IRB Chair Denies Being a Vampire

Patricia Price, a geographer and IRB chair at Florida International University, assures us that her board is not "a malevolent, vampirish entity."

[Patricia L. Price, "Geography, Me, and the IRB: From Roadblock to Resource," Professional Geographer 64, no. 1 (2012): 34-42, DOI:10.1080/00330124.2011.596789]

Emmerich Reviews Behind Closed Doors and Ethical Imperialism

Nathan Emmerich of Queen's University, Belfast, finds that Laura Stark's book and my own "together . . . illustrate the nature of ethics as an aspect of research governance fundamentally contributing to our understanding of the phenomena in a manner that goes beyond the relatively limited or restricted consideration offered by applied ethical analysis."

[Nathan Emmerich, Review of Behind Closed Doors: IRBs and the Making of Ethical Research and Ethical Imperialism: Institutional Review Boards and the Social Sciences, 1965-2009, Sociological Research Online 17, Issue 2 (May 2012).]

IRBs Misunderstand Researchers' Complaints

A study of IRB chairs, members, and staff finds that they understand that researchers regard them as powerful actors, "Yet IRBs may misperceive PI complaints."

[Robert Klitzman, "The Ethics Police?: IRBs’ Views Concerning Their Power," PLoS ONE 6 (2011): e28773. doi:10.1371/journal.pone.0028773. h/t Roberto Veloso]

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.

Less Flexibility, More Freedom

Defenders of the present IRB system often boast of the "flexibility" offered by current regulations. (See, for example, Dr. Jeffrey Cohen's report from the November PRIM&R meeting.)

But flexibility--when combined with the possibility of punishment--can actually empower censorship. Here is how Human Rights Watch describes an analogous system, China's censorship of the Internet:

The display of politically objectionable content can result in reprimands to company management and employees from the MII, the State Council Information Office, the Communist Party's Propaganda Department, and/or various state security organs, accompanied by warnings that insufficient controls will result in revocation of the company's license. In order to minimize reprimands and keep their licenses in good standing, BBS and blog hosting services maintain lists of words and phrases that either cannot be posted or which cause monitoring software to "flag" the content for manual removal by employees.

Search engines likewise maintain lists of thousands of words, phrases and web addresses to be filtered out of search results so that links to politically objectionable websites do not even appear on the search engine's results pages, even when those websites may be blocked at the backbone or ISP level . . . Such lists are not given directly to Internet companies by the Chinese government; rather, the government leaves the exact specifics and methods of censorship up to companies themselves. Companies generate their "block-lists" based on educated guesswork plus trial-and-error: what they know to be politically sensitive, what they are told in meetings with Chinese officials, and complaints they may receive from Chinese authorities in response to the appearance of politically objectionable search results.

But the complicity of companies is even more direct: they actually run diagnostic tests to see which words, phrases, and web addresses are blocked by the Chinese authorities at the router level, and then add them to their lists, without waiting to be asked by the authorities to add them. And because they seek to stay out of trouble and avoid complaints from the authorities, many businesspeople who run [Internet Content Providers] in China confess that they are inclined to err on the side of caution and over-block content which does not clearly violate any specific law or regulation, but which their instincts tell them will displease the authorities who control their license. In all these ways, companies are doing the government's work for it and stifling access to information. Instead of being censored, they have taken on the role of censor.

In other words, by keeping secret the exact terms that will trigger a license revokation, the Chinese government achieves more censorship than it could by publishing a list of forbidden terms, and it makes Google, Yahoo!, and other U.S. companies complicit in the censorship. Similarly, OHRP's vagueness about what will trigger a shutdown fails to assure universities that they can safely deregulate research, so universities restrict research that should be exempt from review.

Fortunately, OHRP's new director, Jerry Menikoff, understands this. In the Winter 2009 issue of AAHRPP Advance he writes,

We often hear that it’s better not to provide specific guidance—that the absence of guidance allows people greater flexibility in interpreting the regulations. In my experience, the opposite can be true. Guidance can empower individuals and advance both research and research protections. In the absence of guidance, people tend to be reluctant to take certain actions out of fear that they are violating the rules. In some instances, important research is not even attempted, all because of a misunderstanding. Guidance could eliminate the misconception and clear the way for research.

I'm delighted that Dr. Menikoff takes this approach, and I look forward to more specific guidance from OHRP that would clear the way for research.

[Thanks to Rob Townsend for altering me to Menikoff's comments.]