The Presidential Commission for the Study of Bioethical Issues (the Bioethics Commission) has just posted to Bioethics.gov a new educational module on informed consent in the management of incidental and secondary findings. The module integrates material from the Bioethics Commission’s December 2013 report Anticipate and Communicate: Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts (Anticipate and Communicate).
The pedagogical product, now available for use in traditional and non-traditional educational settings, takes users through several scenarios. For example, imagine that a patient in the emergency room has a CT scan to rule out appendicitis. The CT scan shows a nodule on an adrenal gland, and while discharging the patient from the emergency room the physician recommends she follow up with her primary care provider. These nodules are benign ninety-eight percent of the time, but without this information the patient leaves the hospital confused and anxious about the finding.
Incidental findings – results that arise that are outside the original purpose for which a test or procedure was conducted – can create practical, legal, and ethical challenges for both recipients and practitioners. In Anticipate and Communicate the Bioethics Commission recommended that patients, research participants, and consumers should be informed about the likelihood of such findings arising from a particular test or procedure. Open communication between practitioners and individuals in all contexts helps ensure that individuals understand risks and benefits before they consent, and helps practitioners think through the consequences of conducting various tests and procedures.
The aim of the new module on informed consent is to highlight the interplay between informed consent and incidental and secondary findings in the clinical, research, and direct-to-consumer contexts, and the different elements of that process in each context. Real-life examples are used to show why it is critical that patients, research participants, and consumers are informed about the likelihood of any incidental findings arising from a test or procedure, understand the process for managing those findings, and can express preferences about which findings they want to know.
In addition to background information and readings the module provides discussion questions, questions based on real-life scenarios, and exercises, such as designing an informed consent document for research participants. The goal of the module is to help instructors incorporate a new perspective on informed consent into their curricula, and explore the particular ethical challenges raised by incidental and secondary findings.