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

Ethics in Context: Anticipating and Communicating Incidental and Secondary Findings in the Direct-to-Consumer Context

In Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts, the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission) explored the ethical issues surrounding incidental and secondary findings arising in a variety of settings, including the direct-to-consumer (DTC) context. A growing number of DTC companies offer consumers a variety of services outside of the traditional clinical or research environment, including genetic testing, whole body scans, computed tomography (CT) colonography, non-medical fetal ultrasounds, and cholesterol tests. Some of these tests, like whole body wellness scans, aim to find any and all anomalies and therefore, by design, do not give rise to incidental or secondary findings. Other DTC tests—such as computed tomography (CT) colonography—can potentially give rise to incidental and secondary findings.

The Bioethics Commission’s recommendations in the DTC context are particularly timely because the DTC market is relatively new and growing, the technologies used are still evolving, and the topic is rather underexplored in the literature.  Because DTC service providers straddle both the business and medical realms, the Bioethics Commission interpreted the ethical principles—respect for persons, beneficence, justice and fairness, and intellectual freedom and responsibility—in light of “private industry’s role in providing health information, as well as the economic nature of the relationships between providers of DTC testing and consumers.”

The Bioethics Commission recommended that DTC companies:

  • Communicate and provide consumers with enough information about their services to allow consumers to make informed decisions regarding their purchase of DTC testing. DTC companies must inform consumers of the testing procedures, communicate which findings will be returned, and disclose any results that will not be returned according to the user agreement.
  • Help in the creation of industry-wide best practices pertaining to the management of incidental and secondary findings. These practice guidelines should include when and how findings should be disclosed to the consumer, as well as standards for referrals to clinicians who could aid in the management of the findings. The Bioethics Commission believed that through a collaborative effort among DTC companies and professional organizations, industry-wide best practices could become standard expectations for consumers thereby giving other companies the incentive to adopt such practices.

The Bioethics Commission further recommended that:

  • Federal agencies continue to evaluate regulatory oversight of DTC health services to ensure safety and reliability and that state governments adopt regulations that ensure a consistent floor of protections for consumers who purchase DTC testing. Policy makers should examine existing regulations governing DTC testing services to identify potential gaps and barriers that affect the safety and reliability of DTC testing. Policy makers should also consider adopting regulations governing the disclosure of incidental and secondary findings.

In Anticipate and Communicate, the Bioethics Commission concludes that consumers, the government, DTC professionals, and society “all share responsibility for ensuring that incidental and secondary findings are responded to in an ethically appropriate manner” in the DTC context.

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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

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