Kojo Nnamdi Show on Common Rule Now Online

Yesterday I had the pleasure of joining Jerry Menikoff of OHRP and Kathy Hudson of NIH on an episode of the Kojo Nnamdi Show entitled, "Rethinking the "Common Rule": The Ethics of Research with Human Subjects." We received many thoughtful, informed comments and questions.

I don't think any of us said anything that will surprise those who have followed the ANPRM debate closely, but I was pleased to hear Dr. Hudson concede that "The level to which current IRB protections actually protect participants is a somewhat understudied area. And I would hope that as we put these new rules in place that we can actually try to measure how effective they are in protecting participants in research."

In other words, after 45 years of imposing IRB review on researchers, we might begin asking if it does any good.

The audio recording and a transcript are now online at the link above.

Radio Show to Feature Menikoff, Hudson, and Me

On Monday (November 21) at 1pm, WAMU's Kojo Nnamdi Show will air "Rethinking the 'Common Rule': The Ethics of Research with Human Subjects." Jerry Menikoff of OHRP, Kathy Hudson of NIH, and I will discuss the ANPRM.

The show airs in Washington on 88.5 FM and is streamed online.

New York Times: Menikoff Promises Not to Restrict Public Information

Today's New York Times reports on historians' and social scientists' hopes and concerns about the ANPRM, especially the prospect of deregulating oral history while restricting the reuse of social science data.

[Patricia Cohen, "Questioning Privacy Protections in Research," New York Times, 24 October 2011.]

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.

Emanuel and Menikoff Explain the ANPRM

Ezekiel Emanuel, head of the Department of Bioethics at NIH, and Jerry Menikoff, director of OHRP, explain the ANPRM for readers of the New England Journal of Medicine.

[Ezekiel J. Emanuel and Jerry Menikoff, "Reforming the Regulations Governing Research with Human Subjects," New England Journal of Medicine, 25 July 2011. h/t Michelle Meyer]

The essay is a very helpful introduction to the ANPRM, clearer than the ANPRM itself. The authors conclude,

After 20 years, and the introduction of significant changes to the research landscape, many believe that the Common Rule needs revision. The ANPRM offers a rare opportunity for needed modernization that is consistent with the President’s mandate to enhance protections while simultaneously eliminating unreasonable burdens. Not everyone will agree with every proposed change. But the ideal should not be the enemy of substantial progress in achieving these two important goals. If this reform effort fails, 20 years from now, someone might write an article for the Journal to bemoan the fact that the Common Rule has undergone essentially no change in 40 years.

Fine, I'll say it. I agree with Jerry Menikoff.

Defino Notes Big Drop in OHRP Letters and Cases

Theresa Defino, editor of Report on Research Compliance, kindly alerted me to her recent analysis of OHRP activity and allowed me to post a reprint of the article.

["Big Drop in OHRP Letters, Open Cases Raise Questions of Agency Commitment," Report on Research Compliance, March 2011, 1-3.]

AAHRPP and PRIM&R Plan Conferences

Both the Association for the Accreditation of Human Research Protection Programs, Inc ., (AAHRPP) and Public Responsibility in Medicine and Research (PRIM&R) plan conferences next month. AAHRPP's conference, "Breaking Down Barriers, will be held in Washington, April 6-8, then PRIM&R meets in Boston, April 28-29, for a "Social, Behavioral & Educational Research Conference."

Menikoff Passes the Buck

Joseph Millum, bioethicist at the National Institutes of Health, and Jerry Menikoff, director of the Office for Human Research Protections, acknowledge the widespread dissatisfaction with present human subjects regulations and wish that "ethics review could be streamlined under the current regulations if institutions, IRBs, and researchers adhered strictly to the definition of human subjects research and used the available options for exemptions, expedited review, and centralized review—options that remain underused in biomedical research." But they put too much blame for this overregulation on IRBs and research institutions rather than on their own agencies.

[Joseph Millum and Jerry Menikoff, "Streamlining Ethical Review," Annals of Internal Medicine 153, no. 10 (November 15, 2010): 655-657.]

