New recommendations on how to ethically manage findings
Executive Summary
All practitioners should anticipate and plan for incidental findings so that patients, research participants, and consumers are informed ahead of time about what to expect, and so that incidental findings are aptly communicated if they are found, according to a report from the Presidential Commission for the Study of Bioethical Issues.
• Clinicians have a fiduciary duty to their patients that requires them to act in the patient’s best interest.
• Investigators have more limited duties to research participants.
• In the commercial, direct-to-consumer context, ethical obligations are unclear and still developing.
Currently, there are no consistent guidelines for how to ethically manage unexpected results discovered through procedures and tests, says Lisa M. Lee, PhD, executive director of The Presidential Commission for the Study of Bioethical Issues. "Recent reports show how unsettled the issue of incidental findings is," she adds.
While one report recommended scans for early cancer screening, another report released the following month suggested early scans can cause more harm than good by detecting too many problems, thus leading to overtreatment, she notes.
The Bioethics Commission’s December 2013 report "Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts" provides recommendations on this issue. (To download the report, go to: http://bioethics.gov/node/3183.)
"Incidental findings typically include findings that lie outside the aim of a test or procedure," says Lee. "However, sensitive and unexpected results in the direct-to-consumer context merit many of the same ethical considerations."
There is no specific formula by which clinicians, researchers, and direct-to-consumer providers identify the right action when it comes to incidental findings. Each is operating on its own set of professional duties and ethical obligations, which vary widely.
"Consequently, patients, research participants, and consumers have inconsistent experiences and expectations when it comes to learning about incidental findings," says Lee.
Lee says that in clinical care, clinicians have a fiduciary duty to their patients that requires them to act in the patient’s best interest. In research, investigators have more limited duties to research participants. "In the commercial, direct-to-consumer context, the ethical obligations are unclear and still developing," she says.
More information is not always better. Incidental findings might, but do not always, have important, actionable implications for a patient’s health and well-being.
"It would be rash — both ethically and practically speaking — to conclude that everything that can be sought should be sought, and reported, in all contexts," says Lee.
Regardless of the setting or the type of test or procedure, when it comes to incidental findings, the Bioethics Commission has one overarching piece of advice — to "anticipate and communicate."
The Bioethics Commission recommends that all practitioners anticipate and plan for incidental findings. Patients, research participants, and consumers should be informed ahead of time about what to expect, and incidental findings should be aptly communicated if they are found.
"The best way forward is shared decision-making between practitioners and potential recipients," says Lee. "Informed consent and open communication between providers and potential recipients is essential."
New questions continuously emerge
The problem of what to do about incidental findings is not new, says Judy Illes, PhD, FRSC, FCAHS, Canada Research Chair in Neuroethics and professor of neurology at the University of British Columbia in Vancouver, Canada.
"We started working on the problem about 10 years ago, and new questions and new solutions continuously emerge," she says. "These are never black and white, but I think we are doing a better job every day."
In the clinical context, there are very good guidelines for disclosure of unexpected findings, says Illes. "If there is something that is discovered in addition to the target or instead of the target, then the physician has to decide what to do and has good professional guidance to refer to," she says.
Historically, the physician was the one who decided if the patient should be contacted. The move toward shared decision-making means physicians disclose more to patients than they used to, says Illes. "The fundamental principles have not changed," she adds. "Clearly, if there is a finding of urgency, it must be followed up on right away. Other decisions can be more cautious, like watchful waiting or further testing."
The response to incidental findings in research is more complicated, says Illes, in part because the information obtained is often more limited in scope. "The duty to warn exists," she says. "There must be disclosure to participants in a research study what kind of procedure will be followed if something is accidentally found."
Researchers are obligated to act in the best interest of their participants in the most logical way, given the nature of the study being conducted. "We’ve heard some frustration from neuroimaging researchers about having too many choices," says Illes. "These were once welcomed, but now have become burdensome."
Researchers might follow different protocols because these vary depending on the institution. In 2013, representatives from the National Institutes of Health, the University of British Columbia, Stanford University, and other institutions collaborated to find ways to harmonize their protocols, which are also consistent with the Presidential Commission guidelines.
"If the researcher is concerned about a participant’s incidental finding, the researcher must be able to tell the participant," says Illes. "Otherwise, the burden on the researcher is just too great."
"Uncharted territory"
What to do if an incidental finding is discovered involving the brain’s functionality is "almost completely uncharted territory," says Illes. She gives the example of unusual patterns that might be predictive of diseases such as Alzheimer’s. "One could be obtaining resting scans from 20-year-olds, and we may later find out, when we know more about the resting state, that we had stumbled upon something that’s predictive of something ominous in the future," she says.
Another question is what duty researchers have to act on information such as changes in oxygenation noted on functional MRIs that could be suggestive of a mental health disorder. For instance, a study of sexual arousal with 20 participants might use both behavioral and physiological measures. "If an individual was measured to have a signal that is different from the other 19, how would we interpret that information?" asks Illes. "It is unknown space, but it is definitely a frontier that we have to be thinking about."
- Judy Illes, PhD, FRSC, FCAHS, Professor of Neurology, Canada Research Chair in Neuroethics, The University of British Columbia, Vancouver, Canada. Phone: (604) 822-0746. E-mail: [email protected].
- Lisa M. Lee, PhD, MS, Executive Director, Presidential Commission for the Study of Bioethical Issues, Washington, DC. Phone: (202) 233-3960. E-mail: [email protected].
