Bioethics Blogs

More failures of "local precedents"

Laura Stark’s 2012 book, Behind Closed Doors: IRBs and the Making of Ethical Research, devotes a chapter to what Stark calls “local precedents,” her term for “the past decisions that guide board members’ evaluations of subsequent research.” “By drawing on local precedent,” Stark claims, “board members can read new protocols as permutations of studies that they have previously debated and settled based on members’ warrants. The result is that IRBs tend to make decisions that are locally consistent over time.” (47)

But I keep getting stories about IRBs that are locally inconsistent.

Stark made her generalization after observing a handful of cases in which IRBs claimed to be either basing decisions on ones they had previously made, or making new decisions that would guide future rulings. But as far as I can tell, she did not systematically audit IRB files to test the degree to which IRB decisions are in fact locally consistent.

I have long had my doubts about this claim of consistency, since so many stories from frustrated researchers concern identical studies presented to the same IRB with differing results. “The process that was approved in the first application was denied in the second because it was deemed coercive,” one complaint notes. “In every case in which we submitted the approved IRB application from the previous year, the IRB required additional changes,” another laments. A candid IRB chair admits that “Investigators may get quite different and inconsistent advice from the committee depending on what it feels like that day.”

Two comments posted in response to Patricia Aufderheide’s essay, “Does This Have to Go Through the IRB?

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.