Re: [xmca] NYTimes article on ethics panels controlling research

From: Rachel Cody (rcody@weber.ucsd.edu)
Date: Wed Feb 28 2007 - 21:54:48 PST


I was fortunate at USC to work with a good IRB. We did the standard
consent forms, protocols, sample interview questions, etc. After a
couple of years of submitting amendments, resubmitting for approval, and
going through revisions... I learned quite a bit about the IRB process.
Their standard protocol and requirements did not fit in very well with
anthropological research, mainly created for psychological or medical
research. It led to a lot of emails/calls to the IRB, and that actually
proved to be the most helpful. Through talking with the IRB coordinator,
I discovered I could simplify forms, did not have to use their templates
(so long as I included the necessary info), do information sheets rather
than signed consent forms for online surveys, could leave some things
more general rather than trying to figure out the specifics of every
single aspect, etc. I did realize we had been overcomplicating some
aspects of the process early on, in our attempts to follow their
standardized templates.

We did have to do a lot of the things specified in the NYT articles, but
I didn't find it to be too much of an inconvenience to include a few
sentences of "data will be stored in a locked filing cabinet in this
such and such office" and detailing how we would keep names confidential
through transcriptions.

So I think I had a minority experience with IRB. Most of our research
was minimal risk (and got through expedited review), but it did involve
children and adults. Based on the horror stories I had been told as an
undergrad about psychology IRB processes, it wasn't nearly as bad as I
had anticipated. I'm sort of dreading working with another IRB board now :(

