A genetic test for breast cancer shows that a patient is not at risk. But the results also reveal that there is an elevated risk of heart disease. What do the researchers owe the participant? What does the participant want to know? This is an increasingly common scenario. This week the Presidential Commission for the Study of Bioethical Issues released a report on so-called "incidental findings", Anticipate and Communicate.
“How clinicians, researchers and direct-to-consumer companies manage incidental and secondary findings will likely touch all of us who seek medical care, participate in research, or send a cheek swab to a company for a peek at our own genetic make-up,” said Amy Gutmann, the chair of the Commission. “The reality is that we might find out more than we bargained for. Yet practitioners are getting conflicting advice about how to manage such findings across contexts and modalities such as genetics, imaging, and biological specimen testing.”
Incidental findings – whether or not we can anticipate them – give rise to a wide range of practical and ethical challenges for recipients and practitioners. Emerging medical technologies, changing cost structures, and evolving medical practice have increased remarkably the likelihood of discovering incidental findings in the clinic, research, and commercial direct-to-consumer contexts. Such findings can be lifesaving, but also can lead to uncertainty and distress if they are unexpected or identify conditions for which no effective treatment is available.
“For every setting and type of test or procedure, when it comes to incidental findings, the Bioethics Commission recommends anticipating and communicating,” Gutmann said. “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. The best way forward is shared decision-making between practitioners and potential recipients.”
Sensitive and unexpected results in the direct-to-consumer context merit many of the same ethical considerations. Secondary findings raise related issues: these discoveries are also not the primary target of the testing but, unlike incidental findings, they are actively sought.
Currently, there are no consistent guidelines for how we best manage these discoveries. Recent reports show how unsettled the issue of incidental findings is: for example, one report recommended scans for early cancer screening; another report, released the next month, suggested early scans can cause more harm than good by detecting too many problems, thus leading to overtreatment.
Earlier this year the American College of Medical Genetics and Genomics (ACMG) made an abrupt and controversial change of policy and decided that it would be unethical not to disclose all the incidental findings, even if a patient does not want to know. In other words, the patient’s autonomy comes second.
“More information is not always better. Incidental findings might, but do not always, have important, actionable implications for our health and emotional as well as physical wellbeing. 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,” Gutmann said.
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