Sunday, January 24, 2010

Canadian Historians Ponder Exclusion from Ethics Board Review

Google rather belatedly alerted me to the Canadian Historical Association's comments on the December 2008 draft of the Tri-Council Policy Statement; I am told the comments were posted on the association's website in late June 2009. Since late is better than never, I mention them now.

The historians are "supportive of the changes that have been made in the second edition and consider it a very good policy paper." They particularly appreciate the various passages sprinkled throughout the statement noting that not all research fits into a standard form, and that research ethics boards need to maintain flexibilility.

But, taking a broader view, the historians are dismayed that these passages appear as mere exceptions to general rules designed for quantitative, especially medical, research. As they put it:

While there is no question that the ethical issues arising from clinical or quantitative research must be addressed, the effect of this emphasis is to marginalize qualitative research in the humanities and some social sciences. Indeed, the TCPS-2 casts all qualitative research as the exception; something best exemplified by the inclusion of Chapter 10, "Qualitative Research." There is no parallel explanation of quantitative research; perhaps because it is considered the "normal" research practice everyone is familiar with.

Casting qualitative research as exceptional puts individuals undertaking such research – like historians – in the position of asking for exemptions from REBs. REBs, like all administrative tribunals, are likely to look on requests for an exemption from the guidelines with suspicion, making the bar higher for those undertaking qualitative research higher – simply because of the kind of research they are doing, not its quality. Not only will historians have to demonstrate the soundness of their particular research designs, but they will also have to establish that the norms of their professional practice are legitimate. In our view, this places an undue burden on our profession and on all those engaged in qualitative research.

This passage neatly summarizes most of what has gone wrong in the regulation of research in the social sciences and humanities over four decades in countries around the world. Medical regulators have written rules based in clinical medical practice, then imposed them on other fields in a way that defines those fields as abnormal, and therefore suspect. Seeing this flaw as intrinsic to the ethics review system, the Canadian Historical Association understandably "urge[s] the Advisory Panel to consider the position of the Oral History Association (US) which since 2003 has argued that oral history should be excluded from institutional review boards."

Thursday, January 14, 2010

United States Handicapper General

Writing in the Journal of Broadcasting & Electronic Media, Ruthann Weaver Lariscy of the University of Georgia argues that "Communication journal editors and concerned participants in the system should implement a policy that assures non-U.S. generated communication scholarship report procedures for assuring the protection of human subjects, the use of informed consent, and compliance with comparable IRB protocols."

[Ruthann Weaver Lariscy, "IRBs and Communication Research: Some Perplexing Issues," Journal of Broadcasting & Electronic Media 53 (October 2009): 668 - 671.]

Lariscy notes that IRB review degrades research. She recalls helping to plan a study of eighth-graders in Georgia, only to find that "the human subjects protection protocol required for this study made the research more difficult and depressed response rates," so that she and her colleagues got a participation rate of only 30 percent. In contrast, she refereed a study--apparently done abroad without IRB intervention--which got a participation rate of more than 85 percent. "I am left to conclude that IRB controls may have a considerable impact on our data collection, and the claims we make based on the data," she writes.

She does not claim that such IRB restrictions protect participants in communication research. To the contrary, she applauds the Illinois White Paper's position that "not all methodologies require the same rigorous overview and approval by IRBs, and that procedural changes should be made that acknowledge such methodological and content area differences."

If IRB review is degrading research without protecting anyone, why does Lariscy want journals to impose it on scholars who are currently free of such review?

First, she argues, "Failure to have uniform reporting requirements tarnishes the blind review process. Once a reviewer can identify that a piece of work originated either domestically or internationally, there is potential for bias." Well, yes. But there are dozens of factors that can flag a manuscript as originating outside of the U.S., including the spellings of words, the places studied, the literature cited, and even the proportions of the document. (While I am doing less work on paper, I still notice when a manuscript is formatted for A4.) This is a pretty thin benefit for a significant cost.

And a cost-free alternative exists. Journals could ask that U.S. authors omit descriptions of human protections procedures from their submissions, just as they now omit their own names. This would retain blind review without destroying data.

Bad as her first argument is, Lariscy follows it with an even worse one: "A non-level playing field exists for those of us conducting human subjects studies in the United States compared to the relative ease of conducting similar studies elsewhere." In other words, IRBs are wrecking our research, so let's be sure they wreck everyone's else's.

If Lariscy wants to make the case that journals should insist on IRB review of non-U.S. research in order to protect children, then let her do it. But it is unworthy of a scholar to advocate interference with research for the sake of interference itself.

Friday, January 1, 2010

Two Years' Inaction at OHRP

On October 26, 2007, OHRP formally requested "written comments on a proposed amendment to item 5 of the categories of research that may be reviewed by the institutional review board (IRB) through an expedited review procedure, last published in the Federal Register on November 9, 1998 (63 FR 60364)."

By the December 26, 2007, deadline, 65 people and institutions submitted comments, two-thirds of which concerned oral history or folklore.

That was two years ago. And as far as I can tell, OHRP has taken no action on these comments.

Meanwhile, OHRP's new guidance on what constitutes research subject to regulation, which Bernard Schwetz promised before the end of 2007, is now two years overdue.