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A series of reforms is underway that the University hopes will streamline Institutional Review Board procedures involving the ethical treatment of human research subjects. In response to recommendations in a report issued by a Research Advisory Board subcommittee last spring, the IRB and the Research Protections Office have initiated changes to expedite the approval process and increase institutional transparency.

The University's IRB procedures have long incited debate among faculty members, students and researchers who felt the strict approval process limited research opportunities for social science projects. But the current reform efforts aim to  pave the way for more efficient IRB operation and ethical oversight.

The culmination of a review begun in 2007 by the Faculty Executive Committee, the RAB and faculty members, the report proposes a set of options to improve communication among students, faculty advisers and the IRB. These include implementing changes to the RPO Web site to clarify the IRB policy, increasing communication by decreasing the IRB's  response time to proposals and requiring basic online ethics training for undergraduates working with human subjects.

The subcommittee also addressed ways to alleviate some of the rigid procedures that often prevent undergraduates conducting research in social sciences from procuring research approval, such as standardizing the review process and removing some restrictions.

The Office of the Vice President for Research, which oversees all research conducted by students and faculty, will be "working through these detailed recommendations of this report during the rest of this semester and updating our Web site appropriately," wrote Vice President for Research Clyde Briant in an e-mail to The Herald. "We are certainly doing all that we can to make the process efficient."
 
History of debate

Though the federal government requires IRB review for all federally funded research, Brown demands a board review for all research involving human subjects, allowing the IRB to decide the extent to which it will oversee a particular project. Unlike many peer institutions, Brown only has one IRB — meaning the lone board considers ethical standards for both biomedical and social sciences research.

Because of these less traditional review procedures, the IRB approval process has often sparked debate — which escalated after administrators instituted a new policy in July 2006 that prohibited students from assuming primary responsibility for the ethical treatment of human subjects. Before the new policy, undergraduates were able to act as the primary investigators for their research projects, but the change meant that students had to seek a faculty adviser to take responsibility for IRB applications.

But this change, along with inconsistent descriptions on the RPO's Web site and lack of specific instructions for proposal submission, often led to frustration among students and faculty members, said Kenneth Wong, chair of the Department of Education and of the subcommittee that produced the report. He said many faculty members, especially those involved in the social sciences, were unfamiliar with the IRB guidelines, making the application process unnecessarily confusing.

"The IRB procedure can be seen as an educational process," Wong said. "People realized (the IRB) needed to be more customer-oriented."

Wong said one of the main complaints from faculty members and students was that the IRB was too medically focused, often subjecting low-risk research involving oral histories or surveys to the same formal guidelines as more-invasive medical studies using human subjects. This slowed the approval process because it was difficult for students to meet the rigid IRB standards, he said.

"There were a lot of good social science practices that I wasn't able to do because of the IRB process," said Fiona Heckscher '09, who conducted research on HIV/AIDS in Mali and wrote a senior honors thesis on the effects of the IRB on undergraduate research.

"The IRB was very well-intentioned, but without the structure for feedback and expertise because the board is so biomedically focused."

Heckscher said the Brown IRB required her to obtain parental consent from minors who were pregnant, which could have endangered the women she was interviewing. Because the board was accustomed to dealing with medically based projects, Heckscher said she felt "it was almost impossible for them to give me feedback." 

Looking to reform
Lack of communication and clarity made submitting project proposals to the IRB difficult because the researchers proposing the projects — and the IRB itself — were frequently unaware of appropriate ethical standards for social science projects, Wong said.

As a result, the committee outlined policy options in their report, including making all projects subject to IRB review and developing other types of educational oversight committees to relieve some of the burden on the IRB.

"The IRB staff have become a lot more supportive to students," Wong said. "The RPO has definitely become more transparent, and they are more reactive because we engaged them along the way."

This year, the RPO has instituted many of the subcommittee's recommendations concerning the office's Web site, which is responsible for disseminating information about appropriate research procedures to students and faculty. These reforms include clearer definitions of ethical issues that might arise when dealing with human subjects, as well as sections providing detailed checklists for effective IRB proposal submissions.

"Students are working now a lot more closely with their advisers," Wong said.

Despite the recommendations outlined in the report, Wong said the IRB process still needs improvements, especially concerning the requirements for undergraduates planning to conduct research abroad.

"The timing can be a little bit of a challenge," Wong said about submitting applications for international research.

He added that undergraduate students frequently do not know they must submit their applications to the IRB before they begin collecting data abroad. "The report is not going to change everything," Wong said. "There are not going to be major changes overnight."

RPO Director Dorinda Williams said many of the recommendations submitted by the subcommittee have been addressed. The RPO Web site now includes "additional language that seems to focus on undergraduates," Williams said, including a section with a "decision-tree type of document" that provides more accessible discussions of the IRB protocol.

In addition to providing more pages on the Web site — the office has already created a page specifically for researchers studying in other countries — Williams said the RPO is more actively disseminating information about the IRB through open hours and direct conversations with different departments.

"The primary mission with the IRB review is helping people understand when you need it," Williams said. "We're getting out there to spread the word."




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