and less time making projects like yours so painful that many would decide it’s just not worth the bother to run the gauntlet.
#2 bill
April 27, 2007

Luck? You’ll need industrial-strength magick.
#3 chezjake
April 27, 2007

So, would the university administration also have to get approval from the IRB to survey the faculty, staff and students about the quality of, and possible improvements to the food service? If not, what’s the difference between the two quests for information?
#4 NJ
April 28, 2007

…and you gave up P Chem for this? At least there you didn’t have to file paperwork demonstrating that “no reagents will be harmed by this experiment”.

Seriously though, please keep us posted (OK, no need to live blog your proposal). It sounds like it will be an interesting story.
#5 Laura
April 28, 2007

Oh, I’m still in a runaround with my grad institution’s irb over my dissertation–to review their public blog posts from a class. I went through the whole thing with my current institution’s irb and they approved it. But the grad institution is freaking out–over blog posts–over adults. Gah. It’s also worth reading Tim Burke’s take on this:

http://weblogs.swarthmore.edu/burke/?p=341
#6 Orac
April 28, 2007

So, would the university administration also have to get approval from the IRB to survey the faculty, staff and students about the quality of, and possible improvements to the food service?

Interesting question. The answer these days is probably yes in many situations.
#7 Ereshkigal
April 28, 2007

You should be able to have your project determined to be exempt from IRB process because it is not “research” under the regulations protecting human participants.

45 CFR 46.102(d) Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

What you are proposing is an internal dialogue, not a systematic investigation, and your purpose is not “to develop or contribute to generalizable knowledge” but to improve internal institutional practices.

Furthermore, this proposal should be exempt under 45 CFR 46.101 (b):

(b) Unless otherwise required by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy:

(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Your proposal engages students, not as volunteers vulnerable to heightened risk from participating as subjects of research, but as equal co-partners in a conversation.

Surely a simple phone call or email message to your IRB administrator should clear this up for you.
#8 Alan Kellogg
April 28, 2007

Institutions such as an IRB are an example of a pernicious phenomenon, the belief that life can be controlled absolutely, and thus made absolutely safe.

If only everything was regulated. if only everything could be fitted into a niche. If only everything could be controlled. Why then our lives would be secure and perfect and we would have no worries or unforseen events. At its best it’s a neurosis. At its worst it’s a full blown pathology.

We let the emotionally insecure have their way, and this is what we get; institutions dedicated to regulating everything they can think of, all for our ostensible benefit. When, really, we need to place such people under guardianship in group homes, where their feeble maladjustments can be dealt with appropriately.

You can’t regulate, control, know, organize, or even slot everything with absolute perfection. It simply isn’t possible. It’s time we acknowledged this, accepted it, and took back our lives from the control freaks.
#9 Mike the Mad Biologist
April 29, 2007

Ereshkigal is absolutely right. Take on the IRB board. This is not human subjects research. They shouldn’t be allowed to run everything.
#10 Bill H
April 29, 2007

Somewhere in this great land is a bureaucrat with common sense, this person is hidden in a locked dungeon lest this disease of common sense spreads to other bureaucrats.
#11 Thomas Robey
April 29, 2007

Per Ereshkigal’s comment (rightly citing the 45 CFR 46), whether this goes to an IRB is still an open question. It seems like your proposal is an internal dialogue, but are you thinking at all of publishing the findings? A clarification here would be helpful to further discussion.

I was interested enough in this post to consult a bioethics prof I took a research regulation course from last quarter about this issue. She commented:

“If it’s solely institutional improvement you are seeking, this project isn’t considered research and you shouldn’t be asked to go through IRB (though you might want to apply for an exemption just to give them a head’s up). If you’re planning on collecting, analyzing, generalizing, and publishing the findings outside the institution, then it is research (even if ‘just’ blogging with folks) so needs review.”

Perhaps your IRB is considering students a potentially exploited population…

It is important to realize that institutional review is an increasingly diverse task, with some large universities having 10 or more different boards. Opinions about regulations and recommendations for IRBs in the social sciences are in flux these days, and this issue might be a way to help your social science review board participate in the reform that probably will take place in the near future.

Many times, our individual conceptions of IRBs are informed by the particular type of science we do. Just as organ transplantation and anthropology look different in goal, method and outcome, I think that IRBs interacting with such diverse topics will have to follow different rules.
#12 Orac
April 29, 2007

Ereshkigal is absolutely right. Take on the IRB board. This is not human subjects research. They shouldn’t be allowed to run everything.

Having the facts and logic on your side is no guarantee that you’ll win with the IRB. I’ve found that, these days, IRBs seem able to stretch the definitions of human subject research. It’s a classic case of mission creep in a bureaucracy.
#13 Drugmonkey
May 1, 2007

How fascinating. You seem to take the formal procedures for conducting human research as surprising and burdensome. Yet you’ve opined in other posts that animal research is insufficiently overseen by IACUCs….
#14 Janet D. Stemwedel
May 1, 2007

Drugmonkey, the point is that no one on our team even conceptualized our project as *research*. It’s a dialogue, whose participants will be self-selecting (so clearly, they’ll be able to opt out at any time). We won’t be “studying” them any more than one studies any human being with whom one engages in discussion.

Does the IRB want me to let them oversee all my discussions? (In class? On the phone? In office hours?) Or is there a principled line we can draw between research with human subjects and humans doing the sort of things humans do — of their own accord — as part of their everyday lives?
#15 Drugmonkey
May 2, 2007

ahh, but much like the situation with animal research the whole point is that the individual researcher cannot be trusted to decide what does and does not require oversight. Hence obligatory IRBs and IACUCs. I would hope that you will be able to take your experience with IRBs, see how similar the IACUC process is and re-consider whether or not animal research is sufficiently over-seen.

a relevant anecdote: i volunteered to advise kids at a local school on science fair topics a while back. turns out that everything under my expertise is basically off limits. kids cannot train the family dog to roll over for goodness sakes. they can’t survey actual humans. all as some perverted extension of IRB/IACUC type concerns no doubt. but here’s why. because it is impossible to draw bright lines about what should/should not be approved.and again, the whole point of IRB/IACUCs is that the researchers cannot be trusted to make appropriate decisions. don’t get me wrong. it is stupid and misguided to EVER have to say “no not that project” when a child comes up with his/her own idea. but i understand how this came about.

on to specifics. in all approved human research the subjects “volunteer” and, everything I’ve ever heard of, can “opt out” at any time. so these are not criteria in your favor. as far as “doing the things humans do” well, the difference is that you are engaging in it for research purposes. surely you understand this. if not, why does any human research require IRB approval? “hey, i’m going to lock a bunch of undergrads in isolation closets for a day to see what happens but heck, that’s just what my 5yr old does to his little sister. It’s just ‘what people do’, I don’t need a protocol!” similarly, i don’t have to have an IACUC protocol to train my dog not to piddle on the rug, nor to fetch and roll over. if i use these as laboratory assays i need a protocol. why? say, I had to “euthanize” some rats last month because they were running wild in my garage- do you think I need oversight for that? no? eliminating household vermin is “just what people do”, no? how about the ones I euthanize in the laboratory? is IACUC oversight necessary? why?