The federal government has regulated informed consent for decades. But some advocacy organizations are warning that proposed federal guidelines-which could be finalized in the upcoming year-could have a chilling effect on innovation, while fundamentally altering which studies get done.
A patient plagued with difficult-to-control asthma is at the end of his rope, until his doctor suggests joining a clinical trial. He’s no longer just a patient but also a research subject, and he’ll be testing one existing treatment approach while others stay on a different therapy. These kinds of studies are the bedrock of medical science—they ensure that medicines and procedures are safe and effective.
Before agreeing, he needs to know what he’s getting himself into—the potential benefits and harms, known as “informed consent.”
The federal government has regulated informed consent for decades. But some advocacy organizations are warning that proposed federal guidelines—which could be finalized in the upcoming year—could have a chilling effect on innovation, while fundamentally altering which studies get done.
The 6-page guidance moves beyond the previous understanding of consent by calling for greater transparency in studies that compare how effective different treatments are.
These types of scientific studies, known as comparative effectiveness research, are among the tools tapped by the Affordable Care Act to help curb health care spending.
The updated policy says researchers must clearly explain all risks subjects might face by participating, and it redefines those risks to include any harm that is being measured or tracked by the study, even if patients would face those downstream effects when receiving regular treatment from a health care provider. That’s a change from prior language, which didn’t explicitly call for such clear and extensive explanation of potential dangers in studies.
The Department of Health and Human Services said Dec. 22 it would extend its timeline for accepting feedback until the end of January, rather than the original Dec. 23 deadline, so that groups can have more time to respond. Many of these stakeholders hope to reshape its approach.
HHS began the process of updating its informed consent policy after a controversial 2009 experiment that drew headlines and lawsuits, in which researchers studied extremely premature babies—those born at 24 to 27 weeks gestation.
That study focused on this very high-risk group, which is prone to death and eye disease, to determine the appropriate level of oxygen treatment commonly used at the time—comparing lower and higher ranges in a randomized test—to reduce instances of retinal disease without hurting the babies in other ways. But HHS found researchers hadn’t properly warned their subjects’ families about the possible risks. In the low-oxygen group, 130 out of the 654 babies died, versus 107 out of 662 infants in the high-oxygen group. Meanwhile, surviving babies in the low-oxygen group had more eye problems.
Unless the informed consent guidance undergoes major revision, it would create uncertainty among both institutional review boards—the independent committees required to approve research projects at medical institutions—and among researchers themselves, said Ann Bonham, chief scientific officer of the Association of American Medical Colleges.
Both parties, she said, might choose to interpret the guidance conservatively—requiring researchers to give long lists of possible risks without proper context—to make sure they don’t accidentally violate federal requirements. She believes this might have a chilling effect on both the interest of researchers in conducting studies and in their ability to sign up potential patients.
At a recent Institute of Medicine meeting, Greg Simon, a Seattle-based psychiatrist who conducts clinical trials with the Group Health Research Institute, says the new rules could lead to standards that make sense for some studies—where a certain treatment clearly presents a strong risk—while that same standard may overstate danger in other studies.
But in a public presentation, Jerry Menikoff, director of the federal Office of Human Research Protections, said the new language wouldn’t require overwhelming or confusing lists, but rather clear and thorough explanations of the dangers studies involve—something he suggested is currently lacking.
“We don’t think it should be confusing to write a good, brief consent form that accurately lays out the potential risks and benefits of the study,” Menikoff said in an emailed statement to Kaiser Health News.
No matter what kind of study, people deserve to know the relative risks of getting one treatment versus another, said Michael Carome, director of the health research group at Public Citizen, a left-leaning public interest group that has long called for stronger regulations. Though the proposal may be confusing, it doesn’t need more than cosmetic editing, he said. “The guidance—in terms of its overall intent and basic conclusion—is more or less on target.”
“The concern that people will no longer enroll in research if we describe the risk, I think, doesn’t make sense,” he added.
And given the proliferation of videos, online forms and other kinds of technology, getting consent doesn’t need to be cumbersome, Menikoff said in the statement, meaning that large numbers of subjects can be warned of study risks “in an efficient and cost-effective way, thus respecting their ability to choose which risks they are willing to be exposed to.”
Arguing the guidance would require consent forms to include 20-page lists of all minor risks is misguided, said Lois Shepherd, a professor at the University of Virginia who specializes in bioethics.
“What [HHS is] trying to get at is the heart of what people need to know in order to volunteer for research,” she said. For clarity, she said, the guidance could be edited to include examples of consent forms — so that review boards and researchers know exactly what they must do.
But the goal should be more open conversations between research interests and patients involved, rather than trying to achieve understanding through a consent form, said Sharon Terry, president of GeneticAlliance. “That doesn’t do justice either to the research or the participants,” she said.