The blog of the 2009 – 2017 Presidential Commission for the Study of Bioethical Issues

An Overview of Incidental Findings

Today, the Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) addressed the role and impact of incidental findings in the clinic, in research, and in the new emerging businesses of direct-to-consumer testing. As Amy Gutmann, Ph.D., Chair of the Bioethics Commission, noted “Emerging medical technologies, changing cost structures, and evolving medical practice have made the likelihood of discovering incidental findings in different contexts a growing certainty.” The Bioethics Commission previously addressed incidental findings in its Privacy and Progress in Whole Genome Sequencing report, but became so interested in the scope of the topic, that it has decided to expand the discussion of incidental findings in a separate report.

Incidental findings include information gathered in a clinical, research, or direct-to-consumer medical setting that is beyond their stated aims or goals. The discovery of incidental findings can have practical, legal, and ethical considerations for the doctor, researcher, business, and most importantly, the recipient of the incidental finding.

Executive Director Lisa M. Lee, Ph.D., M.S., addressed the Bioethics Commission with an introductory presentation on the ethical issues associated with incidental findings. First, there are questions that arise with the discovery of incidental findings in different modalities.

In imaging studies such as X-rays or ultrasounds, Lee informed the Bioethics Commission that the potential for incidental findings is extremely high, with over 40% of scans resulting in incidental findings. For example, in angiography, 50% of angiograms will reveal a non-calcified nodule, but 99% of these nodules will be benign. Follow-up on these findings can produce a great deal of patient anxiety, and is both costly and potentially dangerous. Finally, in the case of research, Lee noted that much of the imaging used in research is of lower quality, and may not provide definitive information.

In biological samples, such as metabolic panels, clinicians and researchers are aware that as the number of tests increase, so does the potential for incidental findings. While health providers and researchers can anticipate a certain set of possible findings, Lee stated that once abnormal findings are found, they are difficult to ignore.

Secondly, Lee informed the Bioethics Commission that incidental findings could give rise to different issues depending on the context in which they are discovered. In the clinic, doctors have a fiduciary duty to patients to act in their best interest, and the question becomes whether returning the incidental findings will provide more benefit than harm. Due to concerns about liability, defensive medicine may lead to over-testing, and the discovery of further incidental findings. Insurance issues could also come into play as some incidental findings may be treated as pre-existing conditions.

In research, ethical issues also arise, with the constraints of the researcher to return the findings, whether they have adequate expertise, and what obligations the researchers owe to the research participants.

Finally, Lee described the emerging field of direct to consumer testing, in which the ethical issues lie at the intersection of medical and business ethics. They raise questions of the obligation that companies have to return incidental results, whether consumers themselves should be involved in the decision making process, and how the autonomy of the customer can best be respected.

All of these questions, the different ethical factors involved in each modality and context, will be discussed today, to provide more information and guidance to the Bioethics Commission.

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This is a space for the members and staff of the 2009 -2017 Presidential Commission for the Study of Bioethical Issues to communicate with the public about the work of the commission and to discuss important issues in bioethics.

As of January 15th, 2017 this blog will no longer be updated but continues to be available as an archive of the work of the 2009-2017 Presidential Commission for the Study of Bioethical Issues

Learn more about the 2009 - 2017 Presidential Commission for the Study of Bioethical Issues.