Wednesday, May 27, 2015

A/B ≠ A&B

A/B testing is the comparison of two products by providing each, simultaneously, to two randomly selected groups. As Michelle Meyer notes, the practice is less ethically suspect than a common alternative: imposing a new product on all of one’s customers without first testing it.

A&B is an abbreviation for assault and battery. Depending on the jurisdiction, the two may be a single crime or distinct crimes, but everywhere A&B is unlawful.

Law professor James Grimmelmann has confused the two:

Suppose that Professor Cranium at Stonewall University wants to find out whether people bleed when hit in the head with bricks, but doesn’t want to bother with the pesky IRB and its concern for “safety” and “ethics.” So Cranium calls up a friend at Brickbook, which actually throws the bricks at people, and the two of them write a paper together describing the results. Professor Cranium has successfully laundered his research through Brickbook, cutting his own IRB out of the loop. This, I submit, is Not Good.

IRBs for everyone, or you get hit with a brick. I suggest that this parade of horribles is missing its elephant. Blame the IACUC?

Anyway, thanks for the link.

ETA(2:18PM): I originally linked to the wrong Meyer paper. Of course, that one's worth reading too.

Elliott Still Wants to Scrap IRBs

Writing in the New York Times about a series of scandals at the University of Minnesota, bioethicist Carl Elliott calls for the IRB system to be abandoned and replaced with “a full-blown regulatory system.” This is essentially the same argument he made in the New York Times in 2011, when the ANPRM was issued.

[Carl Elliott, “The University of Minnesota’s Medical Research Mess,” New York Times, May 26, 2015.]

Sunday, May 17, 2015

Montana Political Scientist: IRB Process Is "Cumbersome, Inadequate" for Political Research

The Montana Commissioner of Political Practices (COPP), Jonathan Motl, has determined “that there are sufficient facts to show that Stanford, Dartmouth and/or its researchers violated Montana campaign practice laws requiring registration, reporting and disclosure of independent expenditures” in October 2014, when they mailed pre-election postcards to 102,780 registered voters. The postcards were part of an effort to see if certain claims about candidates’ place on an ideological spectrum would affect voting patterns.

As part of the investigation, Motl engaged Carroll College political science professor Jeremy Johnson to determine whether the Stanford and Dartmouth researchers had violated IRB requirements. Johnson finds that they did, but also that the Dartmouth IRBs could have approved the studies without addressing the most serious ethical issues they raised. “The fundamental problem with the IRB process,” he writes, “is the narrow focus on protecting the individual subject. Concerns about human subjects in the aggregate often do not even occur to researchers, faculty, and staff involved in the IRB.”

[McCulloch v. Stanford and Dartmouth, Commissioner of Political Practices of the State of Montana, No. COPP 2014-CFP–046, Decision Findind Sufficient Facts to Demonstrate a Violation of Montana’s Campaign Practice Laws, 11 May 2015. h/t Chris Lawrence.]

Wednesday, May 6, 2015

OHRP Inaction Leaves IRBs Reliant on Gut Feelings

Theresa Defino’s Report on Research Compliance describes an April 14 webcast by Robert Klitzman about his new book, The Ethics Police.

[“Books, Bioethics Panel Say OHRP Inaction Weakens Protection System, Thwarts Trials,” Report on Research Compliance, May 2015.]

Most of the excerpts from Klitzman concern the way that OHRP silence hampers IRBs:

When they reach out to OHRP for support, IRB officials reported getting nowhere. In the chapter titled, “Federal Agencies vs. Local IRBs,” Klitzman wrote that one chair told him, “Many times when you call for advice, they essentially just read back the regulations.”

One recounted waiting two years to hear from OHRP on changes it had made. When federal officials respond, “they often refrain from doing so in writing, or say that the clarification does not apply more generally,” Klitzman was told.

Without assurance that they are acting correctly, IRBs act arbitrarily:

IRB chairs and members, according to Klitzman, “relied on gut feelings, intuition, the sniff test. People wanted to feel comfortable….They wanted peace of mind” about the studies they approved. Decisions were influenced by “pet peeves” and the “prudishness” of IRB members and chairs. Some IRBs are “user-friendly” or “pro-research,” he said.

In truth, such arbitrariness serves neither researchers nor research participants. Defino quotes Alice Dreger’s new book Galileo’s Middle Finger, which argues that “in practice, protections for people who become subjects of medical research may be their weakest in decades.”

The IRB system is premised on the notion that, at times, researchers and subjects have competing interests. Thanks to OHRP, they also have a common enemy.