Saturday, February 14, 2009

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.]

Friday, February 13, 2009

AAUP's Rhoades Takes Soft Line on IRB Training

In an essay on compulsory sexual harassment training ("Sexual Harassment and Group Punishment," Inside Higher Ed, 12 February 2009), the new AAUP general secretary, Gary Rhoades, offers side comments on human subjects research training:

In research universities (where professors’ work routinely involves human subjects, though even there literary and some other scholars are not required to undergo such training), perhaps the most obvious example of this is the human subjects training surrounding research grants and activity. Prior to getting grants approved by the sponsored projects division of a university, an investigator must have undergone human subjects training. Although the training varies by university, there are common patterns nationally. Typically, for example, such training is online, and is not particularly rigorous, to put it mildly. Indeed, the format involves investigators taking an exam by reading some written passages and then answering questions about them. After each section or module the person finds out whether he or she missed too many questions in a section, and proceeds. If they have missed too many questions in a section they simply backtrack, get the same questions in a different order, and retake the quiz, until they pass. A widely used set of exams (which are specified to social/behavioral and biomedical research) are those offered by the Collaborative Institutional Training Initiative, which over 830 institutions and facilities (including a very large number of research universities, and indeed including the University of California at Irvine) utilize. The modules for the CITI quiz typically include three to six questions.

For the most part, although faculty complain about the inconvenience and irrelevance of the training, I do not know of anyone who would suggest that such training should be required only of investigators found to have violated the rights of human subjects. The more important questions of process and principle surround the institutional review board activities that regulate the approval of an investigator’s proposal. Here, serious questions have been raised about compromising investigators’ academic freedom to engage in certain types of research and to research certain subject matter. But the controversy is not, for the most part, about the human subjects training per se. Indeed, I would venture to say that for colleagues in the social and behavioral sciences, among the most common comments and complaints about human subjects training are that it is ineffective, that it does little by way of actually protecting human subjects and seems to be geared more to protecting the institution.

Apparently, Dr. Rhoades is unfamiliar with the widespread, principled opposition to CITI and other online training programs. That is worrisome, if it signals the retreat of AAUP from its longtime leadership in the fight against overly broad human subjects regulations and requirements.

Tuesday, February 10, 2009

More Comments on Maryland's IRB Law

In January 2008, I commented on Adil E. Shamoo and Jack Schwartz, "Universal and Uniform Protections of Human Subjects in Research," American Journal of Bioethics 7 (December 2007): 7-9. That essay applauded a 2002 Maryland law that seeks to impose federal regulations on all human subjects research conducted within the state, even if not conducted at an institution with an FWA. As I noted at the time, the law is of dubious constitutionality, and it has probably survived this long only because it has never been enforced.

The November 2008 issue of the same journal reprints the Shamoo/Schwartz essay as a "target article," along with eight invited commentaries. Several of the commentaries complain that the federal regulations--and therefore the Maryland law--are insufficiently protective, rather than overly broad, but none of these address social science.

Three commentators do address Shamoo and Schwartz's failure to consider the impact on social science research. Neil W. Schluger complains that "their solution will do very little to protect human subjects, and perversely, it may actually make the situation worse by simply piling more studies into an overburdened and flawed system." (13) He notes that

a very large percentage of studies that IRBs review are studies involving minimal risk to subjects. Many of these are observational studies, reviews of existing data, studies in which the only intervention is administration of a questionnaire, or other types if studies where there really is no reasonable expectation that any harm could result. Although such studies can be reviewed by the use of expedited review procedures without convening the full IRB, they still require considerable administrative and regulatory oversight by IRB staff. Further efforts should be made to reduce the work associated with these harmless studies. (14)

David B. Resnik notes that the idea of regulating all research nationwide has been kicking around since 1995, and has been the subject of six failed bills in Congress. But, he continues, "it is not obvious that society would gain much by requiring an organization, such as Gallup or ABC News, to submit a proposal to an institutional review board (IRB) to conduct an anonymous survey each time that it decides to gauge public opinion on a particular issue. Social resources might be better spent overseeing riskier research, such as clinical trials." (6) He concludes that "Any proposal that is made into a law should include adequate provisions for exempting some low risk research and clarifying the definitions of important terms." (8)

Lisa M. Rasmussen complains that the Shamoo/Schwartz position "makes no distinction between highly risky biomedical research and, on the opposite end of the spectrum, research that involves no more risk than we all accept daily. Does beneficence really require that human subjects be protected from answering questionnaires or being interviewed? If so, why does this protection not extend to marketing, polling, or journalism?" (18)

