Boost education in light of Guatemala revelation

Could fuel more distrust of researchers

IRB members and research offices need to add the Guatemalan experiment to their human subjects research training and redouble efforts to educate the public about the high level of ethics and protections in research projects today, experts say.

"Among my IRB members there is a very high level of comfort in the work we're doing to protect human subjects and that our efforts and measures are effective," says Scott J. Lipkin, DPM, CIP, an associate vice president of research for LeHigh Valley Health Network in Allentown, PA.

The research office is accredited and works hard to improve communication with subjects, putting in place a venue for complaints, he adds.

But without transparency these efforts might not be enough, especially when the public learns of another dark chapter in U.S. human subjects research.

"This news of the Guatemalan study doesn't change anything in the present or cause us to lose credibility about our current protections," Lipkin notes. "But it does mean we should add another layer of education."

Research institutions have a responsibility to get balanced information out to the community, says Brenda L. Ruotolo, CIP, associate director of the Columbia University IRB office in New York, NY.

"We've developed brochures about questions people should ask about research," she says. "And in New York, there are citizen groups that speak for the community and identify issues, and we work with them."

News of the Guatemalan episode might feed into existing community concerns and distrust, she notes.

"We have to make sure people are informed about how research is conducted because when something like this comes out it raises valid issues," Ruotolo adds. "From the IRB point of view, it's the reason why we're such sticklers."

For instance, it can be a burden for researchers and a research site to make certain they have good communication practices in place, including having informed consent forms and educational materials translated into different languages. But this is an important part of the IRB review, Ruotolo says.

This latest chapter in the darker history of human subjects research is a reminder of the fundamental issues that IRBs need to keep in mind, says Alex Capron, a professor at the University of Southern California in Los Angeles, CA. Capron also is a professor of law and medicine at the Keck School of Medicine, and he's the Scott H. Bice Chair in Healthcare Law, Policy and Ethics and co-director of the Pacific Center for Health Policy and Ethics.

While it's difficult to imagine 21st century research being conducted in as outrageous a manner as what happened six decades ago, it is important for IRBs to worry about ethnic and economic vulnerability among the populations being studied, he adds.

For instance, IRBs should make certain subjects' education and informed consent are clear and simply conveyed.

"IRBs need to make sure that not just the minutia of details, but also the basic frameworks is conveyed to subjects," Capron says. "Tell them they are being asked to enroll in a study because of the benefit to science."

One of the economic vulnerabilities today is that many people will enroll in research because of their need for some kind of health care. This puts them in a position of not freely making a decision, he explains.

Research subjects often are in a situation in which they are volunteering for a study because they don't have other financial or medical prospects, he adds.

"Because of a disability they might not make fully rational and informed decisions," Capron says. "The standard informed consent language says you can withdraw from the study at any time and it will not affect the care you receive, but of course that is false if the only care you receive is in the study."

The goal would be to create a power relationship that puts investigators and subjects on equal footing — a collaboration, he adds.

One way to move toward that objective is to add an extra page to the informed consent form with one sentence in large type at the top of the page, saying that this study is an experiment and not treatment, Capron suggests.

"Let's be clear about what we're talking about here," he says. "It's noble to be in research, but it's not noble if you don't know what you're doing."