University News

IRB likely to undergo review

By
Senior Staff Writer
Thursday, April 26, 2012

 

The University’s Institutional Review Board – the body that approves all faculty research projects involving human subjects – is likely to undergo an external review by an external consultant in the hopes of reforming current practices during President-elect Christina Paxson’s term.

President Ruth Simmons intended to review the IRB “at an appropriate point,” she wrote in an email to The Herald. But that point never occurred during her presidency.

“It would be appropriate for this assessment to take place in the next administration,” she wrote.

One size fits all?

Currently, the IRB is charged with reviewing and sanctioning all faculty research projects that involve human participants, from projects in the biomedical sciences to those in the social and behavioral sciences. But many students and faculty members have expressed grievances over this policy, saying the board, which was founded first to regulate human subject research in medicine, does not differentiate enough today between projects that are clinical in nature and those that are not.

“Since the entire IRB apparatus was set up around the issue of medical experimentation, and since it has expanded to social sciences without ever being amended in any way to address social science issues. … The system needs to be changed,” wrote Ross Cheit, associate professor of political science and public policy, in an email to The Herald.

Cheit, whose research emphasizes the intersection of law, public policy and psychology to examine responses to the sexual abuse of children, said he has had to endure cumbersome IRB paperwork and reformulate research proposals to meet IRB standards.

“IRBs have distorted research priorities and made it less likely that researchers will engage topics like juvenile justice and child sexual abuse,” he wrote.

Some students said they manage to avoid a drawn-out approval process by working with faculty members who are more well-known. “My process was really streamlined, which I think might have been helped by the fact that I had kind of a prominent faculty (member) leading the project. I’m like the lucky exception that had it easy,” said Anna Andreeva ’12.

Some faculty members said the IRB is afflicted by a lack of disciplinary diversity in its makeup, arguing that it is disproportionately biomedical.

“I think we need to revisit the composition, the disciplinary representation of the IRB,” said Kenneth Wong, professor of education and chair of the department. “Are there enough social and behavioral scientists on the board? Even though the clinical side, historically, has always been the reason why we needed to have an IRB, to prevent potential harms on human subjects, we need to think about the nature of other research, which is very different from clinical drugs or medical trials. There needs to be enough balance on the board.”

 

An external review

Though it is unclear whether an external review of the IRB will take place, many faculty members expressed the opinion that reform is in the works and that it should come to fruition as soon as possible.

“I welcome the idea of an external evaluation of the research administration,” Wong said. He served as vice chair of the Research Advisory Board to the Office of the Vice President of Research from 2009 to 2011 and drafted multiple reports with recommendations to the IRB. In 2009, the IRB adopted a series of reforms outlined in one such report, which led to an increase in transparency, responsiveness and a clearer, more helpful website.

“I think one always needs to deal with research, and I think it’s always good to have reviews of organizations and how we do things to see if we can do them better or more efficiently,” said Peter Shank, chair of the Faculty Executive Committee and professor of medical science. “So I think that might be under consideration, but I don’t know. I haven’t spoken to (Paxson) specifically about that.”

 

Possible reforms

What policy recommendations will be made to the IRB in the future cannot be predicted. But some faculty members have a sense of what might arise during the conversation.

Besides revisiting the disciplinary representation on the board, Wong said he believes the University should consider setting up a second board charged with reviewing and approving non-biomedical human subject research.

“There are some universities which have separate boards, and I think that may be one way to think about it. Obviously there are costs in setting up an additional IRB … but if we consider this more like a necessary investment in the infrastructure of the research component of a top research university, then I think these are resources well spent because the students will benefit from it,” Wong said.

He also said the University should consider changing the charge of the IRB to make it not only a monitory board but also one that provides a more supportive and guiding role to research teams. 

“The single focus on just sanctioning may need to be revisited because we also need to provide sufficient support and guidance,” Wong said.

But notwithstanding the possibility of an external review, the IRB remains internally committed to improvement, wrote Clyde Briant, vice president for research, in an email to The Herald. It has worked this past academic year on “addressing the increased submission of (human participant) protocols in the social sciences and responding to concerns about the speed with which protocols are processed,” Briant wrote.

The board is also examining practices at other universities to determine what – if anything – it should try to emulate, he added.