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.