Instead, Rasmussen proposes

the one-time approval of research “templates.” Taking advantage of the fact that a great deal of research follows traditional disciplinary methods, this model suggests that IRBs could approve a variety of research templates (written, for example, by discipline-specific bodies such as the American Psychological Association (Washington, DC), or by a researcher whose classes may repeat experiments semester after semester), and grant automatic exemption to any researcher using such templates. Accountability and oversight could be ensured by requiring the researcher to submit a simple form to the IRB agreeing to use such a template (which would also include provisions for protecting confidential data). Were this form electronically based, research could proceed as soon as the form was submitted, without requiring submission of a protocol or awaiting approval. This achieves the goals of both minimizing bureaucracy and protecting human subjects. It meets our moral obligations to human subjects of research without uniformly requiring IRB oversight of research. (18)

Rasmussen concludes that "universal and uniform regulation of all human subject research is well-meaning but un-nuanced." (18)

It is a pity that the journal does not print a reply by Shamoo and Schwartz. As I noted in my post last year, Shamoo himself has suggested that what he terms "low-risk research" is overregulated. I remain puzzled why he favors state laws that promise even more regulation of such research.

Friday, February 6, 2009

Oral History Wins and Loses

Two large public universities have recently announced policies concerning IRB review of oral history. It was a split decision.

The University of Nebraska-Lincoln (UNL) promulgated Policy # 001: IRB Review of Oral History Projects, dated 1 October 2008. The policy is based on Columbia University's 2007 oral history policy. According to the Nebraska policy,

Oral history interviews, that only document specific historical events or the experiences of individuals or communities over different time periods would not constitute “human subjects research” as they would not support or lead to the development of a hypothesis in a manner that would have predictive value. The collection of such information, like journalism, is generally considered to be a biography, documentary, or a historical record of the individual’s life or experience; or of historical events. Oral history interviews of individuals are not usually intended to be scientific or to produce generalizable information and hence are not usually considered “research” in accordance with the federal regulations or UNL policy. Therefore, such oral history activities should not be submitted to the UNL IRB for review.

The explanatory memo borrows two explanatory examples from Columbia, without attribution. It does cite OHRP's 22 September 2003 letter to the Oral History Association and American Historical Association, in which Dr. Michael Carome promised that "most oral history interviewing projects . . . can be excluded from institutional review board (IRB) oversight because they do not involve research as defined by the HHS regulations."

So far so good. But less than four months later, the University of Illinois at Chicago (UIC) released a policy statement, "IRB Review of Oral History and Other Social Science Projects" and an accompanying Tip Sheet: IRB Review of Oral History and Other Social Science Projects." This policy demands that "investigators wishing to perform oral histories or other social science projects must complete and submit the Determination of Whether an Activity Represents Human Subjects Research form to the [Office for the Protection of Research Subjects]."

UIC claims that "increasingly . . . the application of qualitative research methodologies may render studies that typically would not have required IRB review and approval to be submitted for IRB review or, at least, to require a determination from the IRB as to whether the study is subject to human subjects protection regulations." If anyone at UIC can show me that this statement is based on a study of trends in historical scholarship (rather than being made up to justify the policy), I will send a small box of good chocolates.

Follow a few links, and you can find the real basis for the UIC policy: Dr. Carome's December 2003 e-mail to Lori Bross of Northern Illinois University, in which he backed way from his September 2003 promise to the historians and embraced a set of nonsensical examples first proposed by the UCLA Office for Protection of Research Subjects.

In short, OHRP's perfidy of 2003 still echoes across the country. Depending on whether you believe Michael Carome's statements of September 2003, October 2003, December 2003, or January 2004, you may come away with very different understandings of the federal government's policy toward oral history, and the leeway allowed to institutions.

Thursday, February 5, 2009

PRIM&R Plans SBER Webinar

On February 25, PRIM&R will host a "webinar" entitled "New Solutions to Ongoing Problems When Reviewing Social, Behavioral, and Educational Research." The two faculty are Mary Marshall Clark, who successfully liberated oral history from IRB oversight at Columbia, and J. Michael Oakes, whose chapter in Institutional Review Board: Management and Function more or less claims that questionnaires can drive people to suicide. That's an interesting contrast, though not interesting enough for me to pay $175 to participate.