Saturday, November 22, 2008

OHRP Continues Indiana-Bloomington Investigation

In September I reported on the OHRP investigation of Indiana University-Bloomington, ably covered by the Bloomington Herald-Times. Along with several stories, an editorial, and at least two op-eds, the newspaper posted heavily redacted copies of the OHRP letter and the IU reply.

On October 3, I submitted a Freedom of Information Act request for the unredacted OHRP complaint. This week, I received a reply, dated November 17, stating that "the subject matter of your request is the subject of an open and ongoing investigation. Release of any additional information at this time could reasonably be expected to interfere with ongoing proceedings." Hence, I received no information. We still don't know what Indiana-Bloomington did to bring down the federal hammer, or if the hammer will strike again.

Meanwhile, the crackdown has disrupted research, especially for social scientists. As the Herald-Times reported on October 8 (Nicole Brooks, "IU Research Oversight Office Has More Staff, But Projects Still Delayed"),

The need to “attend to the compliance issue speedily” led to Bloomington researchers using the same proposal forms as IUPUI faculty, according to [Research Affairs Committee chairman Stephen] Burns. These forms are designed for medical research, and are “more complex than needed,” especially for social science researchers.

This has caused some faculty — and students — to not bother with some research projects, Burns said. And some students are changing their thesis topics so they don’t include human subjects research, he said.

Before the compliance issue came into play, when Bloomington campus faculty used their own form and not IUPUI’s, this was a problem, Burns said. Research topics are becoming more and more diverse, and the divide between what information is necessary for different kinds of research is widening, he said.

The upshot is that faculty and students at a major research university are abandoning their research because of secret allegations against their university's administration. It's all very well for OHRP to claim (as Ivor Pritchard did at the October SACHRP meeting) that OHRP enforcement actions are rare. But even the rare crackdown, if as severe as this one, is enough to have IRBs nationwide quaking in fear, and putting regulatory compliance above all other considerations.

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