Jennifer DeWitt wrote:
> I was a grad student in psychology at UCLA in the early 1990s, and
> part of the reason I left before completing the dissertation was
> because of the IRB process. In my research, I planned to have children
> (ages 4-6 or so -- it's been a while, so I forget exactly) choose
> between several explanations for biological processes (such as how
> blue-eyed parents might have blue -- or brown -- eyed children.)
> Because some of the explanations from which children could choose
> would have been incorrect from a scientific viewpoint ('little bits of
> blue stuff go from the mommy to the baby'), a fellow student swore
> that he would raise a stink with the IRB board -- 'by presenting a
> statement that isn't scientifically correct to a child -- by simply
> saying the words, even if it's one among several choices, you could
> confuse them forever, cause them to fail exams in the future, and do
> incredible damage to both their understanding of biology and to their
> standardized test scores'. It did seem a bit much, given that kids are
> constantly exposed to things that aren't entirely correct from a
> scientific viewpoint. But it was a big reason why I left -- because
> there was no way I could do the research I wanted to do without
> 'exposing' children to information that wasn't entirely accurate.
> (Mind you, as it was a choice among several explanations, I was not
> trying to convince them that something incorrect was correct. And
> standardized tests often have choices that are not correct -- that's
> kind of the point. But that was insufficient for the review board, or
> so I was told.)
>
> I firmly belive protecting children -- and their families, teachers,
> etc -- is critical. But it does seem to have gone a bit overboard. But
> perhaps I'm just not sensitive enough to their concerns.
>
>
>> I find the article extremely interesting, and as a graduate student
>> completing my dissertation, I would love to hear (read) the reactions
>> of seasoned researchers to it.
>>
>> I, personally, have gone through a fair amount of agonizing about
>> organizing my studies in such a way as not to violate any IRB
>> regulations, but I also found the non-medical/biological IRB at UCLA
>> to be very understanding of anthropological and sociological research
>> approaches to research.
>>
>> Olga
>> -----Original Message-----
>> From: xmca-bounces@weber.ucsd.edu on behalf of sgabosch@comcast.net
>> Sent: Wed 2/28/2007 7:43 AM
>> To: eXtended Mind, Culture, Activity
>> Subject: [xmca] NYTimes article on ethics panels controlling research
>>
>>
>> New York Times
>> February 28, 2007
>> As Ethics Panels Expand Grip, No Field Is Off Limits
>> By PATRICIA COHEN
>> Ever since the gross mistreatment of poor black men in the Tuskegee
>> Syphilis Study came to light three decades ago, the federal
>> government has required ethics panels to protect people from being
>> used as human lab rats in biomedical studies. Yet now, faculty and
>> graduate students across the country increasingly complain that these
>> panels have spun out of control, curtailing academic freedom and
>> interfering with research in history, English and other subjects that
>> poses virtually no danger to anyone.
>> The panels, known as Institutional Review Boards, are required at all
>> institutions that receive research money from any one of 17 federal
>> agencies and are charged with signing off in advance on almost all
>> studies that involve a living person, whether a former president of
>> the United States or your own grandmother. This results, critics say,
>> in unnecessary and sometimes absurd demands.
>> Among the incidents cited in recent report by the American
>> Association of University Professors are a review board asking a
>> linguist studying a preliterate tribe to "have the subjects read and
>> sign a consent form," and a board forbidding a white student studying
>> ethnicity to interview African-American Ph.D. students "because it
>> might be traumatic for them."
>> "It drives historians crazy," said Joshua Freeman, the director of
>> the City University's graduate history program. "It's a medical
>> model, it's inappropriate and ignorant." One student currently
>> waiting for a board to approve his study of a strike in the 1970s,
>> Mr. Freeman said, had to submit a list of questions he was going to
>> ask workers and union officials, file signed consent forms, describe
>> the locked location where he would keep all his notes, take a test to
>> certify he understood the standards.
>> Review boards, first created in 1974, were initially restricted to
>> biomedical research. In 1981 the regulations were revised to cover
>> all research that involves "human subjects" and is designed to
>> contribute to "generalizable knowledge."
>> Yet precisely how to interpret these rules has largely been left to
>> each review board - 5,564 in all. And while the regulations apply
>> specifically to research that gets federal dollars, many colleges use
>> Institutional Review Boards to monitor all research, no matter where
>> the funds come from. This system of helter-skelter enforcement,
>> critics say, has no meaningful oversight and no appeal process.
>> Debbie S. Dougherty and Michael W. Kramer, two former members of a
>> review board at the University of Missouri, Columbia, who wanted to
>> study review boards, had to first get their own board's O.K. Although
>> they thought their project was exempt from board approval, the only
>> entity authorized to make that decision is the board itself, and the
>> only appeal if the researchers had rejected the ruling is also the
>> board.
>> Bernard A. Schwetz, director of the federal Office for Human Research
>> Protections, which administers the regulations, acknowledges that the
>> guidelines covering the boards' actions have not been clear enough
>> and says he intends to make public new proposed guidelines before the
>> end of the year. Still, he said the priority is to protect human
>> subjects and dismissed the notion that most nonmedical research
>> carries few dangers. "Obviously the balance is very subtle," he said.
>> "I think it's na´ve to say there isn't any risk."
>> But to many faculty and graduate students, review boards are like a
>> blister that gets worse with every step. Those outside of the hard
>> sciences say the legitimate concerns over ethics and safety are
