In a policy change that administrators argue is minor and some faculty say could fundamentally alter research at the University, undergraduates conducting human subject research may no longer take chief ethical responsibility for their work.
The new policy states that only faculty, staff and graduate and medical students may serve as principal investigators on research projects involving humans submitted to the University's Institutional Review Board. The policy was changed because of poorly written undergrad applications to the IRB.
The new policy became effective July 1, though it does not affect undergrads who had previously submitted proposals.
Because of the complex ethical issues that surround research, human subject researchers at universities nationwide must submit proposals of their work to institutional review boards, which are made up of faculty who consider potential ethical problems. According to federal regulations, an IRB must approve all human subject research proposals - everything from clinical trials to questions posed in oral history interviews.
Each research proposal requiring IRB approval must have a principal investigator, who is responsible for presenting the project to the IRB and ensuring that the research follows ethical guidelines. In the past, undergrad researchers at Brown acted as PIs, though they were required to have a faculty advisor. Under the new policy, the advisor must take chief responsibility as PI. The student can sign as a co-investigator.
Last year, the IRB reviewed 135 research proposals, which are also known as protocols, according to Dorinda Williams, director of the Human Research Protections Office, which staffs the IRB. Of those, approximately 35 were from undergraduates. In addition, the IRB also reviews active protocols each year.
After University officials decided to change the policy, the decision "was communicated to (then) Dean of the College Paul Armstrong in a letter dated December 6, 2005, and it was anticipated that he would distribute that letter widely, although perhaps that did not occur," Associate Vice President for Research Regina White wrote in an e-mail to The Herald.
"Functionally, things should be more or less the same," said IRB Chair Ron Seifer, professor of psychiatry and human behavior and director of Brown's Center for the Study of Human Development.
Students will usually still draft IRB protocols and will still conduct research, but Seifer said the requirement that PIs be faculty is "a gentle reminder" that they are responsible for advising students on how to navigate the review process.
"We're making more explicit to faculty their responsibility by saying, 'Your name is going on the front page,'" Seifer said.
The new policy for undergrads mirrors an existing policy barring some grad and medical students at Brown-affiliated teaching hospitals from being PIs, Seifer said, adding that the hospitals have had such policies "for 10 to 12 years with no problems."
Cause for the changePoorly written applications - not any specific violation - precipitated calls for the policy change, which was made by an IRB subcommittee, faculty and administrators said.
One motivation for the policy change was to improve the efficiency of the IRB approval process, administrators said.
"In any setting with human subjects research, there are oversight issues - IRBs provide local oversight within federal guidelines," Seifer said. "The federal guidelines are thick and impenetrable, and it's very difficult to understand their intent."
"IRB protocol submissions from undergrads weren't very well-assembled and they weren't very clear," White said.
Seifer said the lack of clarity slowed down the approval process because poorly prepared protocols must undergo a more elaborate "full-board" review, which only happens once a month. If a protocol is clear and complete, they can usually be reviewed by staff and cleared as either exempt or expedited.
"Undergrads have a clock ticking over their heads," Seifer said. "We want to make sure people can do research in a timely fashion, and when things are missing from an application, it slows down that research."
Seifer said, with the new policy, it is more likely the PI will be at the University long after the research concludes.
"Undergraduates are transient compared to the rest of the institution, and faculty are here much longer, so the IRB has more regulatory access to research projects (when professors are PIs) should things go awry," Seifer said.
Seifer said problems arise "infrequently, but they do happen. More than once every 10 years."
One faculty member who asked to remain anonymous said the new policy puts professors in a precarious position. "It's also scary that someone could come along four years or five years later and say, 'I was abused or harmed during this research,' and now the faculty advisor from all those years ago has to answer for this, even though it wasn't their project to begin with," the faculty member said.
The need for guidanceAt issue is how to best provide guidance for undergrads navigating the IRB approval process. The new policy places responsibility for undergrads' protocols squarely on faculty, sparking a debate over their level of responsibility in advising students.
Associate Professor of Public Policy Ross Cheit said the burden of teaching students about regulation should rest more with IRB staff than faculty, who should primarily advise students within the context of their fields, Cheit said.
"This is the IRB trying to save time. Undergrads are one-shot participants in this, so they have more questions, they aren't as familiar with the process and their proposals maybe aren't perfect," Cheit said. "But instead of dealing with it or increasing staffing at the IRB, they're not letting undergrads come to the IRB at all."
"This rule violates well-established norms about undergraduates at Brown. We give our undergrads responsibility and we say we treat them like adults, and that's always been special about Brown," Cheit said. "The University is saying, 'We're going treat you like an adult,' but then undergrads are told they don't have the maturity to fill out an IRB protocol."
Nina Keough '06.5 is a public policy concentrator who has been working on a thesis that involves interviewing girls, some of whom are pregnant, at the Rhode Island Training School for Youth, a juvenile detention and educational facility in Cranston, R.I. Under federal regulations, any research that involves prisoners, juveniles or pregnant women must be reviewed by the full board - the highest level of IRB scrutiny.
Keough said she began discussing her research with IRB staff during the second half of her junior year. "There was no real guidance (from the IRB staff). They didn't post or give me any samples of what a protocol should look like," Keough said.
But Seifer said the IRB several years ago "tried to elevate the amount of resources available to undergrads," a process that included inviting advisors and undergrad PIs to IRB meetings. "But that was not met with happiness or enthusiasm," Seifer said.
"If we had all the time and space we could devote more resources to tuning up undergrads' protocols, but our meetings wouldn't be four hours - they'd be 40 hours," Seifer said, though he added that a new IRB staff member has been hired this year.
Some advisors probably provided little guidance to their students under the old policy, said a faculty member who wished to remain anonymous. Seifer and White indicated the new policy will necessitate a close relationship between faculty and students.
When asked whether faculty might be overburdened by the shift in responsibility, White told The Herald, "I'd say that's too bad. Our faculty are here to teach our students, and they are the ones who have the experience to guide our students through this process."
Responding to the need for more student guidance, the Office of the Vice President for Research will review how it can better provide researchers with relevant information, White said.
The IRB Web sites of other Ivy League institutions include flow charts, decision trees, written guides and specialized information for undergrads to help researchers navigate the regulatory process. But the Web site of Brown's Human Research Protections Office, which staffs the IRB, is little more than a collection of applicable federal regulations, University procedures and forms.
An unintended consequence?One possible outcome of the policy change is that the amount of undergrad research will decrease, faculty members interviewed by The Herald said.
"Once advisors realize what's involved and that they might have to be answering questions for the IRB, they're not going to want to advise projects," Cheit said.
Two other faculty members said they hesitate to sign their names as PIs on projects they are only advising.
A faculty member said, "This change puts faculty in an awkward position because we are never going to be able to oversee every aspect of undergrads' research."
Both White and Seifer acknowledged that a decrease in research volume is possible, but they do not expect one. White said the Office of the Vice President for Research will monitor the amount of undergrad research to make sure there is not a significant drop.
"If it's only a small number of faculty who don't think they should have that responsibility, then there shouldn't be a real difference," Seifer said.
Another concern is whether the policy change will cause thesis advisors to instruct their students to avoid the IRB.
According to several faculty members, University and federal rules regarding what research must go to the IRB aren't entirely clear, so it is possible for some students - with the help of their advisors - to bypass the IRB through a sort of willful negligence.
Dean of the College Katherine Bergeron, who became Brown's highest undergraduate academic officer July 1, did not respond to an interview request from The Herald.
