Matt Welch | December 28, 2005
Over at the Volokh Conspiracy the other day, Jim Lundgren explained a little-known (to me, anyway) routine practice of government-mandated censorship:
Imagine that I want to write a research article about government abuses of power. I plan to visit a library to look at the public papers of a living person (or a dead person whose papers might embarrass a living person). In most universities, I would be prohibited by federal law--as aggressively interpreted by the federal government--from going to that library without getting PRIOR APPROVAL of a committee set up under federal law, populated with some people outside my university, deciding whether I was allowed to visit the library and read the papers I want to read. If the government had only the desire to check into where I went and what I read after the fact, that would be a serious, though comparatively minor, restriction. No, I am required to get prior approval.
That is the system of Institutional Review Boards (IRBs, formerly called human subject committees) that operates at most major universities. If the government were checking up on me only after I went somewhere or after I read something in a library or after I talked to someone or asked people questions, that would be a big improvement over the current system. The federal government has interpreted its censorship power so broadly that, even for research that is supposed to be exempt from coverage under the federal statute, the federal government has insisted that a researcher get prior approval from an IRB that the work is indeed exempt. [...]
How this massive system of goverment-sponsored censorship got going with little attention from Constitutional scholars (before Philip Hamburger) is a mystery to me. It is time for the courts to declare the IRB system what it is: unconstitutional.
Whole thing, worth reading in full, here.
UPDATE: Be sure to check the comments for testimonials from people who, unlike me, were familiar with the term "IRB" before this morning.
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I knew that IRB's had to OK studies with human subjects. But I thought that only referred to studies where you give them a pill or something. I had no clue that simply going to the library to examine somebody's records counted.
Our university's IRB policy manual states the following under
Definitions:
"Human Subjects Research is a systematic investigation designed to
develop or contribute to general knowledge, which involves the
collection of data from or about living human beings. Activities
which meet this definition constitute "research," whether or not
they are supported or funded under a program that is considered
research for other purposes. For example, some "demonstration" and
"service" programs may include research activities. It does
not include research utilizing published or publicly available
documents or research on elected or appointed public officials or
candidates for public office." (boldface added)
Sorry for the long quote, but I wanted the context. Clearly,
research involving public records does not fall under IRB
purview.
I read the full post over on Volokh. The main case cited is that of
Elizabeth Loftus, which is a particularly egregious example of IRB
power being manipulated. But that doesn't necessarily constitute an
indictment of IRBs in general. I find our own IRB to be overly
bureaucratic, but I can also understand the university's
perspective: without an IRB that passes federal muster, the
institution is ineligible for most (all?) federal grants. IRBs are,
as usual, a good idea made unwieldy through heavy government
regulation and interference.
Education is enemy territory. A pretty good strategy, you'd think that someone planned it.
Wait...what's to stop someone from simply checking out the material in question or readining at the library? Is it kept out of general circulation? Or is it a situation where the person would be censured after the fact?
That should be "reading it at the library". Additional appy-polly-loggies for any other typos found in the above post, or any other, for that matter.
Just want to second what Chuck said. My institution's IRB (a
private school) has pretty much the same guidelines. We do not have
an explicit exemption for public documents the way his does.
However, knowing the work of the committee fairly well, I can tell
you that, at least here, they have NO purview over such work. Our
IRB is only interested in projects that collect data from living
human beings - e.g., anything involving a survey, focus groups, a
study on college student sleep habits, etc.. The kinds of things
Lindgren is talking about, as well as the scholarly article he
links to, certainly seem to be well beyond any reasonable
understanding of what IRBs are supposed to do.
I can already see the development of a dangerous new meme in the
conservative-libertarian blogosphere about IRBs being weapons of
censorship or left-wing bias. Can we put a stop to it right now by
making the same argument we've made about other analogous stories,
namely that they are the exceptions rather than the rules? I sure
hope so, because that's the truth as I see it.
Slightly OT, but Chuck's comment could be a poster for those who
oppose vouchers on the grounds that it will corrupt the private
school market:
" I find our own IRB to be overly bureaucratic, but I can also
understand the university's perspective: without an IRB that passes
federal muster, the institution is ineligible for most (all?)
federal grants."
Once the state starts handing out vouchers, and schools become
dependent on them, all sorts of idiotic requirements will get
grafted onto being eligible to receive them.
Similarly, IRBs are not per se a bad thing (there would probably be
some equivalent in the absence of state interference), but get
warped beyond belief once the government gets its tendrils in
through bribery.
Interesting point on the vouchers, but private schools are already dependent on the State for accreditation. And, worst case you'd have a new third class of schools that are private, but with some State strings. More choice is better.
I'll add my voice to the tally of those well aware of IRBs (though I've never had to interact with them myself--thankfully) and having never heard of them covering anything like what's mentioned in the story.
