NRC Report: Where's the Freedom?

My biggest disappointment with the new NRC report is its silence on the question of academic and personal freedom.

Interview by Washington Monthly - Ten Miles Square

Rachel Cohen interviewed me for Ten Miles Square, a Washington Monthly blog.

I guess in this case the ten miles square still includes Arlington.

Cohen, Rachel. “What Are Institutional Review Boards and Why Should We Care? An Interview with Zach Schrag.” The Washington Monthly - Ten Miles Square, November 1, 2013. http://www.washingtonmonthly.com/ten-miles-square/2013/11/what_are_institutional_review047608.php?

Hamburger: IRBs are Worse than McCarthyism

In a brief article in Commentary, Philip Hamburger summarizes his case against IRBs, made in much greater detail in his 2004 article, “The New Censorship: Institutional Review Boards," Supreme Court Review (2004): 271–354. In this version, he argues that the regulation of human subjects research "is the most widespread and systematic assault on freedom of speech and the press in the nation's history. McCarthyism was more overtly political, but IRB licensing is more pervasive and methodical, and its consequences are far more lethal."

[Hamburger, Philip, "The Censorship You’ve Never Heard Of.” Commentary, July 2013, 21-26]

Oh, I've Heard of It

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Hamburger, Philip. “The Censorship You’ve Never Heard Of.” Commentary, July 2013.

h/t Chris Shea.

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.