One of the themes in the discussion today at the Presidential Commission for the Study of Bioethical Issues: Why did proper concerns for protecting human subjects in trials lead to the creation of a regulatory structure that makes so many researchers cringe?
Researchers equate dealing with Institutional Review Boards (IRBs) as like "going before a (New York City) co-op board or before an IRS auditor," said Ronald Bayer, professor and co-chair of the Center for the History of Ethics of Public Health at the Mailman School of Public Health at Columbia University.
Bayer said he hears endless grumbling about IRB's "picayune questions." "I am concerned," he said. "Is the structure we created something very different than what we wanted it to be?"
He said the the challenge to this commission is "to revisit in a fundamental way the institutions we have created. Something is off when people see the entire process as something we are not proud of, but as a process they find, well, stupefying."
Commission member Dr. John D. Arras, a professor of biomedical ethics and philosophy at the University of Virginia, said he wondered whether the concern about protecting vulnerable populations in medical trials had "given rise to a backlash."
"We pushed for an ethical reform of system, real oversight, and now we are left with this bureaucratic system, really a nitpicking monster," Arras said, addressing Bayer. "And I am as stupefied as you are."
Their concerns ranged from overzealous IRB oversight to requirements of taking standardized tests on ethics.
So, you want to understand change over time? Summon the historians!