Thursday, January 19, 2017

Why is Felice Levine satisfied?

Inside Higher Ed reports that Felice J. Levine, executive director of the American Educational Research Association, is happy with the final rule. I’m curious about why; it doesn’t seem to give her anything she asked for in 2011.

[Scott Jaschik, “U.S. Issues Final Version of ‘Common Rule’ on Research Involving Humans,” Inside Higher Ed, January 19, 2017.]

[Edited at 11:12AM to mention the normal educational practices in penultimate paragraph.]

Here’s Scott Jaschik’s reporting on social science reactions to the final rule:

Early reactions from social science groups to the changes in the common rule were positive. Various provisions suggest that institutional review boards, which must review proposals to study humans, work to understand the needs of different kinds of researchers, and that there are different levels of risk associated with taking an experimental drug and answering confidential survey questions.

A statement from Felice J. Levine, executive director of the American Educational Research Association, said, “The revised regulations definitely show the care and hard work that went into this extensive effort to modernize the common rule. An open process that began in July 2011 has led in January 2017 to regulations that are more nuanced and that far better align human research protection and social and behavioral science research, taking into consideration level of risk and benefits. It is a fine outcome for research participants and for human science.”

For anthropology, the reaction was more mixed. Anthropologists pushed hard for specific mention of “participant observation” (a key tool of their discipline). The hope is that mention of this methodology will make it easier for institutional review boards to approve projects involving this approach. Sometimes in the past, [Edward Liebow of the American Anthropological Association] said, IRB members or others have not understood that the relationship between an anthropologist engaged in participant observation isn’t the same as a scholar who is interviewing his or her research subjects.

But he said that his association was “especially concerned” that the final version of the rule did not exempt participant observation, as his organization had urged.

I can understand Liebow’s disappointment; the final rule offers little aid to frustrated ethnographers.

I have more trouble understanding Levine’s satisfaction. In response to the 2011 ANPRM, she drafted the “Social and Behavioral Science White Paper,” which called for dramatic reforms to the IRB process. The final rule is largely unresponsive to the concerns expressed in that paper:

  • The White Paper objected to the current  §46.116(a)(2) requirement that informed consent include a “description of any reasonably foreseeable risks or discomforts to the subject,” suggesting that “reasonably foreseeable harms” might better apply. The final rule does not make that change.
  • The White Paper objected to the current rule’s “general mandate to apprise subjects as part of the informed consent process of alternatives to treatment or why it may be in their best interest not to participate. (Such requirements are sometimes appropriate, but add complexity and foster confusion where they are not.)” The final rule maintains the current rule’s language on this point.
  • The White Paper “strongly support[ed] the requirement of an appeals process.” This was not included in the NPRM or final rule.
  • The White Paper argued that “it should be incumbent on the reviewer to state specifically in writing what aspect of a registration document leads to doubt a project’s excused status and to refrain from review where it finds none.” The final rule [§__.115(a)(3)] takes a small step in requiring documentation of “the rationale for conducting continuing review of research that otherwise would not require continuing review,” but it does not require such a rationale for denying an exemption.

The final rule, with its announcement, is 543 pages long in its initial format, so perhaps it includes some of the White Paper’s recommendations that I have overlooked.

It’s also possible that Levine is thinking primarily of the final rule’s provisions for research “involving normal educational practices,” which I have not examined so closely. But the new rule seems to make this research harder; to win exemption, research must be “not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction,” something not required by the current regulations.

So far, I can’t see why Levine is calling this a win.

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