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.
Arras and other Commission members also asked about the large shift toward more medical research happening overseas. Arras raised it in connection with whether the research was relevant in places where it was taking place, and whether that should be a requirement for research.
“It seems to me when pharmaceutical companies are farming out research to organizations in Eastern Europe, and get approval (to market products) here (in the United States), they are doing studies overseas in places where there is zero intention to benefit the population beyond the actual studies. To me, this is a real puzzle.”
David A. Borasky, Jr., IRB manager at the Office of Research Protection at RTI International, responded: “It’s not entirely fair to hold industry standard research to that norm.” He said, for instance, that research on male circumcision for HIV prevention also may have uneven benefits to participating communities because it is “rolled out unevenly.”
And Dr. Murray M. Lumpkin, deputy commissioner for International Programs at the U.S. Food and Drug Administration, said he might be “the last person to speak for the pharmaceutical industry,” but added, “How do you define benefits? Is it only access to products after the fact, or is there benefit to building up medical infrastructure, are there benefits to the local community other than having access at the end of the day?’’