Menikoff to Critics: "Yes, We Hear You"

Theresa Defino kindly alerted me to the streaming video feed of Dr. Jerry Menikoff’s May 14 address at the University of Michigan, “The Legal Assault on the Common Rule." The speech was an impressive acknowledgment of the widespread criticism of the foundations of the IRB system, and it ended with the promise of some substantive improvement. But by listing some of the most common critiques of the IRB system without attempting to rebut them, Menikoff fell short of the dialogue he seeks to foster.

Deregulation "Is Not Going to Happen"

Linda Shopes kindly alerts me to the April 20 issue of COSSA Washington Update, the newsletter of the Consortium of Social Science Organizations, which reports on an April 1 meeting of the National Academies’ Board on Behavioral, Cognitive, and Sensory Sciences, at which IRBs were discussed.

Here's the key passage:

Philip Rubin, CEO of Haskins Laboratories in New Haven, CT, and former director of the National Science Foundation’s (NSF) Division of Behavioral and Cognitive Sciences, chairs the Board. He began the session with a review highlighting the difficulties social/behavioral researchers have had with the current system under the Common Rule regulation and its interpretation by campus Institutional Review Boards (IRBs). Complaints have been loud, but mostly anecdotal . . . Once again the bottom line is that despite efforts by Joan Sieber and the Journal of Empirical Research on Human Ethics, which she edits, there are still large gaps in our empirical knowledge of how the system works for social and behavioral scientists.

Rubin was followed by Jerry Menikoff, new head of the U.S. government’s Office of Human Research Protections (OHRP). Menikoff announced that he was all for “flexibility” in the system and that “changes can be made.” He also endorsed conducting more research. He rejected the arguments of the American Association of University Professors and Philip Hamburger of Northwestern University Law School that IRBs violate researchers’ first amendment rights. He acknowledged the importance of expedited review, but stated quite clearly that “removing minimal risk research from the system is not going to happen.”

I don't want to make too much of these comments; an OHRP spokesperson tells me that they were an extemporaneous response to Rubin, and not prepared remarks. Still, I am disappointed. Menikoff's comments suggest a retreat from his earlier concession that "flexibility" often can be code for arbitrary power. And it's a pity for a public official to insist that a given policy "is not going to happen" even as he endorses more research. Wise governance depends on making policies after finding facts, not before.

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.]

Menikoff to Head OHRP

The Department of Health and Human Services has announced the appointment of Dr. Jerry Menikoff as the director of the Office for Human Research Protections (OHRP). Menikoff holds degrees in medicine, law, and public policy, and has served as a law professor and public official.

A quick glance at Dr. Menikoff's CV suggests that while he has published extensively on the ethics of medical experimentation, he is written little on questions of the regulation of social science. The exception is his article, "Where’s the Law? Uncovering The Truth About IRBs and Censorship," Northwestern University Law Review 101 (2007): 791-799, which I described in a January 2007 blog entry. In that article, Menikoff suggested that the 46.101 exemptions were sufficient to avoid any conflict with the First Amendment.

Menikoff does understand that many IRBs have abused social researchers. "There are surely too many instances in which IRBs and others fail to understand, and properly administer, the regulations," he writes. (793, n. 9) Later, in a response to an Inside Higher Ed article about this blog, he wrote, "As to social science and behavioral studies, I do support reforms to relax the rules somewhat, though the claims that the system constitutes censorship under the U.S. Constitution are overkill."

It is not clear, however, that Menikoff understands how rarely the 46.101 exemptions are applied, and how much responsibility OHRP bears in their disappearance. And in his Northwestern piece, Menikoff praises OHRP for "concluding . . . that much of the work performed by oral historians, in sitting down with people and getting information from them, does not fall within the category of doing 'research.'" (798) He seems not to know that OHRP so contradicted itself that its pronouncement had no effect on most universities.

If Menikoff uses his position to revive 45 CFR 46.101, to restore the agreement with oral historians, and to correct other lapses between the regulations as written and as enforced by OHRP, his accession to the OHRP directorship will be great news not only for scholars in the social sciences and humanities, but also to participants in medical research, since resources can be reprogrammed for their protection. Under the leadership of a lawyer, perhaps OHRP will begin to obey the law.