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

Informed Consent in the Bioethics Commission’s Work

The bioethical principle of respect for persons has played a central role in the deliberations and work of the Presidential Commission for the Study of Bioethical Issues (Bioethics Commission), especially in its recent report, Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts. The principle of respect for persons recognizes the importance of self-determination – the autonomous ability to identify personal preferences and to act on those desires. This principle establishes the ethical foundation for informed consent processes – procedures that provide people with information needed to make consequential decisions consistent with their values.

In October 2012, the Bioethics Commission released its report Privacy and Progress in Whole Genome Sequencing.  In Privacy and Progress, the Bioethics Commission addressed, in part, incidental findings discovered during large-scale genetic sequencing. One of the recommendations in that report (Recommendation 3.3) emphasized the importance of informed consent regarding the likelihood of the discovery of incidental findings during whole genome sequencing, and the practitioner’s plan for managing and disclosing those findings. In this recommendation, the Bioethics Commission anticipated the central role that informed consent would play in its next report – a cross-context and cross-modality ethical analysis of incidental and secondary findings.

In Anticipate and Communicate, the Bioethics Commission made four recommendations regarding informed consent: one recommendation applicable in all contexts and one recommendation in each of the clinical, research, and direct-to-consumer (DTC) contexts. The overarching recommendation, Recommendation 1, urges practitioners to describe to potential recipients the incidental and secondary findings that are likely to arise or be sought from the test or procedure being conducted, and to describe the practitioner’s plan for managing and disclosing those findings.

In the clinical context, Recommendation 6 specifies that the clinical informed consent process should consist of shared decision making (that includes both patients and clinicians) about the return of incidental and secondary findings, and urges clinicians to employ effective methods of communicating information about the risk associated with such findings. In the research context, Recommendation 11 advises that the informed consent process should include a discussion about the scope of potential incidental and secondary findings, the process for managing the findings that do arise, and whether and how participants might opt out of receiving certain types of incidental findings. And in the DTC context, Recommendation 15 states that DTC companies should provide consumers with sufficient information to enable informed decision making regarding purchasing a DTC service and should explain clearly which findings will be disclosed and which will not.

All four of these recommendations demonstrate the Bioethics Commission’s commitment to further elucidating what informed consent entails in ethically nuanced situations. In accordance with the principle of respect for persons, these recommendations call on professionals and members of the public alike to be prepared, in advance, for how tests and procedures in the clinic, research, and DTC contexts can reveal information that might influence personal decision making both before and after testing. In addition, the Bioethics Commission has developed, and continues to develop, pedagogical materials, to aid educators in teaching about bioethics in a variety of settings; these materials include a module on informed consent and the role it plays in the Bioethics Commission’s reports, including Ethically Impossible and Privacy and Progress.

The Bioethics Commission firmly believes that informed consent is one of the central mechanisms for encouraging professional practices that recognize the importance of self-determination – as demonstrated both in its recent work on incidental and secondary findings, and in its other reports and pedagogical materials. Informed consent fosters shared decision making between practitioners and potential recipients. 

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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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