Lessons from the headlines

Guest blog by Brad Noren, research administrator at Oregon Health & Science University

The story of Bernard Madoff’s alleged Ponzi scheme is already falling off the front pages. Our fast-paced society has moved on to the next headline of the moment. But before we forget entirely, it should be noted that there are lessons (or reminders) that relate to our efforts toward the regulation of research that utilizes human and animal subjects.

First, the case reminds us that trust can be misplaced. A colleague of mine had a sign on his cubicle that said, “Trust in God. Monitor everyone else.”

Ronald Cass, dean emeritus of Boston University School of Law, pointed out in a December 2008 issue of the Wall Street Journal, that the Securities and Exchange Commission (SEC) warned of a number of “affinity fraud” cases, wherein investors were targeted and duped by a member of their own community (be it religious, racial, ethnic, or professional). Upon hearing a sales pitch from “one of us,” potential investors were more willing to buy in.

Now, replace “investors” with “IRB/IACUC members.”

Review committee members should take this as a reminder to avoid deferring to perceived reputation or experience when considering proposals submitted by a peer. Our charge requires a thoughtful examination of each proposal.

Second, the Madoff case makes one wonder, where were the regulators? How could an elephant with $50 billion in a brief case so easily sneak out of the room? In part, one could point at the inadequate allocation of resources. This should sound familiar to IRB and IACUC administrators. When money is tight, “manage the risk” becomes code for “do more with less.”

Linda Chatman Thomsen, director of the division of enforcement at the SEC, testified before the Senate Committee on Banking, Housing and Urban Affairs on January 27. Her office is responsible for identifying and halting schemes such as the one allegedly perpetrated by Madoff. In her testimony, she described a 50 percent increase in the number of registered investment advisors since 2002. Those are the people she’s charged to monitor. Guess what. The resources allocated to her office have not kept pace with that increase. “While we always do our utmost to do more with less,” she said, she needs technology, access to expertise, and the means to educate investment advisors and potential investors. Sound familiar?

Thomsen ended with a statement that could have well been made by any IRB administrator. She said, “and all of us need to do everything we can to encourage a tone and culture… that mere compliance with the law, narrowly viewed, is not the highest goal to which we aspire, but the base from which we start.”

Amen, Sister.

(I would like to thank PRIM&R for the opportunity to appear as a guest on Ampersand. Blogs reflect the opinions of the bloggers and should not be mistaken as true journalism. My contribution is no exception to that rule.)