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As IRB debate grows, profs push for reform

Though for some time there has been debate among faculty - especially in the social sciences - over procedures governing ethical oversight for research involving human subjects, there has been little institutional movement toward reform. But the volume of debate, both at the University and around the country, is on the rise, and faculty are yet again pushing for change.

At Brown, the Faculty Executive Committee, a governance body comprising 10 professors, will meet with members of the Research Advisory Board and concerned professors later this month to discuss possible reforms of Brown's Institutional Review Board, one of the 5,564 federally mandated ethical review panels that must approve their institutions' human-subject research, including everything from medical studies to sociology questionnaires and oral history interviews.

The FEC has heard from professors in the past, particularly those in the social sciences, who were concerned that the IRB's approval process is too slow to allow undergraduates to submit thesis proposals to complete their work before graduation, said FEC Chair Ruth Colwill, associate professor of psychology. Others, she said, are worried the July 2006 decision to prohibit undergraduates from taking primary ethical responsibility for their research places an unfair liability on faculty, some of whom fear they will wind up responsible for research often conducted far away from their supervision.

"We have to take this seriously, or we really will have an impediment to undergrad research," Colwill said.

In an e-mail to The Herald, RAB Vice Chair Robert Hurt, professor of engineering, wrote that the committee has not undertaken any review yet and that its work is so far isolated to informal discussions, though he expects to be better informed by the spring.

"The topic that I was thinking of talking to some people about was not 'research ethics' per se, but rather how the IRB operates now and if it is working well and efficiently for the faculty and students," he wrote.

This is not the first time a committee has reviewed IRB policy.

In the spring and summer of 2006, a faculty working group of the College Curriculum Council met six times to discuss reforms for research ethics at Brown, but according to minutes from the CCC's Oct. 10, 2006, meeting, that group was dissolved before any recommendations could be issued. The minutes indicate that Dean of the College Katherine Bergeron declined to include any discussion of the IRB on the CCC's agenda.

At that time, some CCC members told Bergeron they were afraid the issue would be forgotten, and she responded that she would continue speaking with officials in the Office of the Vice President for Research to address how to make the IRB's procedures easier to navigate. Both the CCC minutes and an e-mail Bergeron sent to The Herald Monday indicate she met with research administrators several times over the course of the semester to discuss the IRB and that the CCC itself engaged in another discussion in December 2006.

The Herald reported Oct. 4, 2006, that by the time the CCC working group's mandate was withdrawn, faculty were already growing concerned that a new policy keeping undergrads from taking primary ethical responsibility for their work - in a role known as the principal investigator - would burden professors with extra work and unfair liability. Some faculty predicted that the policy change, which brings Brown into line with the other Ivy League colleges, would cause declines in undergrad research and colleagues refusing to advise undergrad projects.

Research on the decrease?

Whether that's happened is unclear. In the 2005-2006 academic year, the IRB approved 135 proposals, of which about 35 came from undergrads, Dorinda Williams, director of the University's Research Protections Office, told The Herald in October 2006. Last year 167 proposals were approved, of which about 26 came from undergrads, according to Senior IRB Manager Susan Toppin. (Though the total number of proposals approved last year is definitive, the number that came from undergrads is only approximate.)

Thus, last year 23.7 percent more research proposals were approved than the previous year, but the number of undergrad proposals approved dropped by an approximate 25.7 percent.

It's not entirely clear what to make of the data because it's only approximate and a trend isn't apparent since the data only represents two years. And the numbers don't necessarily mean students are shying away from independent research altogether - they may just be avoiding work with human subjects. In addition, many faculty and students have suggested that some thesis advisers may urge their pupils to practice a sort of willful negligence by not going to the IRB, which means those students wouldn't be counted in the data.

Williams was unavailable for comment last week, but Bergeron wrote in her e-mail to The Herald that evidence from her office does not suggest waning interest in undergrad research. "We have actually seen an increase in excellent student proposals for UTRA projects, for example, and last year had to turn down many good proposals simply for lack of funds. We are working to increase the budget for this year and next," she wrote.

But Professor of Education Cynthia Garcia Coll said the numbers are "not at all" surprising to her. "That's been my experience with honors theses, independent studies, summer research. Students are doing less research - part of the issue is definitely the IRB," she said.

