Li Abandons Suit, But Brown University Still Ponders IRB Reform

Though it no longer faces a faculty lawsuit, Brown University is considering an outside review of its troubled IRB.

As readers of this blog may remember, Brown faculty have been complaining about the IRB since 2007, if not before.

In 2011, a Brown professor, Jin Li, took the highly unusual step of suing the university because of IRB interference in her work. In March, Li abandoned that effort, her attorneys agreeing to a dismissal with prejudice.

According to the Daily Herald, Brown faculty and administrators are discussing possible reforms, including an external review, broader disciplinary representation on the IRB, the creation of an additional IRB for non-biomedical human subject research, and "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."

[Aparaajit Sriram, "IRB Likely to Undergo Review," Brown Daily Herald, 26 April 2012.]

The article does not mention the possibility of an appeals process, the lack of which was one of Li's complaints.

Li and Brown Continue Negotiations

A correspondent asks for an update in the case of Jin Li, the Brown professor who sued her university after its IRB restricted her research.

I checked Public Access to Court Electronic Records (PACER) and found that on January 13, the parties jointly asked for an extension of the discovery deadline, telling the court "that they continue to negotiate a settlement of the claims. Due to the efforts made negotiating a settlement, only minimal discovery has been propounded so far. As such, if the parties are unable to settle, then the parties will need time to complete formal discovery."

I have posted the motion and other key documents on my IRB Documents page.

Inside Higher Ed Reports on Li v. Brown University

Inside Higher Ed reports on the Brown University professor who is suing the university over IRB restrictions. The story quotes your humble blogger.

[Dan Berrett, "IRB Overreach?," Inside Higher Ed, 18 March 2011.]

Professor Sues Brown University Over IRB Mission Creep

Jin Li, Associate Professor of Education at Brown University, has sued the university in federal court for forbidding her from using data from a study she conducted with private funding.

[Alexandria D'Angelo, "Professor Says Brown U Has a Lot of Nerve," Courthouse News Service, 1 March 2011. Thanks to Illuminata for catching this.]

Brown Pledges IRB Reform

The Brown Daily Herald reports "a series of reforms" at Brown University, intended to "streamline Institutional Review Board procedures." (Sydney Ember, "Reform in the Works for Research Review Board," 13 November 2009.)

The process started in 2007, when Brown faculty complained that IRB operations were inhibiting research, especially by undergraduates. Brown's Research Advisory Board convened a four-person, ad hoc subcommittee to investigate. That subcommittee released a draft report, "Undergraduate Research in the Social Sciences and the Institutional Review Board at Brown" in January 2009.

The January 2009 Report

The draft report found:

Many faculty members from the social sciences report some aspect of the IRB to be or to have been a burden, and a significant fraction feel that IRB practices are having or have had some dampening effect on the quality or availability of undergraduate research opportunities. There is the widely held belief that many social science projects typically consisting of interviews or surveys, have a low intrinsic risk. Most faculty members, however, do recognize the existence of some risk, depending on the nature of the activity, and the need for some type of oversight. Many faculty members believe that the formal and rigidly structured IRB process is not an optimal way to oversee and regulate undergraduate work, due to variable levels of organization, knowledge, and professionalism among the undergraduates, and the special time constraints associated with the undergraduate senior year.

The subcommittee offered three policy options:

A. "Brown adopts IRB review as the standard procedure for undergraduate theses and non-classroom projects dealing with human subjects."

B. "Continue the current system, but clarify several points and communicate the policy more explicitly to avoid faculty and student confusion."

C. "Adopt and communicate a policy in which non-federally-funded undergraduate work is not subject to IRB review, but rather to some other educational and oversight system tailored for undergraduates, to be defined."

It recommended Option B "as the best near-term solution," while keeping C open as a longer-term option.

Brown's Faculty Executive Committee (FEC) received the draft report at its January 2009 meeting. According to the minutes of that meeting, "The FEC was disappointed that the report did not address some of the larger issues. It appears that the definition of research is getting broader so that the IRB has their hand in every aspect of research." As far as I can tell, the report has still not been finalized.

Changes Since January 2009

According to the Daily Herald story, the university's Research Protections Office (RPO) claims that it has implemented many of the recommendations in the report, primarily by updating its website. Since many of the pages on that website are undated, it's hard to know how many have been changed since the release of the draft report in January.

Some of the report's recommendations do seem to have been implemented. For example, the report called for the prominent placement of the information that faculty advisors get to decide whether an undergraduate project needs IRB review. That information is now indeed prominently displayed.

In contrast, the report specifically objected to the assertion that "obvious examples of dissemination [and therefore generalizability] are publication in a scholarly journal, presentation at a professional conference, or placement of a report in a library." It recommended the deletion of the references to conferences and libraries, but as of today, they remain on the RPO website. Given that this was one of the most concrete, immediate proposals of the subcommittee, I suggest that the Daily Herald may have been premature in its announcement of reform.

Erroneous Assertions

Not mentioned in the faculty report are three significant misstatements about federal regulations in the RPO's document, Frequently Asked Questions.

1. "Federal Regulations are clear that it is not up to the investigator alone to determine if a project is exempt."

Federal regulations specify no such thing, as recently reiterated by OHRP.

2. "In certain situations, all involving no more than minimal risk, the IRB can waive the requirement that you obtain the participant's signature on the consent form."

In fact, 45 CFR 46.117(c)(1) also allows IRBs to waive the signature requirement when "the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality." This is true even when the risk is greater than minimal.

3. "As long as your research involves collecting data or information from or about living individuals, you need to have it reviewed by the IRB."

This would put reading a newspaper under the jurisdiction the IRB. Brown's RPO doesn't really believe this, but it hasn't been careful with its explanations.

Unfinished Business

It's great that a Brown faculty committee has taken a look at IRB operations, and that the administration has made some changes in response. But the report indeed failed to address some of the big issues at stake, and the administration has failed to implement some of the minor reforms suggested ten months ago. This case suggests the difficulty of restoring the principle of faculty governance when it comes to social science research.

Brown U. IRB Chair: System is Broken

Ross Frazier of the Brown Daily Herald reports that Brown's "faculty are yet again pushing for change" in the human subjects review system there. ("As IRB Debate Grows, Profs Push for Reform," 16 October 2007).

Frazier reports the views of Ron Seifer, professor of psychiatry:

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.

As reported by Frazier, senior Brown administrators seem unwilling either to defend the current system or to reform it, preferring instead to keep discussion of the issue off official agendas.