ANPRM's Problem Statement: Helpful but Incomplete

One of the many remarkable sections of the July 26 advance notice of proposed rulemaking (ANPRM) is its admission that the Common Rule is flawed.

(Note: I have added a link to the ANPRM at the top of the link list in the sidebar.)

Since the 1970s, IRB apologists have claimed that federal regulations are flexible enough, and that local IRBs are to blame for any problems. In 2007, for example, Jerry Menikoff quoted with approval Jeffrey Cohen's 2006 claim that "the regulations provide sufficient flexibility for the efficient and appropriate review of minimal risk research. IRB review of such research does not have to be burdensome or unreasonable if IRBs appropriately utilize the flexibility in the regulations." Menikoff reiterated his claim of "flexibility within the system" in his 2009 speech, “The Legal Assault on the Common Rule."

After thirty years of such claims, it is wonderfully refreshing that the ANPRM takes so seriously many of the critiques leveled at the federal regulations themselves. And the ANPRM helpfully organizes those critiques into seven general categories.

On the other hand, ANPRM's problem statement (pages 44513-44514 in the Federal Register version) overlooks some major critiques. Fortunately, some of those critiques are implicitly recognized by some of the ANPRM's proposals.

White, "Institutional Review Board Mission Creep"

Ronald F. White, a professor of philosophy at the College of Mount St. Joseph, is fed up with IRB review of the social sciences: "Institutional Review Board Mission Creep: The Common Rule, Social Science, and the Nanny State," Independent Review 11 (Spring 2007): 547-564.

Much of the piece will be familiar to those who have followed recent IRB debates, but I did enjoy White's first-hand account:

My IRB experience with graduate student projects on leadership was eye opening. A colleague and I taught the course. We spent hours checking student IRB forms, and half the semester was consumed in getting their protocols past the committee chair. All of these projects involved harmless interviews and questionnaires to be done in the workplace. The overwhelming majority of the students' employers not only supported their research, but in many instances were paying for them to attend graduate school. All of my students found the IRB debacle to be nitpicking nonsense. Many of them ultimately received an "incomplete" for the course. It would be convenient simply to blame our IRB chair for this debacle. However, that person was not only a highly competent and cooperative IRB chair and an established social scientist, but also an extraordinarily cooperative friend of mine. In short, the IRB fiasco is not about persons, but about a system.

After that initial experience, the program redefined the project so that all students could get IRB approval by providing the same answers on the form. This adaptation made IRB compliance less onerous, but it severely limited the student's choice of topics and deprived them of the opportunity to do real science. Since then, the course has introduced a whole new kind of research option for students that avoids IRB involvement. I surmise that in most educational settings, the demands of IRB compliance have led to requiring topics and projects that are easier to get past boards.

There are a couple of points here. First, as Robert Kerr has noted, research delay may be research denied, so we should not take at face value IRB claims about the low percentage of projects that are rejected outright. Second, boilerplate approval processes may lead to boilerplate research--the chilling effect that IRB critics have noted for decades.

What intrigues me most is how a philosopher got snared in this mess, and I hope to learn more about the course and the research White's students were pursuing.

Even the Best IRB Can Antagonize Researchers

Judging from Samuel P. Jacobs's story, "Stern Lessons For Terrorism Expert," Harvard Crimson, March 23, 2007, the Harvard IRB is pretty darn good when it comes to non-biomedical research. Policy researcher Jessica E. Stern learned from the IRB to "not learn the names of many of the people she is interviewing—preferring to use pseudonyms—thus protecting the privacy of her interviewees and making her notes less valuable to federal investigators." She states, “Harvard’s IRB is the only one I know of to approve the kind of research I do. They’ve bent over backwards to make what I do possible, which is better than any other IRB.” Law professor Elizabeth Warren has “never encountered an IRB as helpful as Harvard’s."

Yet another researcher finds "the process is so cryptic and idiosyncratic" that "his students often can’t anticipate the reasons why the institutional review board will reject a proposal." And Stern herself, who got valuable help from the IRB, complains that "Before I came to Harvard, I had pretty remarkable interviews with terrorists . . . There are a lot of reasons that those kind of interviews would be hard today. One of them is the post-September 11 environment, but the other is the IRB strictures.” One project, to interview radical black Muslims, died entirely because of the delay in approval. (Note: this is just what Robert Kerr warned us about.)

How can we have the best of both worlds—helpful advice without arbitrary rejections and delays? Voluntary review.