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Researchers conduct a memory study, scan a participant's brain, and find more than they bargain for: a tumor. What do the researchers owe the participant? What does the participant want to know? This is an increasingly common scenario for practitioners across contexts and for recipients of unexpected results that can be discovered through a variety of procedures and tests. Today the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) offered analysis and guidance on this issue and released its report Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts.
"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, Ph.D., Commission Chair. "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. We all need to know how to better manage health information we did not expect."
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."
Incidental findings typically include findings that lie outside the aim of a test or procedure. However, 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.
"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.
The Bioethics Commission offered specific recommendations for handling incidental and secondary findings in clinical, research and direct-to-consumer settings. There are, however, some ethical principles and duties that span all three contexts for which the Bioethics Commission made five broad recommendations.
Anticipate and Communicate is the Bioethics Commission's sixth major report. The Bioethics Commission seeks to identify and promote policies and practices that ensure that scientific research, health care delivery, and technological innovation are conducted by the U.S. in a socially and ethically responsible manner. The Bioethics Commission is an independent, deliberative panel of thoughtful experts that advises the President and the Administration, and, in so doing, educates the nation on bioethical issues. To date the Bioethics Commission has:
The report Anticipate and Communicate will be available here.
Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
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Presidential Commission for the Study of Bioethica. "Bioethics Commission on incidental findings: Anticipate and communicate." Medical News Today. MediLexicon, Intl., 17 Dec. 2013. Web.
8 Mar. 2014. <http://www.medicalnewstoday.com/releases/270163>
Presidential Commission for the Study of Bioethica. (2013, December 17). "Bioethics Commission on incidental findings: Anticipate and communicate." Medical News Today. Retrieved from
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