Yes, this system is a mess.
mike
On 2/28/07, sgabosch@comcast.net <sgabosch@comcast.net> wrote:
>
>
> 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 naïve 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
This archive was generated by hypermail 2b29 : Thu Mar 01 2007 - 10:36:51 PST