The federal government is considering possible changes to what risks and benefits researchers must describe to patients who participate in studies comparing the effectiveness of already approved treatments and procedures.
But those recently issued draft recommendations are not sitting well with some researchers, who say they would lead to an informed consent process that confuses researchers and misleads patients.
The Office for Human Research Protections, a federal agency tasked with protecting the rights of patients involved in research conducted or supported by HHS, recently issued a draft report addressing what risks should be revealed to participants in comparative effectiveness research, or CER studies.
This type of research generally looks at approved, widely used therapies, for which there is some disagreement about effectiveness. Efforts toward these types of comparisons have been fueled by provisions of the Patient Protection and Affordable Care Act, which aimed to not only compare the efficacy of competing treatments, but also help drive down healthcare costs.
But as comparative effectiveness research has become more common, so too have questions about how the HHS human subject protection regulations apply to such research, according to guidance issued on Oct. 24 by the Office for Human Research Protections. The agency noted uncertainty about which risks are considered to be “reasonably foreseeable.” Redefining this could change how the treatments are described to prospective subjects during the informed consent process.
The report, published in the Federal Register, cites a determination from last March (PDF) that decided parents did not receive the proper informed consent for a clinical trial in which premature babies received different oxygen supplementation levels. The infants had a 50% chance of being randomly assigned to either a low or high oxygen arm.
Researchers argued both ranges of oxygen saturation provided were within the standard of care and there were no known risks to participants. But OHRP disagreed with that perspective and said the key issue is that the treatment and possible risks were different from those the babies would have been exposed to if they had not been in the trial at all.
The new OHRP guidance aims to address issues such as these, but the report is both “confused and confusing,” according to two Kansas researchers who published commentary on the topic Wednesday in the New England Journal of Medicine.
The OHRP does not distinguish risk from harm and assumes that any change in treatment leads to a foreseeable risk, wrote Dr. John Lantos, director of the Children's Mercy Bioethics Center and Dr. John Spertus, director of health outcomes research at St. Luke's Mid America Heart Institute, both in Kansas City, Mo.
“If the proposed rules became adopted, I would be required to misinform my patients,” Lantos said in a phone interview. If the OHRP view of risk is adopted, it would require a misleading informed-consent document that overstates the risk of being in research and understates the risk of existing practice variation, he said. “I don't see how that meets the ethical requirements of informed consent, and it is likely to confuse researchers,” he said.
The OHRP is soliciting written commentary; interested parties have until Dec. 23 to submit comments.
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