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

Direct-to-Consumer Incidental Findings: the Intersection of Bioethics and Business Ethics

In today’s discussion of incidental findings, the Presidential Commission for the Study of Bioethical Issues (The Bioethics Commission) was eager to address the recent explosion of direct-to-consumer testing, and the role of the corporation in informing customers of incidental findings.

In the case of incidental findings in direct-to-consumer testing, the ethical question becomes one of whether or not corporate responsibility extends beyond the contract between the customer and the corporation, and if so, how much. The dominant view among corporations right now, states Thomas Donaldson, Ph.D. Professor of Legal Studies at The Wharton School of the University of Pennsylvania, is “not very much.” The primary consideration for a corporation is to maximize profit for the shareholders. It may be up to regulation to determine how direct-to-consumer corporations handle incidental findings.

Currently, there is a “lack of clarity in the regulatory environment” states Gail Javitt, J.D. M.P.H., a research scholar at Johns Hopkins University. Javitt pointed out to the Bioethics Commission at today’s public meeting that this lack of clarity is particularly evident in direct-to-consumer testing. While the Centers for Medicare and Medicaid Services (CMS) is concerned with laboratory testing quality, the Food and Drug Administration (FDA) regulates medical devices, including in vitro diagnostic devices. In addition, while most direct-to-consumer testing legislation has been at the level of the federal government, states can regulate medical practice, and may, as in the case of New York, not even permit direct-to-consumer testing.

And this regulatory environment may become more important as the findings from direct-to-consumer testing proliferate. Joanna Mountain, Ph.D. a Senior Director of Research at 23andMe, described how the genetic findings of the company may proliferate over time, increasing the odds that people receive information they might not have wanted to know. From an initial group of only 40 findings, 23andMe now has well over 200 potential findings for each consumer, and the reports grow each year as the company acquires new information through research. 23andMe notes on their website that customers may receive information they may not like, and deliberately locks some information so that consumers have to “opt in” to receive information about some potentially frightening diseases, such as breast cancer.

In the context of direct-to-consumer testing, the panel discussion raises the question of what an incidental finding really is when corporations are conducting these large-scale screenings. If customers have voluntarily signed up to receive the information, and have agreed to continue to receive results from the initial screen, it may be that no finding in this context is really incidental.

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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.