Duty to warn? Paper grapples with how to handle the return of clinical research results.
Kent author's paper exploring how to best return research results to participants
One of the perks researchers can offer participants for enrolling in a study is the promise that they will receive personal health-related information, such as blood work, imaging and other test results.
But what happens if the research result does not have clear meaning? How should the researcher proceed?
“The information we share with participants when we return their results to them is so important,” says UIC Nursing assistant professor Denise Kent, PhD, APRN. “The last thing we want to do is cause them to panic and go to the emergency room.”
Kent examines this issue as lead author in a paper published in the journal of Clinical and Translational Science (July 25 online; Aug. 22 in print). Kent is lead investigator on a study exploring how best to return research results to participants who are part of a large-scale NIH-funded study of long COVID, called RECOVER (Kent’s embedded study is called MIRROR).
As part of the long COVID study, researchers conducted hundreds of tests on participants, including one that measures NT-proBNP, a biomarker commonly used to check for heart failure. In the paper, Kent and her co-authors describe seeking input from three clinicians to determine the appropriate follow-up if the results of that test were abnormal.
The clinicians agreed that the abnormal results could be shared with participants – and could even trigger a duty to “warn” — but there was no consensus on thresholds that warrant immediate action versus general follow-up, according to the paper.
“The clinicians emphasized that while this can provide some valuable clinical information for some participants, returning these results may introduce what they call ‘therapeutic uncertainty’ for others,” Kent says.
Typically, a patient would only have the test done if they present with heart failure symptoms, such as difficulty climbing stairs, shortness of breath and swelling in the ankles, Kent says.
As part of the study, even participants who weren’t exhibiting symptoms of heart failure were subject to the test.
“We understand that transparency is important,” Kent says. “But we’re at a real deficit when we’re sharing the results with a participant, saying, ‘you have an elevated BNP [heart failure test], but we don’t really know what it means in somebody that doesn’t have symptoms or a diagnosis of heart failure.’”
The clinicians agreed that having additional clinical information, such as a chest X-ray, echocardiogram, renal function and physical exam, would help guide their recommendation for follow-up. Two of the three noted that giving the results without additional context could cause a participant to worry.
The clinicians varied in their approach for recommending follow-up. One clinician emphasized that the presence of symptoms should guide whether follow-up should occur in urgent care, an emergency department or with a primary care provider. Another clinician suggested that the test result itself (the NT-proBNP level) could guide follow-up, while the third indicated that a primary care provider is generally the best starting point, unless the participant is showing acute signs of heart failure.
“The message is always to follow-up with your provider who knows you and your health best,” Kent says.
The paper taps into an ongoing debate about whether and how individual research results should be returned to participants. Supporters argue that researchers have an ethical obligation to do so, while opponents argue about the uncertain value outside of the clinical context, according to the paper.
“I think this paper will really resonate with principal investigators that are conducting research and trying to build trust and transparency with their research participants,” Kent says. “They’re not alone in managing these challenges of uncertainty. As a community of researchers and scientists, we need to come together to establish standards to communicate results in a meaningful way to participants.”