In the wake of the 2010 discovery that U.S. government-funded scientists intentionally infected unknowing Guatemalan citizens with syphilis in the 1940s, President Obama has asked his Commission on for the Study of Bioethical Issues to take a good hard look at whether human subjects today are adequately protected in federally funded research.
At the commission’s 5th meeting on 18-19 May in the Warwick New York Hotel, an invited panel’s words rang loud and clear: the system may provide adequate protection, but it’s a mess.
“What began as a venture in confronting the misuse and abuse of research subjects has become a bureaucratized system of regulation that often misses the core of what the mission had begun to do,” says Ronald Bayer, a professor and co-chair of the Center for the History and Ethics of Public Health at Columbia University in New York City. He adds that regulation plays a crucial role, especially in light of history, but the core issues have fallen by the wayside.
Institutional review boards (IRBs) are so concerned with ensuring that researchers comply with regulations that they’ve lost sight of the original underlying ethics, he says. Instead of thoughtful discourse and meaningful education, researchers are subjected to “inane” 20-minute online ethics courses and deal with nitpicky questions from reviewers.
“I listen to people talk about going to the IRB the way one would talk about having an audit at the IRS,” says Bayer. “It creates a sense of contempt for the whole thing. The issues are too important to allow them to be subject to a mood of contempt.”
It’s not just an arduous process, it’s a system that no longer focuses on protecting human subjects, says David Borasky, IRB manager in the Office of Research Protection of RTI International, a research institute based in Research Triangle Park, North Carolina. Concern about institutional liability and regulatory compliance has “hijacked informed consent,” he says, and made it a “vehicle for protecting institutions” rather than subjects.
There is a “serious problem when a 15-page consent form is required for populations with low literacy,” says Borasky.
And often the most important risk vs. benefit information is buried deep in a consent form, rather than featured up front in easy to read language, says Jerry Menikoff, director of the Office for Human Research Protections at the US Department of Health and Human Services (HHS), based in Washington, DC.
“How many times have you seen a consent form that actually says on the front page, ‘by the way, here are things you should think about in deciding not to be in a study’?” he asks.
But if it’s hard for potential research subjects to read consent forms, it’s even harder for researchers, especially those collaborating internationally, to figure out which rules they need to follow. Different agencies and countries have their own regulations, laws, ethics rules and guidelines that researchers have to figure out and follow all at the same time, says Christine Grady, a commission member and deputy chief of the NIH Clinical Center’s Department of Bioethics in Bethesda, Maryland.
“You can see why an investigator trying to do federally supported international research might feel somewhat frustrated,” says Grady, who adds that such frustration can lead researchers either to avoid doing otherwise appropriate research or shift the burden to others to ensure compliance.
“The sheer number of rules and guidance is incentive for some to seek the least burdensome path and in some cases also to cut corners,” she said, adding that there’s a need “for rationalization and streamlining of guidance.”
While panel members had numerous criticisms of the system, they left it to the commission to think of ways to reform it. In the meantime, members indicated by a show of hands that there are enough regulations to adequately protect human subjects, but that the rules need to be implemented better.
“It is a strong system, not a perfect system,” says Menikoff, director of the Office for Human Research Protections at HHS. “We welcome input and we’re very engaged in improving the system.”
After yesterday’s panel, Bayer commented that the meeting brought a crucial issue to light. “There was a receptivity to the idea that somehow we have to energize the conversation about the serious ethical review of research without confusing the role of regulation.”
Meetings continue today with discussions of transnational standards and European perspectives. Live streaming and archived video are available here.