>> largely irrelevant to most of their research.
>> According to a stack of reports, symposiums and studies by academic
>> associations and scholars, the system's "mission creep" is having a
>> pernicious and widespread effect on humanities and social science
>> research. Legal scholars also argue the boards violate the First
>> Amendment.
>> The growing number of complaints in recent years apparently stems
>> from an overall crackdown after a series of medical-research blunders
>> beginning with the death of an 18-year-old in a gene-therapy trial at
>> the University of Pennsylvania in 1999.
>> A board is required to have a minimum of five members, including one
>> nonscientist and one person unaffiliated with the institution, said
>> Pat El-Hinnawy, spokeswoman for the Office for Human Research
>> Protections. Larger universities often have several boards. Members
>> are generally appointed for limited terms.
>> When Robert L. Johnson, the review board administrator for
>> Appalachian State University, talks to students, he said he starts
>> off by asking, "If you were going to participate in a study, what are
>> the things you would like to know?"
>> The usual responses, he said, are: What are you doing? Will you use
>> my name? Who's responsible if I get hurt? What's in it for me? Making
>> sure those questions get answered, said Mr. Johnson, "that's the
>> purpose of the I.R.B."
>> Mr. Johnson said his board met monthly and reviewed approximately 200
>> projects a year; most are routine, require what he called minor
>> changes and get approved within two weeks. About 30 to 40 require
>> full board review, which takes at least six weeks.
>> Timothy Wilson, a social psychologist at the University of Virginia,
>> now in his second term as a member of Virginia's nonmedical review
>> board, said that "I.R.B.'s naturally become cautious," but that given
>> the constraints, "I think our board works extremely well."
>> In the past year, discussions about what some call the "I.R.B. wars"
>> have sprung up in specialty publications like The Chronicle of Higher
>> Education, conferences, scholarly journals and blogs. Although
>> research proposals are rarely rejected, scholars argue that the
>> requested changes in the wording of questions and consent forms can
>> alter the nature of the study and scare off participants.
>> Bernadette McCauley, a historian at Hunter College, said she ran into
>> trouble a couple of years ago when she tried to help students working
>> with the Museum of the City of New York on an exhibition about
>> Washington Heights. She asked if a few nuns who had grown up in that
>> neighborhood and whom she knew from her research would talk to the
>> students. And that, Ms. McCauley said, was "when things went haywire."
>> The review board discovered the request and lambasted Ms. McCauley
>> for failing to consult with it, she said. The board also demanded
>> proof that previous research for a completed book did not use any
>> archival material involving living people and banned her from doing
>> any research.
>> Michael Arena, the director of communications at City University,
>> said in an e-mail message that Ms. McCauley initially refused to send
>> in a "brief description" of her research so that board members could
>> determine whether federal regulations covered her work. Ms. McCauley
>> hired a lawyer and after six months of negotiations, the board agreed
>> that her research was exempt.
>> Ms. Dougherty, an associate professor of communications at Missouri,
>> said review boards were needed because "historically, social science
>> has done things abhorrent to human subjects." Unfortunately the
>> current process "obliterates a lot of research," she said, because
>> untenured faculty and graduate students on a timetable cannot afford
>> to spend months waiting for approval. So, for example, "instead of
>> talking to people who are victims of violence, you might look at
>> newspaper articles," she said, echoing a common complaint that the
>> requirements cause academics to steer clear of controversial topics.
>> Research decisions "should be guided by science," she said, "not
>> whether or not it's going to get through the board."
>> Ms. Dougherty said she was willing to speak openly, unlike many
>> graduate students and faculty, because she had tenure.
>> Professors also say that some board directives, like destroying
>> interview recordings and notes after publication to ensure
>> confidentiality, violate accepted scholarly practices. "There
>> probably will be litigation," predicted Philip Hamburger, a professor
>> at Columbia Law School who argues that prior approval violates the
>> First Amendment. "There are potentially hundreds of thousands of
>> plaintiffs."
>> Mr. Schwetz said there was no chance that some subjects like oral
>> history and journalism would be altogether excluded from review, as
>> some academic organizations have urged. "If we were just to say,
>> 'Assume you don't have to take them before an I.R.B.,' I think we
>> would regret that," he said. But he said the new guidelines "will
>> give a lot of examples and will give more guidance on how to make the
>> decision on what is research and what is not."
>> Some critics fault the universities, placing blame either with
>> overzealous panels or with university administrations that have not
>> done enough to differentiate between research that receives federal
>> money and research that does not.
>> Mr. Freeman of City University said that within the humanities "most
>> faculty members don't know these rules exist." He added, "If they in
>> fact followed these rules, the whole I.R.B. system would grind to a
>> halt."
>> <end>
>> _______________________________________________
>> xmca mailing list
>> xmca@weber.ucsd.edu
>> http://dss.ucsd.edu/mailman/listinfo/xmca
>>
>> _______________________________________________
>> xmca mailing list
>> xmca@weber.ucsd.edu
>> http://dss.ucsd.edu/mailman/listinfo/xmca
>
> _______________________________________________
> xmca mailing list
> xmca@weber.ucsd.edu
> http://dss.ucsd.edu/mailman/listinfo/xmca

_______________________________________________
xmca mailing list
xmca@weber.ucsd.edu
http://dss.ucsd.edu/mailman/listinfo/xmca



This archive was generated by hypermail 2b29 : Thu Mar 01 2007 - 10:36:51 PST