Study participants share their blood and spit in the name of biomedical research. Now, a national group of experts says these volunteers should be told what scientists learn about their health from those samples.
In a report published Tuesday, an expert committee convened by the National Academies of Sciences, Engineering, and Medicine concluded that scientists and their institutions should routinely — and carefully — consider whether to return study results to participants. The report, which was sponsored by three of the leading federal health agencies, also recommends revising a federal regulation that’s caused confusion about when it’s permissible to share research findings with a participant.
“It’s really calling for a sea change in how we handle the issue of research results in studies with human specimens,” said Amy Lynn McGuire, one of the report’s authors and a biomedical ethics professor at Baylor College of Medicine.
More often than not, study findings about a single participant aren’t shared. Many research institutions have long been reluctant to return test results, whether they measured cardiac enzymes or cholesterol levels or sequenced their DNA. Among the chief concerns: Participants might misinterpret their results, the data might not be well-validated, and the work to prepare individuals’ results could further strain limited resources for research.
In recent years, that thinking has shifted in some parts of the scientific community as a growing body of evidence suggests study participants want to know what researchers find. The All of Us initiative — which launched in May and aims to compile detailed health profiles of 1 million Americans — will share data and certain study results with participants. The National Institutes of Health initiative says doing so will help participants learn more about their own health. Some drug companies, including Janssen and Pfizer (PFE), have tested out the practice in clinical trials they’ve sponsored.
The authors say that the more value results hold for a participant and the more feasible it is to release the data, the stronger the case is that the information should be shared. It’s possible to effectively communicate the meaning — and limitations — of those results to a participant to minimize the risk that any findings might be interpreted incorrectly, the authors say.
“From an investigator’s perspective, there should be planning about whether to return results, and if so, how to do so,” McGuire said.
Another issue that has created confusion about returning research results: conflicting regulations. Patients who participate in research can request some study results under HIPAA. But the Centers for Medicare and Medicaid Services (which sponsored the report with the NIH and Food and Drug Administration) doesn’t allow research institutions to return results from labs that aren’t certified under the Clinical Laboratory Improvement Amendments of 1988, or CLIA.
The authors’ conclusion: CMS should revise that policy to allow results to be returned from non-CLIA certified labs when a participant requests the record and an institutional review board gives the all-clear. The committee also says the NIH should spearhead an effort to come up with a new quality-control system that could serve as an alternative to CLIA to make sure all study data is up to snuff.
But there are still big questions about what happens once more participants have their research results in hand.
“It is going to be a real challenge to return these results in a way that is helpful for people,” said Dr. Ellen Wright Clayton, a professor of health policy at Vanderbilt University Law School who studies the translation of research to clinical care.
Clayton said it’s good that there’s a focus on making sure people don’t misinterpret results. But making sure people can actually use them in a meaningful way is an entirely different issue.
“That requires access to knowledgeable clinicians who can help people navigate the system, including payers who may be unwilling to provide coverage,” Clayton said. That might be difficult for some participants, such as those who don’t have easy access to good health care or those who are uninsured. And it’s also not clear physicians are ready to receive those results from patients, particularly if the data shared is outside a doctor’s specialty, Clayton said.
“It’s going to be super important to study the impact of this practice,” she said.
McGuire and the other authors agree: It will take more research and experience to nail down the best practices of determining how and when to share research results. The research community needs to strike a delicate balance between the interests of research participants, safety and quality considerations, and the burden on researchers. And they know figuring that out won’t happen overnight.
“That’s kind of a culture change we think will take time,” McGuire said.