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

Core Principles: Anticipation and Communication of Incidental and Secondary Findings

In its recent report, 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’s (Bioethics Commission) ethical analysis relies on a core set of principles consistently outlined in its work. The four common principles—respect for persons, beneficence, justice and fairness, and intellectual freedom and responsibility—help provide ethical guidance for how to manage incidental and secondary findings while also being attentive to context, given the differences between clinical, research, and direct-to-consumer (DTC) relationships.

 The principle of respect for persons recognizes the importance of self-determination—the autonomous ability to identify personal preferences, act on these desires, and direct the course of one’s life. When grappling with an incidental or secondary finding, the principle of respect for persons highlights the role of information in helping individuals make meaningful choices. Respectful policies acknowledge how new technologies affect a person’s choices about when and how to be tested, and what to do with the results. The Bioethics Commission’s recommendations acknowledge that many people might want to know about information with potential health implications, but others might not want to live with the uncertainty that can accompany some findings.

 The principle of beneficence calls on professionals to take actions to ensure the wellbeing of others. The corollary principle is one of non-maleficence, or “do no harm.” Together, these indicate that practitioners must consider both the potential benefits and harms of disclosing incidental and secondary findings. One specification of the principle of beneficence is the duty to warn. This basic ethical obligation captures the common sense notion that if a person is in grave danger, those who can easily provide a warning ought to do so. Sometimes, incidental and secondary findings can reveal a previously unrecognized condition, placing clinicians, researchers, and DTC professionals in a unique position to be able to warn those undergoing tests or procedures about possible threats to their health or wellbeing.

 The principle of justice and fairness requires fair and equitable treatment of all. The principle of justice and fairness calls upon individuals and institutions to make reasonable efforts to ensure that the benefits and burdens of an enterprise are distributed equitably among those who might be affected. As advancements in science and technology allow us to learn more about ourselves, this principle encourages the responsible development and use of these technologies for the benefit of all.

 Finally, the principle of intellectual freedom protects the creative and innovative spirit that furthers scientific and technological progress that improves our health. Along with the freedom of intellectual pursuits, clinicians, researchers, and providers of DTC testing must take responsibility for how they use and develop these technologies, acknowledging the profound trust afforded them by patients, participants, and consumers. In addition, incidental and secondary finding policies should be designed, consonant with the corollary principle of regulatory parsimony, to limit oversight to that which is necessary to further the public good.

 Through its contextual interpretation of these principles, the Bioethics Commission clarifies the ethical requirements that guide responsible anticipation and communication of incidental or secondary findings. Contextual analysis of principles leads to different applications.  For example, in the clinic, beneficent fiduciary duties are particularly strong; in research, public beneficence plays a greater role; and in DTC, the intersection of the medical and business realms places greater emphasis on respect for persons and intellectual freedom and responsibility. Applying these principles in each context helps professionals fulfill their obligations, and fosters public trust that pertinent information will always be provided in an appropriate and responsible manner.

 

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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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