"I suspect it's a combination of two things," said IRB Chair Ron Seifer, professor of psychiatry and human behavior and director of the Center for the Study of Human Development. "There is a sentiment - something in the ether - that it's harder for students to do research, and they're opting out. Number two, many faculty ... had the idea that there was a fundamental change in policy, which was not intended."

A complex system

Whatever the case, as the RAB undertakes a review of IRB policies at Brown, it will encounter a complex and often vague regulatory scheme that must accommodate a wide array of constituencies, including professors, students, research subjects, administrators and federal regulators. Concerned professors told The Herald that one of the best ways to improve the IRB would be for it to treat research differently depending on the discipline involved.

Associate Professor of Public Policy Ross Cheit, perhaps the most vocal critic of the IRB, told The Herald that ineffective outcomes arise because the panel judges social science research using the same standards applied to natural science research. "All the regulations come out of medicine," he said.

Cheit said that because laboratory faculty are responsible for the conduct of students researching in their lab, it might make sense for professors to take on ethical responsibility. In his case, Cheit said he works with students who conduct research in real-world settings, often far away from College Hill.

Colwill agreed that a better system would treat proposals differently depending on the discipline. "I sent to RAB the IRB policies being developed by the hospitals," she said. "The point I made to RAB is that I don't think we want all our research ethics to be guided by hospitals."

"It's draconian the way it is now," Colwill added. "This is not a good guide for how we want to be dealing with research issues."

Cheit said that the IRB can also be more consistent by releasing data on its activities at regular intervals and issuing written decisions that explain the logic behind its actions. Over time this would allow for a system of precedents to develop, he said, which would give researchers and IRB members more guidance. Under the current system, "the IRB is essentially making its own law," he added.

Garcia Coll said another possibility is to remove entirely from the IRB's jurisdiction undergrad research that isn't going to be published, letting individual departments create "mini-IRBs" for their students. The idea goes back to some professors' complaints that the IRB is overreaching its influence by defining "research" too broadly. The law says research is "a systematic investigation ... designed to develop or contribute to generalizable knowledge."

Concerned professors argue that because honors theses are for a class and a "capstone experience" in their education, they don't contribute to generalizable knowledge. Garcia Coll said if a student doesn't plan to publish his work, it's hard to understand how it falls under the federal definition of research.

Problems with undergrads going through the IRB have been an issue among scholars nationally for some time, with a growing online community, the American Association of University Professors and an increasing amount of press saying IRBs are too restrictive of social sciences research.

Columbia Law School Professor Philip Hamburger spoke on the controversy Monday to a joint session of Cheit's seminar PPAI 1700T: "Good Government," Lecturer in Education Luther Spoehr's course EDUC 1740: "Academic Freedom on Trial: A Century of Campus Controversies," in addition to interested professors and IRB members. In a class discussion following the lecture, Seifer, the IRB chair, acknowledged the system is "fundamentally flawed and broken," adding that, "They are being asked to do something they were never intended to do."

Seifer told the class that the IRBs around the country have expanded their reach because of federal bureaucrats and a community of university research administrators who have created a culture of avoiding risk.

Those factors "all exist within very frightened university environments. They're afraid of lawsuits, and they are afraid of donors going away," Seifer said.

Hamburger argues IRBs violate the First Amendment. "They suppress what you say to other people. You might make that person feel bad - you might hurt their feelings," Hamburger said in his lecture. "If you learn something and don't have permission, you have to destroy the data. If you have permission, you have to destroy it after three years. For scientific purposes, this is frightening. How do you replicate the experiment or discover if there was fraud?"

Garcia Coll said she sees value in having IRBs, even if others believe Brown's panel is in need of reform. "There is no question we need IRBs," Garcia Coll said. "Historically they have a very important reason to be around, and we need their scrutiny."

Cheit said he'd like to see not only a reform of IRBs but increased attention on research ethics for classroom projects - an area where professors get the University's complete trust in overseeing their students. "As long as you're doing it for a class project, you can go out on the street and interview a six-year-old, and it's not within the IRB's purview," he said. "But as soon as you start calling it 'research,' there's no trust."

"The line should be between protection of human subjects and education of our students," Garcia Coll said.


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