My institution's IRB (a private school) has pretty much the
same guidelines.
This has also been my experience.
I can already see the development of a dangerous new meme in
the conservative-libertarian blogosphere about IRBs being weapons
of censorship or left-wing bias.
Yes, I can see this beginning to happen too. Let's not get carried
away. The whole IRB thing is to PROTECT THE SUBJECTS and their
privacy. In most cases researchers can access public records.
What happens, in fact, is that when, say, a sociologist wants to
review murder-suicide numbers throughout the 1980s for the entire,
country, he states in writing his purpose in doing so, and what
persons are likely to be included in that survey (murderers and
victims). The IRB looks over the proposal, determines that in fact
this research is not likely to infringe on anyone's rights, and
approves it.
Everyone seems to HATE dealing with the IRB, feeling they have
too much power.
Now with medical studies, of course, the process is MUCH more
stringent. And I bet everyone here would be extremely upset if it
weren't. So of COURSE researchers hate dealing with the IRB.
They're a pain in the ass! It takes months to get things phrased
just so and get approval, first from your department, then your
university and then from the state IRB. This is still very
preferable to having subjects' medical records misused!
Additionally, you all may not know that it's the IRB that approves the consent forms that subjects sign. I used to be the IRB enforcer for some human subject studies, and believe me, many subjects are NOT looking out for their rights so it's a damn good thing someone does.
I sit on an IRB at a large university and have dealt with dozens
more. There are classes of research that involve human subjects
tangentially- for instance reviewing peoples' medical records
without contacting them- and directly- for instance interviewing
public officials- that are exempt from IRB review. Paradoxically,
my IRB (and I assume most) require certification that a study is
exempt. There is no requirement to review studies that rely solely
on published literature.
That said, IRBs come in many different temperments and a study that
passes unscathed by one can be nixed by another. That doesn't speak
to well about their protection function. Nevertheless, having seen
what some researchers try to get approved, IRBs of some form or
another are necessary. My take is that the top-down federal nature
of the boards creates a lot of inefficiencies. However, even if
IRBs were not a federal mandate they would continue to exist and to
adhere largely to the same set of principles.
Corsair09--
At my institution, there is an expedited review process so that
frequently projects like surveys, that involve "minimal risk" to
the subjects, can be reviewed and approved by the IRB chair. In
such cases, the chair only sends it to the full committee if (s)he
has concerns about the proposal, so your wife probably never sees
95% of those. The part of this that most faculty find annoying is
that even anonymous surveys that do not produce any personally
identifiable data have to go through the approval process. It's
almost always a rubber stamp, but it is just one more bit of sand
in the gears. On the other hand, I suppose it's a good thing that
*somebody* is trying to err on the side of protecting private
information.
If those doctors think the IRBs are a nuisance, they should be
thankful they don't have to get proposals through the animal care
and use committee.
One more general comment: as I hinted at above, an institution's
IRB procedures can give a lot of individual power to the chair.
Like other positions of power, this authority can be abused by the
person wielding it. My own take on the Loftus situation, from not
only on the Lindgren article but also from the earlier Skeptical
Inquirer article it seems to be based on, is that this is a case of
an IRB chair using his authority for some sort of hidden agenda.
Loftus's work has been very controversial, and she has made some
enemies in the psychology field.
Another thread (Hoax Watch) lauds the blogsosphere for its quick
examination of items for plausibility/factuality. It looks like
that's what's happening here.
At my alma mater it was called the ERB - Ethics Review Board - and
it provided a variety of jumpable but nonetheless required hoops
for research approvals and changes. Annoying, but to my eye
appropriate.
My institution also exempts the study of exisiting documents.
Only research involving human subjects is under their jurisdiction.
Alas, this does not mean I didn't curse IRB more than once during
my diss.
Exemptions:
4 6.101(b)(4) Research involving the collection or study of
existing data, documents, records, pathological specimens, or
diagnostic specimens, if these sources are publicly available or if
the information is recorded by the investigator in such a manner
that participants cannot be identified, directly or through
identifiers linked to the participants.
This looks like where privacy rights and free access to public information begin to show how they conflict. Anyway good luck with all that.
I'm involved in medical research, so I've had indirect exposure
to my institution's IRB. From what I understand, if you're doing
medical research in the US on human subjects, you have to have an
IRB, and the IRB often has to sign off on any changes to your
protocol. This can be a real hassle for smaller institutions that
don't have their own IRBs (and either share one, or pay a
commercial firm to act as their IRB).
If I remember correctly, IRBs were mandated as a reaction to some
really nasty research done in the '60s and '70s. I took a class on
human experimentation, and some of the researchers back then were
doing some pretty frightening stuff.
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